Ivo L Abraham

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Scholarly Contributions

Books

• Abraham, I. L. (2025).

  Solid tumor oncology patient journey.

  . Roanoke, VA, USA: CMR Institute.
• Abraham, I. (2023). Applications of evidence-based medicine (6^th ed.). Roanake, VA: CMR Institute.
• Abraham, I. (2023). Diagnostic advances and mutations in oncology. Roanake, VA: CMR Institute.
• Abraham, I. (2023). Precision medicine and patient identification in oncology. Roanake, VA: CMR Institute.
• Abraham, I. (2023). Preparing for the third decade of biosimilars (Special issue of: Expert Opinion on Biological Therapy).. London, IK: Taylor & Francis.
• Abraham, I. (2023). Genetics in oncology. Roanake, VA: CMR Institute.
• Lewandrowski, K., Yeung, A., Zhang, X., & Abraham, I. (2023). The path to personalized pain management (Special  issue: Journal of Personalized Medicine). 
  
  . London, IK: Taylor & Francis.
• Abraham, I. L. (2022). Outcomes: measurement, management, and marketing (9^th ed.). CMR Institute.
• Abraham, I. (2021). The managed care healthcare market (8th ed). Roanake, VA: CMR Institute.
• Abraham, I. L. (2021). Market access - reimbursement. CMR Institute.
• Abraham, I. L. (2021). Protecting market access as biosimilars emerge. CMR Institute.
• Abraham, I. L. (2021). The entry of biosimilars in the US market. CMR Institute.
• Abraham, I. L. (2021). Understanding GPOs. CMR Institute.
• Abraham, I. L. (2020). Co-pay accumulators. CMR Institute.
• Abraham, I. (2019). Market access (7th ed). Roanake, VA: CMR Institute.
• Abraham, I. (2019). Outcomes: measurement, management, and marketing (7th ed). Roanake, VA: CMR Institute.
• Abraham, I. (2019). The managed care healthcare market (7th ed). Roanake, VA: CMR Institute.
• Abraham, I. L. (2019). Immuno-oncology: connecting science, policy, and real-world care delivery. Rockville, MD: Association of Community Cancer Centers.
• Abraham, I. L. (2018). Immuno-oncology: transforming the delivery of cancer care in the community. Rockville, MD: Association of Community Cancer Centers.

Chapters

• Abraham, I., Mezey, M., & Fulmer, T. (2019). The Geriatric Institutional Assessment Profile (initial version): vision, development, and validation.. In NICHE: Nurses Improving Care to Healthsystem Elders. New York, NY: Springer.

Journals/Publications

• Abraham, I., & Gregg, M. (2025). 2024 in review: high impact articles from the Journal of Medical Economics. Journal of Medical Economics, 28(Issue 1). doi:10.1080/13696998.2025.2455859
• Abraham, I., & Macdonald, K. (2025). The Evolving Landscape of Biologics - Biosimilars, Biobetters, and Bioparallels. JAMA Dermatology, 161(Issue 4). doi:10.1001/jamadermatol.2025.0049
• Abraham, I., Beddor, A. N., & MacDonald, K. M. (2025). The Clinical and Economic Value of Follow-on Biologics: Biosimilars, Biobetters, and Bioparallels. British journal of hospital medicine (London, England : 2005), 86(6), 1-7.
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  The advent of biosimilars into the market of biologic treatments less than 20 years ago in Europe and about 10 years ago in the United States heralded a period of rapid and profound changes in biological therapies. While biosimilars where the first disruptors to the biologics market and some lingering concerns have been addressed, they have since been joined by biobetters and bioparallels in a powerful aggregate of follow-on biologics (FOB) competing with originators biologics. Biobetters are drugs derived from existing biological agents, either by design or by coincidence, with improved pharmacological properties or outcomes. Bioparallels are distinct biologic agents in established classes of biological therapeutics (for instance, Programmed Death 1 (PD-1) inhibitors) that mainly compete on price without the burden of demonstrating equivalence in efficacy and safety. Lingering clinical concerns about biosimilars have been addressed. The economic dynamics of a biologics market that includes lower-priced FOBs continues to be demonstrated, especially how the cost-efficiencies from treatment with FOBs enable expanded patient access to and patient equity in biological therapy on a budget-neutral basis. However, this must be considered within a broader context of potential excess FOB capacity in countries with relatively well-funded healthcare systems, the commoditization of FOBs, and associated downward pricing pressures. Positively, however, is how this excess FOB capacity can be parlayed into increased access to biological therapeutics in low- and middle-income countries.
• Abraham, I., Martin, P., Vaghela, S., Klein, T., Chow, E., Rush, M., Morlock, R., & Huang, H. (2025). Budget impact analysis of revumenib for the treatment of relapsed or refractory acute leukemias with a KMT2A translocation in the United States. Journal of Managed Care and Specialty Pharmacy, 31(Issue 7). doi:10.18553/jmcp.2025.25027
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  BACKGROUND: Acute leukemias (ALs), including acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL), are heterogeneous diseases characterized by different phenotypic, genetic, and molecular alterations that can guide treatment decisions. ALs harboring lysine methyltransferase 2A gene translocation (KMT2t), previously known as mixed-lineage leukemia, are associated with high rates of relapsed or refractory (R/R) disease. Revumenib, a first-in-class oral menin inhibitor, has shown improved clinical outcomes in patients with R/R KMT2At ALs. OBJECTIVE: To estimate, using a budget impact model (BIM), the financial impact of introducing revumenib for the treatment of adult patients with R/R KMT2At ALs on the formulary of a hypothetical US 1-million-member commercial health plan. METHODS: The BIM compared scenarios with or without revumenib and the resulting impact on commercial US third-party payers over a 3-year time horizon. Although no other therapies specifically targeted for R/R KMT2At ALs were approved during BIM development, 11 additional pharmacotherapies for R/R ALs (5 for AML and 6 for ALL, not including revumenib) were included as treatment options in the model. Clinical data included adverse event (AE) rates, duration of treatment, time to subsequent treatment, and survival outcomes. Cost inputs (USD 2024) included in the model comprised drug acquisition and administration, grade 3 or greater AEs, treatment-related supportive care and monitoring, subsequent treatment, and end-of-life costs. The differential cost per member per month (PMPM) was estimated. One-way sensitivity analyses varying the costs of drug acquisition and toxicity by ±20% and scenario analyses varying uptake of revumenib and epidemiology inputs, as well as excluding costs related to supportive care and posttreatment discontinuation, were performed. RESULTS: An estimated 1.7 adult patients (AML, 1.1; ALL, 0.6) were treatment eligible annually. Estimated 3-year total plan costs without and with revumenib were $2,146,564 and $2,126,919, respectively, for savings of −$19,646. Including revumenib was estimated to yield a differential PMPM cost of −$0.0005 over 3 years. The total number of grade 3 or greater AEs was lower over 3 years (10.82 vs 10.99, respectively) in the plan with revumenib vs without. Sensitivity and scenario analyses validated the robustness of the model. CONCLUSIONS: The BIM demonstrated that including revumenib in a formulary for adult patients with R/R KMT2At ALs was approximately cost neutral, offering patients access to a targeted treatment with potential for improved clinical outcomes.
• Alsowaida, Y. S., Alsolami, A., Almangour, T. A., & Abraham, I. (2025). Infectious complications associated with immune and targeted anti-cancer therapies: a retrospective study of the FDA adverse events reporting system (FAERS). Expert Opinion on Drug Safety. doi:10.1080/14740338.2025.2461199
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  Background: Immune and targeted anti-cancer therapies are associated with an increased risk of infectious complications. The objectives of the present study were to evaluate the infectious complications associated with immune and targeted anti-cancer drugs. Research design and methods: This was a retrospective study for immune and targeted anti-cancer drugs submitted to the FDA Adverse Event Reporting System (FAERS) from 1996 to 20 March 2024. The primary outcome was the rate of infectious disease events, and the secondary outcomes were the incidence of febrile neutropenia (FN), all-cause mortality, and the top 10 infections in each class. Results: Our study included 14 drug classes comprising 44 drugs. The incidence of infectious complications was 14.31% (110,671/773,130). The highest incidence rate was reported with IL-6 inhibitors (30.89%), the highest incidence of FN was reported with Histone deacetylase inhibitors (8.43%), and the highest all-cause mortality was reported with BCR-ABL tyrosine kinase inhibitors (17.17%). Conclusion: Immune and targeted anti-cancer therapies vary in the incidence of infectious complications. Pirtobrutinib, copanlisib, sirolimus, vorinostat, and tocilizumab were associated with high infectious complications (>30%) that warrant emphasis in the clinical guidelines. Thus, clinicians should vigilantly monitor patients undergoing immune and targeted therapies for infectious complications and use antimicrobial prophylaxes when indicated.
• Mesgarzadeh, S., Amamoo, R. S., Ameneni, G., Gong, A. H., Ayoade, O. O., Stratton, D. B., Latour, E., Yu, W., Curiel-Lewandrowski, C., Abraham, I., & Fazel, M. (2025). Validation of risk prediction models for sentinel lymph node metastasis in melanoma in a high UV index region. JAAD International, 21(Issue). doi:10.1016/j.jdin.2025.04.012
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  Background: Risk prediction models may refine individualized selection for sentinel lymph node biopsy (SLNB) in melanoma. Objective: To evaluate the statistical accuracy and clinical utility of nomograms by the Melanoma Institute of Australia (MIA), Memorial Sloan Kettering Cancer Center (MSKCC), and University of Colorado in a Southern Arizona population. Methods: In this prognostic validation, statistical accuracy was assessed through discrimination, measured with receiver operating characteristic curves and calibration plots. Clinical utility was evaluated via decision curve analysis to determine the net benefit and number of net avoidable interventions achieved with nomogram use. Results: Among 712 melanoma cases included, model discrimination was highest for the MIA nomogram (C-statistic = 0.753; 95% confidence interval = 0.694-0.812), followed by MSKCC (0.729[0.671-0.787]), and University of Colorado (0.601[0.405-0.793]). The MIA and MSKCC nomograms were well-calibrated across clinically relevant risk thresholds. All nomograms achieved a net benefit and net reduction in avoidable SLNBs for risk thresholds ≥5%. There was minimal to no reduction in unnecessary interventions at age extremes (
• Abraham, I., Calamia, M., Alkhatib, N., Pondel, M., & MacDonald, K. (2024). Budget impact analysis of pembrolizumab versus the novel PD-1 inhibitor toripalimab in locally advanced or metastatic nonsquamous non-small cell lung cancer. Journal of Medical Economics, 27(3). doi:10.1080/13696998.2024.2411877
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  Aim: To estimate the budget impact of adding a toripalimab regimen to the existing treatment mix of pembrolizumab, both with pemetrexed and carboplatin, in patients with locally advanced or metastatic nonsquamous NSCLC within two price inputs (wholesale acquisition cost (WAC) and average sales price (ASP)). Methods: Budget impact analysis comparing a treatment mix “without” versus “with” the toripalimab regimen in the annual US nonsquamous NSCLC population treated with a PD-1 inhibitor, a 3-year time horizon, toripalimab market share of 1% in 2024, increasing to 4% (2025) and 5% (2026), and medication use adjustments for discontinuation or progression to estimate fully-treated-patient-equivalents. Cost inputs included drugs, administration, and grade 3/4 adverse event (AE) management. The models were replicated in a 1-million-member plan to estimate costs per-member-per-month (PMPM) and per-member-per-year (PMPY). One-way (OWSA) and probabilistic sensitivity analyses (PSA) as well as two scenario analyses were performed. Results: In the “without” scenario, the 3-year WAC costs for the pembrolizumab regimen total $40,750,234,637 ($39,024,548,745 for treatment and $1,725,685,894 for managing AEs). In the “with” scenario, these costs decline to $39,341,379,081. Corresponding “with” costs for toripalimab are $1,186,027,704 (treatment) and $99,454,471 (AE management) for a total of $1,285,482,175. This yields annual net savings of between $10,779,362 (at 1% market share) in 2024 and $64,858,298 (5% market share) in 2026, for 3-year savings of $123,373,381. The associated savings in a 1-million-member plan are $0.030 PMPM and $0.363 PMPY. The ASP model shows similar patterns. Savings were demonstrated in 68% of PSA simulations; OWSAs and scenario analyses reveal how parameter variability impacts results. Conclusion: Significant savings are likely achievable from treating between 1% (year 1) to 5% (year 3) of nonsquamous NSCLC patients with the toripalimab regimen. Projected 3-year savings range from $122 million (ASP) to $123 million (WAC); corresponding to savings of $0.030 PMPM and $0.363 PMPY.
• Abraham, I., Calamia, M., Alkhatib, N., Pondel, M., & MacDonald, K. (2024). Budget impact analysis of pembrolizumab versus the novel PD-1 inhibitor toripalimab in locally advanced or metastatic nonsquamous non-small cell lung cancer. Journal of medical economics, 27(sup3), 36-50.
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  To estimate the budget impact of adding a toripalimab regimen to the existing treatment mix of pembrolizumab, both with pemetrexed and carboplatin, in patients with locally advanced or metastatic nonsquamous NSCLC within two price inputs (wholesale acquisition cost (WAC) and average sales price (ASP)).
• Abraham, I., Calamia, M., Alkhatib, N., Pondel, M., & MacDonald, K. (2024). Budget impact analysis of the novel PD-1 inhibitor toripalimab versus pembrolizumab in recurrent or metastatic nasopharyngeal carcinoma. Journal of medical economics, 27(sup3), 9-23.
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  To estimate the budget impact of adding a toripalimab regimen as a treatment option to the existing pembrolizumab regimen, both including gemcitabine and cisplatin, in untreated recurrent/metastatic nasopharyngeal carcinoma (R/M NPC) using the published wholesale acquisition cost (WAC) and average sales price (ASP).
• Abraham, I., Crawford, J., & Schwartzberg, L. (2024). On-body injector pegfilgrastim for chemotherapy-induced neutropenia prophylaxis: Current Status. Cancer treatment and research communications, 40, 100824.
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  Myelosuppression, a challenge in cancer treatment, often results in severe complications. Prophylactic granulocyte colony-stimulating factors, particularly pegfilgrastim, mitigate chemotherapy-induced neutropenia. This narrative review evaluates the role of on-body injector (OBI) devices for pegfilgrastim administration. A comprehensive search strategy of PubMed and AI-powered intuitive search tools, complemented by authors' contributions, yielded a body of papers presenting evidence on OBI devices, their effectiveness and safety, the benefits and challenges of OBI versus pre-filled syringe administration, patient preferences for pegfilgrastim administration, and economic considerations.
• Abraham, I., Hiligsmann, M., Lee, K. K., Citrome, L., & Colombo, G. L. (2024). What to expect in 2024: important health economics and outcomes research (HEOR) trends. Expert Review of Pharmacoeconomics and Outcomes Research, 24(Issue 9). doi:10.1080/14737167.2023.2292838
• Abraham, I., Hiligsmann, M., Lee, K. K., Citrome, L., Colombo, G. L., & Gregg, M. (2024). What to expect in 2024: important health economics and outcomes research (HEOR) trends. Current medical research and opinion, 40(2), 185-192.
• Abraham, I., Hiligsmann, M., Lee, K. K., Citrome, L., Colombo, G. L., & Gregg, M. (2024). What to expect in 2024: important health economics and outcomes research (HEOR) trends. Journal of medical economics, 27(1), 69-76.
• Abraham, I., Pondel, M., & MacDonald, K. (2024). Economic evaluation of the novel PD-1 inhibitor toripalimab in recurrent or metastatic nasopharyngeal carcinoma: Cost-efficiency and expanded access modeling versus pembrolizumab.. Journal of Clinical Oncology, 42(16_suppl), e18015-e18015. doi:10.1200/jco.2024.42.16_suppl.e18015
• Altawalbeh, S. M., Almestarihi, E. M., Khasawneh, R. A., Momany, S. M., Abu Hammour, K., Shawaqfeh, M. S., & Abraham, I. (2024). Cost-effectiveness of intravenous resuscitation fluids in sepsis patients: a patient-level data analysis in Jordan. Journal of Medical Economics, 27(Issue 1). doi:10.1080/13696998.2023.2296196
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  Aim: Albumin role as fluid resuscitation in sepsis remains understudied in low- and middle-income countries. This study aimed to evaluate the cost-effectiveness of intravenous (IV) Albumin compared to Crystalloids in sepsis patients using patient-level data in Jordan. Methods: This was a retrospective cohort study of sepsis patients aged 18 or older admitted to intensive care units (ICU) at two major tertiary hospitals during the period 2018–2019. Patients information, type of IV fluid, and clinical outcomes were retrieved from medical records, and charges were retrieved from the billing system. A 90-day partitioned survival model with two health states (alive and dead) was constructed to estimate the survival of sepsis patients receiving either Albumin or Crystalloids as IV fluids for resuscitation. Overall survival was predicted by fitting a Weibull model on the patient-level data from the current study. To further validate the results, and to support the assessment of uncertainty, time-dependent transition probabilities of death at each cycle were estimated and used to construct a state-transition patient-level simulation model with 10,000 microsimulation trials. Adopting the healthcare system perspective, incremental cost-effectiveness ratios(ICERs) of Albumin versus Crystalloids were calculated in terms of the probability to be discharged alive from the ICU. Uncertainty was explored using probabilistic sensitivity analysis. Results: In the partitioned survival model, Albumin was associated with an incremental cost of $1,007 per incremental1% in the probability of being discharged alive from the ICU. In the state-transition patient-level simulation model, ICER was $1,268 per incremental 1% in the probability of being discharged alive. Probabilistic sensitivity analysis showed that Albumin was favored at thresholds >$800 per incremental 1%in the probability of being discharged alive from the ICU. Conclusion: IV Albumin use in sepsis patients might not be cost-effective from the healthcare perspective of Jordan. This has important implications for policymakers to readdress Albumin prescribing practice in sepsis patients.
• Altawalbeh, S. M., Almestarihi, E. M., Khasawneh, R. A., Momany, S. M., Abu Hammour, K., Shawaqfeh, M. S., & Abraham, I. (2024). Cost-effectiveness of intravenous resuscitation fluids in sepsis patients: a patient-level data analysis in Jordan. Journal of medical economics, 27(1), 126-133.
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  Albumin role as fluid resuscitation in sepsis remains understudied in low- and middle-income countries. This study aimed to evaluate the cost-effectiveness of intravenous (IV) Albumin compared to Crystalloids in sepsis patients using patient-level data in Jordan.
• Gamaleldin, M. M., Abraham, I. L., Meabed, M. H., Elberry, A. A., Abdelhalim, S. M., Mahmoud Hussein, A. F., & Hussein, R. R. (2024). Manuka combinations with nigella sativa and hydroxyurea in treating iron overload of pediatric β-thalassemia major, randomized clinical trial. Heliyon, 10(13), e33707.
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  β-thalassemia major is microcytic hypochromic anemia disorder inherited from parents, resulting from a mutation in the β-globin locus. As a result, a quantitative defective hemoglobin synthesis and relative excess in α-globin is occurred. As such, frequent blood transfusion is required, that leads to iron overload. Iron overload results in several pathological complications, including cell death, tissue injury, organ dysfunction, and liver fibrosis. The present study examined the effectiveness of nigella Sativa and manuka honey combination or manuka honey alone to the conventional therapy (Deferasirox + blood transfusion) used for preventing and managing iron overload in pediatric β-thalassemia major patients.
• Gamaleldin, M., Abraham, I., Meabed, M., Elberry, A., Abdelhalim, S., Hussein, A., Waggas, D., & Hussein, R. (2024). Cost-effectiveness analysis of Manuka honey-Omega-3 combination treatments in treating oxidative stress of pediatric β-thalassemia major. European Review for Medical and Pharmacological Sciences, 28(Issue 3). doi:10.26355/eurrev_202402_35353
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  OBJECTIVE: Oxidative stress represents a ruthless complication of β-thalassemia that worsens the severity of that medical condition. There is no conclusive evidence on the best antioxidant used for that issue. Our earlier clinical study concluded that Omega-3 and Manuka honey add-on to the conventional therapy had a potential therapeutic impact on reducing oxidative stress. However, there is no research evaluating their cost-effectiveness. This paper compares the cost-effectiveness of Omega-3 and Manuka honey supplementation to conventional therapy in treating oxidative stress among children with β-thalassemia major. SUBJECTS AND METHODS: Cost-effectiveness evaluation of daily supplementation of Omega-3-Manuka honey and Manuka honey alone to the conventional therapy was performed. The economic evaluation was performed on data from a prospective 10-month randomized clinical trial. Fifty patients were recruited into the Omega-3-Manuka honey plus conventional therapy group, 50 patients were included in the Manuka honey alone plus conventional therapy group, and 50 patients receiving the conventional therapy alone served as a control group. Effectiveness measures from the randomized clinical trial were used to determine incremental effectiveness. Cost estimates were calculated from the healthcare payer’s perspective. The analysis considered the improvement in oxidative stress biomarkers presented here as a percent change from baseline to determine the incremental effectiveness and cost for the treatment by both interventions. RESULTS: Adding Omega-3 or Manuka honey to conventional therapy was a more cost-effective add-on than conventional treatment alone. Omega-3-Manuka honey was more cost-effective than Manuka honey alone in treating oxidative stress in that condition. Oxidative stress biomarkers were significantly reduced with both experimental medications compared to the conventional therapy alone. CONCLUSIONS: The present study showed that using Manuka honey and Omega-3 as add-on treatments for oxidative stress in pediatric β-thalassemia disease could have significant cost-saving and clinical improvement.
• Gamaleldin, M., Abraham, I., Meabed, M., Elberry, A., Abdelhalim, S., Hussein, A., Waggas, D., & Hussein, R. (2024). Cost-effectiveness analysis of Manuka honey-Omega-3 combination treatments in treating oxidative stress of pediatric β-thalassemia major. European review for medical and pharmacological sciences, 28(3), 1144-1154.
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  Oxidative stress represents a ruthless complication of β-thalassemia that worsens the severity of that medical condition. There is no conclusive evidence on the best antioxidant used for that issue. Our earlier clinical study concluded that omega-3 and Manuka honey add-on to the conventional therapy had a potential therapeutic impact on reducing oxidative stress. However, there is no research evaluating their cost-effectiveness. This paper compares the cost-effectiveness of Omega-3 and Manuka honey supplementation to conventional therapy in treating oxidative stress among children with β-thalassemia major.
• Gamaleldin, M., Abraham, I., Meabed, M., Elberry, A., Abdelhalim, S., Mahmoud Hussein, A., & Hussein, R. (2024). Manuka combinations with nigella sativa and hydroxyurea in treating iron overload of pediatric β-thalassemia major, randomized clinical trial. Heliyon, 10(13). doi:10.1016/j.heliyon.2024.e33707
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  Background: β-thalassemia major is microcytic hypochromic anemia disorder inherited from parents, resulting from a mutation in the β-globin locus. As a result, a quantitative defective hemoglobin synthesis and relative excess in α-globin is occurred. As such, frequent blood transfusion is required, that leads to iron overload. Iron overload results in several pathological complications, including cell death, tissue injury, organ dysfunction, and liver fibrosis. The present study examined the effectiveness of nigella Sativa and manuka honey combination or manuka honey alone to the conventional therapy (Deferasirox + blood transfusion) used for preventing and managing iron overload in pediatric β-thalassemia major patients. Methods: One hundred sixty-five patients participated in this randomized, double-blind, standard therapy-controlled, parallel-design multisite trial. The patients were randomly allocated into three groups, receiving either 500 mg nigella sativa oil combined with manuka honey lozenge (344 mg) daily or manuka honey alone plus the conventional therapy for ten treatment months. Ferritin level, serum iron, transferrin saturation, total iron binding capacity, alanine transaminase, and aspartate transaminase were determined at baseline and month 10. Results: Eventually, serum ferritin and iron were decreased significantly in the nigella sativa + manuka honey group as compared with the control group. Other clinical parameters were significantly impacted. The level of alanine transaminase and aspartate transaminase were significantly decreased in the nigella sativa plus manuka honey group compared with the control group. Conclusion: Results showed that nigella sativa plus manuka honey was more effective than manuka alone or the conventional treatment alone in managing iron overload of β-thalassemia major patients.
• Lewandrowski, K. U., Alvim Fiorelli, R. K., Pereira, M. G., Abraham, I., Alfaro Pachicano, H. H., Elfar, J. C., Alhammoud, A., Landgraeber, S., Oertel, J., Hellinger, S., Dowling, Á., De Carvalho, P. S., Ramos, M. R., Defino, H., Bergamaschi, J. P., Montemurro, N., Yeung, C., Brito, M., Beall, D. P., , Ivanic, G., et al. (2024). Polytomous Rasch Analyses of Surgeons' Decision-Making on Choice of Procedure in Endoscopic Lumbar Spinal Stenosis Decompression Surgeries. International journal of spine surgery, 18(2), 164-177.
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  With the growing prevalence of lumbar spinal stenosis, endoscopic surgery, which incorporates techniques such as transforaminal, interlaminar, and unilateral biportal (UBE) endoscopy, is increasingly considered. However, the patient selection criteria are debated among spine surgeons.
• Lewandrowski, K. U., da Silva, R. C., Elfar, J. C., Alhammoud, A., Moghamis, I. S., Burkhardt, B. W., Oertel, J. M., Landgraeber, S., Fiorelli, R. K., de Carvalho, P. S., Abraham, I., León, J. F., Martinez, E., & Lorio, M. P. (2024). Disability-adjusted life years from bone and joint infections associated with antimicrobial resistance: an insight from the 2019 Global Burden of Disease Study. International orthopaedics, 48(7), 1677-1688.
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  Bone and joint infections, complicated by the burgeoning challenge of antimicrobial resistance (AMR), pose significant public health threats by amplifying the disease burden globally. We leveraged results from the 2019 Global Burden of Disease Study (GBD) to explore the impact of AMR attributed to bone and joint infections in terms of disability-adjusted life years (DALYs), elucidating the contemporary status and temporal trends.
• Lewandrowski, K., Fiorelli, R., Pereira, M., Abraham, I., Pachicano, H., Elfar, J., Alhammoud, A., Landgraeber, S., Oertel, J., Hellinger, S., Dowling, Á., de Carvalho, P., Ramos, M., Defino, H., Bergamaschi, J., Montemurro, N., Yeung, C., Brito, M., Beall, D., , Ivanic, G., et al. (2024). Polytomous Rasch Analyses of Surgeons’ Decision-Making on Choice of Procedure in Endoscopic Lumbar Spinal Stenosis Decompression Surgeries. International Journal of Spine Surgery, 18(2). doi:10.14444/8595
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  Background: With the growing prevalence of lumbar spinal stenosis, endoscopic surgery, which incorporates techniques such as transforaminal, interlaminar, and unilateral biportal (UBE) endoscopy, is increasingly considered. However, the patient selection criteria are debated among spine surgeons. Objective: This study used a polytomous Rasch analysis to evaluate the factors influencing surgeon decision-making in selecting patients for endoscopic surgical treatment of lumbar spinal stenosis. Methods: A comprehensive survey was distributed to a representative sample of 296 spine surgeons. Questions encompassed various patient-related and clinical factors, and responses were captured on a logit scale graphically displaying person-item maps and category probability curves for each test item. Using a Rasch analysis, the data were subsequently analyzed to determine the latent traits influencing decision-making. Results: The Rasch analysis revealed that surgeons’ preferences for transforaminal, interlaminar, and UBE techniques were easily influenced by comfort level and experience with the endoscopic procedure and patient-related factors. Harder-to-agree items included technological aspects, favorable clinical outcomes, and postoperative functional recovery and rehabilitation. Descriptive statistics suggested interlaminar as the best endoscopic spinal stenosis decompression technique. However, logit person-item analysis integral to the Rasch methodology showed highest intensity for transforaminal followed by interlaminar endoscopic lumbar stenosis decompression. The UBE technique was the hardest to agree on with a disordered person-item analysis and thresholds in category probability curve plots. Conclusion: Surgeon decision-making in selecting patients for endoscopic surgery for lumbar spinal stenosis is multifaceted. While the framework of clinical guidelines remains paramount, on-the-ground experience-based factors significantly influence surgeons’ selection of patients for endoscopic lumbar spinal stenosis surgeries. The Rasch methodology allows for a more granular psychometric evaluation of surgeon decision-making and accounts better for years-long experience that may be lost in standardized clinical guideline development. This new approach to assessing spine surgeons’ thought processes may improve the implementation of evidence-based protocol change dictated by technological advances was endorsed by the Interamerican Society for Minimally Invasive Spine Surgery (SICCMI), the International Society for Minimal Intervention in Spinal Surgery (ISMISS), the Mexican Spine Society (AMCICO), the Brazilian Spine Society (SBC), the Society for Minimally Invasive Spine Surgery (SMISS), the Korean Minimally Invasive Spine Society (KOMISS), and the International Society for the Advancement of Spine Surgery (ISASS).
• Lewandrowski, K., da Silva, R., Elfar, J., Alhammoud, A., Moghamis, I., Burkhardt, B., Oertel, J., Landgraeber, S., Fiorelli, R., de Carvalho, P., Abraham, I., Martinez, E., Lorio, M., & León, J. (2024). Disability-adjusted life years from bone and joint infections associated with antimicrobial resistance: an insight from the 2019 Global Burden of Disease Study. International Orthopaedics, 48(7). doi:10.1007/s00264-024-06143-2
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  Purpose: Bone and joint infections, complicated by the burgeoning challenge of antimicrobial resistance (AMR), pose significant public health threats by amplifying the disease burden globally. We leveraged results from the 2019 Global Burden of Disease Study (GBD) to explore the impact of AMR attributed to bone and joint infections in terms of disability-adjusted life years (DALYs), elucidating the contemporary status and temporal trends. Methods: Utilizing GBD 2019 data, we summarized the burden of bone and joint infections attributed to AMR across 195 countries and territories in the 30 years from 1990 to 2019. We review the epidemiology of AMR in terms of age-standardized rates, the estimated DALYs, comprising years of life lost (YLLs) and years lived with disability (YLDs), as well as associations between DALYs and socio-demographic indices. Results: The GBD revealed that DALYs attributed to bone and joint infections associated with AMR have risen discernibly between 1990 and 2019 globally. Significant geographical disparities and a positive correlation with socio-demographic indicators were observed. Staphylococcus aureus infections, Group A Streptococcus, Group B Streptococcus, Escherichia coli, Pseudomonas aeruginosa, Klebsiella pneumoniae, and Enterobacter-related bone and joint infections were associated with the highest DALYs because of a high proportion of antimicrobial resistance. Countries with limited access to healthcare, suboptimal sanitary conditions, and inconsistent antibiotic stewardship were markedly impacted. Conclusions: The GBD underscores the escalating burden of bone and joint infections exacerbated by AMR, necessitating urgent, multi-faceted interventions. Strategies to mitigate the progression and impact of AMR should emphasize prudent antimicrobial usage and robust infection prevention and control measures, coupled with advancements in diagnostic and therapeutic modalities.
• MacDonald, K., Pondel, M., & Abraham, I. (2024). Cost-efficiency and budget-neutral expanded access modeling of pembrolizumab versus the novel PD-1 inhibitor toripalimab in locally advanced or metastatic nonsquamous non-small cell lung cancer. Journal of Medical Economics, 27(3). doi:10.1080/13696998.2024.2380872
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  Aims: To estimate in a panel of patients with locally advanced/metastatic nonsquamous non-small cell lung cancer (NSCLC) treated with a programmed death receptor-1 inhibitor in the US in 2024 (1) the cost-efficiency of toripalimab regimens compared to pembrolizumab regimens; and (2) the budget-neutral expanded access to additional toripalimab cycles and regimens from accrued savings. Methods: Simulation modeling of toripalimab + pemetrexed + carboplatin in nonsquamous NSCLC to a similar pembrolizumab regimen in a panel of 49,647 patients; utilizing two cost inputs (wholesale acquisition cost (WAC) at market entry and an estimated ex ante toripalimab price point of 80% of pembrolizumab average sales price (ASP)) plus administration costs over one and two years of treatment with treatment rates from 1%–10%. Scenario analyses with treatment durations equivalent to toripalimab and pembrolizumab trials’ median PFS were also conducted. Results: In the WAC-based models, toripalimab saves $2,223 per patient per cycle and $40,014 over 1 year of treatment ($77,805 over 2 years). Extrapolated to the 49,647-patient panel, estimated 1-year savings range from $19,865,840 (1% treatment rate) to $198,658,399 (10% rate). Reallocating these savings permits budget-neutral expanded access to an additional 1,753 (1% rate) to 17,533 (10% rate) toripalimab maintenance cycles or to an additional 97 (1% rate) to 972 (10%) full 1-year toripalimab regimens with all agents. Two-year savings range from $38,628,022 (1% rate) to $386,280,221 (10%). Reallocating these efficiencies provides expanded access ranging from 3,409 (1% rate) to 34,093 (10%) additional toripalimab cycles or to 97 to 973 full 2-year regimens. The ex ante ASP model showed similar results as did the scenario analyses but at a lower magnitude than the base case. Conclusion: Toripalimab generates significant savings that enable budget-neutral funding for up to 17,533 [34,093] additional maintenance cycles over one year [two years] with toripalimab + pemetrexed in nonsquamous NSCLC, or 972 [973] full one-year [two-year] regimens.
• MacDonald, K., Pondel, M., & Abraham, I. (2024). Cost-efficiency and budget-neutral expanded access modeling of pembrolizumab versus the novel PD-1 inhibitor toripalimab in locally advanced or metastatic nonsquamous non-small cell lung cancer. Journal of medical economics, 27(sup3), 24-33.
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  To estimate in a panel of patients with locally advanced/metastatic nonsquamous non-small cell lung cancer (NSCLC) treated with a programmed death receptor-1 inhibitor in the US in 2024 (1) the cost-efficiency of toripalimab regimens compared to pembrolizumab regimens; and (2) the budget-neutral expanded access to additional toripalimab cycles and regimens from accrued savings.
• MacDonald, K., Pondel, M., & Abraham, I. (2024). Cost-efficiency and budget-neutral expanded access modeling of the novel PD-1 inhibitor toripalimab versus pembrolizumab in recurrent or metastatic nasopharyngeal carcinoma. Journal of Medical Economics, 27(sup3), 1-8. doi:10.1080/13696998.2024.2331905
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  Aims: To estimate, in the setting of recurrent or metastatic nasopharyngeal carcinoma (R/M NPC) for an assumed 1,207 incident US cases in 2024, (1) the cost-efficiency of a toripalimab-gemcitabine-cisplatin regimen compared to a similar pembrolizumab regimen; and (2) the budget-neutral expanded access to additional toripalimab cycles and regimens afforded by the accrued savings. Methods: Simulation modeling utilized two cost inputs (wholesale acquisition cost (WAC) at market entry and an ex ante toripalimab price point of 80% of pembrolizumab average sales price (ASP)) and drug administration costs over 1 and 2 years of treatment with treatment rates ranging from 45% to 90%. In the absence of trial data for pembrolizumab-gemcitabine-cisplatin in R/M NPC, it is assumed that such a regimen would be comparable to toripalimab-gemcitabine-cisplatin in efficacy and safety. Results: In the models utilizing the WAC, toripalimab saves $2,223 per patient per cycle and $40,014 over 1 year of treatment ($77,805 over 2 years). Extrapolated to the 1,207-patient panel, estimated 1-year savings range from $21,733,702 (45% treatment rate) to $43,467,404 (90% rate). Reallocating these savings permits budget-neutral expanded access to an additional 2,359 (45% rate) to 4,717 (90% rate) toripalimab maintenance cycles or to an additional 126 (45% rate) to 252 (90%) full 1-year toripalimab regimens with all agents. Two-year savings range from $42,259,976 (45% rate) to $84,519,952 (90% rate). Reallocating these efficiencies provides expanded access, ranging from an additional 4,586 (45% rate) to 9,172 (90% rate) toripalimab cycles or to an additional 128–257 full 2-year toripalimab regimens. The ex ante ASP model showed similar results. Conclusion: This simulation demonstrates that treatment with toripalimab generates savings that enable budget-neutral funding for up to an additional 252 regimens with toripalimab-gemcitabine-cisplatin for one full year, the equivalent of approximately 21% of the 2024 incident cases of R/M NPC in the US.
• MacDonald, K., Pondel, M., & Abraham, I. (2024). Cost-efficiency and budget-neutral expanded access modeling of the novel PD-1 inhibitor toripalimab versus pembrolizumab in recurrent or metastatic nasopharyngeal carcinoma. Journal of medical economics, 27(sup3), 1-8.
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  To estimate, in the setting of recurrent or metastatic nasopharyngeal carcinoma (R/M NPC) for an assumed 1,207 incident US cases in 2024, (1) the cost-efficiency of a toripalimab-gemcitabine-cisplatin regimen compared to a similar pembrolizumab regimen; and (2) the budget-neutral expanded access to additional toripalimab cycles and regimens afforded by the accrued savings.
• Obeng-Kusi, M., Kreutzfeldt, J. J., Estrada-Mendizabal, R. J., Choi, B. M., Abraham, I., & Recio-Boiles, A. (2024). Network meta-analysis of second line and beyond treatment options in metastatic clear cell renal cell carcinoma. Urologic Oncology: Seminars and Original Investigations, 42(Issue 2). doi:10.1016/j.urolonc.2023.12.002
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  Introduction: Deciding on the optimal second-line (2L) treatment for metastatic clear-cell renal cell carcinoma (ccRCC) remains challenging due to the limited information comparing each of the available options and the influence of the newly expanding first-line (1L) agents. Patients and Methods: We identified phase II/III randomized controlled trials (RCTs) evaluating 2L treatments in metastatic ccRCC. This Network Meta-analysis (NMA) evaluates the overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and severe adverse events (SAE). We used normal likelihood model to incorporate log hazard ratios (HRs), odds ratios (OR), and 95%-confidence-intervals (CI). Treatment p-scores were used for ranking. Data was analyzed in a fixed-effects model using the netmeta package in R v.1.5-0. Results: All therapies demonstrated some benefits over placebo. Lenvatinib + everolimus ranked first for OS (HR = 0.44; 95%CI = 0.24–0.82; p-score = 0.92), PFS (HR = 0.13; 95%CI = 0.07–0.24, p-score = 0.98), and ORR (OR = 35.95; 95%CI = 11.55–111.87; p-score = 0.93) compared to placebo, though with a higher SAE (OR = 5.27; p-score = 0.23). Cabozantinib ranked second for OS (HR = 0.57, p-score = 0.80), PFS (HR = 0.19; p-score = 0.86), and ORR (OR = 27.24, p-score = 0.84). Nivolumab was third for ORR (p-score = 0.79), fourth for OS (p-score = 0.69), fifth for PFS (p-score = 0.61), and last for SAE (p-score = 0.83). Lenvatinib monotherapy ranked worst SAE (OR = 5.89, p-score = 0.17) and third for OS and PFS. The latest drug, tivozanib, was sixth for PFS, OS, and ORR. The NMA matrix revealed no differential OS benefit between cabozantinib, lenvatinib + everolimus, and nivolumab. Other regimens had no significant OS benefit when compared to placebo. Conclusion: Based on OS and PFS, the lenvtatinib + everolimus combination yielded superior, followed by cabozantinib and Lenvatinib monotherapies; all were limited by a worse SAE profile. Nivolumab and pazopanib had the lowest odds of SAEs.
• Obeng-Kusi, M., Kreutzfeldt, J. J., Estrada-Mendizabal, R. J., Choi, B. M., Abraham, I., & Recio-Boiles, A. (2024). Network meta-analysis of second line and beyond treatment options in metastatic clear cell renal cell carcinoma. Urologic oncology.
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  Deciding on the optimal second-line (2L) treatment for metastatic clear-cell renal cell carcinoma (ccRCC) remains challenging due to the limited information comparing each of the available options and the influence of the newly expanding first-line (1L) agents.
• Obeng-Kusi, M., Martin, J. R., Roe, D., Erstad, B. L., & Abraham, I. (2024). Comparative efficacy of later-line therapies for metastatic colorectal cancer: a network meta-analysis of survival curves. Expert review of pharmacoeconomics & outcomes research, 24(8), 923-932.
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  We evaluated the comparative efficacy of six later-line (≥3) therapies for metastatic colorectal cancer (mCRC) over placebo. We applied a novel statistical method of reconstructing pseudo-patient-level data (pseudo-IPD) to inform a network meta-analysis of survival curves that considers shape in addition to scale parameters.
• Obeng-Kusi, M., Martin, J. R., Roe, D., Erstad, B. L., & Abraham, I. (2024). Comparative efficacy of later-line therapies for metastatic colorectal cancer: a network meta-analysis of survival curves.. Expert Review of Pharmacoeconomics & Outcomes Research, 1-10. doi:10.1080/14737167.2024.2365993
• Obeng-Kusi, M., Martin, J., & Abraham, I. (2024). The economic burden of Ebola virus disease: a review and recommendations for analysis. Journal of Medical Economics, 27(Issue 1). doi:10.1080/13696998.2024.2313358
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  Background: Ebola virus disease (EVD) continues to be a major public health threat globally, particularly in the low-and-middle-income countries (LMICs) of Africa. The social and economic burdens of EVD are substantial and have triggered extensive research into prevention and control. We aim to highlight the impact and economic implications, identify research gaps, and offer recommendations for future economic studies pertaining to EVD. Method: We conducted a comprehensive librarian-led search in PubMed/Medline, Embase, Google Scholar, EconLit and Scopus for economic evaluations of EVD. After study selection and data extraction, findings on the impact and economics of EVD were synthesized using a narrative approach, while identifying gaps, and recommending critical areas for future EVD economic studies. Results: The economic evaluations focused on the burden of illness, vaccine cost-effectiveness, willingness-to-pay for a vaccine, EVD funding, and preparedness costs. The estimated economic impact of the 2014 EVD outbreak in Guinea, Liberia, and Sierra Leone across studies ranged from $30 billion to $50 billion. Facility construction and modification emerged as significant cost drivers for preparedness. The EVD vaccine demonstrated cost-effectiveness in a dynamic transmission model; resulting in an incremental cost-effectiveness ratio of about $96 per additional disability adjusted life year averted. Individuals exhibited greater willingness to be vaccinated if it incurred no personal cost, with a minority willing to pay about $1 for the vaccine. Conclusions: The severe impact of EVD puts pressure on governments and the international community for better resource utilization and re-allocation. Several technical and methodological issues related to economic evaluation of EVD remain to be addressed, especially for LMICs. We recommend conducting cost-of-sequelae and cost-of-distribution analyses in addition to adapting existing economic analytical methods to EVD. Characteristics of the affected regions should be considered to provide evidence-based economic plans and economic-evaluation of mitigations that enhance resource allocation for prevention and treatment.
• Obeng-Kusi, M., Martin, J., & Abraham, I. (2024). The economic burden of Ebola virus disease: a review and recommendations for analysis. Journal of medical economics, 1-36.
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  Ebola virus disease (EVD) continues to be a major public health threat globally, particularly in the low-and-middle-income countries (LMICs) of Africa. The social and economic burdens of EVD are substantial and have triggered extensive research into prevention and control. We aim to highlight the impact and economic implications, identify research gaps, and offer recommendations for future economic studies pertaining to EVD.
• Obeng-Kusi, M., Martin, J., & Abraham, I. L. (2023). The economics of ebola virus disease vaccination and treatment: background, scoping review, and recommendations for analysis.. Journal of Medical Economics.
• Okechukwu, A., Magrath, P., Alaofe, H., Farland, L. V., Abraham, I., Marrero, D. G., Celaya, M., & Ehiri, J. (2024). Optimizing Postpartum Care in Rural Communities: Insights from Women in Arizona and Implications for Policy. Maternal and child health journal, 28(7), 1148-1159.
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  Optimal postpartum care promotes healthcare utilization and outcomes. This qualitative study investigated the experiences and perceived needs for postpartum care among women in rural communities in Arizona, United States.
• Okechukwu, A., Magrath, P., Alaofe, H., Farland, L., Abraham, I., Marrero, D., Celaya, M., & Ehiri, J. (2024). Optimizing Postpartum Care in Rural Communities: Insights from Women in Arizona and Implications for Policy. Maternal and Child Health Journal, 28(7). doi:10.1007/s10995-023-03889-w
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  Objectives: Optimal postpartum care promotes healthcare utilization and outcomes. This qualitative study investigated the experiences and perceived needs for postpartum care among women in rural communities in Arizona, United States. Methods: We conducted in-depth interviews with thirty childbearing women and analyzed the transcripts using reflexive thematic analysis to gauge their experiences, needs, and factors affecting postpartum healthcare utilization. Results: Experiences during childbirth and multiple structural factors, including transportation, childcare services, financial constraints, and social support, played crucial roles in postpartum care utilization for childbearing people in rural communities. Access to comprehensive health information and community-level support systems were perceived as critical for optimizing postpartum care and utilization. Conclusions for Practice: This study provides valuable insights for policymakers, healthcare providers, and community stakeholders in enhancing postpartum care services for individuals in rural communities in the United States.
• Roberson, M. L., & Abraham, I. (2024). Relative, Absolute, and Excess Risk of Second Primary Melanomas Among Multiple Racial and Ethnic Groups-Analysis of Rare Events. JAMA dermatology, 160(12), 1272.
• Roberson, M., & Abraham, I. (2024). Relative, Absolute, and Excess Risk of Second Primary Melanomas among Multiple Racial and Ethnic Groups - Analysis of Rare Events. JAMA Dermatology, 160(12). doi:10.1001/jamadermatol.2024.3551
• Abraham, I. (2023). Preparing for the third decade of biosimilars. Expert Opinion on Biological Therapy, 23(Issue 8). doi:10.1080/14712598.2023.2247916
• Abraham, I. (2023). Preparing for the third decade of biosimilars. Expert opinion on biological therapy, 23(8), 651-652.
• Abraham, I. L. (2023). When an RCT is not possible: cause and effect in observational studies. Japanese Journal of Nursing Research, 56, 15-26.
• Abraham, I. L. (2023). When the intervention is not a pill: clinical studies of complex interventions. Japanese Journal of Nursing Research, 56, 27-39.
• Abraham, I. L. (2023). Economic Evaluation of Three BRAF + MEK Inhibitors for the Treatment of Advanced Unresectable Melanoma With BRAF Mutation From a US Payer Perspective. Annals of Pharmacotherapy, 106002802211468. doi:10.1177/10600280221146878
• Abraham, I. L. (2023). The economic value of knowing BRCA status: universal BRCA testing for breast cancer prevention. Expert Review of Pharmacoeconomics & Outcomes Research. doi:10.1080/14737167.2023.2169135
• Abraham, I., , ., & , . (2023). Trends, Changes, and Disruptions: The Fragile Economics of Cancer Treatments. The Oncologist.
• Abraham, I., Al-Foheidi, M., AlAbdalkarim, H., AlJedai, A., Almodaimegh, H., Alshamrani, M., Khan, M. A., Naeem, A., & Yousef, C. C. (2023).

  Cost-efficiency analysis of conversion to biosimilar filgrastim for supportive cancer care and resultant expanded access analysis to supportive care and early-stage HER2+ breast cancer treatment in Saudi Arabia: simulation study

  . Journal of Medical Economics, 26(1), 394-402. doi:10.1080/13696998.2023.2183680
• Abraham, I., Calamia, M., & MacDonald, K. (2023).

  Should a Systematic Review Be Required in a Clinical Trial Report? Perhaps, But Not Yet

  . JAMA Network Open, 6(3), e234226. doi:10.1001/jamanetworkopen.2023.4226
• Abraham, I., Calamia, M., & MacDonald, K. (2023). Should a Systematic Review Be Required in a Clinical Trial Report? Perhaps, But Not Yet. JAMA network open, 6(3), e234226.
• Abraham, I., Gregg, M., & Lee, K. K. (2023).

  Journal of Medical Economics in review: high impact articles from 2022

  . Journal of Medical Economics, 26(1), 303-307. doi:10.1080/13696998.2023.2178690
• Abraham, I., Hiligsmann, M., Lee, K. K., Citrome, L., Colombo, G. L., & , M. G. (2023). What to expect in 2024: important health economics and outcomes research (HEOR) trends. Expert review of pharmacoeconomics & outcomes research, 1-8.
• Abraham, I., Hiligsmann, M., Lee, K. K., Citrome, L., Colombo, G. L., & Gregg, M. (2023). What to Expect in 2024: Important Health Economics and Outcomes Research (HEOR) Trends. ClinicoEconomics and Outcomes Research, 15(Issue). doi:10.2147/ceor.s453171
• Abraham, I., Hiligsmann, M., Lee, K. K., Citrome, L., Colombo, G. L., & Gregg, M. (2023). What to Expect in 2024: Important Health Economics and Outcomes Research (HEOR) Trends. ClinicoEconomics and outcomes research : CEOR, 15, 799-809.
• Abraham, I., Lee, K. K., & Gregg, M. (2023). Journal of Medical Economics in review: high impact articles from 2022. Journal of medical economics, 26(1), 303-307.
• Abraham, I., Lewandrowski, K. U., Elfar, J. C., Li, Z. M., Fiorelli, R. K., Pereira, M. G., Lorio, M. P., Burkhardt, B. W., Oertel, J. M., Winkler, P. A., Yang, H., León, J. F., Telfeian, A. E., Dowling, ., Vargas, R. A., Ramina, R., Asefi, M., de Carvalho, P. S., Defino, H., , Moyano, J., et al. (2023). Randomized Clinical Trials and Observational Tribulations: Providing Clinical Evidence for Personalized Surgical Pain Management Care Models. Journal of personalized medicine, 13(7).
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  Proving clinical superiority of personalized care models in interventional and surgical pain management is challenging. The apparent difficulties may arise from the inability to standardize complex surgical procedures that often involve multiple steps. Ensuring the surgery is performed the same way every time is nearly impossible. Confounding factors, such as the variability of the patient population and selection bias regarding comorbidities and anatomical variations are also difficult to control for. Small sample sizes in study groups comparing iterations of a surgical protocol may amplify bias. It is essentially impossible to conceal the surgical treatment from the surgeon and the operating team. Restrictive inclusion and exclusion criteria may distort the study population to no longer reflect patients seen in daily practice. Hindsight bias is introduced by the inability to effectively blind patient group allocation, which affects clinical result interpretation, particularly if the outcome is already known to the investigators when the outcome analysis is performed (often a long time after the intervention). Randomization is equally problematic, as many patients want to avoid being randomly assigned to a study group, particularly if they perceive their surgeon to be unsure of which treatment will likely render the best clinical outcome for them. Ethical concerns may also exist if the study involves additional and unnecessary risks. Lastly, surgical trials are costly, especially if the tested interventions are complex and require long-term follow-up to assess their benefit. Traditional clinical testing of personalized surgical pain management treatments may be more challenging because individualized solutions tailored to each patient's pain generator can vary extensively. However, high-grade evidence is needed to prompt a protocol change and break with traditional image-based criteria for treatment. In this article, the authors review issues in surgical trials and offer practical solutions.
• Abraham, I., Lewandrowski, K. U., Elfar, J. C., Li, Z. M., Fiorelli, R. K., Pereira, M. G., Lorio, M. P., Burkhardt, B. W., Oertel, J. M., Winkler, P. A., Yang, H., León, J. F., Telfeian, A. E., Dowling, Á., Vargas, R. A., Ramina, R., Asefi, M., de Carvalho, P. S., Defino, H., , Moyano, J., et al. (2023). Randomized Clinical Trials and Observational Tribulations: Providing Clinical Evidence for Personalized Surgical Pain Management Care Models. Journal of Personalized Medicine, 13(Issue 7). doi:10.3390/jpm13071044
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  Proving clinical superiority of personalized care models in interventional and surgical pain management is challenging. The apparent difficulties may arise from the inability to standardize complex surgical procedures that often involve multiple steps. Ensuring the surgery is performed the same way every time is nearly impossible. Confounding factors, such as the variability of the patient population and selection bias regarding comorbidities and anatomical variations are also difficult to control for. Small sample sizes in study groups comparing iterations of a surgical protocol may amplify bias. It is essentially impossible to conceal the surgical treatment from the surgeon and the operating team. Restrictive inclusion and exclusion criteria may distort the study population to no longer reflect patients seen in daily practice. Hindsight bias is introduced by the inability to effectively blind patient group allocation, which affects clinical result interpretation, particularly if the outcome is already known to the investigators when the outcome analysis is performed (often a long time after the intervention). Randomization is equally problematic, as many patients want to avoid being randomly assigned to a study group, particularly if they perceive their surgeon to be unsure of which treatment will likely render the best clinical outcome for them. Ethical concerns may also exist if the study involves additional and unnecessary risks. Lastly, surgical trials are costly, especially if the tested interventions are complex and require long-term follow-up to assess their benefit. Traditional clinical testing of personalized surgical pain management treatments may be more challenging because individualized solutions tailored to each patient’s pain generator can vary extensively. However, high-grade evidence is needed to prompt a protocol change and break with traditional image-based criteria for treatment. In this article, the authors review issues in surgical trials and offer practical solutions.
• AlLehaibi, L. H., Alomar, M., Almulhim, A., Al-Makki, S., Alrwaili, N. R., Al-Bassam, S., Alsultan, S., Al Saeed, J., Alsheef, M., Abraham, I., & Alamer, A. (2023). Effectiveness and Safety of Enoxaparin Versus Unfractionated Heparin as Thromboprophylaxis in Hospitalized COVID-19 Patients: Real-World Evidence. The Annals of pharmacotherapy, 10600280221115299.
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  Coronavirus 2019 (COVID-19) patients are at risk of thrombosis. Literature that compares the effectiveness of enoxaparin to unfractionated heparin (UFH) in COVID-19 patients is scarce.
• Alamer, A., Almutairi, A. R., Halloush, S., Al-jedai, A., Alrashed, A., AlFaifi, M., Mohzari, Y., Almutairi, M., AlHassar, F., Howaidi, J., Almutairi, W., Abraham, I., & Alkhatib, N. (2023). Cost-effectiveness of Favipiravir in moderately to severely ill COVID-19 patients in the real-world setting of Saudi arabian pandemic referral hospitals. Saudi Pharmaceutical Journal, 31(Issue 4). doi:10.1016/j.jsps.2023.02.003
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  Purpose: We aimed to evaluate the cost effectiveness of Favipiravir treatment versus standard of care (SC) in moderately to severely ill COVID-19 patients from the Saudi healthcare payer perspective. Methods: We used the patient-level simulation method to simulate a cohort of 415 patients with moderate to severe COVID-19 disease who were admitted to two Saudi COVID-19 referral hospitals: 220 patients on Favipiravir and 195 patients on SC. We estimated the incremental cost-effectiveness ratio (ICER) of Favipiravir versus SC in terms of the probability to be discharged alive from hospital and the mean time in days to discharge one patient alive. The model was performed twice: first, using unweighted, and second, using weighted clinical and economic data. Weighting using the inverse weight probability method was performed to achieve balance in baseline characteristics. Results: In the unweighted model, base case (probabilistic) ICER estimates favored Favipiravir at savings of Saudi Riyal (SAR)1,611,511 (SAR1,998,948) per 1% increase in the probability of being discharged alive. As to mean time to discharging one patient alive, ICERs favored Favipiravir at savings of SAR11,498 (SAR11,125). Similar results were observed in the weighted model with savings using Favipiravir of SAR1,514,893 (SAR2,453,551) per 1% increase in the probability of being discharged alive, and savings of SAR11,989 (SAR11,277) for each day a patient is discharged alive. Conclusion: From the payer perspective, the addition of Favipiravir in moderately to severely ill COVID-19 patients was cost-savings over SC. Favipiravir was associated with a higher probability of discharging patients alive and lower daily spending on hospitalization than SC.
• Alamer, A., Almutairi, A., Halloush, S., Al-jedai, A., Alrashed, A., Alfifi, M., Mozhari, Y., Almutairi, M., Alhassar, F., Howaidi, J., Almutairi, W., Abraham, I. L., & Alkhatib, N. (2023). Cost-effectiveness of favipiravir in moderately to severely ill COVID-19 patients in the real-world setting of Saudi Arabian pandemic referral hospitals. . Saudi Pharmaceutical Journal, -.
• Alkhatib, N. S., Halloush, S., & Abraham, I. (2023).

  The status and preparation for the next decade of biosimilars in the Middle Eastern and North African region

  . Expert Opinion on Biological Therapy, 23(8), 671-677. doi:10.1080/14712598.2023.2241346
• Alkhatib, N. S., Halloush, S., & Abraham, I. (2023). The status and preparation for the next decade of biosimilars in the Middle Eastern and North African region. Expert opinion on biological therapy, 23(8), 671-677.
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  Little is known about the status and the future potential of biosimilars in the Middle East and North Africa (MENA) region.
• Calamia, M., & Abraham, I. (2023).

  The economics of biosimilars and challenges to biosimilar adoption in low- and middle-income countries

  . Expert Opinion on Biological Therapy, 23(8), 653-657. doi:10.1080/14712598.2023.2247972
• Calamia, M., & Abraham, I. (2023). The economics of biosimilars and challenges to biosimilar adoption in low- and middle-income countries. Expert opinion on biological therapy, 23(8), 653-657.
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  Biologics have shown marked success over the past decades in disease areas as cancer, immunology and diabetes. However, elevated costs of innovative biologic medicines have led to an inequity in accessibility across the world. While 85% of the world's population lives in low- and middle- income countries (LMIC), 80% of the sales of monoclonal antibodies are attributed to Western countries, highlighting the pronounced market imbalance.
• Fernandez, J. M., Poling, K. L., Desai, A. D., Koblinski, J. E., Borgstrom, M., Abraham, I., & Behbahani, S. (2023). Primary cutaneous melanoma in Black patients: An analysis of 2464 cases from the National Cancer Database 2004-2018. Pigment cell & melanoma research.
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  Melanoma in Black patients carries a poor prognosis. Due to its rarity, melanoma in this population has not been well characterized. This study evaluates survival predictors in Black patients with melanoma. This was a retrospective cohort study of Black patients with cutaneous melanoma from the National Cancer Database 2004-2018. Of the 2464 cases, melanoma was more common among females than males (57.1% vs. 42.9%, p 
• Gamaleldin, M., Abraham, I., Meabed, M., Elberry, A., Abdelhalim, S., Waggas, D., & Hussein, R. (2023). Comparative effectiveness of adding omega-3 and Manuka honey combination to conventional therapy in preventing and treating oxidative stress in pediatric β-thalassemia major - a randomized clinical trial. European review for medical and pharmacological sciences, 27(13), 6058-6070.
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  β-thalassemia major is an inherited hematological disorder with significant oxidative stress and iron overload. Oxidative stress results in several pathological complications, including cell death, tissue injury, organ dysfunction, and thyroid dysfunction. The present study examined the effectiveness of omega-3 and Manuka honey combination or Manuka honey alone to the conventional therapy (deferasirox, blood transfusion, and L-carnitine) used for preventing and managing oxidative stress or iron overload-induced oxidative stress conditions in pediatric β-thalassemic patients (type major).
• Gamaleldin, M., Abraham, I., Meabed, M., Elberry, A., Abdelhalim, S., Waggas, D., & Hussein, R. (2023). Comparative effectiveness of adding omega-3 and Manuka honey combination to conventional therapy in preventing and treating oxidative stress in pediatric β-thalassemia major - a randomized clinical trial. European review for medical and pharmacological sciences, 27(Issue 13). doi:10.26355/eurrev_202307_32960
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  OBJECTIVE: β-thalassemia major is an inherited hematological disorder with significant oxidative stress and iron overload. Oxidative stress results in several pathological complications, including cell death, tissue injury, organ dysfunction, and thyroid dysfunction. The present study examined the effectiveness of omega-3 and Manuka honey combination or Manuka honey alone to the conventional therapy (deferasirox, blood transfusion, and L-carnitine) used for preventing and managing oxidative stress or iron overload-induced oxidative stress conditions in pediatric β-thalassemic patients (type major). PATIENTS AND METHODS: 165 patients participated in this randomized, double-blind, standard therapy-controlled, parallel-design multisite trial. The patients were randomly allocated into three groups, receiving either 1,000 mg omega-3 fish oil [350 mg eicosapentaenoic acid (EPA) and 250 mg docosahexaenoic acid (DHA)] combined with Manuka honey lozenge (344 mg) daily or Manuka honey alone plus the conventional therapy for ten months. Plasma 8-iso-prostaglandin F2α (8-iso-PGF2α), Lactate dehydrogenase (LDH), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), CRP (C-reactive protein), ferritin level, and serum iron were determined at baseline and month 10. RESULTS: Omega-3 and Manuka honey combination were a significant add-on to conventional therapy of β-thalassemia in reducing the oxidative stress condition. The combination of Omega-3 and Manuka honey reduced the level of F2-isoprostane(8-iso-PGF2α) significantly compared to the Manuka alone and the control groups. Additionally, they showed an antihemolytic action measured by reduced LDH level. The combination restored the patient's lipid profile (LDL-C and HDL-C) significantly compared to the control group. Manuka honey enhanced the action of omega-3 in reducing oxidative stress by reducing serum iron significantly compared to the control group. CONCLUSIONS: Results showed that omega-3 + Manuka honey was more effective than Manuka alone or the conventional treatment alone in managing oxidative stress of β-thalassemic patients.
• Halawah, H. H., Alkhatib, N. S., Almutairi, A. R., Saleh, M., Halloush, S. S., Rashdan, O., Masadh, L., Abusara, O. H., & Abraham, I. (2023). Cost-efficiency analysis and expanded treatment access modeling of conversion to rituximab biosimilars from reference rituximab in Jordan. Journal of Medical Economics, 26(Issue 1). doi:10.1080/13696998.2023.2226007
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  Aim: To assess the cost-efficiency and expanded access of three rituximab biosimilars versus the reference rituximab from the perspective of the Jordanian national health payer. Methods: A 1-year cost-efficiency and expanded access model of conversion from reference rituximab (Mabthera) to the approved biosimilars (Truxima, Rixathon, and Tromax) to assess five metrics: total annual cost to treat a hypothetical patient; head-to-head cost comparison; changes in patients’ access to rituximab; number-needed-to-convert (NNC) to provide an additional 10 patients access to a rituximab treatment; and relative amount of Jordanian Dinar (JOD) spent on rituximab options. The model included rituximab doses at 100 mg/10 ml and 500 mg/50 ml and considered both cost-saving and cost-wastage scenarios. Costs of treatments were based on the fiscal year 2022 tender prices received by the Joint Procurement Department (JPD). Results: Rixathon was associated with the lowest average annual cost per patient (JOD2,860) across all six indications among all rituximab comparators, followed by Truxima (JOD4,240), Tromax (JOD4,365) and reference Mabthera (JOD11,431). The highest percentage of patient access to rituximab treatment (321%) was achieved when switching patients from Mabthera to Rixathon in the RA and PV indications. At four patients, Rixathon was associated with the lowest NNC to provide an additional 10 patients access to rituximab treatment. For each JOD1 spent on Rixathon, an additional JOD3.21 must be spent on Mabthera, an additional JOD0.55 on Tromax, and an additional JOD0.53 on Truxima. Conclusion: Rituximab biosimilars were associated with cost savings in all approved indications in Jordan compared to reference rituximab. Rixathon was associated with the lowest annual cost, the highest percentage of expanded patient access for all six indications, and the lowest NNC providing 10 additional patients with access.
• Halawah, H. H., Alkhatib, N. S., Almutairi, A. R., Saleh, M., Halloush, S. S., Rashdan, O., Masadh, L., Abusara, O. H., & Abraham, I. (2023). Cost-efficiency analysis and expanded treatment access modeling of conversion to rituximab biosimilars from reference rituximab in Jordan. Journal of medical economics, 26(1), 835-842.
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  To assess the cost-efficiency and expanded access of three rituximab biosimilars versus the reference rituximab from the perspective of the Jordanian national health payer.
• Halloush, S., & Abraham, I. L. (2023). Economic evaluation of three BRAF+MEK inhibitors for the treatment of advanced unresectable melanoma with BRAF mutation from a US payer perspective. Annals of Pharmacotherapy, 57, 1016-1024.
• Halloush, S., Alkhatib, N. S., Almutairi, A. R., Calamia, M., Halawah, H., Obeng-Kusi, M., Hoyle, M., Rashdan, O., Koeller, J., & Abraham, I. (2023). Economic Evaluation of Three BRAF + MEK Inhibitors for the Treatment of Advanced Unresectable Melanoma With BRAF Mutation From a US Payer Perspective. The Annals of pharmacotherapy.
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  The combinations of BRAF + MEK inhibitors-encorafenib (ENC) + binimetinib (BIN), cobimetinib (COB) + vemurafenib (VEM), and dabrafenib (DAB) + trametinib (TRA)-are recommended for the treatment of BRAF-mutated advanced melanoma.
• Kim, H. J., Kim, E., Jung, S. O., & Abraham, I. L. (2023). Neuropsychological effects of chemotherapy: systematic review of longitudinal studies on objective cognitive impairment in breast cancer patients. Cancer Nursing.
• Kim, H. J., Kim, J. E., Jung, S. O., Lee, D., & Abraham, I. (2023). Neuropsychological Effects of Chemotherapy: Systematic Review of Longitudinal Studies on Objective Cognitive Impairment in Breast Cancer Patients. Cancer Nursing, 46(Issue 3). doi:10.1097/ncc.0000000000001079
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  Background Findings from longitudinal studies can provide more conclusive evidence as to the impact of chemotherapy on cognitive functioning. Objectives This study aimed to (a) synthesize the evidence from longitudinal studies of the neuropsychological effects associated with chemotherapy in breast cancer patients, (b) identify associated factors, and (c) evaluate methodological issues. Methods Data were extracted from PubMed, EMBASE, CINAHL, PsycINFO, and the Cochrane Library. Inclusion criteria included the original study with the breast cancer sample, validated measure, and at least 1 baseline data point before and after chemotherapy began. Data accrued for sample characteristics, data-collection time points, statistical methods for longitudinal data analysis, outcome measures, and major findings (eg, longitudinal changes in cognitive function). Results We selected 42 articles for this review. The sample sizes ranged from 20 to 610, and most recruited were younger than 70 years. We found a trend across studies - statistically significant objective cognitive function deteriorations in severity and prevalence after initiating chemotherapy compared with a control group or relative to their baseline observations. A subsample, as high as 65%, experienced marked declines in cognitive function after initiating chemotherapy. The memory domain was most affected. The consistently associated factors were education, IQ, and regimen. Major methodological concerns were the measurement - the wide range of neuropsychological tests and a test's unclear domains. Conclusion Chemotherapy affects objective cognitive function in some subsets. The highest-impact time point, mechanisms, and clinical significance of chemotherapy-associated cognitive impairment need additional evidence. Implication for Practice Clinicians must assess and manage cognitive impairment during and after chemotherapy.
• Kim, H. J., Moon, J. H., Chung, S. W., & Abraham, I. (2023). The role of cytokines and Indolamine-2.3 dioxygenase in experiencing a psycho-neurological symptom cluster in hematological cancer patients: IL-1alpha, IL-1beta, IL-4, IL-6, TNF-alpha, kynurenine, and tryptophan. Journal of Psychosomatic Research, 173(Issue). doi:10.1016/j.jpsychores.2023.111455
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  Objective: This study examined (a) whether there are a subgroup of cancer patients experiencing the selected psycho-neurological symptoms as a cluster (depression, cognitive impairment, fatigue, sleep disturbance, and pain); (b) whether demographic and clinical characteristics and pro-inflammatory cytokines (IL-1α, IL-1β, IL-4, IL-6, TNF-alpha) are associated with subgroup membership; and (c) whether the activity of indolamine-2.3 dioxygenase(IDO) is associated with pro-inflammatory cytokine activity and psycho-neurological symptom cluster experience. Methods: This was a prospective cohort study where 149 hematologic patients were recruited from a university hospital and 65 healthy volunteers provided control data. Latent profile analyses were conducted to identify subgroups at two time points: the last day of chemotherapy and 1 week after chemotherapy completion. Influencing factors of subgroup membership were examined by logistic regression. Results: A substantial number of patients (33%, 34% at each time point) experienced the selected psycho-neurological symptoms as a cluster. Older age and elevated IL-1α and IL-6 were associated with experiencing the psycho-neurological symptom cluster. IDO activity was higher in the patients experiencing psycho-neurological symptom cluster; and was positively associated with IL-6. Symptom severity, IL-1α, IL-6, and IDO activity were all significantly higher in cancer patients than in the healthy controls. The findings were preserved across time points. Conclusions: The activation of pro-inflammatory cytokines and their cross-talk with IDO may be a common biological mechanism, underlying a psycho-neurological symptom cluster experience. The novel approaches for symptom assessment and management can be developed by assessing multiple psycho-neurological symptoms as a cluster and by targeting their common biological pathway.
• Kim, H., Moon, J., Chung, S., & Abraham, I. L. (2023). The role of cytokines and indolamine-2.3 dioxygenase in experiencing a psycho-neurological symptom cluster in hematological cancer patients: IL-1 alpha, IL-1 beta, IL-4, IL-6, TNF-alpha, kynurenine, and tryptophan. 
  
  . Journal of Psychosomatic Research.
• Kurdi, S., Alamer, A., Wali, H., Badr, A. F., Pendergrass, M. L., Ahmed, N., Abraham, I., & Fazel, M. T. (2023). Proof-of-Concept Study of Using Supervised Machine Learning Algorithms to Predict Self-Care and Glycemic Control in Type 1 Diabetes Patients on Insulin Pump Therapy. Endocrine Practice, 29(Issue 6). doi:10.1016/j.eprac.2023.03.002
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  Objective: Using supervised machine learning algorithms (SMLAs), we built models to predict the probability of type 1 diabetes mellitus patients on insulin pump therapy for meeting insulin pump self-management behavioral (IPSMB) criteria and achieving good glycemic response within 6 months. Methods: This was a single-center retrospective chart review of 100 adult type 1 diabetes mellitus patients on insulin pump therapy (≥6 months). Three SMLAs were deployed: multivariable logistic regression (LR), random forest (RF), and K-nearest neighbor (k-NN); validated using repeated three-fold cross-validation. Performance metrics included area under the curve-Receiver of characteristics for discrimination and Brier scores for calibration. Results: Variables predictive of adherence with IPSMB criteria were baseline hemoglobin A1c, continuous glucose monitoring, and sex. The models had comparable discriminatory power (LR = 0.74; RF = 0.74; k-NN = 0.72), with the RF model showing better calibration (Brier = 0.151). Predictors of the good glycemic response included baseline hemoglobin A1c, entering carbohydrates, and following the recommended bolus dose, with models comparable in discriminatory power (LR = 0.81, RF = 0.80, k-NN = 0.78) but the RF model being better calibrated (Brier = 0.099). Conclusion: These proof-of-concept analyses demonstrate the feasibility of using SMLAs to develop clinically relevant predictive models of adherence with IPSMB criteria and glycemic control within 6 months. Subject to further study, nonlinear prediction models may perform better.
• Kurdi, S., Wali, H., Badr, A. F., Pendergrass, M. L., Abraham, I. L., & Fazel, M. (2023). Proof-of-concept study of using supervised machine learning algorithms to predict glycemic control in type 1 diabetes patients on insulin pump therapy. Endocrine Practice.
• Lewandrowski, K., Elfar, J. C., Li, Z., Burkhardt, B. W., Lorio, M. P., Winkler, P. A., Oertel, J. M., Telfeian, A. E., Dowling, Á., Vargas, R. A., Ramina, R., Abraham, I., Assefi, M., Yang, H., Zhang, X., Ramírez León, J. F., Fiorelli, R. K., Pereira, M. G., de Carvalho, P. S., , Defino, H., et al. (2023).

  The Changing Environment in Postgraduate Education in Orthopedic Surgery and Neurosurgery and Its Impact on Technology-Driven Targeted Interventional and Surgical Pain Management: Perspectives from Europe, Latin America, Asia, and The United States

  . Journal of Personalized Medicine, 13(5), 852. doi:10.3390/jpm13050852
• Oh, M., McBride, A., Bhattacharjee, S., Slack, M., Jeter, J., & Abraham, I. (2023). Economic value of knowing BRCA status: BRCA testing for prostate cancer prevention and optimal treatment. Expert Review of Pharmacoeconomics and Outcomes Research, 23(Issue 3). doi:10.1080/14737167.2023.2169137
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  Background: We aimed to estimate the incremental lifetime effects, costs, and net-monetary-benefit (NMB) of knowing BRCA information by testing of patients with low-risk localized prostate cancer (PCa) in the US and guiding subsequent screening and treatment, and the cumulative savings or losses of yearly cohort testing over 16 years. We compared two strategies: (1)‘with BRCA information’ and (2)‘without BRCA information.’ We also estimated the expected value of perfect information. Methods: The incremental NMB (INMB) quantified the monetized benefit per person of knowing BRCA status. The net-monetized-value of knowing BRCA information was estimated by multiplying the INMB with the eligible population. Results: The INMBs of knowing BRCA information were $43,357 (payer) and $43,487 (society). in payer and societal perspectives, respectively. Escalated to the eligible patients in 2020, knowing BRCA status resulted in net monetized lifetime value of $1.7 billion (payer and society) for the 2020 cohort; and yielded accumulated net-monetized-value of $28.0 billion (payer) and $28.1 billion (society) over 16 yearly cohorts of eligible PCa patients. Conclusions: The economic value of knowing BRCA status for all low-risk localized PCa patients in the US provides short-term and long-term evidence for BRCA testing to screen early and optimize treatment.
• Oh, M., McBride, A., Bhattacharjee, S., Slack, M., Jeter, J., & Abraham, I. (2023). The economic value of knowing BRCA status: universal BRCA testing for breast cancer prevention. Expert review of pharmacoeconomics & outcomes research.
• Oh, M., McBride, A., Bhattacharjee, S., Slack, M., Jeter, J., & Abraham, I. (2023). The economic value of knowing BRCA status: BRCA testing for prostate cancer prevention and optimal treatment. Expert review of pharmacoeconomics & outcomes research.
• Okechukwu, A., Abraham, I., Okechukwu, C., Magrath, P., Marrero, D. G., Farland, L. V., & Alaofe, H. (2023). Extended Medicaid coverage will improve access but insufficient to enhance postpartum care utilization: a secondary analysis of the 2016-2019 Arizona Medicaid claims. Frontiers in public health, 11, 1281574.
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  Postpartum Medicaid eligibility extensions may increase access to healthcare for low-income women. However, its implications for healthcare utilization are unknown.
• Okechukwu, A., Abraham, I., Okechukwu, C., Magrath, P., Marrero, D. G., Farland, L. V., & Alaofe, H. (2023). Extended Medicaid coverage will improve access but insufficient to enhance postpartum care utilization: a secondary analysis of the 2016–2019 Arizona Medicaid claims. Frontiers in Public Health, 11(Issue). doi:10.3389/fpubh.2023.1281574
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  Introduction: Postpartum Medicaid eligibility extensions may increase access to healthcare for low-income women. However, its implications for healthcare utilization are unknown. Methods: We analyzed the linked-infant birth certificate and claims data of women whose childbirths were paid for by Medicaid between 2016 and 2019 in Arizona, United States. We evaluated associations between postpartum care visits and Medicaid insurance type and assessed effect modification by the delivery route and type of residence. Results: Women with pregnancy-related Medicaid insurance were less likely to attend postpartum visits, with an adjusted odds ratio (aOR) of 0.70 and a 95% confidence interval (CI) of 0.66 to 0.74 than those with continuous Medicaid insurance. Younger age, rural residence [aOR 0.83, CI 0.78, 0.88], vaginal delivery route [aOR 0.11, CI 0.10, 0.12], and the absence of complications during/after childbirth [aOR 0.58, CI 0.49, 0.70] were associated with the absence of postpartum care visit. Low-income women who lost their pregnancy-related Medicaid coverage after 60 days in Arizona experienced lower rates of postpartum care utilization. Discussion: Interventions to improve postpartum utilization should be considered beyond extending postpartum Medicaid coverage for low-income women.
• Rangan, P., Mashaqi, S., Saleh, A., Abraham, I. L., Gozal, D., Quantitative, S., & Parthasarathy, S. (2023). Biomarkers of gut barrier dysfunction in obstructive sleep apnea: a systematic review and meta-analysis. Sleep Medicine Reviews.
• Shah, B., Gray, J., Abraham, I. L., & Change, M. (2023). Pharmacy considerations: use of anti-CD38 monoclonal antibodies in multiple myeloma.. Journal of Oncology Pharmacy Practice.
• Stocking, J. C., Taylor, S. L., Fan, S., Wingert, T., Drake, C., Aldrich, J. M., Ong, M. K., Amin, A. N., Marmor, R. A., Godat, L., Cannesson, M., Gropper, M. A., Utter, G. H., Sandrock, C. E., Bime, C., Mosier, J., Subbian, V., Adams, J. Y., Kenyon, N. J., , Albertson, T. E., et al. (2023). A Least Absolute Shrinkage and Selection Operator-Derived Predictive Model for Postoperative Respiratory Failure in a Heterogeneous Adult Elective Surgery Patient Population. CHEST Critical Care, 1(Issue 3). doi:10.1016/j.chstcc.2023.100025
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  Background: Postoperative respiratory failure (PRF) is associated with increased hospital charges and worse patient outcomes. Reliable prediction models can help to guide postoperative planning to optimize care, to guide resource allocation, and to foster shared decision-making with patients. Research Question: Can a predictive model be developed to accurately identify patients at high risk of PRF? Study Design and Methods: In this single-site proof-of-concept study, we used structured query language to extract, transform, and load electronic health record data from 23,999 consecutive adult patients admitted for elective surgery (2014-2021). Our primary outcome was PRF, defined as mechanical ventilation after surgery of > 48 h. Predictors of interest included demographics, comorbidities, and intraoperative factors. We used logistic regression to build a predictive model and the least absolute shrinkage and selection operator procedure to select variables and to estimate model coefficients. We evaluated model performance using optimism-corrected area under the receiver operating curve and area under the precision-recall curve and calculated sensitivity, specificity, positive and negative predictive values, and Brier scores. Results: Two hundred twenty-five patients (0.94%) demonstrated PRF. The 18-variable predictive model included: operations on the cardiovascular, nervous, digestive, urinary, or musculoskeletal system; surgical specialty orthopedic (nonspine); Medicare or Medicaid (as the primary payer); race unknown; American Society of Anesthesiologists class ≥ III; BMI of 30 to 34.9 kg/m2; anesthesia duration (per hour); net fluid at end of the operation (per liter); median intraoperative FIO2, end title CO2, heart rate, and tidal volume; and intraoperative vasopressor medications. The optimism-corrected area under the receiver operating curve was 0.835 (95% CI, 0.808-0.862) and the area under the precision-recall curve was 0.156 (95% CI, 0.105-0.203). Interpretation: This single-center proof-of-concept study demonstrated that a structured query language extract, transform, and load process, based on readily available patient and intraoperative variables, can be used to develop a prediction model for PRF. This PRF prediction model is scalable for multicenter research. Clinical applications include decision support to guide postoperative level of care admission and treatment decisions.
• Stocking, J., Co-Authors, S., & Abraham, I. L. (2023).

  Stocking JC, Taylor S, Fan S, Wingert T, Drake C, Aldrich JM, Ong MK, Amin AN, Marmor RA, Godat L, Cannesson M, Gropper MA, Utter GH, Sandrock CE, Bime C, Mosier J, Subbian V, Adams JY, Kenyon NJ, Albertson TE, Garcia JGN, Abraham I. A Least Absolute Shrinkage and Selection Operator-derived predictive model for postoperative respiratory failure in a heterogeneous adult elective surgery patient population. CHEST Critical Care 2023;1:1000025.

  . CHEST Critical Care, 1, 1000025.
• Tugay, D., Top, M., Aydin, ., Bavbek, S., Damadoğlu, E., Öner Erkekol, F., Koca Kalkan, I., Kalyoncu, A. F., Karakaya, G., Oğuzülgen, I. K., Türktaş, H., & Abraham, I. (2023). Real-world patient-level cost-effectiveness analysis of omalizumab in patients with severe allergic asthma treated in four major medical centers in Turkey. Journal of medical economics, 26(1), 720-730.
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  To evaluate the cost-effectiveness of standard-of-care treatment (SoC) to SoC in combination with omalizumab (OML + Soc) in patients with severe asthma using real-world prospective clinical data from four major medical centers in Turkey.
• Tugay, D., Top, M., Aydin, Ö., Bavbek, S., Damadoğlu, E., Öner Erkekol, F., Koca Kalkan, I., Kalyoncu, A. F., Karakaya, G., Oğuzülgen, I. K., Türktaş, H., & Abraham, I. (2023). Real-world patient-level cost-effectiveness analysis of omalizumab in patients with severe allergic asthma treated in four major medical centers in Turkey. Journal of Medical Economics, 26(Issue 1). doi:10.1080/13696998.2023.2209417
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  Aims: To evaluate the cost-effectiveness of standard-of-care treatment (SoC) to SoC in combination with omalizumab (OML + Soc) in patients with severe asthma using real-world prospective clinical data from four major medical centers in Turkey. Materials and methods: Between February 2018 and November 2019, a total of 206 patients with severe asthma, including 126 of whom were in the OML + SoC group and 80 in the SoC group, were followed for 12 months to evaluate their asthma status and quality of life. Cost data for this patient-level economic evaluation were sourced from the MEDULA database of the hospitals and expressed in Turkish Lira (₺). Efficacy data were obtained by means of Turkish versions of the Asthma Control Test for asthma status, the 5-level EQ-5D-5L version (EQ-5D-5L), and the Asthma Quality of Life Scale for quality of life. A Markov model with 2-week cycles was specified, comparing costs and treatment effects of SoC vs. OML + SoC over a lifetime from the Turkish payer perspective. Results: Per-patient costs were ₺23,607.08 in the SoC arm and ₺425,329.81 in the OML + Soc arm, for a difference of ₺401,722.74. Life years (LY) and quality-adjusted life years (QALY) were 13.60 and 10.08, respectively, in the SoC group; and 21.26 and 13.35, respectively, in the OML + SoC group, for differences of 7.66 LYs and 3.27 QALYs. This yielded an incremental cost-effectiveness ratio of an additional ₺52,427.04 to gain 1 LY and an incremental cost-utility ratio of an incremental ₺122,675.57 to gain 1 QALY; the latter being below the ₺156,948 willingness-to-pay threshold for Turkey referenced by WHO. One-way and multivariate sensitivity analyses confirmed the base-case results. Conclusion: Whereas most economic evaluations are based on aggregate data, this independent cost-effectiveness analysis using prospective real-world patient-level data suggests that omalizumab in combination with standard of care is cost-effective for severe asthma from the Turkish public payer perspective.
• Yousef, C. C., Khan, M. A., Almodaimegh, H., Alshamrani, M., Al-Foheidi, M., AlAbdalkarim, H., AlJedai, A., Naeem, A., & Abraham, I. (2023). Cost-efficiency analysis of conversion to biosimilar filgrastim for supportive cancer care and resultant expanded access analysis to supportive care and early-stage HER2+ breast cancer treatment in Saudi Arabia: simulation study. Journal of medical economics, 26(1), 394-402.
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  This study estimated, for Saudi Arabia, the cost-efficiency of converting patients from reference Neupogen and Neulastim to one of two filgrastim biosimilars (Nivestim, Zarzio); the budget-neutral expanded access to supportive care with biosimilar filgrastim and therapeutic care to ado-trastuzumab emtansine thus afforded; and the number-needed-to-convert (NNC) to provide supportive or therapeutic treatment to one patient.
• Abraham, I. L. (2022). Journal of Medical Economics in review: the best of 2021. Journal of Medical Economics, 25(1), 282-286. doi:10.1080/13696998.2022.2036925
• Abraham, I. L. (2022). Budget impact analysis of trilaciclib for decreasing the incidence of chemotherapy-induced myelosuppression in patients with extensive-stage small cell lung cancer in the United States. Journal of Managed Care & Specialty Pharmacy, 28(4), 435-448. doi:10.18553/jmcp.2022.21379
• Abraham, I. L. (2022). Changing paradigms in detecting rare adverse drug reactions: from disproportionality analysis, old and new, to machine learning. Expert Opinion on Drug Safety, 21(10), 1235-1238. doi:10.1080/14740338.2022.2131770
• Abraham, I. L. (2022). Child Maltreatment and the Ecosystem of Socioeconomic Inequities and Inequalities. JAMA Network Open, 5(7), e2221516. doi:10.1001/jamanetworkopen.2022.21516
• Abraham, I. L. (2022). Cost-Effectiveness Analyses of First Line Ibrutinib Versus Acalabrutinib Versus Zanubrutinib Followed By Second Line Venetoclax Plus Rituximab in Previously Untreated Chronic Lymphocytic Leukemia (CLL) Patients. Blood, 140(Supplement 1), 2155-2156. doi:10.1182/blood-2022-156948
• Abraham, I. L. (2022). Decision Curve Analysis and the Net Benefit of Novel Tests. JAMA Dermatology, 158(6), 684. doi:10.1001/jamadermatol.2022.0976
• Abraham, I. L. (2022). Does synthetic pharmacotherapy still have a place in treating chronic spontaneous urticaria?. Expert Opinion on Pharmacotherapy, 23(14), 1563-1567. doi:10.1080/14656566.2022.2128671
• Abraham, I. L. (2022). Effectiveness and Safety of Enoxaparin Versus Unfractionated Heparin as Thromboprophylaxis in Hospitalized COVID-19 Patients: Real-World Evidence. Annals of Pharmacotherapy, 106002802211152. doi:10.1177/10600280221115299
• Abraham, I. L. (2022). Melanoma Epidemiology—Pivoting to Low- and Middle-Income Countries. JAMA Dermatology, 158(5), 489. doi:10.1001/jamadermatol.2022.0162
• Abraham, I. L. (2022). Pharmacy considerations: Use of anti-CD38 monoclonal antibodies in relapsed and/or refractory multiple myeloma. Journal of Oncology Pharmacy Practice, 29(1), 170-182. doi:10.1177/10781552221107850
• Abraham, I. L. (2022). Primary cutaneous melanoma in Black patients: An analysis of 2464 cases from the National Cancer Database 2004–2018. Pigment Cell & Melanoma Research, 36(1), 42-52. doi:10.1111/pcmr.13065
• Abraham, I. L. (2022). Retrospective evaluation of safety and effectiveness of same-day pegfilgrastim in patients with lung cancer. Future Oncology, 18(19), 2381-2390. doi:10.2217/fon-2022-0166
• Abraham, I. L. (2022). Tocilizumab effectiveness in mechanically ventilated COVID-19 patients (T-MVC-19 Study): a multicenter real-world evidence. Expert Review of Anti-infective Therapy, 20(7), 1037-1047. doi:10.1080/14787210.2022.2046462
• Abraham, I. L., Alrawashdh, N., McBride, A., Persky, D. O., Sweasy, J., & Erstad, B. L. (2022). Cost-effectiveness and economic burden analyses of all first-line treatments of chronic lymphocytic leukemia. Value in Health, 25, 1685-1695.
• Abraham, I. L., Goyal, A., Deniz, B., Moran, D., Chioda, M., MacDonald, K., & Huang, H. (2022). Budget impact analysis of trilaciclib for decreasing the incidence of chemotherapy-induced myelosuppression in extensive-stage small cell lung cancer in the United States. Journal of Managed Care and Specialty Pharmacy, 28, 435-448.
• Abraham, I., Abraham, I., Alajlan, S. A., Alajlan, S. A., Alamer, A., Alamer, A., Alamer, A., Alamer, A., Aljobair, F., Aljobair, F., Alrashed, A., Alrashed, A., Alshuraim, R., Alshuraim, R., Alsowaida, Y. S., Alsowaida, Y. S., Alzaaqi, M. A., Alzaaqi, M. A., Asdaq, S. M., , Asdaq, S. M., et al. (2022). Early oral switch to combined cefixime therapy for management of osteoarticular infections in pediatric sickle cell disease patients: A descriptive analysis.. Journal of infection and public health, 15(1), 1-6. doi:10.1016/j.jiph.2021.11.006
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  The treatment of osteoarticular infections in pediatric patients with sickle cell disease (SCD) is a challenging task for the practitioner. The aim of this study is to evaluate cefixime for the treatment of osteoarticular infections in pediatric SCD patients by retrospective design..This study was done in the pediatric hospital of King Saud Medical City, Riyadh, Saudi Arabia. The data was obtained from medical records of patients aged 1-16 years admitted between January 2019 to December 2020, diagnosed with SCD and received cefixime for the treatment of OI. A descriptive study for pediatric patients admitted between January 2019 to December 2020 diagnosed with sickle cell disease and diagnosed with osteoarticular infection. All patients were treated with cefixime. Medians and interquartile ranges (IQRs) were used for the descriptive analysis..A total of 260 patients were screened, and 51 cases [osteomyelitis (OM), n = 43, and septic arthritis (SA), n = 8] met the inclusion criteria. The median age of OM patients was 7 years, with males making up 67.4% of the cohort. The median length of IV antibiotics and hospital stays were 10 days and 11 days, respectively. The median total duration of antibiotic use was 37 and 25 days for OM and SA, respectively. The treatment success rate was 88% in OM cases and 100% in SA patients. Readmission was noted in 39.5% of the OM patients, while only 25% of the SA patients were recorded for reinfection..The study's findings revealed that Cefixime is a viable oral alternative for treating osteoarticular infection in pediatric SCD patients. Nonetheless, a prospective investigation is required to corroborate the findings of this study.
• Abraham, I., Alrawashdh, N., Andritsos, L., Mcbride, A., Persky, D., & Slack, M. (2022). Cost-effectiveness and value of information analyses of Bruton's tyrosine kinase inhibitors in the treatment of relapsed or refractory mantle cell lymphoma in the United States.. Journal of managed care & specialty pharmacy, 28(4), 390-400. doi:10.18553/jmcp.2022.28.4.390
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  BACKGROUND: Ibrutinib, acalabrutinib, and zanubrutinib have shown improvements in efficacy and safety over conventional chemoimmunotherapy in refractory or relapsed mantle cell lymphoma (R/R MCL). OBJECTIVE: To evaluate the comparative cost-effectiveness of the Bruton's tyrosine kinase inhibitors (BTKIs) and estimate the expected value of (partial) perfect information (EV[P]PI) in terms of net health benefits (NHBs) and net monetary benefits (NMBs) forgone. METHODS: Using a two-state Markov model (progression-free; progression or death), we estimated in base-case and probabilistic sensitivity analyses (PSAs) the incremental cost-effectiveness (ICER) and cost-utility ratios (ICUR) of, respectively, progression-free survival (PFS) life-years (PFLYs) and PFS quality-adjusted LY (PFQALY) gained (g) against 3-year and 5-year time horizons. A willingness-to-pay threshold of $150,000/PFQALY was used to assess the probability of being cost-effective in the PSA. EVPI was calculated from the respective NHBs and NMBs. RESULTS: Compared with ibrutinib, acalabrutinib yielded a 3-year ICER of $90,571 (PSA = $88,588)/PFLYg and ICUR of $117,098 ($110,063)/PFQALYg, whereas zanubrutinib yielded a 3-year ICER of $58,422 ($58,907)/PFLYg and ICUR of $73,027 ($73,634)/PFQALYg. The corresponding 5-year estimates were ICER of $73,918 ($74,189)/PFLYg and ICUR of $90,512 ($90,844)/PFQALYg for acalabrutinib and ICER of $48,641 ($48,732)/PFLYg and ICUR of $61,612 ($63,727)/PFQALYg for zanubrutinib. Compared with zanubrutinib, treatment with acalabrutinib yielded a 3-year ICER of $144,633 ($134,964)/PFLYg and ICUR of $197,227 ($166,109)/PFQALYg; the corresponding 5-year estimates were $117,579 ($118,161)/PFLYg and $136,144 ($136,818)/PFQALYg. The EVPI/patient was an NHB of 0.036 PFQALYs and NMB of $3,602 forgone, resulting in a population EVPI of $134,766,957 forgone. The EVPPIs/patient for effectiveness were NHB of 0.015 PFQALYs and NMB of $1,479, with corresponding values of 0.032 and $3,187 for costs and 0.015 and $1,519 for health-related quality of life forgone. CONCLUSIONS: This early cost-effectiveness analysis based on phase I/II clinical trials of BTKIs in R/R MCL suggests an additional PFS benefit for second-generation BTKIs compared with ibrutinib. However, the relative uncertainty due to the lack of direct trial evidence may lead to an opportunity cost or lost health benefits if the current evidence is adopted to compare between these products. Additional evidence is needed to address the relative efficacy of the BTKIs. DISCLOSURES: A. McBride serves on speakers bureaus for Coherus BioSciences and Merck. He is now at Bristol-Myers Squibb in a position unrelated to this study. I. Abraham is joint equity owner in Matrix45. By company policy, owners and employees are prohibited from owning equity in client and sponsor organizations (except through mutual funds or other independently administered collective investment instruments), contracting independently with client and sponsor organizations, or receiving compensation independently from such organizations. Matrix45 provides similar services to biopharmaceutical, diagnostics, and medical device companies on a nonexclusivity basis. Of relevance to this article, Matrix45 has not provided any services to this study. I. Abraham is the quantitative methods editor of JAMA Dermatology and deputy editor-in-chief of the Journal of Medical Economics. The remaining authors have no relevant financial or nonfinancial interests to disclose.
• Abraham, I., Alrawashdh, N., Macdonald, K., & Mcbride, A. (2022). Expanded access to anticancer treatments from conversion to biosimilar pegfilgrastim-cbqv in US breast cancer patients.. Future oncology (London, England), 18(3), 363-373. doi:10.2217/fon-2021-0979
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  Aim: To estimate cost-savings from conversion to biosimilar pegfilgrastim-cbqv that could be reallocated to provide budget-neutral expanded access to AC (doxorubicin/cyclophosphamide) and TCH (docetaxel/carboplatin/trastuzumab) in breast cancer (BC) patients. Methods: Simulation modeling in panels of 20,000 BC and 5000 HER2+ (HER2+ BC) patients, varying treatment duration (one-six cycles) and conversion rates (10-100%), to estimate cost-savings and additional AC and TCH treatment that could be provided. Results: In 20,000 patients, cost-savings of $1,083 per-patient per-cycle translate to $21,652,064 (one cycle) to $129,912,397 (six cycles). Savings range from $5,413,016 to $32,478,097, respectively, in the 5000-patient HER2+ BC panel. Conclusion: Conversion to pegfilgrastim-cbqv could save up to $130 million and provide more than 220,000 additional cycles of antineoplastic treatment on a budget-neutral basis to BC patients.
• Abraham, I., Choi, B., Obeng-kusi, M., & Recio-boiles, A. (2022). Network meta-analysis (NMA) of second-line (2L) treatment options in metastatic renal cell carcinoma.. Journal of Clinical Oncology, 40(6_suppl), 337-337. doi:10.1200/jco.2022.40.6_suppl.337
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  337 Background: Immune checkpoint inhibitors, in combination either with a cytotoxic T-lymphocyte-associated protein 4 or tyrosine kinase inhibitor are approved for first-line (1L) therapy of metastatic renal cell carcinoma (mRCC). Of those, several have been shown to improve median progression-free survival (mPFS) in the 2L. A recent NMA by Irbaz et al. (PMID 33824031) identified the most effective 1L treatments for mRCC. In the absence of head-to-head randomized clinical trials (RCT), we performed an indirect comparison of 2L treatments for mRCC. Methods: We conducted literature searches in Medline, Embase, Cochrane Library, and Google Scholar to identify RCTs evaluating 2L treatments in mRCC. We extracted the mPFS hazard ratios (HR) and 95% confidence intervals (CI). We used a normal likelihood model that incorporates log HRs of the treatment differences for conducting the NMA. P-scores, measuring the certainty that one treatment is better than another averaged over all competing treatments, were used to rank treatments. Higher p scores indicate better outcomes. Data were analyzed with R netmeta package v.1.5-0. Results: All 8 therapies included in this analysis showed benefits in mPFS over placebo (Table). The combination of lenvatinib+everolimus had the lowest hazard of disease progression or death and pazopanib was the highest compared to placebo. Lenvatinib+everolimus ranked highest with a p-score of 0.96 followed by cabozantinib (0.88), and lenvatinib (0.79); with others having p-scores of 0.60 or less (placebo p-score 0.00). Conclusions: This NMA revealed that lenvatinib+everolimus and cabozantinib are most likely to produce the highest PFS benefit in 2L in mRCC. Future studies are needed to evaluate 1L and 2L sequencing options to further inform clinical practice. [Table: see text]
• Abraham, I., Geller, R. B., Walden, P. D., & MacDonald, K. (2022). Ex ante budget impact analysis (BIA) of PD-1 inhibitor toripalimab plus gemcitabine-cisplatin (T+GC) versus a simulated pembrolizumab regimen in first line (1L) treatment of recurrent or metastatic nasopharyngeal cancer (rmNPC).. Journal of Clinical Oncology, 40(16_suppl), e18024-e18024. doi:10.1200/jco.2022.40.16_suppl.e18024
• Adamson, A. S., & Abraham, I. (2022). Decision Curve Analysis and the Net Benefit of Novel Tests. JAMA dermatology, 158(6), 684.
• Alamer, A., Asdaq, S. M., AlYamani, M., AlGhadeer, H., Alnasser, Z. H., Aljassim, Z., Albattat, M., Alhajji, A., Alrashed, A., Mozari, Y., Aledrees, A., Almuhainy, B., Abraham, I., & Alamer, A. (2022). Characteristics of mechanically ventilated COVID-19 patients in the Al-Ahsa Region of Saudi Arabia: a retrospective study with survival analysis. Annals of Saudi medicine, 42(3), 165-173.
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  About 5-10% of coronavirus disease 2019 (COVID-19) infected patients require critical care hospitalization and a variety of respiratory support, including invasive mechanical ventilation. Several nationwide studies from Saudi Arabia have identified common comorbidities but none were focused on mechanically ventilated patients in the Al-Ahsa region of Saudi Arabia.
• Alrashed, A., Cahusac, P., Mohzari, Y. A., Bamogaddam, R. F., Alfaifi, M., Mathew, M., Alrumayyan, B. F., Alqahtani, B. F., Alshammari, A., AlNekhilan, K., Binrokan, A., Alamri, K., Alshahrani, A., Alshahrani, S., Alanazi, A. S., Alhassan, B. M., Alsaeed, A., Almutairi, W., Albujaidy, A., , AlJuaid, L., et al. (2022). A comparison of three thromboprophylaxis regimens in critically ill COVID-19 patients: An analysis of real-world data. Frontiers in Cardiovascular Medicine, 9(Issue). doi:10.3389/fcvm.2022.978420
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  Introduction: Thrombotic complications of coronavirus disease 2019 (COVID-19) have received considerable attention. Although numerous conflicting findings have compared escalated thromboprophylaxis doses with a standard dose to prevent thrombosis, there is a paucity of literature comparing clinical outcomes in three different anticoagulation dosing regimens. Thus, we investigated the effectiveness and safety profiles of standard, intermediate, and high-anti-coagulation dosing strategies in COVID-19 critically ill patients. Methodology: This retrospective multicenter cohort study of intensive care unit (ICU) patients from the period of April 2020 to August 2021 in four Saudi Arabian centers. Inclusion criteria were age ≥ 18 years, diagnosis with severe or critical COVID-19 infection, and receiving prophylactic anticoagulant dose within 24–48 h of ICU admission. The primary endpoint was a composite of thrombotic events, with mortality rate and minor or major bleeding serving as secondary endpoints. We applied survival analyses with a matching weights procedure to control for confounding variables in the three arms. Results: A total of 811 patient records were reviewed, with 551 (standard-dose = 192, intermediate-dose = 180, and high-dose = 179) included in the analysis. After using weights matching, we found that the standard-dose group was not associated with an increase in the composite thrombotic events endpoint when compared to the intermediate-dose group {19.8 vs. 25%; adjusted hazard ratio (aHR) =1.46, [95% confidence of interval (CI), 0.94–2.26]} or when compared to high-dose group [19.8 vs. 24%; aHR = 1.22 (95% CI, 0.88–1.72)]. Also, there were no statistically significant differences in overall in-hospital mortality between the standard-dose and the intermediate-dose group [51 vs. 53.4%; aHR = 1.4 (95% CI, 0.88–2.33)] or standard-dose and high-dose group [51 vs. 61.1%; aHR = 1.3 (95% CI, 0.83–2.20)]. Moreover, the risk of major bleeding was comparable in all three groups [standard vs. intermediate: 4.8 vs. 2.8%; aHR = 0.8 (95% CI, 0.23–2.74); standard vs. high: 4.8 vs. 9%; aHR = 2.1 (95% CI, 0.79–5.80)]. However, intermediate-dose and high-dose were both associated with an increase in minor bleeding incidence with aHR = 2.9 (95% CI, 1.26–6.80) and aHR = 3.9 (95% CI, 1.73–8.76), respectively. Conclusion: Among COVID-19 patients admitted to the ICU, the three dosing regimens did not significantly affect the composite of thrombotic events and mortality. Compared with the standard-dose regimen, intermediate and high-dosing thromboprophylaxis were associated with a higher risk of minor but not major bleeding. Thus, these data recommend a standard dose as the preferred regimen.
• Alrashed, A., Cahusac, P., Mohzari, Y. A., Bamogaddam, R. F., Alfaifi, M., Mathew, M., Alrumayyan, B. F., Alqahtani, B. F., Alshammari, A., AlNekhilan, K., Binrokan, A., Alamri, K., Alshahrani, A., Alshahrani, S., Alanazi, A. S., Alhassan, B. M., Alsaeed, A., Almutairi, W., Albujaidy, A., , AlJuaid, L., et al. (2022). A comparison of three thromboprophylaxis regimens in critically ill COVID-19 patients: An analysis of real-world data. Frontiers in cardiovascular medicine, 9, 978420.
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  Thrombotic complications of coronavirus disease 2019 (COVID-19) have received considerable attention. Although numerous conflicting findings have compared escalated thromboprophylaxis doses with a standard dose to prevent thrombosis, there is a paucity of literature comparing clinical outcomes in three different anticoagulation dosing regimens. Thus, we investigated the effectiveness and safety profiles of standard, intermediate, and high-anti-coagulation dosing strategies in COVID-19 critically ill patients.
• Alrawasdh, N., Vraney, J., Choi, B., Almutairi, A., Abraham, I. L., & McBride, A. (2022). Retrospective evaluation of safety and efficectiveness of same-day pegfilgrastim in patients with lung cancer.. Future Oncology, 18, 2381-2390.
• Alrawashdeh, N., McBride, A., Alkhatib, N., Oh, M., Lee, C., Martin, J., MacDonald, K., & Abraham, I. L. (2022). Meta-analysis of same-day pegfilgrastim administration stratified by myelotoxic febrile neutropenia risk and tumor type.. Journal of the Advanced Practitioner in Oncology, 13, 796-810.
• Alrawashdh, N., McBride, A., Erstad, B., Sweasy, J., Persky, D. O., & Abraham, I. (2022). Cost-Effectiveness and Economic Burden Analyses on All First-Line Treatments of Chronic Lymphocytic Leukemia. Value in Health, 25(Issue 10). doi:10.1016/j.jval.2022.04.001
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  Objectives: Several chemoimmunotherapy and targeted treatment regimens are approved as front-line therapies in chronic lymphocytic leukemia. We estimated for the 10-year cost-effectiveness of these treatment regimens and the economic burden of following the estimated risk-stratified 21 040 patients with chronic lymphocytic leukemia diagnosed in 2020 for 10 years. Methods: A Markov model with 7 exclusive health states was specified over a 10-year time horizon. Treatment effectiveness inputs were obtained from a novel network meta-analysis on the progression-free survival, overall survival curves, and time to next treatment. Costs and utilities inputs were included for each health state for each treatment and discounted at 3.0%/year. Life-years (LYs) and quality-adjusted LYs (QALYs) for each treatment were determined. Using the lowest cost regimen as reference, the incremental cost-effectiveness ratio (ICER) and incremental cost-utility ratio (ICUR) were estimated. The 10-year per-patient cost was determined by risk status and by initial treatment. Results: Venetoclax-plus-obinutuzumab was the lowest cost regimen, hence the reference. Superior in effectiveness to all chemoimmunotherapies, it was cost saving. With the highest effectiveness gains at 6.26 LYs and 5.01 QALYs and despite being the most expensive regimen ($1 298 638 per patient), acalabrutinib-plus-obinutuzumab yielded the best ICER ($409 343/LY gained) and ICUR ($501 236/QALY gained). The remaining ICERs of targeted therapies ranged from $512 101/LY gained to $793 236/LY gained and the ICURs from $579 737/QALY gained to $869 300/QALY gained. The 10-year postdiagnosis low/high (venetoclax-plus-obinutuzumab/acalabrutinib-plus-obinutuzumab) economic burden ranges were $42 690 to $98 665 for low-risk, $141 339 to $326 660 for intermediate-risk, and $273 650 to $632 453 for high-risk patients. Conclusions: Compared with venetoclax-plus-obinutuzumab, chemoimmunotherapies are associated with less health benefits at higher cost. The targeted therapies achieve greater benefits at higher cost.
• Alrawashdh, N., McBride, A., Persky, D. O., Slack, M. K., Andritsos, L., & Abraham, I. L. (2021). Cost effectiveness and value of information analyses of bruton’s tyrosine kinase inhibitors in the treatment of relapsed or refractory mantle cell lymphoma in the United States. Journal of Managed Care and Specialty Pharmacy, 28, 390-400.
• Arku, D., Yousef, C., & Abraham, I. (2022). Changing paradigms in detecting rare adverse drug reactions: from disproportionality analysis, old and new, to machine learning. Expert opinion on drug safety, 21(10), 1235-1238.
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  PLAIN LANGUAGE SUMMARYYour physician, pharmacist, nurse, or even you can voluntarily report suspected adverse events associated with drugs. The FDA Adverse Reporting System (FAERS) and the WHO Vigibase are large databases that store individual reports of adverse drug reactions (ADRs). While some ADRs are very common, others are seen rarely. Detecting rare and very rare ADRs is extremely difficult but very important for the safe use of drugs. Databases such as FAERS and WHO Vigibase contain a large amount of data and are commonly used for analysis applying a statistical method called disproportionately analysis. This type of analysis determines whether there is a higher-than-expected number of adverse reactions for a particular drug. In the future, machine learning will complement this process by applying algorithms to the data, constructing and refining rules of inference, and building predictive models of ADRs. This paradigm change in testing for ADRs is expected to provide a better understanding of the factors impacting drug safety.
• Asdaq, S., Suhail, M., Alghadeer, H., Zahra, H. N., Albattat, M., Alrashed, A., Aldrees, A. S., Abraham, I. L., & Alamer, A. (2022). Characteristics of mechanically ventilated COVID-19 patients, Saudi Arabia, Al-Ahsa region: retrospective study. Annals of Saudi Medicine, 42, 165-173.
• Gregg, M., Lee, K. C., & Abraham, I. L. (2022). Journal of Medical Economics in review: the best of 2021. Journal of Medical Economics, 25, 282-286.
• Kim, H. J., Kim, E., Jung, S. O., & Abraham, I. L. (2022). Association of chemotherapy and subjective cognitive impairment in breast cancer patients: meta-analysis of longitudinal studies. European Journal of Oncology Nursing, 57, 102099.
• Lewandrowski, K. U., Abraham, I., León, J. F., Sánchez, J. A., Dowling, Á., Hellinger, S., Ramos, M. R., De Carvalho, P. S., Yeung, C., Salari, N., & Yeung, A. (2022). Differential Agnostic Effect Size Analysis of Lumbar Stenosis Surgeries. International Journal of Spine Surgery, 16(Issue 2). doi:10.14444/8222
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  Study Design: A meta-analysis of 89 randomized prospective, prospective, and retrospective studies on spinal endoscopic surgery outcomes. Objective: The study aimed to provide familiar Oswestry Disability Index (ODI), visual analog scale (VAS ) back, and VAS leg effect size (ES) data following endoscopic decompression for sciatica-type back and leg pain due to lumbar herniated disc, foraminal, or lateral recess spinal stenosis. Background: Higher-grade objective clinical outcome ES data are more suitable than lower-grade clinical evidence, including cross-sectional retrospective study outcomes or expert opinion to underpin the ongoing debate on whether or not to replace some of the traditional open and with other forms of minimally invasive spinal decompression surgeries such as the endoscopic technique. Methods: A systematic search of PubMed, Embase, Web of Science, and the Cochrane Central Register of Controlled Trials from 1 January 2000 to 31 December 2019 identified 89 eligible studies on lumbar endoscopic decompression surgery enrolling 23,290 patient samples using the ODI and VAS for back and leg pain used for the ES calculation. Results: There was an overall mean overall reduction of ODI of 46.25 (SD 6.10), VAS back decrease of 3.29 (SD 0.65), and VAS leg reduction of 5.77 (SD 0.66), respectively. Reference tables of familiar ODI, VAS back, and VAS leg show no significant impact of study design, follow-up, or patients' age on ES observed with these outcome instruments. There was no correlation of ES with long-term follow-up (P = 0.091). Spinal endoscopy produced an overall ODI ES of 0.92 extrapolated from 81 studies totaling 12,710 patient samples. Provided study comparisons to tubular retractor microdiscectomy and open laminectomy showed an ODI ES of 0.9 (2895 patients pooled from 16 studies) and 0.93 (1188 patients pooled from 5 studies). The corresponding VAS leg ES were 0.92 (12,631 endoscopy patients pooled from 81 studies), 0.92 (2348 microdiscectomy patients pooled from 15 studies), and 0.89 (1188 open laminectomy patients pooled from 5 studies). Conclusion: Successful clinical outcomes can be achieved with various lumbar surgeries. ESs with endoscopic spinal surgery are on par with those found with open laminectomy and microsurgical decompression.
• Lewandrowski, K. U., Abraham, I., León, J. F., Telfeian, A. E., Lorio, M. P., Hellinger, S., Knight, M., De Carvalho, P. S., Ramos, M. R., Dowling, Á., Garcia, M. R., Muhammad, F., Hussain, N., Yamamoto, V., Kateb, B., & Yeung, A. (2022). A Proposed Personalized Spine Care Protocol (SpineScreen) to Treat Visualized Pain Generators: An Illustrative Study Comparing Clinical Outcomes and Postoperative Reoperations between Targeted Endoscopic Lumbar Decompression Surgery, Minimally Invasive TLIF and Open Laminectomy. Journal of Personalized Medicine, 12(Issue 7). doi:10.3390/jpm12071065
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  Background: Endoscopically visualized spine surgery has become an essential tool that aids in identifying and treating anatomical spine pathologies that are not well demonstrated by traditional advanced imaging, including MRI. These pathologies may be visualized during endoscopic lumbar decompression (ELD) and categorized into primary pain generators (PPG). Identifying these PPGs provides crucial information for a successful outcome with ELD and forms the basis for our proposed personalized spine care protocol (SpineScreen). Methods: a prospective study of 412 patients from 7 endoscopic practices consisting of 207 (50.2%) males and 205 (49.8%) females with an average age of 63.67 years and an average follow-up of 69.27 months was performed to compare the durability of targeted ELD based on validated primary pain generators versus image-based open lumbar laminectomy, and minimally invasive lumbar transforaminal interbody fusion (TLIF) using Kaplan-Meier median survival calculations. The serial time was determined as the interval between index surgery and when patients were censored for additional interventional and surgical treatments for low back-related symptoms. A control group was recruited from patients referred for a surgical consultation but declined interventional and surgical treatment and continued on medical care. Control group patients were censored when they crossed over into any surgical or interventional treatment group. Results: of the 412 study patients, 206 underwent ELD (50.0%), 61 laminectomy (14.8%), and 78 (18.9%) TLIF. There were 67 patients in the control group (16.3% of 412 patients). The most common surgical levels were L4/5 (41.3%), L5/S1 (25.0%), and L4-S1 (16.3%). At two-year f/u, excellent and good Macnab outcomes were reported by 346 of the 412 study patients (84.0%). The VAS leg pain score reduction was 4.250 ± 1.691 (p < 0.001). No other treatment during the available follow-up was required in 60.7% (125/206) of the ELD, 39.9% (31/78) of the TLIF, and 19.7% (12/61 of the laminectomy patients. In control patients, only 15 of the 67 (22.4%) control patients continued with conservative care until final follow-up, all of which had fair and poor functional Macnab outcomes. In patients with Excellent Macnab outcomes, the median durability was 62 months in ELD, 43 in TLIF, and 31 months in laminectomy patients (p < 0.001). The overall survival time in control patients was eight months with a standard error of 0.942, a lower boundary of 6.154, and an upper boundary of 9.846 months. In patients with excellent Macnab outcomes, the median durability was 62 months in ELD, 43 in TLIF, and 31 months in laminectomy patients versus control patients at seven months (p < 0.001). The most common new-onset symptom for censoring was dysesthesia ELD (9.4%; 20/206), axial back pain in TLIF (25.6%;20/78), and recurrent pain in laminectomy (65.6%; 40/61) patients (p < 0.001). Transforaminal epidural steroid injections were tried in 11.7% (24/206) of ELD, 23.1% (18/78) of TLIF, and 36.1% (22/61) of the laminectomy patients. The secondary fusion rate among ELD patients was 8.8% (18/206). Among TLIF patients, the most common additional treatments were revision fusion (19.2%; 15/78) and multilevel rhizotomy (10.3%; 8/78). Common follow-up procedures in laminectomy patients included revision laminectomy (16.4%; 10/61), revision ELD (11.5%; 7/61), and multilevel rhizotomy (11.5%; 7/61). Control patients crossed over into ELD (13.4%), TLIF (13.4%), laminectomy (10.4%) and interventional treatment (40.3%) arms at high rates. Most control patients treated with spinal injections (55.5%) had excellent and good functional outcomes versus 40.7% with fair and poor (3.7%), respectively. The control patients (93.3%) who remained in medical management without surgery or interventional care (14/67) had the worst functional outcomes and were rated as fair and poor. Conclusions: clinical outcomes were more favorable with lumbar surgeries than with non-surgical control groups. Of the control patients, the crossover rate into interventional and surgical care was 40.3% and 37.2%, respectively. There are longer symptom-free intervals after targeted ELD than with TLIF or laminectomy. Additional intervention and surgical treatments are more often needed to manage new-onset postoperative symptoms in TLIF-and laminectomy compared to ELD patients. Few ELD patients will require fusion in the future. Considering the rising cost of surgical spine care, we offer SpineScreen as a simplified and less costly alternative to traditional image-based care models by focusing on primary pain generators rather than image-based criteria derived from the preoperative lumbar MRI scan.
• Lewandrowski, K. U., Abraham, I., Ramírez León, J. F., Cantú-Leal, R., Longoria, R. C., Sánchez, J. A., & Yeung, A. (2022). A Differential Clinical Benefit Examination of Full Lumbar Endoscopy vs Interspinous Process Spacers in the Treatment of Spinal Stenosis: An Effect Size Meta-Analysis of Clinical Outcomes. International Journal of Spine Surgery, 16(Issue 1). doi:10.14444/8200
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  Study Design: A design-agnostic standardized effect meta-analysis of 48 randomized, prospective, and retrospective studies on clinical outcomes with spinal endoscopic and interspinous process spacer (IPS) surgery. Objective: The study aimed to provide reference set of Oswestry Disability Index (ODI) and visual analog scale (VAS) effect size data for back and leg pain following endoscopic and IPS decompression for lumbar herniated disc, foraminal, or lateral recess spinal stenosis. Background: Mechanical low back pain following endoscopic transforaminal decompression may be more reliably reduced by simultaneous posterior column stabilization with IPS. Methods: A systematic search of the PubMed, EMBASE, Web of Science, and the Cochrane Central Register of Controlled Trials from 1 January 2000 to 2 April 2020, identified 880 eligible endoscopy and 362 IPS studies varying in design and metrics. The authors compared calculated standardized effect sizes (Cohen’s d) for extracted ODI, VAS-back, and VAS-leg data. Results: The pooled standardized effect size combining the ODI, VAS-back, and VAS-leg data for the total sample of 19862 data sets from the 30 endoscopy and 18 IPS was 0.877 (95% CI = 0.857–0.898). When stratified by surgery, the combined effect sizes were 0.877 (95% CI = 0.849–0.905) for endoscopic decompression and 0.863 (95% CI = 0.796–0.930; P = 0.056) for IPS implantation. The ODI effect sizes calculated on 6462 samples with directly visualized endoscopic decompression were 0.917 (95% CI = 0.891–0.943) versus 0.798 (95% CI = 0.713–0.883; P < 0.001) with indirect IPS decompression (P < 0.001). The VAS-back effect sizes calculated on 3672 samples were 0.661 (95% CI = 0.585–0.738) for endoscopy and 0.784 (95% CI: 0.644–0.923; P = 0.187) for IPS. The VAS-leg effect sizes calculated on 7890 samples were 0.885 (95% CI = 0.852–0.917) for endoscopic decompression and 0.851 (95% CI = 0.767–0.935; P = 0.427). Conclusion: Lumbar IPS implantation produces larger reduction in low back pain than spinal endoscopy. On the basis of this meta-analysis, the combination of lumbar transforaminal endoscopy with simultaneous IPS has merits and should be formally investigated in higher grade clinical studies. Clinical Relevance: Meta-analysis on the added clinical benefit of combining lumbar endoscopic decompression with an interspinous process spacer. Level of Evidence: 2.
• Lewandrowski, K. U., Abraham, I., Ramírez León, J. F., Telfeian, A. E., Lorio, M. P., Hellinger, S., Knight, M., De Carvalho, P. S., Ramos, M. R., Dowling, ., Rodriguez Garcia, M., Muhammad, F., Hussain, N., Yamamoto, V., Kateb, B., & Yeung, A. (2022). A Proposed Personalized Spine Care Protocol (SpineScreen) to Treat Visualized Pain Generators: An Illustrative Study Comparing Clinical Outcomes and Postoperative Reoperations between Targeted Endoscopic Lumbar Decompression Surgery, Minimally Invasive TLIF and Open Laminectomy. Journal of personalized medicine, 12(7).
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  Endoscopically visualized spine surgery has become an essential tool that aids in identifying and treating anatomical spine pathologies that are not well demonstrated by traditional advanced imaging, including MRI. These pathologies may be visualized during endoscopic lumbar decompression (ELD) and categorized into primary pain generators (PPG). Identifying these PPGs provides crucial information for a successful outcome with ELD and forms the basis for our proposed personalized spine care protocol (SpineScreen).
• Lewandrowski, K., Abraham, I. L., Leon, J. F., Cantu-Real, R., Longoria, R. C., Sanchez, J. A., & Yeung, A. (2022). A differential benefit examination of full lumbar endoscopy versus interspinous process spacers in the treatment of spinal stenosis: an effect size meta-analysis of clinical outcomes. International Journal of Spine Surgery., 16, 102-123.
• Lewandrowski, K., Abraham, I. L., Leon, J. F., Sanchez, J. A., Dowling, A., Hellinger, S., Ramos, M. R., De Carvalho, P. S., Yeung, C., Salari, N., & Yeung, A. (2022). Differential agnostic effect size analysis of lumbar stenosis surgeries. International Journal of Spine Surgery., 318-342.
• McBride, A., Alrawashdeh, N., MacDonald, K., & Abraham, I. L. (2021). Expanded access to anticancer treatments from conversion to biosimilar pegfilgrastim-cbqv in US breast cancer patients.. Future Oncology.
• McBride, A., Alrawashdh, N., MacDonald, K., & Abraham, I. (2022). Expanded access to anticancer treatments from conversion to biosimilar pegfilgrastim-cbqv in US breast cancer patients. Future oncology (London, England), 18(3), 363-373.
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  To estimate cost-savings from conversion to biosimilar pegfilgrastim-cbqv that could be reallocated to provide budget-neutral expanded access to AC (doxorubicin/cyclophosphamide) and TCH (docetaxel/carboplatin/trastuzumab) in breast cancer (BC) patients. Simulation modeling in panels of 20,000 BC and 5000 HER2+ (HER2+ BC) patients, varying treatment duration (one-six cycles) and conversion rates (10-100%), to estimate cost-savings and additional AC and TCH treatment that could be provided. In 20,000 patients, cost-savings of $1,083 per-patient per-cycle translate to $21,652,064 (one cycle) to $129,912,397 (six cycles). Savings range from $5,413,016 to $32,478,097, respectively, in the 5000-patient HER2+ BC panel. Conversion to pegfilgrastim-cbqv could save up to $130 million and provide more than 220,000 additional cycles of antineoplastic treatment on a budget-neutral basis to BC patients.
• Mohzari, Y. A., Alamer, A., Allatas, M., Alrashed, A. A., Alshebab, N. A., Alkhaldi, T. K., Alamer, A. A., Aljefri, D., Alajami, H. N., Alsowaida, Y. S., Mathew, M., Al-Musawa, M. I., Alomar, M., Alharbi, R. Y., Khujawa, M., Bamogaddam, R. F., Alharthi, A. H., Faqihi, A. Y., Alrummayan, B. F., , Alshareef, A., et al. (2021). Tocilizumab effectiveness in mechanically ventilated COVID-19 patients (T-MVC-19 study): a multicenter retrospective study. Expert Review of Anti-Infective Therapy, 20, 1037-1047.
• Mohzari, Y. A., Alshuraim, R., Asdaq, S. M., Aljobair, F., Alrashed, A., Alsowaida, Y. S., Alamer, A., Al Munjem, M. F., Al Musawa, M. I., Hatata, M., Alzaaqi, M. A., Binrokan, A., Alajlan, S. A., Abraham, I., & Alamer, A. (2022). Early oral switch to combined cefixime therapy for management of osteoarticular infections in pediatric sickle cell disease patients: A descriptive analysis. Journal of infection and public health, 15(1), 1-6.
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  The treatment of osteoarticular infections in pediatric patients with sickle cell disease (SCD) is a challenging task for the practitioner. The aim of this study is to evaluate cefixime for the treatment of osteoarticular infections in pediatric SCD patients by retrospective design.
• Obeng-Kusi, M., & Abraham, I. (2022). Melanoma Epidemiology-Pivoting to Low- and Middle-Income Countries. JAMA dermatology, 158(5), 489-491.
• Obeng-Kusi, M., Erstad, B., Roe, D. J., & Abraham, I. (2022). Comparative value-based pricing of an Ebola vaccine in resource-constrained countries based on cost-effectiveness analysis. Journal of Medical Economics, 25(Issue 1). doi:10.1080/13696998.2022.2091858
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  Objectives: Pricing, affordability, and access are important deliberations around infectious disease interventions. Determining a fair price that not only incentivizes development but ensures value and access for patients is critical given the increasing global health crisis. Using Ebola virus disease (EVD) as an exemplar, we aim to elucidate the estimation of a jurisdiction-specific value-based price (VBP) for a vaccine package and to consider how prices compare across selected countries that have experienced EVD outbreaks. Methods: Using a dynamic transmission model, we assessed the cost-effectiveness of a vaccine package–composed of the vaccine, storage, maintenance, and administration–for vaccination toward herd immunity in 4 countries affected with EVD (Democratic Republic of Congo, Liberia, Sierra Leone, Uganda). Based on the cost-effectiveness metrics and using willingness-to-pay thresholds equal to varying percentages of the Gross Domestic Product (GDP), we demonstrated how a VBP is calculated using a cost-effectiveness-based approach. Results: The VBP for the vaccine is directly proportional to effectiveness (DALYs prevented), cost-effectiveness (ICER) and GDP per capita. Higher effectiveness, greater cost-effectiveness, and higher GDP per capita resulted in higher price ceilings compared to lower cost-effectiveness and lower GDP. Conclusion: Despite the concerns with the cost-effectiveness-based approach, we illustrated that it is an easily comprehensible method for determining the VBP of a vaccine using cost-effectiveness analysis. Choice of data, population characteristics, and disease dynamics are among the factors that need to be considered when comparisons are made across countries.
• Obeng-Kusi, M., Erstad, B., Roe, D. J., & Abraham, I. (2022). Comparative value-based pricing of an Ebola vaccine in resource-constrained countries based on cost-effectiveness analysis. Journal of medical economics, 25(1), 894-902.
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  Pricing, affordability, and access are important deliberations around infectious disease interventions. Determining a fair price that not only incentivizes development but ensures value and access for patients is critical given the increasing global health crisis. Using Ebola virus disease (EVD) as an exemplar, we aim to elucidate the estimation of a jurisdiction-specific value-based price (VBP) for a vaccine package and to consider how prices compare across selected countries that have experienced EVD outbreaks.
• Oh, M., McBride, A., Bhattacharjee, S., Slack, M., Jeter, J., & Abraham, I. (2023). The economic value of knowing BRCA status: BRCA testing for optimizing treatment in recurrent epithelial ovarian cancer. Expert review of pharmacoeconomics & outcomes research.
• Okechukwu, A., & Abraham, I. (2022). Child Maltreatment and the Ecosystem of Socioeconomic Inequities and Inequalities. JAMA network open, 5(7), e2221516.
• Roberson, M., Adamson, A. S., & Skinkai, K. (2022). JAMA Dermatology's commitment to diversity, equity, and inclusion. JAMA Dermatology, 158, 684.
• Skinkai, K. (2022). A tribute to Constance Maria Murphy. JAMA Dermatology, 158, 684.
• Stocking, J. C., Drake, C., Aldrich, J. M., Ong, M. K., Amin, A., Marmor, R. A., Godat, L., Cannesson, M., Gropper, M. A., Romano, P. S., Sandrock, C., Bime, C., Abraham, I., & Utter, G. H. (2022). Outcomes and risk factors for delayed-onset postoperative respiratory failure: a multi-center case-control study by the University of California Critical Care Research Collaborative (UC3RC). BMC Anesthesiology, 22(Issue 1). doi:10.1186/s12871-022-01681-x
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  Background: Few interventions are known to reduce the incidence of respiratory failure that occurs following elective surgery (postoperative respiratory failure; PRF). We previously reported risk factors associated with PRF that occurs within the first 5 days after elective surgery (early PRF; E-PRF); however, PRF that occurs six or more days after elective surgery (late PRF; L-PRF) likely represents a different entity. We hypothesized that L-PRF would be associated with worse outcomes and different risk factors than E-PRF. Methods: This was a retrospective matched case-control study of 59,073 consecutive adult patients admitted for elective non-cardiac and non-pulmonary surgical procedures at one of five University of California academic medical centers between October 2012 and September 2015. We identified patients with L-PRF, confirmed by surgeon and intensivist subject matter expert review, and matched them 1:1 to patients who did not develop PRF (No-PRF) based on hospital, age, and surgical procedure. We then analyzed risk factors and outcomes associated with L-PRF compared to E-PRF and No-PRF. Results: Among 95 patients with L-PRF, 50.5% were female, 71.6% white, 27.4% Hispanic, and 53.7% Medicare recipients; the median age was 63 years (IQR 56, 70). Compared to 95 matched patients with No-PRF and 319 patients who developed E-PRF, L-PRF was associated with higher morbidity and mortality, longer hospital and intensive care unit length of stay, and increased costs. Compared to No-PRF, factors associated with L-PRF included: preexisiting neurologic disease (OR 4.36, 95% CI 1.81–10.46), anesthesia duration per hour (OR 1.22, 95% CI 1.04–1.44), and maximum intraoperative peak inspiratory pressure per cm H20 (OR 1.14, 95% CI 1.06–1.22). Conclusions: We identified that pre-existing neurologic disease, longer duration of anesthesia, and greater maximum intraoperative peak inspiratory pressures were associated with respiratory failure that developed six or more days after elective surgery in adult patients (L-PRF). Interventions targeting these factors may be worthy of future evaluation.
• Stocking, J., Drake, C., Aldrich, J. M., Ong, M. K., Amin, A., Marmor, R. A., Godat, L., Canneson, M., Gropper, M. A., Romano, P., Sandrock, C., Bime, C., Abraham, I. L., & Utter, G. H. (2022). Outcomes and risk factors for delayed-onset postoperative respiratory failure: a multi-center case-control study by the University of California Critical Care Research Collaborative (UC3RC).. BMC Anesthesiology, 22, 146.
• Thiede, R. M., Fazel, M., MacDonald, K. M., & Abraham, I. (2022). Does synthetic pharmacotherapy still have a place in treating chronic spontaneous urticaria?. Expert opinion on pharmacotherapy, 23(14), 1563-1567.
• Abraham, I. L. (2021). Comparative Cost-Efficiency Analysis of Trilaciclib, a Novel CDK4/6 Inhibitor, in the Prophylaxis of Chemotherapy-Induced Myelosuppression. Blood, 138(Supplement 1), 1907-1907. doi:10.1182/blood-2021-146935
• Abraham, I. L. (2021). Conversion to biosimilar pegfilgrastim-cbqv enables budget-neutral access to FOLFIRINOX treatment for metastatic pancreatic cancer. Future Oncology, 17(33), 4561-4570. doi:10.2217/fon-2021-0718
• Abraham, I. L. (2021). Meta-Analysis of Chemotherapy-Induced (Febrile) Neutropenia and Chemotherapy Disruptions Associated with Same-Day Versus Standard (24-72h) Pegfilgrastim Administration in Non-Hodgkin Lymphoma Patients. Blood, 138(Supplement 1), 3011-3011. doi:10.1182/blood-2021-150989
• Abraham, I., Alkhatib, N. S., Alkhdour, O., Calamia, M., Choi, B., Gulick, D., Halawah, H., Manasrah, A., & Mcbride, A. (2021). Economic evaluation of crizotinib, alectinib, ceritinib, and brigatininb in anaplastic lymphoma kinase positive (ALK+) non-small cell lung cancer (NSCLC) as second-line treatment.. Journal of Clinical Oncology, 39(15_suppl), e21104-e21104. doi:10.1200/jco.2021.39.15_suppl.e21104
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  e21104 Background: Crizotinib, alectinib, ceritinib, and brigatinib are approved as second line treatment for ALK+ NSCLC. Crizotinib was the first ALK inhibitor for first line therapy approved by Food and Drug Administration (2011) then ceritinib (2014), alectinib (2015), and brigatinib (2017) were approved as second line drugs. Following more data, these agents were approved as the first line therapy (2017 for ceritinib and alectinib; 2020 for brigatinib). These remain as a treatment option in patients who fail the first line therapy. Cost-effectiveness/utility analyses were conducted to assess clinical efficacy with varying costs of the agents. Methods: A three state Markov model were assumed (progression free, progression and death). Progression free survival (PFS) curves were digitized and fitted with exponential function. US payer perspective, a lifetime horizon, and discount rate of 3% were applied. Drug costs were Redbook wholesale acquisition cost. Other costs included were monitoring, adverse events and disease progression from published data (US$ 2020). Adverse events reported >5% in patients were included. Measured outcomes were PFS life years (PFSLY) and quality adjusted life years (PFSQALY). Crizotinib was the reference drug. Incremental cost-effectiveness and utility ratios (ICER/ICUR) of PFSLY and PFSQALY gained (PFSLYG, PFSQALYG) and lost were estimated. Base case (BCA) and probabilistic sensitivity analyses (PSA) were conducted. Results: Crizotinib was the reference drug for the following outcomes. For alectinib, with the decremental cost of -$14,653 (-$14,712), the incremental PFSLY of 0.16 (0.16) and PFSQALY of 0.05 (0.05) resulted in an ICER / PFSLYG of -$89,337 (-$88,604) and an ICUR / PFSQALYG of -$269,835 (-$266,510). For brigatinib, with the decremental cost of -$14,975 (-$14,954), the incremental PFSLY of 0.01 (0.01) and PFSQALY of ̃0.01 (0.02) yielded an ICER / PFSLYG of -$1,982,962 (-$1,431,631) and an ICUR / PFSQALYG of -$2,140,534 (-$570,538). For ceritinib, with the incremental cost of $7,590 ($7,514), there were decremental PFSLY of -0.01 (-0.01) and PFSQALY of -0.03 (-0.03). Conclusions: As second line treatment, crizotinib, ceritinib, and brigatinib had comparable PFSLYs and PFSQALYs while alectinib had the most PFSLY and PFSQALY and the lowest cost. Therefore, alectinib is the most cost-effective treatment for treating ALK+ NSCLC as the second line therapy.[Table: see text]
• Abraham, I., Alrawashdh, N., Bartels, T., Mcbride, A., Moore, L., & Persky, D. O. (2021). Evaluation of same day pegfilgrastim (PFG) or PFG-cbqv prophylaxis of chemotherapy induced (Febrile) neutropenia (CIN/FN) in bendamustine plus rituximab (BR) and CHOP+/-R regimens in patients with lymphoma and chronic lymphocytic leukemia (CLL): Real-world, single-center experience.. Journal of Clinical Oncology, 39(15_suppl), e19541-e19541. doi:10.1200/jco.2021.39.15_suppl.e19541
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  e19541 Background: BR and CHOP+/-R regimens are considered an intermediate FN risk (10-20%) per guidelines. Patients (pts) receiving these regimens need to be assessed for FN prophylaxis using specific risk factors. Current guidelines suggest waiting 24 hours post chemotherapy (CTX) to administer PFG due to an increased FN risk. Studies have shown equivocal outcomes between same day (D1) and next day (D2) administration. We evaluated real-world outcomes associated with D1 and D2 PFG administration in pts with lymphoma and CLL treated with these two regimens. Methods: Retrospective chart review of lymphoma or CLL pts treated with CHOP+/-R or BR and PFG or a biosimilar from 11/2013 through 11/2020 at the University of Arizona Cancer Center was conducted. Two pt cohorts were analyzed based on D1 vs D2 PFG administration timing. Outcomes of interest were the incidence of FN across all CTX cycles and after cycle 1, CIN grade 3/4, hospitalizations, antibiotics administration, and CTX dose reduction or delay. A secondary analysis compared the incidence of FN in pts receiving CHOP+/-R in our study with published studies (Burris et al, 2010 and Cheng et al, 2014) of D1 PFG in lymphoma pts. Results: Of the 116 pts meeting inclusion criteria, 103 received PFG on D1 and 13 on D2 of CTX. As shown in the Table, the incidence of 1st cycle FN was 6% vs 8% (P>0.05), FN across all cycles was 4% vs 5% (P>0.05), CIN grade 3/4, hospitalization, anti-biotic administration and dose delays/reductions incidences were 11% vs 16% (P>0.05), 8% vs 11% (P>0.05), 6% vs 32% (P=0.001), 11% vs 5% (P>0.05) for D1 vs D2, respectively. The incidence of 1st cycle FN in D1 cohort was 6% vs 19% (P=0.15) and 11% (P=0.67) in our study vs Burris et al and Cheng et al, respectively. While the incidence of FN across all cycles in D1 group was 5% vs 9% (P=0.03) and 17% (P=0.001) in our study vs Burris et al and Cheng et al, respectively. Conclusions: This data provides evidence that D1 PFG/PFG-cbqv does not increase FN or delayed engraftment risk as compared to previously published studies in lymphoma and may be safe to use after CTX has been administered.[Table: see text]
• Abraham, I., Alrawashdh, N., Calamia, M., Choi, B., Mcbride, A., & Obeng-kusi, M. (2021). Economic evaluation of six and 12 month (m) treatment with isatuximab and carfilzomib and dexamethasone (IKd) versus daratumumab and carfilzomib and dexamethasone (DKd) in patients with relapsed or refractory multiple myeloma (RRMM).. Journal of Clinical Oncology, 39(15_suppl), e20010-e20010. doi:10.1200/jco.2021.39.15_suppl.e20010
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  e20010 Background: Isatuximab and daratumumab target the CD38 transmembrane glycoprotein on MM cells. IKd and DKd regimens have shown reductions of HR=0.53 (95%CI 0.32-0.89) and HR=0.63 (95%CI 0.46-0.85) resp. in progression or death risk compared to Kd in RRMM. In the absence of a direct IKd vs DKd trial, we performed an indirect treatment comparison on progression free survival (PFS) to enable cost-effectiveness analyses. Methods: A 3-state (pre-progression, progression, death) partitioned survival model was specified. NMA-adjusted transition probabilities were estimated from fitted exponential functions (time horizon of 6 and 12 m; cycle length 28 days). Inputs included the Wholesale Acquisition Cost of IKd, DKd, and premedications; cost of medication administration; and cost of adverse event management. Utility inputs for pre-progression (0.65) and progression (0.61) were per literature. Costs and utilities were discounted at 3.5%/y. A payer perspective was adopted. Life years (LY), quality adjusted LY (QALY), and incremental cost-effectiveness (ICER) and cost-utility ratios (ICUR) were estimated in base case (BCA) and probabilistic sensitivity analyses (PSA). Cost-effectiveness acceptability curves (CEAC) were generated. Results: As detailed in the Table, 6m of IKd treatment was associated with incremental gains of 0.01 (PSA 0.01) LYs but no gains in QALYs at cost savings of $24,188 ($23,762), yielding a dominant ICER of $ -2,418,800 ($-2,376,200) per LYg (ICUR not estimable). Further, 12m of IKd treatment was associated with incremental gains of 0.04 (PSA 0.04) LYs (or 0.48m) and 0.02 (0.03) QALYs at incremental cost of $1,585 ($2,239), yielding ICER of $39,625 ($55,975) per LYg and ICUR of $79,250 ($74,633) per QALYg. Per CEAC, IKd is the dominated strategy in the 6m model and had probability of 50% of being cost-effective at WTP of $100,000 in the 12m model. Conclusions: Clinically, compared to DKd, IKd is associated with slight incremental gains in LYs of 0.12m over 6m and 0.48m over 1y. The 6m clinical gain comes with cost savings of approximately $24,000 or about 15% of IKd therapy, while the 12m gain requires a minimal cost commitment of around $2,000 or 0.6% of DKd treatment. These findings imply a clinico-economic benefit of isatuximab compared to daratumumab containing regimens in RRMM. [Table: see text]
• Abraham, I., Onyekwere, U., Deniz, B., Moran, D., Chioda, M., MacDonald, K., & Huang, H. (2021). Trilaciclib and the economic value of multilineage myeloprotection from chemotherapy-induced myelosuppression among patients with extensive-stage small cell lung cancer treated with first-line chemotherapy. Journal of Medical Economics, 24(Issue 1). doi:10.1080/13696998.2021.2014163
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  Aims: Proliferating hematopoietic stem and progenitor cells (HSPCs) are susceptible to chemotherapy-induced damage, resulting in myelosuppressive adverse events (AEs) such as neutropenia, anemia, and thrombocytopenia that are associated with high health care costs and decreased quality of life (QoL). In this study, a trial-based cost-effectiveness analysis was performed to help assess the economic impact of administering trilaciclib, a myeloprotective therapy that protects multilineage HSPCs from chemotherapy-induced damage, prior to standard first-line chemotherapy, using data from a pivotal Phase II study of trilaciclib in the setting of extensive-stage small cell lung cancer (ES-SCLC, NCT03041311). Method: The aim of this study was to assess the cost-effectiveness of administering trilaciclib prior to chemotherapy versus chemotherapy alone among patients with ES-SCLC from a United States payer perspective. Data on the rate and frequency of myelosuppressive AEs and health utility were derived from the pivotal study of trilaciclib. Costs of managing myelosuppressive AEs and costs of chemotherapy treatment were sourced from published literature. Outcomes included the number of myelosuppressive AEs, costs (in 2021 US dollars), quality-adjusted life-years (QALYs), incremental cost, incremental QALY, and an incremental cost-effectiveness ratio. Results: Administering trilaciclib prior to chemotherapy was associated with a reduction in neutropenia (82%), febrile neutropenia (75%), anemia (43%), and thrombocytopenia (96%) compared with chemotherapy alone. Additionally, trilaciclib prior to chemotherapy was cost-saving compared with chemotherapy alone ($99,919 vs $118,759, respectively) and associated with QALY improvement (0.150 vs 0.145, respectively). Probabilistic sensitivity analyses showed 58% of iterations projecting cost savings and QALY improvement with trilaciclib. Conclusions: The findings suggest that the use of trilaciclib prior to first-line chemotherapy in patients with ES-SCLC can be cost-beneficial owing to fewer myelosuppressive AEs and lower costs, together with a favorable QoL profile.
• Abraham, I., Onyekwere, U., Deniz, B., Moran, D., Chioda, M., MacDonald, K., & Huang, H. (2021). Trilaciclib and the economic value of multilineage myeloprotection from chemotherapy-induced myelosuppression among patients with extensive-stage small cell lung cancer treated with first-line chemotherapy. Journal of medical economics, 24(sup1), 71-83.
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  Proliferating hematopoietic stem and progenitor cells (HSPCs) are susceptible to chemotherapy-induced damage, resulting in myelosuppressive adverse events (AEs) such as neutropenia, anemia, and thrombocytopenia that are associated with high health care costs and decreased quality of life (QoL). In this study, a trial-based cost-effectiveness analysis was performed to help assess the economic impact of administering trilaciclib, a myeloprotective therapy that protects multilineage HSPCs from chemotherapy-induced damage, prior to standard first-line chemotherapy, using data from a pivotal Phase II study of trilaciclib in the setting of extensive-stage small cell lung cancer (ES-SCLC, NCT03041311).
• Alamer, A. A., Almulhim, A. S., Alrashed, A. A., & Abraham, I. (2021). Mortality, Severity, and Hospital Admission among COVID-19 Patients with ACEI/ARB Use: A Meta-Analysis Stratifying Countries Based on Response to the First Wave of the Pandemic. Healthcare (Basel, Switzerland), 9(2).
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  The use of angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs) is controversial for treating COVID-19 patients. We aimed to estimate pooled risks of mortality, disease severity, and hospitalization associated with ACEI/ARB use and stratify them by country and country clusters.
• Alamer, A. A., Almulhim, A. S., Alrashed, A. A., & Abraham, I. (2021). Mortality, severity, and hospital admission among covid-19 patients with acei/arb use: A meta-analysis stratifying countries based on response to the first wave of the pandemic. Healthcare (Switzerland), 9(Issue 2). doi:10.3390/healthcare9020127
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  Background: The use of angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs) is controversial for treating COVID-19 patients. We aimed to estimate pooled risks of mortality, disease severity, and hospitalization associated with ACEI/ARB use and stratify them by country and country clusters. Methods: We conducted a search in various databases through 4 July 2020 and then applied random-effects models to estimate pooled risks (ORp) across stratifications by country cluster. Clusters were chosen to reflect outbreak times (China followed by Korea/Italy, others subsequently) and mobility restrictions (China and Denmark/France/Spain with stricter lockdowns than the UK/US). Results: Overall analysis showed no increase in mortality; however, a statistical increase in mortality was seen in the US/UK cluster with ORp = 1.28 [95% CI = 1.04; 1.56] and a decrease in China with ORp = 0.65 [95% CI = 0.43; 0.96] and France with OR = 0.31 [95% CI = 0.14; 0.69]. Severity and hospitalization were not statistically significant in the analysis; however, several associations were seen in specific countries but not in country clusters. Conclusion: The country-cluster meta-analysis provided a reasonable explanation for COVID-19 mortality among ACEI/ARB users. The analysis did not explain differences in severity and suggested the involvement of other factors. Hospitalization findings among ACEI/ARB users may be considered informative as they may have been subjected to clinical decisions and hospital-bed availability.
• Alamer, A., Almulhim, A., Alrashed, A., & Abraham, I. L. (2021). Mortality, severity, and hospital admission among COVID-19 patients with ACEI/ARB use: a meta-analysis stratifying countries based on response to the first wave of the pandemic.. Healthcare, Revision.
• Alamer, A., Alrashed, A. A., Alfaifi, M., Alosaimi, B., AlHassar, F., Almutairi, M., Howaidi, J., Almutairi, W., Mohzari, Y., Sulaiman, T., Al-Jedai, A., Alajami, H. N., Alkharji, F., Alsaeed, A., Alali, A. H., Baredhwan, A. A., Abraham, I., & Almulhim, A. S. (2021). Effectiveness and safety of favipiravir compared to supportive care in moderately to critically ill COVID-19 patients: a retrospective study with propensity score matching sensitivity analysis. Current medical research and opinion, 37(7), 1085-1097.
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  Favipiravir is a repurposed drug to treat coronavirus 2019 (COVID-19). Due to a lack of available real-world data, we assessed its effectiveness and safety in moderately to critically ill COVID-19 patients.
• Algotar, A. M., Hsu, C. H., Chow, H. H., Dougherty, S. T., Babiker, H. M., Marrero, D. G., Abraham, I., Kumar, R., Ligibel, J. A., Courneya, K. S., Smith, T. E., Jones, P. A., Lopez, J. N., Niemiro, G., Ramakumar, S., Hoy, R. D., Mack, C., & Thomson, C. A. (2021). Comprehensive Lifestyle Improvement Program for Prostate Cancer (CLIPP) is associated with improvement in weight and components of metabolic syndrome in men exposed to androgen deprivation therapy for prostate cancer. Prostate Cancer and Prostatic Diseases, 24(Issue 3). doi:10.1038/s41391-021-00346-z
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  Background: Androgen deprivation therapy (ADT) for prostate cancer is associated with adverse effects, such as obesity and metabolic syndrome, which increase cardiovascular risk, the most common cause of non-cancer mortality in men diagnosed with prostate cancer. The Comprehensive Lifestyle Improvement Program for Prostate Cancer (CLIPP) was created to determine the feasibility of conducing a comprehensive lifestyle modification intervention in men on ADT for prostate cancer and determine its early efficacy in reducing obesity and metabolic syndrome. Methods: A single-arm, open-label clinical trial was conducted by recruiting 31 men diagnosed with prostate cancer and exposed to ADT within the last 5 years. A multicomponent lifestyle modification program was delivered weekly for 16 weeks by a trained health coach. This was followed by 8 weeks of passive follow-up resulting in a total trial duration of 24 weeks. Feasibility was determined by calculating study recruitment, retention, and adherence rates. Weight and components of metabolic syndrome (waist circumference, triglycerides (TG), high-density lipoprotein (HDL), serum glucose, and blood pressure (BP)) were measured at baseline, 12, and 24 weeks. Results: Recruitment, retention, and adherence rates were 47.1%, 90.3%, and 100%, respectively. Statistically significant improvements were noted between baseline and end of study measurements for weight (206.3 vs. 191.3 lbs, p < 0.001), waist (41.3 vs. 38.8 inches, p < 0.001), systolic BP (144.1 vs. 133.4 mm of Hg, p = 0.014), diastolic BP (83.3 vs. 76.2 mm of Hg, p = 0.0056), TG (146.0 vs. 113.8 mg/dl, p = 0.022), HDL (51.1 vs. 55.0 mg/dl, p = 0.012), and serum glucose (114.0 vs. 103.2 mg/dl, p = 0.013). Conclusion: CLIPP demonstrates feasibility and early efficacy of a multicomponent lifestyle modification intervention toward addressing obesity as well as components of metabolic syndrome in men on ADT for prostate cancer. This study provides strong preliminary data to develop future clinical trials in this population.
• Algotar, A. M., Hsu, C. H., Chow, H. H., Dougherty, S. T., Babiker, H. M., Marrero, D. G., Abraham, I., Kumar, R., Ligibel, J. A., Courneya, K. S., Smith, T. E., Jones, P. A., Lopez, J. N., Niemiro, G., Ramakumar, S., Hoy, R. D., Mack, C., & Thomson, C. A. (2021). Comprehensive Lifestyle Improvement Program for Prostate Cancer (CLIPP) is associated with improvement in weight and components of metabolic syndrome in men exposed to androgen deprivation therapy for prostate cancer. Prostate cancer and prostatic diseases, 24(3), 903-909.
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  Androgen deprivation therapy (ADT) for prostate cancer is associated with adverse effects, such as obesity and metabolic syndrome, which increase cardiovascular risk, the most common cause of non-cancer mortality in men diagnosed with prostate cancer. The Comprehensive Lifestyle Improvement Program for Prostate Cancer (CLIPP) was created to determine the feasibility of conducing a comprehensive lifestyle modification intervention in men on ADT for prostate cancer and determine its early efficacy in reducing obesity and metabolic syndrome.
• Algotar, A. M., Kumar, R., Babiker, H. M., Dougherty, S. T., Hsu, C. H., Chow, H. H., Smith, T. E., Marrero, D. G., Courneya, K. S., Abraham, I., Ligibel, J. A., & Thomson, C. A. (2021). Protocol for a feasibility and early efficacy study of the Comprehensive Lifestyle Improvement Program for Prostate Cancer-2 (CLIPP2). Contemporary Clinical Trials Communications, 21(Issue). doi:10.1016/j.conctc.2021.100701
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  Background: Although androgen deprivation therapy (ADT) for prostate cancer demonstrates improved overall and disease-free survival, it is associated with adverse effects such as obesity and metabolic syndrome that increase risk of cardiometabolic disease and diabetes type 2. ADT also leads to fatigue, depression and erectile dysfunction, which reduce quality of life (QoL). Lifestyle modification has shown promise in reducing obesity, metabolic syndrome and diabetes type 2 in other disease types. However, there is a paucity of data regarding the utility of lifestyle modification in men receiving ADT for prostate cancer. Methods: The primary aim of the Comprehensive Lifestyle Improvement Program for Prostate Cancer-2 (CLIPP2) is to test the feasibility of conducting a 24-week lifestyle modification intervention in men on ADT for prostate cancer. Additionally, it will also determine the effect of this intervention on weight loss, cardiometabolic markers (secondary aim and markers of interest: serum glucose, insulin resistance, hemoglobin A1C and lipid panel), and QoL (tertiary aim). The intervention will be delivered weekly via telephone for the first 10 weeks and bi-weekly for the remaining 14 weeks. Questionnaires and serum samples will be collected at baseline, week 12, and week 24. Anthropometric measurements will be collected at baseline, week 6, week 12, week 18 and week 24. Results: We hypothesize that the CLIPP2 intervention will produce a 7% weight loss that will result in improved markers associated with cardiometabolic disease and type 2 diabetes in the study population. Conclusion: Results will provide insight into the role of lifestyle modification in addressing ADT adverse effects as well as provide preliminary data to inform the development of future lifestyle interventions in this area. Trial registration: NCT04228055 Clinicaltrials. gov.
• Algotar, A., Hsu, C., Chow, H., Dougherty, S. T., Babiker, H. M., Marrero, D., Abraham, I. L., Kumar, R., Ligibel, J. A., Courneya, C. S., Smith, T. E., Jones, P. A., Lopes, J., Niemiro, G., Ramakumar, S., Hoy, R., Mack, C., & Thomson, C. A. (2020). Comprehensive Lifestyle Improvement Program for Prostate Cancer (CLIPP) is associated wth improvement in weight and components of metabolic syndrome in men on androgen deprivation therapy for prostate cancer. Prostate Cancer and Prostatic Diseases.
• Algotar, A., Kumar, R., Babiker, H. M., Dougherty, S. T., Hsu, C., Chow, H., Smith, T. E., Marrero, D., Courneya, C. S., Abraham, I. L., Ligibel, J. A., & Thomson, C. A. (2021). Protocol for a feasibility study and early efficacy study of a Comprehensive Lifestyle Improvement Program for Prostate Cancer-2 (CLIPP2).. Contemporary Clinical Trials Communications, 21, 100701.
• Alkhatib, N., Sweitzer, N. K., Lee, C. S., Erstad, B., Slack, M., Gharaibeh, M., Karnes, J., Klimecki, W., Ramos, K., & Abraham, I. (2021). Ex Ante Economic Evaluation of Arg389 Genetically Targeted Treatment with Bucindolol versus Empirical Treatment with Carvedilol in NYHA III/IV Heart Failure. American Journal of Cardiovascular Drugs, 21(Issue 2). doi:10.1007/s40256-020-00425-x
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  Objective: The Beta-Blocker Evaluation Survival Trial showed no survival benefit for bucindolol in New York Heart Association (NYHA) class III/IV heart failure (HF) with reduced ejection fraction, but subanalyses suggested survival benefits for non-Black subjects and Arg389 homozygotes. We conducted an ex ante economic evaluation of Arg389 targeted treatment with bucindolol versus carvidolol, complementing a previous ex ante economic evaluation of bucindolol preceded by genetic testing for the Arg389 polymorphism, in which genetic testing prevailed economically over no testing. Methods: A decision tree analysis with an 18-month time horizon was performed to estimate the cost effectiveness/cost utility of trajectories of 100%, 50%, and 0% of patients genetically tested for Arg389 and comparing bucindolol with empirical carvedilol treatment as per prior BEST subanalyses. Incremental cost-effectiveness/cost-utility ratios (ICERs/ICURs) were estimated. Results: Race-based analyses for non-White subjects at 100% testing showed a loss of (0.04) life-years and (0.03) quality-adjusted life-years (QALYs) at an incremental cost of $2185, yielding a negative ICER of ($54,625)/life-year and ICUR of ($72,833)/QALY lost; at 50%, the analyses showed a loss of (0.27) life-years and (0.16) QALYs at an incremental cost of $1843, yielding a negative ICER of ($6826)/life-year and ICUR of ($11,519)/QALY lost; at 0%, the analyses showed a loss of (0.33) life-years and (0.30) QALYs at an incremental cost of $1459, yielding a negative ICER of ($4421)/life-year and ICUR of ($4863)/QALY lost. Arg389 homozygote analyses at 100% testing showed incremental gains of 0.02 life-years and 0.02 QALYs at an incremental cost of $378, yielding an ICER of 18,900/life-year and ICUR of $18,900/QALY gained; at 50%, the analyses showed a loss of (0.24) life-years and (0.09) QALYs at an incremental cost of $1039, yielding a negative ICER of ($4329)/life-year and ICUR of ($9336)/QALY lost; at 0%, the analyses showed a loss of (0.33) life-years and (0.30) QALYs at an incremental cost of $1459, yielding a negative ICER of ($4421)/life-year and ICUR of ($4863)/QALY lost. Conclusion: This independent ex ante economic evaluation suggests that genetically targeted treatment with bucindolol is unlikely to yield clinicoeconomic benefits over empirical treatment with carvedilol in NYHA III/IV HF.
• Alkhatib, N., Sweitzer, N. K., Lee, C. S., Erstad, B., Slack, M., Gharaibeh, M., Karnes, J., Klimecki, W., Ramos, K., & Abraham, I. (2021). Ex Ante Economic Evaluation of Arg389 Genetically Targeted Treatment with Bucindolol versus Empirical Treatment with Carvedilol in NYHA III/IV Heart Failure. American journal of cardiovascular drugs : drugs, devices, and other interventions, 21, 205-217. doi:10.1007/s40256-020-00425-x
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  The Beta-Blocker Evaluation Survival Trial showed no survival benefit for bucindolol in New York Heart Association (NYHA) class III/IV heart failure (HF) with reduced ejection fraction, but subanalyses suggested survival benefits for non-Black subjects and Arg389 homozygotes. We conducted an ex ante economic evaluation of Arg389 targeted treatment with bucindolol versus carvidolol, complementing a previous ex ante economic evaluation of bucindolol preceded by genetic testing for the Arg389 polymorphism, in which genetic testing prevailed economically over no testing.
• Almutairi, A. R., Erstad, B. L., McBride, A., Slack, M., & Abraham, I. (2021). Immune checkpoint inhibitors-associated risk of immune-related hypothyroidism in older patients with advanced melanoma: a real-world analysis of US SEER-Medicare data. Expert Opinion on Drug Safety, 20(Issue 4). doi:10.1080/14740338.2021.1877272
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  Background: The risk of immune-related(ir)-hypothyroidism in older patients with advanced melanoma treated with anti-CTLA4 or anti-PD1 therapies is poorly understood, especially in the real-world setting. Research design and methods: We identified older patients (≥65 years) diagnosed with advanced melanoma between 2011-2015 and treated with anti-CTLA4 or anti-PD1 agents in the SEER-Medicare database. Applying probability-of-treatment-weighting for confounder adjustment and proportional hazards models, we estimated the risk of ir-hypothyroidism between treatment initiation and up to 90 days from last dose between anti-PD1 and anti-CTLA4 users. Results: Of 210 older patients with advanced melanoma identified, 164 received anti-CTLA4 (ipilimumab) and 46 anti-PD1 agents (11 nivolumab, 35 pembrolizumab). There was no statistically significant difference in ir-hypothyroidism risk between anti-PD1 and anti-CTLA4 users (HR=2.15, 95%CI=0.83-5.53). Pairwise medication comparisons showed a lower risk among ipilimumab versus nivolumab (HR=0.15, 95%CI=0.06-0.40) and pembrolizumab versus nivolumab users (HR=0.13, 95%CI=0.03-0.55). Sensitivity analyses using an all-stages melanoma cohort did not show a difference in ir-hypothyroidism risk between medication classes and individual medications. Conclusions:This retrospective claims data analysis revealed no statistically significant difference in ir-hypothyroidism risk between anti-CTLA4 or anti-PD1 users. However, patients with advanced melanoma treated with ipilimumab or pembrolizumab may have a lower ir-hypothyroidism risk compared to nivolumab users.
• Almutairi, A. R., Erstad, B. L., McBride, A., Slack, M., & Abraham, I. (2021). Immune checkpoint inhibitors-associated risk of immune-related hypothyroidism in older patients with advanced melanoma: a real-world analysis of US SEER-Medicare data. Expert opinion on drug safety, E-publication ahead of print. doi:10.1080/14740338.2021.1877272
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  The risk of immune-related(ir)-hypothyroidism in older patients with advanced melanoma treated with anti-CTLA4 or anti-PD1 therapies is poorly understood, especially in the real-world setting.
• Almutairi, A. R., Slack, M., Erstad, B. L., McBride, A., & Abraham, I. (2021). Association of immune-checkpoint inhibitors and the risk of immune-related colitis among elderly patients with advanced melanoma: real-world evidence from the SEER-Medicare database. Therapeutic advances in drug safety, 12, 2042098621991279.
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  The use of anti-cytotoxic T-lymphocyte antigen 4 (anti-CTLA4) therapy (ipilimumab) and anti-programmed cell-death 1 (anti-PD1) agents (nivolumab and pembrolizumab) in advanced melanoma have been associated with immune-related adverse events (irAEs) including colitis. We aimed to estimate the incidence and the risk of colitis in elderly patients with advanced melanoma treated with anti-CTLA4 and anti-PD1 in the real-world setting.
• Almutairi, A. R., Slack, M., Erstad, B. L., McBride, A., & Abraham, I. (2021). Association of immune-checkpoint inhibitors and the risk of immune-related colitis among elderly patients with advanced melanoma: real-world evidence from the SEER–Medicare database. Therapeutic Advances in Drug Safety, 12(Issue). doi:10.1177/2042098621991279
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  Background: The use of anti-cytotoxic T-lymphocyte antigen 4 (anti-CTLA4) therapy (ipilimumab) and anti-programmed cell-death 1 (anti-PD1) agents (nivolumab and pembrolizumab) in advanced melanoma have been associated with immune-related adverse events (irAEs) including colitis. We aimed to estimate the incidence and the risk of colitis in elderly patients with advanced melanoma treated with anti-CTLA4 and anti-PD1 in the real-world setting. Methods: Elderly patients (age ⩾ 65 years) diagnosed with advanced melanoma between 2011 and 2015 and treated with anti-CTLA4 or anti-PD1 agents were identified from the Surveillance, Epidemiology, and End Results (SEER)–Medicare data. We estimated the risk of colitis from start of treatment up to 90 days from the last dose of therapy. We used the log-rank test and logistic regression with adjustment for potential confounders using the inverse probability of treatment weighting method. We conducted several sensitivity analyses. Results: A total of 274 elderly patients with advanced melanoma were included in our cohort. The risk of colitis was similar between anti-PD1 users and anti-CTLA4 users based on log-rank test (p = 0.17) and logistic regression [odds ratio (OR) = 0.35, 95% confidence interval (95%CI) 0.04–2.79]. Sensitivity analyses for patients with all-stage melanoma showed a significantly lower risk of colitis in anti-PD1 compared with anti-CTLA4 treated patients based on log-rank test (p = 0.017) and logistic regression (OR = 0.21, 95%CI 0.09–0.53). Conclusion: Elderly with advanced melanoma treated with anti-CTLA4 or anti-PD1 had a similar risk of developing colitis. However, there was a statistically significant difference in the risk of colitis between anti-CTLA4 or anti-PD1 users among all-stage-melanoma patients. Plain Language Summary: Risk of colitis (inflammation of the large intestine) in elderly patients with melanoma treated with immune-checkpoint inhibitors (a group of medications that uses the patient’s immune system to fight cancer) While the anti-cancer agents known as immune-checkpoint inhibitors have had a great impact on the treatment of melanoma, they may also have side effects. This study estimated the risk of colitis, a chronic inflammation of the colon, in elderly patients with melanoma treated with anti-cytotoxic T-lymphocyte antigen 4 (anti-CTLA4) or anti-programmed cell-death 1 (anti-PD1) agents, using data from the Surveillance, Epidemiology, and End Results (SEER)–Medicare linked database. Overall, we found that the risk of colitis was not different between anti-PD1 users and anti-CTLA4 users with advanced-stage melanoma. However, after including patients across all stages of melanoma, we found a significantly lower risk of colitis with anti-PD1 compared with anti-CTLA4.
• Almutairi, A., Slack, M. K., Erstad, B. L., McBride, A., & Abraham, I. L. (2021). Association of immune checkpoint inhibitors and the risk of immune-related colitis among elderly patients with advanced melanoma: real-world evidence from the SEER-Medicare database. Therapeutic Advances in Drug Safety.
• Alrashed, A. A., Alrashed, A. A., Khan, T. M., Khan, T. M., Alhusseini, N. K., Alhusseini, N. K., Asdaq, S. M., Asdaq, S. M., Enani, M., Enani, M., Alosaimi, B., Alosaimi, B., Alkhani, N. M., Alkhani, N. M., Mohzari, Y., Mohzari, Y., Alghalbi, M. M., Alghalbi, M. M., Alfahad, W., , Alfahad, W., et al. (2021). Severity of COVID-19 infection in ACEI/ARB users in specialty hospitals: A retrospective cohort study. Journal of Infection and Public Health, 14(Issue 6). doi:10.1016/j.jiph.2021.03.004
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  Background: The uncertainty about COVID-19 outcomes in angiotensin-converting enzyme inhibitors (ACEI)/angiotensin receptor blockers (ARB) users continues with contradictory findings. This study aimed to determine the effect of ACEI/ARB use in patients with severe COVID-19. Methods: This retrospective cohort study was done in two Saudi public specialty hospitals designated as COVID-19 referral facilities. We included 354 patients with a confirmed diagnosis of COVID-19 between April and June 2020, of which 146 were ACEI/ARB users and 208 were non-ACEI/ARB users. Controlling for confounders, we conducted multivariate logistic regression and sensitivity analyses using propensity score matching (PSM) and Inverse propensity score weighting (IPSW) for high-risk patient subsets. Results: Compared to non-ACEI/ARB users, ACEI/ARB users had an eight-fold higher risk of developing critical or severe COVID-19 (OR = 8.25, 95%CI = 3.32–20.53); a nearly 7-fold higher risk of intensive care unit (ICU) admission (OR = 6.76, 95%CI = 2.88–15.89) and a nearly 5-fold higher risk of requiring noninvasive ventilation (OR = 4.77,95%CI = 2.15–10.55). Patients with diabetes, hypertension, and/or renal disease had a five-fold higher risk of severe COVID-19 disease (OR = 5.40,95%CI = 2.0−14.54]. These results were confirmed in the PSM and IPSW analyses. Conclusion: In general, but especially among patients with hypertension, diabetes, and/or renal disease, ACEI/ARB use is associated with a significantly higher risk of severe or critical COVID-19 disease, and ICU care.
• Alrashed, A. A., Khan, T. M., Alhusseini, N. K., Asdaq, S. M., Enani, M., Alosaimi, B., Alkhani, N. M., Mohzari, Y., Alghalbi, M. M., Alfahad, W., Alanazi, M. A., Albujaidya, A. S., Ben-Akresh, A., Almutairi, M., Abraham, I., & Alamer, A. (2021). Severity of COVID-19 infection in ACEI/ARB users in specialty hospitals: A retrospective cohort study. Journal of infection and public health, 14(6), 726-733.
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  The uncertainty about COVID-19 outcomes in angiotensin-converting enzyme inhibitors (ACEI)/angiotensin receptor blockers (ARB) users continues with contradictory findings. This study aimed to determine the effect of ACEI/ARB use in patients with severe COVID-19.
• Alrawashdh, N., Persky, D. O., McBride, A., Sweasy, J., Erstad, B., & Abraham, I. (2021). Comparative Efficacy of First-Line Treatments of Chronic Lymphocytic Leukemia: Network Meta-Analyses of Survival Curves. Clinical lymphoma, myeloma & leukemia, 21(11), e820-e831.
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  Multiple treatment options in first-line chronic lymphocytic leukemia (CLL) pose a challenge in identifying the best treatment. We performed novel network meta-analyses (NMA; 8 trials, 11 treatments) on the Kaplan-Meier curves to compare treatments for fludarabine-ineligible patients on progression-free survival (PFS), time-to-next-treatment (TTNT) and overall survival (OS).
• Alrawashdh, N., Sweasy, J., Erstad, B., McBride, A., Persky, D. O., & Abraham, I. (2021). Survival trends in chronic lymphocytic leukemia across treatment eras: US SEER database analysis (1985-2017). Annals of hematology, 100(10), 2501-2512.
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  In this population-based study, we used the SEER database (1985-2015) to examine survival outcomes in chronic lymphocytic leukemia (CLL) patients followed up to the era of advanced treatments including targeted therapies. Data were extracted for patients 15 years or older with a primary diagnosis of CLL. A period analysis was performed to estimate 5- and 10-year relative survival rates for patients diagnosed during different calendar periods from 1985 to 2015. A mixture cure model was used to examine long-term survivors' proportions among patients diagnosed in 1985-2015 and for two cohorts diagnosed in 2000-2003, followed up to 2012 and 2004-2007, and followed up to 2015. Cox proportional hazard modeling was used for the two cohorts to estimate hazard ratios (HRs) of death adjusted for gender and age. The 5-year and 10-year age-adjusted relative survival rate ranged between 73.7 and 89.4% and from 51.6% to "not reached," respectively, for calendar periods of 1985-1989 to 2010-2014. The long-term survivor proportions varied by age and gender from 0 to 59%. The HRs (95%CI) for the 2004-2007 cohort in comparison to the 2000-2003 cohort were 0.58 (0.43-0.78), 0.58 (0.48-0.70), 0.57 (0.49-0.0.67), 0.68 (0.54-0.85), and 0.83 (0.68-1.02) for the age categories of 45-54, 55-64, 65-74, 75-84, and ≥ 85 years, respectively. Overall, relative survival improved significantly for CLL patients diagnosed between 1985 and 2015. These improvements were markedly better following the introduction of targeted therapies.
• Alrawashdh, N., Sweasy, J., Erstad, B., McBride, A., Persky, D. O., & Abraham, I. (2021). Survival trends in chronic lymphocytic leukemia across treatment eras: US SEER database analysis (1985–2017). Annals of Hematology, 100(Issue 10). doi:10.1007/s00277-021-04600-1
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  In this population-based study, we used the SEER database (1985–2015) to examine survival outcomes in chronic lymphocytic leukemia (CLL) patients followed up to the era of advanced treatments including targeted therapies. Data were extracted for patients 15 years or older with a primary diagnosis of CLL. A period analysis was performed to estimate 5- and 10-year relative survival rates for patients diagnosed during different calendar periods from 1985 to 2015. A mixture cure model was used to examine long-term survivors’ proportions among patients diagnosed in 1985–2015 and for two cohorts diagnosed in 2000–2003, followed up to 2012 and 2004–2007, and followed up to 2015. Cox proportional hazard modeling was used for the two cohorts to estimate hazard ratios (HRs) of death adjusted for gender and age. The 5-year and 10-year age-adjusted relative survival rate ranged between 73.7 and 89.4% and from 51.6% to “not reached,” respectively, for calendar periods of 1985–1989 to 2010–2014. The long-term survivor proportions varied by age and gender from 0 to 59%. The HRs (95%CI) for the 2004–2007 cohort in comparison to the 2000–2003 cohort were 0.58 (0.43–0.78), 0.58 (0.48–0.70), 0.57 (0.49–0.0.67), 0.68 (0.54–0.85), and 0.83 (0.68–1.02) for the age categories of 45–54, 55–64, 65–74, 75–84, and ≥ 85 years, respectively. Overall, relative survival improved significantly for CLL patients diagnosed between 1985 and 2015. These improvements were markedly better following the introduction of targeted therapies.
• Alsowaida, Y. S., Almulhim, A. S., Oh, M., Erstad, B., & Abraham, I. (2021). Sensorineural hearing loss with macrolide antibiotics exposure: a meta-analysis of the association. The International journal of pharmacy practice, 29, 21-29.
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  Macrolide antibiotics are among the most commonly used antibiotics; the association of macrolide antibiotics exposure with sensorineural hearing loss (SNHL) has been hypothesized. A systematic search was conducted in PubMed, EMBASE and Cochrane Library from inception to 15 July 2019 to identify studies used macrolide antibiotics for any indication. The results were reported as odds ratio (OR) with 95% confidence interval (CI) using random-effects model to derive the association of macrolide antibiotics exposure with SNHL. The objective of this meta-analysis was to estimate the association of macrolide antibiotics exposure and SNHL from up-to-date evidence.
• Calamia, M., McBride, A., & Abraham, I. (2021). Economic evaluation of polatuzumab-bendamustine-rituximab tafasitamab-lenalidomide in transplant-ineligible R/R DLBCL. Journal of medical economics, 24(sup1), 14-24.
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  Polatuzumab vedotin-bendamustin-rituximab (PBR) and tafasitamab-lenalidomide (Tafa-L) were approved recently for relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) in autologous stem cell transplant (ASCT) ineligible patients. We performed an industry-independent pharmacoeconomic evaluation of both regimens over a 5-year (y) time horizon (US payer perspective; 2020 USD).
• Choi, B. M., & Abraham, I. (2021). The Decline in e-Cigarette Use Among Youth in the United States-An Encouraging Trend but an Ongoing Public Health Challenge. JAMA Network Open, 4(Issue 6). doi:10.1001/jamanetworkopen.2021.12464
• Choi, B. M., & Abraham, I. (2021). The Decline in e-Cigarette Use Among Youth in the United States-An Encouraging Trend but an Ongoing Public Health Challenge. JAMA network open, 4(6), e2112464.
• Choi, B. M., Abraham, R. B., Halawah, H., Calamia, M., Obeng-Kusi, M., Alrawashdh, N., Arku, D., & Abraham, I. (2021). Comparing jurisdiction-specific pharmaco-economic evaluations using medical purchasing power parities. Journal of medical economics, 24(sup1), 34-41.
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  To demonstrate how medical purchasing power parities (mPPP) may harmonize economic evaluations from different jurisdictions and enable comparisons across jurisdictions.
• Faulkner, K. M., MacDonald, K., Abraham, I., Alhossan, A., & Lee, C. S. (2021). 'Real-world' effectiveness of omalizumab in adults with severe allergic asthma: a meta-analysis. Expert review of clinical immunology, 17, 73-83. doi:10.1080/1744666X.2020.1856658
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  Severe asthma affects 5-10% of the 350 million people with asthma worldwide. Findings from the authors' previous meta-analysis supported omalizumab use as an adjuvant treatment for severe allergic asthma. The publication of fourteen new articles necessitates an update of the meta-analysis. To evaluate the 'real-world' effectiveness of omalizumab in the treatment of acute allergic asthma in adults by calculating pooled effects estimates from data in published articles. Articles on omalizumab effectiveness in 'real-world' settings were identified. Effect sizes, including point estimates of the proportion of patients who met a given criteria, mean improvements relative to baseline, and change in the proportion of patients requiring oral corticosteroids compared to baseline were extracted. Meta-analysis of proportions was conducted to pool effect sizes based on proportions. Standardized mean differences (Hedges' g) were calculated from means and standard deviations. Relative risk was calculated from changes in proportions. Variability within and between studies was evaluated. Omalizumab increases the percentage of individuals rated 'good' or 'excellent' on the Global Evaluation of Treatment Effectiveness Scale. Omalizumab also improves respiratory function, quality-of-life, and asthma control while reducing medication usage, exacerbations, hospitalizations, and adverse events. 'Real-world' evidence continues to support the use of omalizumab as adjuvant treatment for severe allergic asthma.
• Fazel, M., AlRawashdh, N., Alamer, A., Curiel-Lewandrowski, C., & Abraham, I. (2021). Is there still a role for talimogene laherparepvec (T-VEC) in advanced melanoma? An indirect efficacy comparison of T-VEC plus ipilimumab combination therapy versus T-VEC alone as salvage therapy in unresectable metastatic melanoma. Expert Opinion on Biological Therapy, 21(Issue 12). doi:10.1080/14712598.2022.1998450
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  Background: Talimogene laherparepvec (T-VEC) improves overall survival (OS) in unresectable stage IIIB/C-IV melanoma T-VEC may have synergistic effects with CTLA-4 inhibitors In the absence of a trial comparing T-VEC and ipilimumab (T-VEC + IPI) to T-VEC, we applied a novel indirect comparison method using extrapolated OS curves to estimate OS outcomes in a simulated trial comparing both regimens in stage IIIB/C-IV unresectable melanoma. Research Design and Methods: Two trials with extractable OS curves for a T-VEC versus T-VEC + IPI comparison were identified. Outcomes were adjusted for heterogeneity in prognostic factors using a calculated adjustment factor. T-VEC and adjusted/unadjusted T-VEC+IPI curves were plotted with 95% CIs. Results: Unadjusted indirect OS comparison of T-VEC versus T-VEC + IPI revealed no significant difference up to 15 months. Extrapolation beyond 15 months showed significant survival benefits for T-VEC + IPI over T-VEC, confirmed in adjusted analyses. The expected OS percentage at 48 months is 32.0% (95% CI = 26.6–37.3) for T-VEC, 60.0% (95% CI = 46.2–69.1) for unadjusted, and 81.1% (95% CI = 72.3–85.9) for adjusted T-VEC + IPI. Conclusions: Our novel indirect comparison suggests that T-VEC + IPI may demonstrate a significantly improved OS versus T-VEC alone. Findings may portend a possible role for the addition of T-VEC to advanced melanoma treatment regimens in select patients as salvage therapy.
• Fazel, M., AlRawashdh, N., Alamer, A., Curiel-Lewandrowski, C., & Abraham, I. (2021). Is there still a role for talimogene laherparepvec (T-VEC) in advanced melanoma? An indirect efficacy comparison of T-VEC plus ipilimumab combination therapy versus T-VEC alone as salvage therapy in unresectable metastatic melanoma. Expert opinion on biological therapy, 21(12), 1647-1653.
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  Talimogene laherparepvec (T-VEC) improves overall survival (OS) in unresectable stage IIIB/C-IV melanoma T-VEC may have synergistic effects with CTLA-4 inhibitors In the absence of a trial comparing T-VEC and ipilimumab (T-VEC + IPI) to T-VEC, we applied a novel indirect comparison method using extrapolated OS curves to estimate OS outcomes in a simulated trial comparing both regimens in stage IIIB/C-IV unresectable melanoma.
• Fontanarosa, P. B., Flanagin, A., & for the JAMA and JAMA Network Editors and Editorial Staff, . (2021). To Howard Bauchner, MD, visionary Editor in Chief of JAMA – a sincere thank you and a fond farewell. JAMA, 326, 33-34.
• Hamarneh, D., Alkhatib, N., Denhaerynck, K., Vancayzeele, S., Brié, H., MacDonald, K., & Abraham, I. (2021). Gender-stratified hierarchical modeling of patient and physician determinants of antihypertensive treatment outcomes: pooled analysis of 7 prospective real-world studies with 17,044 patients. Current medical research and opinion, E-publication ahead of print. doi:10.1080/03007995.2021.1877124
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  . Seven prospective real-world studies conducted in general practices in Belgium of antihypertensive treatment with valsartan-centric regimens were pooled to examine similarities and differences in determinants of blood pressure (BP) values (mmHg) and BP control rates between female and male patients. . Pooled analysis of a total evaluable sample of 17,044 patients, including 8273 (48.5%) women and 8771 men (51.5%) treated over approximately 90 days with valsartan-centric regimens in second- or later-line. Hierarchical linear and logistic regression were applied to identify patient- and physician-related determinants of BP outcomes and a potential physician class effect. . Reductions in BP (mmHg) over 90 days were similar for women and men, and so where changes in BP control rates. Approximately a quarter of the variance in 90-day BP values was attributable to a physician class effect. Both gender groups shared some patient- and physician-related determinants of BP outcomes, though often varying in degree of influence. Analyses also revealed gender-specific determinants. Among others, modifiable/manageable patient-related determinants included BP at hypertension diagnosis (proxy for time of diagnosis), risk factors, antihypertensive treatment, and adherence; while among the physician-related determinantsclinical experience in hypertension treatment was modifiable/manageable. . Valsartan-centric treatment regimens are associated with significant reductions in BP level and improvement in BP control in both women and men. The determinants revealed in modeling provide guidance to clinicians in the common and differential management of hypertension in female and male patients.
• Hamarneh, D., Alkhatib, N., Denhaerynck, K., Vancayzeele, S., Brié, H., MacDonald, K., & Abraham, I. (2021). Gender-stratified hierarchical modeling of patient and physician determinants of antihypertensive treatment outcomes: pooled analysis of seven prospective real-world studies with 17,044 patients. Current Medical Research and Opinion, 37(Issue 3). doi:10.1080/03007995.2021.1877124
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  Objective: Seven prospective real-world studies conducted in general practices in Belgium of antihypertensive treatment with valsartan-centric regimens were pooled to examine similarities and differences in determinants of blood pressure (BP) values (mmHg) and BP control rates between female and male patients. Methods: Pooled analysis of a total evaluable sample of 17,044 patients, including 8273 (48.5%) women and 8771 men (51.5%) treated over approximately 90 days with valsartan-centric regimens in second or later line. Hierarchical linear and logistic regressions were applied to identify patient- and physician-related determinants of BP outcomes and a potential physician class effect. Results: Reductions in BP (mmHg) over 90 days were similar for women and men, and so were changes in BP control rates. Approximately a quarter of the variance in 90 day BP values was attributable to a physician class effect. Both gender groups shared some patient- and physician-related determinants of BP outcomes, though often varying in degree of influence. Analyses also revealed gender-specific determinants. Among others, modifiable/manageable patient-related determinants included BP at hypertension diagnosis (proxy for time of diagnosis), risk factors, antihypertensive treatment and adherence; while among the physician-related determinants clinical experience in hypertension treatment was modifiable/manageable. Conclusion: Valsartan-centric treatment regimens are associated with significant reductions in BP level and improvement in BP control in both women and men. The determinants revealed in modeling provide guidance to clinicians in the common and differential management of hypertension in female and male patients.
• Kim, H. J., & Abraham, I. (2021). Determinants of the Higher Prevalence and Severity of Subjective Cognitive Impairment in Cancer Patients Compared to Healthy Subjects: Fatigue and Stress. Clinical Nursing Research, 30(Issue 6). doi:10.1177/1054773820957474
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  This study examined whether (a) cancer patients in two cohorts reported greater subjective cognitive impairment (SCI) in prevalence and severity than noncancer healthy controls; and (b) selected psychoneurological factors (fatigue, stress, and sleep disturbance) contribute to such differences. Data from 60 prechemotherapy cancer patients, 81 active-chemotherapy cancer patients, and 116 noncancer healthy controls were analyzed using hierarchical regressions. The prevalence rate of SCI was higher in the prechemotherapy cancer cohort (41.6%) and in the active-chemotherapy cancer cohort (46.9%) than in healthy controls (21.5%; p
• Kim, H. J., & Abraham, I. L. (2021). Determinants of the higher prevalence and severity of subjective cognitive impairment in cancer patients compared to healthy subjects: fatigue and stress.. Clinical Nursing Research, 30, 809-817.
• Kim, H., Kim, E., Jung, S., & Abraham, I. L. (2020). Association of chemotherapy with subjective cognitive impairment in breast cancer patients: meta-analysis of longitudinal studies. Psycho-Oncology.
• MacDonald, K., Alrawashdh, N., McBride, A., & Abraham, I. (2021). Conversion to biosimilar pegfilgrastim-cbqv enables budget-neutral access to FOLFIRINOX treatment for metastatic pancreatic cancer. Future oncology (London, England), 17(33), 4561-4570.
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  To estimate the cost-savings from conversion to biosimilar pegfilgrastim-cbqv that can be reallocated to provide budget-neutral expanded access to FOLFIRINOX in patients with metastatic pancreatic cancer. Simulation modeling in a panel of 2500 FOLFIRINOX-treated patients, using varying treatment duration (1-12 cycles) and conversion rates (10-100%), to estimate cost-savings and additional FOLFIRINOX treatment that could be budget neutral. In a 2500-patient panel at 100% conversion, savings of US$6,907.41 per converted patient over 12 cycles of prophylaxis translate to US$17.3 million and could provide 72,273 additional FOLFIRINOX doses or 6023 full 6-month regimens. Conversion to biosimilar CIN/FN prophylaxis can generate significant cost-savings and provide budget-neutral expanded access to FOLFIRINOX treatment for patients with metastatic pancreatic cancer.
• McBride, A., Alrawashdh, N., Bartels, T., Moore, L., Persky, D., & Abraham, I. (2021). Same-day versus next-day pegfilgrastim or pegfilgrastim-cbqv in patients with lymphoma receiving CHOP-like chemotherapy. Future Oncology, 17(Issue 26). doi:10.2217/fon-2021-0532
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  Aim: To compare the incidence of febrile neutropenia and related outcomes of prophylactic same-day versus next-day pegfilgrastim/pegfilgrastim-cbqv in patients with lymphoma receiving cyclophosphamide, hydroxydaunorubicin, vincristine, prednisone (CHOP)-like chemotherapy. Methods: Retrospective, real-world, single-institution study. Results: 93 patients received 460 cycles of CHOP-like chemotherapy. The incidence of febrile neutropenia and grade 3/4 chemotherapy-induced neutropenia was 5 and 16.5%, respectively. In 401 cycles pegfilgrastim was administered same-day versus 12 cycles next-day. Febrile neutropenia occurred in 17 cycles versus 0 cycles (p = 1.00) and grade 3/4 chemotherapy-induced neutropenia in 65 cycles (16.2%) versus 1 cycle (16.7%; p = 1.00) with same-day versus next-day pegfilgrastim administration, respectively. Conclusion: Pegfilgrastim may be safely administered on the same day as chemotherapy in patients with lymphoma receiving CHOP-like chemotherapy.
• McBride, A., Alrawashdh, N., Bartels, T., Moore, L., Persky, D., & Abraham, I. (2021). Same-day versus next-day pegfilgrastim or pegfilgrastim-cbqv in patients with lymphoma receiving CHOP-like chemotherapy. Future oncology (London, England), 17(26), 3485-3497.
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  To compare the incidence of febrile neutropenia and related outcomes of prophylactic same-day versus next-day pegfilgrastim/pegfilgrastim-cbqv in patients with lymphoma receiving cyclophosphamide, hydroxydaunorubicin, vincristine, prednisone (CHOP)-like chemotherapy. Retrospective, real-world, single-institution study. 93 patients received 460 cycles of CHOP-like chemotherapy. The incidence of febrile neutropenia and grade 3/4 chemotherapy-induced neutropenia was 5 and 16.5%, respectively. In 401 cycles pegfilgrastim was administered same-day versus 12 cycles next-day. Febrile neutropenia occurred in 17 cycles versus 0 cycles (p = 1.00) and grade 3/4 chemotherapy-induced neutropenia in 65 cycles (16.2%) versus 1 cycle (16.7%; p = 1.00) with same-day versus next-day pegfilgrastim administration, respectively. Pegfilgrastim may be safely administered on the same day as chemotherapy in patients with lymphoma receiving CHOP-like chemotherapy.
• McBride, A., MacDonald, K., & Abraham, I. (2021). Conversion to supportive care with biosimilar pegfilgrastim-cbqv enables budget-neutral expanded access to R-CHOP treatment in non-Hodgkin lymphoma. Leukemia research, 106, 106591.
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  This pharmacoeconomic simulation (1) assessed the cost-efficiency of converting a panel of 20,000 patients at risk of chemotherapy-induced (febrile) neutropenia (CIN/FN) from reference pegfilgrastim to biosimilar pegfilgrastim-cbqv; (2) estimated how savings can be used to provide budget-neutral expanded access to R-CHOP therapy for non-Hodgkin lymphoma patients; and 3) determined the number-needed-to-convert (NNC) to purchase one additional dose of R-CHOP (US payer perspective). Model inputs included biosimilar conversion from pre-filled syringe [PFS] or on-body injector [OBI] reference pegfilgrastim; age-proportional blended costs for reference pegfilgrastim PFS and OBI, pegfilgrastim-cbqv and R-CHOP; medication administration costs; biosimilar conversion rates of 10-100 %; and 1-6 cycles of prophylaxis. Cost-savings were used to estimate the number of doses of R-CHOP that could be purchased and the NNC to purchase one additional dose. Converting a panel of 20,000 patients requiring CIN/FN prophylaxis to biosimilar pegfilgrastim-cbqv from a low of 1 cycle and 10 % conversion to a high of 6 cycles and 100 % conversion yielded savings from $1,567,195 to $96,668,126. The budget-neutral acquisition of R-CHOP doses afforded by these savings ranged from 227 to 13,999 doses, the latter enabling 2333 patients to receive 6 cycles of R-CHOP treatment with no additional cost to the payer. These results are achieved if all 20,000 panel patients requiring GCSF support are prophylacted with biosimilar pegfilgrastim-cbqv for 6 cycles, yielding an NNC of 1.43 patients per additional R-CHOP dose. This simulation underscores the clinic-economic benefit of prophylaxis with biosimilar growth factor and pegfilgrastim-cbqv specifically.
• McBride, A., MacDonald, K., Fuentes-Alburo, A., & Abraham, I. (2021). Cost-efficiency and expanded access modeling of conversion to biosimilar trastuzumab-dkst with or without pertuzumab in metastatic breast cancer. Journal of Medical Economics, 24(Issue 1). doi:10.1080/13696998.2021.1928515
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  Aims: To investigate the cost-efficiency and budget-neutral expanded access of biosimilar intravenous trastuzumab-dkst versus reference intravenous (trastuzumab-IV) and subcutaneous trastuzumab (trastuzumab-SC) (with/without pertuzumab) in metastatic breast cancer (MBC). Methods: Economic simulation modeling in a panel of 1,000 MBC patients to estimate: 1) cost-savings by conversion from trastuzumab-IV or trastuzumab-SC to trastuzumab-dkst at 10-100% conversion rates in 3 weight groups: first quartile (Q1:62.2 kg), median (73.1 kg), third quartile (Q3:88.6 kg), and 2) budget-neutral expanded access to trastuzumab-dkst from cost-savings. Results: In monotherapy, conversion (%) from trastuzumab-IV generates one-year cost-savings from $2,272,189 (Q1;10%) to $31,506,804 (Q3;100%) and from trastuzumab-SC monotherapy savings range from $2,071,277 (Q3;10%) to $35,775,475 (Q1;100%). In combination with pertuzumab, trastuzumab-dkst is cost-efficient in all patient weights with one-year savings over trastuzumab-IV up to $32,662,714 (Q3;100%) and over trastuzumab-SC up to $35,322,461 (Q1;100%). Savings from conversion from trastuzumab-IV monotherapy could provide between 3,087 (Q1;10%) and 30,911 (Q3;100%) additional trastuzumab-dkst doses—enough to treat 58 to 583 patients for one year. Conversion from trastuzumab-SC monotherapy could provide between 1,559 (Q3;10%) and 48,598 (Q1;100%) additional trastuzumab-dkst doses or 38 to 918 additional one-year treatments with trastuzumab-dkst. In combination with pertuzumab, conversion from trastuzumab-IV could provide from 311 (Q1;10%) to 3,939 (Q3;100%) maintenance doses (pertuzumab + trastuzumab-dkst) or 17 to 210 additional one-year regimens (all agents). Savings from conversion from trastuzumab-SC could expand access to 226 (Q3;10%) to 4,782 (Q1;100%) additional maintenance doses or 12 to 254 one-year regimens. Conclusions: This first cost-efficiency and expanded access study of biosimilar therapeutic cancer agents shows that trastuzumab-dkst is cost-efficient over trastuzumab-IV and trastuzumab-SC across all patient weights in both monotherapy and combination with pertuzumab and paclitaxel. These cost savings could provide more patients with trastuzumab-dkst treatment on a budget-neutral basis.
• McBride, A., MacDonald, K., Fuentes-Alburo, A., & Abraham, I. (2021). Cost-efficiency and expanded access modeling of conversion to biosimilar trastuzumab-dkst with or without pertuzumab in metastatic breast cancer. Journal of medical economics, 24(1), 743-756.
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  To investigate the cost-efficiency and budget-neutral expanded access of biosimilar intravenous trastuzumab-dkst versus reference intravenous (trastuzumab-IV) and subcutaneous trastuzumab (trastuzumab-SC) (with/without pertuzumab) in metastatic breast cancer (MBC).
• McBride, A., MacDonald, K., Fuentes-Alburo, A., & Abraham, I. L. (2021). Conversion from pegfilgrastim with on-body injector to biosimilar pegfilgrastim-jmdb: cost-efficiency analysis and budget neutral access to prophylaxis and treatment.. Journal of Medical Economics.
• Moore, L., Bartels, T., Abraham, I. L., Kumar, A., Persky, D. O., & McBride, A. (2021). Outcomes of primary and secondary prophylaxis of chemotherapy induced and febrile neutropenia in bendamustine plus rituximab regimens in patients with lymphoma and chronic lymphocytic leukemia.. Supportive Care in Cancer.
• Moore, L., Bartels, T., Persky, D. O., Abraham, I., Kumar, A., & McBride, A. (2021). Outcomes of primary and secondary prophylaxis of chemotherapy-induced and febrile neutropenia in bendamustine plus rituximab regimens in patients with lymphoma and chronic lymphocytic leukemia: real-world, single-center experience. Supportive Care in Cancer, 29(Issue 8). doi:10.1007/s00520-020-05982-0
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  Purpose: To examine the outcomes associated with granulocyte colony stimulating factors (G-CSFs) administered as primary versus secondary prophylaxis in setting of bendamustine plus rituximab (BR) regimens. Methods: Eighty-five patients who underwent treatment for non-Hodgkin’s lymphoma (NHL) or chronic lymphocytic leukemia (CLL) with BR at the University of Arizona Cancer Center from November 2013 to June 2019 were evaluated through retrospective chart review. Patients were stratified into two groups: those who were given G-CSF for primary prophylaxis (n = 47) and for secondary prophylaxis (n = 38). G-CSF-included filgrastim or pegfilgrastim. The primary endpoints were incidence of febrile neutropenia and grade 3 or 4 neutropenia. Results: Same-day G-CSF compared with next-day G-CSF was the most common G-CSF dosing method utilized in primary and secondary prophylaxis (94% and 100%), respectively. Primary and secondary prophylaxis groups were similar on baseline characteristics (p > 0.05); the primary outcome of FN (p > 0.05); all secondary outcomes (p > 0.05) except for a higher frequency of dose delays in secondary (40%) vs primary prophylaxis patients (13%; p = 0.01), and mean absolute neutrophil counts (ANC) in cycles 1 through 5. With higher ANC levels observed during all cycles in the primary prophylaxis group compared with secondary prophylaxis. Conclusions: In this single-center retrospective study, BR-treated lymphoma and CLL patients receiving primary versus secondary with G-CSF showed similar outcomes except, notably, for chemotherapy dose delays that may put secondary patients at risk for poor treatment outcomes. Further research is needed to evaluate the impact of primary versus secondary prophylaxis on treatment outcomes.
• Moore, L., Bartels, T., Persky, D. O., Abraham, I., Kumar, A., & McBride, A. (2021). Outcomes of primary and secondary prophylaxis of chemotherapy-induced and febrile neutropenia in bendamustine plus rituximab regimens in patients with lymphoma and chronic lymphocytic leukemia: real-world, single-center experience. Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 29(8), 4867-4874.
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  To examine the outcomes associated with granulocyte colony stimulating factors (G-CSFs) administered as primary versus secondary prophylaxis in setting of bendamustine plus rituximab (BR) regimens.
• Narayan, S. W., Abraham, I., Erstad, B. L., Haas, C. E., Sanders, A., & Patanwala, A. E. (2021). Methods used to attribute costs avoided from pharmacist interventions in acute care: A scoping review. American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists, 78(17), 1576-1590.
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  Cost-avoidance studies are common in pharmacy practice literature. This scoping review summarizes, critiques, and identifies current limitations of the methods that have been used to determine cost avoidance associated with pharmacists' interventions in acute care settings.
• Narayan, S., Abraham, I. L., Erstad, B. L., Hess, C. E., Sanders, A. B., & Patanwala, A. (2021). Methods used to attribute costs avoided from pharmacist interventions in acute care: a scoping review.. American Journal of Health-System Pharmacy.
• Obeng-Kusi, M., Habila, M. A., Roe, D. J., Erstad, B., & Abraham, I. (2021). Economic evaluation using dynamic transition modeling of ebola virus vaccination in lower-and-middle-income countries. Journal of Medical Economics, 24(Issue 1). doi:10.1080/13696998.2021.2002092
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  Background: With the increasing occurrence of infectious diseases in lower-and-middle-income countries (LMICs), emergency preparedness is essential for rapid response and mitigation. Economic evaluations of mitigation technologies and strategies have been recommended for inclusion in emergency preparedness plans. We aimed to perform an economic evaluation using dynamic transition modeling of ebola virus disease (EVD) vaccination in a hypothetical community of 1,000 persons in the Democratic Republic of Congo (DRC). Method: Using a modified SEIR (Susceptible, Exposed, Infectious, Recovered, with Death added [SEIR-D]) model that accounted for death and epidemiological data from an EVD outbreak in the DRC, we modeled the transmission of EVD in a hypothetical population of 1,000. With our model, we estimated the cost-effectiveness of an EVD vaccine and an EVD vaccination intervention. Results: The results showed vaccinating 50% of the population at risk prevented 670 cases, 538 deaths, and 22,022 disability-adjusted life years (DALYs). The vaccine was found to be cost-effective with an incremental cost-effectiveness ratio (ICER) of $95.63 per DALY averted. We also determined the minimum required vaccination coverage for cost-effectiveness to be 40%. Sensitivity analysis showed our model to be fairly robust, assuring relatively consistent results even with variations in such input parameters as cost of screening, as well as transmission, infection, incubation, and case fatality rates. Conclusion: EVD vaccination in our hypothetical population was found to be cost-effective from the payer perspective. Our model presents an efficient and reliable approach for conducting economic evaluations of infectious disease interventions as part of an emergency preparedness plan.
• Obeng-Kusi, M., Habila, M. A., Roe, D. J., Erstad, B., & Abraham, I. (2021). Economic evaluation using dynamic transition modeling of ebola virus vaccination in lower-and-middle-income countries. Journal of medical economics, 24(sup1), 1-13.
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  With the increasing occurrence of infectious diseases in lower-and-middle-income countries (LMICs), emergency preparedness is essential for rapid response and mitigation. Economic evaluations of mitigation technologies and strategies have been recommended for inclusion in emergency preparedness plans. We aimed to perform an economic evaluation using dynamic transition modeling of ebola virus disease (EVD) vaccination in a hypothetical community of 1,000 persons in the Democratic Republic of Congo (DRC).
• Obeng-Kusi, M., MacDonald, K., van Lierde, M. A., Lee, C. S., De Geest, S., & Abraham, I. (2021). No margin for non-adherence: Probabilistic kaplan-meier modeling of imatinib non-adherence and treatment response in CML (ADAGIO study). Leukemia Research, 111(Issue). doi:10.1016/j.leukres.2021.106734
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  Background: Although adherence to imatinib is critical for attaining treatment responses in chronic myeloid leukemia, there is evidence of varying adherence among patients. Our aim was to model and determine the margin of tolerance, if any, required to ensure treatment responses among patients prescribed imatinib before treatment response is at risk. Method: We performed post hoc analyses of the ADAGIO study conducted in Belgium on 169 evaluable patients (Blood 2009). Applying Kaplan-Meier methods using adherence instead of the conventional time variable, we modeled the likelihood of complete cytogenetic (CCyR), complete hematological (CHR), major molecular (MMR) and optimal (OR) response as a function of 90-day pill count adherence. Results: Analyses showed that ∼100 % adherence of prescribed dose is associated with probabilities of 0.84 for CHR, 0.83 for CCyR, 0.82 for OR, and 0.77 for MMR; compared to, 0.37 (CHR and CCyR), 0.35 (OR), and 0.39 (MMR) at 90 % adherence. Increasing intake of imatinib from 90 % to 100 % of the prescribed dose increased the likelihood of the various treatment responses by 1.95–2.35-fold. Conclusion: There is virtually no margin for nonadherence, if the objective is to optimize the likelihood of treatment response, and a minimal margin to avoid impaired treatment response.
• Obeng-Kusi, M., MacDonald, K., van Lierde, M. A., Lee, C. S., De Geest, S., & Abraham, I. (2021). No margin for non-adherence: Probabilistic kaplan-meier modeling of imatinib non-adherence and treatment response in CML (ADAGIO study). Leukemia research, 111, 106734.
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  Although adherence to imatinib is critical for attaining treatment responses in chronic myeloid leukemia, there is evidence of varying adherence among patients. Our aim was to model and determine the margin of tolerance, if any, required to ensure treatment responses among patients prescribed imatinib before treatment response is at risk.
• Patanwala, A. E., Narayan, S. W., Haas, C. E., Abraham, I., Sanders, A., & Erstad, B. L. (2021). Proposed guidance on cost-avoidance studies in pharmacy practice. American Journal of Health-System Pharmacy, 78(Issue 17). doi:10.1093/ajhp/zxab211
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  Purpose: Cost-avoidance studies of pharmacist interventions are common and often the first type of study conducted by investigators to quantify the economic impact of clinical pharmacy services. The purpose of this primer is to provide guidance for conducting cost-avoidance studies pertaining to clinical pharmacy practice. Summary: Cost-avoidance studies represent a paradigm conceptually different from traditional pharmacoeconomic analysis. A cost-avoidance study reports on cost savings from a given intervention, where the savings is estimated based on a counterfactual scenario. Investigators need to determine what specifically would have happened to the patient if the intervention did not occur. This assessment can be fundamentally flawed, depending on underlying assumptions regarding the pharmacists' action and the patient trajectory. It requires careful identification of the potential consequence of nonaction, as well as probability and cost assessment. Given the uncertainty of assumptions, sensitivity analyses should be performed. A step-by-step methodology, formula for calculations, and best practice guidance is provided. Conclusions: Cost-avoidance studies focused on pharmacist interventions should be considered low-level evidence. These studies are acceptable to provide pilot data for the planning of future clinical trials. The guidance provided in this article should be followed to improve the quality and validity of such investigations.
• Patanwala, A. E., Narayan, S. W., Haas, C. E., Abraham, I., Sanders, A., & Erstad, B. L. (2021). Proposed guidance on cost-avoidance studies in pharmacy practice. American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists, 78(17), 1559-1567.
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  Cost-avoidance studies of pharmacist interventions are common and often the first type of study conducted by investigators to quantify the economic impact of clinical pharmacy services. The purpose of this primer is to provide guidance for conducting cost-avoidance studies pertaining to clinical pharmacy practice.
• Tompkinson, M., Fine, K., Gruber, D., Abraham, I., & McBride, A. (2021). Perceptions of Health-Care Workers of the Cost and Safety of Oral Oncolytic Agents for Patients: A Survey. Journal of the advanced practitioner in oncology, 11(4), 354-365.
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  The number of newly approved cancer medications continues to grow; many of these newly approved medications are oral agents. Oral oncolytic agents have advantages including patient convenience, prolonged drug exposure, and noninvasive administration. However, these advantages come at a cost premium that many patients cannot afford, which can lead to change in therapy or abandonment. This study evaluates the perceptions of health-care workers regarding the cost and safety of oral oncolytic agents.
• Abraham, I. L. (2020). Sensorineural hearing loss with macrolide antibiotics exposure: a meta-analysis of the association. International Journal of Pharmacy Practice, 29(1), 21-28. doi:10.1111/ijpp.12670
• Abraham, I. L. (2020). ‘Real-world’ effectiveness of omalizumab in adults with severe allergic asthma: a meta-analysis. Expert Review of Clinical Immunology, 17(1), 73-83. doi:10.1080/1744666x.2020.1856658
• Abraham, I., , ., Alrawashdh, N., Bartels, T., Kumar, A., Mcbride, A., Moore, L., & Persky, D. O. (2020). A Comparison of Same Day Versus Next Day Administration of Pegfilgrastim in Lymphoma Patients Receiving CHOP Chemotherapy. Blood, 136(Supplement 1), 11-11. doi:10.1182/blood-2020-141651
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  Background Febrile neutropenia (FN) is a potentially life-threatening complication of myelotoxic chemotherapy, with increased incidence in patients with high risk chemotherapy or with patients with predisposing comorbidities in intermediate risk regimens. Prophylactic pegfilgrastim has been shown to decrease the incidence, duration, and severity of neutropenia, fever, and infection. Current guidelines recommend at least a 24-hour time lapse from chemotherapy to administration of growth factor; however, many cancer centers give same day growth factor due to convivence. Here, we explored lymphoma patients treated with CHOP+/-R (cyclophosphamide, doxorubicin, vincristine, prednisone, with or without rituximab) and received either same-day (within 24 hours of chemotherapy) or next-day (≥24 hours post chemotherapy) pegfilgrastim to address the safety and efficacy of administration timing in the real-world setting. Methods A retrospective, single center, cohort study was conducted between October 1, 2013 and October 1, 2016 to evaluate lymphoma patients who were treated with CHOP+/-R and given pegfilgrastim for prophylaxis at the University of Arizona Cancer Center. Patients were followed up to six cycles of chemotherapy. In the first cycle, 39 patients were identified: 33 patients received same-day pegfilgrastim and 6 patients received next-day pegfilgrastim. Primary data collected included the incidence of FN, neutropenia, dose reductions, antibiotic administration, and hospitalization rate. Results Two hundred and fourteen R-CHOP (0.90) or CHOP (0.10) chemotherapy cycles (187 cycles for the same-day and 27 cycles for the next-day) were evaluated in 39 patients. Among the first cycles (33 patients in the same-day and 6 patients in the next-day), there were no significant differences in the incidence of FN (0.21 vs. 0.00, P= 0.57), grade 3/4 neutropenia (0.39 vs. 0.33, P= 0.99) and hospitalizations (0.39 vs. 0.00, P= 0.08) between the same day and the next day groups. Among cycle two to six (154 cycles for the same-day and 21 for the next-day), there were no statistically significant differences in the incidence of FN (0.07 vs 0.05, P=0.99)grade 3/4 neutropenia (0.30 vs. 0.24, P= 0.80) and hospitalizations (0.11 vs 0.10, P= 0.99) between the same-day and next-day. The same-day group, had 33% percent of patients received reduced doses of CHOP or R-CHOP (median age= 80.0 yr). The incidence of FN was 0.11 in these patients and 0.06 in patients who received the usual doses (median age=65.5 yr) (P= 0.27). The incidence of grade 3/4 neutropenia was (0.34 vs 0.29, P=0.53) and hospitalizations (0.20 and 0.08, P=0.07) between patients who received reduced doses of chemotherapy because of age versus normal dosing respectively in the same-day arm. Conclusion In our analysis, we have shown that same-day was as safe and effective as next-day pegfilgrastim administration in lymphoma patients receiving CHOP+/-R. There was not a significant increase in FN in either group. Future prospective studies are warranted to investigate the practical benefits of same-day pegfilgrastim or its biosimilar. Potential future study directions could include addressing outcomes, side effects, patient satisfaction, and reduced healthcare costs associated with same-day administration of pegfilgrastim for the prophylaxis of FN. Table Disclosures Abraham: Coherus BioSciences: Research Funding, Speakers Bureau; Celgene: Consultancy; Terumo: Consultancy; Rockwell Medical: Consultancy; Janssen: Consultancy; Mylan: Consultancy; Sandoz: Consultancy; MorphoSys: Consultancy. McBride:Coherus BioSciences: Consultancy, Speakers Bureau; Merck: Speakers Bureau; Pfizer: Consultancy; Sandoz: Consultancy; MorphoSys: Consultancy; Bristol-Myers Squibb: Consultancy.
• Abraham, I., , ., Alrawashdh, N., Mcbride, A., & Slack, M. K. (2020). Economic Evaluation of Ibrutinib Versus Acalabrutinib Versus Zanubrutinib for Patients with Relapsed or Refractory Mantle Cell Lymphoma. Blood, 136(Supplement 1), 9-10. doi:10.1182/blood-2020-136358
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  Background . Refractory or relapsed mantle cell lymphoma (R/R MCL) is generally associated with poor outcomes; median overall survival (OS) is 4-5 years. First generation Bruton's tyrosine kinase inhibitor (BTKi) (Ibrutinib) and second generation BTKi (acalabrutinib and zanubrutinib) have led to significant improvements in efficacy and safety over conventional chemoimmunotherapy in treating R/R MCL. In the absence of direct head to head clinical trials compare between BTKi, indirect comparisons between the first and second BTKi generations show possible differences in safety and efficacy. We used existing evidence from phase I/II clinical trials for second BTKi generation to evaluate the cost-effectiveness of ibrutinib vs acalabrutinib vs zanubrutinib in treating patients with R/R MCL from the US payer perspective. Methods. A Markov model with two health states (progression-free [PF] and progression or death) was specified. Kaplan-Meier (KM) curves of PF survival (PFS) from the phase III trial by Dreyling et al. (Lancet 2016) for ibrutinib, the phase II trial by Wang et al. (Lancet 2018) for acalabrutinib, and the phase I/II trial by Tam et al. (Blood 2019) for zanubrutinib were fitted to exponential distributions to extract transition probabilities between the two health states for each drug. Wholesale acquisition costs (WAC) were obtained from RedBook and costs of adverse events management were derived from the literature. The analysis was conducted over a lifetime horizon with health utility outcomes and costs discounted at 3.5% per year after the first year. The cost and PFS life years (LYs) and PFS quality-adjusted LYs (QALYs) for each treatment, the incremental PFS LYs and PFS QALYs gained with acalabrutinib or zanubrutinib over ibrutinib, and the incremental cost-effectiveness ratio (ICER) and cost-utility ratio (ICUR) were estimated in both base and probabilistic sensitivity analyses (PSA: 100,000 simulations). Results. As detailed in the table, acalabrutinib and zanubrutinib were associated with better clinical outcomes than ibrutinib, with incremental PFS LYs gained of 1.61 and 0.98, and incremental PFS QALYs of 1.27 and 0.77, respectively. The incremental costs when comparing acalabrutinib and zanubrutinib with ibrutinib were $110,931and $64,624, respectively. In probabilistic analyses, the ICERs ($61,689/LYg for acalabrutinib; $53,438/LYg for zanubrutinib) and ICURs ($86,750/QALYg for acalabrutinib; $82,897/QALYg for zanubrutinib) were lower than the US willingness to pay (WTP) threshold of $100,000 to $150,000 per QALY for cancer treatment. At WTP of $100,000, the cost-effectiveness acceptability curves showed the probabilities of acalabrutinib, zanubrutinib, and ibrutinib being cost-effective to be 50%, 34%, and 16%, respectively. Conclusions. Acalabrutinib is more cost-effective compared with ibrutinib and zanubrutinib and improves health outcomes more in R/R MCL patients. This analysis using phase I/II trials should be validated as additional trial and real-world evidence about efficacy, safety, and associated health-related quality of life outcomes. Based on the current data, acalabrutinib offers the most cost-effective treatment option in R/R MCL. Disclosures McBride: Coherus BioSciences: Consultancy, Speakers Bureau; Merck: Speakers Bureau; Pfizer: Consultancy; Sandoz: Consultancy; MorphoSys: Consultancy; Bristol-Myers Squibb: Consultancy. Abraham:Janssen: Consultancy; Coherus BioSciences: Research Funding, Speakers Bureau; Celgene: Consultancy; Sandoz: Consultancy; MorphoSys: Consultancy; Mylan: Consultancy; Rockwell Medical: Consultancy; Terumo: Consultancy.
• Abraham, I., Abraham, I., Almutairi, A. R., Almutairi, A. R., Alrawashdh, N., Alrawashdh, N., Mcbride, A., & Mcbride, A. (2020). Economic Evaluation of Daratumumab and Pomalidomide and Dexamethasone Versus Isatuximab and Pomalidomide and Dexamethasone for Patients with Relapsed or Refractory Multiple Myeloma. Blood, 136, 19-20. doi:10.1182/blood-2020-136348
• Abraham, I., Abraham, I., Macdonald, K., Macdonald, K., Mcbride, A., & Mcbride, A. (2020). Conversion to Biosimilar Pegfilgrastim-Jmdb from Pegfilgrastim with on-Body Injector Device in Diffuse Large B-Cell Lymphoma: Simulation Modeling of Cost-Savings and Budget-Neutral Expanded Access to Prophylaxis and Anti-Neoplastic Therapy Considering Device Failure Rate. Blood, 136, 22-22. doi:10.1182/blood-2020-142749
• Abraham, I., Abraham, I., Macdonald, K., Macdonald, K., Mcbride, A., & Mcbride, A. (2020). Simulation Modeling of Cost-Savings from Conversion to Biosimilar Pegfilgrastim-Cbqv for the Prophylaxis of Chemotherapy-Induced Neutropenia, and Budget-Neutral Expanded Access to Prophylaxis and Anti-Neoplastic Therapy from Derived Cost-Savings in Non-Hodgkin Lymphoma. Blood, 136, 24-25. doi:10.1182/blood-2020-136810
• Alamer, A., & Abraham, I. (2020). Mortality in COVID-19 patients treated with ACEIs/ARBs: Re-estimated meta-analysis results following the Mehra et al. retraction. Pharmacological Research, 160(Issue). doi:10.1016/j.phrs.2020.105053
• Alamer, A., & Abraham, I. (2020). Mortality in COVID-19 patients treated with ACEIs/ARBs: Re-estimated meta-analysis results following the Mehra et al. retraction. Pharmacological research, 160, 105053.
• Alamer, A., Almulhim, A., Alrashed, A., & Abraham, I. L. (2020). Mortality, severity, and hospital admission among COVID-19 patients with ACEI/ARB: a meta-analysis stratifying countries based on response to the first wave of the pandemic.. Research Square (Pre-print server), Mandatory pre-print publication per publisher's COVID-19 policy.
• Alhifany, A. A., McBride, A., Almutairi, A. R., Cheema, E., Shahbar, A., Alatawi, Y., Alharbi, A. S., Babiker, H., MacDonald, K., Aapro, M., & Abraham, I. (2020). Efficacy of olanzapine, neurokinin-1 receptor antagonists, and thalidomide in combination with palonosetron plus dexamethasone in preventing highly emetogenic chemotherapy-induced nausea and vomiting: a Bayesian network meta-analysis. Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 28, 1031-1039.
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  Olanzapine, neurokinin-1-receptor-antagonists (NK-1-RA), and thalidomide added to palonosetron + dexamethasone (PALO-DEX) have been evaluated in separate studies as prophylaxis for chemotherapy-induced nausea and vomiting (CINV) due to highly emetogenic chemotherapy (HEC). We conducted a Bayesian network meta-analysis to compare the prophylactic efficacy of these agents in combination with PALO-DEX.
• Alkhatib, N. S., & Abraham, I. (2020). The six Delta platform for outcome-based contracting for pharmaceuticals. Journal of Medical Economics, 23(Issue 11). doi:10.1080/13696998.2020.1824161
• Alkhatib, N. S., & Abraham, I. (2020). The six Delta platform for outcome-based contracting for pharmaceuticals. Journal of medical economics, 23(11), 1209-1214.
• Alkhatib, N. S., Bhattacharjee, S., McBride, A., Ramos, K., Slack, M., Erstad, B., & Abraham, I. (2020). Pricing methods in outcome-based contracting: δ4: safety-based pricing. Journal of medical economics, 23(11), 1237-1245.
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  Six Delta is a six-dimensional independent platform for outcome-based pricing/contracting. The fourth dimension (δ4) estimates prices on the basis of assessments of the safety of the drug using an analysis based on clinical trial data. We describe this dimension's methodology and present a proof-of-concept application to the treatment of non-small cell lung cancer (NSCLC) with EGFR mutation with osimertinib.
• Alkhatib, N. S., Erstad, B., Ramos, K., McBride, A., Bhattacharjee, S., Slack, M., & Abraham, I. (2020). Pricing methods in outcome-based contracting: δ3: reference-based pricing. Journal of Medical Economics, 23(Issue 11). doi:10.1080/13696998.2020.1815027
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  Aims: Six Delta is a six-dimensional independent platform for outcome-based pricing/contracting. The third dimension (δ3) estimates prices on the basis of international drug price referencing methods. We describe this dimension’s methodology and present a proof-of-concept application to the treatment of non-small cell lung cancer (NSCLC) with EGFR mutation with osimertinib. Materials and methods: The reference-based pricing dimension utilizes a six-step method: (1) selecting foreign countries based on a set of four criteria (drug is available in the foreign country, price information is available in the foreign country, foreign countries are members within the organization for Economic Co-operation and Development, pricing methods in the foreign countries involve value assessment); (2) adjusting for exchange rates; (3) generating reference price (RP) scenarios; (4) adjusting with the medical inflation rate; (5) pooling all generated RP scenarios and calculating average and standard deviation (SD); (6) and Monte Carlo Simulation (MCS) to estimate the dimension-specific DSPReference. A proof-of-concept exercise with osimertinib in NSCLC was performed for two hypothetical outcome-based contracts: 1-year (2019–2020) and 2-year (2019–2021). Results: The United Kingdom and Canada met the four criteria. For the osimertinib 1-year contract price, the average of eight RP scenarios, adjusted for inflation by 0.44%, was $8,892 (SD = $2,606) for a 30-day prescription. MCS yielded a DSPReference estimate of $9,395 or −35.72% of the wholesale acquisition cost (WAC) of $14,616. For the 2-year contract, the average, adjusted for inflation by 0.72%, was $8,928 (SD = $2,610). MCS yielded a DSPReference estimate of $9,442 or −35.40% of the WAC of $14,616. Conclusions: We demonstrated that international price referencing methods can be integrated into our proposed Six Delta platform for outcome-based pricing/contracting.
• Alkhatib, N. S., Erstad, B., Ramos, K., McBride, A., Bhattacharjee, S., Slack, M., & Abraham, I. (2020). Pricing methods in outcome-based contracting: δ3: reference-based pricing. Journal of medical economics, 23(11), 1230-1236.
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  Six Delta is a six-dimensional independent platform for outcome-based pricing/contracting. The third dimension (δ3) estimates prices on the basis of international drug price referencing methods. We describe this dimension's methodology and present a proof-of-concept application to the treatment of non-small cell lung cancer (NSCLC) with EGFR mutation with osimertinib.
• Alkhatib, N. S., McBride, A., Bhattacharjee, S., Ramos, K., Erstad, B., Slack, M., Billheimer, D., & Abraham, I. (2020). Pricing methods in outcome-based contracting: δ5: risk of efficacy failure-based pricing. Journal of medical economics, 23(11), 1246-1255.
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  Six Delta is a six-dimensional independent platform for outcome-based pricing/contracting. The fifth dimension (δ5) estimates prices on the basis of the risk of efficacy failure of a drug. We describe this dimension's methodology and present a proof-of-concept application to the treatment of non-small cell lung cancer (NSCLC) with EGFR mutation with osimertinib.
• Alkhatib, N. S., McBride, A., Slack, M., Bhattacharjee, S., Erstad, B., Ramos, K., & Abraham, I. (2020). Pricing methods in outcome-based contracting: integration analysis of the six dimensions (6 δs). Journal of medical economics, 23(11), 1266-1272.
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  Six Delta is a six-dimensional independent platform for outcome-based pricing/contracting. The six dimensions have been described separately: (δ1) cost-effectiveness analysis and cost-utility analysis-based pricing; (δ2) willingness-to-pay-based pricing; (δ3) reference-based pricing; (δ4) safety-based pricing; (δ5) risk of efficacy failure-based pricing; and (δ6) adherence-based pricing. The final step is to integrate the various dimension-specific pricing estimates into a composite estimate termed the All-Dimensional Price (ADP). We describe the methodology for this integration and present a proof-of-concept application to the treatment of non-small cell lung cancer (NSCLC) with EGFR mutation with osimertinib.
• Alkhatib, N. S., Ramos, K., Erstad, B., Slack, M., McBride, A., Bhattacharjee, S., & Abraham, I. (2020). Pricing methods in outcome-based contracting: δ1: cost effectiveness analysis and cost-utility analysis-based pricing. Journal of medical economics, 23(11), 1215-1222.
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  Six Delta is a six-dimensional independent platform for outcome-based pricing/contracting. The first dimension (δ1) estimates prices on the basis of cost-effectiveness (CEA) and cost-utility analysis (CUA). We describe this dimension's methodology and present a proof-of-concept application to the treatment of non-small cell lung cancer (NSCLC) with EGFR mutation with osimertinib.
• Alkhatib, N. S., Ramos, K., Erstad, B., Slack, M., McBride, A., Bhattacharjee, S., & Abraham, I. (2020). Pricing methods in outcome-based contracting: δ2: willingness-to-pay-based pricing. Journal of medical economics, 23(11), 1223-1229.
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  Six Delta is a six-dimensional independent platform for outcome-based pricing/contracting. The second dimension (δ2) estimates prices on the basis of four willingness-to-pay (WTP) thresholds. We describe this dimension's methodology and present a proof-of-concept application to the treatment of non-small cell lung cancer (NSCLC) with EGFR mutation with osimertinib.
• Alkhatib, N. S., Slack, M., Bhattacharjee, S., Erstad, B., Ramos, K., McBride, A., & Abraham, I. (2020). Pricing methods in outcome-based contracting: δ6: adherence-based pricing. Journal of medical economics, 23(11), 1256-1265.
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  Six Delta is a six-dimensional independent platform for outcome-based pricing/contracting. The sixth dimension (δ6) estimates prices on the basis of adherence to the prescribed regimen, whereby manufacturers provide payers with adherence-enhancing programs and whereby payers implement these programs and provide adherence data to the manufacturer. We describe this dimension's methodology and present a proof-of-concept application to the treatment of non-small cell lung cancer (NSCLC) with EGFR mutation with osimertinib.
• Alkhatib, N., Sun, D., Denhaerynck, K., Hamarneh, D., Van Camp, Y., Villa, L., Brié, H., Vancayzeele, S., MacDonald, K., & Abraham, I. (2021). Hierarchical modeling of blood pressure determinants and outcomes following valsartan treatment in hypertensive patients with known comorbidities: pooled analysis of six prospective real-world studies including 11,999 patients. Current medical research and opinion, 37, 1-8. doi:10.1080/03007995.2020.1853082
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  Six prospective real-world studies of antihypertensive treatment with valsartan-centric regimens were pooled to: (1) examine the effectiveness of ∼90 days of second- or later-line valsartan treatment in hypertensive patients with known comorbidities; and (2) identify physician- and patient-related determinants associated with systolic (SBP) and diastolic blood pressure (DBP) outcomes in these patients.
• Alkhushaym, N., Almutairi, A. R., Althagafi, A., Fallatah, S. B., Oh, M., Martin, J. R., Babiker, H. M., McBride, A., & Abraham, I. (2020). Exposure to proton pump inhibitors and risk of pancreatic cancer: a meta-analysis. Expert Opinion on Drug Safety, 19(Issue 3). doi:10.1080/14740338.2020.1715939
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  Objectives: To estimate the pancreatic cancer risk among subjects exposed versus not exposed to proton pump inhibitors. Methods: The authors searched PubMed, EMBASE, Scopus, Cochrane Library, and clinicaltrials.gov to identify relevant studies. The authors quantified pancreatic cancer risk among subjects exposed versus not exposed to PPIs, expressed as the pooled (adjusted) odds ratio (OR/aOR) and 95% confidence interval (95%CI) in overall and sensitivity analyses. Results: One randomized trial, two cohort, four case-control, and five nested case-control studies with 700,178 subjects (73,985 cases; 626,193 controls) were retained. PPI exposure was associated with pancreatic cancer risk (OR = 1.75, 95%CI = 1.12–2.72, I2 = 99%); confirmed in sensitivity analyses for high-quality studies, observational studies, case-control studies, studies with pancreatic cancer as the primary outcome, and in sensitivity analyses for diabetes and obesity but not for pancreatitis and smoking. This association was independent of the duration and Defined Daily Dose of PPI exposure. Rabeprazole had a singular significant association with pancreatic cancer (OR = 5.40, 95%CI = 1.98–14.703, I2 = 87.9%). Conclusion: The class of PPIs is associated with a 1.75-fold increase in pancreatic cancer risk, confirmed in sensitivity analyses.
• Alkhushaym, N., Almutairi, A. R., Althagafi, A., Fallatah, S. B., Oh, M., Martin, J. R., Babiker, H. M., McBride, A., & Abraham, I. (2020). Exposure to proton pump inhibitors and risk of pancreatic cancer: a meta-analysis. Expert opinion on drug safety, 19, 327-334.
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  : To estimate the pancreatic cancer risk among subjects exposed versus not exposed to proton pump inhibitors.: The authors searched PubMed, EMBASE, Scopus, Cochrane Library, and clinicaltrials.gov to identify relevant studies. The authors quantified pancreatic cancer risk among subjects exposed versus not exposed to PPIs, expressed as the pooled (adjusted) odds ratio (OR/aOR) and 95% confidence interval (95%CI) in overall and sensitivity analyses.: One randomized trial, two cohort, four case-control, and five nested case-control studies with 700,178 subjects (73,985 cases; 626,193 controls) were retained. PPI exposure was associated with pancreatic cancer risk (OR = 1.75, 95%CI = 1.12-2.72, I = 99%); confirmed in sensitivity analyses for high-quality studies, observational studies, case-control studies, studies with pancreatic cancer as the primary outcome, and in sensitivity analyses for diabetes and obesity but not for pancreatitis and smoking. This association was independent of the duration and Defined Daily Dose of PPI exposure. Rabeprazole had a singular significant association with pancreatic cancer (OR = 5.40, 95%CI = 1.98-14.703, I = 87.9%).: The class of PPIs is associated with a 1.75-fold increase in pancreatic cancer risk, confirmed in sensitivity analyses.
• Almutairi, A. R., McBride, A., Slack, M., Erstad, B. L., & Abraham, I. (2020). Potential Immune-Related Adverse Events Associated With Monotherapy and Combination Therapy of Ipilimumab, Nivolumab, and Pembrolizumab for Advanced Melanoma: A Systematic Review and Meta-Analysis. Frontiers in oncology, 10, 91.
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  The use of ipilimumab, nivolumab, and pembrolizumab as monotherapies or in combination has transformed the management of advanced melanoma even though these drugs are associated with a new profile of immune-related adverse events (irAEs). The incidence of irAEs from clinical trials of these agents is an important factor for clinicians when treating patients with advanced melanoma. In the current study, we aimed to profile the incidence of potential irAEs of these agents when used as monotherapy and as combination therapy. We searched the Medline, Embase, and Cochrane databases; clinicaltrials.gov; and websites of regulatory agencies in the USA, Europe, Australia, and Japan for phase 1-3 trials of ipilimumab, nivolumab, and pembrolizumab for advanced melanoma. Random effect meta-analysis was utilized to profile the incidence of potential irAEs. A total of 58 reports of 35 trials including 6,331 patients with advanced melanoma and reporting irAE data were included in the meta-analyses. We found higher incidences of potential irAEs in combination therapies vs. monotherapies for most of the types of irAEs. Among the monotherapies, ipilimumab users had the most frequent incidence of potential irAEs related to the gastrointestinal system (diarrhea, 29%; and colitis, 8%) and skin (rash, 31%; pruritus, 27%; and dermatitis, 10%), with hypophysitis in 4% of the patients. The most frequent potential irAEs among nivolumab users were maculopapular rash (13%), erythema (4%), hepatitis (3%), and infusion-related reactions (3%), while they were arthralgia (12%), hypothyroidism (8%), and hyperglycemia (6%), among pembrolizumab users. Especially the combination therapies tend to elevate the incidence of potential irAEs. Clinicians should be vigilant about irAEs following combination therapy as well as gastrointestinal and skin irAEs following ipilimumab therapy, in addition to being aware of potential irAEs leading to hyperglycemia, thyroid, hepatic, and musculoskeletal disorders following nivolumab and pembrolizumab therapy.
• Alrashed, A., Alhusseini, A. A., Enani, M., Alosaimi, B., Alkani, N. M., Mohzari, Y., Alghalbi, M., Khan, T. H., Alfaha, W., Alanazi, M. A., Albujaidya, A. S., Ben-Akresh, A., Almutairi, M., Abraham, I. L., & Alamer, A. (2020). Severity of COVID-19 infection in ACEI/ARB Users in two Saudi public specialty hospitals: retrospective cohort study. Research Square (Pre-print server), Mandatory pre-print publication per publisher's COVID-19 policy.
• Combs, D., Edgin, J. O., Klewer, S., Barber, B. J., Morgan, W. J., Hsu, C. H., Abraham, I., & Parthasarathy, S. (2020). OSA and Neurocognitive Impairment in Children With Congenital Heart Disease. Chest, 158(3), 1208-1217.
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  Children with congenital heart disease (CHD) have an increased risk of neurocognitive impairment. No prior studies have evaluated the role of OSA, which is associated with neurocognitive impairment in children without CHD.
• Kim, H. J., Jung, S. O., Kim, H., & Abraham, I. (2020). Systematic review of longitudinal studies on chemotherapy-associated subjective cognitive impairment in cancer patients. Psycho-oncology, 29(4), 617-631.
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  This systematic review of longitudinal studies, assessing subjective cognitive impairment (SCI) reported by adult cancer patients, aimed to summarize evidence on the impact of chemotherapy on SCI, identify moderators of SCI, and evaluate methodological issues.
• Kim, H., & Abraham, I. (2020). Determinants of the Higher Prevalence and Severity of Subjective Cognitive Impairment in Cancer Patients Compared to Healthy Subjects: Fatigue and Stress. Clinical nursing research, E-publication ahead of print. doi:10.1177/1054773820957474
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  This study examined whether (a) cancer patients in two cohorts reported greater subjective cognitive impairment (SCI) in prevalence and severity than noncancer healthy controls; and (b) selected psychoneurological factors (fatigue, stress, and sleep disturbance) contribute to such differences. Data from 60 prechemotherapy cancer patients, 81 active-chemotherapy cancer patients, and 116 noncancer healthy controls were analyzed using hierarchical regressions. The prevalence rate of SCI was higher in the prechemotherapy cancer cohort (41.6%) and in the active-chemotherapy cancer cohort (46.9%) than in healthy controls (21.5%;  
• Leys, A. M., Ramboer, E., Favreau, M., Denhaerynck, K., MacDonald, K., Abraham, I., & Brié, H. (2020). Long-Term Ranibizumab Treatment in Neovascular Age-Related Macular Degeneration: A Belgian Subanalysis from the Global Real-World LUMINOUS Study. Clinical ophthalmology (Auckland, N.Z.), 14, 1473-1481.
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  To evaluate long-term, real-world treatment patterns and outcomes of ranibizumab 0.5 mg for neovascular age-related macular degeneration (nAMD) in a Belgian cohort.
• MacDonald, K., McBride, A., Alrawashdh, N., & Abraham, I. (2020). Cost-efficiency and expanded access of prophylaxis for chemotherapy-induced (febrile) neutropenia: economic simulation analysis for the US of conversion from reference pegfilgrastim to biosimilar pegfilgrastim-cbqv. Journal of medical economics, E-publication ahead of print. doi:10.1080/13696998.2020.1833339
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  In this pharmacoeconomic simulation, we: (1) modeled the cost-efficiency of converting patients from reference pegfilgrastim to biosimilar pegfilgrastim-cbqv for prophylaxis of chemotherapy-induced (febrile) neutropenia (CIN/FN) from the US payer perspective, (2) simulated how savings enable, on a budget-neutral basis, expanded access to pegfilgrastim-cbqv, and (3) estimated the number-needed-to-convert (NNC) to purchase one additional dose of pegfilgrastim-cbqv.
• McBride, A., Krendyukov, A., Mathieson, N., Campbell, K., Balu, S., Natek, M., MacDonald, K., & Abraham, I. (2020). Febrile neutropenia hospitalization due to pegfilgrastim on-body injector failure compared to single-injection pegfilgrastim and daily injections with reference and biosimilar filgrastim: US cost simulation for lung cancer and non-Hodgkin lymphoma. Journal of medical economics, 23(1), 28-36.
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  Guidelines recommend febrile neutropenia (FN) prophylaxis following myelotoxic chemotherapy with either daily injections of filgrastim (Neupogen) or biosimilar filgrastim-sndz (Zarzio/Zarxio), single-injection pegfilgrastim (Neulasta), or pegfilgrastim administered through an on-body injector (PEG-OBI; Neulasta Onpro). PEG-OBI failure rates up to 6.9% have been reported, putting patients at incremental risk for FN and FN-related hospitalization. Our objective was to estimate, from a US payer perspective, the incremental costs of FN hospitalizations and the total incremental costs associated with PEG-OBI prophylaxis at varying device failure rates over assured FN prophylaxis with daily injections of filgrastim or filgrastim-sndz or a single injection of pegfilgrastim. Cost simulations comparing prophylaxis with PEG-OBI at failure rates of 1-10% versus assured prophylaxis in cycle 1 of chemotherapy were performed for panels of 10,000 patients with lung cancer treated with cyclophosphamide, doxorubicin, and etoposide (1 analysis) or non-Hodgkin lymphoma (NHL) treated with CHOP or CNOP (2 analyses). Daily injection scenarios were 4.3, 5, and 11 injections for lung cancer and 5, 6.5, and 11 for NHL. The analyses are from the US payer perspective. For lung cancer, the total incremental cost of PEG-OBI prophylaxis at varying failure rates and durations ranged from $6,691,969‒$31,765,299 over filgrastim and $18,901,969‒$36,538,299 over filgrastim-sndz. For NHL, in scenario 1, the total incremental costs ranged from $6,794,984‒$30,361,345 over filgrastim and $19,004,984‒$35,911,345 over filgrastim-sndz; in scenario 2, the incremental costs ranged from $7,003,657‒$32,448,067 over filgrastim and $19,213,657‒$37,998,067 over filgrastim-sndz. In this simulation, the incremental costs of FN-related hospitalization due to PEG-OBI failure in cycle 1 compared to assured prophylaxis with reference pegfilgrastim, reference filgrastim, and biosimilar filgrastim-sndz varied depending upon the PEG-OBI failure rate and the alternative G-CSF prophylaxis option. Biosimilar filgrastim-sndz offers the greatest cost-efficiency.
• McBride, A., Wang, W., Campbell, K., Balu, S., MacDonald, K., & Abraham, I. (2020). Economic modeling for the US of the cost-efficiency and associated expanded treatment access of conversion to biosimilar pegfilgrastim-bmez from reference pegfilgrastim. Journal of Medical Economics, 23(Issue 8). doi:10.1080/13696998.2020.1760284
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  Aims: For this economic analysis, we aimed to model: (1) the cost-efficiency of prophylaxis with biosimilar pegfilgrastim-bmez for chemotherapy-induced (febrile) neutropenia (CIN/FN) compared to reference pegfilgrastim, and (2) the expanded access to CIN/FN prophylaxis and anti-neoplastic treatment that could be achieved with biosimilar cost-savings on a budget-neutral basis. Methods: In a hypothetical panel of 20,000 cancer patients receiving CIN/FN prophylaxis and using the average sales price (ASP) for the second quarter of 2019 for reference pegfilgrastim, we: conducted an ex ante simulation from the payer perspective of the cost-savings of 10–100% conversion from reference to biosimilar pegfilgrastim-bmez using drug price discounting ranging from 10–35%; estimated the budget-neutral expanded access to biosimilar pegfilgrastim-bmez enabled by these cost-savings; and estimated the budget-neutral expanded access to anti-neoplastic treatment with pembrolizumab. The simulations were replicated using fourth quarter 2019 wholesale acquisition cost (WAC) for reference pegfilgrastim and biosimilar pegfilgrastim-bmez in a post facto analysis. Results: In ASP simulations, cost-savings of using pegfilgrastim-bmez over reference pegfilgrastim in a 20,000 patient panel range from $1.3 M (at 15% price discount) to $3 M (35%) at 10% conversion rate and from $6.4 M to $14.9 M, respectively, at 50% conversion. These savings could provide prophylaxis with pegfilgrastim-bmez to an additional 352 (15% discount) to 1,076 patients (35%) at 10% conversion or 1,764–5,384, respectively, at 50% conversion. Alternatively, savings could be reallocated for anti-neoplastic treatment with pembrolizumab to 3 (15% discount) to 9 (35%) patients at 10% conversion or 19–45, respectively, at 50% conversion. When utilizing WAC, cost-savings range from $4.6 M (10% conversion) to $23.1 M (50%) which could provide pegfilgrastim-bmez to an additional 1,174 (10% conversion) to 5,873 patients (50%). Conclusions: Prophylaxis with biosimilar pegfilgrastim-bmez increases the value of cancer care by generating significant cost-savings that could be reallocated to provide expanded access to CIN/FN prevention and anti-neoplastic therapy on a budget-neutral basis.
• McBride, A., Wang, W., Campbell, K., Balu, S., MacDonald, K., & Abraham, I. (2020). Economic modeling for the US of the cost-efficiency and associated expanded treatment access of conversion to biosimilar pegfilgrastim-bmez from reference pegfilgrastim. Journal of medical economics, 23(8), 856-863.
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  For this economic analysis, we aimed to model: (1) the cost-efficiency of prophylaxis with biosimilar pegfilgrastim-bmez for chemotherapy-induced (febrile) neutropenia (CIN/FN) compared to reference pegfilgrastim, and (2) the expanded access to CIN/FN prophylaxis and anti-neoplastic treatment that could be achieved with biosimilar cost-savings on a budget-neutral basis. In a hypothetical panel of 20,000 cancer patients receiving CIN/FN prophylaxis and using the average sales price (ASP) for the second quarter of 2019 for reference pegfilgrastim, we: conducted an simulation from the payer perspective of the cost-savings of 10-100% conversion from reference to biosimilar pegfilgrastim-bmez using drug price discounting ranging from 10-35%; estimated the budget-neutral expanded access to biosimilar pegfilgrastim-bmez enabled by these cost-savings; and estimated the budget-neutral expanded access to anti-neoplastic treatment with pembrolizumab. The simulations were replicated using fourth quarter 2019 wholesale acquisition cost (WAC) for reference pegfilgrastim and biosimilar pegfilgrastim-bmez in a analysis. In ASP simulations, cost-savings of using pegfilgrastim-bmez over reference pegfilgrastim in a 20,000 patient panel range from $1.3 M (at 15% price discount) to $3 M (35%) at 10% conversion rate and from $6.4 M to $14.9 M, respectively, at 50% conversion. These savings could provide prophylaxis with pegfilgrastim-bmez to an additional 352 (15% discount) to 1,076 patients (35%) at 10% conversion or 1,764-5,384, respectively, at 50% conversion. Alternatively, savings could be reallocated for anti-neoplastic treatment with pembrolizumab to 3 (15% discount) to 9 (35%) patients at 10% conversion or 19-45, respectively, at 50% conversion. When utilizing WAC, cost-savings range from $4.6 M (10% conversion) to $23.1 M (50%) which could provide pegfilgrastim-bmez to an additional 1,174 (10% conversion) to 5,873 patients (50%). Prophylaxis with biosimilar pegfilgrastim-bmez increases the value of cancer care by generating significant cost-savings that could be reallocated to provide expanded access to CIN/FN prevention and anti-neoplastic therapy on a budget-neutral basis.
• Nguyen, L., Zhang, X., Roberts, E., Yun, S., McGraw, K., Abraham, I., Song, J., Braswell, D., Qin, D., Sallman, D. A., Lancet, J. E., List, A. F., Moscinski, L. C., Padron, E., & Zhang, L. (2020). Comparison of mutational profiles and clinical outcomes in patients with acute myeloid leukemia with mutated versus acute myeloid leukemia with myelodysplasia-related changes with mutated. Leukemia & lymphoma, 61(6), 1395-1405.
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  Studies comparing the prognostic role of mutations () in acute myeloid leukemia (AML) and acute myeloid leukemia-with myelodysplasia-related changes (AML-MRC) are limited. Our study examines the genetic profile of 118 AML patients including 57 AML with and 61 AML-MRC with and 100 AML, NOS patients with wild type (). Results revealed that AML-MRC patients with had shorter median overall survival (OS) (11 ± 3.3 months) when compared to AML with (19 ± 7.1 months) and AML, NOS with (not reached) ( = .001). The most common concurrent mutations observed in AML-MRC with patients were , , , and while in AML with patients were , , , , and . and mutations appeared to adversely affect OS in AML-MRC, but not in AML with . Concurrent mutations, in contrast had negative impact on OS in AML with , but not in AML-MRC with .
• Nguyen, L., Zhang, X., Roberts, E., Yun, S., McGraw, K., Abraham, I., Song, J., Braswell, D., Qin, D., Sallman, D. A., Lancet, J. E., List, A. F., Moscinski, L. C., Padron, E., & Zhang, L. (2020). Comparison of mutational profiles and clinical outcomes in patients with acute myeloid leukemia with mutated RUNX1 versus acute myeloid leukemia with myelodysplasia-related changes with mutated RUNX1. Leukemia and Lymphoma, 61(Issue 6). doi:10.1080/10428194.2020.1723016
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  Studies comparing the prognostic role of RUNX1 mutations (RUNX1mut) in acute myeloid leukemia (AML) and acute myeloid leukemia-with myelodysplasia-related changes (AML-MRC) are limited. Our study examines the genetic profile of 118 RUNX1mut AML patients including 57 AML with RUNX1mut and 61 AML-MRC with RUNX1mut and 100 AML, NOS patients with wild type RUNX1 (RUNX1wt). Results revealed that AML-MRC patients with RUNX1mut had shorter median overall survival (OS) (11 ± 3.3 months) when compared to AML with RUNX1mut (19 ± 7.1 months) and AML, NOS with RUNX1wt (not reached) (p =.001). The most common concurrent mutations observed in AML-MRC with RUNX1mut patients were DNMT3A, SRSF2, ASXL1, and IDH2 while in AML with RUNX1mut patients were ASXL1, SRSF2, TET2, IDH2, and DNMT3A. ASXL1 and TET2 mutations appeared to adversely affect OS in AML-MRC, but not in AML with RUNX1mut. Concurrent RUNX1/DNMT3A mutations, in contrast had negative impact on OS in AML with RUNX1mut, but not in AML-MRC with RUNX1mut.
• Oh, M., McBride, A., Yun, S., Bhattacharjee, S., Slack, M., Martin, J. R., Jeter, J., & Abraham, I. (2020). Response to Yang, Shi, Wang et al.. Journal of the National Cancer Institute, 112(Issue 4). doi:10.1093/jnci/djz163
• Oh, M., McBride, A., Yun, S., Bhattacharjee, S., Slack, M., Martin, J. R., Jeter, J., & Abraham, I. (2020). Response to Yang, Shi, Wang, et al. Journal of the National Cancer Institute, 112, 428.
• Oh, M., Patanwala, A. E., Alkhatib, N., Almutairi, A., Abraham, I., & Erstad, B. (2020). Cost Analysis of Adjunctive Hydrocortisone Therapy for Septic Shock: U.S. Payer Perspective. Critical Care Medicine, 48(Issue 10). doi:10.1097/ccm.0000000000004501
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  Objectives: To conduct a cost analysis of adjunctive hydrocortisone therapy for severe septic shock from the perspective of a third-party payer in the United States. Design: Estimates of outcomes were aggregate data from the Adjunctive Corticosteroid Treatment in Critically Ill Patients with Septic Shock and Activated Protein C and Corticosteroids for Human Septic Shock trials. In these trials, the outcomes of interests were ICU length of stay, vasopressor-free days, ventilation-free days, and the proportion of patients receiving blood transfusion. Each outcome was monetized into a set of mutually exclusive components and was aggregated to estimate the cost-per-patient based on each trial. Cost inputs for each outcome were obtained from literature and adjusted based on the medical care consumer price index. To estimate the budget impact using adjunctive hydrocortisone therapy, per-patient avoided cost was multiplied by expected septic shock annual incidence. Deterministic one-way sensitivity analysis evaluated the robustness of the findings, and Monte Carlo simulation estimated 95% CI of the findings. Setting: A total of 103 medical-surgical ICU (69 for Adjunctive Corticosteroid Treatment in Critically Ill Patients with Septic Shock and 34 for Activated Protein C and Corticosteroids for Human Septic Shock). Patients: Adults greater than or equal to 18 years old with septic shock. Interventions: Adjunctive hydrocortisone therapy (hydrocortisone at a dose of 200 mg/d for 7 d for Adjunctive Corticosteroid Treatment in Critically Ill Patients with Septic Shock and hydrocortisone at a 50 mg IV bolus every 6 hr and fludrocortisone as a 50 μg tablet once daily). Measurements and Main Results: Per Adjunctive Corticosteroid Treatment in Critically Ill Patients with Septic Shock, adjunctive hydrocortisone therapy showed a 90-day monetized benefit of $8,111 (95% CI, $3,914-$12,307) per patient, driven by improvements in ICU-free days, vasopressor-free days, ventilation-free days, and blood transfusion proportion. The total estimated annual impact of adjunctive hydrocortisone therapy, in 2019 dollars, was $750 million. Per Activated Protein C and Corticosteroids for Human Septic Shock, adjunctive hydrocortisone therapy showed a 90-day monetized benefit of $25,539 per patient (95% CI, $22,853-$28,224), driven by improvements in ICU free-days, vasopressor-free days, and ventilation-free days. The total estimated annual impact of adjunctive hydrocortisone therapy, in 2019 dollars, was $2.3 billion. The deterministic one-way sensitivity analysis showed the cost of ICU stays to be the most influential factor in both analyses. The sensitivity analysis using the reported median showed a greater monetized benefit of $10,658 (Adjunctive Corticosteroid Treatment in Critically Ill Patients with Septic Shock) and $30,911 (Activated Protein C and Corticosteroids for Human Septic Shock) per patient. Conclusions: Using adjunctive hydrocortisone therapy yields a significant monetized benefit based on inputs from the Adjunctive Corticosteroid Treatment in Critically Ill Patients with Septic Shock and Activated Protein C and Corticosteroids for Human Septic Shock trials.
• Oh, M., Patanwala, A. E., Alkhatib, N., Almutairi, A., Abraham, I., & Erstad, B. (2020). Cost Analysis of Adjunctive Hydrocortisone Therapy for Septic Shock: U.S. Payer Perspective. Critical care medicine, 48(10), e906-e911.
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  To conduct a cost analysis of adjunctive hydrocortisone therapy for severe septic shock from the perspective of a third-party payer in the United States.
• Tompkinson, M., Fine, K., Gruber, D., Abraham, I. L., & McBride, A. (2020). Perceptions of health-care workers of the cost and safety of oral oncolytic agents for patients: a survey.. Journal of the Advanced Practitioner in Oncology, 11, 354-365.
• Van Aken, E., Favreau, M., Ramboer, E., Denhaerynck, K., MacDonald, K., Abraham, I., & Brié, H. (2020). Real-World Outcomes in Patients with Diabetic Macular Edema Treated Long Term with Ranibizumab (VISION Study). Clinical ophthalmology (Auckland, N.Z.), 14, 4173-4185.
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  Evaluate long-term real-world treatment patterns and associated effectiveness and safety outcomes in patients with diabetic macular edema (DME) treated ≥36 months with 0.5mg ranibizumab.
• Van Aken, E., Favreau, M., Ramboer, E., Denhaerynck, K., Macdonald, K., Abraham, I., & Brié, H. (2020). Real-world outcomes in patients with diabetic macular edema treated long term with ranibizumab (Vision study). Clinical Ophthalmology, 14(Issue). doi:10.2147/opth.s281501
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  Aim: Evaluate long-term real-world treatment patterns and associated effectiveness and safety outcomes in patients with diabetic macular edema (DME) treated ≥36 months with 0.5mg ranibizumab. Methods: Open-label observational effectiveness study in 9 Belgian clinics. Included were primary treated eyes of 55 DME patients between August 2014 and March 2015 and followed for 3.5±1.8 years. Eyes were 21.8% treatment (TX)-naïve, 9.1% non-naïve with exclusive prior anti-VEGF treatment (PRIOR-anti-VEGF), and 63.6% non-naïve with other prior treatments (PRIOR-other). Intravitreal injections with ranibizumab were administered per ophthalmologists’ best clinical judgment. Trend testing of changes in best-corrected visual acuity (BCVA) and central retinal thickness (CRT) over time occurred using mixed regression analysis. Results: The mean±SD number of treatments in the first year was 5.1±3.0 (TX-naïve), 4.5 ±2.7 (PRIOR-anti-VEGF) and 5.6±3.1 (PRIOR-other). At 12 months, BCVA increased by 8.9±16.4 letters from 59.7±9.3 at baseline in TX-naïve (p
• Abraham, I. L. (2019). Febrile neutropenia hospitalization due to pegfilgrastim on-body injector failure compared to single-injection pegfilgrastim and daily injections with reference and biosimilar filgrastim: US cost simulation for lung cancer and non-Hodgkin lymphoma. Journal of Medical Economics, 23(1), 28-36. doi:10.1080/13696998.2019.1658591
• Abraham, I. L. (2019). The Importance of Outcome and Precise Evaluation in Economic Analysis of Cancer Drugs—Reply. JAMA Dermatology, 155(7), 863. doi:10.1001/jamadermatol.2019.0135
• Abraham, I., Alkhatib, N. S., Almutairi, A. R., Alrawashdh, N., Babiker, H. M., Macdonald, K., Mcbride, A., & Oh, M. (2019). 30-year extrapolations of overall survival (OS) and metastasis-free survival (MFS) from the SPCG-4 trial of radical prostatectomy (RP) versus watchful waiting (WW) in patients (pts) with early prostate cancer (ePCa).. Journal of Clinical Oncology, 37(15_suppl), e16597-e16597. doi:10.1200/jco.2019.37.15_suppl.e16597
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  e16597Background: Bill-Axelson et al (NEJM, 2014) reported 18 year (y) mortality and metastasis (mets) data on ePCa pts randomized in the SPCG-4 trial to RP (n = 347) vs WW (n = 348) for all pts an...
• Abraham, I., Almutairi, A. R., Alsaid, N., Erstad, B. L., Oh, M., & Patanwala, A. E. (2019). 1651: COST ANALYSIS OF ADJUNCTIVE HYDROCORTISONE THERAPY FOR SEPTIC SHOCK FROM THE U.S. PAYER PERSPECTIVE. Critical Care Medicine, 47(1), 800. doi:10.1097/01.ccm.0000552391.78431.6d
• Abraham, I., Almutairi, A. R., Althagafi, A., Babiker, H. M., Fallatah, S., Khushaym, N. M., Mcbride, A., & Oh, M. (2019). Proton pump inhibitor (PPI) exposure and risk of pancreatic cancer (PC): Meta-analysis.. Journal of Clinical Oncology, 37(15_suppl), e15755-e15755. doi:10.1200/jco.2019.37.15_suppl.e15755
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  e15755Background: PPIs are widely used in the treatment of various acid related disorders. Observational studies have raised concern about an association of PPI use and PC but findings have been in...
• Abraham, I., Almutairi, A. R., Mcbride, A., & Sundararajan, S. (2019). Immune related adverse events (irAE) of mono-, combination, and sequential therapy regimens of ipilimumab (IPI), nivolumab (NIV), and pembrolizumab (PEM) for advanced melanoma.. Journal of Clinical Oncology, 37(15_suppl), e21011-e21011. doi:10.1200/jco.2019.37.15_suppl.e21011
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  e21011Background: The immunotherapy agents IPI, NIV, and PEM have transformed the management of advanced melanoma but are associated with irAEs. We estimated the incidence of irAEs as observed in c...
• Abraham, I., Alsheikh, R., & MacDonald, K. (2019). A Cautionary Research Note on Standard Versus Extended Release Tacrolimus. Progress in Transplantation, 29(Issue 1). doi:10.1177/1526924818817070
• Abraham, I., Benitez, L. L., Bixby, D. L., Burke, P. W., Marini, B. L., Mcbride, A., Oh, M., Perissinotti, A. J., & Pettit, K. M. (2019). Bayesian network meta-analysis (NMA) of complete remission without or with incomplete hematologic recovery (CR/CRi) to CPX-351, FLAG, and standard 7+3 (7+3) chemotherapy in the treatment of newly diagnosed secondary acute myeloid leukemia (sAML).. Journal of Clinical Oncology, 37(15_suppl), e18514-e18514. doi:10.1200/jco.2019.37.15_suppl.e18514
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  e18514Background: Patients (pts) sAML have poor outcomes (CR/CRi= 25-35%) with standard 7+3 induction chemotherapy (7+3). CPX-351 (liposomal encapsulated daunorubicin + cytarabine at a synergistic ...
• Abraham, I., Combs, D., Hsu, C. H., Morgan, W. J., Parthasarathy, S., & Patel, S. I. (2019). 0739 Comparison Of Parent And Child Treatment Preferences For Obstructive Sleep Apnea. Sleep, 42(Supplement_1), A297-A297. doi:10.1093/sleep/zsz067.737
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  Obstructive sleep apnea (OSA) is common in children and is associated with negative neurocognitive and behavioral effects. While adenotonsillectomy is typically the first-line recommended therapy for OSA in children, other therapeutic options include medication therapy with montelukast (with or without intranasal steroid) and positive airway pressure therapy (PAP). To our knowledge, no prior studies have examined parent and child treatment preferences for OSA. Given this, our objective was to compare OSA treatment preferences between parents and children. Children with a new diagnosis of OSA (obstructive apnea-hypopnea index ≥1) were recruited from the pediatric sleep medicine clinic. Parent and child separately rated each available treatment option (adenotonsillectomy, medication, PAP or watchful waiting) on a scale from 0-100. A percent preference for each treatment was created by dividing the rating for each individual treatment by the sum of the ratings for all treatments. Intraclass correlation coefficients (ICC) were used to determine the level of agreement between parent and child preference for each therapy, and t-tests were used to compare the overall differences between parent and child preference for each therapy. Eighteen children, mean age 11.1 ± 2.8 years, participated in the study. 61% selected adenotonsillectomy, 11% chose medication therapy, 22% chose PAP and 6% chose watchful waiting. Parent-child agreement was excellent for adenotonsillectomy (ICC=0.798, p=0.001) and PAP (ICC=0.816, p=0.001). Limited agreement was seen for watchful waiting (ICC=0.342, p=0.20) and medical therapy (ICC=0.335, p=0.21). Comparison of parent and child mean preference showed no significant difference in parent vs. child preference for adenotonsillectomy (mean preference 36% vs 35%, p=0.89), PAP (mean 29% vs 26%, p=0.43), medication therapy (mean 23% vs 26%, p=0.55) or watchful waiting (mean 12% vs 13%, p=0.81). Parents and children have similar preferences for OSA treatment. There was a high level of agreement for adenotonsillectomy and PAP therapy between children and parents, with lesser agreement for medical therapy and watchful waiting. Based on these results, parent treatment preference appears to be a good proxy for child preference. Grant from the AASM Foundation
• Abraham, I., Crews, J. R., Dawkins, M., Gregg, J. P., Perloff, T., & Schwartzberg, L. S. (2019). A multispecialty approach to immuno-oncology education for community providers.. Journal of Clinical Oncology, 37(8_suppl), 80-80. doi:10.1200/jco.2019.37.8_suppl.80
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  80Background: The Association of Community Cancer Centers (ACCC) Immuno-Oncology Institute was developed in 2015 to prepare all members of the multidisciplinary cancer care team for the complex imp...
• Al Yami, M. S., McBride, A., Katragadda, C., Martin, J. R., Badreldin, H. A., Mohammed, A. H., Elmubark, A. M., Alzahrani, M. Y., Alsheri, A. M., & Abraham, I. (2019). Correction to: Direct oral anticoagulants for the treatment of venous thromboembolism in patients with active malignancy: a systematic review and meta-analysis (Journal of Thrombosis and Thrombolysis, (2018), 46, 2, (145-153), 10.1007/s11239-018-1696-0). Journal of Thrombosis and Thrombolysis, 47(Issue 1). doi:10.1007/s11239-018-1777-0
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  Unfortunately the author list in the original article is incomplete. The correct list of contributing authors is given in this Correction.
• Al Yami, M. S., McBride, A., Katragadda, C., Martin, J. R., Badreldin, H. A., Mohammed, A. H., Elmubark, A. M., Alzahrani, M. Y., Alsheri, A. M., & Abraham, I. (2019). Correction to: Direct oral anticoagulants for the treatment of venous thromboembolism in patients with active malignancy: a systematic review and meta-analysis. Journal of thrombosis and thrombolysis, 47(1), 166.
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  Unfortunately the author list in the original article is incomplete. The correct list of contributing authors is given in this Correction.
• Algotar, A., Hsu, C. H., Sherry Chow, H. H., Dougherty, S., Babiker, H. M., Marrero, D., Abraham, I., Kumar, R., Ligibel, J., Courneya, K. S., & Thomson, C. (2019). Comprehensive Lifestyle Improvement Program for Prostate Cancer (CLIPP): Protocol for a Feasibility and Exploratory Efficacy Study in Men on Androgen Deprivation Therapy. JMIR research protocols, 8(2), e12579.
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  Androgen deprivation therapy (ADT) for prostate cancer is associated with adverse cardiometabolic effects such as reduced libido, hot flashes, metabolic syndrome, diabetes, myocardial infarction, and stroke. This reduces quality of life and potentially increases mortality. Several large clinical trials have demonstrated improvements in cardiometabolic risk with comprehensive multimodality lifestyle modification. However, there is a lack of data for such interventions in men on ADT for prostate cancer, and existing studies have used non-standardized interventions or lacked data on metabolic risk factors.
• Algotar, A., Hsu, C. H., Sherry Chow, H. H., Dougherty, S., Babiker, H. M., Marrero, D., Abraham, I., Kumar, R., Ligibel, J., Courneya, K. S., & Thomson, C. (2019). Comprehensive lifestyle improvement program for prostate cancer (CLIPP): Protocol for a feasibility and exploratory efficacy study in men on androgen deprivation therapy. JMIR Research Protocols, 8(Issue 2). doi:10.2196/12579
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  Background: Androgen deprivation therapy (ADT) for prostate cancer is associated with adverse cardiometabolic effects such as reduced libido, hot flashes, metabolic syndrome, diabetes, myocardial infarction, and stroke. This reduces quality of life and potentially increases mortality. Several large clinical trials have demonstrated improvements in cardiometabolic risk with comprehensive multimodality lifestyle modification. However, there is a lack of data for such interventions in men on ADT for prostate cancer, and existing studies have used non-standardized interventions or lacked data on metabolic risk factors. Objective: The Comprehensive Lifestyle Improvement Project for Prostate Cancer (CLIPP) is designed to address these gaps by using an intervention modeled on the Diabetes Prevention Program, a standardized multicomponent intervention with demonstrated effectiveness in reducing cardiometabolic risk factors that has been successfully adapted for multiple disease types including breast cancer. Methods: A single-arm unblinded clinical trial will be conducted to determine the feasibility of conducting a 24-week comprehensive lifestyle modification intervention that targets weight loss and increased physical activity modeled on the Diabetes Prevention Program in 30 men on ADT for prostate cancer. Secondary aims are to determine the effect of the intervention on cardiometabolic markers and quality of life. The tertiary aim is to determine the effect of the intervention on markers of inflammation and angiogenesis, important mechanisms for prostate cancer progression. Participants will be recruited from the University of Arizona Cancer Center and the surrounding community. The intervention will be delivered weekly in person and over the phone for 16 weeks. For Weeks 16-24, participants receive weekly phone calls from the study health coach to motivate them to continue their lifestyle modification. Questionnaire and biological data are collected at baseline, 12 weeks, and 24 weeks. Body composition using dual-energy x-ray absorptiometry scans will be performed at baseline and end of study. Results: Based on a sample size of 30, the two-sided 95% confidence interval will not be wider than 0.373 standard deviations for the adherence rate and will not be wider than 0.374 for the retention rate. In addition, the study will have a power of 80% to detect a change of 0.47 standard deviations from baseline for each of the markers investigated in the secondary and tertiary aims assuming a within-subject correlation of 0.20 at a significance level of 5%. The recruitment period is from October 2018 to April 2019. Conclusions: The aim of CLIPP is to determine the feasibility of conducting a Diabetes Prevention Program–style comprehensive lifestyle modification intervention in men with ADT for prostate cancer and its effects on cardiometabolic adverse effects, quality of life, as well as markers of inflammation and angiogenesis. Results will inform the development of future clinical trials in this population.
• Alhifany, A. A., Almutairi, A. R., Almangour, T. A., Shahbar, A. N., Abraham, I., Alessa, M., Alnezary, F. S., & Cheema, E. (2019). Comparing the efficacy and safety of faecal microbiota transplantation with bezlotoxumab in reducing the risk of recurrent infections: a systematic review and Bayesian network meta-analysis of randomised controlled trials. BMJ open, 9(11), e031145.
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  The risk of recurrent infections (RCDIs) is high when treated with standard antibiotics therapy (SAT) alone. It is suggested that the addition of faecal microbiota transplantation (FMT) or bezlotoxumab after SAT reduces the risk of RCDI. In the absence of head-to-head randomised controlled trials (RCTs), this review attempts to compare the efficacy and safety of bezlotoxumab with FMT in reducing the risk of RCDI in hospitalised patients.
• Alhifany, A. A., Almutairi, A. R., Almangour, T. A., Shahbar, A. N., Abraham, I., Alessa, M., Alnezary, F. S., & Cheema, E. (2019). Comparing the efficacy and safety of faecal microbiota transplantation with bezlotoxumab in reducing the risk of recurrent Clostridium difficile infections: A systematic review and Bayesian network meta-analysis of randomised controlled trials. BMJ Open, 9(Issue 11). doi:10.1136/bmjopen-2019-031145
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  Objectives The risk of recurrent Clostridium difficile infections (RCDIs) is high when treated with standard antibiotics therapy (SAT) alone. It is suggested that the addition of faecal microbiota transplantation (FMT) or bezlotoxumab after SAT reduces the risk of RCDI. In the absence of head-to-head randomised controlled trials (RCTs), this review attempts to compare the efficacy and safety of bezlotoxumab with FMT in reducing the risk of RCDI in hospitalised patients. Design A systematic review and Bayesian network meta-analysis. Data source A comprehensive search from inception to 30 February 2019 was conducted in four databases (Medline/PubMed, Embase, Scopus, ClinicalTrials.gov). Eligibility criteria RCTs reporting the resolution of diarrhoea associated with RCDI without relapse for at least 60 days after the end of treatments as the primary outcome. Data extraction and synthesis We extracted author, year of publication, study design and binomial data that represented the resolution of diarrhoea or adverse events of monoclonal antibodies and FMT infusion. Random-effects models were used for resolution rate of RCDI and adverse events. The Cochrane Risk of Bias tool was used to assess the quality of included RCTs. Results Out of 1003 articles identified, seven RCTs involving 3043 patients contributed to the review. No difference was reported between single or multiple infusions of FMT and bezlotoxumab in resolving RCDI, (OR 1.53, 95% credible interval (CrI) 0.39 to 5.16) and (OR 2.86, 95% CrI 1.29 to 6.57), respectively. Patients treated with SAT alone or bezlotoxumab with SAT showed significantly lower rates of diarrhoea than FMT (OR 0, 95% CrI 0 to 0.09) and (OR 0, 95% CrI 0 to 0.19), respectively. There was no difference in terms of other adverse events. Conclusions This is the first network meta-analysis that has compared the recently Food and Drug Administration-approved monoclonal antibody bezlotoxumab with FMT for resolving RCDI. The quality of the included RCTs was variable. The findings of this study suggested no difference between single or multiple infusions of FMT and bezlotoxumab. However, FMT was associated with a higher rate of non-serious diarrhoea as opposed to SAT used alone or in combination with bezlotoxumab.
• Almulhim, A. S., Fallatah, S., & Abraham, I. (2019). Comparing incomparables with the wrong analytics: Anticoagulation, disability, intracranial hemorrhage, and mortality in acute cerebral vein thrombosis. Thrombosis Research, 178(Issue). doi:10.1016/j.thromres.2019.04.009
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  Significant progress has been made in the prevention and management of hypercoagulation. Unfractionated heparin (UF) and low molecular weight heparin (LMWH) are indicated for acute cerebral vein thrombosis with or without intracranial hemorrhage (ICH). A recent meta-analysis of four trials comparing UF and LMWH aimed to evaluate the efficacy and safety of both agents in terms of disability, intracranial hemorrhage, and mortality. However, several methodological aspects of the meta-analysis warrant further discussion. It appears that the disability outcome was not sufficiently harmonized by design or statistical standardization, some inputs could not be validated, incorrect statistical analyses were performed, major results could not be replicated, and conclusions were not supported by the statistical results. The conclusion of a statistically significant reduction in mortality is not supported by the data.
• Almulhim, A. S., Fallatah, S., & Abraham, I. (2019). Comparing incomparables with the wrong analytics: Anticoagulation, disability, intracranial hemorrhage, and mortality in acute cerebral vein thrombosis. Thrombosis research, 178, 110-111.
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  Significant progress has been made in the prevention and management of hypercoagulation. Unfractionated heparin (UF) and low molecular weight heparin (LMWH) are indicated for acute cerebral vein thrombosis with or without intracranial hemorrhage (ICH). A recent meta-analysis of four trials comparing UF and LMWH aimed to evaluate the efficacy and safety of both agents in terms of disability, intracranial hemorrhage, and mortality. However, several methodological aspects of the meta-analysis warrant further discussion. It appears that the disability outcome was not sufficiently harmonized by design or statistical standardization, some inputs could not be validated, incorrect statistical analyses were performed, major results could not be replicated, and conclusions were not supported by the statistical results. The conclusion of a statistically significant reduction in mortality is not supported by the data.
• Almutairi, A. R., Alkhatib, N. S., & Abraham, I. (2019). The Importance of Outcome and Precise Evaluation in Economic Analysis of Cancer Drugs-Reply. JAMA dermatology, 155(7), 863.
• Almutairi, A. R., Alkhatib, N. S., Oh, M., Curiel-Lewandrowski, C., Babiker, H. M., Cranmer, L. D., McBride, A., & Abraham, I. (2019). Economic Evaluation of Talimogene Laherparepvec Plus Ipilimumab Combination Therapy vs Ipilimumab Monotherapy in Patients With Advanced Unresectable Melanoma. JAMA dermatology, 155(1), 22-28.
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  A phase 2 trial comparing talimogene laherparepvec plus ipilimumab vs ipilimumab monotherapy in patients with advanced unresectable melanoma found no differential benefit in progression-free survival (PFS) but noted objective response rates (ORRs) of 38.8% (38 of 98 patients) vs 18.0% (18 of 100 patients), respectively.
• Almutairi, A. R., Alkhatib, N. S., Oh, M., Curiel-Lewandrowski, C., Babiker, H. M., Cranmer, L. D., McBride, A., & Abraham, I. (2019). Economic Evaluation of Talimogene Laherparepvec Plus Ipilimumab Combination Therapy vs Ipilimumab Monotherapy in Patients with Advanced Unresectable Melanoma. JAMA Dermatology, 155(Issue 1). doi:10.1001/jamadermatol.2018.3958
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  Importance: A phase 2 trial comparing talimogene laherparepvec plus ipilimumab vs ipilimumab monotherapy in patients with advanced unresectable melanoma found no differential benefit in progression-free survival (PFS) but noted objective response rates (ORRs) of 38.8% (38 of 98 patients) vs 18.0% (18 of 100 patients), respectively. Objective: To perform an economic evaluation of talimogene laherparepvec plus ipilimumab combination therapy vs ipilimumab monotherapy. Design, Setting, and Participants: For PFS, cost-effectiveness and cost-utility analyses using a 2-state Markov model (PFS vs progression or death) was performed. For ORRs, cost-effectiveness analysis of the incremental cost of 1 additional patient achieving objective response was performed. In this setting based on a US payer perspective (2017 US dollars), participants were patients with advanced unresectable melanoma. Main Outcomes and Measures: The PFS life-years and PFS quality-adjusted life-years were determined, and the associated incremental cost-effectiveness ratios (ICERs) and incremental cost-utility ratios (ICURs) were estimated. Also estimated was the ICER per 1 additional patient (out of 100 treated patients) achieving objective response. Base-case analyses were validated by sensitivity analyses. Results: In PFS analyses, the cost of talimogene laherparepvec plus ipilimumab ($494983) exceeded the cost of ipilimumab monotherapy ($132950) by $362033. The ICER was $2129606 per PFS life-years, and the ICUR was $2262706 per PFS quality-adjusted life-year gained. Probabilistic sensitivity analyses yielded an ICER of $1481208 per PFS life-year gained and an ICUR of $1683191 per PFS quality-adjusted life-year gained. In 1-way sensitivity analyses, the PFS hazard ratio and the utility of response were the most influential parameters. Talimogene laherparepvec plus ipilimumab has a 50% likelihood of being cost-effective at a willingness-to-pay threshold of $1683191 per PFS quality-adjusted life-year gained. In ORR analyses, talimogene laherparepvec plus ipilimumab ($474904) vs ipilimumab alone ($132810), a $342094 difference, yielded an ICER of $1629019 per additional patient achieving objective response. In subgroup analyses by disease stage and BRAF V600E mutation status, ICERs ranged from $1069044 to $17104700 per 1 additional patient achieving objective response. Conclusions and Relevance: The cost to gain 1 additional progression-free quality-adjusted life-year, 1 additional progression-free life-year, or to have 1 additional patient attain objective response is about $1.6 million. This amount may be beyond what payers typically are willing to pay. Combination therapy of talimogene laherparepvec plus ipilimumab does not offer an economically beneficial treatment option relative to ipilimumab monotherapy at the population level. This should not preclude treatment for individual patients for whom this regimen may be indicated.
• Almutairi, A. R., Alkhatib, N., Martin, J., Babiker, H. M., Garland, L. L., McBride, A., & Abraham, I. (2019). Comparative efficacy and safety of immunotherapies targeting the PD-1/PD-L1 pathway for previously treated advanced non-small cell lung cancer: A Bayesian network meta-analysis. Critical reviews in oncology/hematology, 142, 16-25.
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  Two PD-1 (pembrolizumab, nivolumab) and one PD-L1(atezolizumab) inhibitors are approved for previously treated advanced non-small cell lung cancer but have not been compared in head-to-head trials.
• Ambade, P. N., Ambade, P. N., Katragadda, C., Katragadda, C., Sun, D., Sun, D., Bootman, J. L., Bootman, J. L., Abraham, I., & Abraham, I. (2019). Why health policies should be transnational: A case for East Asia Pacific countries. International Journal of Risk and Safety in Medicine, 30(Issue 2). doi:10.3233/jrs-199001
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  This paper argues that health policies should transcend national boundaries yet should not reach the supranational level. Along with multinational global health efforts, such cross-national health policies are essential to leverage joint efforts by countries learning from their peers that experience similar health system challenges. In our analysis, we used World Bank Health, Nutrition, and Population (HNP) data from 1995 to 2014 for East Asia Pacific (EAP) countries to explore health system comparability across member nations. We applied a hierarchical cluster analysis using Ward's method and a squared Euclidean distance approach to classify 24 EAP countries into four relatively stable clusters based on their (dis)similarities over nine selected health expenditure and health system performance related indicators. One-way analysis of variance (ANOVA) was used to assess the discreteness of the formed clusters. Each cluster had unique characteristics based on the included indicators and health system performance of the member countries. We present transnational health policy recommendations for the EAP region based on both our use of robust methodology and the resulting comparative clusters.
• Ambade, P. N., Katragadda, C., Sun, D., Bootman, J. L., & Abraham, I. (2019). Why health policies should be transnational: A case for East Asia Pacific countries. The International journal of risk & safety in medicine, 30(2), 101-125.
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  This paper argues that health policies should transcend national boundaries yet should not reach the supranational level. Along with multinational global health efforts, such cross-national health policies are essential to leverage joint efforts by countries learning from their peers that experience similar health system challenges. In our analysis, we used World Bank Health, Nutrition, and Population (HNP) data from 1995 to 2014 for East Asia Pacific (EAP) countries to explore health system comparability across member nations. We applied a hierarchical cluster analysis using Ward's method and a squared Euclidean distance approach to classify 24 EAP countries into four relatively stable clusters based on their (dis)similarities over nine selected health expenditure and health system performance related indicators. One-way analysis of variance (ANOVA) was used to assess the discreteness of the formed clusters. Each cluster had unique characteristics based on the included indicators and health system performance of the member countries. We present transnational health policy recommendations for the EAP region based on both our use of robust methodology and the resulting comparative clusters.
• Andritsos, L. A., Huang, Y., Abraham, I., Huff, K., Scrape, S. R., Fan, T., Alkhatib, N., Hofmeister, C. C., Drea, E., & McBride, A. (2019). Clinical and cost outcomes of pre-emptive plerixafor administration in patients with multiple myeloma undergoing stem cell mobilization. Leukemia Research, 85(Issue). doi:10.1016/j.leukres.2019.106215
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  Purpose: The stem cell mobilization agent plerixafor significantly improves CD34+ stem cell procurement in patients with multiple myeloma undergoing autologous stem cell transplant. We compared mobilization success rates and costs of two regimens of plerixafor administration: pre-emptive (P-PL, initiated the evening prior to the first day of stem cell collection) and standard (S-PL, initiated the evening prior to the second day of stem cell collection in the event of inadequate collection on the first day). Methods: Patients with multiple myeloma undergoing mobilization were categorized as either P-PL or S-PL. Stem cell collection success was evaluated using logistic regression models. Associated costs were aggregated in terms of average collections per patient in each mobilization option (patient level), and escalated to a panel of 5000 patients (population level). Results: 299 patients were evaluable; 241 received P-PL and 58 received S-PL. Patients receiving P-PL had higher median CD34+ count pre-collection and higher median total CD34+ cell harvest on the first collection (6.75 × 106/kg for P-PL, 1.96 × 106/kg for S-PL; P
• Andritsos, L. A., Huang, Y., Abraham, I., Huff, K., Scrape, S. R., Fan, T., Alkhatib, N., Hofmeister, C. C., Drea, E., & McBride, A. (2019). Clinical and cost outcomes of pre-emptive plerixafor administration in patients with multiple myeloma undergoing stem cell mobilization. Leukemia research, 85, 106215.
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  The stem cell mobilization agent plerixafor significantly improves CD34 stem cell procurement in patients with multiple myeloma undergoing autologous stem cell transplant. We compared mobilization success rates and costs of two regimens of plerixafor administration: pre-emptive (P-PL, initiated the evening prior to the first day of stem cell collection) and standard (S-PL, initiated the evening prior to the second day of stem cell collection in the event of inadequate collection on the first day).
• Barqawi, Y. K., Borrego, M. E., Roberts, M. H., & Abraham, I. (2019). Cost-effectiveness model of abiraterone plus prednisone, cabazitaxel plus prednisone and enzalutamide for visceral metastatic castration resistant prostate cancer therapy after docetaxel therapy resistance. Journal of Medical Economics, 22(Issue 11). doi:10.1080/13696998.2019.1661581
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  Aims: Among patients diagnosed with prostate cancer, 10–20% will develop castration-resistant prostate cancer (CRPC) within 5 years; for 70%, CRPC will metastasize, mostly to the lungs and/or liver. We performed a cost-effectiveness model comparing abiraterone plus prednisone (ABI + PRD), cabazitaxel plus prednisone (CAB + PRD) and enzalutamide (ENZ) for visceral metastatic CRPC post-docetaxel therapy resistance. Methods: A three-state (Progression-Free, Progression, Death) lifetime Markov model was constructed to compare ABI + PRD, CAB + PRD, and ENZ from a United States healthcare payer perspective (2019 US$; discount rate 3%/yr.). Effectiveness was measured in life-years (LYs) and quality-adjusted life years (QALYs). Inputs included treatment costs, grade III/IV adverse events with incidence ≥5%, physician follow-up, lab and imaging tests. Phase III trial Kaplan-Meier curves were extrapolated to estimate overall survival and Progression-Free transition probabilities. Incremental cost-effectiveness ratios (ICERs) and utility ratios (ICURs), probabilistic sensitivity analyses (PSAs) and cost-effectiveness acceptability curves at willingness-to-pay (WTP) thresholds were estimated. Results: Models estimated 3-year overall survival rates of 1.3% for patients treated with ABI + PRD, 16.2% for CAB + PRD, and 13.2% for ENZ. Estimated Progression-Free rates at 1.5 years were 0.51% for ABI + PRD, 0.27% for CAB + PRD, and 14.47% for ENZ. LYs and QALYs were 1.20 and 0.58 respectively for ABI + PRD, 1.48 and 0.56 for CAB + PRD, and 1.58 and 0.79 for ENZ. Total treatment costs were: $115,433 for ABI + PRD, $85,337 for CAB + PRD and $109,213 for ENZ. CAB + PRD and ENZ dominated ABI + PRD due to higher LYs gained. Incremental QALYs for ENZ vs. CAB + PRD were larger than incremental LYs. The ICUR for ENZ was $103,674/QALY compared to CAB + PRD. Conclusions: This analysis found ENZ provided greater LYs and QALYs than both ABI + PRD and CAB + PRD, at a lower cost than ABI + PRD, but at a higher cost compared to CAB + PRD. For patients with visceral mCRPC after docetaxel therapy resistance, ENZ was cost-effective 92% of the time with a WTP threshold of $100,000/QALY.
• Barqawi, Y. K., Borrego, M. E., Roberts, M. H., & Abraham, I. (2019). Cost-effectiveness model of abiraterone plus prednisone, cabazitaxel plus prednisone and enzalutamide for visceral metastatic castration resistant prostate cancer therapy after docetaxel therapy resistance. Journal of medical economics, 22(11), 1202-1209.
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  Among patients diagnosed with prostate cancer, 10-20% will develop castration-resistant prostate cancer (CRPC) within 5 years; for 70%, CRPC will metastasize, mostly to the lungs and/or liver. We performed a cost-effectiveness model comparing abiraterone plus prednisone (ABI + PRD), cabazitaxel plus prednisone (CAB + PRD) and enzalutamide (ENZ) for visceral metastatic CRPC post-docetaxel therapy resistance. A three-state (Progression-Free, Progression, Death) lifetime Markov model was constructed to compare ABI + PRD, CAB + PRD, and ENZ from a United States healthcare payer perspective (2019 US$; discount rate 3%/yr.). Effectiveness was measured in life-years (LYs) and quality-adjusted life years (QALYs). Inputs included treatment costs, grade III/IV adverse events with incidence ≥5%, physician follow-up, lab and imaging tests. Phase III trial Kaplan-Meier curves were extrapolated to estimate overall survival and Progression-Free transition probabilities. Incremental cost-effectiveness ratios (ICERs) and utility ratios (ICURs), probabilistic sensitivity analyses (PSAs) and cost-effectiveness acceptability curves at willingness-to-pay (WTP) thresholds were estimated. Models estimated 3-year overall survival rates of 1.3% for patients treated with ABI + PRD, 16.2% for CAB + PRD, and 13.2% for ENZ. Estimated Progression-Free rates at 1.5 years were 0.51% for ABI + PRD, 0.27% for CAB + PRD, and 14.47% for ENZ. LYs and QALYs were 1.20 and 0.58 respectively for ABI + PRD, 1.48 and 0.56 for CAB + PRD, and 1.58 and 0.79 for ENZ. Total treatment costs were: $115,433 for ABI + PRD, $85,337 for CAB + PRD and $109,213 for ENZ. CAB + PRD and ENZ dominated ABI + PRD due to higher LYs gained. Incremental QALYs for ENZ vs. CAB + PRD were larger than incremental LYs. The ICUR for ENZ was $103,674/QALY compared to CAB + PRD. This analysis found ENZ provided greater LYs and QALYs than both ABI + PRD and CAB + PRD, at a lower cost than ABI + PRD, but at a higher cost compared to CAB + PRD. For patients with visceral mCRPC after docetaxel therapy resistance, ENZ was cost-effective 92% of the time with a WTP threshold of $100,000/QALY.
• Bime, C., Casanova, N., Oita, R. C., Ndukum, J., Lynn, H., Camp, S. M., Lussier, Y., Abraham, I., Carter, D., Miller, E. J., Mekontso-Dessap, A., Downs, C. A., & Garcia, J. G. (2019). Development of a biomarker mortality risk model in acute respiratory distress syndrome. Critical Care, 23(Issue 1). doi:10.1186/s13054-019-2697-x
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  Background: There is a compelling unmet medical need for biomarker-based models to risk-stratify patients with acute respiratory distress syndrome. Effective stratification would optimize participant selection for clinical trial enrollment by focusing on those most likely to benefit from new interventions. Our objective was to develop a prognostic, biomarker-based model for predicting mortality in adult patients with acute respiratory distress syndrome. Methods: This is a secondary analysis using a cohort of 252 mechanically ventilated subjects with the diagnosis of acute respiratory distress syndrome. Survival to day 7 with both day 0 (first day of presentation) and day 7 sample availability was required. Blood was collected for biomarker measurements at first presentation to the intensive care unit and on the seventh day. Biomarkers included cytokine-chemokines, dual-functioning cytozymes, and vascular injury markers. Logistic regression, latent class analysis, and classification and regression tree analysis were used to identify the plasma biomarkers most predictive of 28-day ARDS mortality. Results: From eight biologically relevant biomarker candidates, six demonstrated an enhanced capacity to predict mortality at day 0. Latent-class analysis identified two biomarker-based phenotypes. Phenotype A exhibited significantly higher plasma levels of angiopoietin-2, macrophage migration inhibitory factor, interleukin-8, interleukin-1 receptor antagonist, interleukin-6, and extracellular nicotinamide phosphoribosyltransferase (eNAMPT) compared to phenotype B. Mortality at 28 days was significantly higher for phenotype A compared to phenotype B (32% vs 19%, p = 0.04). Conclusions: An adult biomarker-based risk model reliably identifies ARDS subjects at risk of death within 28 days of hospitalization.
• Bime, C., Casanova, N., Oita, R. C., Ndukum, J., Lynn, H., Camp, S. M., Lussier, Y., Abraham, I., Carter, D., Miller, E. J., Mekontso-Dessap, A., Downs, C. A., & Garcia, J. G. (2019). Development of a biomarker mortality risk model in acute respiratory distress syndrome. Critical care (London, England), 23(1), 410.
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  There is a compelling unmet medical need for biomarker-based models to risk-stratify patients with acute respiratory distress syndrome. Effective stratification would optimize participant selection for clinical trial enrollment by focusing on those most likely to benefit from new interventions. Our objective was to develop a prognostic, biomarker-based model for predicting mortality in adult patients with acute respiratory distress syndrome.
• Combe, C., Mann, J., Goldsmith, D., Dellanna, F., Zaoui, P., London, G., Denhaerynck, K., Krendyukov, A., Abraham, I., & MacDonald, K. (2019). Potential life-years gained over a 5-year period by correcting DOPPS-identified modifiable practices in haemodialysis: results from the European MONITOR-CKD5 study. BMC Nephrology, 20(Issue 1). doi:10.1186/s12882-019-1251-z
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  Background: DOPPS reported that thousands of life-years could be gained in the US and Europe over 5 years by correcting six modifiable haemodialysis practices. We estimated potential life-years gained across 10 European countries using MONITOR-CKD5 study data. Methods: The DOPPS-based target ranges were used, except for haemoglobin due to label changes, as well as DOPPS-derived relative mortality risks. Percentages of MONITOR-CKD5 patients outside targets were calculated. Consistent with the DOPPS-based analyses, we extrapolated life-years gained for the MONITOR-CKD5 population over 5 years if all patients were within targets. Results: Bringing the 10 MONITOR-CKD5 countries’ dialysis populations into compliance on the six practices results in a 5-year gain of 97,428 patient-years. In descending order, survival impact was the highest for albumin levels, followed by phosphate levels, vascular access, haemoglobin, dialysis adequacy, and interdialytic weight gain. Conclusions: Optimal management of the six modifiable haemodialysis practices may achieve 6.2% increase in 5-year survival. Trial Registration: NCT01121237 . Clinicaltrials.gov registration May 12, 2010 (retrospectively registered).
• Combe, C., Mann, J., Goldsmith, D., Dellanna, F., Zaoui, P., London, G., Denhaerynck, K., Krendyukov, A., Abraham, I., & MacDonald, K. (2019). Potential life-years gained over a 5-year period by correcting DOPPS-identified modifiable practices in haemodialysis: results from the European MONITOR-CKD5 study. BMC nephrology, 20(1), 81.
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  DOPPS reported that thousands of life-years could be gained in the US and Europe over 5 years by correcting six modifiable haemodialysis practices. We estimated potential life-years gained across 10 European countries using MONITOR-CKD5 study data.
• Crocker, R. L., Hurwitz, J. T., Grizzle, A. J., Abraham, I., Rehfeld, R., Horwitz, R., Weil, A. T., & Maizes, V. (2019). Real-World Evidence from the Integrative Medicine Primary Care Trial (IMPACT): Assessing Patient-Reported Outcomes at Baseline and 12-Month Follow-Up. Evidence-based Complementary and Alternative Medicine, 2019(Issue). doi:10.1155/2019/8595409
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  Purpose. The University of Arizona Integrative Health Center (UAIHC) was an innovative membership-supported integrative medicine (IM) adult primary care clinic in Phoenix, Arizona. UAIHC delivered healthcare using an integrative medicine model that combined conventional and complementary medical treatments, including nutrition, mind-body medicine, acupuncture, manual medicine, health coaching, educational classes, and groups. Results from pre-post evaluation of patient-reported outcomes on several standardized measures are presented here. Methods. UAIHC patients completed surveys at baseline and after 12 months of continuous integrative primary care. Patients reported on perceived changes in health outcomes as measured by Short-Form Health Survey (SF-12 general, mental, and physical health), Perceived Stress Scale (PSS4), Work Productivity and Activity Impairment Questionnaire (WPAI), World Health Organization Well-Being Index (WHO-5), Pain Visual Analog Scale (VAS), Fatigue Severity Scale (VAS; FSS), Generalized Anxiety Disorder Scale (GAD2), Patient Health Questionnaire for depression (PHQ2), Pittsburgh Sleep Quality Index (PSQI) global rating of sleep quality, and the Behavioral Risk Factor Surveillance System (BRFSS; nutrition, exercise, and physical activity). Overall differences between time points were assessed for statistical significance. Patient demographics are also described. Results. 177 patients completed baseline and follow-up outcome measures. Patients were predominantly white, female, college-educated, and employed. Baseline to one-year follow-up results indicate statistically significant improvements (p
• Crocker, R. L., Hurwitz, J. T., Grizzle, A. J., Abraham, I., Rehfeld, R., Horwitz, R., Weil, A. T., & Maizes, V. (2019). Real-World Evidence from the Integrative Medicine Primary Care Trial (IMPACT): Assessing Patient-Reported Outcomes at Baseline and 12-Month Follow-Up. Evidence-based complementary and alternative medicine : eCAM, 2019, 8595409.
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  The University of Arizona Integrative Health Center (UAIHC) was an innovative membership-supported integrative medicine (IM) adult primary care clinic in Phoenix, Arizona. UAIHC delivered healthcare using an integrative medicine model that combined conventional and complementary medical treatments, including nutrition, mind-body medicine, acupuncture, manual medicine, health coaching, educational classes, and groups. Results from pre-post evaluation of patient-reported outcomes on several standardized measures are presented here.
• Eckstrom, J., Bartels, T., Abraham, I., Patel, H., Elquza, E., Scott, A. J., Malangone, S., Hollings, J., & McBride, A. (2019). A single-arm, retrospective analysis of the incidence of febrile neutropenia using same-day versus next-day pegfilgrastim in patients with gastrointestinal cancers treated with FOLFOX or FOLFIRI. Supportive Care in Cancer, 27(Issue 3). doi:10.1007/s00520-018-4373-0
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  Background: Practice patterns of same-day versus next-day pegfilgrastim vary in numerous practice settings across the country. Current utilization with same-day pegfilgrastim reduced overall visits and reduced treatment time for chemotherapy administration. Objective: To assess the efficacy and safety of same-day versus next-day pegfilgrastim in patients with colorectal cancer. Methods: Patient data was extracted through electronic health records (EHR) search of ICD-9 codes that matched patients with CRC and treated with FOLFOX or FOLFIRI from November 2013 to January 2016. The incidence rates of primary and secondary endpoints were estimated for patients who received either FOLFOX or FOLFIRI and same-day pegfilgrastim with 2-sided 95% confidence intervals. Fisher’s exact test for 2 × 2 contingency tables was used to compare the incidence of primary and secondary endpoints between the two study groups performed at the α = 0.05 significance level. A study by Hecht et al. served as a historical control for next-day pegfilgrastim. Results: A total of 109 out of an initial 330 patients with appropriate ICD-9 criteria were eligible for study inclusion. The primary endpoint of incidence of FN recorded over 4 chemotherapy cycles with either FOLFOX6 or FOLFIRI occurred in 3.7% of patients (95% CI, 1.1–9.4%). Secondary endpoints also occurred with a relatively low incidence: 13 patients developed grades 3/4 neutropenia (11.9%; 95% CI, 7.0–19.5%); 11 patients required dose reductions because of neutropenia or FN (10.1%; 95% CI, 5.6–17.3%); and 5 patients were hospitalized due to neutropenia or FN (4.6%; 1.7–10.6%). There were 4 reported events of FN (3.2%; 95% CI, 1.0–8.3%) for those who received next-day pegfilgrastim compared to 11 events in the placebo group (9.4%; 95% CI, 5.1–16.4%). The incidence of dose delays or dose reductions due to neutropenia or FN were 5 (4.1%, 95% CI, 1.5–9.4%) in the next-day pegfilgrastim group versus 26 (22.1%, 95% CI, 15.5–30.4%) in the placebo group. Limitations: The study was retrospective in design and utilized a historical control for the comparator. Conclusions: Our study results suggest that same-day pegfilgrastim administration may be a safe and effective alternative to 24-h post-chemotherapy administration in patients with esophageal, gastric, appendiceal, or colorectal cancer undergoing treatment with FOLFOX or FOLFIRI.
• Eckstrom, J., Bartels, T., Abraham, I., Patel, H., Elquza, E., Scott, A. J., Malangone, S., Hollings, J., & McBride, A. (2019). A single-arm, retrospective analysis of the incidence of febrile neutropenia using same-day versus next-day pegfilgrastim in patients with gastrointestinal cancers treated with FOLFOX or FOLFIRI. Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 27(3), 873-878.
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  Practice patterns of same-day versus next-day pegfilgrastim vary in numerous practice settings across the country. Current utilization with same-day pegfilgrastim reduced overall visits and reduced treatment time for chemotherapy administration.
• Garcia, A., Frahm, C., Jeter, J. M., Abraham, I., Chambers, S. K., Cragun, J. M., & McBride, A. (2019). Evaluation of hypersensitivity reaction incidence to carboplatin or paclitaxel in patients with ovarian, fallopian tube, or primary peritoneal cancer with or without BRCA1 or BRCA2 mutation.. Journal of the Advanced Practitioner in Oncology.
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  There is a compelling unmet medical need for biomarker-based models to risk-stratify patients with acute respiratory distress syndrome. Effective stratification would optimize participant selection for clinical trial enrollment by focusing on those most likely to benefit from new interventions. Our objective was to develop a prognostic, biomarker-based model for predicting mortality in adult patients with acute respiratory distress syndrome.
• Garcia, A., Frahm, C., Jeter, J. M., Abraham, I., Chambers, S. K., Cragun, J. M., & McBride, A. (2019). Incidence of Hypersensitivity Reactions to Carboplatin or Paclitaxel in Patients With Ovarian, Fallopian Tube, or Primary Peritoneal Cancer With or Without or Mutations. Journal of the advanced practitioner in oncology, 10(5), 428-439.
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  The association of mutation status with hypersensitivity reactions (HSRs) to carboplatin has gained interest in recent years, particularly in patients with ovarian, fallopian tube, and primary peritoneal cancer. The primary objective of this study is to determine whether the presence of mutations increased the likelihood of HSRs to carboplatin. The incidence of HSRs to paclitaxel and symptom grade based on the Common Terminology Criteria for Adverse Events, version 4.0, were explored as secondary endpoints. A retrospective chart review of patients with ovarian, fallopian tube, or primary peritoneal cancer at the University of Arizona Cancer Center who underwent treatment with carboplatin-containing regimens and received genetic testing was performed. Institutional review board approval was obtained for this study. Fisher's exact test was used to analyze the primary outcome. Out of 167 initial patients, 62 with germline test results constituted the evaluable sample. 15 of 62 (24.2%) -tested patients were treated with carboplatin monotherapy, while 44 of 62 (71.0%) patients were treated with paclitaxel-containing regimens. Hypersensitivity reactions occurred in 4 of 13 (30.8%) -mutated patients and 22 of 49 (44.9%) wild-type patients ( = .5291). Hypersensitivity reactions to paclitaxel occurred in 1 of 13 (7.7%) -mutated patients and 26 of 49 (53.1%) wild-type patients ( = .0039). Overall, there were 11 grade 1 reactions, 14 grade 2 reactions, and 16 grade 3 reactions to carboplatin. All reactions to carboplatin in -mutated patients were grade 1. All paclitaxel reactions manifested as grade 2. The sample size was the main study limitation. The presence of mutations was not statistically significantly associated with a higher incidence of HSRs to carboplatin, but was statistically significant with regards to paclitaxel.
• Garland, L. L., Abraham, I., Alkhatib, N. S., Babiker, H. M., Choi, B., Henglefelt, A., Mcbride, A., & Pae, E. (2019). Economic evaluation crizotinib, alectinib and brigatinib in anaplastic lymphoma kinase positive (ALK+) non-small cell lung cancer (NSCLC).. Journal of Clinical Oncology, 37(15_suppl), e20714-e20714. doi:10.1200/jco.2019.37.15_suppl.e20714
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  e20714Background: Crizotinib and alectinib are approved as 1st and brigatinib as 2nd line (post crizotinib) therapy for ALK+ NSCLC. Alectinib and brigatinib are more expensive but potentially clini...
• Garland, L. L., Abraham, I., Alkhatib, N. S., Babiker, H. M., Choi, B., Henglefelt, A., Mcbride, A., & Pae, E. (2019). Economic evaluation of anaplastic lymphoma kinase (ALK) inhibitors brigatinib, alectinib and crizotinib in non-small cell lung cancer (NSCLC): Analysis for intracranial metastasis-related progression free survival (CNSPFS).. Journal of Clinical Oncology, 37(15_suppl), e20515-e20515. doi:10.1200/jco.2019.37.15_suppl.e20515
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  e20515Background: ALK inhibitors (ALKI) have shown clinical benefit in preventing progression or death related to central nervous system (CNS) metastasis in NSCLC. We performed cost-effectiveness/u...
• Kumar, A., Abraham, I., Bartels, T., Henglefelt, A., Mcbride, A., Moore, L., Ortega, A., Persky, D. O., & Sanders, L. (2019). Outcomes of Primary and Secondary Prophylaxis of Chemotherapy Induced and Febrile Neutropenia (CIN/FN) in Bendamustine Plus Rituximab (BR) Regimens in Patients with Lymphoma and Chronic Lymphocytic Leukemia (CLL): Real-World, Single-Center Experience. Blood, 134(Supplement_1), 5353-5353. doi:10.1182/blood-2019-132148
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  Introduction: Granulocyte stimulating growth factors (G-CSF) such as filgrastim or pegfilgrastim are indicated as prophylaxis of chemotherapy-induced neutropenia (CIN) and febrile neutropenia (FN). BR regimen is considered an intermediate FN risk (10-20%) per National Comprehensive Cancer Network guidelines. Therefore, patients receiving BR need to be assessed using patient specific risk factors to evaluate the need for primary prophylaxis. This study evaluates real-world patterns and outcomes associated with primary and secondary G-CSF prophylaxis in patients with B-cell lymphoma and CLL treated with BR. Methods: Retrospective chart review of all lymphoma or CLL patients treated with BR from 11/2013 through 6/2019 at the University of Arizona Cancer Center was conducted. Baseline demographic and chemotherapy cycle data was analyzed through Chi-Squared test and Unpaired t-test with a-priori p-value of 0.05 being considered statistically significant. Results: Eighty-five patients met inclusion criteria. Of these, 48 received G-CSF during all chemotherapy cycles for primary prophylaxis while 37 received G-CSF only for secondary prophylaxis. Same-day pegfilgrastim compared to next-day pegfilgrastim or filgrastim was the most common G-CSF dosing utilized with primary and secondary prophylaxis patients receiving it (87.5%, 94.6%) respectively. As shown in Table, primary and secondary prophylaxis groups were similar on baseline characteristics (p>0.05); the primary outcome of FN (p>0.05); all secondary outcomes (p>0.05) except for a higher frequency of dose delays in secondary (37.8%) vs primary prophylaxis patients (14.6%; p=0.01); and mean absolute neutrophil counts (ANC) in all cycles (p>0.05) except for cycles 3 and 5. Higher ANC levels were found in primary prophylaxis patients (4.06+0.43) vs secondary prophylaxis (3.03+0.30; p=0.03) for cycle 3 and (3.57+0.25) vs (2.88+0.26; p=0.03) for cycle 5. Conclusion: In this single-center retrospective study, BR-treated lymphoma and CLL patients receiving primary vs secondary with G-CSF showed similar outcomes except, notably, for chemotherapy dose delays that may put secondary patients at risk for poor treatment outcomes. Further research is needed to evaluate the impact of primary vs secondary prophylaxis on chemotherapy treatment outcomes. Table Disclosures Persky: Sandoz: Consultancy; Debiopharm: Other: Member, Independent Data Monitoring Committee; Bayer: Consultancy; Morphosys: Other: Member, Independent Data Monitoring Committee. McBride:Sanofi Genzyme: Consultancy; Sandoz: Consultancy; teva: Consultancy.
• Louis, R., Pilette, C., Michel, O., Michils, A., Brusselle, G., Poskin, A., Van Schoor, J., Denhaerynck, K., Vancayzeele, S., Abraham, I., & Gurdain, S. (2019). Variability in total serum IgE over 1 year in severe asthmatics. Allergy, Asthma and Clinical Immunology, 15(Issue 1). doi:10.1186/s13223-019-0331-8
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  Background: Immunoglobulin E (IgE) is the treatment target of omalizumab, a monoclonal antibody indicated in the treatment of severe allergic asthma. Long-term variability of serum total IgE (sIgEtot) in asthmatics remains poorly documented. Methods: In this prospective study, sIgEtot levels were measured over 1 year at 7 time points in 41 severe asthmatics treated with high-dose of inhaled corticosteroids and long-acting β2 agonists. 33 patients were atopic based on at least one positive RAST to common aeroallergens. Patients were divided into three groups according to their baseline sIgEtot level: low (< 76 IU/mL; n = 10), intermediate (76-700 IU/mL; n = 20) or high (> 700 IU/mL; n = 11). Patients also completed the six-item Juniper Asthma Control Questionnaire (ACQ6). The sIgEtot variability and factors predictive for this variability were studied, as well as ACQ6 outcomes. Results: The variation in sIgEtot level was mostly the consequence of between patient-variability, which represented 96%, 71% and 96% of the total variability in the low, intermediate and high sIgEtot subgroups, respectively. The residual within-patient variability was therefore limited. In 10/41 patients, sIgEtot levels increased or decreased, for at least one visit, beyond the predefined range of the subgroups to which they were assigned (< 76 IU/mL; 76-700 IU/mL; > 700 IU/mL). There was a significant but weak correlation between sIgEtot and ACQ6 score over all time points (r = 0.15, p = 0.02), but sIgEtot failed to associate with severe exacerbation. sIgEtot decreased by 3% with any additional year of age for the whole group (p = 0.01) and increased by 5% per one unit of allergen exposure score in atopic patients (p = 0.002). Conclusion: In severe asthmatics, limited within-patient variability of sIgEtot levels was observed over 1 year as opposed to marked between-subject variability. sIgEtot decreases with age. Variation in sIgEtot weakly associates with asthma control but not with exacerbation.
• Louis, R., Pilette, C., Michel, O., Michils, A., Brusselle, G., Poskin, A., Van Schoor, J., Denhaerynck, K., Vancayzeele, S., Abraham, I., & Gurdain, S. (2019). Variability in total serum IgE over 1 year in severe asthmatics. Allergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology, 15, 20.
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  Immunoglobulin E (IgE) is the treatment target of omalizumab, a monoclonal antibody indicated in the treatment of severe allergic asthma. Long-term variability of serum total IgE (sIgE) in asthmatics remains poorly documented.
• Ludwig, H., Bokemeyer, C., Aapro, M., Boccadoro, M., Gascón, P., Denhaerynck, K., Krendyukov, A., Abraham, I., & MacDonald, K. (2019). Chemotherapy-induced neutropenia/febrile neutropenia prophylaxis with biosimilar filgrastim in solid tumors versus hematological malignancies: MONITOR-GCSF study. Future oncology (London, England), 15(8), 897-907.
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  This study aimed to report patterns of biosimilar filgrastim prophylaxis and outcomes of chemotherapy-induced neutropenia (CIN)/febrile neutropenia (FN) in patients with hematological malignancies or solid tumors.
• Ludwig, H., Bokemeyer, C., Aapro, M., Boccadoro, M., Gascón, P., Denhaerynck, K., Krendyukov, A., Abraham, I., & Macdonald, K. (2019). Chemotherapy-induced neutropenia/febrile neutropenia prophylaxis with biosimilar filgrastim in solid tumors versus hematological malignancies: MONITOR-GCSF study. Future Oncology, 15(Issue 8). doi:10.2217/fon-2018-0814
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  Aim: This study aimed to report patterns of biosimilar filgrastim prophylaxis and outcomes of chemotherapy-induced neutropenia (CIN)/febrile neutropenia (FN) in patients with hematological malignancies or solid tumors. Patients & methods: MONITOR-GCSF is a real-world study of 1447 cancer patients receiving CIN/FN prophylaxis with biosimilar filgrastim (solid tumors: 77.2%; hematological malignancies: 22.8%). Results: Differences in prophylaxis intensity and day of initiation relative to guideline recommendations were observed. In hematology patients, higher rates of CIN and FN occurred at cycle level, and rate of FN was higher at patient level (9.1 vs 5.0% in solid tumor patients). Conclusion: Adequate GCSF support in hematology and solid tumor patients is important to prevent CIN/FN and related hospitalizations and chemotherapy disturbances.
• Ludwig, H., Gascón, P., Bokemeyer, C., Aapro, M., Boccadoro, M., Denhaerynck, K., Krendyukov, A., MacDonald, K., & Abraham, I. (2019). Outcomes of chemotherapy-induced (febrile) neutropenia prophylaxis with biosimilar filgrastim (Zarzio®) initiated "same-day" (< 24 h), "per-guidelines" (24-72 h), and "late" (> 72 h): findings from the MONITOR-GCSF study. Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 27(6), 2301-2312.
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  Granulocyte colony-stimulating factors (G-CSFs) are indicated for prophylaxis or management of chemotherapy-induced neutropenia (CIN) and febrile neutropenia (FN). Guidelines recommend G-CSF 24-72 h following chemotherapy; however, some evidence suggests that G-CSF initiated
• Ludwig, H., Gascón, P., Bokemeyer, C., Aapro, M., Boccadoro, M., Denhaerynck, K., Krendyukov, A., MacDonald, K., & Abraham, I. (2019). Outcomes of chemotherapy-induced (febrile) neutropenia prophylaxis with biosimilar filgrastim (Zarzio®) initiated “same-day” (< 24 h), “per-guidelines” (24–72 h), and “late” (> 72 h): findings from the MONITOR-GCSF study. Supportive Care in Cancer, 27(Issue 6). doi:10.1007/s00520-018-4513-6
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  Purpose: Granulocyte colony-stimulating factors (G-CSFs) are indicated for prophylaxis or management of chemotherapy-induced neutropenia (CIN) and febrile neutropenia (FN). Guidelines recommend G-CSF 24–72 h following chemotherapy; however, some evidence suggests that G-CSF initiated < 24 h may benefit some patients. Methods: MONITOR-GCSF was a prospective, observational, multicenter, pan-European study of 1447 chemotherapy-treated patients receiving daily biosimilar (standard) filgrastim (Zarzio®/Zarxio®, filgrastim-sndz, Hexal AG, Sandoz Inc.). In this analysis, cycles were classified as same-day, per-guidelines, or late if G-CSF support was initiated < 24 h, 24–72 h, and > 72 h after chemotherapy. Outcomes included occurrence of CIN of any grade (CIN1/4), grade 3 or 4 (CIN3/4), grade 4 (CIN4), or FN: CIN/FN-related hospitalization or CIN/FN-related chemotherapy disturbance. Results: A total of 5930 chemotherapy cycles from 1423 evaluable patients from MONITOR-GCSF had data for day of G-CSF initiation: 795 cycles (13.4%) classified as same-day, 3320 (56.0%) as per-guidelines, and 1815 (30.6%) as late. Groups did not differ as to CIN1/4 and FN episodes, or CIN/FN-related hospitalizations or chemotherapy disturbances. Patients in the same-day and per-guidelines groups had statistically similar odds of not experiencing any outcomes of interest in any given cycle. Patients in the late group had worse odds of experiencing CIN1/4, CIN3/4, and CIN4 episodes in any given cycle. Proportions of patients reporting clinical events of interest were generally similar. Conclusions: This real-world evidence indicates that CIN/FN prophylaxis initiated with biosimilar filgrastim within 24–72 h post-chemotherapy is effective and safe. Filgrastim administration on the day of chemotherapy may be appropriate in some patients.
• MacDonald, K. M., Kavati, A., Ortiz, B., Alhossan, A., Lee, C. S., & Abraham, I. (2019). Short- and long-term real-world effectiveness of omalizumab in severe allergic asthma: systematic review of 42 studies published 2008-2018. Expert review of clinical immunology, 15(5), 553-569.
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  Omalizumab is a recombinant monoclonal anti-IgE antibody approved in the US as add-on treatment in moderate-to-severe allergic asthma (in severe allergic asthma [SAA] in Europe). A 2016 review of 24 real-world effectiveness studies in SAA published between 2008-2015 concluded that omalizumab was associated with significant improvements in objective and subjective outcomes with benefits extending beyond 2 years. Several new real-world studies have been published since, bringing the total to 42 studies. Areas covered: This systematic review of 42 studies published since 2008 updates and extends the 2016 review on the real-word evidence on omalizumab in SAA. It offers greater granularity as to time windows within which outcomes are reported and includes studies extending well beyond 4 years post omalizumab initiation. Expert commentary: This review firmly establishes the short-term effectiveness of omalizumab in adolescent and adult patients with SAA at 1 year, and provides strong evidence of long-term effectiveness up to 4 years and emergent evidence of effectiveness beyond 4 years. In the aggregate, these 42 studies underscore the long-term effectiveness of omalizumab in terms of: reducing exacerbations and symptoms, achieving asthma control, improving lung function, enhancing quality of life, decreasing emergency department visits and hospitalizations, and promoting concomitant medication-sparing.
• Oh, M., Alkhushaym, N., Fallatah, S., Althagafi, A., Aljadeed, R., Alsowaida, Y., Jeter, J., Martin, J. R., Babiker, H. M., McBride, A., & Abraham, I. (2019). The association of BRCA1 and BRCA2 mutations with prostate cancer risk, frequency, and mortality: A meta-analysis. Prostate, 79(Issue 8). doi:10.1002/pros.23795
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  Background: A prior meta-analysis found no association between BRCA1 mutation and prostate cancer (PCa). Subsequent BRCA2 mutation studies have shown an association with PCa risk and mortality. We conducted a meta-analysis of overall BRCA mutation carriers and in subgroups to (1) estimate PCa risk in BRCA mutation carriers, (2) evaluate the frequency of BRCA mutation carriers in patients with PCa, and (3) compare cancer-specific survival (CSS) and overall survival (OS) among BRCA mutation carriers and noncarriers. Methods: We searched the PubMed/MEDLINE, Embase, and Cochrane databases. Unadjusted odds ratio (OR), percentage (%), and hazard ratio (HR) were used to calculate pooled estimates for PCa risk, frequency, and survival, respectively. Subgroup analyses by mutation type (BRCA1 or BRCA2) were conducted for the three objectives. Further subgroup analyses by study design (age-sex-adjusted or crude), ascertainment method (ascertained or inferred genotyping), population (Ashkenazi Jewish or general population), and survival outcomes (CSS or OS) were conducted. The associations were evaluated using random-effects models, in two-sided statistical tests. Results: A total of 8 cohort, 7 case-control, 4 case-series, 28 frequency, and 11 survival studies were included. Being a BRCA mutation carrier (BRCA1 and/or BRCA2) was associated with a significant increase in PCa risk (OR = 1.90, 95% CI = 1.58-2.29), with BRCA2 mutation being associated with a greater risk of PCa (OR = 2.64, 95% CI = 2.03-3.47) than BRCA1 (OR = 1.35, 95% CI = 1.03-1.76). The frequency of BRCA1 and BRCA2 carriers in patients with PCa was 0.9% and 2.2%, respectively. OS (HR = 2.21, 95% CI = 1.64-2.30) and CSS (HR = 2.63, 95% CI = 2.00-3.45) were significantly worse among BRCA2 carriers compared to noncarriers, whereas OS (HR = 0.47, 95% CI = 0.11-1.99) and CSS (HR = 1.07, 95% CI = 0.38-2.96) were statistically not significant when comparing BRCA1 carriers and noncarriers. Conclusions: There is a 1.90-fold greater risk of PCa in overall BRCA mutation carriers. This elevated PCa risk is attributable mainly to a 2.64-fold greater risk of PCa in BRCA2 carriers compared to a moderate 1.35-fold greater risk in BRCA1 carriers. The frequency of BRCA2 mutations was higher than BRCA1 mutations among patients with PCa. BRCA2 but not BRCA1 mutations were associated with higher PCa mortality. The BRCA mutation may be a clinical factor to stratify high-risk patients and guide clinical strategies for more effective treatments for patients with PCa.
• Oh, M., Alkhushaym, N., Fallatah, S., Althagafi, A., Aljadeed, R., Alsowaida, Y., Jeter, J., Martin, J. R., Babiker, H. M., McBride, A., & Abraham, I. (2019). The association of BRCA1 and BRCA2 mutations with prostate cancer risk, frequency, and mortality: A meta-analysis. The Prostate, 79(8), 880-895.
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  A prior meta-analysis found no association between BRCA1 mutation and prostate cancer (PCa). Subsequent BRCA2 mutation studies have shown an association with PCa risk and mortality. We conducted a meta-analysis of overall BRCA mutation carriers and in subgroups to (1) estimate PCa risk in BRCA mutation carriers, (2) evaluate the frequency of BRCA mutation carriers in patients with PCa, and (3) compare cancer-specific survival (CSS) and overall survival (OS) among BRCA mutation carriers and noncarriers.
• Oh, M., McBride, A., Yun, S., Bhattacharjee, S., Slack, M., Martin, J. R., Jeter, J., & Abraham, I. (2019). Response to Katona et al. Journal of the National Cancer Institute, 111(5), 524-525.
• Oh, M., McBride, A., Yun, S., Bhattacharjee, S., Slack, M., Martin, J. R., Jeter, J., & Abraham, I. (2019). Response to Katona et al. Journal of the National Cancer Institute, 111(Issue 5). doi:10.1093/jnci/djz013
• Tahaineh, L., Wazaify, M., Alomoush, F., Nasser, S. A., Alrawashdh, N., & Abraham, I. (2019). Physicians' perceptions, expectations, and experiences of clinical pharmacists in Jordan-2017. International journal of clinical pharmacy, 41(5), 1193-1201.
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  Background A decade ago, clinical pharmacy was a new concept in hospital settings in Jordan, as evidenced in our 2006/2007 study. Changes in the perceptions, expectations, and experiences of physicians regarding the role of clinical pharmacists need to be investigated. Objective To document physicians' perceptions and expectations of, and experiences with, clinical pharmacists in hospital settings in 2017, and to assess differences in these areas between the 2017 and the 2006/2007 samples. Setting: The study was conducted at four hospitals in the north of Jordan. Method Physicians completed a self-administered questionnaire similar to the one used in our 2006/2007 study, which recorded demographics and assessed physicians' perceptions, expectations, and experiences regarding clinical pharmacists. Data of the 2017 sample were analyzed and compared descriptively to those of the 2006/2007 sample. Main outcome measure Physicians' perceptions, expectations, and experiences of pharmacists in hospital settings in 2017. Results Two hundred and ninety-five physicians completed the questionnaire. Physicians in the 2017 sample were most comfortable with pharmacists suggesting the use of prescription medications such as antibiotics (53.6%). Physicians in the 2017 cohort agreed with the eight expectations stated in the questionnaire. Physicians' experiences with clinical pharmacists improved in 2017 from 2006/2007 in all eight areas evaluated. Conclusion Physicians' perceptions, expectations, and experiences towards the professional role of pharmacists have changed over the past 10 years in Jordan.
• Tahaineh, L., Wazaify, M., Alomoush, F., Nasser, S. A., Alrawashdh, N., & Abraham, I. (2019). Physicians’ perceptions, expectations, and experiences of clinical pharmacists in Jordan-2017. International Journal of Clinical Pharmacy, 41(Issue 5). doi:10.1007/s11096-019-00884-6
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  Background A decade ago, clinical pharmacy was a new concept in hospital settings in Jordan, as evidenced in our 2006/2007 study. Changes in the perceptions, expectations, and experiences of physicians regarding the role of clinical pharmacists need to be investigated. Objective To document physicians’ perceptions and expectations of, and experiences with, clinical pharmacists in hospital settings in 2017, and to assess differences in these areas between the 2017 and the 2006/2007 samples. Setting: The study was conducted at four hospitals in the north of Jordan. Method Physicians completed a self-administered questionnaire similar to the one used in our 2006/2007 study, which recorded demographics and assessed physicians’ perceptions, expectations, and experiences regarding clinical pharmacists. Data of the 2017 sample were analyzed and compared descriptively to those of the 2006/2007 sample. Main outcome measure Physicians’ perceptions, expectations, and experiences of pharmacists in hospital settings in 2017. Results Two hundred and ninety-five physicians completed the questionnaire. Physicians in the 2017 sample were most comfortable with pharmacists suggesting the use of prescription medications such as antibiotics (53.6%). Physicians in the 2017 cohort agreed with the eight expectations stated in the questionnaire. Physicians’ experiences with clinical pharmacists improved in 2017 from 2006/2007 in all eight areas evaluated. Conclusion Physicians’ perceptions, expectations, and experiences towards the professional role of pharmacists have changed over the past 10 years in Jordan.
• Tate, W. R., Abraham, I., & Cranmer, L. D. (2019). Center-specific modeling predicts cancer trial accrual more accurately than investigators and random effects modeling at 16 cancer centers. JCO Clinical Cancer Informatics, 3(Issue). doi:10.1200/cci.19.00005
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  PURPOSE Clinical trials often exceed their anticipated enrollment periods, and study sites often do not meet accrual goals. We previously reported the development and validation of a single-site accrual prediction model. Here, we describe the expansion of this methodology at 16 cancer centers (CCs) and compare an overall model versus site-specific models. METHODS This retrospective cohort study used data from treatment and supportive care intervention studies permanently closed to accrual between 2009 and 2015 at 16 United States–based CCs. Center and ClinicalTrials.gov data were used to generate both site-specific and random effects mixed models (random effect: institution). Accrual predictions were generated from each model and compared with the accrual prediction of the disease team (DT). RESULTS Sixteen institutions submitted 5,787 eligible trials (range, 93 to 697 trials per institution). Local accrual ranged from 363 to 6,716 participants; 1,053 studies (18%) accrued no participants. Actual average accrual was 8.5 participants (median, four participants). Site-specific models predicted accrual at 99% of actual and correctly predicted whether a study would accrue four or more participants 73% of the time versus DT prediction of 58%. Correlation at the category level was 30%; model sensitivity and specificity were 83% and 62%, respectively. The overall model predicted accrual 93% of actual and correctly predicted accrual of four or more participants 66% of the time, with a correlation at the category level of 28%. CONCLUSION Both regression models predicted clinical trial accrual at least as or more accurately than DT at all but one center. Site-specific models generally performed slightly better than the random effects model. This study confirms the previous finding that this method is an accurate and objective metric that can be easily implemented to improve clinical research resource allocation across multiple centers.
• Tate, W. R., Abraham, I., & Cranmer, L. D. (2019). Center-specific modeling predicts cancer trial accrual more accurately than investigators and random effects modeling at 16 cancer centers.. Journal of Clinical Oncology: Clinical Cancer Informatics.
• Tharp, M. D., Bernstein, J. A., Kavati, A., Ortiz, B., MacDonald, K., Denhaerynck, K., Abraham, I., & Lee, C. S. (2019). Benefits and Harms of Omalizumab Treatment in Adolescent and Adult Patients With Chronic Idiopathic (Spontaneous) Urticaria: A Meta-analysis of "Real-world" Evidence. JAMA dermatology, 155(1), 29-38.
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  Omalizumab is indicated for the management of chronic idiopathic urticaria (CIU) (also known as chronic spontaneous urticaria) in adolescents and adults with persistent hives not controlled with antihistamines. The effectiveness of omalizumab in the real-world management of CIU is largely unknown.
• Tharp, M. D., Bernstein, J. A., Kavati, A., Ortiz, B., MacDonald, K., Denhaerynck, K., Abraham, I., & Lee, C. S. (2019). Benefits and Harms of Omalizumab Treatment in Adolescent and Adult Patients with Chronic Idiopathic (Spontaneous) Urticaria: A Meta-analysis of "real-world" Evidence. JAMA Dermatology, 155(Issue 1). doi:10.1001/jamadermatol.2018.3447
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  Importance: Omalizumab is indicated for the management of chronic idiopathic urticaria (CIU) (also known as chronic spontaneous urticaria) in adolescents and adults with persistent hives not controlled with antihistamines. The effectiveness of omalizumab in the real-world management of CIU is largely unknown. Objective: To quantitatively synthesize what is known about the benefits and harms of omalizumab in the real-world clinical management of CIU regarding urticaria activity, treatment response, and adverse events. Data Sources: Published observational studies (January 1, 2006, to January 1, 2018) and scientific abstracts on the effectiveness of omalizumab in CIU were identified using PubMed, Embase, Web of Science, and Cochrane search engines; references were searched to identify additional studies. Study Selection: Included studies were observational in design and included at least 1 outcome in common with other studies and at a concurrent time point of exposure to omalizumab. A total of 67 articles (35.2% of those screened) were included in the analysis. Data Extraction and Synthesis: PRISMA and MOOSE guidelines were followed; independent selection and data extraction were completed by 2 observers. Random-effects meta-analyses were performed. Main Outcomes and Measures: Main outcomes were change in weekly Urticaria Activity Score (UAS7; range, 0-42), change in Urticaria Activity Score (UAS; range 0-6) (higher score indicating worse outcome in both scales), complete and partial response rates (percentages), and adverse event rate (percentage). Results: Omalizumab therapy was associated with an improvement in UAS7 scores (-25.6 points, 95% CI, -28.2 to -23.0; P
• Van Gaal, L., Hermans, M. P., Daci, E., Denhaerynck, K., De Meester, L., MacDonald, K., Abraham, I., Vancayzeele, S., & Maris, M. (2019). Effectiveness and Tolerability of Vildagliptin and the Single Pill Combination of Vildagliptin and Metformin in "Real-World" Management of Type 2 Diabetes Mellitus: The G-FORCE Study. Diabetes therapy : research, treatment and education of diabetes and related disorders, 10(3), 965-979.
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  Randomized clinical trials showed that vildagliptin is well tolerated and leads to clinically meaningful decreases in glycated hemoglobin (HbA1c) and fasting plasma glucose (FPG) both in monotherapy and as add-on therapy in inadequately controlled type 2 diabetes mellitus (T2DM) patients. Nevertheless, there is an increased interest for real-life studies to confirm the clinical trial findings in the setting of a daily clinical practice. The aim of this study was to evaluate the effectiveness and tolerability of vildagliptin in a real-life clinical setting and to explore factors determining drug adherence and T2DM management.
• Van Gaal, L., Hermans, M. P., Daci, E., Denhaerynck, K., De Meester, L., MacDonald, K., Abraham, I., Vancayzeele, S., & Maris, M. (2019). Effectiveness and Tolerability of Vildagliptin and the Single Pill Combination of Vildagliptin and Metformin in “Real-World” Management of Type 2 Diabetes Mellitus: The G-FORCE Study. Diabetes Therapy, 10(Issue 3). doi:10.1007/s13300-019-0601-y
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  Introduction: Randomized clinical trials showed that vildagliptin is well tolerated and leads to clinically meaningful decreases in glycated hemoglobin (HbA1c) and fasting plasma glucose (FPG) both in monotherapy and as add-on therapy in inadequately controlled type 2 diabetes mellitus (T2DM) patients. Nevertheless, there is an increased interest for real-life studies to confirm the clinical trial findings in the setting of a daily clinical practice. The aim of this study was to evaluate the effectiveness and tolerability of vildagliptin in a real-life clinical setting and to explore factors determining drug adherence and T2DM management. Methods: G-FORCE was a prospective, observational, open-label, multi-center study in which T2DM patients were prescribed de novo vildagliptin. Clinical effectiveness was determined by changes in HbA1c and FPG and by the proportion of patients reaching glycemic goal. Data were collected at baseline, after 105 ± 15 days and after 180 ± 15 days. Results: A total of 1230 patients were included in this analysis. Mean age was 63.9 ± 10.8 years, and mean HbA1c and FPG levels were 8.2 ± 1.3% and 171.0 ± 53.3 mg/dL, respectively. At 180 days of treatment, HbA1c and FPG levels decreased to 7.2 ± 1.0% and 141.1 ± 44.0 mg/dL, respectively, while the proportion of patients reaching HbA1c and FPG goals rose from 8.6 to 44.6% and from 14.2 to 42.8%, respectively. Conclusion: In this real-world study, vildagliptin was an effective and safe treatment for T2DM patients already treated with metformin, while the single pill combination of vildagliptin and metformin provides a convenient alternative while ensuring comparable effectiveness and tolerability. Funding: Novartis Pharma.
• Yun, S., Sharma, R., Chan, O., Vincelette, N. D., Sallman, D. A., Sweet, K., Padron, E., Komrokji, R., Lancet, J. E., Abraham, I., Moscinski, L. C., Cleveland, J. L., List, A. F., & Zhang, L. (2019). Prognostic significance of MYC oncoprotein expression on survival outcome in patients with acute myeloid leukemia with myelodysplasia related changes (AML-MRC). Leukemia Research, 84(Issue). doi:10.1016/j.leukres.2019.106194
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  MYC is an oncoprotein that coordinates the expression of genes involved in metabolism, cell differentiation and survival in various types of malignancies. However, the underlying oncogenic mechanisms and the clinical significance of MYC expression in the acute myeloid leukemia with myelodysplasia related changes (AML-MRC) remain to be answered. A total of 135 patients were retrospectively identified using Total Cancer Care (TCC) Moffitt Cancer Center (MCC) databases. Diagnosis of AML-MRC was based on the 2016 WHO classification utilizing bone marrow (BM) evaluation. MYC protein expression level was assessed by immunohistochemistry (IHC) staining using paraffin-embedded BM trephine biopsy samples obtained at the time of diagnosis or relapse. Concurrent somatic mutations were assessed using targeted next generation sequencing that include 54 genes. A total of 38% (n = 51) and 62% (n = 84) patients had high and low MYC expression, respectively. The most common somatic mutation in our cohort was TP53 followed by DNMT3A, and ASXL1. The median OS was significantly longer in low MYC patients (median OS 42.3 vs. 17.05 months, p = 0.0109). Multivariate analysis including MYC expression level, transplantation status, gender and age demonstrated high MYC expression (HR 1.77, 95% CI 1.004–3.104, p = 0.045) to be an independent poor prognostic factor. Further studies are needed to identify the underlying mechanism of MYC driven oncogenesis in AML-MRC. Additionally, the prognostic impact of MYC on the AML survival in a larger cohort that include diverse somatic mutations and chromosomal abnormalities requires further investigation.
• Yun, S., Sharma, R., Chan, O., Vincelette, N. D., Sallman, D. A., Sweet, K., Padron, E., Komrokji, R., Lancet, J. E., Abraham, I., Moscinski, L. C., Cleveland, J. L., List, A. F., & Zhang, L. (2019). Prognostic significance of MYC oncoprotein expression on survival outcome in patients with acute myeloid leukemia with myelodysplasia related changes (AML-MRC). Leukemia research, 84, 106194.
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  MYC is an oncoprotein that coordinates the expression of genes involved in metabolism, cell differentiation and survival in various types of malignancies. However, the underlying oncogenic mechanisms and the clinical significance of MYC expression in the acute myeloid leukemia with myelodysplasia related changes (AML-MRC) remain to be answered. A total of 135 patients were retrospectively identified using Total Cancer Care (TCC) Moffitt Cancer Center (MCC) databases. Diagnosis of AML-MRC was based on the 2016 WHO classification utilizing bone marrow (BM) evaluation. MYC protein expression level was assessed by immunohistochemistry (IHC) staining using paraffin-embedded BM trephine biopsy samples obtained at the time of diagnosis or relapse. Concurrent somatic mutations were assessed using targeted next generation sequencing that include 54 genes. A total of 38% (n = 51) and 62% (n = 84) patients had high and low MYC expression, respectively. The most common somatic mutation in our cohort was TP53 followed by DNMT3A, and ASXL1. The median OS was significantly longer in low MYC patients (median OS 42.3 vs. 17.05 months, p = 0.0109). Multivariate analysis including MYC expression level, transplantation status, gender and age demonstrated high MYC expression (HR 1.77, 95% CI 1.004-3.104, p = 0.045) to be an independent poor prognostic factor. Further studies are needed to identify the underlying mechanism of MYC driven oncogenesis in AML-MRC. Additionally, the prognostic impact of MYC on the AML survival in a larger cohort that include diverse somatic mutations and chromosomal abnormalities requires further investigation.
• Abraham, I. (2018). Letter to the Editor: When Claiming a U-shaped Association between Uric Acid Levels and Major Adverse Cardiac Events, Perhaps Show the Evidence?. Journal of Korean medical science, 33(6), e50.
• Abraham, I. (2018). Letter to the editor: When claiming a U-shaped association between uric acid levels and major adverse cardiac events, perhaps show the evidence?. Journal of Korean Medical Science, 33(Issue 6). doi:10.3346/jkms.2018.33.e50
• Abraham, I. L. (2018). BRCA1andBRCA2Gene Mutations and Colorectal Cancer Risk: Systematic Review and Meta-analysis. JNCI: Journal of the National Cancer Institute, 110(11), 1178-1189. doi:10.1093/jnci/djy148
• Abraham, I. L., Al Yami, M., & Kurdi, S. (2018). Direct oral anticoagulants for extended thromboprophylaxis in medically ill patients: review, meta-analysis, and risk/benefit assessment.. Journal of Blood Medicine, 9, 25-34.
• Abraham, I. L., McBride, A., Campbell, K., MacDonald, K., & Balu, S. (2018). Reply: Cost-efficiency analyses for the US of biosimilar filgrastim-sndz, reference filgrastim, and pegfilgrastim with on-body injector in the prophylaxis of chemotherapy-induced (febrile) neutropenia.. Journal of Medical Economics, 21, 606-609.
• Abraham, I., Alhifany, A. A., Ali, Z., Almutairi, A. R., Bhattacharjee, S., Kohli, M., & Riaz, I. B. (2018). Abiraterone acetate (AA) or docetaxel (D) in metastatic castration-sensitive prostate cancer (mCSPC): A systematic review and network meta-analysis of randomized clinical trials (RCTs).. Journal of Clinical Oncology, 36(6_suppl), 243-243. doi:10.1200/jco.2018.36.6_suppl.243
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  243Background: AA and D have been shown in separate trials to increase overall survival in patients with mCSPC compared to Androgen Derivation Therapy (ADT). In the absence of head to head clinical trials and to provide clinical guidance, we performed an indirect comparison of AA and D using network meta-analysis. Methods: We performed a search of MEDLINE, EMBASE, Cochrane Library, and Cochrane Central Register of Controlled Trials to identify relevant clinical trials. Collected data included hazard ratio and confidence interval (CI) for Overall Survival (OS) and number of adverse events in each study arm. Risk for bias was assessed using the Cochrane Collaboration’s tool. Bayesian network meta-analysis was conducted using WinBUGS 1.4.3 software (MRC Biostatistics Unit, Cambridge, UK) to perform an indirect comparison of D and AA. Results: Five clinical trials were included in this analysis. Two trials (LATITUDE, STAMPEDE) compared AA to ADT and three trials (CHAARTED,STAMPEDE, GETUG-AFU 15 study) compare...
• Abraham, I., Alkhatib, N. S., Alrawashdh, N., Mcbride, A., & Persky, D. O. (2018). Economic Evaluation for the US of Ibrutinib Versus Acalabrutinib for Patients with Relapsed or Refractory Mantle Cell Lymphoma. Blood, 132(Supplement 1), 4829-4829. doi:10.1182/blood-2018-99-112619
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  Introduction. Mantle cell lymphoma (MCL) is a rare subtype of Non-Hodgkin lymphoma (NHL) with a poor prognosis. Ibrutinib is an oral Bruton9s tyrosine kinase inhibitor (BTKi) approved in the US in 2013 for, among other indications, MCL patients with at least one prior therapy (i.e., relapsed/refractory [R/R] MCL). The BTKi acalabrutinib was approved in late 2017 specifically for this same indication. No studies have assessed the comparative efficacy and cost-effectiveness and cost-utility of both agents in the management of R/R MCL. We performed an indirect comparison of both agents in terms of progression-free survival (PFS) and overall survival (OS) to subsequently evaluate the relative cost-effectiveness and cost-utility of both treatment options of R/R MCL from a USA payer perspective. Methods. A life time horizon Markov model with 3 health states was specified: PFS, progression, and death. Trials to simulate these health outcomes under the respective treatment regimens included Dreyling et al (Lancet 2016) for ibrutinib and Wang et al (Lancet 2018) for acalabrutinib. Kaplan-Meier PFS and OS curves were digitized, PFS and OS data extracted, Weibull distributions fitted to these data, and extrapolations to the life time horizon estimated for both acalabrutinib and ibrutinib to estimate the life time efficacy of each treatment. Naive patient simulation was performed to indirectly estimate and compare the OS and PFS estimates of the two agents. Wholesale acquisition costs (WAC) were obtained from RedBook (average sales price not yet available for acalabrutinib): $12,180 for ibrutinib and $14,064 for acalabrutinib. Costs of managing side effects and EQ-5D utility values were sourced from published literature. Costs were inflated based on the medical consumer price index to the first quarter of 2018. Disutility values for side effects were assumed the same for both interventions. A discount rate of 3% was applied when survival exceeded one year. The life years (LY) and quality adjusted LY (QALY) for each treatment, the incremental LY and QALY gained with acalabrutinib over ibrutinib, and the incremental cost-effectiveness (ICER) and cost-utility ratios (ICUR) were estimated in both base and probabilistic sensitivity analyses (PSA; 2000 simulations). The cost-effectiveness plane (CEP) and cost-effectiveness acceptability curves (CEAC) were plotted. Results. In the naive patient simulation median PFS and OS were estimated to be 14.6 months and 25.1 months for ibrutinib, and 27.6 months and 168 months for acalabrutinib. As shown in the table below, in the life time horizon Markov model acalabrutinib showed incremental cost of $259,200/LY (PSA: $258,780/LY) and incremental gains of 0.48 LY (PSA: 0.48 LY) and 0.36 QALY (PSA: 0.36 QALY) over ibrutinib. This yielded an ICER of $540,000 per LY gained (PSA: $539,125 per LY gained) and an ICUR of $720,000 per QALY gained (PSA: $718,833 per QALY gained). In the CEP scatter plot, all estimates were in the upper-right quadrant indicating greater incremental QALY at higher incremental cost. Per the CEAC plot, the probability that acalabrutinib would be considered cost-effective was 50% at a willingness to pay threshold (WTP) of $718,833 per QALY and 70% at a WTP threshold of $748,000 per QALY. Conclusions. Clinically, treating patients with R/R MCL with acalabrutinib was associated with an absolute survival gain of 0.48 years (~6 months) and a quality-adjusted survival gain of 0.36 years (~4 months) over treatment with ibrutinib but at an additional cost of nearly $260,000 per year of treatment. Treating patients with RR/MCL acalabrutinib requires high WTP thresholds to be considered cost-effective to US payers. Disclosures Persky:Genentech: Honoraria; Spectrum: Research Funding; Merck: Research Funding; Morphosys (IDMC): Consultancy. Abraham:Sandoz: Consultancy.
• Abraham, I., Almutairi, A. R., Alsaid, N., Babiker, H. M., Mcbride, A., & Oh, M. (2018). Economic evaluation of the combination of talimogene laherparepvec (T-vec) plus ipilimumab (T-vec+Ipi) versus ipilimumab (Ipi) in patients (pts) with advanced unresectable melanoma.. Journal of Clinical Oncology, 36(15_suppl), e21545-e21545. doi:10.1200/jco.2018.36.15_suppl.e21545
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  e21545Background: A recent trial comparing T-vec+Ipi vs Ipi found no differential benefit in progression-free survival (PFS) (HR 0.83, 95%CI 0.56–1.23), but noted objective response rates (ORR) of ...
• Abraham, I., Almutairi, A. R., Babiker, H. M., Hinchman, A., Lattimore, L., Mcbride, A., & Sundararajan, S. (2018). Clinical experience with talimogene laherparepvec in a melanoma population at a university based cancer center.. Journal of Clinical Oncology, 36(15_suppl), e21547-e21547. doi:10.1200/jco.2018.36.15_suppl.e21547
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  e21547Background: Talimogene laherparepvec (Imlygic or T-VEC) is a first-in-class oncolytic virus that received FDA approval for recurrent unresectable melanoma based on the OPTiM trial. Since its ...
• Abraham, I., Alrawashdh, N., Babiker, H. M., Bagalagel, A., Bakhsh, H. T., Diri, R., Lee, C. S., Macdonald, K., & Mcbride, A. (2018). Outcomes of pegfilgrastim (PFG) administration on the same day vs the day after chemotherapy (CTX) in the prophylaxis of chemotherapy-induced (Febrile) neutropenia (CIN/FN): Systematic review and meta-analysis.. Journal of Clinical Oncology, 36(15_suppl), e14510-e14510. doi:10.1200/jco.2018.36.15_suppl.e14510
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  e14510Background: PFG should be administered 24-72 h after CTX, but there is a trend to administer it on the same day as CTX. The aim of our systematic review and meta-analysis (MA) was to compare ...
• Abraham, I., Alsheikh, R., & MacDonald, K. (2018). A Cautionary Research Note on Standard Versus Extended Release Tacrolimus. Progress in transplantation (Aliso Viejo, Calif.), 1526924818817070.
• Abraham, I., Alsheikh, R., & MacDonald, K. (2019). A Cautionary Research Note on Standard Versus Extended Release Tacrolimus. Progress in transplantation (Aliso Viejo, Calif.).
• Abraham, I., Balu, S., Bikkina, M., Campbell, K., Macdonald, K., & Mcbride, A. (2018). Abstract P4-12-07: Cost-minimization of chemotherapy-induced (febrile) neutropenia prophylaxis with biosimilar ZARXIO® over NEUPOGEN®, NEULASTA®, and NEULASTA/ONPRO®: Breast cancer case study. Cancer Research, 78(4_Supplement), P4-12-07-P4-12-07. doi:10.1158/1538-7445.sabcs17-p4-12-07
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  RATIONALE & OBJECTIVES: Biosimilar filgrastim may offer significant cost advantages over originator filgrastim and pegfilgrastim. The objectives were (1) to evaluate for the US the comparative cost-minimization of chemotherapy-induced (febrile) neutropenia (CIN/FN) prophylaxis with biosimilar filgrastim ZARZIO® over originator filgrastim NEUPOGEN®, and originator pegfilgrastim NEULASTA® and NEULASTA/ONPRO® injection device with the health-care provider (HP) providing full administration, using 3Q2016 average selling price (ASP); and (2) to apply the different savings estimates to a breast cancer case study. METHODS: Cost-minimization analysis of [1] acquisition costs for one patient for one chemotherapy cycle for 1 to 14 days (d) using per unit dose, and [2] administration costs using Current Procedural Terminology (CPT) codes. We calculated [1] the general cost of prophylaxis for one cycle with each agent, with standard filgrastim administrations ranging from 1-14 days and pegfilgrastim limited to single administration; and [2] the cost-savings that could be accrued from 1-14d prophylaxis with ZARXIO® over the three originator options. The case study concerns a 43 y/o Caucasian female, newly diagnosed with stage 2 HER2-negative breast cancer being started on TAC (FN risk >20%); unremarkable medical history; no comorbidities; with primary prophylaxis initiated in cycle 1 and continued through 6 cycles per local protocol (single NEULASTA® or NEULASTA/ONPRO® or 11d NEUPOGEN® or ZARXIO®). RESULTS: Using ASP+CPT, prophylaxis cost per dose (rounded) was $260 for ZARXIO®, $326 for NEUPOGEN®, $3,926 for NEULASTA®; $3,910 for NEULASTA®. In general, cost-savings per cycle from ZARXIO® over NEUPOGEN® ranged from $65 (1d) to $916 (14d); over Neulasta®, from $3,666 (1d) to $284 (14d); and over NEULASTA/ONPRO®, from $3,649 (1d) to $267 (14d). In the breast cancer case study, cost of prophylaxis per one cycle was $2,862 for ZARXIO® (11d), $3,582 for NEUPOGEN® (11d) vs. $3926 for NEULASTA® and $3910 for NEULASTA/ONPRO® single-injection. Cost-savings per cycle from ZARXIO® use were $719 vs. NEUPOGEN®, $1,064 vs. NEULASTA®, and $1,047 vs. NEULASTA/ONPRO®. Total savings from ZARXIO® use over all 6 TAC cycles were $4,316 vs. NEUPOGEN®, $6,385 vs. NEULASTA®, and $6,284 vs. NEULASTA/ONPRO®. CONCLUSIONS: In general, CIN/FN prophylaxis with ZARXIO® for 1-14d generates significant cost savings over NEUPOGEN®, NEULASTA® and NEULASTA/ONPRO generating significant cost-savings. In the case study of the 43 y/o HER-negative breast cancer patient treated with TAC and prescribed 6 cycles of primary prophylaxis with 11d standard or single-administration pegfilgrastim, savings reached as high as $6,385 for the full course of chemotherapy. Given the trial evidence of non-inferiority of pegfilgrastim over filgrastim, the clinical trend for Citation Format: McBride A, Campbell K, Bikkina M, MacDonald K, Abraham I, Balu S. Cost-minimization of chemotherapy-induced (febrile) neutropenia prophylaxis with biosimilar ZARXIO® over NEUPOGEN®, NEULASTA®, and NEULASTA/ONPRO®: Breast cancer case study [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr P4-12-07.
• Abraham, I., Balu, S., Campbell, K., Krendyukov, A., Macdonald, K., Mathieson, N., & Mcbride, A. (2018). Cost Simulation for Febrile Neutropenia Hospitalization in the US Due to Pegfilgrastim on-Body Injector Failure Compared to Single-Injection Pegfilgrastim and Daily Injections with Reference and Biosimilar Filgrastim in Non-Hodgkin Lymphoma. Blood, 132(Supplement 1), 2251-2251. doi:10.1182/blood-2018-99-116315
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  Abstract Introduction: Failure rates ranging from 1.7-3.8% of the pegfilgrastim on-body injector (PEG-OBI) device have been reported (Joshi, Curr Med Res Opin 2017; Stuessy, J Clin Onc 2017; Mahler, Clin J Onc Nurs 2017). Failures may increase the risk of chemotherapy-induced febrile neutropenia (FN) and FN-related hospitalizations (FN-HOSP) beyond the FN and FN-HOSP rates for prophylaxis with single-injection pegfilgrastim (PEG) or daily injections of reference (REF-FIL) or Sandoz filgrastim biosimilar (BIOSIM-FIL). We aimed to estimate for a US panel of 10,000 patients with non-Hodgkin lymphoma (NHL) the total incremental costs of PEG-OBI prophylaxis and incremental FN-HOSP costs at different PEG-OBI failure rates versus (vs) assured prophylaxis administration with PEG, REF-FIL, or BIOSIM-FIL. Methods: Simulation analysis from a US payer perspective of the total incremental prophylaxis costs associated with PEG-OBI failure rates of 1-5% compared to assured prophylaxis administration with PEG, REF-FIL, and BIOSIM-FIL in chemotherapy cycle 1 for a panel of 10,000 NHL patients. Filgrastim daily injection regimens included real-world durations of 5 (Gascón, Support Care Cancer 2016) and 6.5 days (Weycker, Ann Pharmacother 2006) and standard 11 days, all clinician-administered. Differential base rates of FN-HOSP (rate of FN-HOSP without colony-stimulating factor [CSF] minus rate with CSF) in NHL patients was computed for two chemotherapy regimens: 1) cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) (Chrischilles, Cancer Control 2002; 13.25% with CSF, 23.28% without), and 2) CHOP or cyclophosphamide, mitoxantrone, vincristine and prednisone (CNOP) (Osby, Blood 2003; 33.0% with CSF, 50.0% without). Costs (US$) were based on 1Q2018 average selling price for drugs and 2018 Current Procedural Terminology reimbursement for administration. FN-HOSP costs in 2012 of $25,676 per episode for NHL patients (Tai, J Oncol Pract 2017) were adjusted per the Consumer Price Index for Medical Care to $29,938.63 for 2018. Results: Table 1 (Chrischilles; CHOP) and Table 2 (Osby; CHOP/CNOP) present, for PEG-OBI failures rates of 0.01-0.05, the incremental number of patients at risk for FN-HOSP and associated incremental costs; and total incremental costs of PEG-OBI prophylaxis over the costs of assured prophylaxis administration with other CSFs in CTX cycle 1 for a panel of 10,000 NHL patients. Except for one scenario (savings of $72,916 at 0.1 failure rate due to the lower PEG-OBI administration costs), all scenarios showed incremental costs associated with PEG-OBI prophylaxis and failures of the PEG-OBI device (Tables 1 and 2). Per Chrischilles rates, in a panel of 10,000 NHL patients, incremental FN-HOSP costs due to PEG-OBI device failure ranged from $300,284 (at 0.01 failure rate) to $1,501,422 (at 0.05 failure rate). Total incremental costs of PEG-OBI over PEG ranged from $227,369 to $1,128,222. Total incremental costs of PEG-OBI over REF-FIL ranged from $6,794,984 to $28,859,922; and over BIOSIM-FIL from $19,004,984 to $34,409,922. Per the Osby rates, in a panel of 10,000 NHL patients, incremental FN-HOSP costs due to PEG-OBI device failure ranged from $508,957 to $2,544,784. Total incremental costs of PEG-OBI over PEG ranged from $135,757 to $2,171,584; over REF-FIL from $7,003,657 to $29,903,284; and over BIOSIM-FIL from $19,213,657 to $35,453,284. Conclusions: In this simulation of NHL patients treated with CHOP or CNOP, the total incremental costs of PEG-OBI prophylaxis vs assured prophylaxis administration with other CSFs vary as a function of PEG-OBI failure rates, baseline and failure-associated FN-HOSP risk, and the alternative CSF prophylaxis option. Incremental costs of PEG-OBI prophylaxis and failure are lowest vs PEG and highest vs BIOSIM-FIL at real-world duration of 5 days. Disclosures Krendyukov: Sandoz: Employment. Mathieson:Sandoz: Employment. Campbell:Sandoz Inc.: Employment. Balu:Sandoz Inc.: Employment. MacDonald:Sandoz: Consultancy. Abraham:Sandoz: Consultancy.
• Abraham, I., Barber, B. J., Combs, D., Edgin, J. O., Hsu, C. H., Morgan, W. J., & Parthasarathy, S. (2018). 0745 Sleep-disordered Breathing Is Associated With Neurocognitive Impairment In Children With Congenital Heart Disease. Sleep, 41(suppl_1), A277-A277. doi:10.1093/sleep/zsy061.744
• Abraham, I., Olson, T. P., Rourk, Z. T., & Snyder, E. M. (2018). Abstract P285: Potential Direct Medical Cost-Savings Attributable to Physical Activity in Major Disease Categories. Circulation, 137(suppl_1). doi:10.1161/circ.137.suppl_1.p285
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  Introduction: Physical activity (PA) is known to be effective in treating and preventing many lifestyle diseases including CVD, stroke, depression, type II diabetes, Alzheimer’s disease, as well as...
• Al Yami, M. S., Kurdi, S., & Abraham, I. (2018). Direct oral anticoagulants for extended thromboprophylaxis in medically ill patients: Meta-analysis and risk/benefit assessment. Journal of Blood Medicine, 9(Issue). doi:10.2147/jbm.s149202
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  Background: Standard-duration (7-10 days) thromboprophylaxis with low molecular weight heparin, low dose unfractionated heparin, or fondaparinux in hospitalized medically ill patients is associated with ~50% reduction in venous thromboembolism (VTE) risk. However, these patients remain at high risk for VTE post-discharge. The direct oral anticoagulants (DOACs) apixaban, rivaroxaban and betrixaban have been evaluated for extended-duration (30-42 days) thromboprophylaxis in this population. Methods: We review the efficacy and safety results from the 3 pivotal trials of extended-duration DOAC thromboprophylaxis in medically ill patients. We performed a meta-analysis of these pivotal trials focusing on 6 VTE (efficacy) and three bleeding outcomes (safety). These results were integrated into a quantitative risk/benefit assessment. Results: The trials evaluating extended-duration DOAC thromboprophylaxis in medically ill patients failed to establish clear efficacy and/or safety signals for each agent. Our meta-analysis shows that, as a class, DOACs have selective and partial extended-duration prophylactic activity in preventing VTE events. However, this is associated with a marked increase in the risk of various bleeding events. The risk/benefit analyses fail to show a consistent net clinical benefit of extended-duration DOAC prophylaxis in medically ill patients. Conclusion: At this time, the evidence of safe and effective extended-duration thromboprophylaxis with DOACs in this population is inconclusive.
• Al Yami, M., McBride, A., Katragadda, C., Martin, J. R., Badreldin, H. A., Mohammed, A. H., Elmubark, A. M., Alzahrani, M. Y., Alsheri, A. M., & Abraham, I. L. (2018). Direct oral anticoagulants for the treatment of venous thromboembolism in patients with active malignancy: a systematic review and meta-analysis. 2018;46:145-153.. Journal of Thrombosis and Thrombolysis, 46, 145-153.
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  Erratum published: Journal of Thrombosis and Thrombolysis 2019;47:166.
• Alkhatib, N. S., Ramos, K., Slack, M., Erstad, B., Gharaibeh, M., Klimecki, W., Karnes, J. H., Sweitzer, N. K., & Abraham, I. (2018). Ex ante economic evaluation of genetic testing for the ARG389 beta1-adrenergic receptor polymorphism to support bucindolol treatment decisions in Stage III/IV heart failure. Expert Review of Precision Medicine and Drug Development, 3(Issue 5). doi:10.1080/23808993.2018.1526079
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  Background: Sub-analyses from the BEST trial in heart failure (HF) indicated that Arg389 homozygote patients may respond to bucindolol. Bucindolol is currently being evaluated in Arg389 genotype patients in the GENETIC-AF trial. Our aim is to conduct ex ante economic evaluations of Arg389 genetic testing to support β-blocker treatment in HF. Methods: Using survival results from two BEST sub-analyses, we constructed a decision-tree model (time-horizon 18 months, divided into three 6-month cycles) to estimate the cost-effectiveness/utility of Arg389 genetic testing with bucindolol or carvedilol versus no testing and empirical bucindolol. Costs of bucindolol and genetic testing were set conservatively at 1.5x carvedilol cost and $250, respectively. Incremental cost-effectiveness (ICER) and cost-utility ratios (ICUR) were estimated. Results: Per one BEST sub-analysis, Arg389 genetic testing was associated with incremental gains of 0.29 life-years (LYs) and 0.27 quality-adjusted life years (QALYs) at incremental costs of $726; yielding ICER of US$2,503/LY and ICUR of US$2,688/QALY gained. Per a different BEST sub-analysis, Arg-389 genetic testing was associated with incremental gains of 0.35LYs and 0.32QALYs at savings of (US$1,081); for ICER of (US$3,089)/LY and ICUR of (US$3,378)/QALY gained. Conclusions: Assuming conservative cost estimates, Arg389 genetic testing to inform bucindolol versus carvedilol treatment decisions prevailed economically over bucindolol treatment without genetic testing.
• Alkhatib, N., Abraham, I. L., Ramos, K., Sweitzer, N. K., Gharaibeh, M., Klimecki, W., Slack, M. K., Karnes, J. H., Erstad, B. L., Erstad, B. L., Karnes, J. H., Slack, M. K., Gharaibeh, M., Klimecki, W., Sweitzer, N. K., Ramos, K., Alkhatib, N., & Abraham, I. L. (2018). Economic evaluation of genetic testing for Arg389 in the management of stage III/IV heart failure.. Expert Review of Precision Medicine and Drug Development, 3, 319-329.
• Bea, J. W., Hsu, C. H., Blew, R. M., Irving, A. P., Caan, B. J., Kwan, M. L., Abraham, I., & Going, S. B. (2018). Use of iDXA spine scans to evaluate total and visceral abdominal fat. American journal of human biology : the official journal of the Human Biology Council, 30(1), e23057.
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  Abdominal fat may be a better predictor than body mass index (BMI) for risk of metabolically-related diseases, such as diabetes, cardiovascular disease, and some cancers. We sought to validate the percent fat reported on dual energy X-ray absorptiometry (DXA) regional spine scans (spine fat fraction, SFF) against abdominal fat obtained from total body scans using the iDXA machine (General Electric, Madison, WI), as previously done on the Prodigy model.
• Bernstein, J. A., Bernstein, J. A., Kavati, A., Kavati, A., Tharp, M. D., Tharp, M. D., Ortiz, B., Ortiz, B., MacDonald, K., MacDonald, K., Denhaerynck, K., Denhaerynck, K., Abraham, I., & Abraham, I. (2018). Effectiveness of omalizumab in adolescent and adult patients with chronic idiopathic/spontaneous urticaria: a systematic review of 'real-world' evidence. Expert opinion on biological therapy, 18(4), 425-448.
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  Chronic idiopathic/spontaneous urticaria (CIU/CSU) is a dermatological condition characterized by itchy wheals and/or angioedema of continuous or intermittent duration of ≥6 weeks with a high burden of disease and impact on quality of life. Omalizumab is a recombinant humanized monoclonal antibody that inhibits the binding of IgE to high affinity receptors, and is approved for the CIU/CSU indication. The objective of this systematic review was to evaluate and synthesize the evidence on the real-world effectiveness of omalizumab in CIU/CSU in daily clinical practice.
• Bernstein, J. A., Kavati, A., Tharp, M., Ortiz, B., MacDonald, K., Denhaerynck, K., & Abraham, I. L. (2018). Effectiveness of omalizumab in adolescent and adult patients with chronic idiopathic/spontaneous urticaria: a systematic review of “real-world” evidence.. Expert Opinion on Biological Therapy, 18, 425-448.
• Chow, H., Thomson, C. A., Marrero, D., Abraham, I. L., Hsu, C., & Algotar, A. (2019). Comprehensive lifestyle improvement program for prostate cancer (CLIPP): Protocol for a feasibility and exploratory efficacy study in men on androgen deprivation therapy. Journal of Medical Internet Research.
• Gharaibeh, M., McBride, A., Alberts, D. S., Erstad, B. L., Slack, M. K., Alsaid, N. S., Bootman, J. L., & Abraham, I. L. (2018). Economic evaluation for the UK of systemic chemotherapies in first-line treatment of metastatic pancreatic cancer.. PharmacoEconomics, 36, 1333-1343.
• Gharaibeh, M., McBride, A., Alberts, D. S., Erstad, B., Slack, M., Alsaid, N., Bootman, J. L., & Abraham, I. (2018). Economic Evaluation for the UK of Systemic Chemotherapies as First-Line Treatment of Metastatic Pancreatic Cancer. PharmacoEconomics, 36(11), 1333-1343.
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  Gemcitabine (GEM), oxaliplatin plus GEM (OX + GEM), cisplatin plus GEM (CIS + GEM), capecitabine plus GEM (CAP + GEM), FOLFIRINOX (FFX), and nab-paclitaxel plus GEM (NAB-P + GEM) are the most commonly used regimens as first-line treatment of metastatic pancreatic cancer (MPC) in the UK. Independent economic evaluation of these regimens simultaneously has not been conducted for the UK.
• Gharaibeh, M., McBride, A., Alberts, D. S., Erstad, B., Slack, M., Alsaid, N., Bootman, J. L., & Abraham, I. (2018). Economic Evaluation for the UK of Systemic Chemotherapies as First-Line Treatment of Metastatic Pancreatic Cancer. PharmacoEconomics, 36(Issue 11). doi:10.1007/s40273-018-0684-8
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  Background: Gemcitabine (GEM), oxaliplatin plus GEM (OX + GEM), cisplatin plus GEM (CIS + GEM), capecitabine plus GEM (CAP + GEM), FOLFIRINOX (FFX), and nab-paclitaxel plus GEM (NAB-P + GEM) are the most commonly used regimens as first-line treatment of metastatic pancreatic cancer (MPC) in the UK. Independent economic evaluation of these regimens simultaneously has not been conducted for the UK. Objective: Using data from a network meta-analysis as efficacy measures, we estimated the cost effectiveness and cost utility of these regimens for the UK. Methods: A three-state Markov model (progression-free, progressed-disease, and death) simulating the total costs and health outcomes (quality-adjusted life-years [QALYs] gained and life-years [LYs]) was developed to estimate the incremental cost-utility (ICUR) and incremental cost-effectiveness ratios (ICER) for patients with MPC, from the payer perspective. The model was specified to calculate total costs in 2017 British pounds (GBP, £). All values were discounted at 3.5% per year over a full lifetime horizon. One-way sensitivity and probabilistic sensitivity analyses were conducted to assess the impact of parameter uncertainty on the results. Results: FFX was the most effective regimen, NAB-P + GEM was the most costly regimen, and GEM was the least costly and least effective regimen. OX + GEM, CIS + GEM, and NAB-P + GEM were dominated by CAP + GEM and FFX. Compared with GEM, the ICUR for CAP + GEM and FFX was £28,066 and £33,020/QALY gained, respectively; compared with GEM, the ICER for CAP + GEM and FFX was £17,437 and £22,291/LY gained, respectively; and compared with CAP + GEM, the ICUR and ICER for FFX were £34,947/QALY gained and 24,414/LY gained, respectively. Conclusions: At a threshold value of £30,000/QALY, CAP + GEM was found to be the only cost-effective regimen in the management of MPC in the UK.
• Gharaibeh, M., McBride, A., Alberts, D. S., Slack, M. K., Erstad, B. L., Alsaid, N. S., Bootman, J. L., & Abraham, I. L. (2018). Economic evaluation for USA of systemic chemotherapies in first-line treatment of metastatic pancreatic cancer.. PharmacoEconomics, 36, 1273-1284.
• Gharaibeh, M., McBride, A., Alberts, D. S., Slack, M., Erstad, B., Alsaid, N., Bootman, J. L., & Abraham, I. (2018). Economic Evaluation for USA of Systemic Chemotherapies as First-Line Treatment of Metastatic Pancreatic Cancer. PharmacoEconomics, 36(10), 1273-1284.
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  Treatments for metastatic pancreatic cancer include monotherapy with gemcitabine (GEM); combinations of GEM with oxaliplatin (OX + GEM), cisplatin (CIS + GEM), capecitabine (CAP + GEM), or nab-paclitaxel (NAB-P + GEM); and the non-GEM combination FOLFIRINOX. Combination therapies have yielded better survival outcomes than GEM alone. A sponsor-independent economic evaluation of these regimens has not been conducted for USA.
• Kelley, E. F., Snyder, E. M., Alkhatib, N. S., Snyder, S. C., Sprissler, R., Olson, T. P., Akre, M. K., & Abraham, I. (2018). Economic evaluation of a pharmacogenomic multi-gene panel test to optimize anti-hypertension therapy: simulation study. Journal of Medical Economics, 21(Issue 12). doi:10.1080/13696998.2018.1531011
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  Aims: Hypertension is the strongest modifiable risk factor for cardiovascular disease, affecting 80 million individuals in the US and responsible for ∼360,000 deaths, at total annual costs of $93.5 billion. Antihypertension therapies guided by single genotypes are clinically more effective and may avert more adverse events than the standard of care of layering anti-hypertensive drug therapies, thus potentially decreasing costs. This study aimed to determine the economic benefits of the implementation of multi-gene panel guided therapies for hypertension from the payer perspective within a 3-year time horizon. Materials and methods: A simulation analysis was conducted for a panel of 10 million insured patients categorized clinically as untreated, treated but uncontrolled, and treated and controlled over a 3-year treatment period. Inputs included research data; empirical data from a 11-gene panel with known functional, heart, blood vessel, and kidney genotypes; and therapy efficacy and safety estimates from literature. Cost estimates were categorized as related to genetic testing, evaluation and management, medication, or adverse events. Results: Multi-gene panel guided therapy yielding savings of $6,256,607,500 for evaluation and management, $908,160,000 for medications, and $37,467,508,716 for adverse events, after accounting for incremental genetic testing costs of $2,355,540,000. This represents total 3-year savings of $42,276,736,216, or a 47% reduction, and 3-year savings of $4,228 and annual savings of $1,409 per covered patient. Conclusions: A precision medicine approach to genetically guided therapy for hypertension patients using a multi-gene panel reduced total 3-year costs by 47%, yielding savings exceeding $42.3 billion in an insured panel of 10 million patients. Importantly, 89% of these savings are generated by averting specific adverse events and, thus, optimizing choice of therapy in function of both safety and efficacy.
• Kelley, E. F., Snyder, E. M., Alkhatib, N. S., Snyder, S. C., Sprissler, R., Olson, T. P., Akre, M. K., & Abraham, I. (2018). Economic evaluation of a pharmacogenomic multi-gene panel test to optimize anti-hypertension therapy: simulation study. Journal of medical economics, 21(12), 1246-1253.
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  Hypertension is the strongest modifiable risk factor for cardiovascular disease, affecting 80 million individuals in the US and responsible for ∼360,000 deaths, at total annual costs of $93.5 billion. Antihypertension therapies guided by single genotypes are clinically more effective and may avert more adverse events than the standard of care of layering anti-hypertensive drug therapies, thus potentially decreasing costs. This study aimed to determine the economic benefits of the implementation of multi-gene panel guided therapies for hypertension from the payer perspective within a 3-year time horizon.
• Kelley, E., Snyder, E., Alkhatib, N., Snyder, S., Sprissler, R. S., Olson, T., & Abraham, I. L. (2018). Economic evaluation of a pharmacogenomic multi-gene panel test to optimize anti-hypertension therapy: simulation study.. Journal of Medical Economics, 21, 1246-1253.
• Kumar, A., Abraham, I., Alsaid, N., Andritsos, L. A., Anwer, F., Babiker, H. M., Mcbride, A., Persky, D. O., & Yun, S. (2018). Economic evaluation for the US of venetoclax (VEN) versus ibrutinib (IBR) versus allogeneic hematopoietic stem-cell transplantation (HSCT) for patients (pts) with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) with 17p deletion (del 17p).. Journal of Clinical Oncology, 36(15_suppl), 7527-7527. doi:10.1200/jco.2018.36.15_suppl.7527
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  7527Background: Prior to targeted agents, HSCT was the primary treatment for R/R CLL del 17p. VEN and IBR have been shown to improve progression free (PFS) and overall survival (OS). We performed a...
• London, G., Mann, J., Goldsmith, D., Combe, C., Dellanna, F., Zaoui, P., Hoebel, N., Krendyukov, A., MacDonald, K., & Abraham, I. (2018). Long-term treatment with biosimilar epoetin-α (HX575) in hemodialysis patients with renal anemia: Real-world effectiveness and safety in the MONITOR-CKD5 study. Clinical Nephrology, 89(Issue 1). doi:10.5414/cn109245
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  Aims: To assess real-world effectiveness and safety of intravenous (IV) HX575, a biosimilar epoetin-α, in hemodialysis (HD) patients. Materials and methods: This prospective, observational, pharmacoepidemiological study of adult HD patients treated with IV HX575 for renal anemia for up to 24 months was conducted in 114 centers in 10 European countries. Of 2,086 enrolled subjects (safety sample), 2,023 had ≥ 1 follow-up visit (effectiveness sample). Results: Most (59.3%) patients were male, median age was 68 years. At enrollment, most (82.5%) had been treated with an erythropoiesis-stimulating agent, and 73.0% had adequate iron stores. At baseline, mean (± standard deviation) baseline hemoglobin (Hb) was 11.09 (± 1.14) g/dL and HX575 dose 106.5 (± 78.7) international units (IU)/ kg/week; at month 24, Hb was 11.25 (± 1.19) g/dL and HX575 dose 113.0 (± 102.5) IU/ kg/week. Variations in mean HX575 dose and Hb over the study were not statistically significant. As to safety, 140 patients (6.7%) experienced ≥ 1 adverse event; of these, 19 events (16 patients; 0.8%) were related to HX575 treatment, 148 (108 patients; 5.2%) were reported as serious, including 12 events in 11 patients (0.5%) stated to be related. No cases of anti-epoetin antibodies or pure red cell aplasia were reported. Conclusions: MONITOR-CKD5 confirmed the real-world effectiveness and safety profile of IV biosimilar HX575. HD patients treated for up to 24 months showed stable dosing patterns and Hb outcomes. The safety profile of HX575 is likewise comparable to reference epoetin-α.
• London, G., Mann, J., Goldsmith, D., Combe, C., Dellanna, F., Zaoui, P., Hoebel, N., Krendyukov, A., MacDonald, K., & Abraham, I. (2018). Long-term treatment with biosimilar epoetin-α (HX575) in hemodialysis patients with renal anemia: real-world effectiveness and safety in the MONITOR-CKD5 study. Clinical nephrology, 89 (2018)(1), 1-9.
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  To assess real-world effectiveness and safety of intravenous (IV) HX575, a biosimilar epoetin-α, in hemodialysis (HD) patients.
• Macdonald, K., Abraham, I., Balu, S., Campbell, K., Krendyukov, A., Macdonald, K. P., Mathieson, N., & Mcbride, A. (2018). Cost simulation for the US of febrile neutropenia hospitalization due to pegfilgrastim on-body injector failure compared to single-injection pegfilgrastim and daily injections with reference and biosimilar filgrastim in lung cancer.. Annals of oncology : official journal of the European Society for Medical Oncology, 29 Suppl 9, ix133-ix134. doi:10.1093/annonc/mdy444.017
• McBride, A., Campbell, K., Bikkina, M., MacDonald, K., Abraham, I., & Balu, S. (2018). Reply: Cost-efficiency analyses for the US of biosimilar filgrastim-sndz, reference filgrastim, pegfilgrastim, and pegfilgrastim with on-body injector in the prophylaxis of chemotherapy-induced (febrile) neutropenia. Journal of Medical Economics, 21(Issue 6). doi:10.1080/13696998.2018.1452749
• McBride, A., Campbell, K., Bikkina, M., MacDonald, K., Abraham, I., & Balu, S. (2018). Reply: Cost-efficiency analyses for the US of biosimilar filgrastim-sndz, reference filgrastim, pegfilgrastim, and pegfilgrastim with on-body injector in the prophylaxis of chemotherapy-induced (febrile) neutropenia. Journal of medical economics, 21(6), 606-609.
• Mushtaq, A., Kapoor, V., Latif, A., McBride, A., Abraham, I. L., Iftikhar, A., Zahid, U., Bin Riaz, I., & Anwer, F. (2018). Efficacy and toxicity profiles of carfilzomib based regimens for treatment of multiple myeloma: a systematic review.. Critical Reviews in Oncology and Hematology, 125, 1-11.
• Oh, M., McBride, A., Yun, S., Bhattacharjee, S., Slack, M. K., Martin, J. R., Jeter, J., & Abraham, I. L. (2018). BRCA1 and BRCA2 gene mutations and colorectal cancer risk: systematic review and meta-analysis.. Journal of the National Cancer Institute, 110, 1178-1189.
• Oh, M., McBride, A., Yun, S., Bhattacharjee, S., Slack, M., Martin, J. R., Jeter, J., & Abraham, I. (2018). BRCA1 and BRCA2 Gene Mutations and Colorectal Cancer Risk: Systematic Review and Meta-analysis. Journal of the National Cancer Institute, 110(11), 1178-1189.
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  Investigations of the associations with colorectal cancer have yielded conflicting results. The aim of our study was to synthesize the research on colorectal cancer risks in BRCA mutation carriers by means of a systematic review and quantitatively by means of meta-analyses overall and in subgroups of BRCA mutation carriers.
• Aapro, M., Bokemeyer, C., Ludwig, H., Gascón, P., Boccadoro, M., Denhaerynck, K., Gorray, M., Krendyukov, A., MacDonald, K., & Abraham, I. (2017). Chemotherapy-induced (febrile) neutropenia prophylaxis with biosimilar filgrastim in elderly versus non-elderly cancer patients: Patterns, outcomes, and determinants (MONITOR-GCSF study). Journal of Geriatric Oncology, 8(Issue 2). doi:10.1016/j.jgo.2016.09.006
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  Background Myelotoxic chemotherapy is associated with chemotherapy-induced (febrile) neutropenia (CIN/FN). The MONITOR-GCSF study evaluated biosimilar filgrastim (Zarzio®) prophylaxis patterns, associated outcomes, and determinants. We performed stratified analyses comparing elderly and non-elderly patients. Methods Comparative (elderly/non-elderly) analysis of demographics and clinical status, prophylaxis, associated CIN/FN outcomes (CIN grade 4 [CIN4], FN, CIN/FN-related hospitalizations and chemodisturbances, composite), and, per hierarchical modeling, determinants thereof evaluated at the patient- and cycle-level. Results There were no significant differences between both cohorts in prophylaxis initiation/duration and associated outcomes, but proportionately more elderly patients were correctly-prophylacted and fewer over-prophylacted. Common determinants of poor CIN/FN outcomes included concomitant antibiotic prophylaxis, impaired performance status, and any grade CIN in a previous cycle, whereas common determinants of good outcomes included over-prophylaxis and prophylaxis initiation within 24–72 h. In the elderly, female gender, liver/renal/cardiovascular disease, secondary prophylaxis, and under-prophylaxis were associated with poorer outcomes. In the non-elderly, CIN4 at baseline or in a prior cycle was associated with poorer CIN/FN outcomes, and higher biosimilar filgrastim dose and, perhaps counter-intuitively, under-prophylaxis with better outcomes. Conclusion Adequate GCSF support is essential for all patients, but especially for elderly patients with serious chronic disease, certainly, if concomitant antibiotic prophylaxis is indicated and if a CIN4 episode occurred in a prior cycle. The potential impact of impaired performance status, especially ECOG ≥ 2 at chemotherapy start or a worsening to such during chemotherapy; under-prophylaxis, including inadequate secondary prophylaxis, should be considered in elderly patients. Timely GCSF initiation and over-prophylaxis is associated with lower rates of adverse CIN/FN events in elderly and non-elderly patients, and should be further evaluated in prospective randomized trials.
• Aapro, M., Bokemeyer, C., Ludwig, H., Gascón, P., Boccadoro, M., Denhaerynck, K., Gorray, M., Krendyukov, A., MacDonald, K., & Abraham, I. (2017). Chemotherapy-induced (febrile) neutropenia prophylaxis with biosimilar filgrastim in elderly versus non-elderly cancer patients: Patterns, outcomes, and determinants (MONITOR-GCSF study). Journal of geriatric oncology, 8(2), 86-95.
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  Myelotoxic chemotherapy is associated with chemotherapy-induced (febrile) neutropenia (CIN/FN). The MONITOR-GCSF study evaluated biosimilar filgrastim (Zarzio®) prophylaxis patterns, associated outcomes, and determinants. We performed stratified analyses comparing elderly and non-elderly patients.
• Abraham, I. L., Yun, S., Raz, Y., Kutbi, H. I., Gharaibeh, M., Huckleberry, Y., Aljabri, A., Erstad, B. L., & Karnes, J. H. (2017). Medical Management of Heparin-Induced Thrombocytopenia: Pharmacoeconomic Considerations. Blood e-letter (19 June, 2017). Blood.
• Abraham, I., Agarwal, A. B., Alsaid, N., Anwer, F., Mcbride, A., & Mutairi, A. (2017). Cost effectiveness of carfilzomib (CAR), ixazomib (IXA), elotuzumab (ELO), or daratumumab (DAR) with lenalidomide and dexamethasone (LEN+DEX) vs LEN+DEX in relapsed/refractory multiple myeloma (R/R MM).. Journal of Clinical Oncology, 35(15_suppl), 8030-8030. doi:10.1200/jco.2017.35.15_suppl.8030
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  8030Background: CAR, IXA, ELO, and DAR in triplet combination with LEN+DEX have shown superior efficacy over LEN+DEX in R/R MM, but their comparative efficacy and cost effectiveness has not been es...
• Abraham, I., Alsaid, N., & Gharaibeh, M. (2017). An Algorithm To Quantttatively Estimate Extrapolated Lifetime Survival Curves For Economic Evaluation (EE) of Cancer Treatments When Only Aggregated Patient Data Are Available; With Application To Metastatic Pancreatic Cancer. Value in Health, 20(9), A733-A734. doi:10.1016/j.jval.2017.08.2006
• Abraham, I., Alsaid, N., Erstad, B. L., Ramos, K. S., Slack, M. K., & Sweitzer, N. K. (2017). Classification of Causes of Hospitalization For Heart Failure Patients In Cost-Effectiveness and Cost-Utility Evaluations of Pharmacotherapeutic, Surgical, and Managed-Care Interventions: Systematic Review. Value in Health, 20(9), A740. doi:10.1016/j.jval.2017.08.2043
• Abraham, I., Balu, S., Bikkina, M., Campbell, K., Macdonald, K., & Mcbride, A. (2017). Cost savings of conversion from filgrastim or pegfilgrastim to biosimilar filgrastim-sndz for chemotherapy-induced (febrile) neutropenia (CIN/FN) prophylaxis and expanded access to biosimilar GCSF on a budget neutral basis.. Journal of Clinical Oncology, 35(15_suppl), e18334-e18334. doi:10.1200/jco.2017.35.15_suppl.e18334
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  e18334Background: Biosimilar filgrastim (Zarxio) provides a more cost-efficient alternative to reference and pegylated filgrastim for CIN/FN prophylaxis. Using biosimilar conversion rates, we determined savings achieved, number needed to convert (NNC) to purchase additional Zarxio, and the incremental number (n) of patients (pts) that could be provided Zarxio on a budget neutral basis using various filgrastim cycle/treatments scenarios. Prior real-world practice studies have shown variations in GCSF duration including shorter durations (Weycker 2006; Gascon 2016) relative to registration trials and guideline recommendations. Methods: Calculations were done for a panel of 20000 pts; chemotherapy of 1 or 6 cycles with 5, 7 or 11 filgrastim injections; cost of medicines using average selling price (Zarxio $245.08, Neupogen $283.87, Neulasta $3761.22) and subcutaneous administration per Current Procedural Terminology ($42.31 hospital outpt). NNC is the n to be converted to Zarxio to purchase 1 additional Zarx...
• Abraham, I., Balu, S., Bikkina, M., Campbell, K., Macdonald, K., & Mcbride, A. (2017). Expanded Access To Pembrolizumab from Cost-Savings Generated by Biosimilar Filgrastim (BIOSIM-FIL) in The Prophylaxis of Chemotherapy-Induced (FEBRILE) Neutropenia (CIN/FN): Simulation Study. Value in Health, 20(9), A443. doi:10.1016/j.jval.2017.08.258
• Abraham, I., Kurdi, S., & MacDonald, K. (2017). The hypertension, diabetes and chronic kidney disease triangle in Arab countries. Journal of human hypertension, 31(6), 373-375.
• Abraham, I., Yami, M. A., Yun, S., Kim, H. J., Vincelette, N. D., McBride, A., & MacDonald, K. (2017). Survival outcomes in iron chelated and non-chelated patients with lower-risk myelodysplastic syndromes: Review and pooled analysis of observational studies. Leukemia Research, 57(Issue). doi:10.1016/j.leukres.2017.03.007
• Abraham, I., Yami, M. A., Yun, S., Kim, H. J., Vincelette, N. D., McBride, A., & MacDonald, K. (2017). Survival outcomes in iron chelated and non-chelated patients with lower-risk myelodysplastic syndromes: Review and pooled analysis of observational studies. Leukemia research, 57, 104-108.
• Al Yami, M., Kurdi, S., & Abraham, I. L. (2017). The risk-benefit of extended thromboprophylaxis with direct oral anticoagulants in medically-ill patients may be very limited (e-Letter).. Blood.
• Alhossan, A., Alhossan, A., Lee, C. S., Lee, C. S., MacDonald, K., MacDonald, K., Abraham, I., & Abraham, I. (2017). “Real-life” Effectiveness Studies of Omalizumab in Adult Patients with Severe Allergic Asthma: Meta-analysis. Journal of Allergy and Clinical Immunology: In Practice, 5(Issue 5). doi:10.1016/j.jaip.2017.02.002
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  Background After the approval of omalizumab for severe allergic asthma, a total of 25 studies have evaluated the effectiveness of omalizumab under “real-life” conditions of heterogeneity in patients, clinicians, sites, and treatment patterns. Objective We conducted a meta-analysis to evaluate the effectiveness of omalizumab focusing on treatment response, lung function, quality of life, symptom control, corticosteroid use, and exacerbations and hospitalizations at 4-6, 12, and 24 months. Methods We searched PubMed and Embase for real-life studies on omalizumab in severe asthma published up to 2015. Three effect size types were extracted: single-point proportions; mean ± SD of change relative to baseline as raw numbers and standardized as Cohen's d; and changes in proportions of patients as relative risk. Random-effects meta-analyses were performed to account for within- and between-study heterogeneity. Studies were weighted by the DerSimonian and Laird method. Results Per data available at the 3 time points, omalizumab therapy was consistently associated with large proportions of patients classified as “good” to “excellent” treatment responders (Global Evaluation of Treatment Effectiveness scale); improvements in forced expiratory volume in 1 second, quality of life (Asthma-related Quality-of-Life Questionnaire scale), and asthma symptom control (Asthma Control Test scale); reductions in oral and inhaled corticosteroid (ICS) use; and reductions in exacerbations and hospitalizations. Conclusions This meta-analysis of noncontrolled studies documents the real-life pharmacotherapeutic effectiveness of omalizumab, as add-on treatment to ICS ± long-acting β2-agonists agents, in improving outcomes in patients with severe allergic asthma under conditions of heterogeneity in patients, clinicians, sites, and treatment patterns. The results mirror, complement, and extend the efficacy data from randomized controlled trials.
• Alhossan, A., Lee, C., MacDonald, K., & Abraham, I. (2017). "Real-life" Effectiveness Studies of Omalizumab in Adult Patients with Severe Allergic Asthma: Meta-analysis. The journal of allergy and clinical immunology. In practice, 5(5), 1362-1370.e2.
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  After the approval of omalizumab for severe allergic asthma, a total of 25 studies have evaluated the effectiveness of omalizumab under "real-life" conditions of heterogeneity in patients, clinicians, sites, and treatment patterns.
• Ashy, N., Nguyen, T. N., Denhaerynck, K., Gharaibeh, M., Alhossan, A., Vancayzeele, S., Brié, H., Aerts, A., MacDonald, K., & Abraham, I. (2017). Hierarchical Modeling of Patient and Physician Determinants of Blood Pressure Outcomes in Hypertensive Patients with and without Diabetes: Pooled Analysis of Six Observational Valsartan Studies with 15,282 Evaluable Patients. International journal of chronic diseases, 2017, 9842450.
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  We pooled data from 6 valsartan-related studies including 3,658 diabetic and 11,624 nondiabetic patients to evaluate blood pressure (BP) outcomes after approximately 90 days of second- or later-line valsartan treatment. Hierarchical linear and logistic regressions were applied to identify determinants of BP outcomes. Similar reductions in BP values and similar BP control rates were achieved in both groups after approximately 90 days of therapy. The modeling analyses identified several common and different patient- and physician-related determinants of BP outcomes for both groups, many of which are modifiable or clinically manageable. Through varying in terms of association and influence between the diabetic and nondiabetic groups, patient-related determinants included age, BP at diagnosis of hypertension, risk factors, valsartan regimen, concomitant antihypertensive treatment, and adherence; and physician-related determinants included gender, years in practice, and hypertension management. In summary, in both diabetic and nondiabetic patients, the use of valsartan-centric treatment regimens in second- or later-line antihypertensive treatment is associated with significant reductions in BP level and improvement in BP control. The determinants identified in modeling provide guidance to clinicians in the common and differential management of hypertension in diabetic and nondiabetic patients.
• Bokemeyer, C., Gascón, P., Aapro, M., Ludwig, H., Boccadoro, M., Denhaerynck, K., Gorray, M., Krendyukov, A., Abraham, I., & MacDonald, K. (2017). Over- and under-prophylaxis for chemotherapy-induced (febrile) neutropenia relative to evidence-based guidelines is associated with differences in outcomes: findings from the MONITOR-GCSF study. Supportive Care in Cancer, 25(Issue 6). doi:10.1007/s00520-017-3572-4
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  Purpose: In the MONITOR-GCSF study of chemotherapy-induced (febrile) neutropenia with biosimilar filgrastim, 56.6% of patients were prophylacted according to amended EORTC guidelines, but 17.4% were prophylacted below and 26.0% above guideline recommendations. Methods: MONITOR-GCSF is a prospective, observational study of 1447 evaluable patients from 140 cancers centers in 12 European countries treated with myelosuppressive chemotherapy for up to 6 cycles receiving biosimilar GCSF prophylaxis. Patients were classified as under-, correctly-, or over-prophylacted with GCSF relative to guideline recommendations based on their chemotherapy risk, individual risk factors, and type of GCSF prophylaxis (primary versus secondary). Results: Differences between under- (17.4%), correctly- (56.6%), or over-prophylacted (26.0%) groups were found in terms of patient risk factors (age, performance status, history of FN, comorbid conditions) as well as prophylaxis patterns (type of prophylaxis, day of GCSF initiation, and GCSF duration). Rates of chemotherapy-induced neutropenia (CIN) (all grades), FN, and CIN-related hospitalizations were consistently lower in over-prophylacted patients relative to under- and correctly-prophylacted patients. No differences were observed between under- and correctly-prophylacted patients except for CIN/FN-related chemotherapy disturbances. No GCSF safety differences were found between groups (except for headaches). Conclusions: The real-world evidence provided by the MONITOR-GCSF study indicates that providing GCSF support may yield better CIN, FN, and CIN/FN-related hospitalization outcomes if patients are prophylacted at levels above guideline recommendations. Patients who are under-prophylacted are at higher risk for disturbances to their chemotherapy regimens. Our findings support the guideline recommendation that CIN/FN risk be assessed at the beginning of each chemotherapy cycle.
• Bokemeyer, C., Gascón, P., Aapro, M., Ludwig, H., Boccadoro, M., Denhaerynck, K., Gorray, M., Krendyukov, A., Abraham, I., & MacDonald, K. (2017). Over- and under-prophylaxis for chemotherapy-induced (febrile) neutropenia relative to evidence-based guidelines is associated with differences in outcomes: findings from the MONITOR-GCSF study. Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 25(6), 1819-1828.
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  In the MONITOR-GCSF study of chemotherapy-induced (febrile) neutropenia with biosimilar filgrastim, 56.6% of patients were prophylacted according to amended EORTC guidelines, but 17.4% were prophylacted below and 26.0% above guideline recommendations.
• Crocker, R. L., Grizzle, A. J., Hurwitz, J. T., Rehfeld, R. A., Abraham, I., Horwitz, R., Weil, A., & Maizes, V. (2017). Integrative medicine primary care: Assessing the practice model through patients' experiences. BMC Complementary and Alternative Medicine, 17(Issue 1). doi:10.1186/s12906-017-1996-5
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  Background: The University of Arizona Integrative Health Center (UAIHC) was an innovative integrative medicine (IM) adult primary care clinic in Phoenix, Arizona. UAIHC used a hybrid payment model to deliver comprehensive healthcare that includes conventional and complementary medical treatments. Methods: Fidelity measures were collected to evaluate how well the IM care delivery process matched ideals for IM. Patient experiences are presented here. Patients visiting UAIHC on 1 of 10 randomly selected days between September 2013 and February 2015 were surveyed. Patients were asked about their experience with: holistic care; promotion of health, self-care, and well-being; relationship and communication with practitioners; and overall satisfaction. Results: Eighty-three patients completed surveys. Based on patient-reported experiences, UAIHC delivered IM care as defined by the practice model. Conclusions: Patients received holistic care, established positive caring relationships with providers who promoted their self-care and well-being, and reported high overall satisfaction with UAIHC.
• Crocker, R. L., Grizzle, A. J., Hurwitz, J. T., Rehfeld, R. A., Abraham, I., Horwitz, R., Weil, A., & Maizes, V. (2017). Integrative medicine primary care: assessing the practice model through patients' experiences. BMC complementary and alternative medicine, 17(1), 490.
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  The University of Arizona Integrative Health Center (UAIHC) was an innovative integrative medicine (IM) adult primary care clinic in Phoenix, Arizona. UAIHC used a hybrid payment model to deliver comprehensive healthcare that includes conventional and complementary medical treatments.
• Eljaaly, K., Alshehri, S., Aljabri, A., Abraham, I., Al Mohajer, M., Kalil, A. C., & Nix, D. E. (2017). Clinical failure with and without empiric atypical bacteria coverage in hospitalized adults with community-acquired pneumonia: a systematic review and meta-analysis. BMC infectious diseases, 17(1), 385.
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  Both typical and atypical bacteria can cause community-acquired pneumonia (CAP); however, the need for empiric atypical coverage remains controversial. Our objective was to evaluate the impact of antibiotic regimens with atypical coverage (a fluoroquinolone or combination of a macrolide/doxycycline with a β-lactam) to a regimen without atypical antibiotic coverage (β-lactam monotherapy) on rates of clinical failure (primary endpoint), mortality, bacteriologic failure, and adverse events, (secondary endpoints).
• Eljaaly, K., Eljaaly, K., Alshehri, S., Alshehri, S., Aljabri, A., Aljabri, A., Abraham, I., Abraham, I., Al Mohajer, M., Al Mohajer, M., Kalil, A. C., Kalil, A. C., Nix, D. E., & Nix, D. E. (2017). Clinical failure with and without empiric atypical bacteria coverage in hospitalized adults with community-acquired pneumonia: A systematic review and meta-analysis. BMC Infectious Diseases, 17(Issue 1). doi:10.1186/s12879-017-2495-5
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  Background: Both typical and atypical bacteria can cause community-acquired pneumonia (CAP); however, the need for empiric atypical coverage remains controversial. Our objective was to evaluate the impact of antibiotic regimens with atypical coverage (a fluoroquinolone or combination of a macrolide/doxycycline with a β-lactam) to a regimen without atypical antibiotic coverage (β-lactam monotherapy) on rates of clinical failure (primary endpoint), mortality, bacteriologic failure, and adverse events, (secondary endpoints). Methods: We searched the PubMed, EMBASE and Cochrane Library databases for relevant RCTs of hospitalized CAP adults. We estimated risk ratios (RRs) with 95% confidence intervals (CIs) using a fixed-effect model, but used a random-effects model if significant heterogeneity (I 2 ) was observed. Results: Five RCTs with a total of 2011 patients were retained. A statistically significant lower clinical failure rate was observed with empiric atypical coverage (RR, 0.851 [95% CI, 0.732-0.99; P = 0.037]; I 2 = 0%). The secondary outcomes did not differ between the two study groups: mortality (RR = 0.549 [95% CI, 0.259-1.165, P = 0.118], I 2 = 61.434%) bacteriologic failure (RR = 0.816 [95% CI, 0.523-1.272, P = 0.369], I 2 = 0%), diarrhea (RR = 0.746 [95% CI, 0.311-1.790, P = 0.512], I 2 = 65.048%), and adverse events requiring antibiotic discontinuation (RR = 0.83 [95% CI, 0.542-1.270, P = 0.39], I 2 = 0%). Conclusions: Empiric atypical coverage was associated with a significant reduction in clinical failure in hospitalized adults with CAP. Reduction in mortality, bacterial failure, diarrhea, and discontinuation due to adverse effects were not significantly different between groups, but all estimates favored atypical coverage. Our findings provide support for the current guidelines recommendations to include empiric atypical coverage.
• Finnane, A., Curiel-Lewandrowski, C., Wimberley, G., Caffery, L., Katragadda, C., Halpern, A., Marghoob, A. A., Malvehy, J., Kittler, H., Hofmann-Wellenhof, R., Abraham, I., & Soyer, H. P. (2017). Proposed technical guidelines for the acquisition of clinical images of skin-related conditions. JAMA Dermatology, 153(Issue 5). doi:10.1001/jamadermatol.2016.6214
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  IMPORTANCE Standardizing dermatological imaging is important to improve monitoring of skin lesions and skin conditions, ensure the availability of high-quality images for teledermatology, and contribute to the development of a robust archive of skin images to be used for research. OBJECTIVE To provide guidelines for the clinical application of the Standards for Dermatological Imaging set forward by the ISIC. EVIDENCE REVIEW The ISIC recommendations were developed through a hybrid Delphi methodology. Themethods for achieving consensus have been described previously. The practical application of these recommendations was evaluated by 2 clinical photographers with expertise in skin imaging. Images corresponding to each recommendation were taken by a clinical photographer and provided as visual examples of how these recommendations can be implemented in clinical practice. RESULTS The Standards for Dermatological Imaging developed by the ISIC members could be followed in the clinical setting. Images showing appropriate lighting, background color, field of view, image orientation, focus and depth of field, resolution, and scale and color calibration were obtained by the clinical photographer, by following the detailed recommendations for regional, close-up and dermoscopic images. CONCLUSIONSANDRELEVANCE Adheringtotherecommendationsisbothfeasibleandachievable in practice. Adopting these Standards is the first step in achieving international standardization of skin imaging, with the potential to improve clinical outcomes and research activities.
• Finnane, A., Curiel-Lewandrowski, C., Wimberley, G., Caffery, L., Katragadda, C., Halpern, A., Marghoob, A. A., Malvehy, J., Kittler, H., Hofmann-Wellenhof, R., Abraham, I., Soyer, H. P., & , I. S. (2017). Proposed Technical Guidelines for the Acquisition of Clinical Images of Skin-Related Conditions. JAMA dermatology, 153(5), 453-457.
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  Standardizing dermatological imaging is important to improve monitoring of skin lesions and skin conditions, ensure the availability of high-quality images for teledermatology, and contribute to the development of a robust archive of skin images to be used for research.
• Gharaibeh, M., Bootman, J. L., McBride, A., Martin, J., & Abraham, I. (2017). Economic Evaluations of First-Line Chemotherapy Regimens for Pancreatic Cancer: A Critical Review. PharmacoEconomics, 35(1), 83-95.
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  Effect sizes of efficacy of first-line treatments for (metastatic) pancreas cancer are constrained, underscoring the need for evaluations of the efficacy-to-cost relationship. We critically review economic evaluations of first-line chemotherapy regimens for pancreatic cancer since the 1997 introduction of gemcitabine. We searched PubMed/MEDLINE and EMBASE (1997-2015), and the websites of health technology assessment agencies. Two authors independently reviewed economic studies for eligibility in this review; evaluated peer-reviewed, journal-published studies in terms of the Drummond Checklist; and critiqued the technical and scientific merit of all studies. Sixteen pharmacoeconomic evaluations were included: ten published in nine peer-reviewed journals and six on three websites. Six were on single-agent therapies and ten on combination therapies. Analyses conducted included cost-effectiveness (three studies), cost-utility (one study), or combined cost-effectiveness and cost-utility (12 studies). Studies diverged in results, mainly because of different assumptions, methods, inputs, and country-specific guidelines. The two most recent regimens, nanoparticle albumin-bound paclitaxel plus gemcitabine (NAB-P + GEM) and the combination of fluorouracil, oxaliplatin, leucovorin, and irinotecan (FOLFIRINOX), were evaluated in an indirect comparison, yielding a statistically similar benefit in overall survival but superior progression-free survival for FOLFIRINOX. NAB-P + GEM showed greater economic benefit over FOLFIRINOX. In conclusion, the divergence in results observed across studies is attributable to economic drivers that are specific to countries and their healthcare (financing) systems. No recommendations regarding the relative economic benefit of treatment regimens, general or country-specific, are made as the purpose of pharmacoeconomic analysis is to inform policy decision-making and clinical practice, not set policy or define clinical practice.
• Gharaibeh, M., McBride, A., Bootman, J. L., Patel, H., & Abraham, I. (2017). Economic evaluation for the US of nab-paclitaxel plus gemcitabine versus FOLFIRINOX versus gemcitabine in the treatment of metastatic pancreas cancer. Journal of medical economics, 20(4), 345-352.
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  Nab-paclitaxel plus gemcitabine (NAB-P + GEM) and FOLFIRINOX have shown superior efficacy over gemcitabine (GEM) in the treatment of metastatic pancreatic ductal adenocarcinoma (mPDA). Although the incremental clinical benefits are modest, both treatments represent significant advances in the treatment of a high-mortality cancer. In this independent economic evaluation for the US, the aim was to estimate the comparative cost-utility and cost-effectiveness of these three regimens from the payer perspective.
• Jacob, J., Brié, H., Leys, A., Levecq, L., Mergaerts, F., Denhaerynck, K., Vancayzeele, S., Van Craeyveld, E., Abraham, I., & MacDonald, K. (2017). Six-year outcomes in neovascular age-related macular degeneration with ranibizumab. International journal of ophthalmology, 10(1), 81-90.
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  To evaluate the outcomes of ≥6y ranibizumab therapy in neovascular age-related macular degeneration (AMD).
• Jacob, J., Brié, H., Leys, A., Levecq, L., Mergaerts, F., Denhaerynck, K., Vancayzeele, S., van Craeyveld, E., Abraham, I., & Macdonald, K. (2017). Six-year outcomes in neovascular age-related macular degeneration with ranibizumab. International Journal of Ophthalmology, 10(Issue 1). doi:10.18240/ijo.2017.01.14
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  AIM: To evaluate the outcomes of ≥6y ranibizumab therapy in neovascular age-related macular degeneration (AMD). ● METHODS: HELIX was a retrospective, observational eff-eciveness study using medical records of patients treated in three clinics in Belgium. Patients had neovascular AMD and were initially treated with intravitreal ranibizumab (0.5 mg) between November 1, 2007 and October 31, 2008, had ≥6y of data available, and were treated on an ongoing, as-needed basis. Outcomes included best-corrected visual acuity (BCVA) and central retinal thickness (CRT). ● RESULTS: The sample consisted of 88 eyes from 69 patients. Mean age was 76.4±6.5y, most patients were female (62.3%). Most eyes (62.5%) were treatment-naive, 33 previously treated eyes had received predominantly other anti-vascular endothelial growth factor agents and verteporfin. Mean baseline BCVA was 57.4±12.7 ETDRS letters and CRT was 292±86 μm. On average, patients received 20.6±11.9 ranibizumab injections over the ≥6y. Intervals between injections were on average 12.7±16.1wk. Mean change in BCVA from baseline to last observation for the sample was less than one letter (-0.9±17.3 letters), with an average loss of -3.2±15.6 letters in previously treated eyes versus a gain of 0.6±18.4 letters in treatment-naïve eyes. When considering a loss of
• Katragadda, C., Finnane, A., Soyer, H. P., Marghoob, A. A., Halpern, A., Malvehy, J., Kittler, H., Hofmann-Wellenhof, R., Da Silva, D., Abraham, I., & Curiel-Lewandrowski, C. (2017). Technique Standards for Skin Lesion Imaging: A Delphi Consensus Statement. JAMA dermatology, 153, 207-213.
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  Variability in the metrics for image acquisition at the total body, regional, close-up, and dermoscopic levels impacts the quality and generalizability of skin images. Consensus guidelines are indicated to achieve universal imaging standards in dermatology.
• Katragadda, C., Finnane, A., Soyer, H. P., Marghoob, A. A., Halpern, A., Malvehy, J., Kittler, H., Hofmann-Wellenhof, R., Da Silva, D., Abraham, I., & Curiel-Lewandrowski, C. (2017). Technique standards for skin lesion imaging a delphi consensus statement. JAMA Dermatology, 153(Issue 2). doi:10.1001/jamadermatol.2016.3949
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  IMPORTANCE Variability in the metrics for image acquisition at the total body, regional, close-up, and dermoscopic levels impacts the quality and generalizability of skin images. Consensus guidelines are indicated to achieve universal imaging standards in dermatology. OBJECTIVE To achieve consensus among members of the International Skin Imaging Collaboration (ISIC) on standards for image acquisition metrics using a hybrid Delphi method. EVIDENCE REVIEW Delphi study with 5 rounds of ratings and revisions until relative consensus was achieved. The initial set of statements was developed by a core group (CG) on the basis of a literature review and clinical experience followed by 2 rounds of rating and revisions. The consensus process was validated by an extended group (EG) of ISIC members through 2 rounds of scoring and revisions. In all rounds, respondents rated the draft recommendations on a 1 (strongly agree) to 5 (strongly disagree) scale, explained ratings of less than 5, and optionally provided comments. At any stage, a recommendation was retained if both mean and median rating was 4 or higher. RESULTS The initial set of 45 items (round 1) was expanded by the CG to 56 variants in round 2, subsequently reduced to 42 items scored by the EG in round 3, yielding an EG set of 33 recommendations (rounds 4 and 5): General recommendation (1 guideline), lighting (5), background color (3), field of view (3), image orientation (8), focus/depth of field (3), resolution (4), scale (3), color calibration (2), and image storage (1). CONCLUSIONS AND RELEVANCE This iterative process of ratings and comments yielded a strong consensus on standards for skin imaging in dermatology practice. Adoption of these methods for image standardization is likely to improve clinical practice, information exchange, electronic health record documentation, harmonization of clinical studies and database development, and clinical decision support. Feasibility and validity testing under real-world clinical conditions is indicated.
• Kim, H. J., & Abraham, I. (2017). Measurement of fatigue: Comparison of the reliability and validity of single-item and short measures to a comprehensive measure. International Journal of Nursing Studies, 65(Issue). doi:10.1016/j.ijnurstu.2016.10.012
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  Background Evidence is needed on the clinicometric properties of single-item or short measures as alternatives to comprehensive measures. Objectives We examined whether two single-item fatigue measures (i.e., Likert scale, numeric rating scale) or a short fatigue measure were comparable to a comprehensive measure in reliability (i.e., internal consistency and test–retest reliability) and validity (i.e., convergent, concurrent, and predictive validity) in Korean young adults. Methods For this quantitative study, we selected the Functional Assessment of Chronic Illness Therapy–Fatigue for the comprehensive measure and the Profile of Mood States–Brief, Fatigue subscale for the short measure; and constructed two single-item measures. A total of 368 students from four nursing colleges in South Korea participated. We used Cronbach's alpha and item-total correlation for internal consistency reliability and intraclass correlation coefficient for test–retest reliability. We assessed Pearson's correlation with a comprehensive measure for convergent validity, with perceived stress level and sleep quality for concurrent validity and the receiver operating characteristic curve for predictive validity. Results The short measure was comparable to the comprehensive measure in internal consistency reliability (Cronbach's alpha = 0.81 vs. 0.88); test–retest reliability (intraclass correlation coefficient = 0.66 vs. 0.61); convergent validity (r with comprehensive measure = 0.79); concurrent validity (r with perceived stress = 0.55, r with sleep quality = 0.39) and predictive validity (area under curve = 0.88). Single-item measures were not comparable to the comprehensive measure. Conclusions A short fatigue measure exhibited similar levels of reliability and validity to the comprehensive measure in Korean young adults.
• Kim, H. J., & Abraham, I. (2017). Measurement of fatigue: Comparison of the reliability and validity of single-item and short measures to a comprehensive measure. International journal of nursing studies, 65, 35-43.
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  Evidence is needed on the clinicometric properties of single-item or short measures as alternatives to comprehensive measures.
• Macdonald, K., Aapro, M., Abraham, I., Boccadoro, M., Bokemeyer, C., Denhaerynck, K., Gascon, P., Krendyukov, A., Ludwig, H., & Macdonald, K. P. (2017). 522PProof-of-concept of a risk calculator of chemotherapy induced (febrile) neutropenia (CIN/FN) based on real-world evidence (Monitor-GCSF study). Annals of Oncology, 28, x161-x162. doi:10.1093/annonc/mdx676.021
• McBride, A., Balu, S., Campbell, K., Bikkina, M., MacDonald, K., & Abraham, I. (2017). Expanded access to cancer treatments from conversion to neutropenia prophylaxis with biosimilar filgrastim-sndz. Future oncology (London, England), 13(25), 2285-2295.
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  Biosimilar medicines offer significant cost-savings potential over their reference products, which can be re-allocated to provide access to other cancer treatments on a budget-neutral basis.
• McBride, A., Campbell, K., Bikkina, M., MacDonald, K., Abraham, I., & Balu, S. (2017). Cost-efficiency analyses for the US of biosimilar filgrastim-sndz, reference filgrastim, pegfilgrastim, and pegfilgrastim with on-body injector in the prophylaxis of chemotherapy-induced (febrile) neutropenia. Journal of Medical Economics, 20(Issue 10). doi:10.1080/13696998.2017.1358173
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  Aims: Guidelines recommend prophylaxis with granulocyte colony-stimulating factor for chemotherapy-induced (febrile) neutropenia (CIN/FN) based on regimen myelotoxicity and patient-related risk factors. The aim was to conduct a cost-efficiency analysis for the US of the direct acquisition and administration costs of the recently approved biosimilar filgrastim-sndz (Zarxio EP2006) with reference to filgrastim (Neupogen), pegfilgrastim (Neulasta), and a pegfilgrastim injection device (Neulasta Onpro; hereafter pegfilgrastim-injector) for CIN/FN prophylaxis. Methods: A cost-efficiency analysis of the prophylaxis of one patient during one chemotherapy cycle under 1–14 days’ time horizon was conducted using the unit dose average selling price (ASP) and Current Procedural Terminology (CPT) codes for subcutaneous prophylactic injection under four scenarios: cost of medication only (COSTMED), patient self-administration (SELFADMIN), healthcare provider (HCP) initiating administration followed by self-administration (HCPSTART), and HCP providing full administration (HCPALL). Two case studies were created to illustrate real-world clinical implications. The analyses were replicated using wholesale acquisition cost (WAC). Results: Using ASP + CPT, cost savings achieved with filgrastim-sndz relative to reference filgrastim ranged from $65 (1 day) to $916 (14 days) across all scenarios. Relative to pegfilgrastim, savings with filgrastim-sndz ranged from $834 (14 days) up to $3,666 (1 day) under the COSTMED, SELFADMIN, and HPOSTART scenarios; and from $284 (14 days) up to $3,666 (1 day) under the HPOALL scenario. Similar to the cost-savings compared to pegfilgrastim, filgrastim-sndz achieved savings relative to pegfilgrastim-injector: from $834 (14 days) to $3,666 (1 day) under the COSTMED scenario, from $859 (14 days) to $3,692 (1 day) under SELFADMIN, from $817 (14 days) to $3,649 (1 day) under HPOSTART, and from $267 (14 days) to $3,649 (1 day) under HPOALL. Cost savings of filgrastim-sndz using WAC + CPT were even greater under all scenarios. Conclusions: Prophylaxis with filgrastim-sndz, a biosimilar filgrastim, was associated consistently with significant cost-savings over prophylaxis with reference filgrastim, pegfilgrastim, and pegfilgrastim-injector, and this across various administration scenarios.
• McBride, A., Campbell, K., Bikkina, M., MacDonald, K., Abraham, I., & Balu, S. (2017). Cost-efficiency analyses for the US of biosimilar filgrastim-sndz, reference filgrastim, pegfilgrastim, and pegfilgrastim with on-body injector in the prophylaxis of chemotherapy-induced (febrile) neutropenia. Journal of medical economics, 20(10), 1083-1093.
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  Guidelines recommend prophylaxis with granulocyte colony-stimulating factor for chemotherapy-induced (febrile) neutropenia (CIN/FN) based on regimen myelotoxicity and patient-related risk factors. The aim was to conduct a cost-efficiency analysis for the US of the direct acquisition and administration costs of the recently approved biosimilar filgrastim-sndz (Zarxio EP2006) with reference to filgrastim (Neupogen), pegfilgrastim (Neulasta), and a pegfilgrastim injection device (Neulasta Onpro; hereafter pegfilgrastim-injector) for CIN/FN prophylaxis.
• Yun, S., Khoubyari, R., & Abraham, I. (2017). Potential benefit of low-dose candesartan in trastuzumab-induced cardiotoxic effects. JAMA Oncology, 3(Issue 2). doi:10.1001/jamaoncol.2016.3637
• Yun, S., Khoubyari, R., & Abraham, I. L. (2017). Potential benefit of low-dose candesartan in trastuzumab-induced cardiotoxicity.. JAMA Oncology, 3, 279-280.
• Yun, S., Vincelette, N. D., Acharya, U., & Abraham, I. (2017). Risk of Atrial Fibrillation and Bleeding Diathesis Associated With Ibrutinib Treatment: A Systematic Review and Pooled Analysis of Four Randomized Controlled Trials. Clinical Lymphoma, Myeloma and Leukemia, 17(Issue 1). doi:10.1016/j.clml.2016.09.010
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  The goal of the present study was to precisely assess the risk of atrial fibrillation/flutter (Afib/Aflutter) and bleeding associated with ibrutinib compared to other treatments. The risks of Afib/Aflutter and all-grade bleeding were significantly higher in the ibrutinib group. Background Clinical trials raised concern that ibrutinib may increase the risk of atrial fibrillation/flutter (Afib/Aflutter) and major bleeding. However, the association has not been statistically validated, and there is no consensus regarding optimal management of anticoagulation among patients receiving ibrutinib who develop Afib/Aflutter. We performed a systematic review and pooled analysis to precisely assess the risk of Afib/Aflutter and bleeding associated with ibrutinib treatment in patients with hematologic malignancies. Patients and Methods We searched PubMed, EMBASE, Cochrane Database, and meeting abstracts up to May 15, 2016, for randomized controlled trials comparing ibrutinib to chemotherapy, monoclonal antibody, or a combination. Primary outcomes were serious Afib/Aflutter and major bleeding. Secondary outcomes were all-grade Afib/Aflutter and bleeding. We calculated the Mantel-Haenszel risk ratio (RR) and estimated the effect of the treatments using a fixed-effects model. Results Ibrutinib treatment was associated with a significantly higher incidence of serious Afib/Aflutter (3.03% vs. 0.80%, RR = 3.80, 95% confidence interval [CI] = 1.56-9.29, P = .003), all-grade Afib/Aflutter (8.18% vs. 0.93%, RR = 8.81, 95% CI = 2.70-28.75, P = .0003), and all-grade bleeding (4.85% vs. 1.55%, RR = 2.93, 95% CI = 1.14-7.52, P = .03) compared to control treatments. The observed between-treatment difference in major bleeding rates was not statistically significant (3.69% vs. 2.13%, RR = 1.72, 95% CI = 0.95-3.11, P = .07). The risk of these adverse events was not different between subgroups on the basis of pathology, treatment setting, dose, and duration of ibrutinib exposure. Conclusion The risks of Afib/Aflutter and all-grade bleeding were significantly higher in the ibrutinib group. These results indicate the need for vigilant monitoring while the patient is receiving ibrutinib therapy, and careful assessment of the risks and benefits of anticoagulation is required.
• Yun, S., Vincelette, N. D., Acharya, U., & Abraham, I. (2017). Risk of Atrial Fibrillation and Bleeding Diathesis Associated With Ibrutinib Treatment: A Systematic Review and Pooled Analysis of Four Randomized Controlled Trials. Clinical lymphoma, myeloma & leukemia, 17(1), 31-37.e13.
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  Clinical trials raised concern that ibrutinib may increase the risk of atrial fibrillation/flutter (Afib/Aflutter) and major bleeding. However, the association has not been statistically validated, and there is no consensus regarding optimal management of anticoagulation among patients receiving ibrutinib who develop Afib/Aflutter. We performed a systematic review and pooled analysis to precisely assess the risk of Afib/Aflutter and bleeding associated with ibrutinib treatment in patients with hematologic malignancies.
• Zimmer, A., Coslovsky, M., Abraham, I., & Décard, B. F. (2017). Adherence to fingolimod in multiple sclerosis: An investigator-initiated, prospective, observational, Single-Center cohort study. Patient Preference and Adherence, 11(Issue). doi:10.2147/ppa.s140293
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  Objectives: Adherence to multiple sclerosis (MS) treatment is essential to optimize the likelihood of full treatment effect. This prospective, observational, single-center cohort study investigated adherence to fingolimod over the 2 years following treatment initiation. Two facets of adherence-implementation and persistence-were examined and compared between new and experienced users of disease-modifying treatments (DMTs). Materials and methods: Implementation rates were based on the proportion of days covered and calculated as percentages per half-yearly visits and over 2 years, captured through refill data, pill count, and self-report. Nonadherence was defined as taking less than 85.8% of prescribed pills. Implementation rates were classified as nonadherent (
• Zimmer, A., Coslovsky, M., Abraham, I., & Décard, B. F. (2017). Adherence to fingolimod in multiple sclerosis: an investigator-initiated, prospective, observational, single-center cohort study. Patient preference and adherence, 11, 1815-1830.
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  Adherence to multiple sclerosis (MS) treatment is essential to optimize the likelihood of full treatment effect. This prospective, observational, single-center cohort study investigated adherence to fingolimod over the 2 years following treatment initiation. Two facets of adherence - implementation and persistence - were examined and compared between new and experienced users of disease-modifying treatments (DMTs).
• Aapro, M., Ludwig, H., Bokemeyer, C., Gascón, P., Boccadoro, M., Denhaerynck, K., Krendyukov, A., Gorray, M., MacDonald, K., & Abraham, I. (2016). Predictive modeling of the outcomes of chemotherapy-induced (febrile) neutropenia prophylaxis with biosimilar filgrastim (MONITOR-GCSF study). Annals of oncology : official journal of the European Society for Medical Oncology, 27(11), 2039-2045.
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  Risk models of chemotherapy-induced (CIN) and febrile neutropenia (FN) have to date focused on determinants measured at the start of chemotherapy. We extended this static approach with a dynamic approach of CIN/FN risk modeling at the start of each cycle.
• Aapro, M., Ludwig, H., Bokemeyer, C., Gascón, P., Boccadoro, M., Denhaerynck, K., Krendyukov, A., Gorray, M., MacDonald, K., & Abraham, I. (2016). Predictive modeling of the outcomes of chemotherapyinduced (febrile) neutropenia prophylaxis with biosimilar filgrastim (MONITOR-GCSF study). Annals of Oncology, 27(Issue 11). doi:10.1093/annonc/mdw309
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  Background: Risk models of chemotherapy-induced (CIN) and febrile neutropenia (FN) have to date focused on determinants measured at the start of chemotherapy. We extended this static approach with a dynamic approach of CIN/FN risk modeling at the start of each cycle. Design: We applied predictive modeling using multivariate logistic regression to identify determinants of CIN/FN episodes and related hospitalizations and chemotherapy disturbances (CIN/FN consequences) in analyses at the patient ('ever' during the whole period of chemotherapy) and cycle-level (during a given chemotherapy cycle). Statistical dependence of cycle data being 'nested' under patients was managed using generalized estimation equations. Predictive performance of each model was evaluated using bootstrapped c concordance statistics. Results: Static patient-level risk models of 'ever' experiencing CIN/FN adverse events and consequences during a planned chemotherapy regimen included predictors related to history, risk factors, and prophylaxis initiation and intensity. Dynamic cycle-level risk models of experiencing CIN/FN adverse events and consequences in an upcoming cycle included predictors related to history, risk factors, and prophylaxis initiation and intensity; as well as prophylaxis duration, CIN/FN in prior cycle, and treatment center characteristics. Conclusion(s): These 'real-world evidence' models provide clinicians with the ability to anticipate CIN/FN adverse events and their consequences at the start of a chemotherapy line (static models); and, innovatively, to assess risk of CIN/ FN adverse events and their consequences at the start of each cycle (dynamic models). This enables individualized patient treatment and is consistent with the EORTC recommendation to re-appraise CIN/FN risk at the start of each cycle. Prophylaxis intensity (under-, correctly-, or over-prophylacted relative to current EORTC guidelines) is a major determinant. Under-prophylaxis is clinically unsafe. Over-prophylaxis of patients administered chemotherapy with intermediate or low myelotoxicity levels may be beneficial, both in patients with and without risk factors, and must be validated in future studies.
• Abraham, I. L. (2016). Economic evaluation for the US of nab-paclitaxel plus gemcitabine versus FOLFIRINOX versus gemcitabine in the treatment of metastatic pancreas cancer. Journal of Medical Economics, 20(4), 345-352. doi:10.1080/13696998.2016.1269015
• Abraham, I., Akcan, T., Akpinar, T. S., Amikishiyev, S., Anwer, F., Appelbaum, F. R., Augeul-meunier, K., Bakkaloglu, O. K., Baljevic, M., Balsat, M., Bay, J., Cabrespine, A., Chen, C., Chen, H., Cornillon, J., Coutre, S., Dou, L., Dumitriu, B., Fang, M., , Fenton, B., et al. (2016). Content Vol. 136, 2016. Acta Haematologica, 136(4), I-IV. doi:10.1159/000452874
• Abraham, I., Alberts, D. S., Erstad, B. L., Gharaibeh, M., Mcbride, A., & Slack, M. K. (2016). Economic Evaluation for the United Kingdom of Systemic Chemotherapies as First-Line Treatment for Metastatic Pancreatic Cancer. Value in Health, 19(7), A354. doi:10.1016/j.jval.2016.09.044
• Abraham, I., Alhossan, A., Alrabiah, Z., Macdonald, K., & Yun, S. (2016). Adherence to Tyrosine Kinase Inhibitor Therapy in Patients with Chronic Myeloid Leukemia: Meta-Analyses of Prevalence Rates By Measurement Method. Blood, 128(22), 3610-3610. doi:10.1182/blood.v128.22.3610.3610
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  Abstract Introduction: First- (imatinib) and second-generation (dasatinib, nilotinib) tyrosine kinase inhibitors are the standard of care in the management of chronic myeloid leukemia. Despite their high efficacy and the convenience of oral administration, studies have reported variation in patient medication behavior with non-adherence rates varying from low to moderate based on definition and measurement method. We conducted study-level meta-analyses stratified by measurement method to quantify adherence prevalence rates in chronic myeloid leukemia patients as reported in non-controlled "real-life" studies. Methods: We searched PubMed, Embase, and Cochrane Library for non-controlled studies reporting adherence or non-adherence rates to tyrosine kinase inhibitor treatment in chronic myeloid leukemia patients across various methods of measurement. For retained studies, adherence rates and 95% confidence interval (95% CI) were extracted or calculated; and grouped by method of measurement. Random-effects meta-analyses were performed to account for estimated (Q, I2, tau2) within and between study heterogeneity, and associated forest plots were generated. Analyses were done using Comprehensive Meta-Analysis V.3. Results: From 649 publications yielded by the search, 40 articles and abstracts were retained. Measurement methods included structured interview, medical/pharmacy chart review, medication possession ratio, proportion of days covered, electronic monitoring, and self-report. Electronic monitoring and self-report were used in one study each and thus excluded from meta-analysis. Table 1 summarizes, by the remaining four methods, the number of studies and patients included in each meta-analysis, the estimated adherence event rates with 95%CI, and heterogeneity indices. In random-effects analyses, adherence rate estimates as measured by each method ranged (in descending order) from 0.75 (95%CI=0.66-0.82) for structured interview, 0.68 (95%CI=0.54-0.79) for medical/pharmacy chart review, 0.57 (95%CI=0.47-0.67) for medication possession ratio, to 0.56 (95%CI=0.36-0.74) for proportion of days covered. All four analyses showed significant heterogeneity. Conclusion: Our meta-analyses using clinical data (structured interview; medical/pharmacy chart review) indicate that, while the majority of chronic myeloid leukemia patients are adherent to their tyrosine kinase inhibitor regimens, between 1/3rd and 1/4th of them are not. Indirect methods using prescription claims data (medication possession ratio; proportion of days covered) yielded lower adherence rates, though caution about such indirect results is warranted. Considering evidence linking adherence to impaired cytogenetic (Noens et al, Blood 2009) and molecular response (Marin et al, J Clin Oncol 2010), clinicians should integrate adherence assessment and enhancement into routine clinical practice. Table 1 Table 1. Disclosures MacDonald: Matrix45: Employment, Equity Ownership; Ex Ante International: Equity Ownership. Abraham:Matrix45: Equity Ownership; Belgamis: Equity Ownership; Ex Ante International: Equity Ownership.
• Abraham, I., Aljabri, A., Alshehri, S., Eljaaly, K., & Nix, D. E. (2016). Clinical Failure Rates With and Without Atypical Coverage in Hospitalized Adults With Community-Acquired Pneumonia: A Meta-analysis. Open Forum Infectious Diseases, 3(suppl_1). doi:10.1093/ofid/ofw172.941
• Abraham, I., Aljabri, A., Erstad, B. L., Gharaibeh, M., Huckleberry, Y., Karnes, J. H., Kutbi, H. I., Raz, Y., & Yun, S. (2016). Abstract 15582: Cost-effectiveness of Anticoagulants for the Management of Suspected Heparin-induced Thrombocytopenia in the US. Circulation, 134.
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  Introduction: Despite the availability of multiple non-heparin anticoagulants for the treatment of heparin-induced thrombocytopenia (HIT), little data are available comparing the cost effectiveness of these agents. This analysis is particularly important considering differences in risks of adverse effects, routes of administration, requirements for phlebotomy and laboratory monitoring, and overall drug costs. We conducted a cost-effectiveness analysis of argatroban, bivalirudin, and fondaparinux for the treatment of suspected HIT. Methods: A three-arm decision-tree model was developed that employs standard practices for anticoagulation monitoring. We incorporated published data on drug efficacy and probability of HIT-related thromboembolism and major bleeding. We considered both institutional costs and Average Wholesale Price (AWP) and performed probabilistic sensitivity analysis (PSA) to address any uncertainty in model parameters. Results: Using institutional costs, fondaparinux outperformed both argatroban and bivalirudin in terms of cost ($151 vs. $1,250 and $1,466, respectively) and adverse events averted (0.9989 vs. 0.9957 and 0.9947, respectively). Results were consistent when AWP was used, with fondaparinux being less expensive ($555 vs. $3,081 and $2,187, respectively) and more effective in terms of adverse events averted (0.9989 vs. 0.9957 and 0.9947, respectively). The PSA confirmed our findings using both institutional costs and AWP. Conclusions: Fondaparinux subcutaneous injection afforded significant advantages in terms of cost savings and adverse events averted compared to intravenous argatroban or bivalirudin infusions. Our data strongly suggest potential cost savings with fondaparinux and underscore the critical need for larger clinical studies of fondaparinux in the treatment of suspected HIT.
• Abraham, I., Bootman, J. L., Gharaibeh, M., Mcbride, A., & Patel, H. (2016). Optimized economic evaluation for the United States (US) of nab-paclitaxel plus gemcitabine (NAB-P+GEM), FOLFIRINOX (FFX), and gemcitabine (GEM) as first-line treatment for metastatic pancreatic cancer (mPDA).. Journal of Clinical Oncology, 34(15_suppl), 4113-4113. doi:10.1200/jco.2016.34.15_suppl.4113
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  4113Background: Per conference feedback we optimized our 2015 ASCO reported independent economic evaluation of GEM, NAB-P+GEM, and FFX in mPDA by improving survival curve fitting (exponential v. We...
• Abraham, I., Campen, C., Diri, R., & Mcbride, A. (2016). Evaluation of Efficacy and Safety of Direct Oral Anticoagulants (DOACS) in the Treatment of Venous Thromboembolism in Cancer Patients. Blood, 128(22), 5016-5016. doi:10.1182/blood.v128.22.5016.5016
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  Background: Nearly twenty percent of all patients with deep venous thrombosis (DVT) or pulmonary embolism (PE) have an underlying malignancy. Current guidelines recommend low molecular weight heparin (LMWH)-based therapy for venous thromboembolism (VTE) treatment in cancer patients; however, patient considerations including access for treatment and monitoring, co-pay costs and self-administration can be a limitation for its use. Alternative treatments such as direct oral anticoagulants (DOACs) are an attractive alternative to patients and clinicians because of limited monitoring, fixed dosing and limited drug and food interaction. Current guidelines, including those of the American Society of Clinical Oncology and National Comprehensive Cancer Network, do not recommend the use of DOACs for VTE treatment at this time in cancer patients as there is limited data for VTE treatment and secondary prophylaxis with DOAC9s. Methods:We performed a retrospective evaluation of cancer patients at our institution with an active VTE diagnosis who were administered DOACs (rivaroxaban, apixaban and dabigatran) between November 2013 and April 2016. Data collected included patient demographics, diagnosis, and chemotherapy regimen, previous history of VTE, and efficacy and safety during anticoagulation with DOAC9s. Results: One hundred and thirty-seven patients were included in the study (Table 1), with 112 patients on rivaroxaban, 20 patients on apixaban, and 5 patients on dabigatran. DOACs were administered to treat deep venous thrombosis (DVT) in 86 patients, pulmonary embolism (PE) in 31 patients, and both DVT and PE diagnosis in 20 patients. Only four patients had a secondary clot on therapy during treatment: one patient with pancreatic cancer on apixaban developed recurrent portal vein thrombosis, and three patients with pancreatic cancer, adenocarcinoma of the lung, and Factor V Leiden deficiency on rivaroxaban; 2 patients developed recurrent DVT, and 1 patient developed recurrent PE. Overall, 34/137 (25%) patients experienced a total of 37 bleeding episodes, of which 33/37 were classified as clinically relevant non-major bleeding and 4/37 as minor bleeding. Thirty eight patients had their doses held ,discontinued, discontinued or switched to different anticoagulation therapy; in 11 patients secondary to bleeding, four failed therapy, three experienced intolerance to DOAC, two patients were changed secondary to drug interactions and two patients could not continue therapy secondary to co-pay costs, and two were held prior to surgery. Ten patients had recurrent (>2) bleeding episodes including epistaxis, hematochezia, hematuria, and hematemesis. Conclusion:In our analysis, DOACs did yield efficacy in cancer patients treated for secondary prophylaxis of VTE with few noted side effects. In our study, DOAC9s did not cause fatal or major bleeding. Future prospective studies are warranted for secondary prophylaxis in this setting. Table 1. Baseline characteristics and outcomes of patients on DOAC9s for Secondary DVT prophylaxis Disclosures McBride:Sanofi: Research Funding.
• Abraham, I., Canais, L., Larriva, M., McBride, A., Diri, R., & MacDonald, K. (2016). What does it take to provide cancer patients with comprehensive medication therapy management services for oral chemotherapy?. Expert opinion on drug safety, 15(4), 413-5.
• Abraham, I., Canais, L., Larriva, M., McBride, A., Diri, R., & Macdonald, K. (2016). What does it take to provide cancer patients with comprehensive medication therapy management services for oral chemotherapy?. Expert Opinion on Drug Safety, 15(Issue 4). doi:10.1517/14740338.2016.1158249
• Abraham, I., McBride, A., & MacDonald, K. (2016). Arguing (About) the Value of Cancer Care. Journal of the National Comprehensive Cancer Network : JNCCN, 14(11), 1487-1489.
• Abraham, I., McBride, A., & MacDonald, K. (2016). Arguing (About) the value of cancer care. JNCCN Journal of the National Comprehensive Cancer Network, 14(Issue 11). doi:10.6004/jnccn.2016.0155
• Aljabri, A., Huckleberry, Y., Karnes, J. H., Gharaibeh, M., Kutbi, H. I., Raz, Y., Yun, S., Abraham, I., & Erstad, B. (2016). Cost-effectiveness of anticoagulants for suspected heparin-induced thrombocytopenia in the United States. Blood, 128(26), 3043-3051.
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  Despite the availability of multiple nonheparin anticoagulants for the treatment of heparin-induced thrombocytopenia (HIT), few data are available comparing the cost-effectiveness of these agents. This analysis is particularly important when considering differences in the risk of adverse effects, routes of administration, requirements for phlebotomy and laboratory monitoring, and overall drug costs. We conducted a cost-effectiveness analysis of argatroban, bivalirudin, and fondaparinux for the treatment of suspected HIT from the institutional perspective. A 3-arm decision-tree model was developed that employs standard practices for anticoagulation monitoring. We incorporated published data on drug efficacy and probability of HIT-related thromboembolism and major bleeding. We considered both institutional costs and average wholesale price (AWP) and performed probabilistic sensitivity analyses (PSA) to address any uncertainty in model parameters. Using institutional costs, fondaparinux prevailed over both argatroban and bivalirudin in terms of cost ($151 vs $1250 and $1466, respectively) and adverse events averted (0.9989 vs 0.9957 and 0.9947, respectively). Results were consistent when AWP was used, with fondaparinux being less expensive ($555 vs $3081 and $2187, respectively) and more effective in terms of adverse events averted (0.9989 vs 0.9957 and 0.9947, respectively). The PSA confirmed our findings using both institutional costs and AWP. In conclusion, fondaparinux subcutaneous injection afforded significant advantages in terms of cost savings and adverse events averted compared with IV argatroban or bivalirudin infusions. Our data strongly suggest potential cost savings with fondaparinux and underscore the critical need for larger clinical studies of fondaparinux in the treatment of suspected HIT.
• Aljabri, A., Huckleberry, Y., Karnes, J. H., Gharaibeh, M., Kutbi, H. I., Raz, Y., Yun, S., Abraham, I., & Erstad, B. (2016). Cost-effectiveness of anticoagulants for suspected heparin-induced thrombocytopenia in the United States. Blood, 128(Issue 26). doi:10.1182/blood-2016-07-728030
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  Despite the availability of multiple nonheparin anticoagulants for the treatment of heparin-induced thrombocytopenia (HIT), few data are available comparing the cost-effectiveness of these agents. This analysis is particularly important when considering differences in the risk of adverse effects, routes of administration, requirements for phlebotomy and laboratory monitoring, and overall drug costs. We conducted a cost-effectiveness analysis of argatroban, bivalirudin, and fondaparinux for the treatment of suspected HIT from the institutional perspective. A 3-arm decision-tree model was developed that employs standard practices for anticoagulation monitoring. We incorporated published data on drug efficacy and probability of HIT-related thromboembolism and major bleeding. We considered both institutional costs and average wholesale price (AWP) and performed probabilistic sensitivity analyses (PSA) to address any uncertainty in model parameters. Using institutional costs, fondaparinux prevailed over both argatroban and bivalirudin in terms of cost ($151 vs $1250 and $1466, respectively) and adverse events averted (0.9989 vs 0.9957 and 0.9947, respectively). Results were consistent when AWP was used, with fondaparinux being less expensive ($555 vs $3081 and $2187, respectively) and more effective in terms of adverse events averted (0.9989 vs 0.9957 and 0.9947, respectively). The PSA confirmed our findings using both institutional costs and AWP. In conclusion, fondaparinux subcutaneous injection afforded significant advantages in terms of cost savings and adverse events averted compared with IV argatroban or bivalirudin infusions. Our data strongly suggest potential cost savings with fondaparinux and underscore the critical need for larger clinical studies of fondaparinux in the treatment of suspected HIT.
• Cranmer, L. D., Abraham, I., & Tate, W. R. (2016). Accuracy of a model to predict cancer trial accrual compared to prediction accuracy by investigators at sixteen cancer centers.. Journal of Clinical Oncology, 34(15_suppl), 6525-6525. doi:10.1200/jco.2016.34.15_suppl.6525
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  6525Background: Multiple studies underscore poor clinical trial accrual, leading to increased costs, longer enrollment periods, and incomplete trials. We previously reported single center developme...
• Fulmer, T., Mezey, M., Bottrell, M., Abraham, I., Sazant, J., Grossman, S., & Grisham, E. (2002). Nurses Improving Care for Healthsystem Elders (NICHE): using outcomes and benchmarks for evidenced-based practice. Geriatric nursing (New York, N.Y.), 23(3), 121-7.
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  This article describes Nurses Improving Care for Healthsystem Elders (NICHE), a project begun in 1992 with four pilot hospitals. These pilot hospitals gathered baseline data using a geriatric institutional assessment profile (GIAP) with a pre- and postdesign to capture changes in staff attitudes, knowledge, and perceptions of the care of older adults. Based on the success of the pilot effort, NICHE, now in its eighth year, has evolved into a program that involves 32 health systems comprising 105 hospitals nationally. To date, more than 10,000 GIAPs have been collected by NICHE hospital staff. All NICHE settings are able to benchmark their GIAP data against comparable institutions (eg, urban, rural, university, community settings) to understand how they compare and then interpret the data at their unique sites. The opportunities for continuous quality improvement through the NICHE program are described.
• Gascón, P., Aapro, M., Ludwig, H., Bokemeyer, C., Boccadoro, M., Turner, M., Denhaerynck, K., MacDonald, K., & Abraham, I. (2016). Erratum to: Treatment patterns and outcomes in the prophylaxis of chemotherapy-induced (febrile) neutropenia with biosimilar filgrastim (the MONITOR-GCSF study) (Support Care Cancer, (2016), 10.1007/s00520-015-2861-z). Supportive Care in Cancer, 24(Issue 2). doi:10.1007/s00520-015-2991-3
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  Purpose: The purpose of this study is to examine the real-world treatment patterns and outcomes of chemotherapy-induced (febrile) neutropenia (chemotherapy-induced (CIN)/febrile neutropenia (FN)) prophylaxis with biosimilar filgrastim (Zarzio®). Methods: MONITOR-GCSF is an international (12 countries), multi-center (140), prospective (max. six cycles), observational, open-label, pharmaco-epidemiologic study of cancer patients (n = 1447) treated with myelosuppressive chemotherapy across a total of 6,213 cycles and receiving prophylaxis with Zarzio®. Data were analyzed using both the patient and cycle as unit of analysis. Results: Most (72.3 %) received primary prophylaxis; dosed mainly (53.2 %) at 30 MIU but differentiated by weight, chemotoxicity, and tumor type; and mainly (53.2 %) initiated in the 24–72h post-chemotherapy window but differentiated by prophylaxis type, tumor type, and chemotoxicity and for modal/median duration of 5 days. Relative to European Organisation for Research and Treatment of Cancer (EORTC) guidelines, 56.6 % were correctly prophylacted, 17.4 % under-prophylacted, and 26.0 % over-prophylacted. The following incidence rates were recorded: CIN grade 4 13.2 % of patients and 3.9 % of cycles, FN 5.9 % of patients and 1.4 % of cycles, CIN/FN-related hospitalizations 6.1 % of patients and 1.5 % of cycles, CIN/FN-related chemotherapy disturbances 9.5 % of patients and 2.8 % of cycles, and composite outcomes index 22.3 % of patients and 6.7 % of cycles. Rates varied by type of prophylaxis and tumor, chemotoxicity, initiation day, and prophylaxis duration. There were 1834 musculoskeletal events with 24.7 % of patients reporting bone pain of any grade (mostly mild to moderate), and 148 adverse drug reactions, including 4 serious, were recorded in 76 patients. Conclusions: The clinical and safety outcomes are well within the range of historically reported data for originator filgrastim underscoring the clinical effectiveness and safety of biosimilar filgrastim in daily clinical practice.
• Gascón, P., Aapro, M., Ludwig, H., Bokemeyer, C., Boccadoro, M., Turner, M., Denhaerynck, K., MacDonald, K., & Abraham, I. (2016). Treatment patterns and outcomes in the prophylaxis of chemotherapy-induced (febrile) neutropenia with biosimilar filgrastim (the MONITOR-GCSF study). Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 24(2), 911-25.
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  The purpose of this study is to examine the real-world treatment patterns and outcomes of chemotherapy-induced (febrile) neutropenia (chemotherapy-induced (CIN)/febrile neutropenia (FN)) prophylaxis with biosimilar filgrastim (Zarzio®).
• Hermans, M., Van Gaal, L., Rézette, I., Daci, E., MacDonald, K., Denhaerynck, K., Vancayzeele, S., De Meester, L., Clemens, A., Yee, B., & Abraham, I. (2016). Patient engagement impacts glycemic management with vildagliptin and vildagliptin/metformin (single pill) regimens in type 2 diabetes mellitus (the GLORIOUS study). Primary Care Diabetes, 10(Issue 6). doi:10.1016/j.pcd.2016.05.008
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  Aims To evaluate the real-world effectiveness of vildagliptin and vildagliptin/metformin, combined with patient engagement, on glycemic outcomes. Patient engagement included both clinicians’ engaging patients through education and counseling; and patients’ self-engagement through disease awareness, lifestyle changes, and medication adherence. Methods Prospective, observational, open-label, multi-center, pharmacoepidemiologic study of type 2 diabetes mellitus (T2DM) patients treated de novo with vildagliptin or vildagliptin/metformin. Data were collected at baseline (treatment initiation), 105 ± 15 d, and ≥145 d. Results The evaluable sample included 896 mainly male (58%), overweight (mean ± SD BMI = 30.3 ± 5.4 kg/m2), in later middle age (mean ± SD age = 64 ± 11years) patients. Over the three visits, mean(±SD) HbA1c levels declined from 8.1%(±1.0) to 7.3%(±1.0) to 7.2%(±0.9); HbA1c control rates rose from 7% to 36% to 43%. Mean ± SD FPG levels decreased from 170(±49) to 141(±41) to 139(±42) mg/dL; control rates increased from 12% to 39% to 43% (all p < 0.0001). Weight decreased nominally by 2 kg (p = 0.0290) and BMI by 0.8 kg/m2 (p < 0.0001). Modeling showed patient engagement activities by clinicians and by patients to be major determinants of glycemic outcomes. No unknown safety signals were detected. Conclusions Vildagliptin and vildagliptin/metformin are effective and safe oral agents in the management of T2DM, especially if part of a treatment program with active patient engagement by clinicians and empowered patients.
• Hermans, M., Van Gaal, L., Rézette, I., Daci, E., MacDonald, K., Denhaerynck, K., Vancayzeele, S., De Meester, L., Clemens, A., Yee, B., & Abraham, I. (2016). Patient engagement impacts glycemic management with vildagliptin and vildagliptin/metformin (single pill) regimens in type 2 diabetes mellitus (the GLORIOUS study). Primary care diabetes, 10(6), 425-433.
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  To evaluate the real-world effectiveness of vildagliptin and vildagliptin/metformin, combined with patient engagement, on glycemic outcomes. Patient engagement included both clinicians' engaging patients through education and counseling; and patients' self-engagement through disease awareness, lifestyle changes, and medication adherence.
• Hurwitz, J. T., Grizzle, A. J., Augustine, J., Rehfeld, R., Wild, A., & Abraham, I. (2016). Accepting Medication Therapy Management Recommendations to Add ACEIs or ARBs in Diabetes Care. Journal of managed care & specialty pharmacy, 22(1), 40-8.
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  National guidelines and initiatives have promoted the use of angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) for patients with diabetes. The University of Arizona Medication Management Center (UA-MMC) is contracted by Medicare health plans, pharmacy benefit managers (PBMs), and multiple commercial health insurance plans to provide medication therapy management (MTM) services for plan members. As part of the MTM program, recommendations have been made for those patients who may benefit from the addition of an ACEI/ARB. Although the intervention benefits and guidelines for using ACEIs/ARBs are clear, real-world evidence is needed to understand and potentially increase uptake of guideline interventions among eligible patients.
• Hurwitz, J. T., Hurwitz, J. T., Grizzle, A. J., Grizzle, A. J., Augustine, J., Augustine, J., Rehfeld, R., Rehfeld, R., Wild, A., Wild, A., Abraham, I., & Abraham, I. (2016). Accepting medication therapy management recommendations to add ACEIs or ARBs in diabetes care. Journal of Managed Care and Specialty Pharmacy, 22(Issue 1). doi:10.18553/jmcp.2016.22.1.40
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  BACKGROUND: National guidelines and initiatives have promoted the use of angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) for patients with diabetes. The University of Arizona Medication Management Center (UA-MMC) is contracted by Medicare health plans, pharmacy benefit managers (PBMs), and multiple commercial health insurance plans to provide medication therapy management (MTM) services for plan members. As part of the MTM program, recommendations have been made for those patients who may benefit from the addition of an ACEI/ ARB. Although the intervention benefits and guidelines for using ACEIs/ ARBs are clear, real-world evidence is needed to understand and potentially increase uptake of guideline interventions among eligible patients. OBJECTIVES: To (a) identify patient characteristics that predict acceptance of guideline recommendations to add ACEI/ARB medications to diabetic treatment via MTM services and (b) examine how well different case characteristics (i.e., patient age and sex, type and number of recommendation attempts, type of health care plan) predict the odds of adding ACEI/ARB medications to diabetic regimens when recommended through an MTM call center. METHODS: This was a retrospective analysis of secondary data provided by the UA-MMC. The de-identified national data included adult plan members with diabetes who the UA-MMC recommended adding an ACEI/ARB prescription based on 2012 national guidelines. The UA-MMC made recommendations by either patient letters, patient phone calls, physician faxes, or any combination thereof. We conducted a binary logistic regression analysis to assess the impact of case characteristics on the likelihood of accepting recommendations to add ACEI/ARB medications. The outcome variable was recommendation acceptance (yes/no), defined as new prescription claims for an ACEI/ARB within 120 days following the recommendation. Five predictor variables were assessed: (1) patient's age quartile; (2) method of communicating recommendations (letter, phone call, fax, or some combination thereof); (3) whether recommendations were made once or twice on separate dates; (4) patient's sex; and (5) type of health care plan. RESULTS: Recommendations were made for 31,495 members of health plans or PBMs that contracted with the UA-MMC. Patients' ages ranged from 19-90 (Mean = 72.01; SD = 10.21), with females comprising 56[%] of the sample. The recommendation to add ACEI/ARB medications was accepted for 14.5[%] (4,559) of patients. In most cases (73[%]), recommendations occurred via a letter to patients together with a fax to their providers. The fitted model, containing 3 predictor variables (age quartile, type of contact to communicate the recommendations, and whether recommendation contacts were made twice), was statistically significant, ?2(10; N = 31,495) = 112.82 (P < 0.001), indicating that the model was able to distinguish between those who did and did not accept UA-MMC's recommendations to add ACEI/ARB medications. The likelihood of recommendation acceptance decreased as patient age increased compared with patients in the first age quartile (ages 19-67; P = 0.005 at all levels). Compared with sending only a provider fax, patients who received all 3 types of contact (provider fax with patient phone call and letter) were estimated to be 1.34 times more likely (34[%] increase) to have recommendation acceptance (P = 0.004; 95[%] CI = 1.10-1.63). Similarly, patients who received only letters were also 1.32 times more likely (32[%] increase) than provider faxes alone to result in recommendation acceptance (P = 0.003; 95[%] CI = 1.10-1.59). Patients for whom recommendations were made twice were less likely to have recommendation acceptance than for those contacted once, controlling for all other predictor variables in the model (P < 0.001; OR = 0.77; 95[%] CI = 0.69-0.86). CONCLUSIONS: Recommendations to add an ACEI/ARB to diabetic regimens are more likely to be accepted for younger patients and those who receive recommendations through all 3 communication types (provider fax combined with patient phone call and letter) or just letters than provider faxes alone. Further research is needed to understand why prescribers are not accepting MTM recommendations.
• Krishnadasan, R., Abraham, I., Campen, C., Chalasani, P., Diri, R., & Mcbride, A. (2016). Evaluation of Direct Oral Anticoagulants in the Treatment of Venous Thromboembolism for Inherited Thrombophilia Disorders. Blood, 128(22), 5007-5007. doi:10.1182/blood.v128.22.5007.5007
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  Background Venous thromboembolism can be classified according to the presence of either environmental or genetic risk factors. Risk factors for thrombosis can include activated protein C resistance, and heritable including deficiencies of antithrombin, protein C or protein S. Factor V Leiden deficiency and prothrombin gene mutations are some of the more common thrombophilias, with a slight increased risk for venous thromboembolism (VTE). Current guidelines suggest the use of low-molecular weight heparins for secondary prophylaxis in patients with VTE. However, there is a lack of data on the use of Direct Oral Anticoagulant (DOACs) in patients with inherited thrombophilia. We evaluated our use of rivaroxaban in patients with thrombophilia disorders treated for secondary DVT prophylaxis. Method We performed a retrospective evaluation of patients in our institution with inherited thrombophilia with an active VTE diagnosis who received DOACs for secondary prophylaxis from November 2013 until April 2016. Data collected included patient demographics, inherited thrombophilia mutation, previous history of VTE, prior treatments, and efficacy and safety of anticoagulation with DOACs. Results We had 13 patients with inherited thrombophilia mutation and 4 patients diagnosed with concomitant cancer (non-Hodgkin lymphoma, melanoma, and 2 with breast cancer) (Table 1). Out of 13 patients 3 failed warfarin, and one failed fondaparinux prior to switching to a DOAC. Mutation with heterozygous Factor V Leiden deficiency was reported in 7 patients, while mutations with Protein C and/or S deficiency were found in 4 patients. One patient had both Factor V Leiden and Protein C deficiency mutations. The prothrombin gene mutation was identified in one patient. The median of length of therapy was 2 years with 8/13 still on rivaroxaban in April 2016. The shortest treatment duration was 41 days for a patient who failed rivaroxaban with a second clot and was switched to apixaban without subsequent treatment failure. Two patients experienced 4 non-major episodes of gastrointestinal bleeding, nose bleeding and dark stool. One patient developed rash with noted bruising during their rivaroxaban therapy. Conclusion: This is the first report on outcomes for secondary DVT prophylaxis with DOACs in patients with underlying thrombophilia mutations. Safety and efficacy of DOACs for secondary VTE prophylaxis yielded favorable results; however, future prospective studies in the setting of thrombophilia are warranted. Disclosures McBride:Sanofi: Research Funding.
• Taverna, J. A., Yun, S., Jonnadula, J., Saleh, A., Riaz, I. B., Abraham, I., Yeager, A. M., Persky, D. O., McBride, A., Haldar, S., & Anwer, F. (2016). Role of Maintenance Therapy after High-Dose Chemotherapy and Autologous Hematopoietic Cell Transplantation in Aggressive Lymphomas: A Systematic Review. Biology of Blood and Marrow Transplantation, 22(Issue 7). doi:10.1016/j.bbmt.2016.02.007
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  Significant uncertainty exists in regard to the efficacy of maintenance therapy after high-dose chemotherapy (HDC) as well as autologous stem cell transplantation (ASCT) for the treatment of patients with aggressive lymphoma. A systematic review was performed to evaluate the effectiveness of post-ASCT maintenance therapy in patients with relapsed/refractory lymphoma. A comprehensive literature search yielded 4476 studies and a total of 42 studies (11 randomized controlled trials [RCT], 9 retrospective comparative studies, and 22 single-arm studies) were included in the systematic review. There was significant heterogeneity in study design, chemotherapeutic regimens, post-ASCT maintenance strategies, patient enrollment criteria, and study endpoints. Our findings suggest that post-ASCT maintenance immune-targeting strategies, including PD-1/PD-L1 blocking antibodies, rituximab, and brentuximab, may improve progression-free survival but not overall survival. Collectively, the results indicate a need for testing new strategies with well-designed and adequately powered RCTs to better address the role of post-ASCT maintenance in relapsed/refractory lymphomas.
• Taverna, J. A., Yun, S., Jonnadula, J., Saleh, A., Riaz, I. B., Abraham, I., Yeager, A. M., Persky, D. O., McBride, A., Haldar, S., & Anwer, F. (2016). Role of Maintenance Therapy after High-Dose Chemotherapy and Autologous Hematopoietic Cell Transplantation in Aggressive Lymphomas: A Systematic Review. Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation, 22(7), 1182-1196.
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  Significant uncertainty exists in regard to the efficacy of maintenance therapy after high-dose chemotherapy (HDC) as well as autologous stem cell transplantation (ASCT) for the treatment of patients with aggressive lymphoma. A systematic review was performed to evaluate the effectiveness of post-ASCT maintenance therapy in patients with relapsed/refractory lymphoma. A comprehensive literature search yielded 4476 studies and a total of 42 studies (11 randomized controlled trials [RCT], 9 retrospective comparative studies, and 22 single-arm studies) were included in the systematic review. There was significant heterogeneity in study design, chemotherapeutic regimens, post-ASCT maintenance strategies, patient enrollment criteria, and study endpoints. Our findings suggest that post-ASCT maintenance immune-targeting strategies, including PD-1/PD-L1 blocking antibodies, rituximab, and brentuximab, may improve progression-free survival but not overall survival. Collectively, the results indicate a need for testing new strategies with well-designed and adequately powered RCTs to better address the role of post-ASCT maintenance in relapsed/refractory lymphomas.
• Yun, S., Khoubyari, R., & Abraham, I. (2016). Potential Benefit of Low-Dose Candesartan in Trastuzumab-Induced Cardiotoxic Effects. JAMA oncology.
• Yun, S., Vincelette, N. D., & Abraham, I. (2016). Multiple Causes of Cardiotoxic Effects in Patients With Chronic Myeloid Leukemia. JAMA oncology, 2(6), 828-9.
• Yun, S., Vincelette, N. D., & Abraham, I. (2016). Multiple causes of cardiotoxic effects in patients with chronic myeloid leukemia. JAMA Oncology, 2(Issue 6). doi:10.1001/jamaoncol.2016.1005
• Yun, S., Vincelette, N. D., Abraham, I., Puvvada, S., & Anwer, F. (2016). Outcome Comparison of Allogeneic versus Autologous Stem Cell Transplantation in Transformed Low-Grade Lymphoid Malignancies: A Systematic Review and Pooled Analysis of Comparative Studies. Acta haematologica, 136(4), 244-255.
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  Some patients with low-grade lymphoid malignancies develop transformed disease, requiring stem cell transplantation (SCT). SCT outcomes in transformed low-grade lymphoid malignancies may differ from those of nontransformed disease or other aggressive non-Hodgkin lymphomas. We conducted a pooled analysis of the clinical outcomes of allogeneic versus high-dose therapy (HDT) with autologous SCT in adult patients with transformed low-grade lymphoid malignancies.
• Yun, S., Vincelette, N. D., Abraham, I., Puvvada, S., & Anwer, F. (2016). Outcome comparison of allogeneic versus autologous stem cell transplantation in transformed low-grade lymphoid malignancies: A systematic review and pooled analysis of comparative studies. Acta Haematologica, 136(Issue 4). doi:10.1159/000449031
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  Background: Some patients with low-grade lymphoid malignancies develop transformed disease, requiring stem cell transplantation (SCT). SCT outcomes in transformed low-grade lymphoid malignancies may differ from those of nontransformed disease or other aggressive non-Hodgkin lymphomas. We conducted a pooled analysis of the clinical outcomes of allogeneic versus high-dose therapy (HDT) with autologous SCT in adult patients with transformed low-grade lymphoid malignancies. Methods: A PubMed, EMBASE, and Cochrane search yielded 4 comparative studies reporting allogeneic versus HDT with autologous SCT outcomes in adults (age ≥18) with transformed low-grade lymphoid malignancies, including follicular, chronic/small lymphocytic, and marginal zone lymphoma. Risk ratio (RR) and 95% CI were calculated using random-effects models. Results: Rates for overall survival (OS) were 51.0 versus 69.5% (RR = 1.55, 95% CI 1.19-2.02, p = 0.001), rates of relapse were 37.3 versus 35.3% (RR = 1.04, 95% CI 0.70-1.55, p = 0.84), and rates of transplant-related mortality (TRM) were 33.3 versus 7.2% (RR = 4.52, 95% CI 2.75-7.43, p < 0.00001) for allogeneic versus autologous SCT. Previous rituximab treatment, reduced intensity conditioning regimen prior to SCT, or original pathology had no prognostic impact. Conclusion: HDT followed by autologous SCT was associated with lower TRM and a better OS, but there was no difference in relapse versus allogeneic SCT. Autologous SCT may be the better therapeutic option, considering the second chance of allogeneic SCT in the case of relapse.
• Yun, S., Vincelette, N. D., Abraham, I., Robertson, K. D., Fernandez-Zapico, M. E., & Patnaik, M. M. (2016). Targeting epigenetic pathways in acute myeloid leukemia and myelodysplastic syndrome: a systematic review of hypomethylating agents trials. Clinical epigenetics, 8, 68.
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  Aberrant DNA methylation has been identified as a key molecular event regulating the pathogenesis of myelodysplastic syndromes (MDS); myeloid neoplasms with an inherent risk of transformation to acute myeloid leukemia (AML). Based on the above findings, DNA hypomethylating agents (HMA) have been widely used to treat AML and MDS, especially in elderly patients and in those who are not eligible for allogeneic stem cell transplantation (SCT). Our goal was to determine if there is any therapeutic advantage of HMA vs. conventional care regimens (CCR) and indirectly compare the efficacy of azacitidine and decitabine in this patient population.
• Yun, S., Vincelette, N. D., Green, M. R., Wahner Hendrickson, A. E., & Abraham, I. (2016). Targeting immune checkpoints in unresectable metastatic cutaneous melanoma: a systematic review and meta-analysis of anti-CTLA-4 and anti-PD-1 agents trials. Cancer Medicine, 5(Issue 7). doi:10.1002/cam4.732
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  Anti-cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) and anti-programmed cell death-1 (PD-1) inhibitors have been shown to significantly improve survival in patients with metastatic cutaneous melanoma. However, there was some heterogeneity as well as some variation in the degree of benefit across studies. We reviewed randomized trials and performed a meta-analysis to determine the efficacy and safety of immune checkpoint inhibitors in comparison with conventional regimens. Eligible studies were limited to randomized controlled trials comparing anti-CTLA-4 or anti-PD-1 inhibitors to chemotherapy or vaccination treatment in adult patients with unresectable cutaneous metastatic melanoma. Progression-free survival (PFS) rate at 6 months was 28.5% versus 17.7% (RR: 0.84, 95% CI: 0.76–0.93), overall survival (OS) rate at 1 year was 51.2% versus 38.8% (RR: 0.72, 95% CI: 0.59–0.88), and overall response rate (ORR) at 6 months was 29.6% versus 17.7% (RR: 0.85, 95% CI: 0.76–0.95) favoring immune check point inhibitors over chemotherapies or vaccination. Immune check point inhibitors were associated with more frequent immune-related adverse events at 13.7% versus 2.4% of treated patients (RR: 6.74, 95% CI: 4.65–9.75). Subgroup analyses demonstrated significant PFS (RR: 0.92 vs. 0.74, P < 0.00001) and ORR (RR: 0.95 vs. 0.76, P = 0.0004) improvement with anti-PD-1 treatment compared to anti-CTLA-4 when each of them was compared to control treatments. Collectively, these results demonstrate that immune checkpoint inhibitors have superior outcomes compared to conventional chemotherapies or vaccination, and support the results of recent randomized trials that showed superior outcomes with anti-PD-1 agents over ipilimumab in unresectable metastatic cutaneous melanoma patients.
• Yun, S., Vincelette, N. D., Green, M. R., Wahner Hendrickson, A. E., & Abraham, I. (2016). Targeting immune checkpoints in unresectable metastatic cutaneous melanoma: a systematic review and meta-analysis of anti-CTLA-4 and anti-PD-1 agents trials. Cancer medicine, 5(7), 1481-91.
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  Anti-cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) and anti-programmed cell death-1 (PD-1) inhibitors have been shown to significantly improve survival in patients with metastatic cutaneous melanoma. However, there was some heterogeneity as well as some variation in the degree of benefit across studies. We reviewed randomized trials and performed a meta-analysis to determine the efficacy and safety of immune checkpoint inhibitors in comparison with conventional regimens. Eligible studies were limited to randomized controlled trials comparing anti-CTLA-4 or anti-PD-1 inhibitors to chemotherapy or vaccination treatment in adult patients with unresectable cutaneous metastatic melanoma. Progression-free survival (PFS) rate at 6 months was 28.5% versus 17.7% (RR: 0.84, 95% CI: 0.76-0.93), overall survival (OS) rate at 1 year was 51.2% versus 38.8% (RR: 0.72, 95% CI: 0.59-0.88), and overall response rate (ORR) at 6 months was 29.6% versus 17.7% (RR: 0.85, 95% CI: 0.76-0.95) favoring immune check point inhibitors over chemotherapies or vaccination. Immune check point inhibitors were associated with more frequent immune-related adverse events at 13.7% versus 2.4% of treated patients (RR: 6.74, 95% CI: 4.65-9.75). Subgroup analyses demonstrated significant PFS (RR: 0.92 vs. 0.74, P 
• Yun, S., Vincelette, N. D., Segar, J. M., Dong, Y., Shen, Y., Kim, D. W., & Abraham, I. (2016). Comparative Effectiveness of Newer Tyrosine Kinase Inhibitors Versus Imatinib in the First-Line Treatment of Chronic-Phase Chronic Myeloid Leukemia Across Risk Groups: A Systematic Review and Meta-Analysis of Eight Randomized Trials. Clinical Lymphoma, Myeloma and Leukemia, 16(Issue 6). doi:10.1016/j.clml.2016.03.003
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  Background BCR-ABL1 tyrosine kinase inhibitors (TKIs) have significantly improved the survival outcomes for patients with chronic myeloid leukemia (CML). In addition to imatinib, 3 newer generation TKIs (NG-TKIs) have been approved as first-line treatment of chronic phase (CP)-CML. These have been preferably used in patients with CP-CML with a high Sokal or Hasford risk score. We performed a systematic review and meta-analysis to compare the outcomes with NG-TKIs as a category versus imatinib in patients with newly diagnosed CP-CML and to indirectly compare the efficacy of NG-TKIs among each other. Furthermore, we assessed the effect of the risk scores on the complete cytogenetic response (CCyR) and major molecular response (MMR). Materials and Methods The eligible studies were limited to randomized controlled trials comparing the efficacy of first-line treatment using NG-TKIs versus imatinib in adult patients (aged ≥ 18 years) with CP-CML. Results The differences in the CCyR, progression-free survival, and overall survival between the NG-TKIs and imatinib were not statistically significant. NG-TKI-treated patients showed a significantly greater likelihood of MMR (relative risk [RR], 0.76; 95% confidence interval, 0.63-0.91; P =.003) and lower likelihood of progression to an accelerated phase/blast crisis (RR, 0.37; 95% confidence interval, 0.20-0.67; P =.001) than did imatinib-treated patients. Nilotinib, dasatinib, and radotinib showed significantly greater CCyR rates compared with bosutinib and ponatinib. All risk groups showed statistically equivalent benefits from NG-TKIs for the CCyR and MMR. Conclusion In first-line treatment, the NG-TKIs as a category showed greater effectiveness in MMR and prevention of accelerated phase/blast crisis progression. Risk stratification was not found to affect the RR of CCyR and MMR.
• Yun, S., Vincelette, N. D., Segar, J. M., Dong, Y., Shen, Y., Kim, D. W., & Abraham, I. (2016). Comparative Effectiveness of Newer Tyrosine Kinase Inhibitors Versus Imatinib in the First-Line Treatment of Chronic-Phase Chronic Myeloid Leukemia Across Risk Groups: A Systematic Review and Meta-Analysis of Eight Randomized Trials. Clinical lymphoma, myeloma & leukemia, 16(6), e85-94.
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  BCR-ABL1 tyrosine kinase inhibitors (TKIs) have significantly improved the survival outcomes for patients with chronic myeloid leukemia (CML). In addition to imatinib, 3 newer generation TKIs (NG-TKIs) have been approved as first-line treatment of chronic phase (CP)-CML. These have been preferably used in patients with CP-CML with a high Sokal or Hasford risk score. We performed a systematic review and meta-analysis to compare the outcomes with NG-TKIs as a category versus imatinib in patients with newly diagnosed CP-CML and to indirectly compare the efficacy of NG-TKIs among each other. Furthermore, we assessed the effect of the risk scores on the complete cytogenetic response (CCyR) and major molecular response (MMR).
• Aapro, M., Abraham, I., Boccadoro, M., Bokemeyer, C., Denhaerynck, K., Gascon, P., Ludwig, H., Macdonald, K., & Turner, M. (2015). 1596 Predictive modeling of the outcomes of chemotherapy-induced (febrile) neutropenia (CIN/FN) prophylaxis with biosimilar filgrastim and development of an outcomes risk calculator (MONITOR-GCSF study). European Journal of Cancer, 51, S236. doi:10.1016/s0959-8049(16)30684-0
• Aapro, M., Abraham, I., Boccadoro, M., Bokemeyer, C., Denhaerynck, K., Gascon, P., Ludwig, H., Macdonald, K., Muenzberg, M., & Turner, M. (2015). Abstract P5-15-19: Prophylaxis of chemotherapy-induced febrile neutropenia with biosimilar filgrastim: Description of patients, treatment patterns and outcomes in the MONITOR-GCSF study in the breast cancer cohort. Cancer Research, 75(9_Supplement), P5-15-19-P5-15-19. doi:10.1158/1538-7445.sabcs14-p5-15-19
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  Introduction: MONITOR-GCSF is a European prospective observational study of practice patterns and outcomes of patients treated with Sandoz9 filgrastim (EP-2006) in the prophylaxis of chemotherapy-induced febrile neutropenia (CIN/FN). Objectives: To describe patients, treatment patterns of EP-2006, and outcomes in the breast cancer cohort of the MONITOR-GCSF study. Methods: Prospective observational study following 466 evaluable patients from 23 centers in Europe for up to 6 cycles within a single chemotherapy line including a total of 2714 cycles. Results: Median age was 56y (range 25-91); all but 3 patients were female. Table 1 presents chemotoxicity in terms of % FN risk and prophylaxis type. GCSF was correctly initiated as either primary or secondary prophylaxis per EORTC guideline recommendations (considering chemotherapy-related FN risk and patient-related factors) in 62% of patients. Eleven percent were undertreated, i.e., secondary prophylaxis when primary was indicated–either when CIN/FN risk >20% or when CIN/FN risk was 10-20% in combination with patient-related risk factors. Twenty-seven percent were overtreated, i.e., primary or secondary when not indicated–either primary prophylaxis in Conclusions: Variation in treatment with biosimilar GCSF in breast cancer patients is evident in terms of decision to treat with primary prophylaxis relative to guideline recommendations as well as day of initiation, duration and dose, yet incidence of CIN/FN and related events is low. Forthcoming analyses will determine whether variability in treatment is associated with differential outcomes. Citation Format: Pere Gascon, Matti Aapro, Heinz Ludwig, Mario Boccadoro, Carsten Bokemeyer, Matthew Turner, Michael Muenzberg, Ivo Abraham, Kris Denhaerynck, Karen MacDonald. Prophylaxis of chemotherapy-induced febrile neutropenia with biosimilar filgrastim: Description of patients, treatment patterns and outcomes in the MONITOR-GCSF study in the breast cancer cohort [abstract]. In: Proceedings of the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2014 Dec 9-13; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2015;75(9 Suppl):Abstract nr P5-15-19.
• Abraham, I. L., & MacDonald, K. M. (2006). Postapproval drug safety. Health affairs (Project Hope), 25(4), 1186-7; author reply 1187-8.
• Abraham, I., Aljabri, A., Erstad, B. L., Gharaibeh, M., Huckleberry, Y., Kutbi, H. I., Raz, Y., & Yun, S. (2015). Cost-Effectiveness Evaluation for the US of Fondaparinux Compared to Argatroban in the Management of Suspected HIT. Blood, 126(23), 4727-4727. doi:10.1182/blood.v126.23.4727.4727
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  Introduction. The relative efficacy and safety of fondaparinux and argatroban in the management of suspected heparin-induced thrombocytopenia (HIT) have been documented. We conducted a cost-effectiveness analysis of both agents in terms of cost and adverse events averted. Methods. We developed a two-armed decision tree model to simulate a cohort of patients with suspected or confirmed HIT managed with argatroban or fondaparinux, using published efficacy data and probabilities of developing HIT-related VTE or major bleeding. The primary base case analysis considered our institutional cost while the secondary analysis used the Average Wholesale Price. Probabilistic sensitivity analysis (PSA) was performed to confirm findings and one-way sensitivity analysis to evaluate additional scenarios. Results. In the primary base case analysis, fondaparinux dominated argatroban treatment as it was less expensive in managing suspected HIT ($154 vs. $2,064) and more effective in terms of adverse events averted (0.998878 vs. 0.995739). This was confirmed in PSA in terms of both cost ($154 vs. $1,999) and adverse events averted (0.9988711 vs. 0.9957212). Sensitivity analysis showed that the total costs of argatroban would never be less than fondaparinux based on our assumptions. In the secondary analysis, fondaparinux was less expensive ($362 vs. $3722) and more effective in terms of adverse event averted (0.998878 vs. 0.995739). The PSA confirmed these findings both in terms of cost ($343 vs. $3477) adverse events averted. (0.9988711 vs. 0.9957212). Conclusions. The cost savings from a once-daily SC fondaparinux injection with limited laboratory monitoring are more advantageous than IV argatroban infusion that requires continuous titration. Disclosures Off Label Use: Fondaparinux is used as "off-label" for the management of patients with suspected or confirmed HIT.
• Abraham, I., Bagalagel, A., Bakhsh, H. T., Diri, R., Lee, C. S., Macdonald, K., Martin, J. R., Mcbride, A., & Persky, D. O. (2015). Efficacy of Same-Day Vs. Next-Day Pegfilgrastim for the Prevention of Chemotherapy-Induced (Febrile) Neutropenia (CIN/FN): A Meta-Analysis. Blood, 126(23), 4764-4764. doi:10.1182/blood.v126.23.4764.4764
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  Introduction: CIN/FN is a major dose-limiting toxicity of many cancer chemotherapy (CTX) regimens. CIN/FN may require hospitalization, increase monitoring requirements and diagnostic and treatment costs, and reduce patient quality of life. Myeloid growth factors such as filgrastim or pegfilgrastim have been shown to reduce the incidence and severity of neutropenic complications. International guidelines recommend that pegfilgrastim be administered once per cycle 24-72 hours after chemotherapy, though recent NCCN guidelines mention the option of same-day administration. From the patients9 perspective, the time lag is potentially cumbersome because of the need for additional visits. Several studies varying in design and outcomes have evaluated same-day administration of pegfilgrastim compared to standard (next-day) administration 24-72 hours after completion of the CTX cycle. Purpose: To conduct a meta-analysis of studies of same-day vs. next-day pegfilgrastim administration in terms of the incidence of (1) Grade 4 CIN during cycle 1 of CTX and (2) CTX dose reduction in subsequent CTX cycles. Methods: We performed a search for same-day administration of pegfilgrastim using PubMed search engines to complement investigators9 familiarity with the literature. Considering heterogeneity (I2) across studies, random-effects meta-analyses were used to quantify pooled estimates of relative risk (RR), taking into account both within- (standard error) and between-study variance (τ2) using the DerSimonian and Laird method. Z-scores (weighted mean divided by the standard error of the weighted mean) and associated p-values (testing against the null hypothesis of RR = 1.0) quantified the precision of pooled RRs across studies. All analyses were performed using StataMP 14 (College Station, Texas, USA). Results: There were8 comparative studies with data on Grade 4 neutropenia that included a total of 446 patients treated the same day and 697 patients treated next day (Figure 1). Patients treated with pegfilgrastim on the same day after the first cycle of chemotherapy were equally likely to develop Grade 4 neutropenia as those treated the next day (RR = 1.13, 95% CI 0.87-1.47, p =0.371; I2 =54.1%, p=0.033). There were 8 comparative studies with data on chemotherapy dose reduction that included a total of 414 patients treated the same day and 428 patients treated next day (Figure 2). Patients treated with pegfilgrastim on the same day were equally likely to require a reduction in chemotherapy dose compared with those treated the next day (RR = 0.97, 95% CI 0.68-1.39, p =0.863; I2 =62.7%, p=0.009). Conclusion: The incidence of Grade 4 neutropenia and CTX dose reduction in patients receiving same-day pegfilgrastim were equal to those undergoing standard administration. To be confirmed through controlled studies, same-day administration of pegfilgrastim can be considered in the prophylaxis of CIN/FN in patients receiving myelotoxic CTX. Disclosures McBride:Janssen Scientific Affairs, LLC: Consultancy. Persky:Gilead Sciences, Inc: Speakers Bureau.
• Abraham, I., Bootman, J. L., Gharaibeh, M., & Mcbride, A. (2015). Economic evaluation for the UK of nab-paclitaxel plus gemcitabine in the treatment of metastatic pancreas cancer.. British journal of cancer, 112(8), 1301-5. doi:10.1038/bjc.2015.65
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  The combination of nab-paclitaxel plus gemcitabine (NAB-P+GEM) has shown superior efficacy over GEM monotherapy in metastatic pancreas cancer (MPC). Independent cost-effectiveness/utility analyses of NAB-P+GEM from the payer perspective have not been conducted for the UK..A Markov model simulating the health outcomes and total costs was developed to estimate the life years gained (LYG) and quality-adjusted life years gained (QALY) and incremental cost-effectiveness (ICER) and cost-utility ratios (ICUR) for patients with MPC in a base case and in a probabilistic (PSA) sensitivity analysis. Total cost included the cost of supportive care medications, administration, chemotherapy, disease monitoring, and adverse reactions; and was discounted at 3.5% per year. A full lifetime horizon and third party payer perspective was chosen..The total cost of NAB-P+GEM was £5466 higher than the cost for GEM. Respectively, LYGs were 0.97 vs 0.79 and QALYs were 0.52 vs 0.45, with ICER of £30 367/LYG and ICUR of £78 086/QALY, confirmed by PSA..The superior survival efficacy of NAB-P+GEM over GEM in the management of MPC is associated with positive cost-effectiveness and cost-utility.
• Abraham, I., De Geest, J., De Geest, W., De Troy, E., & MacDonald, K. (2015). Detectability and acceptability of continuous bipolar pulse signals for the MemoPatch™ device, an electronic skin patch intended to deliver tactile medication reminder signals.. Medical Devices: Evidence and Research, 8, 119-129.
• Abraham, I., De Geest, J., De Geest, W., De Troy, E., & MacDonald, K. (2015). Detectability and acceptability of continuous pulse signals for the MemoPatch(®) device, an electronic skin patch intended to deliver tactile medication reminder signals. Medical devices (Auckland, N.Z.), 8, 119-29.
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  Unintended forgetfulness is the most common cause of medication nonadherence. MemoPatch(®) is an electronic skin patch intended to deliver discreet tactile medication reminder stimuli. This study aimed 1) to evaluate, within an experimental setup, the detectability and acceptability of fifteen continuous bipolar pulse signals; 2) to identify variables, if any, associated with differential perception of the candidate reminder signals; and 3) to collect safety data as reported by subjects or observed by staff.
• Abraham, I., De Geest, J., De Geest, W., De Troy, E., & MacDonald, K. (2015). Detectability and acceptability of continuous pulse signals for the MemoPatch® device, an electronic skin patch intended to deliver tactile medication reminder signals. Medical Devices: Evidence and Research, 8(Issue). doi:10.2147/mder.s72806
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  Background: Unintended forgetfulness is the most common cause of medication nonadherence. MemoPatch® is an electronic skin patch intended to deliver discreet tactile medication reminder stimuli. This study aimed 1) to evaluate, within an experimental setup, the detectability and acceptability of fifteen continuous bipolar pulse signals; 2) to identify variables, if any, associated with differential perception of the candidate reminder signals; and 3) to collect safety data as reported by subjects or observed by staff. Methods: This was a laboratory experiment involving 147 healthy adult volunteers (55.1% female, 98.0% Caucasian, with age 41.8±16.0 years, body mass index [BMI] 24.7±4.4, upper body adiposity 28.5%±8.3% body fat, and skin impedance 367.6±140.8 Ω) and using an experimental version of the MemoPatch®. Following four training signals administered in fixed order, subjects were exposed to a set of fifteen randomly sequenced signals varying in rise and fall time, width, and current, to be rated in terms of detectability (“too weak”, “appropriate”, or “too strong”) and acceptability. Results: Ratings of “appropriate” were virtually independent of such variables as sex, BMI, upper body adiposity, and skin impedance at the patch location. Five signals were rated as “appropriate” by ³67% of subjects and acceptable by ³95% of subjects, virtually independently of the indicators of interest, and were retained as candidate signals for use in next stages of development and commercialization. Nine adverse events, none serious, were observed in six subjects. Conclusion: This study yielded five effective and safe candidate signals for potential use in the MemoPatch® device, all equally considered to be of appropriate detectability and high acceptability, in an experimental context. The signals were independent from, and therefore highly robust relative to, sex, BMI, upper body adiposity, and skin impedance at the patch site, lending additional generalizability to the signals and hence their potential relevance to broad commercial application.
• Abraham, I., Demosthenes, L., MacDonald, K., Lee, C. S., Reel, S., Brié, H., Hermans, C., Vancayzeele, S., & Van der Niepen, P. (2010). Hierarchical linear and logistic modeling of outcomes of antihypertensive treatment in elderly patients: findings from the PREVIEW study. Archives of gerontology and geriatrics, 51(1), 45-53.
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  Achieving guideline-recommended blood pressure targets is difficult in older adults with hypertension. We completed a subgroup analysis of patients 65 years of age or older enrolled in PREVIEW, a prospective, multicenter, pharmacoepidemiological study of the determinants and outcomes of second-line antihypertensive treatment with valsartan in Belgium. Multilevel modeling was used to identify physician- and patient-level determinants of blood pressure values and practice guideline-derived definitions of blood pressure control. Data on 1560 patients and 504 physicians were used in this analysis. Blood pressure control rates for patients age 65 and over were lower for systolic (34.2% vs. 38.6%) and combined systolic/diastolic blood pressure (31.2% vs. 34.4%) compared to the entire PREVIEW sample. Twenty-seven percent of the variability in systolic, and 32% in diastolic pressure after 90 days of treatment were attributable to such variables as physicians' knowledge and adherence to evidence-based guidelines, practice patterns, and experience; with the remaining variance attributable to various demographic, behavioral, and clinical patient-related factors. Several independent predictors of uncontrolled blood pressure after 90 days of treatment were identified, largely confirming factors identified as determinants of blood pressure values. Recommendations for managing hypertension in the elderly are made in view of these findings.
• Covic, A., & Abraham, I. (2015). State-of-the-art biosimilar erythropoietins in the management of renal anemia: lessons learned from Europe and implications for US nephrologists. International Urology and Nephrology, 47(Issue 9). doi:10.1007/s11255-015-1042-9
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  The European Medicines Agency (EMA), under a strictly regulated pathway, has approved several biosimilar products since 2005, including biosimilar versions of the erythropoiesis-stimulating agent (ESA) epoetin alfa since 2007. Subsequent to these approvals, the use of biosimilar epoetin alfa in the management of renal anemia has grown steadily throughout Europe. With the enactment of the US Biologics Price Competition and Innovation Act of 2009, a US Food and Drug Administration regulatory approval process for biosimilars was legalized. Thus, biosimilar erythropoietin products are expected to be available for prescription in the USA by mid-decade, presumably at a price that is competitive with the originator brand-name reference products. In this paper, we describe the status of originator and biosimilar ESAs, review the clinical development and regulatory approval of biosimilar erythropoietins in Europe, and summarize relevant efficacy and safety information of biosimilar erythropoietins in relation to their reference products to provide a background for US nephrologists as they appraise biosimilar erythropoietins as treatment options for renal anemia. Key lessons learned from Europe are that (a) EMA-approved biosimilar erythropoietins have comparable efficacy and safety profiles to their reference product erythropoietin; (b) pharmacovigilance preapproval and postapproval are critical, especially with regard to immunogenicity and vascular thromboembolic events; (c) strict preapproval and postapproval requirements must guide the regulatory pathway for biosimilars; and (d) high-quality manufacturing and production processes must be established to ensure quality biosimilar products. The availability of biosimilar erythropoietins in the USA will provide nephrologists with alternative effective, and potentially more affordable, treatment options for patients with renal anemia.
• Covic, A., & Abraham, I. (2015). State-of-the-art biosimilar erythropoietins in the management of renal anemia: lessons learned from Europe and implications for US nephrologists. International urology and nephrology, 47(9), 1529-39.
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  The European Medicines Agency (EMA), under a strictly regulated pathway, has approved several biosimilar products since 2005, including biosimilar versions of the erythropoiesis-stimulating agent (ESA) epoetin alfa since 2007. Subsequent to these approvals, the use of biosimilar epoetin alfa in the management of renal anemia has grown steadily throughout Europe. With the enactment of the US Biologics Price Competition and Innovation Act of 2009, a US Food and Drug Administration regulatory approval process for biosimilars was legalized. Thus, biosimilar erythropoietin products are expected to be available for prescription in the USA by mid-decade, presumably at a price that is competitive with the originator brand-name reference products. In this paper, we describe the status of originator and biosimilar ESAs, review the clinical development and regulatory approval of biosimilar erythropoietins in Europe, and summarize relevant efficacy and safety information of biosimilar erythropoietins in relation to their reference products to provide a background for US nephrologists as they appraise biosimilar erythropoietins as treatment options for renal anemia. Key lessons learned from Europe are that (a) EMA-approved biosimilar erythropoietins have comparable efficacy and safety profiles to their reference product erythropoietin; (b) pharmacovigilance preapproval and postapproval are critical, especially with regard to immunogenicity and vascular thromboembolic events; (c) strict preapproval and postapproval requirements must guide the regulatory pathway for biosimilars; and (d) high-quality manufacturing and production processes must be established to ensure quality biosimilar products. The availability of biosimilar erythropoietins in the USA will provide nephrologists with alternative effective, and potentially more affordable, treatment options for patients with renal anemia.
• Gascón, P., Aapro, M., Ludwig, H., Bokemeyer, C., Boccadoro, M., Turner, M., Denhaerynck, K., MacDonald, K., & Abraham, I. (2015). Erratum to: Treatment patterns and outcomes in the prophylaxis of chemotherapy-induced (febrile) neutropenia with biosimilar filgrastim (the MONITOR-GCSF study). Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer.
• Gesualdo, L., Combe, C., Covic, A., Dellanna, F., Goldsmith, D., London, G., Mann, J. F., Zaoui, P., Turner, M., Muenzberg, M., MacDonald, K., & Abraham, I. (2015). Risk-based individualisation of target haemoglobin in haemodialysis patients with renal anaemia in the post-TREAT era: theoretical attitudes versus actual practice patterns (MONITOR-CKD5 study). International urology and nephrology, 47(5), 837-45.
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  Data from an ongoing European pharmacoepidemiological study (MONITOR-CKD5) were used to examine congruence between physician-reported risk-based individualisation of target haemoglobin (Hb) and the actual Hb targets set by these physicians for their patients, as well as actual Hb levels in their patients.
• Gesualdo, L., Gesualdo, L., Combe, C., Combe, C., Covic, A., Covic, A., Dellanna, F., Dellanna, F., Goldsmith, D., Goldsmith, D., London, G., London, G., Mann, J. F., Mann, J. F., Zaoui, P., Zaoui, P., Turner, M., Turner, M., Muenzberg, M., , Muenzberg, M., et al. (2015). Risk-based individualisation of target haemoglobin in haemodialysis patients with renal anaemia in the post-TREAT era: theoretical attitudes versus actual practice patterns (MONITOR-CKD5 study). International Urology and Nephrology, 47(Issue 5). doi:10.1007/s11255-015-0970-8
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  Purpose: Data from an ongoing European pharmacoepidemiological study (MONITOR-CKD5) were used to examine congruence between physician-reported risk-based individualisation of target haemoglobin (Hb) and the actual Hb targets set by these physicians for their patients, as well as actual Hb levels in their patients. Methods: Physician investigators participating in the study completed a questionnaire about their anaemia practice patterns and attitudes post-TREAT at the start of the study (T1) and in summer 2013 (T2). These data were compared with the Hb targets identified at baseline for actual patients (n = 1197) enrolled in the study. Risk groups included presence/absence of hypertension, diabetes, cardiovascular complications, history of stroke, history of cancer, and age/activity level (elderly/inactive or young/active). Results: At each time point, more than three quarters of physicians responded that results from the TREAT study, in patients not on dialysis, have influenced their use of erythropoiesis-stimulating agents in patients on haemodialysis. At T1, there was a clear difference in physician-reported (theoretical) target Hb levels for patients across the different risk groups, but there was no difference in patients’ actual Hb levels across the risk groups. A similar disparity was noted at T2. Conclusions: Physicians’ theoretical attitudes to anaemia management in patients on haemodialysis appear to have been influenced by the results of the TREAT study, which involved patients not on dialysis. Physicians claim to use risk-based target Hb levels to guide renal anaemia care. However, there is discrepancy between these declared risk-based target Hb levels and actual target Hb levels for patients with variable risk factors.
• Kim, H., & Abraham, I. (2015). Psychometric comparison of single-item, short, and comprehensive depression screening measures in Korean young adults. International journal of nursing studies.
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  Integrating long depression-screening instruments into routine clinical practice and research studies is often impractical, necessitating short-item if not single-item measures with comparable psychometric properties.
• Levengood, M., Abraham, I., Aerts, A., Cordova, P., Denhaerynck, K., Fernandez, P., Lopez, M., Macdonald, K., Morales, F., Rivera, O., Vancayzeele, S., & Villa, L. (2015). Association of Adherence Status As Measured Using Two Single-Item Physician-Administered Methods With Cardiovascular Risk In Patients Taking Antihypertensive Medication.. Value in Health, 18(7), A809. doi:10.1016/j.jval.2015.09.096
• Sun, D., Andayani, T. M., Altyar, A., MacDonald, K., & Abraham, I. (2015). Potential cost savings from chemotherapy-induced febrile neutropenia with biosimilar filgrastim and expanded access to targeted antineoplastic treatment across the European union g5 countries: a simulation study. Clinical therapeutics, 37(4), 842-57.
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  The objectives of this study were to simulate for the European Union G5 countries the potential cost savings of converting patients from originator granulocyte colony-stimulating factor (G-CSF) filgrastim and pegfilgrastim to a biosimilar filgrastim, to evaluate how reallocating these savings could increase patient access to antineoplastic therapy, and to estimate the number of patients needed to convert to provide antineoplastic treatment to one patient.
• Sun, D., Andayani, T. M., Altyar, A., Macdonald, K., & Abraham, I. (2015). Potential cost savings from chemotherapy-induced febrile neutropenia with biosimilar filgrastim and expanded access to targeted antineoplastic treatment across the european union G5 countries: A simulation study. Clinical Therapeutics, 37(Issue 4). doi:10.1016/j.clinthera.2015.01.011
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  Purpose The objectives of this study were to simulate for the European Union G5 countries the potential cost savings of converting patients from originator granulocyte colony-stimulating factor (G-CSF) filgrastim and pegfilgrastim to a biosimilar filgrastim, to evaluate how reallocating these savings could increase patient access to antineoplastic therapy, and to estimate the number of patients needed to convert to provide antineoplastic treatment to one patient. Methods Three models were built: (1) to estimate the costs of using originator G-CSFs and the savings generated from switching to a biosimilar G-CSF, (2) to estimate the incremental number of patients who could be provided antineoplastic therapy - rituximab or trastuzumab - in a hypothetical panel of 10,000 patients with cancer, and (3) to calculate the number of patients needed to convert to provide access to anticancer therapy. Scenarios were developed in which the rate of conversion was varied to estimate the effect on total cost savings. This study took the perspective of the payer in the European Union. Findings The savings associated with the biosimilar filgrastim over the originator filgrastim ranged from €785 (day 4) to €2747 (day 14) and increased with longer duration of therapy. By contrast, the savings associated with the biosimilar filgrastim over pegfilgrastim decreased over time, ranging from €6199 (day 4) to €471 (day 14). In a hypothetical panel of 10,000 patients with cancer, the savings associated with the biosimilar filgrastim over the originator filgrastim and the expanded access to antineoplastic therapy improved over time, irrespective of conversion rates. Conversely, in the same hypothetical panel, the savings associated with the biosimilar filgrastim over pegfilgrastim reduced over time, irrespective of conversion rates, along with the expanded access to antineoplastic treatment. Under conversion of the originator filgrastim to the biosimilar filgrastim, the number needed to convert to expand access to rituximab ranged from 4 to 14 patients, and the number needed to convert to expand access to trastuzumab ranged from 11 to 38 patients. Under conversion of pegfilgrastim to the biosimilar filgrastim, the number needed to convert to expand access to rituximab ranged from 2 to 24 patients, and the number needed to convert to expand access to trastuzumab ranged from 5 to 63 patients. Implications Use of biosimilar G-CSFs for supportive cancer care could yield potential cost savings and improve patient access to antineoplastic therapy in a budget neutral way - a financial effect with an ethical perspective.
• Villa, L., Sun, D., Denhaerynck, K., Vancayzeele, S., Brié, H., Hermans, C., Aerts, A., Levengood, M., MacDonald, K., & Abraham, I. (2015). Predicting blood pressure outcomes using single-item physician-administered measures: A retrospective pooled analysis of observational studies in Belgium. British Journal of General Practice, 65(Issue 630). doi:10.3399/bjgp15x683101
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  Background Patient adherence is often not monitored because existing methods of evaluating adherence are either burdensome or do not accurately predict treatment outcomes. Aim To examine whether two simple, single-item physician-administered measures of patient adherence to antihypertensive medication are predictive of blood pressure outcomes. Design and setting Retrospective database analysis of patients with hypertension treated in Belgian primary care. Method Using pooled data from five observational studies, a sample was identified of 9725 patients who were assessed using two single-item physician-administered measures of adherence to antihypertensive medication: the first item of the Basel Assessment of Adherence Scale (BAAS) and the Visual Analogue Scale (VAS). These two assessment tools were administered by GPs during regular appointments with patients. Systolic blood pressure (SBP), diastolic blood pressure (DBP), and combined SBP/DBP were measured at baseline and at 90 days. Results BAAS-identified adherent patients achieved lower mean SBP and DBP compared with nonadherent patients at 90 days ( P
• Villa, L., Sun, D., Denhaerynck, K., Vancayzeele, S., Brié, H., Hermans, C., Aerts, A., Levengood, M., MacDonald, K., & Abraham, I. (2015). Predicting blood pressure outcomes using single-item physician-administered measures: a retrospective pooled analysis of observational studies in Belgium (abridged version). The British journal of general practice : the journal of the Royal College of General Practitioners, 65(630), 15-16.
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  Patient adherence is often not monitored because existing methods of evaluating adherence are either burdensome or do not accurately predict treatment outcomes.
• Villa, L., Sun, D., Denhaerynck, K., Vancayzeele, S., Brié, H., Hermans, C., Aerts, A., Levengood, M., MacDonald, K., & Abraham, I. (2015). Predicting blood pressure outcomes using single-item physician-administered measures: a retrospective pooled analysis of observational studies in Belgium. The British journal of general practice : the journal of the Royal College of General Practitioners, 65(630), e9-e15.
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  Patient adherence is often not monitored because existing methods of evaluating adherence are either burdensome or do not accurately predict treatment outcomes.
• Yun, S., Vincelette, N. D., & Abraham, I. (2015). Cardioprotective role of β-blockers and angiotensin antagonists in early-onset anthracyclines-induced cardiotoxicity in adult patients: A systematic review and meta-analysis. Postgraduate Medical Journal, 91(Issue 1081). doi:10.1136/postgradmedj-2015-133535
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  Background Anthracyclines are commonly used chemotherapeutic agents with proven efficacy in such malignancies as breast cancer, Hodgkin and nonHodgkin lymphomas. These agents are associated with irreversible accumulative dose-related cardiomyopathy. Many agents have been examined to reduce cardiotoxicity risk. Aims We performed a systematic review and metaanalysis to determine the efficacy of β-blockers and angiotensin antagonists to prevent early-onset anthracyclines-induced left ventricular dysfunction and cardiac events. Methods Relevant articles were searched in PubMed, EMBASE and Cochrane database of systematic reviews up to July 2015. Eligible studies were limited to randomised controlled trials comparing the efficacy of cardioprotective agents (β-blocker and angiotensin antagonist) with control (either no treatment or placebo) in adult patients (age >18 years) treated with anthracyclines-based regimens. Results Pooled analysis showed an association of β-blockers and/or angiotensin antagonists treatment with higher post-chemotherapy left ventricular ejection fraction (LVEF) of 64.03% compared with 57.48% for control treatment. The mean difference estimate (95% CI) was 6.06% (0.54 to 11.58), p=0.03, with significant heterogeneity, I2 (95% CI)=96% (82.7 to 109.3). Though the point estimate for the relative rate of cardiac events was lower in the experimental arm, the difference was not statistically significant. In an exploratory subgroup analysis, the benefit of experimental agents on LVEF preservation was prominent in patients treated with higher accumulative dose of anthracyclines, but not in the lower dose group. Conclusions β-Blockers and angiotensin antagonists treatments were associated with better LVEF preservation, and the benefit was prominent in patients treated with higher anthracyclines accumulative dose. Unexplained heterogeneity remains, indicating the need for more controlled studies. This analysis provides some support for the routine use of β-blockers or angiotensin antagonists in patients undergoing anthracyclines treatment, especially when higher accumulative dose is expected.
• Yun, S., Vincelette, N. D., & Abraham, I. (2015). Cardioprotective role of β-blockers and angiotensin antagonists in early-onset anthracyclines-induced cardiotoxicity in adult patients: a systematic review and meta-analysis. Postgraduate medical journal, 91(1081), 627-33.
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  Anthracyclines are commonly used chemotherapeutic agents with proven efficacy in such malignancies as breast cancer, Hodgkin and non-Hodgkin lymphomas. These agents are associated with irreversible accumulative dose-related cardiomyopathy. Many agents have been examined to reduce cardiotoxicity risk.
• Abraham, I., Altyar, A. E., Altyar, A., Gharaibeh, M., Macdonald, K., Martin, J. R., & Sun, D. (2014). Economic Evaluation of Primary Prophylaxis Using Filgrastim Versus Pegfilgrastim in Patients With Solid Tumor Cancer: A Systematic Literature Review.. Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research, 17(7), A736. doi:10.1016/j.jval.2014.08.112
• Abraham, I., Han, L., Sun, D., MacDonald, K., & Aapro, M. (2014). Cost savings from anemia management with biosimilar epoetin alfa and increased access to targeted antineoplastic treatment: a simulation for the EU G5 countries. Future oncology (London, England), 10(9), 1599-609.
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  We simulated the budget impact of biosimilar erythropoiesis-stimulating agent (ESA) in EU G5 countries.
• Abraham, I., Han, L., Sun, D., Macdonald, K., & Aapro, M. (2014). Cost savings from anemia management with biosimilar epoetin alfa and increased access to targeted antineoplastic treatment: A simulation for the EU G5 countries. Future Oncology, 10(Issue 9). doi:10.2217/fon.14.43
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  Aim: We simulated the budget impact of biosimilar erythropoiesis- stimulating agent (ESA) in EU G5 countries. Materials & methods: Three models were built to estimate the number of patients who could be provided with antineoplastic therapy with rituximab, bevacizumab or trastuzumab from cost savings of biosimilar erythropoietin use in a hypothetical panel of 100,000 patients. The associated number of patients needed to convert to biosimilar ESA to provide such treatments was also calculated. Results: Under fixed dosing, the savings from 100% conversion were €110,592,159, translating into an additional 9770 rituximab, 3912 bevacizumab, or 3713 trastuzumab treatments. Under weight-based dosing, the savings from 100% conversion were €146,170,333, corresponding to an additional 12,913 rituximab, 5171 bevacizumab or 4908 trastuzumab treatments. The number of patients needed to convert ranged from four to 51. Conclusion: Using biosimilar ESA for supportive cancer care yields significant savings and increases accessibility to primary antineoplastic therapy in a budget neutral way. © 2014 Future Medicine Ltd.
• Arnet, I., Abraham, I., Messerli, M., & Hersberger, K. E. (2014). A method for calculating adherence to polypharmacy from dispensing data records. International Journal of Clinical Pharmacy, 1-10.
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  Abstract: Background Several measures for calculating adherence to one medication from dispensing data records have been proposed, but the nomenclature is inconsistent and computations vary. The same measures, like the medication possession ratio (MPR), have been used for multiple medication regimens, and have tended to over- or under-estimate adherence rates. Objective To demonstrate the impact of varying elements in MPR to a single medication regimen; to define standards for the estimation of adherence to polypharmacy; to propose a new method for calculating adherence to polypharmacy; to face validate it. Setting Face validity of the proposed method. Method Variations in the MPR formula were simulated. Standards for the estimation of adherence to polypharmacy were defined. A new method to calculate adherence to polypharmacy was established. Its face validity with three illustrative cases obtained from a pharmacy refill database was assessed. Main outcome measure Adherence rate to polypharmacy from refill data records. Results MPR to a single medication is operationalized in the numerator and denominator and is influenced by the parameters like observation period, medication gaps, overlap. For polypharmacy, an average MPR is commonly used, which is not accounting for the specificity of multiple medications, and hence overestimating adherence rate. We propose the daily polypharmacy possession ratio (DPPR) as an index of adherence to polypharmacy. It estimates the proportion of time a patient had medication available for use by considering the presence or absence of multiple medications on each day in the observation period. We calculated possession rates from refill histories over 31 months (January 1, 2011-July 31, 2013) for three illustrative patients. The average MPR estimates were 80 % for a patient with 6 medications/20 refill dates, 90 % for a patient with 4 medications/11 refill dates, and 89 % for a patient with 3 medications/17 refill dates. The corresponding DPPRs were 75, 88 and 99 %, indicating overestimations by 5 and 2 %, and underestimation by 10 %, respectively. Conclusion The DPPR accounts for the specificity of polypharmacy including number of medications, medication switching, duplication, overlapping. Research is needed to further confirm the validity of this new index. © 2013 The Author(s).
• Arnet, I., Abraham, I., Messerli, M., & Hersberger, K. E. (2014). A method for calculating adherence to polypharmacy from dispensing data records. International Journal of Clinical Pharmacy, 36(Issue 1). doi:10.1007/s11096-013-9891-8
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  Background: Several measures for calculating adherence to one medication from dispensing data records have been proposed, but the nomenclature is inconsistent and computations vary. The same measures, like the medication possession ratio (MPR), have been used for multiple medication regimens, and have tended to over- or under-estimate adherence rates. Objective: To demonstrate the impact of varying elements in MPR to a single medication regimen; to define standards for the estimation of adherence to polypharmacy; to propose a new method for calculating adherence to polypharmacy; to face validate it. Setting: Face validity of the proposed method. Method: Variations in the MPR formula were simulated. Standards for the estimation of adherence to polypharmacy were defined. A new method to calculate adherence to polypharmacy was established. Its face validity with three illustrative cases obtained from a pharmacy refill database was assessed. Main outcome measure: Adherence rate to polypharmacy from refill data records. Results: MPR to a single medication is operationalized in the numerator and denominator and is influenced by the parameters like observation period, medication gaps, overlap. For polypharmacy, an average MPR is commonly used, which is not accounting for the specificity of multiple medications, and hence overestimating adherence rate. We propose the daily polypharmacy possession ratio (DPPR) as an index of adherence to polypharmacy. It estimates the proportion of time a patient had medication available for use by considering the presence or absence of multiple medications on each day in the observation period. We calculated possession rates from refill histories over 31 months (January 1, 2011-July 31, 2013) for three illustrative patients. The average MPR estimates were 80% for a patient with 6 medications/20 refill dates, 90% for a patient with 4 medications/11 refill dates, and 89% for a patient with 3 medications/17 refill dates. The corresponding DPPRs were 75, 88 and 99%, indicating overestimations by 5 and 2%, and underestimation by 10%, respectively. Conclusion: The DPPR accounts for the specificity of polypharmacy including number of medications, medication switching, duplication, overlapping. Research is needed to further confirm the validity of this new index. © The Author(s) 2013.
• Arnet, I., Abraham, I., Messerli, M., & Hersberger, K. E. (2014). A method for calculating adherence to polypharmacy from dispensing data records. International journal of clinical pharmacy, 36(1), 192-201.
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  Several measures for calculating adherence to one medication from dispensing data records have been proposed, but the nomenclature is inconsistent and computations vary. The same measures, like the medication possession ratio (MPR), have been used for multiple medication regimens, and have tended to over- or under-estimate adherence rates.
• Delforge, M., Selleslag, D., Beguin, Y., Triffet, A., Mineur, P., Theunissen, K., Graux, C., Trullemans, F., Boulet, D., Van Eygen, K., Noens, L., Van Steenweghen, S., Lemmens, J., Pierre, P., D'hondt, R., Ferrant, A., Deeren, D., Van De Velde, A., Wynendaele, W., , André, M., et al. (2014). Adequate iron chelation therapy for at least six months improves survival in transfusion-dependent patients with lower risk myelodysplastic syndromes. Leukemia Research, 38(Issue 5). doi:10.1016/j.leukres.2014.02.003
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  Background: Most patients with myelodysplastic syndromes (MDS) require transfusions at the risk of iron overload and associated organ damage, and death. Emerging evidence indicates that iron chelation therapy (ICT) could reduce mortality and improve survival in transfusion-dependent MDS patients, especially those classified as International Prognostic Scoring System (IPSS) Low or Intermediate-1 (Low/Int-1). Methods: Follow-up of a retrospective study. Sample included 127 Low/Int-1 MDS patients from 28 centers in Belgium. Statistical analysis stratified by duration (≥6 versus
• Delforge, M., Selleslag, D., Beguin, Y., Triffet, A., Mineur, P., Theunissen, K., Graux, C., Trullemans, F., Boulet, D., Van Eygen, K., Noens, L., Van Steenweghen, S., Lemmens, J., Pierre, P., D'hondt, R., Ferrant, A., Deeren, D., Van De Velde, A., Wynendaele, W., , André, M., et al. (2014). Adequate iron chelation therapy for at least six months improves survival in transfusion-dependent patients with lower risk myelodysplastic syndromes. Leukemia research, 38(5), 557-63.
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  Most patients with myelodysplastic syndromes (MDS) require transfusions at the risk of iron overload and associated organ damage, and death. Emerging evidence indicates that iron chelation therapy (ICT) could reduce mortality and improve survival in transfusion-dependent MDS patients, especially those classified as International Prognostic Scoring System (IPSS) Low or Intermediate-1 (Low/Int-1).
• Delforge, M., Selleslag, D., Beguin, Y., Triffet, A., Mineur, P., Theunissen, K., Graux, C., Trullemans, F., Boulet, D., Van Eygen, K., Noens, L., Van Steenweghen, S., Lemmens, J., Pierre, P., D'hondt, R., Ferrant, A., Deeren, D., Van de Velde, A., Wynendaele, W., , Andre, M., et al. (2014). Adequate iron chelation therapy for at least six months improves mortality in transfusion-dependent patients with lower risk myelodysplastic syndromes.. Leukemia Research, 38, 557-573.
• Devogelaer, J. P., Geusens, P., Daci, E., Gielen, E., Denhaerynck, K., MacDonald, K., Hermans, C., Vancayzeele, S., Abraham, I. L., & Boonen, S. (2014). Remission over three years in patients with Paget’s disease of bone treated with a single intravenous infusion of 5mg zoledronic acid.. Calcified Tissue International, 94, 311-318.
• Devogelaer, J. P., Geusens, P., Daci, E., Gielen, E., Denhaerynck, K., MacDonald, K., Hermans, C., Vancayzeele, S., Abraham, I., & Boonen, S. (2014). Remission over 3 years in patients with Paget disease of bone treated with a single intravenous infusion of 5 mg zoledronic acid. Calcified Tissue International, 94(Issue 3). doi:10.1007/s00223-013-9812-9
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  Using data from the Belgian Paget's Disease Registry of 142 patients treated with a 5 mg intravenous infusion of zoledronic acid, we examined disease remission over 3 years in 98 patients with Paget disease of bone (PDB) seen in routine practice. Median age was 76 years, most patients (60.2 %) were male, and all were Caucasian. Median time since PDB diagnosis was 11.5 years, few patients (5.1 %) had a family history of PDB, and 32.6 % had received prior bisphosphonate and/or other treatments. The most common pagetic locations were pelvis, spine, femur, tibia, and skull. The most common symptoms included pain, impaired mobility, bone deformities, and joint disease: 36.7 % of patients had comorbid osteoarthritis and 16.3 % comorbid osteoporosis. Response rates were 93.3 % at 1 year, 89.5 % at 2 years, and 91.6 % at 3 years, statistically similar to an extension study of the original zoledronic acid trials. Twenty-one patients experienced a relapse over the 3-year period at a median of 20.7 months posttreatment; of these, 13 regained remission by the end of the observation period. Relapse was not associated with osteoarthritis, osteoporosis, or other comorbidities. Safety data were similar to those reported elsewhere. In summary, in this somewhat frailer sample of patients with PDB, effectiveness and safety data were similar to those observed in the original trial populations. These findings, which are the first on the use of zoledronic acid for PDB in routine clinical practice, underscore the therapeutic benefits and relative safety of zoledronic acid in the management of PDB in "real-world" clinical settings. © 2013 Springer Science+Business Media.
• Herman, P. M., Dodds, S. E., Logue, M. D., Abraham, I., Rehfeld, R. A., Grizzle, A. J., Urbine, T. F., Horwitz, R., Crocker, R. L., & Maizes, V. H. (2014). IMPACT - Integrative Medicine PrimAry Care Trial: Protocol for a comparative effectiveness study of the clinical and cost outcomes of an integrative primary care clinic model. BMC Complementary and Alternative Medicine, 14(Issue). doi:10.1186/1472-6882-14-132
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  Background: Integrative medicine (IM) is a patient-centered, healing-oriented clinical paradigm that explicitly includes all appropriate therapeutic approaches whether they originate in conventional or complementary medicine (CM). While there is some evidence for the clinical and cost-effectiveness of IM practice models, the existing evidence base for IM depends largely on studies of individual CM therapies. This may in part be due to the methodological challenges inherent in evaluating a complex intervention (i.e., many interacting components applied flexibly and with tailoring) such as IM.Methods/Design: This study will use a combination of observational quantitative and qualitative methods to rigorously measure the health and healthcare utilization outcomes of the University of Arizona Integrative Health Center (UAIHC), an IM adult primary care clinic in Phoenix, Arizona. There are four groups of study participants. The primary group consists of clinic patients for whom clinical and cost outcomes will be tracked indicating the impact of the UAIHC clinic (n = 500). In addition to comparing outcomes pre/post clinic enrollment, where possible, these outcomes will be compared to those of two matched control groups, and for some self-report measures, to regional and national data. The second and third study groups consist of clinic patients (n = 180) and clinic personnel (n = 15-20) from whom fidelity data (i.e., data indicating the extent to which the IM practice model was implemented as planned) will be collected. These data will be analyzed to determine the exact nature of the intervention as implemented and to provide covariates to the outcomes analyses as the clinic evolves. The fourth group is made up of patients (n = 8) whose path through the clinic will be studied in detail using qualitative (periodic semi-structured interviews) methods. These data will be used to develop hypotheses regarding how the clinic works.Discussion: The US health care system needs new models of care that are more patient-centered and empower patients to make positive lifestyle changes. These models have the potential to reduce the burden of chronic disease, lower the cost of healthcare, and offer a sustainable financial paradigm for our nation. This protocol has been designed to test whether the UAIHC can achieve this potential. Trial registration: Clinical Trials.gov NCT01785485. © 2014 Herman et al.; licensee BioMed Central Ltd.
• Herman, P., Dodds, S., Logue, M., Abraham, I. L., Rehfeld, R., Grizzle, A., Urbine, T., Horwitz, R., Crocker, R., & Maizes, V. (2014). IMPACT - Integrative Medicine PrimAry Care Trial: protocol for a comparative effectiveness study of the clinical and cost outcomes of an integrative primary care clinic model.. BMC Complementary and Alternative Medicine, 14, 132.
• Lee, Y. J., Boyd, A. D., Li, J. J., Gardeux, V., Kenost, C., Saner, D., Li, H., Abraham, I., Krishnan, J. A., & Lussier, Y. A. (2014). COPD Hospitalization Risk Increased with Distinct Patterns of Multiple Systems Comorbidities Unveiled by Network Modeling. AMIA ... Annual Symposium proceedings / AMIA Symposium. AMIA Symposium, 2014(Issue).
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  Earlier studies on hospitalization risk are largely based on regression models. To our knowledge, network modeling of multiple comorbidities is novel and inherently enables multidimensional scoring and unbiased feature reduction. Network modeling was conducted using an independent validation design starting from 38,695 patients, 1,446,581 visits, and 430 distinct clinical facilities/hospitals. Odds ratios (OR) were calculated for every pair of comorbidity using patient counts and compared their tendency with hospitalization rates and ED visits. Network topology analyses were performed, defining significant comorbidity associations as having OR≥5 & False-Discovery-Rate≤10(-7). Four COPD-associated comorbidity sub-networks emerged, incorporating multiple clinical systems: (i) metabolic syndrome, (ii) substance abuse and mental disorder, (iii) pregnancy-associated conditions, and (iv) fall-related injury. The latter two have not been reported yet. Features prioritized from the network are predictive of hospitalizations in an independent set (p
• Lee, Y. J., Boyd, A. D., Li, J. J., Gardeux, V., Kenost, C., Saner, D., Li, H., Abraham, I., Krishnan, J. A., & Lussier, Y. A. (2014). COPD Hospitalization Risk Increased with Distinct Patterns of Multiple Systems Comorbidities Unveiled by Network Modeling. AMIA ... Annual Symposium proceedings / AMIA Symposium. AMIA Symposium, 2014, 855-64.
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  Earlier studies on hospitalization risk are largely based on regression models. To our knowledge, network modeling of multiple comorbidities is novel and inherently enables multidimensional scoring and unbiased feature reduction. Network modeling was conducted using an independent validation design starting from 38,695 patients, 1,446,581 visits, and 430 distinct clinical facilities/hospitals. Odds ratios (OR) were calculated for every pair of comorbidity using patient counts and compared their tendency with hospitalization rates and ED visits. Network topology analyses were performed, defining significant comorbidity associations as having OR≥5 & False-Discovery-Rate≤10(-7). Four COPD-associated comorbidity sub-networks emerged, incorporating multiple clinical systems: (i) metabolic syndrome, (ii) substance abuse and mental disorder, (iii) pregnancy-associated conditions, and (iv) fall-related injury. The latter two have not been reported yet. Features prioritized from the network are predictive of hospitalizations in an independent set (p
• Lee, Y. l., Boyd, A. D., Gardeux, V., Li, J., Kenost, C., Saner, D., Li, H., Abraham, I. L., Krishnan, J. A., & Lussier, Y. A. (2014). COPD hospitalization risk increased with distinct patterns of multiple comorbidities unveiled by network modeling.. American Medical Informatics Association Annual Symposium Proceedings, 2014, 855-864.
• Sun, D., Abraham, I., Slack, M., & Skrepnek, G. H. (2014). Emergency department visits in the United States for pediatric depression: Estimates of charges and hospitalization. Academic Emergency Medicine, 21(Issue 9). doi:10.1111/acem.12457
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  Objectives: The objective of this study was to calculate national estimates of depression-related emergency department (ED) visits and associated health care resource use among children and adolescents 17 years or younger. Another goal was to explore the effects of certain sociodemographic and health care system factors and comorbidities on ED charges and subsequent hospitalization in the United States. Methods: The authors analyzed data from the 2006 and 2009 National Emergency Department Sample (NEDS), the largest source of U.S. ED data. ED visits with all listed diagnoses (i.e., principal diagnosis plus secondary conditions) of depression were identified using International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes 293.83, 296.2X, 296.3X, 300.4, and 311. Population-based estimates of ED visits, hospitalization, resource use, comorbidities, and demographics associated with pediatric depression were calculated. Potentially significant covariate associations were also explored using ED charges and hospital admission from the ED. Results: The 2006 and 2009 NEDS sample contained 365,713 ED visits for pediatric depression; the majority were made by adolescents (87.9%). Of these, 27.2% were admitted to the hospital, 69.5% were treated and released, and
• Sun, D., Abraham, I., Slack, M., & Skrepnek, G. H. (2014). Emergency department visits in the United States for pediatric depression: estimates of charges and hospitalization. Academic emergency medicine : official journal of the Society for Academic Emergency Medicine, 21(9), 1003-14.
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  The objective of this study was to calculate national estimates of depression-related emergency department (ED) visits and associated health care resource use among children and adolescents 17 years or younger. Another goal was to explore the effects of certain sociodemographic and health care system factors and comorbidities on ED charges and subsequent hospitalization in the United States.
• Tharmarajah, S., Mohammed, A., Bagalagel, A., MacDonald, K., & Abraham, I. L. (2014). Clinical efficacy and safety of Zarzio (EP2006), a biosimilar recombinant human granulocyte colony stimulating factor.. Biosimilars, 4, 1-9.
• Van Camp, Y. P., Vrijens, B., Abraham, I. L., Van Rompaey, B., & Elseviers, M. M. (2014). Adherence to phosphate binders in hemodialysis patients: prevalence and determinants. Journal of Nephrology, 27, 673-679.
• Van Camp, Y. P., Vrijens, B., Abraham, I., Van Rompaey, B., & Elseviers, M. M. (2014). Adherence to phosphate binders in hemodialysis patients: prevalence and determinants. Journal of Nephrology, 27(Issue 6). doi:10.1007/s40620-014-0062-3
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  Background: Phosphate control is a crucial treatment goal in end-stage renal disease, but poor patient adherence to phosphate binder therapy remains a challenge. This study aimed to estimate the extent of phosphate binder adherence in hemodialysis patients and to identify potential determinants. Methods: Phosphate binder adherence was measured blindly in 135 hemodialysis patients for 2 months using the medication event monitoring system. Patient data, gathered at inclusion through medical records, ad hoc questionnaires and the short form (SF)-36 health survey, included: (1) demographics, (2) perceived side-effects, belief in benefit, self-reported adherence to the therapy, (3) knowledge about phosphate binder therapy, (4) social support, and (5) quality of life (SF-36). Phosphatemia data was collected from charts. ‘Being adherent’ was defined as missing
• Van Camp, Y. P., Vrijens, B., Abraham, I., Van Rompaey, B., & Elseviers, M. M. (2014). Adherence to phosphate binders in hemodialysis patients: prevalence and determinants. Journal of nephrology.
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  Phosphate control is a crucial treatment goal in end-stage renal disease, but poor patient adherence to phosphate binder therapy remains a challenge. This study aimed to estimate the extent of phosphate binder adherence in hemodialysis patients and to identify potential determinants.
• Van Camp, Y., Vrijens, B., Abraham, I. L., Van Rompaey, B., & Elseviers, M. M. (2014). Adherence to antihypertensive medications in type 2 diabetes: prevalence and determinants.. British Journal of Medicine and Medical Research, 4, 4627-4641.
• Van Meerbeeck, J., Galdermans, D., Bustin, F., De Vos, L., Lechat, I., & Abraham, I. (2014). Survival outcomes in patients with advanced non-small cell lung cancer treated with erlotinib: expanded access programme data from Belgium (the TRUST study). European journal of cancer care, 23(3), 370-9.
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  Erlotinib has been shown to prolong progression-free (PFS) and overall survival (OS) in patients with advanced non-small cell lung cancer (NSCLC). We report here on effectiveness data on the subsample of 261 patients from 40 centres in Belgium involved in the TRUST study. Median age was 63 years. Most (69.0%) were male and current/former smokers (84.7%); with Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 (74.3%), stage IV disease (75.1%) and adenocarcinoma by histology (54.0%). Erlotinib was administered mainly as second- (47.1%) or third-line treatment (48.3%). Response rate was 6.5%; disease control rate 58.3%. Median PFS was 2.2 months. Better PS (P = 0.0384), stage IIIB disease (P = 0.0018) and presence of rash (P < 0.0001) were associated with longer PFS. OS rates at 1, 2 and 3 years were 26.4%, 10.9% and 6.4% respectively. Median OS was 5.9 months. Female gender (P = 0.007), better PS (P < 0.0001), stage IIIB disease (P = 0.0355) and presence of rash (P < 0.0001) were associated with longer OS. The findings confirm the therapeutic benefit of erlotinib in a broad range of patients in a sample from a country with a historically high lung cancer morbidity and mortality burden. Several determinants of PFS and OS are identified.
• Van Meerbeeck, J., Galdermans, D., Bustin, F., De Vos, L., Lechat, I., & Abraham, I. L. (2014). Survival outcomes in patients with advanced non-small-cell lung cancer treated with erlotinib: expanded access program data from Belgium (the TRUST study).. European Journal of Cancer Care, 23, 370-379.
• Abraham, I., & Macdonald, K. (2013). Clinical efficacy and safety of SB309, a biosimilar recombinant human erythropoietin, in the management of anemia. Biosimilars, 35. doi:10.2147/bs.s28708
• Abraham, I., & Nuno, T. (2013). Abstract C07: Colorectal cancer screening utilization among rural and minority populations in the United States. Cancer Prevention Research, 6(11_Supplement), C07-C07. doi:10.1158/1940-6215.prev-13-c07
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  The American Cancer Society estimates that approximately 142,820 new colorectal cancer cases are expected to occur in the United States in 2013, with a total of 50,830 estimated deaths expected to occur. Colorectal cancer is the third most commonly diagnosed cancer and the second leading cause of cancer death among both men and women in the United States. Colorectal cancer can be prevented by early detection and colorectal cancer screening has been shown to be effective. Screening reduces mortality both by decreasing incidence and by detecting cancers at more treatable stages of disease. Despite this, colorectal cancer screening is underutilized, with only about half of people age 50 or older reporting having had colorectal cancer testing that is consistent with current screening guidelines from the American Cancer Society. Low rates of colorectal cancer screening are especially problematic among underserved populations, including rural and racial/ethnic minority populations. In particular, National Health Interview Survey data shows that Hispanics age 50 and older reported having had either a fecal occult blood test (FOBT) within the past year or sigmoidoscopy or colonoscopy within 10 years less frequently (45%) compared to non-Hispanic Whites (59%). The purpose of this study was to quantify and compare recent national surveillance data on colorectal cancer screening uptake among rural, urban, and suburban populations in the United States. Rates of FOBT and colonoscopy were estimated for these populations. Data utilized in this study included Behavioral Risk Factor Surveillance System (BRFSS) data from 2008 and 2010. A total of n=557,553 subjects that were 50 years of age and older participated in the BRFSS surveys over this time period. Subjects were coded into rural, urban, and suburban residence by using metropolitan statistical area codes. In comparison between Hispanic, American Indian, and non-Hispanic White populations, we found that rural Hispanic populations had the lowest percentage that reported a FOBT within the past year (10%; 95% CI=8.1%-12.3%) and suburban American Indian populations had the highest percentage (16%; 95% CI=12.8%-20.6%). Rural Hispanic populations also had the lowest percentage that reported a colonoscopy within the past 10 years (35%; 95% CI=32.2%-38.3%) and urban non-Hispanic White populations had the highest percentage (60%; 95% CI=59.1%-60.2%). Overall, the population with the highest percentage that was up-to-date with colorectal cancer screening was urban-dwelling non-Hispanic Whites (65%; 95% CI=64.8-65.8). In addition, 24% (95% CI=23.1%-25.4%) of rural populations that did not have a personal doctor reported having had a colonoscopy within the past 10 years, compared to 56% (95% CI=55.3%-56.1%) of rural populations, 60% (95% CI=59.9%-60.8%) of suburban populations and 60% (95% CI=59.6%-60.5%) of urban populations that had a personal doctor reporting a colonoscopy within the past 10 years. These results provide evidence that there continues to exist a great need to increase colorectal cancer screening uptake, especially among rural and underserved minority populations. Citation Format: Tomas Nuno, Ivo Abraham. Colorectal cancer screening utilization among rural and minority populations in the United States. [abstract]. In: Proceedings of the Twelfth Annual AACR International Conference on Frontiers in Cancer Prevention Research; 2013 Oct 27-30; National Harbor, MD. Philadelphia (PA): AACR; Can Prev Res 2013;6(11 Suppl): Abstract nr C07.
• Abraham, I., Bagalagel, A., Macdonald, K., & Mohammed, A. (2013). Clinical efficacy and safety of XM01, a biosimilar recombinant human erythropoietin, in the management of anemia. Biosimilars, 3, 45-53. doi:10.2147/bs.s28709
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  Since the expiration of the patent for epoetin alfa in Europe in 2004, the European Medicines Agency has approved three biosimilar erythropoietins. Using the European Medicines Agency's European Public Assessment Reports and scientific publications, we review the evidence regarding the clinical efficacy and safety of HX575 (Sandoz/Novartis) relative to the originator product Eprex/Erypo (Johnson & Johnson). Clinical efficacy is assessed as a function of therapeutic equivalence of a biosimilar and originator product, while safety is evaluated in terms of immunogenicity, venous thromboembolism, and mortality. Five studies that examined chronic renal failure and oncology populations are reviewed. In the renal setting, these stud- ies include a randomized controlled trial on Hb maintenance in patients receiving long-term hemodialysis, a randomized safety trial in patients with chronic kidney disease not yet requiring renal replacement therapy, and a post-approval saftey commitment study. Studies in the cancer setting include a clinical validation study in patients with solid tumors receiving antineoplastic chemotherapy and a retrospective clinical audit of Binocrit in routine clinical practice. Based on available therapeutic equivalence and safety data, the clinical and safety outcomes of treatment with HX575 are likely to be similar to those of the originator product Eprex/Erypo. Both products can be considered interchangeable in the management of anemia in the approved indications, and patients transferred from the reference product to the biosimilar product are expected to show the same efficacy and safety outcomes. There is no evidence of the interchangeability of HX575 with other biosimilar or originator erythropoietins other than Eprex/Erypo. In keeping with European Medicines Agency guidance about traceability, it is recommended that clinicians document the product prescribed by its commercial name, especially when switching patients from an originator to a biosimilar or vice versa.
• Abraham, I., Bustin, F., De Vos, L., Galdermans, D., Lechat, I., & Van Meerbeeck, J. (2013).

  Survival outcomes in patients with advanced non-small cell lung cancer treated with erlotinib: expanded access programme data from Belgium (the TRUST study): Survival in erlotinib-treated NSCL patients

  . European Journal of Cancer Care, 23(3), 370-379. doi:10.1111/ecc.12146
• Abraham, I., Camp, Y. V., Villa, L., Denhaerynck, K., Sun, D., Vancayzeele, S., Brié, H., Aerts, A., Hermans, C., & Macdonald, K. (2013). Hierarchical modeling of patient and physician determinants of blood pressure outcomes in adherent vs nonadherent hypertensive patients: Pooled analysis of 6 studies with 14,646 evaluable patients. Journal of Clinical Hypertension, 15(9), 663-673.
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  PMID: 24034660;Abstract: The authors used pooled data from 6 valsartan-related studies including 3983 adherent and 10,663 nonadherent patients to evaluate blood pressure (BP) outcomes in both groups after 90 days of treatment, applying hierarchical linear and logistic regression to identify determinants of BP outcomes. The principal findings were that: (1) BP outcomes were consistently better in adherent patients; (2) approximately a quarter of the variance in 90-day BP values was attributable to a physician class effect; (3) common and unique patient- and physician-related variables were associated with BP outcomes in both groups; (4) physician vigilance was associated with better outcomes, especially in adherent patients; and (5) adherent patients were more likely to exhibit target organ damage and associated events while being prescribed more complex medication regimens. Adherence to antihypertensive medication may be a function of prior line treatment failure, severity of illness, and sequelae, and the ensuing patient resolution to change medication behavior. © 2013 Wiley Periodicals, Inc.
• Abraham, I., De Geest, W., De Geest, J., De Troy, E., & MacDonald, K. (2013). Detectability and appraisal thresholds of split pulse signals for the MemoPatch™ device, an electronic skin patch intended to deliver tactile medication reminder signals (study TS-104). Conference proceedings : ... Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual Conference, 2013, 914-7.
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  Patient non-adherence to prescribed medication regimens is a significant problem and affects clinical treatment outcomes. The MemoPatch™ medical device, currently in development, is an electronic skin patch intended to deliver tactile medication reminder signals. Fifty volunteers completed a laboratory experiment that evaluated the detectability and appraisal thresholds of five split signals; specifically, the current thresholds (in mA) at which a signal was detected (threshold T1), was considered sufficiently detectable to serve as a reminder signal (threshold T2), and became too strong as a reminder signal (threshold T3). Signals were selected under consideration of three data points: T1Max and T2Max (defined as, resp., the maximum current observed at T1 and T2) and T3Pct90 (the T3 current at the 90(th) percentile). A signal was considered to be useable in future versions of the MemoPatch™ device if it met the constraint that (T3Pct90-T2Max) should not be negative. One signal met the constraint requirement as its T3Pct90-T2Max=0.96mA.
• Abraham, I., Geest, W. D., Geest, J. D., Troy, E. D., & Macdonald, K. (2013). Detectability and appraisal thresholds of split pulse signals for the MemoPatch™ device, an electronic skin patch intended to deliver tactile medication reminder signals (study TS-104). Proceedings of the Annual International Conference of the IEEE Engineering in Medicine and Biology Society, EMBS, 914-917.
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  PMID: 24109837;Abstract: Patient non-adherence to prescribed medication regimens is a significant problem and affects clinical treatment outcomes. The MemoPatch™ medical device, currently in development, is an electronic skin patch intended to deliver tactile medication reminder signals. Fifty volunteers completed a laboratory experiment that evaluated the detectability and appraisal thresholds of five split signals; specifically, the current thresholds (in mA) at which a signal was detected (threshold T1), was considered sufficiently detectable to serve as a reminder signal (threshold T2), and became too strong as a reminder signal (threshold T3). Signals were selected under consideration of three data points: T1Max and T2Max (defined as, resp., the maximum current observed at T1 and T2) and T3Pct90 (the T3 current at the 90th percentile). A signal was considered to be useable in future versions of the MemoPatch™ device if it met the constraint that (T3Pct90-T2Max) should not be negative. One signal met the constraint requirement as its T3Pct90-T2Max=0.96mA. © 2013 IEEE.
• Abraham, I., MacDonald, K., Song, M., Ciesielski, G., Pacheco, C., Lee, C., Cholette, M., Kinsey, K., Speaks, P., Hermans, C., Brié, H., Reel, S., Van der Niepen, P., Yee, B., & Vancayzeele, S. (2013). Patient- and physician-level determinants of blood pressure response to treatment in normal weight and overweight patients (the PREVIEW study). Nutrition, Metabolism and Cardiovascular Diseases, 23(Issue 4). doi:10.1016/j.numecd.2011.06.005
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  Background and aims: Obesity combined with hypertension places patients at greater risk for target-organ damage and cardiovascular disease. The purpose of this secondary analysis was to identify physician- and patient-levels determinants of blood pressure (BP) values and predictors of uncontrolled BP through subgroup analysis by body mass index (BMI). Methods and results: We conducted a subgroup analysis of 3006 patients with High-BMI (BMI >25kg/m2; n=2124) and Normal-BMI (BMI
• Abraham, I., MacDonald, K., Song, M., Ciesielski, G., Pacheco, C., Lee, C., Cholette, M., Kinsey, K., Speaks, P., Hermans, C., Brié, H., Reel, S., Van, P., Yee, B., & Vancayzeele, S. (2013). Patient- and physician-level determinants of blood pressure response to treatment in normal weight and overweight patients (the PREVIEW study). Nutrition, Metabolism and Cardiovascular Diseases, 23(4), 314-322.
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  PMID: 21930367;Abstract: Background and aims: Obesity combined with hypertension places patients at greater risk for target-organ damage and cardiovascular disease. The purpose of this secondary analysis was to identify physician- and patient-levels determinants of blood pressure (BP) values and predictors of uncontrolled BP through subgroup analysis by body mass index (BMI). Methods and results: We conducted a subgroup analysis of 3006 patients with High-BMI (BMI >25kg/m2; n=2124) and Normal-BMI (BMI
• Abraham, I., MacDonald, K., Tharmarajah, S., Bokemeyer, C., Ludwig, H., Soubeyran, P., Battistel, V., & Aapro, M. (2013). Modeling of treatment response to erythropoiesis-stimulating agents in older (age≥70years) and younger (age<70years) patients with cancer and anemia: Findings from the Anemia Cancer Treatment study. Journal of Geriatric Oncology, 4(2), 196-201.
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  PMID: 24071545;Abstract: Introduction: The Anemia Cancer Treatment study assessed hemoglobin (Hb) outcomes following treatment with erythropoiesis-stimulating agents (ESA) in anemic (Hb ≤ 11. g/dL) patients in Europe. We replicated the original analyses stratifying by age, namely patients aged ≥ 70 (n. =637) versus those aged < 70 (n. =1555). Materials and methods: A secondary analysis of Hb outcomes was assessed over 8-10. weeks. Treatment response criteria included increases of Hb ≥ 1. g/dL, Hb ≥ 1. g/dL over 8. weeks, and Hb ≥ 2. g/dL over the course of the study period. Results: Mean Hb increased from similar levels of 9.5. g/dL [p. =not significant (ns)] at visit one to 10.9. g/dL (p. =ns) at visit three (both p < 0.001). Patients aged ≥ 70 had higher mean Hb at visit two (10.6. g/dL vs. 10.3. g/dL, p < 0.001). Cohorts did not differ in treatment response rates (all p. =ns). Mean performance status differed between cohorts at each visit (all p ≤ 0.011); both groups showed significant improvements (both p < 0.001). Immediacy of response was a consistent determinant but was more pronounced among patients aged ≥ 70. Less consistent determinants included performance status in the age ≥ 70 group, as well as hematological malignancy and Hb at ESA start in the age < 70 group. The proportion of variance in Hb outcomes attributable to treatment center ranged from 0.090 to 0.289 in the age ≥ 70 cohort and 0.126 to 0.361 in the age < 70 cohort. Conclusions: Both groups achieved similar Hb levels with the age ≥ 70 cohort showing a higher initial evolution rate and potentially a different Hb response trajectory. Patients age ≥ 70 were more likely to benefit from ESAs if showing an early erythropoietic response and exhibiting no or little impairment in performance status. Differential attribution of variability in older vs. younger adults suggests that individualization of ESA therapy may facilitate Hb response in geriatric patients with cancer. © 2012 Elsevier Inc.
• Abraham, I., MacDonald, K., Tharmarajah, S., Bokemeyer, C., Ludwig, H., Soubeyran, P., Battistel, V., & Aapro, M. (2013). Modeling of treatment response to erythropoiesis-stimulating agents in older (age≥70years) and younger (age<70years) patients with cancer and anemia: Findings from the Anemia Cancer Treatment study. Journal of Geriatric Oncology, 4(Issue 2). doi:10.1016/j.jgo.2012.09.058
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  Introduction: The Anemia Cancer Treatment study assessed hemoglobin (Hb) outcomes following treatment with erythropoiesis-stimulating agents (ESA) in anemic (Hb ≤ 11. g/dL) patients in Europe. We replicated the original analyses stratifying by age, namely patients aged ≥ 70 (n. =637) versus those aged < 70 (n. =1555). Materials and methods: A secondary analysis of Hb outcomes was assessed over 8-10. weeks. Treatment response criteria included increases of Hb ≥ 1. g/dL, Hb ≥ 1. g/dL over 8. weeks, and Hb ≥ 2. g/dL over the course of the study period. Results: Mean Hb increased from similar levels of 9.5. g/dL [p. =not significant (ns)] at visit one to 10.9. g/dL (p. =ns) at visit three (both p < 0.001). Patients aged ≥ 70 had higher mean Hb at visit two (10.6. g/dL vs. 10.3. g/dL, p < 0.001). Cohorts did not differ in treatment response rates (all p. =ns). Mean performance status differed between cohorts at each visit (all p ≤ 0.011); both groups showed significant improvements (both p < 0.001). Immediacy of response was a consistent determinant but was more pronounced among patients aged ≥ 70. Less consistent determinants included performance status in the age ≥ 70 group, as well as hematological malignancy and Hb at ESA start in the age < 70 group. The proportion of variance in Hb outcomes attributable to treatment center ranged from 0.090 to 0.289 in the age ≥ 70 cohort and 0.126 to 0.361 in the age < 70 cohort. Conclusions: Both groups achieved similar Hb levels with the age ≥ 70 cohort showing a higher initial evolution rate and potentially a different Hb response trajectory. Patients age ≥ 70 were more likely to benefit from ESAs if showing an early erythropoietic response and exhibiting no or little impairment in performance status. Differential attribution of variability in older vs. younger adults suggests that individualization of ESA therapy may facilitate Hb response in geriatric patients with cancer. © 2012 Elsevier Inc.
• Abraham, I., MacDonald, K., Tharmarajah, S., Bokemeyer, C., Ludwig, H., Soubeyran, P., Battistel, V., & Aapro, M. (2013). Modeling of treatment response to erythropoiesis-stimulating agents in older (age≥70years) and younger (age<70years) patients with cancer and anemia: findings from the Anemia Cancer Treatment study. Journal of geriatric oncology, 4(2), 196-201.
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  The Anemia Cancer Treatment study assessed hemoglobin (Hb) outcomes following treatment with erythropoiesis-stimulating agents (ESA) in anemic (Hb≤11g/dL) patients in Europe. We replicated the original analyses stratifying by age, namely patients aged ≥70 (n=637) versus those aged
• Abraham, I., Macdonald, K., Bagalagel, A., & Mohammed, A. (2013). Clinical efficacy and safety of Tevagrastim ® (XM02), a biosimilar recombinant human granulocyte colony-stimulating factor. Biosimilars, 3, 55-62. doi:10.2147/bs.s27712
• Abraham, I., Sun, D., Bagalagel, A., Altyar, A., Mohammed, A., Tharmarajah, S., & MacDonald, K. (2013). Biosimilars in 3D: Definition, development and differentiation. Bioengineered, 4(4), 203-206.
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  PMID: 23714845;PMCID: PMC3728190;
• Abraham, I., Sun, D., Bagalagel, A., Altyar, A., Mohammed, A., Tharmarajah, S., & MacDonald, K. (2013). Biosimilars in 3D: Definition, development and differentiation. Bioengineered, 4(Issue 4). doi:10.4161/bioe.25067
• Abraham, I., Sun, D., Bagalagel, A., Altyar, A., Mohammed, A., Tharmarajah, S., & MacDonald, K. (2013). Biosimilars in 3D: definition, development and differentiation. Bioengineered, 4(4), 203-6.
• Abraham, I., Tharmarajah, S., & MacDonald, K. (2013). Clinical safety of biosimilar recombinant human granulocyte colony-stimulating factors. Expert opinion on drug safety, 12(2), 235-46.
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  A 'biosimilar', or 'similar biological medicinal product', is a biologic agent that is similar in terms of quality, safety and efficacy to an authorized reference biological medicine. Since the expiration of the filgrastim patent in Europe, three agents have received marketing authorization from the EMA: Tevagrastim, Zarzio and Nivestim. Tevagrastim has also been approved as a biologic by the FDA as tbo-filgrastim.
• Abraham, I., Tharmarajah, S., & Macdonald, K. (2013). Clinical safety of biosimilar recombinant human granulocyte colony-stimulating factors. Expert Opinion on Drug Safety, 12(2), 235-246.
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  PMID: 23419039;Abstract: Introduction: A 'biosimilar', or 'similar biological medicinal product', is a biologic agent that is similar in terms of quality, safety and efficacy to an authorized reference biological medicine. Since the expiration of the filgrastim patent in Europe, three agents have received marketing authorization from the EMA: Tevagrastim, Zarzio and Nivestim. Tevagrastim has also been approved as a biologic by the FDA as tbo-filgrastim. Areas covered: Using the EMA dossiers (all three agents), the FDA dossier (Tevagrastim), and journal publications, this article reviews clinical safety data for these products with emphasis on serious/severe adverse events and special consideration of immunogenicity, bone pain, splenomegaly, allergic reactions, acute respiratory distress syndrome and mortality. Expert opinion: All three agents have similar safety profiles. None were statistically higher on safety parameters to what is known about originator filgrastim (Neupogen). What is known about filgrastim in general regarding safety can be extended to biosimilar filgrastim. Safety profiles may become more differentiated once long-term product-specific safety data are available. Large-sample, long-term, observational studies of real-world practice will provide the heterogeneity and statistical power to demonstrate product-specific safety profiles. Current evidence indicates that statistically no one product is less and no one product is more safe. © 2013 Informa UK, Ltd.
• Abraham, I., Van Camp, Y., Villa, L., Denhaerynck, K., Sun, D., Vancayzeele, S., Brié, H., Aerts, A., Hermans, C., & MacDonald, K. (2013). Hierarchical modeling of patient and physician determinants of blood pressure outcomes in adherent vs nonadherent hypertensive patients: pooled analysis of 6 studies with 14,646 evaluable patients. Journal of clinical hypertension (Greenwich, Conn.), 15(9), 663-73.
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  The authors used pooled data from 6 valsartan-related studies including 3983 adherent and 10,663 nonadherent patients to evaluate blood pressure (BP) outcomes in both groups after 90 days of treatment, applying hierarchical linear and logistic regression to identify determinants of BP outcomes. The principal findings were that: (1) BP outcomes were consistently better in adherent patients; (2) approximately a quarter of the variance in 90-day BP values was attributable to a physician class effect; (3) common and unique patient- and physician-related variables were associated with BP outcomes in both groups; (4) physician vigilance was associated with better outcomes, especially in adherent patients; and (5) adherent patients were more likely to exhibit target organ damage and associated events while being prescribed more complex medication regimens. Adherence to antihypertensive medication may be a function of prior line treatment failure, severity of illness, and sequelae, and the ensuing patient resolution to change medication behavior.
• Abraham, I., Van Camp, Y., Villa, L., Denhaerynck, K., Sun, D., Vancayzeele, S., Brié, H., Aerts, A., Hermans, C., & Macdonald, K. (2013). Hierarchical modeling of patient and physician determinants of blood pressure outcomes in adherent vs nonadherent hypertensive patients: Pooled analysis of 6 studies with 14,646 evaluable patients. Journal of Clinical Hypertension, 15(Issue 9). doi:10.1111/jch.12163
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  The authors used pooled data from 6 valsartan-related studies including 3983 adherent and 10,663 nonadherent patients to evaluate blood pressure (BP) outcomes in both groups after 90 days of treatment, applying hierarchical linear and logistic regression to identify determinants of BP outcomes. The principal findings were that: (1) BP outcomes were consistently better in adherent patients; (2) approximately a quarter of the variance in 90-day BP values was attributable to a physician class effect; (3) common and unique patient- and physician-related variables were associated with BP outcomes in both groups; (4) physician vigilance was associated with better outcomes, especially in adherent patients; and (5) adherent patients were more likely to exhibit target organ damage and associated events while being prescribed more complex medication regimens. Adherence to antihypertensive medication may be a function of prior line treatment failure, severity of illness, and sequelae, and the ensuing patient resolution to change medication behavior. © 2013 Wiley Periodicals, Inc.
• Dodds, S. E., Dodds, S. E., Herman, P. M., Herman, P. M., Sechrest, L., Sechrest, L., Abraham, I., Abraham, I., Logue, M. D., Logue, M. D., Grizzle, A. L., Grizzle, A. L., Rehfeld, R. A., Rehfeld, R. A., Urbine, T. J., Urbine, T. J., Horwitz, R., Horwitz, R., Crocker, R. L., , Crocker, R. L., et al. (2013). When a whole practice model is the intervention: Developing fidelity evaluation components using program theory-driven science for an integrative medicine primary care clinic. Evidence-based Complementary and Alternative Medicine, 2013(Issue). doi:10.1155/2013/652047
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  Integrative medicine (IM) is a clinical paradigm of whole person healthcare that combines appropriate conventional and complementary medicine (CM) treatments. Studies of integrative healthcare systems and theory-driven evaluations of IM practice models need to be undertaken. Two health services research methods can strengthen the validity of IM healthcare studies, practice theory, and fidelity evaluation. The University of Arizona Integrative Health Center (UAIHC) is a membership-supported integrative primary care clinic in Phoenix, AZ. A comparative effectiveness evaluation is being conducted to assess its clinical and cost outcomes. A process evaluation of the clinic's practice theory components assesses model fidelity for four purposes: (1) as a measure of intervention integrity to determine whether the practice model was delivered as intended; (2) to describe an integrative primary care clinic model as it is being developed and refined; (3) as potential covariates in the outcomes analyses, to assist in interpretation of findings, and for external validity and replication; and (4) to provide feedback for needed corrections and improvements of clinic operations over time. This paper provides a rationale for the use of practice theory and fidelity evaluation in studies of integrative practices and describes the approach and protocol used in fidelity evaluation of the UAIHC. © 2013 Sally E. Dodds et al.
• Dodds, S. E., Herman, P. M., Sechrest, L., Abraham, I., Logue, M. D., Grizzle, A. L., Rehfeld, R. A., Urbine, T. J., Horwitz, R., Crocker, R. L., & Maizes, V. H. (2013). When a whole practice model is the intervention: Developing fidelity evaluation components using program theory-driven science for an integrative medicine primary care clinic. Evidence-based Complementary and Alternative Medicine, 2013.
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  Abstract: Integrative medicine (IM) is a clinical paradigm of whole person healthcare that combines appropriate conventional and complementary medicine (CM) treatments. Studies of integrative healthcare systems and theory-driven evaluations of IM practice models need to be undertaken. Two health services research methods can strengthen the validity of IM healthcare studies, practice theory, and fidelity evaluation. The University of Arizona Integrative Health Center (UAIHC) is a membership-supported integrative primary care clinic in Phoenix, AZ. A comparative effectiveness evaluation is being conducted to assess its clinical and cost outcomes. A process evaluation of the clinic's practice theory components assesses model fidelity for four purposes: (1) as a measure of intervention integrity to determine whether the practice model was delivered as intended; (2) to describe an integrative primary care clinic model as it is being developed and refined; (3) as potential covariates in the outcomes analyses, to assist in interpretation of findings, and for external validity and replication; and (4) to provide feedback for needed corrections and improvements of clinic operations over time. This paper provides a rationale for the use of practice theory and fidelity evaluation in studies of integrative practices and describes the approach and protocol used in fidelity evaluation of the UAIHC. © 2013 Sally E. Dodds et al.
• Dodds, S. E., Herman, P. M., Sechrest, L., Abraham, I., Logue, M. D., Grizzle, A. L., Rehfeld, R. A., Urbine, T. J., Horwitz, R., Crocker, R. L., & Maizes, V. H. (2013). When a whole practice model is the intervention: developing fidelity evaluation components using program theory-driven science for an integrative medicine primary care clinic. Evidence-based complementary and alternative medicine : eCAM, 2013, 652047.
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  Integrative medicine (IM) is a clinical paradigm of whole person healthcare that combines appropriate conventional and complementary medicine (CM) treatments. Studies of integrative healthcare systems and theory-driven evaluations of IM practice models need to be undertaken. Two health services research methods can strengthen the validity of IM healthcare studies, practice theory, and fidelity evaluation. The University of Arizona Integrative Health Center (UAIHC) is a membership-supported integrative primary care clinic in Phoenix, AZ. A comparative effectiveness evaluation is being conducted to assess its clinical and cost outcomes. A process evaluation of the clinic's practice theory components assesses model fidelity for four purposes: (1) as a measure of intervention integrity to determine whether the practice model was delivered as intended; (2) to describe an integrative primary care clinic model as it is being developed and refined; (3) as potential covariates in the outcomes analyses, to assist in interpretation of findings, and for external validity and replication; and (4) to provide feedback for needed corrections and improvements of clinic operations over time. This paper provides a rationale for the use of practice theory and fidelity evaluation in studies of integrative practices and describes the approach and protocol used in fidelity evaluation of the UAIHC.
• Gesualdo, L., London, G., Turner, M., Lee, C., MacDonald, K., Goldsmith, D., Covic, A., Zaoui, P., Combe, C., Mann, J., Dellanna, F., Muenzberg, M., & Abraham, I. (2013). A pharmacoepidemiological study of the multi-level determinants, predictors, and clinical outcomes of biosimilar epoetin alfa for renal anaemia in haemodialysis patients: Background and methodology of the MONITOR-CKD5 study. Internal and Emergency Medicine, 8(5), 389-399.
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  PMID: 21590439;Abstract: Prior longitudinal observational studies have examined the practice patterns and outcomes of anaemia management, including the use of erythropoiesis-stimulating agents (ESAs). Several dimensions of effectiveness remain unaddressed; especially considering the revised ESA label (target Hb levels between 10 and 12 g/dL), the recently published TREAT study, and the European approval of the first ESA biosimilar (HX575). Anecdotal evidence suggests that patient outcomes are influenced by physician-related variables and whether anaemia management is congruent with practice guidelines, but this has not been studied systematically. MONITOR-CKD5 is an international, prospective, observational, pharmacoepidemiological study evaluating the multi-level factors and outcomes of treatment with HX575 for renal anaemia in haemodialysis patients. Driven by a novel, integrated, multi-focal framework for post-approval observational studies, it examines determinants of response at both the patient and the physician level; integrates an advocated statistical methodology here to fore used mainly in the social and behavioural sciences; assesses factors potentially predictive of a poor treatment response; and evaluates the extent to which treatment is congruent with evidence-based guidelines, good practice evidence, and the revised ESA label. This pan-European study will recruit at least 1,000 patients from a minimum of 75 centres, and follow them for up to 24 months following initiation of anaemia management with biosimilar epoetin alfa. MONITOR-CKD5 will not only study the core issues addressed by prior observational studies but also aims to take knowledge discovery a step further by assessing outcomes across varying cohorts of patients, and examining the impact of evidence-based practice on clinical outcomes, differentiating, in the process, between physician-level and patient-level determinants. © 2011 SIMI.
• Gesualdo, L., London, G., Turner, M., Lee, C., MacDonald, K., Goldsmith, D., Covic, A., Zaoui, P., Combe, C., Mann, J., Dellanna, F., Muenzberg, M., & Abraham, I. (2013). A pharmacoepidemiological study of the multi-level determinants, predictors, and clinical outcomes of biosimilar epoetin alfa for renal anaemia in haemodialysis patients: Background and methodology of the MONITOR-CKD5 study. Internal and Emergency Medicine, 8(Issue 5). doi:10.1007/s11739-011-0622-7
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  Prior longitudinal observational studies have examined the practice patterns and outcomes of anaemia management, including the use of erythropoiesis-stimulating agents (ESAs). Several dimensions of effectiveness remain unaddressed; especially considering the revised ESA label (target Hb levels between 10 and 12 g/dL), the recently published TREAT study, and the European approval of the first ESA biosimilar (HX575). Anecdotal evidence suggests that patient outcomes are influenced by physician-related variables and whether anaemia management is congruent with practice guidelines, but this has not been studied systematically. MONITOR-CKD5 is an international, prospective, observational, pharmacoepidemiological study evaluating the multi-level factors and outcomes of treatment with HX575 for renal anaemia in haemodialysis patients. Driven by a novel, integrated, multi-focal framework for post-approval observational studies, it examines determinants of response at both the patient and the physician level; integrates an advocated statistical methodology here to fore used mainly in the social and behavioural sciences; assesses factors potentially predictive of a poor treatment response; and evaluates the extent to which treatment is congruent with evidence-based guidelines, good practice evidence, and the revised ESA label. This pan-European study will recruit at least 1,000 patients from a minimum of 75 centres, and follow them for up to 24 months following initiation of anaemia management with biosimilar epoetin alfa. MONITOR-CKD5 will not only study the core issues addressed by prior observational studies but also aims to take knowledge discovery a step further by assessing outcomes across varying cohorts of patients, and examining the impact of evidence-based practice on clinical outcomes, differentiating, in the process, between physician-level and patient-level determinants. © 2011 SIMI.
• Gesualdo, L., London, G., Turner, M., Lee, C., Macdonald, K., Goldsmith, D., Covic, A., Zaoui, P., Combe, C., Mann, J., Dellanna, F., Muenzberg, M., & Abraham, I. (2013). A pharmacoepidemiological study of the multi-level determinants, predictors, and clinical outcomes of biosimilar epoetin alfa for renal anaemia in haemodialysis patients: background and methodology of the MONITOR-CKD5 study. Internal and emergency medicine, 8(5), 389-99.
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  Prior longitudinal observational studies have examined the practice patterns and outcomes of anaemia management, including the use of erythropoiesis-stimulating agents (ESAs). Several dimensions of effectiveness remain unaddressed; especially considering the revised ESA label (target Hb levels between 10 and 12 g/dL), the recently published TREAT study, and the European approval of the first ESA biosimilar (HX575). Anecdotal evidence suggests that patient outcomes are influenced by physician-related variables and whether anaemia management is congruent with practice guidelines, but this has not been studied systematically. MONITOR-CKD5 is an international, prospective, observational, pharmacoepidemiological study evaluating the multi-level factors and outcomes of treatment with HX575 for renal anaemia in haemodialysis patients. Driven by a novel, integrated, multi-focal framework for post-approval observational studies, it examines determinants of response at both the patient and the physician level; integrates an advocated statistical methodology here to fore used mainly in the social and behavioural sciences; assesses factors potentially predictive of a poor treatment response; and evaluates the extent to which treatment is congruent with evidence-based guidelines, good practice evidence, and the revised ESA label. This pan-European study will recruit at least 1,000 patients from a minimum of 75 centres, and follow them for up to 24 months following initiation of anaemia management with biosimilar epoetin alfa. MONITOR-CKD5 will not only study the core issues addressed by prior observational studies but also aims to take knowledge discovery a step further by assessing outcomes across varying cohorts of patients, and examining the impact of evidence-based practice on clinical outcomes, differentiating, in the process, between physician-level and patient-level determinants.
• Kim, H., Abraham, I., & Malone, P. S. (2013). Analytical methods and issues for symptom cluster research in oncology. Current Opinion in Supportive and Palliative Care, 7(1), 45-53.
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  PMID: 23196378;Abstract: Purpose of review Within a broader perspective on the next challenges in oncologic symptom cluster research, the objectives of this review are to examine the statistical methods that have been used to quantify and/or model the dynamic nature of symptom clustering, the methodological issues associated with those methods, and the statistical modeling techniques for the underlying mechanisms of symptom clustering. Recent findings Correlation, factor analysis, principal component analysis, and cluster analysis are analytical methods to identify symptom clusters and/or to examine the influence of symptom clusters on patient outcomes. More recent techniques include latent variable methods, such as latent profile analysis, to examine the phenotypes of symptom cluster experience and growth modeling to examine the longitudinal nature of symptom cluster experience. Future endeavors include an investigation of the underlying mechanisms of symptom clustering using longitudinal data analysis. The methodological issues include the domain of the symptoms, measurement errors, stability of the solution within the data, measurement timing, and sample size. Summary Each method has unique strengths and weaknesses, and the method choice should be driven by the aims and research questions of a given study. © 2013 Wolters Kluwer Health Lippincott Williams and Wilkins.
• Kim, H., Abraham, I., & Malone, P. S. (2013). Analytical methods and issues for symptom cluster research in oncology. Current opinion in supportive and palliative care, 7(1), 45-53.
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  Within a broader perspective on the next challenges in oncologic symptom cluster research, the objectives of this review are to examine the statistical methods that have been used to quantify and/or model the dynamic nature of symptom clustering, the methodological issues associated with those methods, and the statistical modeling techniques for the underlying mechanisms of symptom clustering.
• Maa, S. H., Wang, C. H., Hsu, K. H., Lin, H. C., Yee, B., Macdonald, K., & Abraham, I. (2013). Acupressure improves the weaning indices of tidal volumes and rapid shallow breathing index in stable coma patients receiving mechanical ventilation: Randomized controlled trial. Evidence-based Complementary and Alternative Medicine, 2013(Issue). doi:10.1155/2013/723128
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  Background. Acupressure has been shown to improve respiratory parameters. We investigated the effects of acupressure on weaning indices in stable coma patients receiving mechanical ventilation. Methods. Patients were randomly allocated to one of three treatments: standard care with adjunctive acupressure on one (n = 32) or two days (n = 31) and standard care (n = 31). Acupressure in the form of 10 minutes of bilateral stimulation at five acupoints was administered per treatment session. Weaning indices were collected on two days before, right after, and at 0.5 hrs, 1 hr, 1.5 hrs, 2 hrs, 2.5 hrs, 3 hrs, 3.5 hrs, and 4 hrs after the start of treatment. Results. There were statistically significant improvements in tidal volumes and index of rapid shallow breathing in the one-day and two-day adjunctive acupressure study arms compared to the standard care arm immediately after acupressure and persisting until 0.5, 1 hr, and 2 hrs after adjustment for covariates. Conclusions. In the stable ventilated coma patient, adjunctive acupressure contributes to improvements in tidal volumes and the index of rapid shallow breathing, the two indices most critical for weaning patients from mechanical ventilation. These effects tend to be immediate and likely to be sustained for 1 to 2 hours. © 2013 Suh-Hwa Maa et al.
• Maa, S., Wang, C., Hsu, K., Lin, H., Yee, B., Macdonald, K., & Abraham, I. (2013). Acupressure improves the weaning indices of tidal volumes and rapid shallow breathing index in stable coma patients receiving mechanical ventilation: Randomized controlled trial. Evidence-based Complementary and Alternative Medicine, 2013.
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  PMID: 23710234;PMCID: PMC3655565;Abstract: Background. Acupressure has been shown to improve respiratory parameters. We investigated the effects of acupressure on weaning indices in stable coma patients receiving mechanical ventilation. Methods. Patients were randomly allocated to one of three treatments: standard care with adjunctive acupressure on one (n = 32) or two days (n = 31) and standard care (n = 31). Acupressure in the form of 10 minutes of bilateral stimulation at five acupoints was administered per treatment session. Weaning indices were collected on two days before, right after, and at 0.5 hrs, 1 hr, 1.5 hrs, 2 hrs, 2.5 hrs, 3 hrs, 3.5 hrs, and 4 hrs after the start of treatment. Results. There were statistically significant improvements in tidal volumes and index of rapid shallow breathing in the one-day and two-day adjunctive acupressure study arms compared to the standard care arm immediately after acupressure and persisting until 0.5, 1 hr, and 2 hrs after adjustment for covariates. Conclusions. In the stable ventilated coma patient, adjunctive acupressure contributes to improvements in tidal volumes and the index of rapid shallow breathing, the two indices most critical for weaning patients from mechanical ventilation. These effects tend to be immediate and likely to be sustained for 1 to 2 hours. © 2013 Suh-Hwa Maa et al.
• Maa, S., Wang, C., Hsu, K., Lin, H., Yee, B., Macdonald, K., & Abraham, I. (2013). Acupressure improves the weaning indices of tidal volumes and rapid shallow breathing index in stable coma patients receiving mechanical ventilation: randomized controlled trial. Evidence-based complementary and alternative medicine : eCAM, 2013, 723128.
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  Background. Acupressure has been shown to improve respiratory parameters. We investigated the effects of acupressure on weaning indices in stable coma patients receiving mechanical ventilation. Methods. Patients were randomly allocated to one of three treatments: standard care with adjunctive acupressure on one (n = 32) or two days (n = 31) and standard care (n = 31). Acupressure in the form of 10 minutes of bilateral stimulation at five acupoints was administered per treatment session. Weaning indices were collected on two days before, right after, and at 0.5 hrs, 1 hr, 1.5 hrs, 2 hrs, 2.5 hrs, 3 hrs, 3.5 hrs, and 4 hrs after the start of treatment. Results. There were statistically significant improvements in tidal volumes and index of rapid shallow breathing in the one-day and two-day adjunctive acupressure study arms compared to the standard care arm immediately after acupressure and persisting until 0.5, 1 hr, and 2 hrs after adjustment for covariates. Conclusions. In the stable ventilated coma patient, adjunctive acupressure contributes to improvements in tidal volumes and the index of rapid shallow breathing, the two indices most critical for weaning patients from mechanical ventilation. These effects tend to be immediate and likely to be sustained for 1 to 2 hours.
• MacDonald, K., Brié, H., Vancayzeele, S., Lee, C., Bowles, J., Piotrowski, K., Hermans, C., & Abraham, I. (2013). Modelling of blood pressure outcomes in patients with and without established cardiovascular or renal disease following treatment with valsartan (the PREVIEW study). Archives of Cardiovascular Diseases, 106(3), 124-134.
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  PMID: 23582674;Abstract: Background: Hypertensive patients with established cardiovascular or renal disease (ECVRD) have an added 10-year risk of cardiovascular events, classified by the European Society of Hypertension/European Society of Cardiology as 'very high'. Aims: To identify determinants of blood pressure (BP) outcomes in hypertensive patients with and without ECVRD treated in second-line with valsartan. Methods: This was a subgroup analysis comparing patients with and without ECVRD who participated in the PREVIEW study, a 90-day observational prospective effectiveness study of valsartan, conducted in Belgium. Two-level (patients 'nested' under physicians) hierarchical linear and logistic modelling of BP values and BP control (140/90 mmHg; 130/80 mmHg for diabetics) at 90 days was applied to data from 1107 patients with and 2087 patients without ECVRD treated with valsartan by 504 general practitioners. Results: Absolute reductions in BP were similar across subgroups, with minor variations in actual BP levels in general and by subgroup. Fewer patients with versus without ECVRD achieved targets for systolic BP, diastolic BP and combined systolic/diastolic BP control. Variability in BP values and control at 90 days attributable to a physician-level class effect ranged from 24.6% to 28.1% and 15.0% to 22.4%, respectively. Physician- and patient-related determinants of 90-day BP outcomes varied considerably between the two subgroups. Conclusion: Several determinants of BP outcomes were identified comparing patients with and without ECVRD, including amenable physician-level and patient-level factors and warning signs for continued risk of uncontrolled BP. ECVRD patients present with differential characteristics, conditions and determinants that mandate individualized attention to complement general evidence-based antihypertensive treatment. © 2013 Elsevier Masson SAS.
• MacDonald, K., Brié, H., Vancayzeele, S., Lee, C., Bowles, J., Piotrowski, K., Hermans, C., & Abraham, I. (2013). Modelling of blood pressure outcomes in patients with and without established cardiovascular or renal disease following treatment with valsartan (the PREVIEW study). Archives of Cardiovascular Diseases, 106(Issue 3). doi:10.1016/j.acvd.2012.11.006
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  Background: Hypertensive patients with established cardiovascular or renal disease (ECVRD) have an added 10-year risk of cardiovascular events, classified by the European Society of Hypertension/European Society of Cardiology as 'very high'. Aims: To identify determinants of blood pressure (BP) outcomes in hypertensive patients with and without ECVRD treated in second-line with valsartan. Methods: This was a subgroup analysis comparing patients with and without ECVRD who participated in the PREVIEW study, a 90-day observational prospective effectiveness study of valsartan, conducted in Belgium. Two-level (patients 'nested' under physicians) hierarchical linear and logistic modelling of BP values and BP control (140/90 mmHg; 130/80 mmHg for diabetics) at 90 days was applied to data from 1107 patients with and 2087 patients without ECVRD treated with valsartan by 504 general practitioners. Results: Absolute reductions in BP were similar across subgroups, with minor variations in actual BP levels in general and by subgroup. Fewer patients with versus without ECVRD achieved targets for systolic BP, diastolic BP and combined systolic/diastolic BP control. Variability in BP values and control at 90 days attributable to a physician-level class effect ranged from 24.6% to 28.1% and 15.0% to 22.4%, respectively. Physician- and patient-related determinants of 90-day BP outcomes varied considerably between the two subgroups. Conclusion: Several determinants of BP outcomes were identified comparing patients with and without ECVRD, including amenable physician-level and patient-level factors and warning signs for continued risk of uncontrolled BP. ECVRD patients present with differential characteristics, conditions and determinants that mandate individualized attention to complement general evidence-based antihypertensive treatment. © 2013 Elsevier Masson SAS.
• Macdonald, K., Brié, H., Vancayzeele, S., Lee, C., Bowles, J., Piotrowski, K., Hermans, C., & Abraham, I. (2013). Modelling of blood pressure outcomes in patients with and without established cardiovascular or renal disease following treatment with valsartan (the PREVIEW study). Archives of cardiovascular diseases, 106(3), 124-34.
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  Hypertensive patients with established cardiovascular or renal disease (ECVRD) have an added 10-year risk of cardiovascular events, classified by the European Society of Hypertension/European Society of Cardiology as 'very high'.
• Rakic, J. M., Leys, A., Brié, H., Denhaerynck, K., Pacheco, C., Vancayzeele, S., Hermans, C., MacDonald, K., & Abraham, I. (2013). Real-world variability in ranibizumab treatment and associated clinical, quality of life, and safety outcomes over 24 months in patients with neovascular age-related macular degeneration: The HELIOS study. Clinical Ophthalmology, 7(Issue). doi:10.2147/opth.s49385
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  Introduction: The aim of this study was to examine ranibizumab treatment patterns in "real-world" practice and clinical settings, as well as to assess quality of life outcomes over a 24-month period. Materials and methods: This was a prospective, observational, multicenter, open-label study of 0.5 mg of ranibizumab administered intravitreally. Patients were followed over 24 ± 3 months with intermediate data points at 6 ± 2 months and 12 ± 2 months, and a limited data point at 2.5 ± 1 month that coincided with the end of the loading phase. Outcomes included visual acuity (Early Treatment Diabetic Retinopathy Study), visual function (National Eye Institute Visual Function Questionnaire-25 [NEI VFQ-25]), quality of life (Health Utilities Index Mark III [HUI3]), and safety. Results: A total of 267 patients with wet age-related macular degeneration (mean ± standard deviation [SD] age = 78.5 ± 7.3 years; 62.4% were female; 34.5% with dual eye involvement; 74.9% were treatment-naïve) were treated (309 eyes were treated). The mean ± SD Early Treatment Diabetic Retinopathy Study score at baseline was 56.3 ± 14.3 letters. The mean ± SD number of injections over 24 months was 7.6 ± 4.1, including 2.5 ± 0.7 and 5.9 ± 3.6 during the loading and maintenance phases, respectively, with corresponding treatment intervals of 4.8 ± 1.4 weeks and 11.5 ± 9.5 weeks, respectively. Improvements in visual acuity over baseline were reached at 2.5 months and maintained at 6 months (both P < 0.0001). The mean visual acuity increase over baseline at 12 months was not significant (P = 0.08); the decline over baseline at 24 months statistically significant (P = 0.02). Overall, 94.3% of patients showed stable or improved disease at 6 months and 81.5% of patients showed stable or improved disease at 24 months. At 6 months, improvements over baseline were significant for VFQ-25 (P = 0.03) and HUI3 (P = 0.02), but not at 12 months and 24 months. Improvements in VFQ-25 and HUI3 were maintained at 24 months in 38% and 34% of patients, respectively. In total 78 serious adverse events were reported in 40 patients and 77 nonserious adverse events in 34 patients. Nine serious adverse events and nine nonserious adverse events in 14 patients were suspected to be related to ranibizumab treatment. Conclusion: The "real-world" clinical effectiveness of ranibizumab was evidenced by the initial improvements over baseline in visual acuity and quality of life, as well as the maintenance of these outcomes at baseline levels at 24 months, and this was observed under variable treatment conditions. The findings underscore the need for individualized treatment with regular monitoring to achieve optimal vision and quality of life outcomes. © 2013 Rakic et al.
• Rakic, J., Leys, A., Brié, H., Denhaerynck, K., Pacheco, C., Vancayzeele, S., Hermans, C., MacDonald, K., & Abraham, I. (2013). Real-world variability in ranibizumab treatment and associated clinical, quality of life, and safety outcomes over 24 months in patients with neovascular age-related macular degeneration: The HELIOS study. Clinical Ophthalmology, 7, 1849-1858.
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  PMID: 24092964;PMCID: PMC3788820;Abstract: Introduction: The aim of this study was to examine ranibizumab treatment patterns in "real-world" practice and clinical settings, as well as to assess quality of life outcomes over a 24-month period. Materials and methods: This was a prospective, observational, multicenter, open-label study of 0.5 mg of ranibizumab administered intravitreally. Patients were followed over 24 ± 3 months with intermediate data points at 6 ± 2 months and 12 ± 2 months, and a limited data point at 2.5 ± 1 month that coincided with the end of the loading phase. Outcomes included visual acuity (Early Treatment Diabetic Retinopathy Study), visual function (National Eye Institute Visual Function Questionnaire-25 [NEI VFQ-25]), quality of life (Health Utilities Index Mark III [HUI3]), and safety. Results: A total of 267 patients with wet age-related macular degeneration (mean ± standard deviation [SD] age = 78.5 ± 7.3 years; 62.4% were female; 34.5% with dual eye involvement; 74.9% were treatment-naïve) were treated (309 eyes were treated). The mean ± SD Early Treatment Diabetic Retinopathy Study score at baseline was 56.3 ± 14.3 letters. The mean ± SD number of injections over 24 months was 7.6 ± 4.1, including 2.5 ± 0.7 and 5.9 ± 3.6 during the loading and maintenance phases, respectively, with corresponding treatment intervals of 4.8 ± 1.4 weeks and 11.5 ± 9.5 weeks, respectively. Improvements in visual acuity over baseline were reached at 2.5 months and maintained at 6 months (both P < 0.0001). The mean visual acuity increase over baseline at 12 months was not significant (P = 0.08); the decline over baseline at 24 months statistically significant (P = 0.02). Overall, 94.3% of patients showed stable or improved disease at 6 months and 81.5% of patients showed stable or improved disease at 24 months. At 6 months, improvements over baseline were significant for VFQ-25 (P = 0.03) and HUI3 (P = 0.02), but not at 12 months and 24 months. Improvements in VFQ-25 and HUI3 were maintained at 24 months in 38% and 34% of patients, respectively. In total 78 serious adverse events were reported in 40 patients and 77 nonserious adverse events in 34 patients. Nine serious adverse events and nine nonserious adverse events in 14 patients were suspected to be related to ranibizumab treatment. Conclusion: The "real-world" clinical effectiveness of ranibizumab was evidenced by the initial improvements over baseline in visual acuity and quality of life, as well as the maintenance of these outcomes at baseline levels at 24 months, and this was observed under variable treatment conditions. The findings underscore the need for individualized treatment with regular monitoring to achieve optimal vision and quality of life outcomes. © 2013 Rakic et al.
• Rakic, J., Leys, A., Brié, H., Denhaerynck, K., Pacheco, C., Vancayzeele, S., Hermans, C., Macdonald, K., & Abraham, I. (2013). Real-world variability in ranibizumab treatment and associated clinical, quality of life, and safety outcomes over 24 months in patients with neovascular age-related macular degeneration: the HELIOS study. Clinical ophthalmology (Auckland, N.Z.), 7, 1849-58.
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  The aim of this study was to examine ranibizumab treatment patterns in "real-world" practice and clinical settings, as well as to assess quality of life outcomes over a 24-month period.
• Rastogi, A., Robinson, B. M., Locatelli, F., Kleophas, W., Goldsmith, D., Goldsmith, D., Rottembourg, J. B., Abraham, I., Abraham, I., Ambrus, C., Barany, P., Beck, W., Benke, A., Beshara, S., Borbas, B., Brunelli, S. M., Carmelo, I. G., Casero, R. C., Chmielewski, M., , Clyne, N., et al. (2013). Anaemia in CKD 5D. Nephrology Dialysis Transplantation, 28(suppl 1), i240-i248. doi:10.1093/ndt/gft119
• Swimberghe, S., Ghislain, P. D., Daci, E., Allewaert, K., Denhaerynck, K., Hermans, C., Pacheco, C., Vancayzeele, S., MacDonald, K., & Abraham, I. (2013). Clinical, quality of life, patient adherence, and safety outcomes of short-course (12 Weeks) treatment with cyclosporine in patients with severe psoriasis (the practice study). Annals of Dermatology, 25(Issue 1). doi:10.5021/ad.2013.25.1.28
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  Apart from clinical outcomes, the "realworld" outcomes of intermittent short-course cyclosporine treatment remain poorly documented. Objective: To evaluate various outcomes of short-course cyclosporine treatment for severe psoriasis; and to describe dermatologists' use of the Rule of Tens. Methods: A 12-week pharmacoepidemiological study; 112 evaluable patients recruited by 43 dermatologists. Results: The mean initial cyclosporine dose was 2.88±0.74 mg/kg/day. At 12 weeks, 64.3% of patients were continued beyond the study period at mean dose of 2.51±0.91 mg/kg/day. Percent body surface affected, Psoriasis Area Severity Index score, and patient and physician rating of psoriasis severity decreased significantly, while quality of life (QoL) improved significantly. Median patient satisfaction at 12 weeks was 85 (0∼100 scale). Patient-reported non-adherence was 43.9% and 56.1%, respectively at both the time points (p=0.18). In modeling on logarithmized outcomes variables, living along was consistently the single most important (negative) determinant of therapeutic and patient outcomes. Safety and tolerance parameters were similar to the ones reported in the literature. Only 7.3% of physicians correctly identified the measures included in the Rule of Tens and the Rule's criterion for inferring severe psoriasis. Conclusion: With adequate monitoring and patient adherence, cyclosporine treatment reduces the severity of severe psoriasis, improves QoL, and is appropriately tolerated; leading to high patient satisfaction. Social support is a key determinant of therapeutic and patient outcomes and patients living along may require clinical attention. The relevance of the Rule of Tens was not evident.
• Swimberghe, S., Ghislain, P., Daci, E., Allewaert, K., Denhaerynck, K., Hermans, C., Pacheco, C., Vancayzeele, S., MacDonald, K., & Abraham, I. (2013). Clinical, quality of life, patient adherence, and safety outcomes of short-course (12 Weeks) treatment with cyclosporine in patients with severe psoriasis (the practice study). Annals of Dermatology, 25(1), 28-35.
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  PMID: 23467644;PMCID: PMC3582925;Abstract: Apart from clinical outcomes, the "realworld" outcomes of intermittent short-course cyclosporine treatment remain poorly documented. Objective: To evaluate various outcomes of short-course cyclosporine treatment for severe psoriasis; and to describe dermatologists' use of the Rule of Tens. Methods: A 12-week pharmacoepidemiological study; 112 evaluable patients recruited by 43 dermatologists. Results: The mean initial cyclosporine dose was 2.88±0.74 mg/kg/day. At 12 weeks, 64.3% of patients were continued beyond the study period at mean dose of 2.51±0.91 mg/kg/day. Percent body surface affected, Psoriasis Area Severity Index score, and patient and physician rating of psoriasis severity decreased significantly, while quality of life (QoL) improved significantly. Median patient satisfaction at 12 weeks was 85 (0∼100 scale). Patient-reported non-adherence was 43.9% and 56.1%, respectively at both the time points (p=0.18). In modeling on logarithmized outcomes variables, living along was consistently the single most important (negative) determinant of therapeutic and patient outcomes. Safety and tolerance parameters were similar to the ones reported in the literature. Only 7.3% of physicians correctly identified the measures included in the Rule of Tens and the Rule's criterion for inferring severe psoriasis. Conclusion: With adequate monitoring and patient adherence, cyclosporine treatment reduces the severity of severe psoriasis, improves QoL, and is appropriately tolerated; leading to high patient satisfaction. Social support is a key determinant of therapeutic and patient outcomes and patients living along may require clinical attention. The relevance of the Rule of Tens was not evident.
• Swimberghe, S., Ghislain, P., Daci, E., Allewaert, K., Denhaerynck, K., Hermans, C., Pacheco, C., Vancayzeele, S., Macdonald, K., & Abraham, I. (2013). Clinical, Quality of Life, Patient Adherence, and Safety Outcomes of Short-Course (12 Weeks) Treatment with Cyclosporine in Patients with Severe Psoriasis (the Practice Study). Annals of dermatology, 25(1), 28-35.
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  Apart from clinical outcomes, the "real-world" outcomes of intermittent short-course cyclosporine treatment remain poorly documented.
• Tucker, G., Clark, N. K., & Abraham, I. (2013). Enhancing ED Triage to Accommodate the Special Needs of Geriatric Patients. Journal of Emergency Nursing, 39(3), 309-314.
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  PMID: 23647994;
• Tucker, G., Clark, N. K., & Abraham, I. (2013). Enhancing ED Triage to Accommodate the Special Needs of Geriatric Patients. Journal of Emergency Nursing, 39(Issue 3). doi:10.1016/j.jen.2010.07.007
• Tucker, G., Clark, N. K., & Abraham, I. (2013). Enhancing ED triage to accommodate the special needs of geriatric patients. Journal of emergency nursing: JEN : official publication of the Emergency Department Nurses Association, 39(3), 309-14.
• Aapro, M., Cornes, P., & Abraham, I. (2012). Comparative cost-efficiency across the European G5 countries of various regimens of filgrastim, biosimilar filgrastim, and pegfilgrastim to reduce the incidence of chemotherapy-induced febrile neutropenia. Journal of Oncology Pharmacy Practice, 18(2), 171-179.
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  PMID: 21610020;Abstract: Objectives: This cost-efficiency analysis of the granulocyte colony-stimulating factors (G-CSF) filgrastim (originator Neupogen® and biosimilar Zarzio®) and pegfilgrastim (Neulasta®) examined against a time horizon of 1-14 days of treatment and across the European Union G5 countries (a) when, cost-wise, using Neulasta® 6 mg versus Neupogen® or Zarzio® 300 μg may be cost-saving in reducing the incidence of chemotherapy-induced febrile neutropenia; and (b) if cost-wise, treatment with Zarzio® 300 μg yields a savings advantage over Neupogen® 300 μg.Methods: Cost-efficiency analysis of the direct costs a buyer or payer would incur when purchasing or covering any of these agents for managing one patient during one cycle of chemotherapy under regimens of 1-14 days of standard filgrastim using the population-weighted average unit dose cost of each agent per their public pack cost across the European G5 countries.Results: The cost of Neupogen® treatment ranged from €128.16 (1 day) to €1794.30 (14 days), compared to €95.46 and €1336.46 for Zarzio®, thus yielding potential cost savings from €32.70 to €457.84 for the latter. Neulasta® turns cost-saving at day 12 of Neupogen® treatment. At no point over a 14-day treatment period did Neulasta® yield a savings advantage over Zarzio®.Conclusion: Prophylaxis or treatment of febrile neutropenia with Zarzio® is cost-efficient under all possible treatment scenarios relative to Neupogen® and to Neulasta®. In the absence of convincing evidence that pegfilgrastim is pharmacotherapeutically superior to standard filgrastim, there is no cost-efficiency rationale to treat with Neulasta® over Zarzio®, though there may be a small window of approximately 3 days where Neulasta® is cost-efficient over Neupogen®. Regardless, our analysis shows Zarzio® to be the most cost-efficient approach to reducing the incidence of febrile neutropenia in chemotherapy-treated patients. © The Author(s) 2011.
• Aapro, M., Cornes, P., & Abraham, I. (2012). Comparative cost-efficiency across the European G5 countries of various regimens of filgrastim, biosimilar filgrastim, and pegfilgrastim to reduce the incidence of chemotherapy-induced febrile neutropenia. Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners, 18(2), 171-9.
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  This cost-efficiency analysis of the granulocyte colony-stimulating factors (G-CSF) filgrastim (originator Neupogen® and biosimilar Zarzio®) and pegfilgrastim (Neulasta®) examined against a time horizon of 1-14 days of treatment and across the European Union G5 countries (a) when, cost-wise, using Neulasta® 6 mg versus Neupogen® or Zarzio® 300 µg may be cost-saving in reducing the incidence of chemotherapy-induced febrile neutropenia; and (b) if cost-wise, treatment with Zarzio® 300 µg yields a savings advantage over Neupogen® 300 µg.
• Aapro, M., Cornes, P., Sun, D., & Abraham, I. (2012). Comparative cost efficiency across the European G5 countries of originators and a biosimilar erythropoiesis-stimulating agent to manage chemotherapy-induced anemia in patients with cancer. Therapeutic Advances in Medical Oncology, 4(3), 95-105.
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  PMID: 22590483;PMCID: PMC3349078;Abstract: Objectives: To evaluate the comparative cost efficiency across the European Union G5 countries of the erythropoiesis-stimulating agents (ESAs) epoetin α (originator [Eprex] and biosimilar [Binocrit®] once weekly), epoetin β (NeoRecormon® once weekly), and darbepoetin α (Aranesp® once weekly or once every 3 weeks) under different scenarios of fixed and weight-based dosing in the management of chemotherapy-induced anemia.Methods: Direct costs of ESA treatment were calculated for one patient with cancer undergoing chemotherapy (six cycles at 3-week intervals) with ESA initiated at week 4 and continued for 15 weeks. Five scenarios were developed under fixed and weight-based dosing: continuous standard dose for 15 weeks; sustained dose escalation to 1.5× or double the standard dose at week 7, continued for 12 weeks; and discontinued dose escalation to 1.5× or double the standard dose at week 7 for a 3-week period, then 9 weeks of standard dose.Results: Under fixed dosing, the average cost of biosimilar epoetin α treatment across scenarios was €4643 (30,000 IU) or €6178 (40,000 IU). Corresponding estimates were €7168 for originator epoetin α, €7389 for epoetin β, €8299 for darbepoetin α once weekly, and €9221 for darbepoetin α once every 3 weeks. Under weight-based dosing, the average cost of biosimilar epoetin α treatment across scenarios was €4726. Corresponding estimates were €5484 for originator epoetin α, €5652 for epoetin β, and €8465 for both darbepoetin α once weekly and once every three weeks.Conclusion: Managing chemotherapy-induced anemia with biosimilar epoetin α is consistently cost efficient over treatment with originator epoetin α, epoetin β, and darbepoetin α under both fixed and weight-based dosing scenarios. © The Author(s), 2012.
• Aapro, M., Cornes, P., Sun, D., & Abraham, I. (2012). Comparative cost efficiency across the European G5 countries of originators and a biosimilar erythropoiesis-stimulating agent to manage chemotherapy-induced anemia in patients with cancer. Therapeutic Advances in Medical Oncology, 4(Issue 3). doi:10.1177/1758834012444499
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  Objectives: To evaluate the comparative cost efficiency across the European Union G5 countries of the erythropoiesis-stimulating agents (ESAs) epoetin α (originator [Eprex®] and biosimilar [Binocrit®]; once weekly), epoetin β (NeoRecormon®; once weekly), and darbepoetin α (Aranesp®; once weekly or once every 3 weeks) under different scenarios of fixed and weight-based dosing in the management of chemotherapy-induced anemia. Methods: Direct costs of ESA treatment were calculated for one patient with cancer undergoing chemotherapy (six cycles at 3-week intervals) with ESA initiated at week 4 and continued for 15 weeks. Five scenarios were developed under fixed and weight-based dosing: continuous standard dose for 15 weeks; sustained dose escalation to 1.5× or double the standard dose at week 7, continued for 12 weeks; and discontinued dose escalation to 1.5× or double the standard dose at week 7 for a 3-week period, then 9 weeks of standard dose. Results: Under fixed dosing, the average cost of biosimilar epoetin α treatment across scenarios was €4643 (30,000 IU) or €6178 (40,000 IU). Corresponding estimates were €7168 for originator epoetin α, €7389 for epoetin β, €8299 for darbepoetin α once weekly, and €9221 for darbepoetin α once every 3 weeks. Under weight-based dosing, the average cost of biosimilar epoetin α treatment across scenarios was €4726. Corresponding estimates were €5484 for originator epoetin α, €5652 for epoetin β, and €8465 for both darbepoetin α once weekly and once every three weeks. Conclusion: Managing chemotherapy-induced anemia with biosimilar epoetin α is consistently cost efficient over treatment with originator epoetin α, epoetin β, and darbepoetin α under both fixed and weight-based dosing scenarios. © 2012, SAGE Publications. All rights reserved.
• Aapro, M., Cornes, P., Sun, D., & Abraham, I. (2012). Comparative cost efficiency across the European G5 countries of originators and a biosimilar erythropoiesis-stimulating agent to manage chemotherapy-induced anemia in patients with cancer. Therapeutic advances in medical oncology, 4(3), 95-105.
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  To evaluate the comparative cost efficiency across the European Union G5 countries of the erythropoiesis-stimulating agents (ESAs) epoetin α (originator [Eprex®] and biosimilar [Binocrit®]; once weekly), epoetin β (NeoRecormon®; once weekly), and darbepoetin α (Aranesp®; once weekly or once every 3 weeks) under different scenarios of fixed and weight-based dosing in the management of chemotherapy-induced anemia.
• Abraham, I., & Bootman, J. L. (2012). Why pharmacoeconomic policy should be transnational. Pharmaceuticals Policy and Law, 14(1), 7-16.
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  Abstract: There is an inherent disconnect between the global-level endeavor of innovating pharmacotherapeutics and the (still) national-level of decision-making about access to innovation. In this paper, we argue that rational pharmacoeconomic policy should not be at the national, neither at the supranational, but at the transnational level: based on the relative similarity of countries in terms of their per capita health care spending. The 2010 OECD Health database, complemented as necessary with secondary data sources to substitute for missing data, was used to compile an analysis sample of all but two OECD countries (Chile and Greece) with data through 2007. We first established the overall divergence of, and heterogeneity among, countries in terms of 2007 per capita total and pharmaceutical health care spending as relative proxies of pharmacoeconomic policy. Next, we applied cluster analytic methods to identify OECD member countries that are similar in terms of 2007 per capita pharmaceutical and total health care expenditures, and the ratio of both. © 2012 - Network of Centres for Study of Pharmaceutical Law. All rights reserved.
• Abraham, I., & Bootman, J. L. (2012). Why pharmacoeconomic policy should be transnational. Pharmaceuticals Policy and Law, 14(Issue 1). doi:10.3233/ppl-2011-0338
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  There is an inherent disconnect between the global-level endeavor of innovating pharmacotherapeutics and the (still) national-level of decision-making about access to innovation. In this paper, we argue that rational pharmacoeconomic policy should not be at the national, neither at the supranational, but at the transnational level: based on the relative similarity of countries in terms of their per capita health care spending. The 2010 OECD Health database, complemented as necessary with secondary data sources to substitute for missing data, was used to compile an analysis sample of all but two OECD countries (Chile and Greece) with data through 2007. We first established the overall divergence of, and heterogeneity among, countries in terms of 2007 per capita total and pharmaceutical health care spending as relative proxies of pharmacoeconomic policy. Next, we applied cluster analytic methods to identify OECD member countries that are similar in terms of 2007 per capita pharmaceutical and total health care expenditures, and the ratio of both. © 2012 - Network of Centres for Study of Pharmaceutical Law. All rights reserved.
• Abraham, I., & MacDonald, K. (2012). Clinical safety of biosimilar recombinant human erythropoietins. Expert Opinion on Drug Safety, 11(5), 819-840.
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  PMID: 22880621;Abstract: A "biosimilar" or "similar biological medicinal product" is a biological agent that is similar in terms of quality, safety, and efficacy to an authorized reference biological medicine. Since the expiration of the epoetin alfa patent in Europe, three agents have received marketing authorization from the European Medicines Agency: Binocrit (epoetin alfa; aka Abseamed and Epoetin Alfa Hexal), Retacrit (epoetin zeta; aka Silapo), and Eporatio (epoetin theta; aka Biopoin and Ratioepo). Areas covered: Using the EMA dossiers and journal publications, this article reviews clinical safety data for these products, with emphasis on serious/severe adverse events and a special consideration of immunogenicity, venous thromboembolism, and mortality. Expert opinion: A review of the available safety evidence shows that all three agents discussed have similar safety profiles. None were statistically higher on safety parameters to what is known about ESA as a class, when stratified by population. As with ESAs in general, immunogenicity, venous thromboembolism, and mortality are all concerns. What is known about ESAs regarding safety can be extended to biosimilar erythropoietins. Since biosimilars are unique, complex biological molecules, safety profiles may evolve from common to differentiated, once long-term product-specific safety data are available. Large-sample, long-term, observational studies of real-world practice will provide the heterogeneity and statistical power to demonstrate product-specific effectiveness and safety profiles. Statistically, out of the commercially available formulations of the three products reviewed, no single product is less or more safe. © 2012 Informa UK, Ltd.
• Abraham, I., & MacDonald, K. (2012). Clinical safety of biosimilar recombinant human erythropoietins. Expert opinion on drug safety, 11(5), 819-40.
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  A "biosimilar" or "similar biological medicinal product" is a biological agent that is similar in terms of quality, safety, and efficacy to an authorized reference biological medicine. Since the expiration of the epoetin alfa patent in Europe, three agents have received marketing authorization from the European Medicines Agency: Binocrit (epoetin alfa; aka Abseamed and Epoetin Alfa Hexal), Retacrit (epoetin zeta; aka Silapo), and Eporatio (epoetin theta; aka Biopoin and Ratioepo).
• Abraham, I., & MacDonald, K. (2012). Safety of erythropoiesis-stimulating agents in patients with end-stage kidney disease: Data are safer than extrapolations. Expert Opinion on Drug Safety, 11(6), 885-887.
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  PMID: 22998694;
• Abraham, I., & MacDonald, K. (2012). Safety of erythropoiesis-stimulating agents in patients with end-stage kidney disease: data are safer than extrapolations. Expert opinion on drug safety, 11(6), 885-7.
• Abraham, I., & MacDonald, K. (2012). Why are patients with chronic myeloid leukaemia (non-)adherent. British Journal of Cancer, 107(6), 901-903.
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  PMID: 22951951;PMCID: PMC3464769;
• Abraham, I., & MacDonald, K. (2012). Why are patients with chronic myeloid leukaemia (non-)adherent. British Journal of Cancer, 107(Issue 6). doi:10.1038/bjc.2012.349
• Abraham, I., & Sun, D. (2012). Cost of allogeneic blood transfusion. World Journal of Hepatology, 1(3), 8-13. doi:10.5315/wjh.v1.i3.8
• Abraham, I., & Sun, D. (2012). The cost of blood transfusion in Western Europe as estimated from six studies. Transfusion, 52(9), 1983-1988.
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  PMID: 22313531;Abstract: BACKGROUND: Blood is a costly and scarce resource. We report on a systematic review of the literature to estimate the cost of a 2-unit red blood cell (RBC) transfusion in Western Europe. STUDY DESIGN AND METHODS: Medline was searched for studies about the cost of RBC transfusion in Europe. Data extracted included authors, country, year of data, cost perspective, cost types, cost elements, units examined, study design, study population, and cost of a 2-unit blood transfusion. The population-weighted mean cost per 2 units of transfused blood was calculated. RESULTS: Six studies met inclusion and exclusion criteria and reported data from the United Kingdom, Sweden, Switzerland, Austria, and France. Methodology used to derive cost estimates differed across the studies. The population-weighted mean cost of transfusing 2 units of blood was €877.69. CONCLUSION: The estimated cost of transfusing 2 units of RBCs in Western Europe is significant. Differences in methodology were partially diffused by aggregation of prior estimates into a population-weighted mean. Future cost studies should follow the Cost of Blood Consensus Conference (COBCON) recommendation to apply activity-based costing methods. © 2012 American Association of Blood Banks.
• Abraham, I., & Sun, D. (2012). The cost of blood transfusion in Western Europe as estimated from six studies. Transfusion, 52(9), 1983-8.
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  Blood is a costly and scarce resource. We report on a systematic review of the literature to estimate the cost of a 2-unit red blood cell (RBC) transfusion in Western Europe.
• Macdonald, K., Aapro, M., Aapro, A., Abraham, I., Boccadoro, M., Bokemeyer, C., Denhaerynck, K., Gascon, P., Ludwig, H., Macdonald, K. P., Muenzberg, M., & Turner, M. (2012). Biosimilar Filgrastim Initiation in Patients Enrolled in the Monitor G-CSF Observational Study Relative to EORTC Guidelines. Annals of Oncology, 23, ix502. doi:10.1016/s0923-7534(20)34099-0
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  ABSTRACT Introduction MONITOR G-CSF is a prospective observational study of practice patterns and outcomes for prophylaxis of chemotherapy-induced febrile neutropenia (FN) with biosimilar filgrastim (Zarzio®, Sandoz Biopharmaceuticals). Methods This analysis describes treatment initiation with biosimilar filgrastim in the 788 patients enrolled to date (target 1500) in the MONITOR G-CSF study relative to the 2010 EORTC G-CSF guidelines. Patients were enrolled at 134 centres (199 open) across 12 European countries. Results In this mainly female (62%) and older (61.6 ± 11.9 years) cohort with predominately solid tumours (79%), FN risk based on chemotherapy (CT) regimen was 20% in 39% of patients. All patients with Table 1 . All patients Prophylaxis (%) Initiation (%) Duration (%) Primary Secondary 24-72 h Days 5-8 3 days 5 days Tumour type: Oncology Haematology 70 70 30 30 56 24 30 56 16 11 42 47 CT toxicity: > 20% 10-20% 76 74 56 24 26 44 53 49 54 29 32 25 13 13 15 44 39 41 Table 2 . FN risk 10-20% Prophylaxis (%) Patient-related risk factors Primary Secondary Age >65 years 79 21 Advanced disease (Stage IV) 74 26 History of prior FN 29 71 No antibiotic prophylaxis 73 24 Poor performance (ECOG >2) 83 17 Female 76 24 Hb 70 30 Liver, renal or CV disease 72 28 One or more risks 74 26 Conclusions Variability exists in biosimilar filgrastim initiation by tumour type (day of initiation), CT toxicity and patient-related risk. About a quarter of patients with FN risk >20% or 10-20% in combination with other risk factors did not receive primary prophylaxis as recommended. The trend to initiate filgrastim in regimens with Disclosure M.S. Aapro: Member of the steering committee for Sandoz Biopharmaceuticals supported study. P. Gascon: Member of the steering committee for Sandoz Biopharmaceuticals supported study. H. Ludwig: Member of the steering committee for Sandoz Biopharmaceuticals supported study. On Speakers Bureau and advisory board for Amgen. C. Bokemeyer: Member of the steering committee for Sandoz Biopharmaceuticals supported study. M. Boccadoro: Member of the steering committee for Sandoz Biopharmaceuticals supported study. M. Turner: Employee of Sandoz Biopharmaceuticals. M. Muenzberg: Employee of Sandoz Biopharmaceuticals. K. Denhaerynck: Employee of Matrix 45. I. Abraham: Employee of Matrix 45. K. Macdonald: Employee of Matrix 45.
• Olvey, E. L., MacDonald, K., & Abraham, I. (2012). Comparative effectiveness research: The translational science of comparing the what, how, when, in whom, by whom, and why of treatment effectiveness. Pharmaceuticals Policy and Law, 14(1), 27-35.
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  Abstract: Recent health care legislation in the United States has turned considerable focus to comparative effectiveness research (CER) domestically, though it has been a topic of discussion internationally for many years. Without a fully comprehensive and consistent definition of CER developed, much uncertainty and confusion surrounds its utilization. In addition, contention exists regarding the incorporation of cost and economic considerations as a component of CER. This discussion includes various suggested definitions of CER, methodological considerations, legislation and utilization, and the role of cost-effectiveness evaluations in CER. © 2012 - Network of Centres for Study of Pharmaceutical Law. All rights reserved.
• Olvey, E. L., MacDonald, K., & Abraham, I. (2012). Comparative effectiveness research: The translational science of comparing the what, how, when, in whom, by whom, and why of treatment effectiveness. Pharmaceuticals Policy and Law, 14(Issue 1). doi:10.3233/ppl-2011-0340
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  Recent health care legislation in the United States has turned considerable focus to comparative effectiveness research (CER) domestically, though it has been a topic of discussion internationally for many years. Without a fully comprehensive and consistent definition of CER developed, much uncertainty and confusion surrounds its utilization. In addition, contention exists regarding the incorporation of cost and economic considerations as a component of CER. This discussion includes various suggested definitions of CER, methodological considerations, legislation and utilization, and the role of cost-effectiveness evaluations in CER. © 2012 - Network of Centres for Study of Pharmaceutical Law. All rights reserved.
• Abraham, I. L. (2011). Comparative cost-efficiency across the European G5 countries of various regimens of filgrastim, biosimilar filgrastim, and pegfilgrastim to reduce the incidence of chemotherapy-induced febrile neutropenia. Journal of Oncology Pharmacy Practice, 18(2), 171-179. doi:10.1177/1078155211407367
• Abraham, I., Lee, C. S., & Skrepnek, G. H. (2011). Abstract P30: Gender-Specific Profiles of Lifestyle Behaviors Among US Adults Treated for Hypertension. Circulation-cardiovascular Quality and Outcomes, 4(suppl_2). doi:10.1161/circoutcomes.4.suppl_2.ap30
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  Background: The 7th Joint National Committee (JNC7) recommends lifestyle behavior modification as an essential strategy in the management of hypertension. Purpose: To identify gender-specific profi...
• Abraham, I., Lee, C., Song, M., Vancayzeele, S., Brié, H., Hermans, C., van der Niepen, P., & MacDonald, K. (2011). "Later, lazier, and unluckier": A heuristic profile of high vulnerability is an independent predictor of uncontrolled blood pressure (the PREVIEW study). American Journal of Clinical Hypnosis, 53(Issue 4).
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  Objective: Vulnerability profiling, an alternative to deterministic risk assessment, offers clinicians a more intuitive but empirically-grounded assessment of patient risk. This study aimed to determine whether a heuristic profile of high vulnerability is an independent predictor of uncontrolled hypertension. Methods: Secondary analysis of prospective observational study data on 2999 hypertensive patients treated with valsartan. Predictive validity of vulnerability profiling for first-line, secondline, and first-or-second-line antihypertensive treatment was inferred from 1) logistic regression models with adequate statistical fit, 2) statistically significant odds ratios for uncontrolled BP for the high-vulnerability cluster exceeding 1.00, and 3) correct classification rates for patients' BP control status. Results: All models of uncontrolled BP were significant (P
• Abraham, I., Lee, C., Song, M., Vancayzeele, S., Brié, H., Hermans, C., van, P., & MacDonald, K. (2011). "Later, lazier, and unluckier": A heuristic profile of high vulnerability is an independent predictor of uncontrolled blood pressure (the PREVIEW study). International Journal of General Medicine, 53(4), 163-166.
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  Abstract: Objective: Vulnerability profiling, an alternative to deterministic risk assessment, offers clinicians a more intuitive but empirically-grounded assessment of patient risk. This study aimed to determine whether a heuristic profile of high vulnerability is an independent predictor of uncontrolled hypertension. Methods: Secondary analysis of prospective observational study data on 2999 hypertensive patients treated with valsartan. Predictive validity of vulnerability profiling for first-line, secondline, and first-or-second-line antihypertensive treatment was inferred from 1) logistic regression models with adequate statistical fit, 2) statistically significant odds ratios for uncontrolled BP for the high-vulnerability cluster exceeding 1.00, and 3) correct classification rates for patients' BP control status. Results: All models of uncontrolled BP were significant (P
• Abraham, I., MacDonald, K., Hermans, C., Aerts, A., Lee, C., Brié, H., & Vancayzeele, S. (2011). Real-world effectiveness of valsartan on hypertension and total cardiovascular risk: review and implications of a translational research program. Vascular health and risk management, 7, 209-35.
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  The pharmacological efficacy of various monotherapy, single pill, and combination therapies of the angiotensin II receptor blocker valsartan have been established, mainly through randomized controlled trials that used similar methodological and statistical platforms and thus enabled synthesis of evidence. The real world effectiveness of valsartan has been studied extensively, but the relative lack of scientific and technical congruence of these studies render synthesis virtually impossible. To date, all have focused on blood pressure outcomes, despite evidence-based calls to grade antihypertensive treatment to patients' total cardiovascular risk. We review a T3 translational research program of seven studies involving valsartan monotherapy as well as single and separate pill combinations, and the determinants and effect on blood pressure and total cardiovascular risk outcomes. All seven studies examined not only the impact of valsartan-based regimens on blood pressure values and control, but also, within a statistical hierarchical approach, the physician- and patient-related determinants of these blood pressure outcomes. Two studies also investigated the determinants and outcomes of valsartan-based treatment on total cardiovascular risk - among the first studies to use this risk coefficient as an outcome rather than only a determinant. These seven studies included a total of 19,533 patients, contributed by 3434 physician-investigators in Belgium - a country particularly well-suited for observational effectiveness studies because of demographics and epidemiology. Each study used the same methodological and statistical platform. We summarize the impact of various valsartan regimens on such outcomes as blood pressure values and control, change in total cardiovascular risk, and reduction in risk by at least one category. We also review the results of statistical multilevel and logistic modeling of physician- and patient-related determinants on these outcomes, including the proportion of variance attributable to a physician class effect before patients enter the equation. In its different formulations, valsartan has major real-world benefits in lowering blood pressure and total cardiovascular risk within a 90-day period. It is essential to understand the physician- and patient-related determinants of blood pressure and total cardiovascular risk outcomes associated with valsartan treatment. Antihypertensive research should expand its historical focus on lowering blood pressure with an emphasis on lowering total cardiovascular research.
• Abraham, I., MacDonald, K., Hermans, C., Aerts, A., Lee, C., Brié, H., & Vancayzeele, S. (2011). Real-world effectiveness of valsartan on hypertension and total cardiovascular risk: review and implications of a translational research program.. Vascular health and risk management, 7, 209-235.
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  PMID: 21490947;PMCID: PMC3072745;Abstract: The pharmacological efficacy of various monotherapy, single pill, and combination therapies of the angiotensin II receptor blocker valsartan have been established, mainly through randomized controlled trials that used similar methodological and statistical platforms and thus enabled synthesis of evidence. The real world effectiveness of valsartan has been studied extensively, but the relative lack of scientific and technical congruence of these studies render synthesis virtually impossible. To date, all have focused on blood pressure outcomes, despite evidence-based calls to grade antihypertensive treatment to patients' total cardiovascular risk. We review a T3 translational research program of seven studies involving valsartan monotherapy as well as single and separate pill combinations, and the determinants and effect on blood pressure and total cardiovascular risk outcomes. All seven studies examined not only the impact of valsartan-based regimens on blood pressure values and control, but also, within a statistical hierarchical approach, the physician- and patient-related determinants of these blood pressure outcomes. Two studies also investigated the determinants and outcomes of valsartan-based treatment on total cardiovascular risk - among the first studies to use this risk coefficient as an outcome rather than only a determinant. These seven studies included a total of 19,533 patients, contributed by 3434 physician-investigators in Belgium - a country particularly well-suited for observational effectiveness studies because of demographics and epidemiology. Each study used the same methodological and statistical platform. We summarize the impact of various valsartan regimens on such outcomes as blood pressure values and control, change in total cardiovascular risk, and reduction in risk by at least one category. We also review the results of statistical multilevel and logistic modeling of physician- and patient-related determinants on these outcomes, including the proportion of variance attributable to a physician class effect before patients enter the equation. In its different formulations, valsartan has major real-world benefits in lowering blood pressure and total cardiovascular risk within a 90-day period. It is essential to understand the physician- and patient-related determinants of blood pressure and total cardiovascular risk outcomes associated with valsartan treatment. Antihypertensive research should expand its historical focus on lowering blood pressure with an emphasis on lowering total cardiovascular research.
• Delforge, M., Selleslag, D., Triffet, A., Mineur, P., Bries, G., Graux, C., Trullemans, F., MacDonald, K., Abraham, I., Pluymers, W., & Ravoet, C. (2011). Iron status and treatment modalities in transfusion-dependent patients with myelodysplastic syndromes. Annals of Hematology, 90(6), 655-666.
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  PMID: 21318574;Abstract: Transfusion dependency and iron overload are common among patients with myelodysplastic syndromes (MDS) treated with red blood cell (RBC) transfusions. Transfusion dependency is associated with leukemic progression and shorter survival. Guidelines recommend iron chelation therapy to manage iron overload, however little is known about the chelation patterns in daily clinical practice. The objective of this multicenter, retrospective, cross-sectional, observational study was to evaluate iron status and its management in transfusion-dependent MDS patients. A total of 193 patient records from 29 centers were eligible for inclusion. Median patient age was 76, and median age at diagnosis of MDS was 74. Patients had received an average of 13.4±7.6 RBC units in the past 4 months; 44% had received more than 50 units since their MDS diagnosis. Medium serum ferritin was 1,550 μg/L. Ninety patients (46.6%) received iron chelation therapy with either deferoxamine (41%), deferasirox (36%), and deferoxamine followed by deferasirox (23%). There were no statistically significant differences between chelated and nonchelated patients in terms of International Prognostic Scoring System (IPSS), French-American- British (FAB), and/or World Health Organization (WHO) status, though chelated patients had received more RBC transfusions (p=0.014). Iron chelation therapy may be underutilized in transfusion-dependent patients. Undertreatment can be reduced by complementing sound clinical judgment with the generally accepted guidelines of a serum ferritin level >1,000 μg/L and/or two or more RBC transfusions per month for the past year; considering patients on the basis of their IPSS, FAB, and/or WHO status; and individually tailored treatment regimens. Prospective randomized trials are necessary to establish causally the efficacy of iron chelation therapy in MDS. © 2011 Springer-Verlag.
• Delforge, M., Selleslag, D., Triffet, A., Mineur, P., Bries, G., Graux, C., Trullemans, F., MacDonald, K., Abraham, I., Pluymers, W., & Ravoet, C. (2011). Iron status and treatment modalities in transfusion-dependent patients with myelodysplastic syndromes. Annals of Hematology, 90(Issue 6). doi:10.1007/s00277-011-1164-9
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  Transfusion dependency and iron overload are common among patients with myelodysplastic syndromes (MDS) treated with red blood cell (RBC) transfusions. Transfusion dependency is associated with leukemic progression and shorter survival. Guidelines recommend iron chelation therapy to manage iron overload, however little is known about the chelation patterns in daily clinical practice. The objective of this multicenter, retrospective, cross-sectional, observational study was to evaluate iron status and its management in transfusion-dependent MDS patients. A total of 193 patient records from 29 centers were eligible for inclusion. Median patient age was 76, and median age at diagnosis of MDS was 74. Patients had received an average of 13.4±7.6 RBC units in the past 4 months; 44% had received more than 50 units since their MDS diagnosis. Medium serum ferritin was 1,550 μg/L. Ninety patients (46.6%) received iron chelation therapy with either deferoxamine (41%), deferasirox (36%), and deferoxamine followed by deferasirox (23%). There were no statistically significant differences between chelated and nonchelated patients in terms of International Prognostic Scoring System (IPSS), French-American- British (FAB), and/or World Health Organization (WHO) status, though chelated patients had received more RBC transfusions (p=0.014). Iron chelation therapy may be underutilized in transfusion-dependent patients. Undertreatment can be reduced by complementing sound clinical judgment with the generally accepted guidelines of a serum ferritin level >1,000 μg/L and/or two or more RBC transfusions per month for the past year; considering patients on the basis of their IPSS, FAB, and/or WHO status; and individually tailored treatment regimens. Prospective randomized trials are necessary to establish causally the efficacy of iron chelation therapy in MDS. © 2011 Springer-Verlag.
• Gascón, P., Aapro, M., Ludwig, H., Rosencher, N., Boccadoro, M., Turner, M., MacDonald, K., Muenzberg, M., & Abraham, I. (2011). Update on the MONITOR-GCSF study of biosimilar filgrastim to reduce the incidence of chemotherapy-induced febrile neutropenia in cancer patients: Protocol amendments. Critical Reviews in Oncology/Hematology, 77(3), 198-200.
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  PMID: 21377576;Abstract: The MONITOR-GCSF study is an international, prospective, observational, pharmaco-epidemiological study to evaluate the multi-level factors and outcomes associated with the use of biosimilar filgrastim in the prophylaxis of febrile neutropenia in chemotherapy-treated cancer patients. The background and methodology of this study are described in an article published concurrently in this journal. As important amendments have been made to the protocol, and the purpose of the prior article was to serve as a resource for future referencing, we detail these amendments in this present article: explicit statement about the use of biosimilar filgrastim for both primary and secondary prophylaxis of chemotherapy-induced febrile neutropenia in the objectives and methodology of the study; length of observation; the addition of stage III and stage IV ovarian cancer and multiple myeloma to the tumor types studied; and the deletion of dose dense chemotherapy regimens as an exclusion criterion. © 2011 Elsevier Ireland Ltd.
• Gascón, P., Aapro, M., Ludwig, H., Rosencher, N., Boccadoro, M., Turner, M., MacDonald, K., Muenzberg, M., & Abraham, I. (2011). Update on the MONITOR-GCSF study of biosimilar filgrastim to reduce the incidence of chemotherapy-induced febrile neutropenia in cancer patients: Protocol amendments. Critical Reviews in Oncology/Hematology, 77(Issue 3). doi:10.1016/j.critrevonc.2011.01.006
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  The MONITOR-GCSF study is an international, prospective, observational, pharmaco-epidemiological study to evaluate the multi-level factors and outcomes associated with the use of biosimilar filgrastim in the prophylaxis of febrile neutropenia in chemotherapy-treated cancer patients. The background and methodology of this study are described in an article published concurrently in this journal. As important amendments have been made to the protocol, and the purpose of the prior article was to serve as a resource for future referencing, we detail these amendments in this present article: explicit statement about the use of biosimilar filgrastim for both primary and secondary prophylaxis of chemotherapy-induced febrile neutropenia in the objectives and methodology of the study; length of observation; the addition of stage III and stage IV ovarian cancer and multiple myeloma to the tumor types studied; and the deletion of dose dense chemotherapy regimens as an exclusion criterion. © 2011 Elsevier Ireland Ltd.
• Gascón, P., Aapro, M., Ludwig, H., Rosencher, N., Boccadoro, M., Turner, M., MacDonald, K., Muenzberg, M., & Abraham, I. (2011). Update on the MONITOR-GCSF study of biosimilar filgrastim to reduce the incidence of chemotherapy-induced febrile neutropenia in cancer patients: Protocol amendments. Critical reviews in oncology/hematology, 77(3), 198-200.
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  The MONITOR-GCSF study is an international, prospective, observational, pharmaco-epidemiological study to evaluate the multi-level factors and outcomes associated with the use of biosimilar filgrastim in the prophylaxis of febrile neutropenia in chemotherapy-treated cancer patients. The background and methodology of this study are described in an article published concurrently in this journal. As important amendments have been made to the protocol, and the purpose of the prior article was to serve as a resource for future referencing, we detail these amendments in this present article: explicit statement about the use of biosimilar filgrastim for both primary and secondary prophylaxis of chemotherapy-induced febrile neutropenia in the objectives and methodology of the study; length of observation; the addition of stage III and stage IV ovarian cancer and multiple myeloma to the tumor types studied; and the deletion of dose dense chemotherapy regimens as an exclusion criterion.
• Gascón, P., Aapro, M., Ludwig, H., Rosencher, N., Turner, M., Song, M., MacDonald, K., Lee, C., Muenzberg, M., & Abraham, I. (2011). Background and methodology of MONITOR-GCSF, a pharmaco-epidemiological study of the multi-level determinants, predictors, and clinical outcomes of febrile neutropenia prophylaxis with biosimilar granulocyte-colony stimulating factor filgrastim. Critical Reviews in Oncology/Hematology, 77(3), 184-197.
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  PMID: 20189821;Abstract: The MONITOR-GCSF study is an international, prospective, observational, pharmaco-epidemiological study to evaluate the multi-level factors and outcomes associated with the use of Zarzio® in the prophylaxis of febrile neutropenia in chemotherapy-treated cancer patients. Driven by a novel, integrated, multi-focal framework for post-approval observational studies, it examines determinants of response at both the patient and the physician level; integrates statistical methodologies from the social and behavioral sciences; assesses factors predictive of poor treatment response; and evaluates the congruence of treatment with EORTC guidelines and the approved label. This pan-European study will recruit at least 1000 patients from a minimum of 75 centers and follow them for maximum 6 cycles of chemotherapy. Apart from descriptive and associative procedures, statistical analysis will include variance attribution methods; hierarchical linear, logistic, and Poisson modeling; Kaplan-Meier time-to-event analysis, Mantel-Cox log-rank or generalized Wilcoxon-Breslow tests, and Cox proportional hazards modeling; and clustering and related data mining techniques. © 2010 Elsevier Ireland Ltd.
• Gascón, P., Aapro, M., Ludwig, H., Rosencher, N., Turner, M., Song, M., MacDonald, K., Lee, C., Muenzberg, M., & Abraham, I. (2011). Background and methodology of MONITOR-GCSF, a pharmaco-epidemiological study of the multi-level determinants, predictors, and clinical outcomes of febrile neutropenia prophylaxis with biosimilar granulocyte-colony stimulating factor filgrastim. Critical reviews in oncology/hematology, 77(3), 184-97.
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  The MONITOR-GCSF study is an international, prospective, observational, pharmaco-epidemiological study to evaluate the multi-level factors and outcomes associated with the use of Zarzio(®) in the prophylaxis of febrile neutropenia in chemotherapy-treated cancer patients. Driven by a novel, integrated, multi-focal framework for post-approval observational studies, it examines determinants of response at both the patient and the physician level; integrates statistical methodologies from the social and behavioral sciences; assesses factors predictive of poor treatment response; and evaluates the congruence of treatment with EORTC guidelines and the approved label. This pan-European study will recruit at least 1000 patients from a minimum of 75 centers and follow them for maximum 6 cycles of chemotherapy. Apart from descriptive and associative procedures, statistical analysis will include variance attribution methods; hierarchical linear, logistic, and Poisson modeling; Kaplan-Meier time-to-event analysis, Mantel-Cox log-rank or generalized Wilcoxon-Breslow tests, and Cox proportional hazards modeling; and clustering and related data mining techniques.
• Lins, R., Aerts, A., Coen, N., Hermans, C., MacDonald, K., Brié, H., Lee, C., Shen, Y., Vancayzeele, S., Mecum, N., & Abraham, I. (2011). Effectiveness of amlodipine-valsartan single-pill combinations: hierarchical modeling of blood pressure and total cardiovascular disease risk outcomes (the EXCELLENT study). The Annals of pharmacotherapy, 45(6), 727-39.
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  Both patient- and physician-related factors have been shown to explain variability in the outcomes of antihypertensive treatment. Total cardiovascular risk (TCVR) is increasingly used as a determinant of treatment effectiveness but has also been proposed as a treatment outcome. To our knowledge, no studies have reported how antihypertensive treatment impacts blood pressure and TCVR outcomes.
• Lins, R., Aerts, A., Coen, N., Hermans, C., Macdonald, K., Brié, H., Lee, C., Shen, Y. M., Vancayzeele, S., Mecum, N., & Abraham, I. (2011). Effectiveness of amlodipine-valsartan single-pill combinations: Hierarchical modeling of blood pressure and total cardiovascular disease risk outcomes (the excellent study). Annals of Pharmacotherapy, 45(Issue 6). doi:10.1345/aph.1p663
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  BACKGROUND: Both patient- and physician-related factors have been shown to explain variability in the outcomes of antihypertensive treatment. Total cardiovascular risk (TCVR) is increasingly used as a determinant of treatment effectiveness but has also been proposed as a treatment outcome. To our knowledge, no studies have reported how antihypertensive treatment impacts blood pressure and TCVR outcomes. OBJECTIVE: To examine in patients treated with a regimen including single-pill combinations (SPCs) of amlodipine/valsartan (1) blood pressure (BP) reduction and control, total cardiovascular risk (TCVR) change, and TCVR reduction of 1 class or more; (2) hierarchical patient- and physician-level determinants of these outcomes; and (3) predictors of uncontrolled BP and improved TCVR classification. METHODS: A prospective (90 days), multicenter, multilevel pharmacoepidemiologic study was conducted in 3546 patients with hypertension treated with SPC amlodipine/valsartan by 698 general practitioners. Statistical analysis included hierarchical linear and logistic modeling of BP and TCVR outcomes. RESULTS: Mean (SD) systolic BP (SBP) reductions were 20.1 (15.5) mm Hg and diastolic BP (DBP) reductions were 9.8 (10.3) mm Hg, with higher reductions among high-risk patients. SBP, DBP, and SBP/DBP control rates were 33.3%, 45.3%, and 25.5%, respectively, with lower rates among high-risk patients. Mean TCVR improvement was a reduction of 0.73 (0.96) classes (-4 [best] to +4 [worst]), with higher reductions for high-risk patients; 58.2% of patients achieved a TCVR reduction of 1 or more classes, with lower percentages for high-risk patients. Twenty-two percent of systolic variability and 26% of diastolic variability in 90-day BP values were attributable to a physician class effect, as was 16% of TCVR change. CONCLUSIONS: Regimens that include SPC amlodipine/valsartan formulations are effective in reducing BP and TCVR in a real-world observational setting. Hierarchical modeling identified patient- and physician-related determinants of BP values and TCVR change, as well as independent predictors of uncontrolled BP and reduced TCVR. TCVR is a scientifically feasible and clinically relevant effectiveness outcome of antihypertensive treatment.
• Lins, R., Aerts, A., Coen, N., Hermans, C., Macdonald, K., Brié, H., Lee, C., Shen, Y., Vancayzeele, S., Mecum, N., & Abraham, I. (2011). Effectiveness of amlodipine-valsartan single-pill combinations: Hierarchical modeling of blood pressure and total cardiovascular disease risk outcomes (the excellent study). Annals of Pharmacotherapy, 45(6), 727-739.
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  PMID: 21666094;Abstract: BACKGROUND: Both patient- and physician-related factors have been shown to explain variability in the outcomes of antihypertensive treatment. Total cardiovascular risk (TCVR) is increasingly used as a determinant of treatment effectiveness but has also been proposed as a treatment outcome. To our knowledge, no studies have reported how antihypertensive treatment impacts blood pressure and TCVR outcomes. OBJECTIVE: To examine in patients treated with a regimen including single-pill combinations (SPCs) of amlodipine/valsartan (1) blood pressure (BP) reduction and control, total cardiovascular risk (TCVR) change, and TCVR reduction of 1 class or more; (2) hierarchical patient- and physician-level determinants of these outcomes; and (3) predictors of uncontrolled BP and improved TCVR classification. METHODS: A prospective (90 days), multicenter, multilevel pharmacoepidemiologic study was conducted in 3546 patients with hypertension treated with SPC amlodipine/valsartan by 698 general practitioners. Statistical analysis included hierarchical linear and logistic modeling of BP and TCVR outcomes. RESULTS: Mean (SD) systolic BP (SBP) reductions were 20.1 (15.5) mm Hg and diastolic BP (DBP) reductions were 9.8 (10.3) mm Hg, with higher reductions among high-risk patients. SBP, DBP, and SBP/DBP control rates were 33.3%, 45.3%, and 25.5%, respectively, with lower rates among high-risk patients. Mean TCVR improvement was a reduction of 0.73 (0.96) classes (-4 [best] to +4 [worst]), with higher reductions for high-risk patients; 58.2% of patients achieved a TCVR reduction of 1 or more classes, with lower percentages for high-risk patients. Twenty-two percent of systolic variability and 26% of diastolic variability in 90-day BP values were attributable to a physician class effect, as was 16% of TCVR change. CONCLUSIONS: Regimens that include SPC amlodipine/valsartan formulations are effective in reducing BP and TCVR in a real-world observational setting. Hierarchical modeling identified patient- and physician-related determinants of BP values and TCVR change, as well as independent predictors of uncontrolled BP and reduced TCVR. TCVR is a scientifically feasible and clinically relevant effectiveness outcome of antihypertensive treatment.
• Lins, R., Coen, N., Aerts, A., MacDonald, K., Brié, H., Hermans, C., Shen, Y., Lee, C., Vancayzeele, S., Mecum, N., & Abraham, I. (2011). Modelling of blood pressure and total cardiovascular risk outcomes after second-line valsartan therapy: The BSCORE study. Archives of Cardiovascular Diseases, 104(8-9), 428-434.
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  PMID: 21944144;Abstract: Background: European guidelines recommend that antihypertensive management should be graded as a function of total cardiovascular risk. Aims: To examine the multilevel (patient- and physician-level) determinants of blood pressure and residual total cardiovascular risk outcomes associated with second-line valsartan therapy. Methods: The BSCORE study was a prospective, multi-centre, pharmacoepidemiological study of the "real-world" effectiveness of second-line valsartan with or without hydrochlorothiazide. Results: A total of 3497 patients were recruited by 354 physicians. Mean age was 63.8 ± 12.0 years; 52.3% were male; 20.9% were smokers; 47.7% were dyslipidaemic; and 23.6% had diabetes. On average, reductions in blood pressure and increases in the proportions of patients with controlled blood pressure after 90 days were statistically significant (all P < 0.001). Twenty-one percent of systolic blood pressure and 25.6% of diastolic blood pressure variability at follow-up was attributable to physician-level characteristics. Significant reductions in total cardiovascular risk were observed (P < 0.001); with 12.5% of the variability in total cardiovascular risk change attributable to physician-level characteristics. Several independent determinants of blood pressure outcomes were identified, many of which are modifiable. Conclusions: Second-line valsartan therapy improves blood pressure outcomes under variable real-world conditions, and is associated with a decrease in total cardiovascular risk. Optimizing antihypertensive effectiveness, including the reduction of residual cardiovascular risk, involves managing concomitant conditions and risk factors, improving adherence, and identifying physician-level factors amenable to intervention. © 2011 Elsevier Masson SAS. All rights reserved.
• Lins, R., Coen, N., Aerts, A., Macdonald, K., Brié, H., Hermans, C., Shen, Y., Lee, C., Vancayzeele, S., Mecum, N., & Abraham, I. (2011). Modelling of blood pressure and total cardiovascular risk outcomes after second-line valsartan therapy: the BSCORE study. Archives of cardiovascular diseases, 104(8-9), 428-34.
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  European guidelines recommend that antihypertensive management should be graded as a function of total cardiovascular risk.
• Lins, R., Lins, R., Coen, N., Coen, N., Aerts, A., Aerts, A., MacDonald, K., MacDonald, K., Brié, H., Brié, H., Hermans, C., Hermans, C., Shen, Y. M., Shen, Y. M., Lee, C., Lee, C., Vancayzeele, S., Vancayzeele, S., Mecum, N., , Mecum, N., et al. (2011). Modelling of blood pressure and total cardiovascular risk outcomes after second-line valsartan therapy: The BSCORE study. Archives of Cardiovascular Diseases, 104(Issue 8-9). doi:10.1016/j.acvd.2010.12.005
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  Background: European guidelines recommend that antihypertensive management should be graded as a function of total cardiovascular risk. Aims: To examine the multilevel (patient- and physician-level) determinants of blood pressure and residual total cardiovascular risk outcomes associated with second-line valsartan therapy. Methods: The BSCORE study was a prospective, multi-centre, pharmacoepidemiological study of the "real-world" effectiveness of second-line valsartan with or without hydrochlorothiazide. Results: A total of 3497 patients were recruited by 354 physicians. Mean age was 63.8 ± 12.0 years; 52.3% were male; 20.9% were smokers; 47.7% were dyslipidaemic; and 23.6% had diabetes. On average, reductions in blood pressure and increases in the proportions of patients with controlled blood pressure after 90 days were statistically significant (all P < 0.001). Twenty-one percent of systolic blood pressure and 25.6% of diastolic blood pressure variability at follow-up was attributable to physician-level characteristics. Significant reductions in total cardiovascular risk were observed (P < 0.001); with 12.5% of the variability in total cardiovascular risk change attributable to physician-level characteristics. Several independent determinants of blood pressure outcomes were identified, many of which are modifiable. Conclusions: Second-line valsartan therapy improves blood pressure outcomes under variable real-world conditions, and is associated with a decrease in total cardiovascular risk. Optimizing antihypertensive effectiveness, including the reduction of residual cardiovascular risk, involves managing concomitant conditions and risk factors, improving adherence, and identifying physician-level factors amenable to intervention. © 2011 Elsevier Masson SAS. All rights reserved.
• MacDonald, K., Lee, C. S., Chen, H. -., Ko, M. L., Fidel, G. E., Brié, H., Hermans, C., Vancayzeele, S., Reel, S., Van, P., & Abraham, I. (2011). Gender-specific, multi-level determinants of outcomes of antihypertensive treatment: A sub-analysis of the Belgian PREVIEW study. Journal of Human Hypertension, 25(6), 372-382.
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  PMID: 20631740;Abstract: Gender-specific determinants of blood pressure (BP) values and control have not been the focus of clinical hypertension research. The purpose of this analysis was to identify gender-specific and multi-level (physician and patient) determinants of BP values and predictors of uncontrolled BP. We completed a subgroup analysis comparing men and women who participated in the Belgian PREVIEW study of second-line treatment effectiveness of valsartan, applying two-level hierarchical modelling of 90-day BP values and guideline-defined BP control. In total, 1665 women and 1525 men were treated by 504 general practitioners. Fewer women than men reached systolic BP (SBP) (P=0.015) and combined BP targets at 90 days (P=0.007). More than 26% of the variance in 90-day SBP (intra-class correlation coefficient (ICC)=0.270) and diastolic BP (DBP) (ICC=0.262) was attributable to physician-level factors for men; the physician-level ICCs for SBP and DBP were 0.259 and 0.268, respectively, for women. Determinants of 90-day BP values and predictors of uncontrolled BP varied considerably by gender. Many of the multi-level determinants of BP by gender are amenable to intervention, and the remainder can serve as warning signs to clinicians that patients may remain vulnerable to poor outcomes associated with sub-optimal BP control. © 2011 Macmillan Publishers Limited All rights reserved.
• MacDonald, K., Lee, C. S., Chen, H. C., Ko, M. L., Fidel, G. E., Brié, H., Hermans, C., Vancayzeele, S., Reel, S., Van Der Niepen, P., & Abraham, I. (2011). Gender-specific, multi-level determinants of outcomes of antihypertensive treatment: A sub-analysis of the Belgian PREVIEW study. Journal of Human Hypertension, 25(Issue 6). doi:10.1038/jhh.2010.71
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  Gender-specific determinants of blood pressure (BP) values and control have not been the focus of clinical hypertension research. The purpose of this analysis was to identify gender-specific and multi-level (physician and patient) determinants of BP values and predictors of uncontrolled BP. We completed a subgroup analysis comparing men and women who participated in the Belgian PREVIEW study of second-line treatment effectiveness of valsartan, applying two-level hierarchical modelling of 90-day BP values and guideline-defined BP control. In total, 1665 women and 1525 men were treated by 504 general practitioners. Fewer women than men reached systolic BP (SBP) (P=0.015) and combined BP targets at 90 days (P=0.007). More than 26% of the variance in 90-day SBP (intra-class correlation coefficient (ICC)=0.270) and diastolic BP (DBP) (ICC=0.262) was attributable to physician-level factors for men; the physician-level ICCs for SBP and DBP were 0.259 and 0.268, respectively, for women. Determinants of 90-day BP values and predictors of uncontrolled BP varied considerably by gender. Many of the multi-level determinants of BP by gender are amenable to intervention, and the remainder can serve as warning signs to clinicians that patients may remain vulnerable to poor outcomes associated with sub-optimal BP control. © 2011 Macmillan Publishers Limited All rights reserved.
• Mazzeo, F., Duck, L., Joosens, E., Dirix, L., Focan, C., Forget, F., De Geest, S., Muermans, K., VAN Lierde, M., Macdonald, K., Abraham, I., & De Grève, J. (2011). Nonadherence to imatinib treatment in patients with gastrointestinal stromal tumors: the ADAGIO study. Anticancer research, 31(4), 1407-9.
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  To determine imatinib nonadherence rates in patients with gastrointestinal tumors (GIST) over 90 days.
• Mazzeo, F., Duck, L., Joosens, E., Dirix, L., Focan, C., Forget, F., De Geest, S., Muermans, K., Van Lierde, M. A., Macdonald, K., Abraham, I., & De Grève, J. (2011). Nonadherence to imatinib treatment in patients with gastrointestinal stromal tumors: The ADAGIO study. Anticancer Research, 31(Issue 4).
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  Aim: To determine imatinib nonadherence rates in patients with gastrointestinal tumors (GIST) over 90 days. Patients and Methods: A prospective 90-day observational, open-label, multicenter study was carried out of 28 evaluable GIST patients on imatinib. Nonadherence behavior was measured using a 4-item patient interview. Clinicians, patients, and collaterals rated perceived patient adherence on a 0-100 VAS scale. Results: Nonadherence rates in the 4 weeks prior to baseline and follow-up were 29% (95% CI=26-32) and 24% (95% CI=21-27, p>0.05). Mean VAS ratings of perceived adherence ranged from 952±102 to 973±4.8 (p>0.05 for time and source of rating). Correlations between perceptions of and actual adherence behavior were negative. Conclusion: In this first study on imatinib nonadherence in GIST patients, rates were similar to those observed in patients with chronic myeloid leukemia, higher than clinically expected and exceeding meta-analytic estimates for cancer. Nonadherence rates were consistent across the 90-day period. Nonadherence behavior should be assessed by clinicians.
• Mazzeo, F., Duck, L., Joosens, E., Dirix, L., Focan, C., Forget, F., Geest, S. D., Muermans, K., Lierde, M. V., Macdonald, K., Abraham, I., & Grève, J. D. (2011). Nonadherence to imatinib treatment in patients with gastrointestinal stromal tumors: The ADAGIO study. Anticancer Research, 31(4), 1407-1410.
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  PMID: 21508393;Abstract: Aim: To determine imatinib nonadherence rates in patients with gastrointestinal tumors (GIST) over 90 days. Patients and Methods: A prospective 90-day observational, open-label, multicenter study was carried out of 28 evaluable GIST patients on imatinib. Nonadherence behavior was measured using a 4-item patient interview. Clinicians, patients, and collaterals rated perceived patient adherence on a 0-100 VAS scale. Results: Nonadherence rates in the 4 weeks prior to baseline and follow-up were 29% (95% CI=26-32) and 24% (95% CI=21-27, p>0.05). Mean VAS ratings of perceived adherence ranged from 952±102 to 973±4.8 (p>0.05 for time and source of rating). Correlations between perceptions of and actual adherence behavior were negative. Conclusion: In this first study on imatinib nonadherence in GIST patients, rates were similar to those observed in patients with chronic myeloid leukemia, higher than clinically expected and exceeding meta-analytic estimates for cancer. Nonadherence rates were consistent across the 90-day period. Nonadherence behavior should be assessed by clinicians.
• Milisen, K., Coussement, J., Boonen, S., Geeraerts, A., Druyts, L., Van Wesenbeeck, A., Abraham, I., & Dejaeger, E. (2011). Nursing staff attitudes of hip protector use in long-term care, and differences in characteristics between adherent and non-adherent residents: A survey and observational study. International Journal of Nursing Studies, 48(Issue 2). doi:10.1016/j.ijnurstu.2010.07.008
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  Background: Hip fractures represent an increasing public health burden with a simple fall to the floor as the most common cause. Because nursing home residents are particularly at risk, nursing homes should implement a broad range of fall prevention strategies. However, not all fall incidents can be avoided and external hip protectors may contribute to prevent hip fractures. A major problem in studying the effectiveness of hip protectors is residents' poor adherence. In nursing homes, adherence is dependent not only on the resident, but also on staff knowledge of and attitudes about hip protectors. Objectives: To describe (1) attitudes of day versus night shift caregivers towards the use of a soft hip protector, (2) residents' adherence about the use of such protectors, and (3) differences in characteristics between adherent and non-adherent residents. Design: Survey and observational study. Setting: Nursing home. Participants/methods:: Survey of care staff (n=. 37) in a nursing home after 8 months of continued application of a soft hip protector policy in residents (n=. 68). Adherence to wearing the hip protector, measured by weekly unannounced, randomly determined checks during day and night in the 8 months after the start of the study. Results: Overall, 85% agreed to wear a hip protector. At 8 months, only 29% was still wearing their hip protector; with significant differences between day and night shifts. Although virtually all caregivers (97%) considered a hip protector policy in residential care as feasible, the attitude towards hip protectors was found to be significantly different between day and night caregivers. Pain and discomfort, patient insight in the usefulness of these devices, interference with incontinence materials, and the overall resident mix and care acuity were reported as major barriers. Conclusion: Implementing a hip protector policy for injury prevention in long-term care is not an issue of whether or not to use the devices. Rather, it is a continued clinical nursing decision process about when and when not, by whom and by whom not, why and why not, for how long, and to what clinical benefit - considering both the needs of the individual resident and the feasibility of such a policy in the context of resident mix and nursing staff. © 2010 Elsevier Ltd.
• Milisen, K., Coussement, J., Boonen, S., Geeraerts, A., Druyts, L., Van Wesenbeeck, A., Abraham, I., & Dejaeger, E. (2011). Nursing staff attitudes of hip protector use in long-term care, and differences in characteristics between adherent and non-adherent residents: a survey and observational study. International journal of nursing studies, 48(2), 193-203.
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  Hip fractures represent an increasing public health burden with a simple fall to the floor as the most common cause. Because nursing home residents are particularly at risk, nursing homes should implement a broad range of fall prevention strategies. However, not all fall incidents can be avoided and external hip protectors may contribute to prevent hip fractures. A major problem in studying the effectiveness of hip protectors is residents' poor adherence. In nursing homes, adherence is dependent not only on the resident, but also on staff knowledge of and attitudes about hip protectors.
• Milisen, K., Coussement, J., Boonen, S., Geeraerts, A., Druyts, L., Wesenbeeck, A. V., Abraham, I., & Dejaeger, E. (2011). Nursing staff attitudes of hip protector use in long-term care, and differences in characteristics between adherent and non-adherent residents: A survey and observational study. International Journal of Nursing Studies, 48(2), 193-203.
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  PMID: 20708185;Abstract: Background: Hip fractures represent an increasing public health burden with a simple fall to the floor as the most common cause. Because nursing home residents are particularly at risk, nursing homes should implement a broad range of fall prevention strategies. However, not all fall incidents can be avoided and external hip protectors may contribute to prevent hip fractures. A major problem in studying the effectiveness of hip protectors is residents' poor adherence. In nursing homes, adherence is dependent not only on the resident, but also on staff knowledge of and attitudes about hip protectors. Objectives: To describe (1) attitudes of day versus night shift caregivers towards the use of a soft hip protector, (2) residents' adherence about the use of such protectors, and (3) differences in characteristics between adherent and non-adherent residents. Design: Survey and observational study. Setting: Nursing home. Participants/methods:: Survey of care staff (n=. 37) in a nursing home after 8 months of continued application of a soft hip protector policy in residents (n=. 68). Adherence to wearing the hip protector, measured by weekly unannounced, randomly determined checks during day and night in the 8 months after the start of the study. Results: Overall, 85% agreed to wear a hip protector. At 8 months, only 29% was still wearing their hip protector; with significant differences between day and night shifts. Although virtually all caregivers (97%) considered a hip protector policy in residential care as feasible, the attitude towards hip protectors was found to be significantly different between day and night caregivers. Pain and discomfort, patient insight in the usefulness of these devices, interference with incontinence materials, and the overall resident mix and care acuity were reported as major barriers. Conclusion: Implementing a hip protector policy for injury prevention in long-term care is not an issue of whether or not to use the devices. Rather, it is a continued clinical nursing decision process about when and when not, by whom and by whom not, why and why not, for how long, and to what clinical benefit - considering both the needs of the individual resident and the feasibility of such a policy in the context of resident mix and nursing staff. © 2010 Elsevier Ltd.
• Verpooten, G. A., Aerts, A., Coen, N., Vancayzeele, S., Hermans, C., Bowles, J., MacDonald, K., Abraham, I., & Lee, C. S. (2011). Antihypertensive effectiveness of aliskiren for the 'real-world' management of hypertension: Multilevel modelling of 180-day blood pressure outcomes (the Belgian DRIVER Study). International Journal of Clinical Practice, 65(1), 54-63.
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  PMID: 21155943;Abstract: Aims: The 'DRIVER' study was designed to investigate the 'real-world' effectiveness of aliskiren-based treatment of hypertension. This article reports the 180-day blood pressure (BP) outcomes, and the multilevel (physician- and patient-level) determinants thereof. Methods and results: DRIVER was a prospective, observational, open-label, multi-centre, pharmaco-epidemiologic study of hypertensive patients treated with aliskiren in whom prior treatment failed or was not tolerated. 2070 patients (enrolled by 426 physicians) were enrolled; 1695 patients (81.9%) completed the 180-day aliskiren treatment period. Mean patient age was 64.2 ± 12.1 years; 53.7% were men, 25.3% diabetic and 40.7% had a high or very high cardiovascular (CV) risk. At 180 days, the mean ± SD reductions in systolic and diastolic BP were -22.9 ± 16.7 mmHg and -10.5 ± 10.9 mmHg respectively (both p
• Abraham, I. (2010). Intravenous bisphosphonate treatment and osteonecrosis of the jaw in patients with cancer: Wide CIs, Yule-Simpson and King Kong effects, and no therapeutic outcomes. Journal of Clinical Oncology, 28(9), e143-e144.
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  PMID: 20159796;
• Abraham, I. (2010). Intravenous bisphosphonate treatment and osteonecrosis of the jaw in patients with cancer: Wide CIs, Yule-Simpson and King Kong effects, and no therapeutic outcomes. Journal of Clinical Oncology, 28(Issue 9). doi:10.1200/jco.2009.27.1270
• Abraham, I. (2010). Intravenous bisphosphonate treatment and osteonecrosis of the jaw in patients with cancer: wide CIs, Yule-Simpson and King Kong effects, and no therapeutic outcomes. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 28(9), e143-4; author reply e145-7.
• Abraham, I., Demosthenes, L., MacDonald, K., Lee, C. S., Reel, S., Brié, H., Hermans, C., Vancayzeele, S., & Van der Niepen, P. (2010). Hierarchical linear and logistic modeling of outcomes of antihypertensive treatment in elderly patients: Findings from the PREVIEW study. Archives of Gerontology and Geriatrics, 51(Issue 1). doi:10.1016/j.archger.2009.07.009
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  Achieving guideline-recommended blood pressure targets is difficult in older adults with hypertension. We completed a subgroup analysis of patients 65 years of age or older enrolled in PREVIEW, a prospective, multicenter, pharmacoepidemiological study of the determinants and outcomes of second-line antihypertensive treatment with valsartan in Belgium. Multilevel modeling was used to identify physician- and patient-level determinants of blood pressure values and practice guideline-derived definitions of blood pressure control. Data on 1560 patients and 504 physicians were used in this analysis. Blood pressure control rates for patients age 65 and over were lower for systolic (34.2% vs. 38.6%) and combined systolic/diastolic blood pressure (31.2% vs. 34.4%) compared to the entire PREVIEW sample. Twenty-seven percent of the variability in systolic, and 32% in diastolic pressure after 90 days of treatment were attributable to such variables as physicians' knowledge and adherence to evidence-based guidelines, practice patterns, and experience; with the remaining variance attributable to various demographic, behavioral, and clinical patient-related factors. Several independent predictors of uncontrolled blood pressure after 90 days of treatment were identified, largely confirming factors identified as determinants of blood pressure values. Recommendations for managing hypertension in the elderly are made in view of these findings. © 2009 Elsevier Ireland Ltd.
• Abraham, I., Demosthenes, L., MacDonald, K., Lee, C. S., Reel, S., Brié, H., Hermans, C., Vancayzeele, S., & Van, P. (2010). Hierarchical linear and logistic modeling of outcomes of antihypertensive treatment in elderly patients: Findings from the PREVIEW study. Archives of Gerontology and Geriatrics, 51(1), 45-53.
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  PMID: 19716190;Abstract: Achieving guideline-recommended blood pressure targets is difficult in older adults with hypertension. We completed a subgroup analysis of patients 65 years of age or older enrolled in PREVIEW, a prospective, multicenter, pharmacoepidemiological study of the determinants and outcomes of second-line antihypertensive treatment with valsartan in Belgium. Multilevel modeling was used to identify physician- and patient-level determinants of blood pressure values and practice guideline-derived definitions of blood pressure control. Data on 1560 patients and 504 physicians were used in this analysis. Blood pressure control rates for patients age 65 and over were lower for systolic (34.2% vs. 38.6%) and combined systolic/diastolic blood pressure (31.2% vs. 34.4%) compared to the entire PREVIEW sample. Twenty-seven percent of the variability in systolic, and 32% in diastolic pressure after 90 days of treatment were attributable to such variables as physicians' knowledge and adherence to evidence-based guidelines, practice patterns, and experience; with the remaining variance attributable to various demographic, behavioral, and clinical patient-related factors. Several independent predictors of uncontrolled blood pressure after 90 days of treatment were identified, largely confirming factors identified as determinants of blood pressure values. Recommendations for managing hypertension in the elderly are made in view of these findings. © 2009 Elsevier Ireland Ltd.
• Abraham, I., Lee, C., Song, M., Vancayzeele, S., Brié, H., Hermans, C., Van der Niepen, P., & Macdonald, K. (2010). "Later, lazier, and unluckier": a heuristic profile of high vulnerability is an independent predictor of uncontrolled blood pressure (the PREVIEW study). International journal of general medicine, 3, 163-6.
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  Vulnerability profiling, an alternative to deterministic risk assessment, offers clinicians a more intuitive but empirically-grounded assessment of patient risk. This study aimed to determine whether a heuristic profile of high vulnerability is an independent predictor of uncontrolled hypertension.
• Abraham, I., Lee, C., Song, M., Vancayzeele, S., Brié, H., Hermans, C., van der Niepen, P., & MacDonald, K. (2010). "Later, lazier, and unluckier": A heuristic profile of high vulnerability is an independent predictor of uncontrolled blood pressure (the PREVIEW study). International Journal of General Medicine, 3(Issue). doi:10.2147/ijgm.s11638
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  Objective: Vulnerability profiling, an alternative to deterministic risk assessment, offers clinicians a more intuitive but empirically-grounded assessment of patient risk. This study aimed to determine whether a heuristic profile of high vulnerability is an independent predictor of uncontrolled hypertension. Methods: Secondary analysis of prospective observational study data on 2999 hypertensive patients treated with valsartan. Predictive validity of vulnerability profiling for first-line, secondline, and first-or-second-line antihypertensive treatment was inferred from 1) logistic regression models with adequate statistical fit, 2) statistically significant odds ratios for uncontrolled BP for the high-vulnerability cluster exceeding 1.00, and 3) correct classification rates for patients' BP control status. Results: All models of uncontrolled BP were significant (P
• Abraham, I., Lee, C., Song, M., Vancayzeele, S., Brié, H., Hermans, C., van, P., & MacDonald, K. (2010). "Later, lazier, and unluckier": A heuristic profile of high vulnerability is an independent predictor of uncontrolled blood pressure (the PREVIEW study). International Journal of General Medicine, 3, 163-166.
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  Abstract: Objective: Vulnerability profiling, an alternative to deterministic risk assessment, offers clinicians a more intuitive but empirically-grounded assessment of patient risk. This study aimed to determine whether a heuristic profile of high vulnerability is an independent predictor of uncontrolled hypertension. Methods: Secondary analysis of prospective observational study data on 2999 hypertensive patients treated with valsartan. Predictive validity of vulnerability profiling for first-line, secondline, and first-or-second-line antihypertensive treatment was inferred from 1) logistic regression models with adequate statistical fit, 2) statistically significant odds ratios for uncontrolled BP for the high-vulnerability cluster exceeding 1.00, and 3) correct classification rates for patients' BP control status. Results: All models of uncontrolled BP were significant (P
• Chisholm-Burns, M. A., Graff Zivin, J. S., Lee, J. K., Spivey, C. A., Slack, M., Herrier, R. N., Hall-Lipsy, E., Abraham, I., & Palmer, J. (2010). Economic effects of pharmacists on health outcomes in the United States: A systematic review. American Journal of Health-System Pharmacy, 67(Issue 19). doi:10.2146/ajhp100077
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  Purpose. A systematic review examining the economic effects of pharmacist-provided direct patient care on health outcomes in the United States was conducted. Methods. A comprehensive literature search was conducted using 13 academic and medical databases. Studies were included in the analysis if they described pharmacist-provided direct patient care, used comparison groups, evaluated economic outcomes, and were conducted in the United States. Outcome results were categorized as (1) favorable, indicating significant improvement as a result of pharmacists' interventions or services, (2) not favorable, indicating significant improvement as a result of nonpharmacist care, (3) mixed, having favorable results on one measure of a study variable but not favorable results or no effect on another, (4) having no effect, indicating no significant difference between pharmacists' interventions or services and the comparison, or (5) unclear, indicating the outcome could not be determined based on presented data. Results. Of the 56,573 citations considered, a total of 126 studies met the criteria for inclusion in this systematic review. Results favoring pharmacist-provided care were found in 20 studies (15.9%), mixed results were seen in 53 studies (42.1%), no effect was found in 6 studies (4.8%), and unclear results were found in 47 studies (37.3%). Conclusion. A majority of studies examining the economic effects of pharmacist-provided direct patient care in the United States were limited by their partial cost analyses, study design, and other analysis considerations. A majority of the 20 studies that found positive economic benefits examined pharmacists' interventions involving technical methods or multimodal approaches. United States Copyright © 2010, American Society of Health-System Pharmacists, Inc. All rights reserved.
• Chisholm-Burns, M. A., Graff Zivin, J. S., Lee, J. K., Spivey, C. A., Slack, M., Herrier, R. N., Hall-Lipsy, E., Abraham, I., & Palmer, J. (2010). Economic effects of pharmacists on health outcomes in the United States: A systematic review. American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists, 67(19), 1624-34.
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  A systematic review examining the economic effects of pharmacist-provided direct patient care on health outcomes in the United States was conducted.
• Chisholm-Burns, M. A., Kim Lee, J., Spivey, C. A., Slack, M., Herrier, R. N., Hall-Lipsy, E., Graff Zivin, J., Abraham, I., Palmer, J., Martin, J. R., Kramer, S. S., & Wunz, T. (2010). US pharmacists' effect as team members on patient care: Systematic review and meta-analyses. Medical Care, 48(Issue 10). doi:10.1097/mlr.0b013e3181e57962
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  Background: One approach postulated to improve the provision of health care is effective utilization of team-based care including pharmacists. Objective: The objective of this study was to conduct a comprehensive systematic review with focused meta-analyses to examine the effects of pharmacist-provided direct patient care on therapeutic, safety, and humanistic outcomes. Methods: The following databases were searched from inception to January 2009: NLM PubMed; Ovid/MEDLINE; ABI/INFORM; Health Business Fulltext Elite; Academic Search Complete; International Pharmaceutical Abstracts; PsycINFO; Cochrane Database of Systematic Reviews; National Guideline Clearinghouse; Database of Abstracts of Reviews of Effects; ClinicalTrials.gov; LexisNexis Academic Universe; and Google Scholar. Studies selected included those reporting pharmacist-provided care, comparison groups, and patient-related outcomes. Of these, 56,573 citations were considered. Data were extracted by multidisciplinary study review teams. Variables examined included study characteristics, pharmacists' interventions/services, patient characteristics, and study outcomes. Data for meta-analyses were extracted from randomized controlled trials meeting meta-analysis criteria. Results: A total of 298 studies were included. Favorable results were found in therapeutic and safety outcomes, and meta-analyses conducted for hemoglobin A1c, LDL cholesterol, blood pressure, and adverse drug events were significant (P < 0.05), favoring pharmacists' direct patient care over comparative services. Results for humanistic outcomes were favorable with variability. Medication adherence, patient knowledge, and quality of life-general health meta-analyses were significant (P < 0.05), favoring pharmacists' direct patient care. Conclusions: Pharmacist-provided direct patient care has favorable effects across various patient outcomes, health care settings, and disease states. Incorporating pharmacists as health care team members in direct patient care is a viable solution to help improve US health care. © 2010 by Lippincott Williams & Wilkins.
• Chisholm-Burns, M. A., Kim Lee, J., Spivey, C. A., Slack, M., Herrier, R. N., Hall-Lipsy, E., Graff Zivin, J., Abraham, I., Palmer, J., Martin, J. R., Kramer, S. S., & Wunz, T. (2010). US pharmacists' effect as team members on patient care: systematic review and meta-analyses. Medical care, 48(10), 923-33.
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  One approach postulated to improve the provision of health care is effective utilization of team-based care including pharmacists.
• Chisholm-Burns, M. A., Lee, J. K., Spivey, C. A., Slack, M., Herrier, R. N., Hall-Lipsy, E., Zivin, J. G., Abraham, I., Palmer, J., Martin, J. R., Kramer, S. S., & Wunz, T. (2010). US pharmacists' effect as team members on patient care: Systematic review and meta-analyses. Medical Care, 48(10), 923-933.
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  PMID: 20720510;Abstract: Background: One approach postulated to improve the provision of health care is effective utilization of team-based care including pharmacists. Objective: The objective of this study was to conduct a comprehensive systematic review with focused meta-analyses to examine the effects of pharmacist-provided direct patient care on therapeutic, safety, and humanistic outcomes. Methods: The following databases were searched from inception to January 2009: NLM PubMed; Ovid/MEDLINE; ABI/INFORM; Health Business Fulltext Elite; Academic Search Complete; International Pharmaceutical Abstracts; PsycINFO; Cochrane Database of Systematic Reviews; National Guideline Clearinghouse; Database of Abstracts of Reviews of Effects; ClinicalTrials.gov; LexisNexis Academic Universe; and Google Scholar. Studies selected included those reporting pharmacist-provided care, comparison groups, and patient-related outcomes. Of these, 56,573 citations were considered. Data were extracted by multidisciplinary study review teams. Variables examined included study characteristics, pharmacists' interventions/services, patient characteristics, and study outcomes. Data for meta-analyses were extracted from randomized controlled trials meeting meta-analysis criteria. Results: A total of 298 studies were included. Favorable results were found in therapeutic and safety outcomes, and meta-analyses conducted for hemoglobin A1c, LDL cholesterol, blood pressure, and adverse drug events were significant (P < 0.05), favoring pharmacists' direct patient care over comparative services. Results for humanistic outcomes were favorable with variability. Medication adherence, patient knowledge, and quality of life-general health meta-analyses were significant (P < 0.05), favoring pharmacists' direct patient care. Conclusions: Pharmacist-provided direct patient care has favorable effects across various patient outcomes, health care settings, and disease states. Incorporating pharmacists as health care team members in direct patient care is a viable solution to help improve US health care. © 2010 by Lippincott Williams & Wilkins.
• Chisholm-Burns, M. A., S., J., Lee, J. K., Spivey, C. A., Slack, M., Herrier, R. N., Hall-Lipsy, E., Abraham, I., & Palmer, J. (2010). Economic effects of pharmacists on health outcomes in the United States: A systematic review. American Journal of Health-System Pharmacy, 67(19), 1624-1634.
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  PMID: 20852164;Abstract: Purpose. A systematic review examining the economic effects of pharmacist-provided direct patient care on health outcomes in the United States was conducted. Methods. A comprehensive literature search was conducted using 13 academic and medical databases. Studies were included in the analysis if they described pharmacist-provided direct patient care, used comparison groups, evaluated economic outcomes, and were conducted in the United States. Outcome results were categorized as (1) favorable, indicating significant improvement as a result of pharmacists' interventions or services, (2) not favorable, indicating significant improvement as a result of nonpharmacist care, (3) mixed, having favorable results on one measure of a study variable but not favorable results or no effect on another, (4) having no effect, indicating no significant difference between pharmacists' interventions or services and the comparison, or (5) unclear, indicating the outcome could not be determined based on presented data. Results. Of the 56,573 citations considered, a total of 126 studies met the criteria for inclusion in this systematic review. Results favoring pharmacist-provided care were found in 20 studies (15.9%), mixed results were seen in 53 studies (42.1%), no effect was found in 6 studies (4.8%), and unclear results were found in 47 studies (37.3%). Conclusion. A majority of studies examining the economic effects of pharmacist-provided direct patient care in the United States were limited by their partial cost analyses, study design, and other analysis considerations. A majority of the 20 studies that found positive economic benefits examined pharmacists' interventions involving technical methods or multimodal approaches. United States Copyright © 2010, American Society of Health-System Pharmacists, Inc. All rights reserved.
• Erps, J. V., Aapro, M., MacDonald, K., Soubeyran, P., Turner, M., Warrinnier, H., Albrecht, T., & Abraham, I. (2010). Promoting evidence-based management of anemia in cancer patients: Concurrent and discriminant validity of RESPOND, a web-based clinical guidance system based on the EORTC guidelines for supportive care in cancer. Supportive Care in Cancer, 18(7), 847-858.
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  PMID: 19904563;Abstract: Goal of work The goal of this study is to test the validity of RESPOND, a web-based decision support system to assess and manage anemia in cancer patients as per the European Organisation for Research and Treatment of Cancer (EORTC) guidelines. The intraclass correlation metrics for the algorithmic definitions were reported previously. Reported here are the concurrent validity, the extent to which clinicians' anemia management is guidelines-congruent when using the system; and discriminant validity, the extent to which clinicians practice in congruence with guidelines when vs. when not using the system. Patients and methods Hybrid matched design with precohort (retrospective; clinicians not using RESPOND) and postcohort (prospective; clinicians using RESPOND) of anemic patients matched on cancer type and chemotherapy regimen and followed up over 4 months after treatment initiation with erythropoietic proteins (34 patients per cohort; total N=68). Congruence scores quantified the extent to which anemia management was congruent with the EORTC guidelines (range 0-10). Main results Hemoglobin (Hb) increased significantly for both cohorts, but the postcohort group showed more rapid rate of Hb increase over time (p
• Maa, S. H., Chang, Y. C., Chou, C. L., Ho, S. C., Sheng, T. F., MacDonald, K., Wang, Y., Shen, Y. M., & Abraham, I. (2010). Evaluation of the feasibility of a school-based asthma management programme in Taiwan. Journal of Clinical Nursing, 19(Issue 17-18). doi:10.1111/j.1365-2702.2010.03283.x
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  Aims and objectives.: To investigate the feasibility of a school-based asthma management programme for middle school children. Background.: Asthma rates are increasing among school-aged children. Successful asthma treatment in children depends in part on clear communication and effective education. Design.: This feasibility study employed a one-group only longitudinal design with four time points over 18 months. Methods.: Nineteen female and twelve male (n = 31) seventh-grade children with asthma (13 SD 0·71 years) were identified using a six-stage asthma case-finding approach. Teachers and school staff were trained in the principles and methods of the proposed school-based asthma management programme. An individualised guided asthma self-management programme was developed for each child by a clinical team at a major academic medical centre. We assisted teachers in implementing the school programme; building a support network and monitoring children's activities. Outcome measures included lung function tests (at 0, six, 12 and 18 months), disease-related symptoms, psychosocial status and impact of asthma on learning (at 0 and 18 months). School provided data on academic achievement and school absences at 0, six, 12 and 18 months. Results.: Significant improvements were noted at six, 12 and 18 months on forced vital capacity (FVC)% of predicted (p = 0·001, 0·015, 0·015, respectively), forced expiratory volume in one second (FEV1)% of predicted (p = 0·001, 0·006, 0·088, respectively) and FEV1/FVC% of predicted (p = 0·001, 0·015, 0·099, respectively). There was a trend towards improved asthma symptoms (p = 0·050) and a significant decrease in positive perception of curriculum (p = 0·017) at 18 months after adjustment for covariates. Conclusions.: This programme was associated with respiratory benefits on physiological asthma markers commonly, with a trend for symptom control. Academic and psychosocial outcomes are subject of further inquiry. Relevance to clinical practice.: School-based asthma management holds promise as a feasible clinical option for middle school children with asthma in the Taiwanese school system. © 2010 Blackwell Publishing Ltd.
• Maa, S., Chang, Y., Chou, C., Ho, S., Sheng, T., MacDonald, K., Wang, Y., Shen, Y., & Abraham, I. (2010). Evaluation of the feasibility of a school-based asthma management programme in Taiwan. Journal of Clinical Nursing, 19(17-18), 2415-2423.
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  PMID: 20920069;Abstract: Aims and objectives.: To investigate the feasibility of a school-based asthma management programme for middle school children. Background.: Asthma rates are increasing among school-aged children. Successful asthma treatment in children depends in part on clear communication and effective education. Design.: This feasibility study employed a one-group only longitudinal design with four time points over 18 months. Methods.: Nineteen female and twelve male (n = 31) seventh-grade children with asthma (13 SD 0·71 years) were identified using a six-stage asthma case-finding approach. Teachers and school staff were trained in the principles and methods of the proposed school-based asthma management programme. An individualised guided asthma self-management programme was developed for each child by a clinical team at a major academic medical centre. We assisted teachers in implementing the school programme; building a support network and monitoring children's activities. Outcome measures included lung function tests (at 0, six, 12 and 18 months), disease-related symptoms, psychosocial status and impact of asthma on learning (at 0 and 18 months). School provided data on academic achievement and school absences at 0, six, 12 and 18 months. Results.: Significant improvements were noted at six, 12 and 18 months on forced vital capacity (FVC)% of predicted (p = 0·001, 0·015, 0·015, respectively), forced expiratory volume in one second (FEV1)% of predicted (p = 0·001, 0·006, 0·088, respectively) and FEV1/FVC% of predicted (p = 0·001, 0·015, 0·099, respectively). There was a trend towards improved asthma symptoms (p = 0·050) and a significant decrease in positive perception of curriculum (p = 0·017) at 18 months after adjustment for covariates. Conclusions.: This programme was associated with respiratory benefits on physiological asthma markers commonly, with a trend for symptom control. Academic and psychosocial outcomes are subject of further inquiry. Relevance to clinical practice.: School-based asthma management holds promise as a feasible clinical option for middle school children with asthma in the Taiwanese school system. © 2010 Blackwell Publishing Ltd.
• Maa, S., Chang, Y., Chou, C., Ho, S., Sheng, T., Macdonald, K., Wang, Y., Shen, Y., & Abraham, I. (2010). Evaluation of the feasibility of a school-based asthma management programme in Taiwan. Journal of clinical nursing, 19(17-18), 2415-23.
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  To investigate the feasibility of a school-based asthma management programme for middle school children.
• Milisen, K., Busser, T. D., Kayaert, A., Abraham, I., & Dierckx, B. (2010). The evolving professional nursing self-image of students in baccalaureate programs: A cross-sectional survey. International Journal of Nursing Studies, 47(6), 688-698.
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  PMID: 19962697;Abstract: Background: We have previously examined the professional self-image of practicing nurses in Belgium and its association with various professional decisions, however there is limited knowledge about the professional self-image of nurses-to-be. Despite prior research on nursing students' perceptions of nursing or their self-esteem, students' professional image, defined as "the way students perceive themselves in their clinical practice environment and their anticipated work environment", has not been described nor compared to that of practicing nurses. Objective: To describe the professional nursing self-image among students in their final year of baccalaureate education. Design: Cross-sectional survey. Settings: Nine geographically spread baccalaureate programs in the Flemish region of Belgium. Participants: 427 evaluable students from 455 recruited from 663 potential. Methods: Data collected in each school during regular hours using an adapted version of the BELIMAGE (Belgian professional self-image instrument for hospital nurses) including questions on personal demographics, education and competence, nursing care, team and practice environment. Voluntary participation with returned questionnaire deemed informed consent. Results: Respondents identified several curricular components as contributing to their perceived competence. They also identified several skills deemed important to professional nursing, however did not feel competent in all of these. Important nursing care aspects included individualizing patient care, detecting care problems and potential complications, and promoting patient well-being; within a care environment with open interdisciplinary communication, where care problems could be discussed with nursing colleagues, where one cares for the same patient regularly, and led by a team leader with vision. Society's view of nursing was generally more negative than students'. Most students planned on working in nursing after their studies and many had thought about additional education at some point. Most were proud of becoming a nurse, would recommend nursing to others, and would choose nursing again as field of study. Conclusions: Students' evolving professional self-image was positive, rich, and enthusiastic; and higher than that observed in working nurses in a prior study. There is a significant gap between nursing care aspects deemed important and perceived competence in these areas, which has implications for both educators and future employers. Once employed, students are likely to experience differences in their perceptions of professional self-image with those of senior colleagues; another area of attention for employers. © 2009 Elsevier Ltd. All rights reserved.
• Milisen, K., De Busser, T., Kayaert, A., Abraham, I., & Dierckx de Casterlé, B. (2010). The evolving professional nursing self-image of students in baccalaureate programs: A cross-sectional survey. International Journal of Nursing Studies, 47(Issue 6). doi:10.1016/j.ijnurstu.2009.11.008
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  Background: We have previously examined the professional self-image of practicing nurses in Belgium and its association with various professional decisions, however there is limited knowledge about the professional self-image of nurses-to-be. Despite prior research on nursing students' perceptions of nursing or their self-esteem, students' professional image, defined as "the way students perceive themselves in their clinical practice environment and their anticipated work environment", has not been described nor compared to that of practicing nurses. Objective: To describe the professional nursing self-image among students in their final year of baccalaureate education. Design: Cross-sectional survey. Settings: Nine geographically spread baccalaureate programs in the Flemish region of Belgium. Participants: 427 evaluable students from 455 recruited from 663 potential. Methods: Data collected in each school during regular hours using an adapted version of the BELIMAGE (Belgian professional self-image instrument for hospital nurses) including questions on personal demographics, education and competence, nursing care, team and practice environment. Voluntary participation with returned questionnaire deemed informed consent. Results: Respondents identified several curricular components as contributing to their perceived competence. They also identified several skills deemed important to professional nursing, however did not feel competent in all of these. Important nursing care aspects included individualizing patient care, detecting care problems and potential complications, and promoting patient well-being; within a care environment with open interdisciplinary communication, where care problems could be discussed with nursing colleagues, where one cares for the same patient regularly, and led by a team leader with vision. Society's view of nursing was generally more negative than students'. Most students planned on working in nursing after their studies and many had thought about additional education at some point. Most were proud of becoming a nurse, would recommend nursing to others, and would choose nursing again as field of study. Conclusions: Students' evolving professional self-image was positive, rich, and enthusiastic; and higher than that observed in working nurses in a prior study. There is a significant gap between nursing care aspects deemed important and perceived competence in these areas, which has implications for both educators and future employers. Once employed, students are likely to experience differences in their perceptions of professional self-image with those of senior colleagues; another area of attention for employers. © 2009 Elsevier Ltd. All rights reserved.
• Milisen, K., De Busser, T., Kayaert, A., Abraham, I., & de Casterlé, B. D. (2010). The evolving professional nursing self-image of students in baccalaureate programs: a cross-sectional survey. International journal of nursing studies, 47(6), 688-98.
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  We have previously examined the professional self-image of practicing nurses in Belgium and its association with various professional decisions, however there is limited knowledge about the professional self-image of nurses-to-be. Despite prior research on nursing students' perceptions of nursing or their self-esteem, students' professional image, defined as "the way students perceive themselves in their clinical practice environment and their anticipated work environment", has not been described nor compared to that of practicing nurses.
• Van Erps, J., Aapro, M., MacDonald, K., Soubeyran, P., Turner, M., Warrinnier, H., Albrecht, T., & Abraham, I. (2010). Promoting evidence-based management of anemia in cancer patients: Concurrent and discriminant validity of RESPOND, a web-based clinical guidance system based on the EORTC guidelines for supportive care in cancer. Supportive Care in Cancer, 18(Issue 7). doi:10.1007/s00520-009-0718-z
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  Goal of work The goal of this study is to test the validity of RESPOND, a web-based decision support system to assess and manage anemia in cancer patients as per the European Organisation for Research and Treatment of Cancer (EORTC) guidelines. The intraclass correlation metrics for the algorithmic definitions were reported previously. Reported here are the concurrent validity, the extent to which clinicians' anemia management is guidelines-congruent when using the system; and discriminant validity, the extent to which clinicians practice in congruence with guidelines when vs. when not using the system. Patients and methods Hybrid matched design with precohort (retrospective; clinicians not using RESPOND) and postcohort (prospective; clinicians using RESPOND) of anemic patients matched on cancer type and chemotherapy regimen and followed up over 4 months after treatment initiation with erythropoietic proteins (34 patients per cohort; total N=68). Congruence scores quantified the extent to which anemia management was congruent with the EORTC guidelines (range 0-10). Main results Hemoglobin (Hb) increased significantly for both cohorts, but the postcohort group showed more rapid rate of Hb increase over time (p
• Aapro, M., Abraham, I., Albrecht, T., Bokemeyer, C., Ludwig, H., Macdonald, K., Soubeyran, P., & Turner, M. (2009). A146 Management of Anemia in Multiple Myeloma Patients with Anemia: Findings from the A.C.T. Study. Clinical Lymphoma, Myeloma & Leukemia, 9, S24. doi:10.1016/s1557-9190(11)70479-6
• Aapro, M., Erps, J. V., MacDonald, K., Soubeyran, P., Muenzberg, M., Turner, M., Warrinnier, H., Albrecht, T., & Abraham, I. (2009). Managing cancer-related anaemia in congruence with the EORTC guidelines is an independent predictor of haemoglobin outcome: Initial evidence from the RESPOND study. European Journal of Cancer, 45(1), 8-11.
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  PMID: 19058959;Abstract: Purpose: To model the relationship between scores for practicing in congruence (CSs; 0-10) with EORTC guidelines for erythropoietic proteins (EPs) and haemoglobin (Hb) outcomes observed in the validation study of the RESPOND system. Methods: Thirty four patient pairs matched on cancer type and chemotherapy in pre- (retrospective; clinicians not using RESPOND) and post-cohorts (prospective; clinicians using RESPOND) followed over 4 months following EP treatment initiation. CSs quantify the extent that care was guideline-adherent. Linear and logistic regressions controlling for cohort examined Hb outcomes as a function of CSs. Results: A one-point increase in CS was associated with 0.60 g/dL increase in Hb at month 4 (R2 = 0.40) and 0.56 g/dL increase in Hb change from month 1-4 (R2 = 0.33). Each one-point increase in CS increased the odds of reaching Hb ≥ 11 g/dL by 3.14 (R2 = 0.42) and Hb ≥ 12 g/dL by 2.77 (R2 = 0.45). Conclusion: Guideline-adherent EP treatment may improve Hb outcomes but specifically designed outcomes studies are necessary. © 2008 Elsevier Ltd. All rights reserved.
• Aapro, M., Ludwig, H., Bokemeyer, C., MacDonald, K., Soubeyran, P., Turner, M., Albrecht, T., & Abraham, I. (2009). Modeling of treatment response to erythropoiesis-stimulating agents as a function of center- and patient-related variables: Results from the Anemia Cancer Treatment (ACT) study. Annals of Oncology, 20(10), 1714-1721.
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  PMID: 19570966;Abstract: Background: In anemic cancer patients treated with erythropoiesis-stimulating agent (ESA), (i) to examine the proportion of variance in hemoglobin (Hb) outcomes attributable to patients versus center, country, and region and (ii) to develop predictive models of treatment response. Methods: Retrospective study with a minimum of three visits at 1-month intervals. Three hundred and seven centers in 13 European countries contributed 2192 anemic ESA-treated cancer patients. Treatment response criteria included: Hb↑≥1 g/dl, Hb↑≥1 g/dl within 8 weeks, hematopoietic response (Hb↑≥2 g/dl or Hb ≥ 12 g/dl), Hb↑≥2 g/dl, and Hb between 12 and 13 g/dl. Results: Hb increased from 9.54 ± 0.95 g/dl (baseline) to 10.88 ± 1.49 g/dl (visit 3). Hb change from visits 1 to 2 (index of relative immediacy of response to ESA) averaged 0.81 ± 1.17 g/dl. The proportion of variance in Hb outcomes attributable to center was 11.8%-34.3%, country 2.9%-20.7%, and region 0.0%-7.6%. Immediacy of response to ESA was the most prevalent predictor of treatment response, followed by diagnosis of hematological malignancy and age
• Aapro, M., Ludwig, H., Bokemeyer, C., MacDonald, K., Soubeyran, P., Turner, M., Albrecht, T., & Abraham, I. (2009). Modeling of treatment response to erythropoiesis-stimulating agents as a function of center- and patient-related variables: Results from the Anemia Cancer Treatment (ACT) study. Annals of Oncology, 20(Issue 10). doi:10.1093/annonc/mdp063
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  Background: In anemic cancer patients treated with erythropoiesis-stimulating agent (ESA), (i) to examine the proportion of variance in hemoglobin (Hb) outcomes attributable to patients versus center, country, and region and (ii) to develop predictive models of treatment response. Methods: Retrospective study with a minimum of three visits at 1-month intervals. Three hundred and seven centers in 13 European countries contributed 2192 anemic ESA-treated cancer patients. Treatment response criteria included: Hb↑≥1 g/dl, Hb↑≥1 g/dl within 8 weeks, hematopoietic response (Hb↑≥2 g/dl or Hb ≥ 12 g/dl), Hb↑≥2 g/dl, and Hb between 12 and 13 g/dl. Results: Hb increased from 9.54 ± 0.95 g/dl (baseline) to 10.88 ± 1.49 g/dl (visit 3). Hb change from visits 1 to 2 (index of relative immediacy of response to ESA) averaged 0.81 ± 1.17 g/dl. The proportion of variance in Hb outcomes attributable to center was 11.8%-34.3%, country 2.9%-20.7%, and region 0.0%-7.6%. Immediacy of response to ESA was the most prevalent predictor of treatment response, followed by diagnosis of hematological malignancy and age
• Aapro, M., Van Erps, J., MacDonald, K., Soubeyran, P., Muenzberg, M., Turner, M., Warrinnier, H., Albrecht, T., & Abraham, I. (2009). Managing cancer-related anaemia in congruence with the EORTC guidelines is an independent predictor of haemoglobin outcome: Initial evidence from the RESPOND study. European Journal of Cancer, 45(Issue 1). doi:10.1016/j.ejca.2008.09.036
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  Purpose: To model the relationship between scores for practicing in congruence (CSs; 0-10) with EORTC guidelines for erythropoietic proteins (EPs) and haemoglobin (Hb) outcomes observed in the validation study of the RESPOND system. Methods: Thirty four patient pairs matched on cancer type and chemotherapy in pre- (retrospective; clinicians not using RESPOND) and post-cohorts (prospective; clinicians using RESPOND) followed over 4 months following EP treatment initiation. CSs quantify the extent that care was guideline-adherent. Linear and logistic regressions controlling for cohort examined Hb outcomes as a function of CSs. Results: A one-point increase in CS was associated with 0.60 g/dL increase in Hb at month 4 (R2 = 0.40) and 0.56 g/dL increase in Hb change from month 1-4 (R2 = 0.33). Each one-point increase in CS increased the odds of reaching Hb ≥ 11 g/dL by 3.14 (R2 = 0.42) and Hb ≥ 12 g/dL by 2.77 (R2 = 0.45). Conclusion: Guideline-adherent EP treatment may improve Hb outcomes but specifically designed outcomes studies are necessary. © 2008 Elsevier Ltd. All rights reserved.
• Aapro, M., Van Erps, J., MacDonald, K., Soubeyran, P., Muenzberg, M., Turner, M., Warrinnier, H., Albrecht, T., & Abraham, I. (2009). Managing cancer-related anaemia in congruence with the EORTC guidelines is an independent predictor of haemoglobin outcome: initial evidence from the RESPOND study. European journal of cancer (Oxford, England : 1990), 45(1), 8-11.
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  To model the relationship between scores for practicing in congruence (CSs; 0-10) with EORTC guidelines for erythropoietic proteins (EPs) and haemoglobin (Hb) outcomes observed in the validation study of the RESPOND system.
• Brusselle, G., Michils, A., Louis, R., Dupont, L., Van de Maele, B., Delobbe, A., Pilette, C., Lee, C. S., Gurdain, S., Vancayzeele, S., Lecomte, P., Hermans, C., MacDonald, K., Song, M., & Abraham, I. (2009). "Real-life" effectiveness of omalizumab in patients with severe persistent allergic asthma: The PERSIST study. Respiratory Medicine, 103(Issue 11). doi:10.1016/j.rmed.2009.06.014
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  Objective: To evaluate the 16- and 52-week effectiveness of add-on omalizumab treatment under real-life heterogeneity in patients, settings, and physicians in an open-label, multicenter, pharmaco-epidemiologic study of patients with severe persistent allergic asthma in Belgium. Methods: Effectiveness outcomes included improvement in 2005 global initiative for asthma (GINA) classification, physician-rated global evaluation of treatment effectiveness (GETE), quality of life (Juniper asthma-related quality of life (AQLQ) and European quality of life questionnaire 5 dimensions (EQ-5D)), and severe asthma exacerbations. Patients studied included both intent-to-treat and per-protocol populations. Results: The sample (n = 158) had a mean age of 48.17 ± 17.18 years, and a slight majority were female (53.8%). Despite being treated with high-dose inhaled corticosteroids and long-acting β2-agonists, all patients experienced frequent symptoms and had exacerbations in the past year. At 16 weeks, >82% had good/excellent GETE (P values 82% had an improvement in total AQLQ scores of ≥0.5 points (P < 0.001), and >91% were severe exacerbation-free (P < 0.001). At 52 weeks, >72% had a good/excellent GETE rating (P < 0.001), >84% had improvements in total AQLQ score of ≥0.5 points (P < 0.001), >56% had minimally important improvements in EQ-5D utility scores (P = 0.012), and >65% were severe exacerbation-free (P < 0.001). Significant reductions in healthcare utilization compared to the one year prior to treatment were noted. Conclusion: The PERSIST study shows better physician-rated effectiveness, greater improvements in quality of life, greater reductions in exacerbation rates, and greater reductions in healthcare utilization than previously reported in efficacy studies. Under real-life conditions, omalizumab is effective as add-on therapy in the treatment of patients with persistent severe allergic asthma. © 2009 Elsevier Ltd. All rights reserved.
• Brusselle, G., Michils, A., Louis, R., Dupont, L., Van, B., Delobbe, A., Pilette, C., Lee, C. S., Gurdain, S., Vancayzeele, S., Lecomte, P., Hermans, C., MacDonald, K., Song, M., & Abraham, I. (2009). "Real-life" effectiveness of omalizumab in patients with severe persistent allergic asthma: The PERSIST study. Respiratory Medicine, 103(11), 1633-1642.
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  PMID: 19619998;Abstract: Objective: To evaluate the 16- and 52-week effectiveness of add-on omalizumab treatment under real-life heterogeneity in patients, settings, and physicians in an open-label, multicenter, pharmaco-epidemiologic study of patients with severe persistent allergic asthma in Belgium. Methods: Effectiveness outcomes included improvement in 2005 global initiative for asthma (GINA) classification, physician-rated global evaluation of treatment effectiveness (GETE), quality of life (Juniper asthma-related quality of life (AQLQ) and European quality of life questionnaire 5 dimensions (EQ-5D)), and severe asthma exacerbations. Patients studied included both intent-to-treat and per-protocol populations. Results: The sample (n = 158) had a mean age of 48.17 ± 17.18 years, and a slight majority were female (53.8%). Despite being treated with high-dose inhaled corticosteroids and long-acting β2-agonists, all patients experienced frequent symptoms and had exacerbations in the past year. At 16 weeks, >82% had good/excellent GETE (P values 82% had an improvement in total AQLQ scores of ≥0.5 points (P < 0.001), and >91% were severe exacerbation-free (P < 0.001). At 52 weeks, >72% had a good/excellent GETE rating (P < 0.001), >84% had improvements in total AQLQ score of ≥0.5 points (P < 0.001), >56% had minimally important improvements in EQ-5D utility scores (P = 0.012), and >65% were severe exacerbation-free (P < 0.001). Significant reductions in healthcare utilization compared to the one year prior to treatment were noted. Conclusion: The PERSIST study shows better physician-rated effectiveness, greater improvements in quality of life, greater reductions in exacerbation rates, and greater reductions in healthcare utilization than previously reported in efficacy studies. Under real-life conditions, omalizumab is effective as add-on therapy in the treatment of patients with persistent severe allergic asthma. © 2009 Elsevier Ltd. All rights reserved.
• Ludwig, H., Aapro, M., Bokemeyer, C., MacDonald, K., Soubeyran, P., Turner, M., Albrecht, T., & Abraham, I. (2009). Treatment patterns and outcomes in the management of anaemia in cancer patients in Europe: Findings from the Anaemia Cancer Treatment (ACT) study. European Journal of Cancer, 45(9), 1603-1615.
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  PMID: 19278851;Abstract: Objectives: To examine anaemia management in cancer patients treated with erythropoiesis-stimulating agents (ESAs) in Europe. Methods: Retrospective pharmacoepidemiologic study of 2192 patients from 307 centres. Minimum of 3 visits over 8-10 weeks with ESA treatment initiated at visit 1. Results: Most patients were treated per guidelines, except for low iron supplementation rates. Mean Hb rose from 9.54 ± 0.95 g/dl to 10.88 ± 1.49 g/dl at visit 3, without concomitant rise in WHO/ECOG score. Response rates were 65.0% (Hb increase ↑ ≥ 1 g/dl); 54.3% (Hb increase ↑ ≥ 1 g/dl in 8 weeks); 38.9% (haematopoietic response); 33.7% (Hb increase ↑ ≥ 2 g/dl) and 18.8% (Hb between12.0 and 12.9 g/dl). Conclusions: Treatment patterns were guideline congruent, except for (intravenous) iron supplementation. Hb increased by 1.34 g/dl. A net erythropoiesis boost of Hb ≥ 1 g/dl is attainable in two-thirds of patients and should be condensed to 8 weeks on an individual patient basis. Anaemia management in Europe has improved significantly. The general effectiveness and relative safety of judicious ESA treatment are evident. © 2009 Elsevier Ltd. All rights reserved.
• Ludwig, H., Aapro, M., Bokemeyer, C., MacDonald, K., Soubeyran, P., Turner, M., Albrecht, T., & Abraham, I. (2009). Treatment patterns and outcomes in the management of anaemia in cancer patients in Europe: Findings from the Anaemia Cancer Treatment (ACT) study. European Journal of Cancer, 45(Issue 9). doi:10.1016/j.ejca.2009.02.003
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  Objectives: To examine anaemia management in cancer patients treated with erythropoiesis-stimulating agents (ESAs) in Europe. Methods: Retrospective pharmacoepidemiologic study of 2192 patients from 307 centres. Minimum of 3 visits over 8-10 weeks with ESA treatment initiated at visit 1. Results: Most patients were treated per guidelines, except for low iron supplementation rates. Mean Hb rose from 9.54 ± 0.95 g/dl to 10.88 ± 1.49 g/dl at visit 3, without concomitant rise in WHO/ECOG score. Response rates were 65.0% (Hb increase ↑ ≥ 1 g/dl); 54.3% (Hb increase ↑ ≥ 1 g/dl in 8 weeks); 38.9% (haematopoietic response); 33.7% (Hb increase ↑ ≥ 2 g/dl) and 18.8% (Hb between12.0 and 12.9 g/dl). Conclusions: Treatment patterns were guideline congruent, except for (intravenous) iron supplementation. Hb increased by 1.34 g/dl. A net erythropoiesis boost of Hb ≥ 1 g/dl is attainable in two-thirds of patients and should be condensed to 8 weeks on an individual patient basis. Anaemia management in Europe has improved significantly. The general effectiveness and relative safety of judicious ESA treatment are evident. © 2009 Elsevier Ltd. All rights reserved.
• Ludwig, H., Aapro, M., Bokemeyer, C., Macdonald, K., Soubeyran, P., Turner, M., Albrecht, T., & Abraham, I. (2009). Treatment patterns and outcomes in the management of anaemia in cancer patients in Europe: findings from the Anaemia Cancer Treatment (ACT) study. European journal of cancer (Oxford, England : 1990), 45(9), 1603-15.
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  To examine anaemia management in cancer patients treated with erythropoiesis-stimulating agents (ESAs) in Europe.
• Noens, L., Lierde, M. V., Bock, R. D., Verhoef, G., Zachée, P., Berneman, Z., Martiat, P., Mineur, P., Eygen, K. V., MacDonald, K., Geest, S. D., Albrecht, T., & Abraham, I. (2009). Prevalence, determinants, and outcomes of nonadherence to imatinib therapy in patients with chronic myeloid leukemia: The ADAGIO study. Blood, 113(22), 5401-5411.
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  PMID: 19349618;Abstract: Imatinib mesylate (imatinib) has been shown to be highly efficacious in the treatment of chronic myeloid leukemia (CML). Continuous and adequate dosing is essential for optimal outcomes and with imatinib treatment possibly being lifelong, patient adherence is critical. The ADAGIO (Adherence Assessment with Glivec: Indicators and Outcomes) study aimed to assess prospectively over a 90-day period the prevalence of imatinib nonadherence in patients with CML; to develop a multivariate canonical correlation model of how various determinants may be associated with various measures of nonadherence; and to examine whether treatment response is associated with adherence levels. A total of 202 patients were recruited from 34 centers in Belgium, of whom 169 were evaluable. One-third of patients were considered to be nonadherent. Only 14.2% of patients were perfectly adherent with 100% of prescribed imatinib taken. On average, patients with suboptimal response had significantly higher mean percentages of imatinib not taken (23.2%, standard deviation [SD] = 23.8) than did those with optimal response (7.3%, SD = 19.3, P = .005; percentages calculated as proportions x 100). Nonadherence is more prevalent than patients, physicians, and family members believe it is, and therefore should be assessed routinely. It is associated with poorer response to imatinib. Several determinants may serve as alert signals, many of which are clinically modifiable. © 2009 by The American Society of Hematology.
• Noens, L., Van Lierde, M. A., De Bock, R., Verhoef, G., Zachée, P., Berneman, Z., Martiat, P., Mineur, P., Van Eygen, K., MacDonald, K., De Geest, S., Albrecht, T., & Abraham, I. (2009). Prevalence, determinants, and outcomes of nonadherence to imatinib therapy in patients with chronic myeloid leukemia: The ADAGIO study. Blood, 113(Issue 22). doi:10.1182/blood-2008-12-196543
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  Imatinib mesylate (imatinib) has been shown to be highly efficacious in the treatment of chronic myeloid leukemia (CML). Continuous and adequate dosing is essential for optimal outcomes and with imatinib treatment possibly being lifelong, patient adherence is critical. The ADAGIO (Adherence Assessment with Glivec: Indicators and Outcomes) study aimed to assess prospectively over a 90-day period the prevalence of imatinib nonadherence in patients with CML; to develop a multivariate canonical correlation model of how various determinants may be associated with various measures of nonadherence; and to examine whether treatment response is associated with adherence levels. A total of 202 patients were recruited from 34 centers in Belgium, of whom 169 were evaluable. One-third of patients were considered to be nonadherent. Only 14.2% of patients were perfectly adherent with 100% of prescribed imatinib taken. On average, patients with suboptimal response had significantly higher mean percentages of imatinib not taken (23.2%, standard deviation [SD] = 23.8) than did those with optimal response (7.3%, SD = 19.3, P = .005; percentages calculated as proportions x 100). Nonadherence is more prevalent than patients, physicians, and family members believe it is, and therefore should be assessed routinely. It is associated with poorer response to imatinib. Several determinants may serve as alert signals, many of which are clinically modifiable. © 2009 by The American Society of Hematology.
• Van Der Niepen, P., Woestenburg, A., Brié, H., Vancayzeele, S., MacDonald, K., Denhaerynck, K., Lee, C., Hermans, C., & Abraham, I. (2009). Effectiveness of valsartan for treatment of hypertension: Patient profiling and hierarchical modeling of determinants and outcomes (the PREVIEW study). Annals of Pharmacotherapy, 43(Issue 5). doi:10.1345/aph.1l576
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  BACKGROUND: Patient- and clinician-related factors may explain variability in blood pressure (BP) outcomes and the differences between real-world effectiveness and efficacy seen in randomized trials of antihypertensive agents. OBJECTIVE: To examine the effectiveness of 90 days of second-line valsartan treatment and identify patient- and physician-level determinants that impact BP outcomes. METHODS: A prospective, multicenter, multilevel pharmacoepidemiologic study was conducted in 3194 hypertensive patients (systolic BP [SBP] ≥140 mm Hg, diastolic BP [DBP] ≥90 mm Hg; for diabetic patients, ≥130 and ≥80 mm Hg, respectively) treated by 504 general practitioners (GPs). Statistical analysis included heuristic data mining, and hierarchical linear and logistic modeling. RESULTS: With valsartan treatment, mean ± SD SBP decreased from 154.4 ± 15.5 mmHg to 139.0 ± 12.0 mmHg and mean DBP decreased from 91.3 ± 9.2 mmHg to 82.6 ± 7.4 mmHg. SBP control rates increased from 9.0% to 38.6%, DBP from 25.5% to 65.5%, and combined SBP/DBP from 7.3% to 34.4%. A highly vulnerable cohort (n = 1063; 35.4%) of patients was identified. Twenty-four percent of variability in SBP and 25% of variability in DBP at 90 days were attributable to physician-related variables: guideline-compliant BP management, hypertension, practice patterns, hypertensive patient volume, and years in practice. The remaining 76% and 75% of variability in SBP and DBP, respectively, were due to patient factors, notably diabetes and related complications, vulnerability to uncontrolled BP, nonadherence, cardiovascular risk, and age. Similar factors increased the odds of treatment nonresponse, with diabetes being the single largest determinant of uncontrolled SBP (OR 8.99), DBP (OR 20.35), and combined SBP/DBP (OR = 18.64). CONCLUSIONS: Valsartan is effective and well tolerated in a broad range of patients in whom first-line antihypertensive treatment failed or was not tolerated. Mitigating the impact of BP-elevating variables and optimizing the effect of BP-lowering factors provides therapeutic benefits incremental to valsartan's pharmacologic effect. Improving outcomes in hypertensive patients involves 3 steps: (1) identifying, intuitively rather than formally, patients less likely to achieve BP control; (2) targeting modifiable or manageable patient- and physician-level determinants with BP-elevating or BP-lowering effects; and (3) managing variables that increase the odds and optimizing those that lower the odds of uncontrolled BP.
• Van der Niepen, P., Woestenburg, A., Brié, H., Vancayzeele, S., MacDonald, K., Denhaerynck, K., Lee, C., Hermans, C., & Abraham, I. (2009). Effectiveness of valsartan for treatment of hypertension: patient profiling and hierarchical modeling of determinants and outcomes (the PREVIEW study). The Annals of pharmacotherapy, 43(5), 849-61.
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  Patient- and clinician-related factors may explain variability in blood pressure (BP) outcomes and the differences between real-world effectiveness and efficacy seen in randomized trials of antihypertensive agents.
• Van, P., Woestenburg, A., Brié, H., Vancayzeele, S., MacDonald, K., Denhaerynck, K., Lee, C., Hermans, C., & Abraham, I. (2009). Effectiveness of valsartan for treatment of hypertension: Patient profiling and hierarchical modeling of determinants and outcomes (the PREVIEW study). Annals of Pharmacotherapy, 43(5), 849-861.
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  PMID: 19351876;Abstract: BACKGROUND: Patient- and clinician-related factors may explain variability in blood pressure (BP) outcomes and the differences between real-world effectiveness and efficacy seen in randomized trials of antihypertensive agents. OBJECTIVE: To examine the effectiveness of 90 days of second-line valsartan treatment and identify patient- and physician-level determinants that impact BP outcomes. METHODS: A prospective, multicenter, multilevel pharmacoepidemiologic study was conducted in 3194 hypertensive patients (systolic BP [SBP] ≥140 mm Hg, diastolic BP [DBP] ≥90 mm Hg; for diabetic patients, ≥130 and ≥80 mm Hg, respectively) treated by 504 general practitioners (GPs). Statistical analysis included heuristic data mining, and hierarchical linear and logistic modeling. RESULTS: With valsartan treatment, mean ± SD SBP decreased from 154.4 ± 15.5 mmHg to 139.0 ± 12.0 mmHg and mean DBP decreased from 91.3 ± 9.2 mmHg to 82.6 ± 7.4 mmHg. SBP control rates increased from 9.0% to 38.6%, DBP from 25.5% to 65.5%, and combined SBP/DBP from 7.3% to 34.4%. A highly vulnerable cohort (n = 1063; 35.4%) of patients was identified. Twenty-four percent of variability in SBP and 25% of variability in DBP at 90 days were attributable to physician-related variables: guideline-compliant BP management, hypertension, practice patterns, hypertensive patient volume, and years in practice. The remaining 76% and 75% of variability in SBP and DBP, respectively, were due to patient factors, notably diabetes and related complications, vulnerability to uncontrolled BP, nonadherence, cardiovascular risk, and age. Similar factors increased the odds of treatment nonresponse, with diabetes being the single largest determinant of uncontrolled SBP (OR 8.99), DBP (OR 20.35), and combined SBP/DBP (OR = 18.64). CONCLUSIONS: Valsartan is effective and well tolerated in a broad range of patients in whom first-line antihypertensive treatment failed or was not tolerated. Mitigating the impact of BP-elevating variables and optimizing the effect of BP-lowering factors provides therapeutic benefits incremental to valsartan's pharmacologic effect. Improving outcomes in hypertensive patients involves 3 steps: (1) identifying, intuitively rather than formally, patients less likely to achieve BP control; (2) targeting modifiable or manageable patient- and physician-level determinants with BP-elevating or BP-lowering effects; and (3) managing variables that increase the odds and optimizing those that lower the odds of uncontrolled BP.
• Aapro, M., Abraham, I., Albrecht, T., Bokemeyer, C., Ludwig, H., Macdonald, K., Muenzberg, M., Soubeyran, P., & Turner, M. (2008). Comparison of the Management of Anemia in Patients with Solid Versus Hematological Malignancies Treated with Erythropoiesis Stimulating Agents (ESAs): Findings from the European Anemia Cancer Treatment (A.C.T.) Study. Blood, 112(11), 4715-4715. doi:10.1182/blood.v112.11.4715.4715
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  BACKGROUND. The A.C.T. study has shown that in Europe more cancer patients (pts) with anemia are being treated with ESAs than 7 years ago. ESAs are indicated in solid and hematological malignancies. Variability in treatment patterns, outcomes, and response rates in these tumor categories needs to be further explored. OBJECTIVE. To examine differences in anemia treatment patterns, outcomes, and response rates between patients with solid vs. hematological malignancies. DESIGN & PATIENTS. Multicenter, longitudinal retrospective study with 3 time points at approximately 1 month intervals; start of ESA treatment at visit 1. 307 centers in 13 European countries contributed 2192 pts (n=630 with hematological tumors; n=1562 with solid tumors) who were anemic (hemoglobin [Hb] 11g/dL) and treated with an ESA. MEASUREMENTS. Retrospective chart review. Variables reported here: age, chemotherapy regimen, Hb, WHO/ECOG performance status, ESA type, ESA dose incl. escalation, and iron supplementation. Response to ESA Rx: Hb rise≥1g/dl within 8 weeks, hematopoietic response (Hb rise≥2g/dl or Hb≥12g/dl achieved), Hb rise≥2g/dl, and Hb target range of 12.0–12.9g/dl achieved by visit 3. RESULTS. Pts ranged in age from 18 to 94 years (61.5 12.7) with no difference between groups ( p =ns). 95.2% of pts were on chemotherapy, of which 92.9% on standard vs. 7.1% on high dose (solid 94.3% and 5.7% vs. hemato 89.1% and 10.9%, p =0.001); and 40.5% on platinum vs. 59.5% on nonplatinum (solid 49.1% and 50.9% vs. hemato 12.8% and 87.2%, p = p Table 1. Table 2. CONCLUSIONS. Slight increase in mean ESA dose between tumor types and across visits was not in accordance with the stable median ESA dose. Hb increased from visit 1 from visit 3 for all pts, but more so for pts with hematological malignancy, who moreover started out at lower Hb levels. Performance status increased in parallel with Hb, but more so for hematological patients. Hb levels were found to be an interaction of tumor type and time. A concomitant pattern was observed for performance status. Iron supplementation with esp. IV iron was consistently low, however with more hematological pts receiving esp. IV iron. Dose escalation rates were low, perhaps reflecting that this be an individualized patient decision. Response rates for pts with hematological malignancies were consistently higher than those for solid tumors, except for reaching Hb target of 12–12.9 g/dl. Hematological pts tended to have ESA Rx initiated at lower Hb levels thus showing more room for Hb improvement and therefore greater likelihood to fall in various responder categories. Overall, an increase of 1g/dl is achievable for the majority of pts. Adding time constraints, increasing the threshold level to ≥2g/dl, and/or setting an evidence-based target range of 12–12.9g/dl is associated with lower response rates in both groups, with slight advantage for hematological patients within caution above. ESAs are effective and safe in the management of cancer-related anemia for pts with hematological malignancies and solid tumors.
• Aapro, M., Abraham, I., Albrecht, T., Bokemeyer, C., Ludwig, H., Macdonald, K., Muenzberg, M., Soubeyran, P., & Turner, M. (2008). Management of Anemia in Multiple Myeloma Patients Treated with Erythropoiesis Stimulating Agents (ESAs): Findings from the European Anemia Cancer Treatment (A.C.T.) Study. Blood, 112(11), 4716-4716. doi:10.1182/blood.v112.11.4716.4716
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  BACKGROUND. The A.C.T. study has shown that in Europe more cancer patients (pts) with anemia are being treated with ESAs than 7 years ago. ESAs are indicated for lymphoma. Variability in treatment patterns, outcomes, and response rates in daily clinical practice need to be further investigated. OBJECTIVE. To examine anemia treatment patterns, outcomes, and response rates in the subsample of A.C.T. patients with lymphoma. DESIGN & PATIENTS. Multicenter, longitudinal retrospective study with at least 3 time points at approximately 1 month intervals, with visit 1 coinciding with start of ESA treatment. 128 centers in 13 European countries contributed 324 multiple myeloma pts who were anemic (hemoglobin [Hb] 11g/dL) and treated with an ESA (14.8% of total European sample). MEASUREMENTS. All data collected through retrospective chart review. Key variables reported here: age, chemotherapy regimen, Hb, WHO/ECOG performance status, ESA type, ESA dose incl. escalation, and iron supplementation. Response to ESA Rx: Hb rise ≥1g/dL, Hb rise ≥1g/dL within 8 weeks, hematopoietic response (Hb rise ≥2g/dL or Hb≥12g/dL achieved), Hb rise ≥2g/dL, and Hb target range of 12.0–12.9g/dL achieved by visit 3. RESULTS. Pts ranged in age from 18 to 92 years (58.4±17.6). 96.1% of pts were on chemotherapy, of which 83.4% on standard vs. 16.6% on high dose; and 17.8% on platinum vs. 82.2% on nonplatinum. Types of ESA prescribed included epoetin alfa (13.0%), epoetin beta (43.5%), darbepoetin alfa (43.5%). Results are summarized in Table 1. No severe adverse events were reported. Table 1 CONCLUSIONS. The slight increase in ESA dose was not in accordance with the stable median ESA dose across the three visits. Hb increased from visit 1 from visit 3 with a concomitant rise in performance status. Iron supplementation with, in particular, IV iron was consistently low. Dose escalation rates were low, perhaps reflecting that this be an individualized patient decision. An increase in Hb of 1g/dL over the course of treatment is an attainable goal in two-thirds of lymphoma pts with anemia. Adding time constraints, increasing the threshold level to 2g/dL, and/or setting an evidence-based target range of 12–12.9g/dL is associated with lower response rates. In lymphoma pts, the therapeutic Hb goal to be achieved may need to be determined under consideration of multiple factors, however the general effectiveness of ESAs in this population is evident.
• Aapro, M., Abraham, I., Albrecht, T., Bokemeyer, C., Ludwig, H., Macdonald, K., Muenzberg, M., Soubeyran, P., & Turner, M. (2008). Management of Anemia in Patients with Hematological Malignancies Treated with Erythropoiesis Stimulating Agents (ESAs): Findings from the European Anemia Cancer Treatment (A.C.T.) Study. Blood, 112(11), 4672-4672. doi:10.1182/blood.v112.11.4672.4672
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  BACKGROUND. The A.C.T. study has shown that in Europe more cancer patients (pts) with anemia are being treated with ESAs than 7 years ago. ESAs are indicated for hematological malignancies. Variability in treatment patterns, outcomes, and response rates in daily clinical practice need to be further investigated. OBJECTIVE. To examine anemia treatment patterns, outcomes, and response rates in the subsample of A.C.T. patients with hematological malignancies. DESIGN & PATIENTS. Multicenter, longitudinal retrospective study with at least 3 time points at approximately 1 month intervals, with visit 1 coinciding with start of ESA treatment. 152 centers in 13 European countries contributed 630 pts with hematological malignancies who were anemic (hemoglobin [Hb] ≤11g/dL) and treated with an ESA (14.8% of total European sample). MEASUREMENTS. All data collected through retrospective chart review. Key variables reported here: age, chemotherapy regimen, Hb, WHO/ECOG performance status, ESA type, ESA dose incl. escalation, and iron supplementation. Response to ESA Rx: Hb rise ≥1g/dL, Hb rise ≥1g/dL within 8 weeks, hematopoietic response (Hb rise ≥2g/dL or Hb ≥12g/dL achieved), Hb rise ≥2g/dL, and Hb target range of 12.0–12.9g/dL achieved by visit 3. RESULTS. Pts ranged in age from 18 to 92 years (62.4±15.3). 94.4% of pts were on chemotherapy, of which 89.1% on standard vs. 10.9% on high dose; and 12.8% on platinum vs. 87.2% on nonplatinum. Types of ESA prescribed included epoetin alfa (14.4%), epoetin beta (44.8%), darbepoetin alfa (40.8%). Results are summarized in Table 1.No severe adverse events were reported. Table 1 CONCLUSIONS. The slight increase in ESA dose was not in accordance with the stable median ESA dose across the three visits. Hb increased from visit 1 from visit 3 with a concomitant rise in performance status. Iron supplementation with, in particular, IV iron was consistently low. Dose escalation rates were low, perhaps reflecting that this be an individualized patient decision. An increase in Hb of 1g/dL over the course of treatment is an attainable goal in over two-thirds of pts with hematological malignancies who are anemic. Adding time constraints, increasing the threshold level to 2g/dL, and/or setting an evidence-based target range of 12–12.9g/dL is associated with lower response rates. In pts with hematological malignancies, the therapeutic Hb goal to be achieved may need to be determined under consideration of multiple factors, however the general effectiveness of ESAs in this population is evident.
• Aapro, M., Abraham, I., Albrecht, T., Erps, J. V., Macdonald, K., Muenzberg, M., Soubeyran, P., & Warrinnier, H. (2008). Evidence-based management of anemia in cancer patients: Validity of RESPOND, a web-based clinical guidance system based on the EORTC guidelines. Journal of Clinical Oncology, 26(15_suppl), 20573-20573. doi:10.1200/jco.2008.26.15_suppl.20573
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  20573 Background: The EORTC has published evidence-based guidelines for the management of anemia using erythropoiesis- stimulating agents (ESA). We previously described background/validation method...
• Aapro, M., Abraham, I., Bokemeyer, C., Ludwig, H., MacDonald, K., Soubeyran, P., & Turner, M. (2008). The background and methodology of the Anaemia Cancer Treatment (A.C.T.) study: A global retrospective study of practice patterns and outcomes in the management of anaemia in cancer patients and their congruence with evidence-based guidelines. Supportive Care in Cancer, 16(2), 193-200.
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  PMID: 17874142;Abstract: Goal: The benefit of supportive care with erythropoiesis-stimulating agents (ESAs) for patients with cancer-related anaemia is well known. However, the European Cancer Anaemia Survey (ECAS, data from 2001) showed that about 60% of cancer patients with anaemia do not receive any treatment. Since ECAS, evidence-based guidelines have provided recommendations for ESA use, but it is not known to what extent current treatment patterns follow these guidelines. To address this issue, the Anaemia Cancer Treatment (A.C.T.) study was initiated. The background to the development of the A.C.T. study and study methodology are described. Materials and methods: The A.C.T. study is a global, retrospective, pharmacoepidemiologic study of at least 2,560 medical records of anaemic patients with cancer who were previously treated with an ESA from a minimum of 186 centres. Records from patients aged greater than or equal to 18 years with a diagnosis of solid tumour or myeloma or lymphoma and who were started on ESAs 3-12 months before inclusion and followed for 8-10 weeks will be eligible. Factors associated with ESA non-responsiveness will also be evaluated. Main results: Completion of the European phase of the study is anticipated in late 2007 with the rest of the world closing in late 2007 or early 2008. Publication of findings is anticipated in 2008. Conclusions: By examining the extent to which anaemia management in clinical practice is congruent with best practice guidelines, the A.C.T. study will provide a further foundation for the development of evidence-based supportive cancer care. © 2007 Springer-Verlag.
• Aapro, M., Abraham, I., Bokemeyer, C., Ludwig, H., MacDonald, K., Soubeyran, P., & Turner, M. (2008). The background and methodology of the Anaemia Cancer Treatment (A.C.T.) study: A global retrospective study of practice patterns and outcomes in the management of anaemia in cancer patients and their congruence with evidence-based guidelines. Supportive Care in Cancer, 16(Issue 2). doi:10.1007/s00520-007-0311-2
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  Goal: The benefit of supportive care with erythropoiesis-stimulating agents (ESAs) for patients with cancer-related anaemia is well known. However, the European Cancer Anaemia Survey (ECAS, data from 2001) showed that about 60% of cancer patients with anaemia do not receive any treatment. Since ECAS, evidence-based guidelines have provided recommendations for ESA use, but it is not known to what extent current treatment patterns follow these guidelines. To address this issue, the Anaemia Cancer Treatment (A.C.T.) study was initiated. The background to the development of the A.C.T. study and study methodology are described. Materials and methods: The A.C.T. study is a global, retrospective, pharmacoepidemiologic study of at least 2,560 medical records of anaemic patients with cancer who were previously treated with an ESA from a minimum of 186 centres. Records from patients aged greater than or equal to 18 years with a diagnosis of solid tumour or myeloma or lymphoma and who were started on ESAs 3-12 months before inclusion and followed for 8-10 weeks will be eligible. Factors associated with ESA non-responsiveness will also be evaluated. Main results: Completion of the European phase of the study is anticipated in late 2007 with the rest of the world closing in late 2007 or early 2008. Publication of findings is anticipated in 2008. Conclusions: By examining the extent to which anaemia management in clinical practice is congruent with best practice guidelines, the A.C.T. study will provide a further foundation for the development of evidence-based supportive cancer care. © 2007 Springer-Verlag.
• Aapro, M., Abraham, I., Bokemeyer, C., Ludwig, H., Macdonald, K., Soubeyran, P., & Turner, M. (2008). The background and methodology of the Anaemia Cancer Treatment (A.C.T.) study: a global retrospective study of practice patterns and outcomes in the management of anaemia in cancer patients and their congruence with evidence-based guidelines. Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 16(2), 193-200.
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  The benefit of supportive care with erythropoiesis-stimulating agents (ESAs) for patients with cancer-related anaemia is well known. However, the European Cancer Anaemia Survey (ECAS, data from 2001) showed that about 60% of cancer patients with anaemia do not receive any treatment. Since ECAS, evidence-based guidelines have provided recommendations for ESA use, but it is not known to what extent current treatment patterns follow these guidelines. To address this issue, the Anaemia Cancer Treatment (A.C.T.) study was initiated. The background to the development of the A.C.T. study and study methodology are described.
• Aapro, M., Erps, J. V., MacDonald, K., Soubeyran, P., Turner, M., Muenzberg, M., Dunlop, R., Warrinnier, H., & Abraham, I. (2008). Promoting evidence-based management of anemia in cancer patients: Background, development, and scientific validation of RESPOND, a web-based clinical guidance system based on the EORTC guidelines. Critical Reviews in Oncology/Hematology, 65(1), 32-42.
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  PMID: 17570677;Abstract: The 2006 EORTC guidelines for erythropoietic proteins in cancer-related anemia provide the most up-to-date assessment of the evidence base. Considering general concerns in medicine about clinicians' adoption of evidence-based guidelines, it is critical to find ways of bringing guidelines to the point of care. We describe the rationale behind RESPOND, a web-based clinical guidance system based on the EORTC guidelines, and the methodologies of two studies conducted to validate the system. In a first descriptive study, experts are asked to rate the accuracy of every algorithm derived from the guidelines. In a second step and using a hybrid matched pre-post design, separate retrospective and prospective patient cohorts matched by type of cancer and similarity of chemotherapy regimen (33 pairs) are used to examine the extent to which clinicians' practice patterns converge with the EORTC guidelines when they use or not use the RESPOND system. It is hypothesized that these studies will provide the necessary validation for RESPOND as an evidence-based clinical support tool. © 2007 Elsevier Ireland Ltd. All rights reserved.
• Aapro, M., Van Erps, J., MacDonald, K., Soubeyran, P., Turner, M., Muenzberg, M., Dunlop, R., Warrinnier, H., & Abraham, I. (2008). Promoting evidence-based management of anemia in cancer patients: background, development, and scientific validation of RESPOND, a web-based clinical guidance system based on the EORTC guidelines. Critical reviews in oncology/hematology, 65(1), 32-42.
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  The 2006 EORTC guidelines for erythropoietic proteins in cancer-related anemia provide the most up-to-date assessment of the evidence base. Considering general concerns in medicine about clinicians' adoption of evidence-based guidelines, it is critical to find ways of bringing guidelines to the point of care. We describe the rationale behind RESPOND, a web-based clinical guidance system based on the EORTC guidelines, and the methodologies of two studies conducted to validate the system. In a first descriptive study, experts are asked to rate the accuracy of every algorithm derived from the guidelines. In a second step and using a hybrid matched pre-post design, separate retrospective and prospective patient cohorts matched by type of cancer and similarity of chemotherapy regimen (33 pairs) are used to examine the extent to which clinicians' practice patterns converge with the EORTC guidelines when they use or not use the RESPOND system. It is hypothesized that these studies will provide the necessary validation for RESPOND as an evidence-based clinical support tool.
• Abraham, I., Delforge, M., Doyen, C., Duck, L., Lefever, A., Macdonald, K., Wildiers, H., & Wouters, C. (2008). Baseline characteristics, prior bisphosphonate (BPH) therapy (Rx), and clinical parameters of patients in LOTUZ, a prospective pharmacoepidemiological study of long-term zoledronic acid (ZOL) treatment (>=2 years) in patients (pts) with solid and hematologic malignancies. Journal of Clinical Oncology, 26(15), 20597-20597. doi:10.1200/jco.2008.26.15_suppl.20597
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  20597 Background: There is a trend towards long-term Rx with ZOL. The LOTUZ study is among the first to examine ZOL Rx treatment patterns, effectiveness, and safety beyond 2 years. Reported are bas...
• Abraham, L., Abraham, I., Albrecht, T., Berneman, Z. N., Bock, P. D., Eygen, K. V., Geest, S. D., Lierde, V., Macdonald, K., Martiat, M., Mineur, M., Noens, L., Verhoef, G., & Zachee, P. (2008). NONADHERENCE WITH IMATINIB TREATMENT IN CHRONIC MYELOID LEUKEMIA IS A FUNCTION OF DISEASE, HEALTH, KNOWLEDGE, AND SOCIAL FACTORS - RESULTS FROM THE ADAGIO STUDY. Haematologica-the Hematology Journal, 93, 223-223.
• Dobbels, F., Moons, P., Abraham, I., Larsen, C. P., Dupont, L., & De Geest, S. (2008). Measuring symptom experience of side-effects of immunosuppressive drugs: The Modified Transplant Symptom Occurrence and Distress Scale. Transplant International, 21(Issue 8). doi:10.1111/j.1432-2277.2008.00674.x
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  Measurement of the patients' subjective experience of side-effects of immuno-suppressants is a critical post-transplant outcome. This study aimed to update and validate the 45-item Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSD) for novel immunosuppressive regimens. We used four steps: (1) literature review to identify immunosuppressant-related symptoms; (2) screening of adverse event forms; (3) international experts' evaluation of the appropriateness of each symptom; and (4) a pilot study in 24 renal transplant patients to test the clarity of instructions and items, and a pilot study in 84 lung transplant patients, to determine content and discriminant validity. Steps 1 and 2 produced a list of 76 symptoms. Clinical experts deemed 59 symptoms as being relevant for assessing symptom experience (step 3). Based on the first pilot testing, items and instructions were adapted to improve clarity. The second pilot testing showed that the updated MTSOSD-59R was easy to complete, that items and instructions were understandable, and that symptom profiles differed between males and females, and between depressed and nondepressed patients (step 4). The MTSOSD-59R is an instrument with established content and discriminant validity for assessing transplant patients' symptom experience of side-effects stemming from currently available immunosuppressive regimens. © 2008 European Society.
• Dobbels, F., Moons, P., Abraham, I., Larsen, C. P., Dupont, L., & De Geest, S. (2008). Measuring symptom experience of side-effects of immunosuppressive drugs: the Modified Transplant Symptom Occurrence and Distress Scale. Transplant international : official journal of the European Society for Organ Transplantation, 21(8), 764-73.
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  Measurement of the patients' subjective experience of side-effects of immunosuppressants is a critical post-transplant outcome. This study aimed to update and validate the 45-item Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSD) for novel immunosuppressive regimens. We used four steps: (1) literature review to identify immunosuppressant-related symptoms; (2) screening of adverse event forms; (3) international experts' evaluation of the appropriateness of each symptom; and (4) a pilot study in 24 renal transplant patients to test the clarity of instructions and items, and a pilot study in 84 lung transplant patients, to determine content and discriminant validity. Steps 1 and 2 produced a list of 76 symptoms. Clinical experts deemed 59 symptoms as being relevant for assessing symptom experience (step 3). Based on the first pilot testing, items and instructions were adapted to improve clarity. The second pilot testing showed that the updated MTSOSD-59R was easy to complete, that items and instructions were understandable, and that symptom profiles differed between males and females, and between depressed and nondepressed patients (step 4). The MTSOSD-59R is an instrument with established content and discriminant validity for assessing transplant patients' symptom experience of side-effects stemming from currently available immunosuppressive regimens.
• Dobbels, F., Moons, P., Abraham, I., Larsen, C. P., Dupont, L., & Geest, S. D. (2008). Measuring symptom experience of side-effects of immunosuppressive drugs: The Modified Transplant Symptom Occurrence and Distress Scale. Transplant International, 21(8), 764-773.
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  PMID: 18435683;Abstract: Measurement of the patients' subjective experience of side-effects of immuno-suppressants is a critical post-transplant outcome. This study aimed to update and validate the 45-item Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSD) for novel immunosuppressive regimens. We used four steps: (1) literature review to identify immunosuppressant-related symptoms; (2) screening of adverse event forms; (3) international experts' evaluation of the appropriateness of each symptom; and (4) a pilot study in 24 renal transplant patients to test the clarity of instructions and items, and a pilot study in 84 lung transplant patients, to determine content and discriminant validity. Steps 1 and 2 produced a list of 76 symptoms. Clinical experts deemed 59 symptoms as being relevant for assessing symptom experience (step 3). Based on the first pilot testing, items and instructions were adapted to improve clarity. The second pilot testing showed that the updated MTSOSD-59R was easy to complete, that items and instructions were understandable, and that symptom profiles differed between males and females, and between depressed and nondepressed patients (step 4). The MTSOSD-59R is an instrument with established content and discriminant validity for assessing transplant patients' symptom experience of side-effects stemming from currently available immunosuppressive regimens. © 2008 European Society.
• Kim, H. J., & Abraham, I. L. (2008). Statistical approaches to modeling symptom clusters in cancer patients. Cancer Nursing, 31(Issue 5). doi:10.1097/01.ncc.0000305757.58615.c8
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  This study examined statistical methods to identify and quantify symptom clusters in diverse disciplines, discussed methodological issues in symptom cluster research in oncology, and provided guidance to researchers and clinicians as to the choice and conceptual implications of particular methods. Correlation and related measures of association show the mathematical evidence of a concurrent tendency for 2 or more symptoms. Graphical modeling reveals a more concrete image of possible symptom clusters and provides an idea as to how and why they are correlated. Structural equation modeling can be used to identify symptom clusters with a large number of symptoms, complex relationships, and/or directional relationships. Factor analysis can identify groups of symptoms which are interrelated due to a common underlying cause. Cluster analysis can group symptoms which have similar patterns across patients and find clinical subgroups based on symptom experience. The best strategy to study symptom clusters is to combine various methods while recognizing the strengths and limitations inherent in each method. A tight partnership of clinicians, clinical oncology researchers, and statisticians is essential. Designing a research to identify symptom clusters involves practical issues related to levels of measurement, dimensionality, confounding variables, symptom selection, and heuristic versus deterministic search. Copyright © 2008 Lippincott Williams & Wilkins.
• Kim, H., & Abraham, I. L. (2008). Statistical approaches to modeling symptom clusters in cancer patients. Cancer Nursing, 31(5), E1-E10.
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  PMID: 18772651;Abstract: This study examined statistical methods to identify and quantify symptom clusters in diverse disciplines, discussed methodological issues in symptom cluster research in oncology, and provided guidance to researchers and clinicians as to the choice and conceptual implications of particular methods. Correlation and related measures of association show the mathematical evidence of a concurrent tendency for 2 or more symptoms. Graphical modeling reveals a more concrete image of possible symptom clusters and provides an idea as to how and why they are correlated. Structural equation modeling can be used to identify symptom clusters with a large number of symptoms, complex relationships, and/or directional relationships. Factor analysis can identify groups of symptoms which are interrelated due to a common underlying cause. Cluster analysis can group symptoms which have similar patterns across patients and find clinical subgroups based on symptom experience. The best strategy to study symptom clusters is to combine various methods while recognizing the strengths and limitations inherent in each method. A tight partnership of clinicians, clinical oncology researchers, and statisticians is essential. Designing a research to identify symptom clusters involves practical issues related to levels of measurement, dimensionality, confounding variables, symptom selection, and heuristic versus deterministic search. Copyright © 2008 Lippincott Williams & Wilkins.
• Kim, H., & Abraham, I. L. (2008). Statistical approaches to modeling symptom clusters in cancer patients. Cancer nursing, 31(5), E1-10.
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  This study examined statistical methods to identify and quantify symptom clusters in diverse disciplines, discussed methodological issues in symptom cluster research in oncology, and provided guidance to researchers and clinicians as to the choice and conceptual implications of particular methods. Correlation and related measures of association show the mathematical evidence of a concurrent tendency for 2 or more symptoms. Graphical modeling reveals a more concrete image of possible symptom clusters and provides an idea as to how and why they are correlated. Structural equation modeling can be used to identify symptom clusters with a large number of symptoms, complex relationships, and/or directional relationships. Factor analysis can identify groups of symptoms which are interrelated due to a common underlying cause. Cluster analysis can group symptoms which have similar patterns across patients and find clinical subgroups based on symptom experience. The best strategy to study symptom clusters is to combine various methods while recognizing the strengths and limitations inherent in each method. A tight partnership of clinicians, clinical oncology researchers, and statisticians is essential. Designing a research to identify symptom clusters involves practical issues related to levels of measurement, dimensionality, confounding variables, symptom selection, and heuristic versus deterministic search.
• Maa, S. H., Lee, H. L., Huang, Y. C., June, H. W., Tsou, T. S., MacDonald, K., & Abraham, I. (2008). Incidence density and relative risk of nosocomial infection in Taiwan's only children's hospital, 1999-2003. Infection Control and Hospital Epidemiology, 29(Issue 8). doi:10.1086/589724
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  We report on 2,688 nosocomial infection episodes involving 3,238 pathogens in Taiwan's only children's hospital. The mean annual incidence density was 4.06 cases per 1,000 patient-days. The relative risk was highest in intensive care units, oncology wards, and neonatal observation wards. Very young, low-birth-weight, critically ill, and oncology patients were most at risk. © 2008 by The Society for Healthcare Epidemiology of America. All rights reserved.
• Maa, S., Lee, H., Huang, Y., June, H. W., Tsou, T., MacDonald, K., & Abraham, I. (2008). Incidence density and relative risk of nosocomial infection in Taiwan's only children's hospital, 1999-2003. Infection Control and Hospital Epidemiology, 29(8), 767-770.
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  PMID: 18690787;Abstract: We report on 2,688 nosocomial infection episodes involving 3,238 pathogens in Taiwan's only children's hospital. The mean annual incidence density was 4.06 cases per 1,000 patient-days. The relative risk was highest in intensive care units, oncology wards, and neonatal observation wards. Very young, low-birth-weight, critically ill, and oncology patients were most at risk. © 2008 by The Society for Healthcare Epidemiology of America. All rights reserved.
• Maa, S., Lee, H., Huang, Y., Wu, J. H., Tsou, T., MacDonald, K., & Abraham, I. (2008). Incidence density and relative risk of nosocomial infection in Taiwan's Only Children's Hospital, 1999-2003. Infection control and hospital epidemiology, 29(8), 767-70.
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  We report on 2,688 nosocomial infection episodes involving 3,238 pathogens in Taiwan's only children's hospital. The mean annual incidence density was 4.06 cases per 1,000 patient-days. The relative risk was highest in intensive care units, oncology wards, and neonatal observation wards. Very young, low-birth-weight, critically ill, and oncology patients were most at risk.
• Aapro, M., Abraham, I., MacDonald, K., Soubeyran, P., Foubert, J., Bokemeyer, C., Muenzberg, M., Erps, J. V., & Turner, M. (2007). Intraclass correlation metrics for the accuracy of algorithmic definitions in a computerized decision support system for supportive cancer care. Supportive Care in Cancer, 15(11), 1325-1329.
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  PMID: 17393188;Abstract: As part of the development of a computerized clinical decision support system for anemia management in cancer patients, we applied psychometric principles and techniques to assess the accuracy of the algorithmic operationalizations of a set of evidence-based practice guidelines. In an iterative rating process, five medical and nursing experts rated 27 algorithmic sets derived from 18 guidelines, the objective being an intraclass coefficient (ICC) exceeding 0.90. The first round of review yielded an ICC of 1.00 for 22 sets. After revision and resubmission to the expert panel, an ICC of 1.00 was obtained for the additional five sets. The evolving decision support system is based on algorithms that accurately specify evidence-based guidelines for anemia management in cancer patients. © 2007 Springer-Verlag.
• Aapro, M., Abraham, I., MacDonald, K., Soubeyran, P., Foubert, J., Bokemeyer, C., Muenzberg, M., Van Erps, J., & Turner, M. (2007). Intraclass correlation metrics for the accuracy of algorithmic definitions in a computerized decision support system for supportive cancer care. Supportive Care in Cancer, 15(Issue 11). doi:10.1007/s00520-007-0246-7
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  As part of the development of a computerized clinical decision support system for anemia management in cancer patients, we applied psychometric principles and techniques to assess the accuracy of the algorithmic operationalizations of a set of evidence-based practice guidelines. In an iterative rating process, five medical and nursing experts rated 27 algorithmic sets derived from 18 guidelines, the objective being an intraclass coefficient (ICC) exceeding 0.90. The first round of review yielded an ICC of 1.00 for 22 sets. After revision and resubmission to the expert panel, an ICC of 1.00 was obtained for the additional five sets. The evolving decision support system is based on algorithms that accurately specify evidence-based guidelines for anemia management in cancer patients. © 2007 Springer-Verlag.
• Aapro, M., Abraham, I., MacDonald, K., Soubeyran, P., Foubert, J., Bokemeyer, C., Muenzberg, M., Van Erps, J., & Turner, M. (2007). Intraclass correlation metrics for the accuracy of algorithmic definitions in a computerized decision support system for supportive cancer care. Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 15(11), 1325-9.
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  As part of the development of a computerized clinical decision support system for anemia management in cancer patients, we applied psychometric principles and techniques to assess the accuracy of the algorithmic operationalizations of a set of evidence-based practice guidelines. In an iterative rating process, five medical and nursing experts rated 27 algorithmic sets derived from 18 guidelines, the objective being an intraclass coefficient (ICC) exceeding 0.90. The first round of review yielded an ICC of 1.00 for 22 sets. After revision and resubmission to the expert panel, an ICC of 1.00 was obtained for the additional five sets. The evolving decision support system is based on algorithms that accurately specify evidence-based guidelines for anemia management in cancer patients.
• Abraham, I., Albrecht, T., Geest, S. D., Letvak, L., Lierde, M. V., Macdonald, K., Rop, L. D., Serra, F., Strobbe, E., & Vancayzeele, S. (2007). Canonical Correlation Analysis (CCA) of Imatinib Treatment (ImRx) Nonadherence (NA) with Associated Patient Variables (APVs) in Chronic Myeloid Leukemia (CML) - Results from the ADAGIO Study.. Blood, 110(11), 5164-5164. doi:10.1182/blood.v110.11.5164.5164
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  BACKGROUND. ImRx for CML is a long-term treatment potentially compromised by NA. Identifying APVs may assist in reducing NA and optimizing treatment outcomes. OBJECTIVE. To model the relationships between two NA measures and selected APVs using CCA, a multivariate analog of multiple regression to accommodate multiple criterion variables. DESIGN AND PATIENTS. Data subset from prospective, 90d observational, open-label, multicenter study. 169 evaluable pts on ImRx for minimum 30d at enrollment [[1][1]]. MEASUREMENTS. NA at 90d vector: Basel Assessment of Adherence Scale for pts (pBAAS; 0/1 with 1=NA); and % of ImRx taken per pill count (%ImRx, subtracted from 100 to reflect NA). APVs at BL vector: age; months since CML diagnosis (mCML); months since ImRx initiation (mImRx); knowledge of CML disease, treatment, and ImRx (KCMLRx); and general health (SF-8). RESULTS. The criterion (dependent) vector of NA indicators included pBAAS and %ImRX. The predictor (independent) vector of APVs included: age, mCML, mImRx, KCMLRx, and SF-8. Two canonical correlations were generated: 0.389 (Bartlett Chi-squared=23.564, P =0.009) and 0.170 (Bartlett Chi-squared= 3.590, P =0.464); the second correlation was deleted due to nonsignificance from zero. The canonical loadings (or structure coefficients) for the retained model were: age 0.951, mCML 0.205, mImRx 0.145, SF-8 0.016, and KCMLRx -0.367. Redundancy analysis showed that 22.1% of variance in the predictor set was explained by variables within that set. CONCLUSIONS. The patient NA vector (composed of a binary assessment of NA per pBAAS 0/1 with 1=NA) and continuous quantification of % of ImRx not taken was related to the APV vector as follows: NA increased as patients were older, had been diagnosed with CML for a longer period of time, had been on imatinib treatment for a longer period time, and were in slightly better health at enrollment. These may be considered warning signs for NA for clinicians to consider in practice, given the long-term nature of ImRx. Importantly, better patient knowledge of disease and treatment, a clinically modifiable APV, was associated with a decrease in NA. The initial insights in patient NA with ImRX provided by these findings, though some are counterintuitive to the NA literature at large, must be studied further to better understand the dynamics of NA in the CML population. [1]: #ref-1
• Abraham, I., Albrecht, T., Geest, S. D., Letvak, L., Lierde, M. V., Macdonald, K., Rop, L. D., Serra, F., Strobbe, E., & Vancayzeele, S. (2007). Multimethod Clinical Assessment of Patterns and Prevalence of Nonadherence (NA) to Imatinib Treatment (IMRx) in Patients (Pts) with Chronic Myeloid Leukemia (CML): Results from the ADAGIO Study.. Blood, 110(11), 5163-5163. doi:10.1182/blood.v110.11.5163.5163
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  BACKGROUND. ImRx for CML is a long-term treatment. Patterns and prevalence of NA to ImRx remain largely unknown. Short-term NA trends may be indicative of long-term NA. Methods for clinical NA assessment vary in reliability. A multimethod approach is indicated. OBJECTIVE. Multimethod estimation of patterns and prevalence of ImRx NA in CML pts at baseline (BL) and follow-up (FU) at 90 days (90d), incl. BL to 90d changes. DESIGN AND PATIENTS. Data subset from prospective, 90d observational, open-label, multicenter study. 169 evaluable pts on ImRx for minimum 30d at enrollment [[1][1]]. METHODS OF NA ASSESSMENT. At BL (NA with prior ImRx) and 90d (NA during study): visual analog scale (VAS) for physicians (phs; mVAS), pts (pVAS), cos (cVAS); Basel Assessment of Adherence Scale for pts (pBAAS; structured interview re NA in past 4 weeks [4wks]); pts reported persistence (pPST); % clinic appointments (%CAPPTS) kept (if any scheduled). At 90d also: % of ImRx taken per pill count (%pts@ImRx). RESULTS. See Table 1. CONCLUSIONS. Intuitive adherence ratings (VAS) by phs, pts, and cos are very high and differ from those from structured interview, where about one-third of patients exhibited NA behavior in 4wks prior to BL and FU - despite high persistence. Pill count suggests patterns of under- and overtaking, with only 1 out 7 patients being perfectly adherent. Rate of clinic appointments may be affected by physician scheduling practices and collateral input is a function of availability of collateral person. Consenting to participate in the ADAGIO study did not reduce NA. Though patient self-reports in structured interview (pBAAS) and pill counts have inherent biases, both indices suggest that NA with ImRx may be similar to NA rates in other disease categories. Especially pBAAS and pill count may be useful rapid clinical assessment tools, with pBAAS having the benefit of validated categorical assessment (vs. continuous in other methods). Determinants of NA and the impact of NA on treatment outcomes must be examined. | Method | | BL | 90d | | |:--------- | --- | --------------- | --------------------- | ----- | | | n | M±SD/Min-Max | M±SD/Min-Max | P | | mVAS | 164 | 95.0±7.6/60–100 | 94.9±9.9/0–100 | ns | | pVAS | 169 | 95.3±8.5/25–100 | 95.7±6.1/75–100 | ns | | cVAS | 56 | 97.1±5.1/80–100 | 97.4±5.1/75–100 | ns | | %pts@ImRx | 162 | - | 91.0±21.1/29.5–2002.2 | | | | | | 71.0% @ < 100% ImRx | | | | | | 14.2% @ 100% ImRx | | | | n | % NA | % NA | P | | pBAAS | 163 | 36.2% | 32.5% | ns | | %CAPPTS | 51 | 94.1% | 88.2% | 0.001 | | pPST | 163 | 98.8% | 100.0% | ns | Table 1 - Multimethod Assessment of Non-Adherence with Imatinib [1]: #ref-1
• Abraham, I., Derop, L., Geelhand, M., Geest, S. D., Lierde, V., Macdonald, K., Serra, F., Strobbe, E., Vancayzeele, S., & Vermeylen, K. (2007). 6019 POSTER Background and methodology of the ADAGIO study–aprospective, observational, multicenter study to determine the prevalence, predictors, and mediators of non-adherence in patients treated with imatinib. Ejc Supplements, 5(4), 350-351. doi:10.1016/s1359-6349(07)71310-1
• De Geest, W., De Geest, J., De Geest, S., & Abraham, I. (2007). Description, specifications, and ASIC configurations of MEMOPATCH, a transdermal pulse generator medical device to promote patient compliance with medication regimens. Conference proceedings : ... Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual Conference, 2007, 508-11.
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  Current methods for improving patients' compliance with their prescribed treatment regimens, especially in those cases where noncompliance is a function of mere forgetfulness, have distinct disadvantages, chief among them their relative obtrusiveness and impact on patient privacy. The MemoPatch concept is a patent-pending electronic reminder system consisting of a dermal patch outfitted with a miniaturized programmable pulse generator (ASIC) that gives patients a perceptible stimulus to the skin. This paper describes the concept, reviews specification, and presents three ASIC-based configurations.
• Geest, W. D., Geest, J. D., Geest, S. D., & Abraham, I. (2007). Description, specifications, and ASIC configurations of MEMOPATCH, a transdermal pulse generator medical device to promote patient compliance with medication regimens. Annual International Conference of the IEEE Engineering in Medicine and Biology - Proceedings, 508-511.
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  Abstract: Current methods for improving patients' compliance with their prescribed treatment regimens, especially In those cases where noncompliance Is a function of mere forgetfulness, have distinct disadvantages, chief among them their relative obtruslveness and impact on patient privacy. The MemoPatch concept is a patent-pending electronic reminder system consisting of a dermal patch outfitted with a miniaturized programmable pulse generator (ASIC) that gives patients a perceptible stimulus to the skin. This paper describes the concept, reviews specification, and presents three ASIC-based configurations. © 2007 IEEE.
• Geest, W. D., Geest, J. D., Geest, S. D., & Abraham, I. (2007). Description, specifications, and ASIC configurations of MEMOPATCH, a transdermal pulse generator medical device to promote patient compliance with medication regimens.. Conference proceedings : ... Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Conference, 2007, 508-511.
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  PMID: 18002000;Abstract: Current methods for improving patients' compliance with their prescribed treatment regimens, especially in those cases where noncompliance is a function of mere forgetfulness, have distinct disadvantages, chief among them their relative obtrusiveness and impact on patient privacy. The MemoPatch concept is a patent-pending electronic reminder system consisting of a dermal patch outfitted with a miniaturized programmable pulse generator (ASIC) that gives patients a perceptible stimulus to the skin. This paper describes the concept, reviews specification, and presents three ASIC-based configurations.
• Mets, T., Vandewoude, M., Jacquy, J., Deblander, A., MacDonald, K., Sloesen, A., & Abraham, I. (2007). Patient and caregiver outcomes after 6 ± 1.5-months of rivastigmine therapy for mild-to-moderate Alzheimer's disease: The Belgian FExT study. Current Medical Research and Opinion, 23(Issue 10). doi:10.1185/030079907x226375
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  Objective: Despite response variability, Cholinesterase inhibitors are recommended in mild to moderate Alzheimer's disease. Dose titration is common; however randomized controlled trials (RCTs) have mainly investigated fixed-dose regimens. We examined practice patterns and outcomes of 6 ± 1.5-month rivastigmine therapy. Methods: Prospective, pharmacoepidemiologic, naturalistic study of 175 evaluable patients with mild to moderate Alzheimer's disease (+ 151 caregivers) from 52 centers in Belgium on 6 ± 1.5 month (titrated) rivastigmine treatment. Main outcome measures: Measured at baseline (enrollment) and follow-up (6 ± 1.5 months). For patients: Mini-Mental State Exam (MMSE), Activities of Daily Living (ADL), Neuropsychiatric Inventory (NPI), Global Deterioration Scale (GDS) scores; treatment response (improvement, maintenance, or decline less than normative slope). For caregivers: hours/week spent caring; Zarit Caregiver Burden Scale (ZCBS), 12-item version of General Health Questionnaire (GHQ-12), Instrumental Activities of Daily Living (IADL) scores. © 2007 LIBRAPHARM LIMITED. Results. Patients' MMSE and NPI scores (p < 0.001) improved from baseline to follow-up, but not ADL and GDS scores. Treatment response was 89.1% of patients for MMSE (including 60.6% with improvement) and 77.7% for NPI (including 57.1% with improvement). Quadratic curves were fitted for the average daily dose and the MMSE and NPI scores; with a trend towards average daily dose of 6.0 ± 3.0 mg/day. Caregivers' ZCBS (p = 0.036) and GHQ-12 (p = 0.029) scores improved, but not IADL scores and time spent caring. Conclusions: Patients' MMSE and ADL scores confirmed the meta-analyses of rivastigmine efficacy trials, while NPI scores exceeded efficacy results. Proportionately more patients responded to (titrated) treatment than in fixed-dose RCTs. Caregivers reported less burden (similar to metaanalysis) and better general health over the study period. Where efficacy and effectiveness results diverge, the benefit is in 'real-world' effectiveness. Large sample, multi-country replications, less sensitive to censoring secondary to missing data and powered to permit advanced modeling, as well as RCTs with adaptive designs to accommodate titration, are needed. The profile of patients most likely to benefit from treatment or most vulnerable to treatment outcome must be studied, as must the impact of physician- and center-related variables on outcomes. © 2007 Librapharm Limited.
• Mets, T., Vandewoude, M., Jacquy, J., Deblander, A., MacDonald, K., Sloesen, A., & Abraham, I. (2007). Patient and caregiver outcomes after 6 ± 1.5-months of rivastigmine therapy for mild-to-moderate Alzheimer's disease: The Belgian FExT study. Current Medical Research and Opinion, 23(10), 2485-2501.
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  PMID: 17784995;Abstract: Objective: Despite response variability, Cholinesterase inhibitors are recommended in mild to moderate Alzheimer's disease. Dose titration is common; however randomized controlled trials (RCTs) have mainly investigated fixed-dose regimens. We examined practice patterns and outcomes of 6 ± 1.5-month rivastigmine therapy. Methods: Prospective, pharmacoepidemiologic, naturalistic study of 175 evaluable patients with mild to moderate Alzheimer's disease (+ 151 caregivers) from 52 centers in Belgium on 6 ± 1.5 month (titrated) rivastigmine treatment. Main outcome measures: Measured at baseline (enrollment) and follow-up (6 ± 1.5 months). For patients: Mini-Mental State Exam (MMSE), Activities of Daily Living (ADL), Neuropsychiatric Inventory (NPI), Global Deterioration Scale (GDS) scores; treatment response (improvement, maintenance, or decline less than normative slope). For caregivers: hours/week spent caring; Zarit Caregiver Burden Scale (ZCBS), 12-item version of General Health Questionnaire (GHQ-12), Instrumental Activities of Daily Living (IADL) scores. © 2007 LIBRAPHARM LIMITED. Results. Patients' MMSE and NPI scores (p < 0.001) improved from baseline to follow-up, but not ADL and GDS scores. Treatment response was 89.1% of patients for MMSE (including 60.6% with improvement) and 77.7% for NPI (including 57.1% with improvement). Quadratic curves were fitted for the average daily dose and the MMSE and NPI scores; with a trend towards average daily dose of 6.0 ± 3.0 mg/day. Caregivers' ZCBS (p = 0.036) and GHQ-12 (p = 0.029) scores improved, but not IADL scores and time spent caring. Conclusions: Patients' MMSE and ADL scores confirmed the meta-analyses of rivastigmine efficacy trials, while NPI scores exceeded efficacy results. Proportionately more patients responded to (titrated) treatment than in fixed-dose RCTs. Caregivers reported less burden (similar to metaanalysis) and better general health over the study period. Where efficacy and effectiveness results diverge, the benefit is in 'real-world' effectiveness. Large sample, multi-country replications, less sensitive to censoring secondary to missing data and powered to permit advanced modeling, as well as RCTs with adaptive designs to accommodate titration, are needed. The profile of patients most likely to benefit from treatment or most vulnerable to treatment outcome must be studied, as must the impact of physician- and center-related variables on outcomes. © 2007 Librapharm Limited.
• Mets, T., Vandewoude, M., Jacquy, J., Deblander, A., MacDonald, K., Sloesen, A., Abraham, I., & , F. S. (2007). Patient and caregiver outcomes after 6 +/- 1.5-months of rivastigmine therapy for mild-to-moderate Alzheimer's disease: the Belgian FExT study. Current medical research and opinion, 23(10), 2485-501.
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  Despite response variability, cholinesterase inhibitors are recommended in mild to moderate Alzheimer's disease. Dose titration is common; however randomized controlled trials (RCTs) have mainly investigated fixed-dose regimens. We examined practice patterns and outcomes of 6 +/- 1.5-month rivastigmine therapy.
• Well, M. V., Warrinnier, H., Soubeyran, P., Muenzberg, M., Macdonald, K., Erps, J. V., Eeckhout, C., Dunlop, R., Abraham, I., & Aapro, M. (2007). Promoting evidence-based management of anemia in cancer patients: Background and scientific validation of RESPOND, a web-based clinical decision support system. Journal of Clinical Oncology, 25(18_suppl), 19676-19676. doi:10.1200/jco.2007.25.18_suppl.19676
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  19676 Background: The 2006 European Organisation for Research and Treatment of Cancer (EORTC) guidelines for erythropoietic proteins in cancer-related anemia provide the most up-to-date assessment of the evidence base. To promote clinicians’ adoption of evidence- based (EB) practice guidelines (EBPGs), it is critical to bring guidelines to the point of care. RESPOND is an EB clinical decision support system (CDSS) based on the EORTC guidelines. CDSSs are seldom validated. We describe the methodologies of two studies being conducted to validate RESPOND. Methods. Study 1: descriptive design - accuracy and content validity. Five experts are asked to rate the accuracy of algorithms derived from the guidelines; the objective being an intraclass correlation coefficient =0.90 for each of 27 algorithmic sets. Study 2: hybrid matched pre-post design - concurrent and discriminant validity. Two patient cohorts (n=33 each) matched by type of cancer and similarity of chemotherapy regimen ie, sample 1 (4 months prospec...
• Abraham, I. L. (2006). Alzheimer's disease. Nursing Clinics of North America, 41(Issue 1). doi:10.1016/j.cnur.2005.11.001
• Abraham, I. L. (2006). Alzheimer's disease. Nursing Clinics of North America, 41(1), xi-xiii.
• Abraham, I. L. (2006). Dementia and Alzheimer's disease: A practical orientation. Nursing Clinics of North America, 41(1), 119-127.
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  PMID: 16492458;Abstract: This article presents a functional, brief, and, above all, practical orientation to AD. This disease, with its many unanswered questions (and occasional unquestioned answers), is in first instance a disease to be cared for. The burden of this caring initially falls on caregivers and families; however, once Alzheimer's patients enter the formal health care system, nurses will be at the forefront of care. The foundation to good care is a solid but also applied understanding of the disease, how it manifests itself, and how it is experienced by patients, caregivers, and families. © 2005 Elsevier Inc. All rights reserved.
• Abraham, I. L. (2006). Dementia and Alzheimer's disease: a practical orientation. The Nursing clinics of North America, 41(1), 119-27, viii.
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  This article presents a functional, brief, and, above all, practical orientation to Alzheimer's disease. This disease, with its many unanswered questions (and occasional unquestioned answers), is in first instance a disease to be cared for. The burden of this caring initially falls on care-givers and families; however, once Alzheimer's patients enter the formal health care system, nurses will be at the forefront of care. The foundation to good care is a solid but also applied understanding of the disease,how it manifests itself, and how it is experienced by patients, caregivers,and families.
• Abraham, I. L., & MacDonald, K. M. (2006). Postapproval drug safety [7]. Health Affairs, 25(4), 1186-1187.
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  PMID: 16835206;
• Abraham, I. L., & MacDonald, K. M. (2006). Postapproval drug safety [7]. Health Affairs, 25(Issue 4). doi:10.1377/hlthaff.25.4.1186-a
• Abraham, I. L., MacDonald, K. M., & Nadzam, D. M. (2006). Measuring the quality of nursing care to Alzheimer's patients. Nursing Clinics of North America, 41(1), 95-104.
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  PMID: 16492456;Abstract: The process of outcome measurement and quality management in nursing care of Alzheimer's patients is not a mystery. It is hard work identifying what to measure, selecting the measures, collecting the data, analyzing and presenting results, and implementing change. To summarize, when determining the final measures that are good for you and your organization, three things matter: 1. It works for your organization. 2. It is well defined, tested, and applied. 3. Quality improvement happens! © 2005 Elsevier Inc. All rights reserved.
• Abraham, I. L., MacDonald, K. M., & Nadzam, D. M. (2006). Measuring the quality of nursing care to Alzheimer's patients. The Nursing clinics of North America, 41(1), 95-104, vi-vii.
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  Facilities that provide care to Alzheimer's disease patients are under unrelenting pressure to document the quality of nursing care they provide to various stakeholders. Unfortunately, little consensus exists nor is guidance given as to how to measure the quality of nursing care. Regulations and standards exist but are seldom translated into systematic outcome measures that assist nurses and facilities to measure, report,and manage the quality of care they provide to residents in general and Alzheimer's patients in particular. This article offers practical ad-vice on conceptualizing quality of nursing care to Alzheimer's patients and the selection of outcome measures to collect, analyze, use, and re-port quality of nursing care data.
• MacDonald, K. M., Vancayzeele, S., Deblander, A., & Abraham, I. L. (2006). Longitudinal observational studies to study the efficacy-effectiveness gap in drug therapy: Application to mild and moderate dementia. Nursing Clinics of North America, 41(1), 105-117.
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  PMID: 16492457;Abstract: If well-designed, longitudinal observational studies (LOSs) can provide insights to the linkages between real-world outcomes and their multilevel determinants. In this article, some of the scientific and methodologic issues related to LOSs in pharmacotherapeutic evaluations are discussed. A case of such a study in the treatment of mild to moderate dementia is provided - a case in which a pharmaceutic sponsor addressing a medical question (long-term effectiveness) realized that caring for patients who have Alzheimer's disease involves the clinical community of caregivers, physicians, families, nurses, psychologists, and pharmacists, among others, and partnered with nurse researchers to design their inquiry. The authors conclude by presenting an argument for nurses to take the lead in effectiveness research. © 2005 Elsevier Inc. All rights reserved.
• MacDonald, K. M., Vancayzeele, S., Deblander, A., & Abraham, I. L. (2006). Longitudinal observational studies to study the efficacy-effectiveness gap in drug therapy: application to mild and moderate dementia. The Nursing clinics of North America, 41(1), 105-17, vii.
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  If well-designed, longitudinal observational studies (LOSs) can provide insights to the linkages between real-world outcomes and their multilevel determinants. In this article, some of the scientific and methodologic issues related to LOSs in pharmacotherapeutic evaluations are discussed. A case of such a study in the treatment of mild to moderate dementia is provided-a case in which a pharmaceutic sponsor addressing a medical question (long-term effectiveness) realized that caring for patients who have Alzheimer's disease involves the clinical community of caregivers, physicians, families, nurses, psychologists, and pharmacists, among others, and partnered with nurse researchers to design their inquiry. The authors conclude by presenting an argument for nurses to take the lead in effectiveness research.
• Milisen, K., Abraham, I., Siebens, K., Darras, E., & Dierckx de Casterlé, B. (2006). Work environment and workforce problems: A cross-sectional questionnaire survey of hospital nurses in Belgium. International Journal of Nursing Studies, 43(Issue 6). doi:10.1016/j.ijnurstu.2005.10.008
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  Objectives: This study investigated Belgian hospital nurses' perceptions on work environment and workforce issues, quality of care, job satisfaction and professional decision making. Methods: All eligible nurses in a selection of 22 hospitals received the BELIMAGE questionnaire for a total of 13,958 potential respondents. Of these, 9941 returned study materials (response rate=71.2%) of which 9638 were valid and useable for statistical analysis (valid response rate=69.1%). Results: The study identified several areas of tension in the nursing profession. The commitment to being competent providers of quality care was remarkably strong among the nurses, but they also perceived the barriers in the work environment to be multiple and complex. Concerns about the quality of leadership and management, insufficient staff, time demands and stressful work environment are experienced as obstacles in providing good nursing care. Four out of ten nurses (39.2%) would not choose nursing again as a career and more than half of the nurses (54.3%) have contemplated leaving the profession at some point in time. Conclusions: To effectively tackle the professional and workforce issues in nursing, investments should focus on redesigning a work environment that supports nurses in providing comprehensive professional care. © 2005 Elsevier Ltd. All rights reserved.
• Milisen, K., Abraham, I., Siebens, K., Darras, E., & Dierckx, B. (2006). Work environment and workforce problems: A cross-sectional questionnaire survey of hospital nurses in Belgium. International Journal of Nursing Studies, 43(6), 745-754.
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  PMID: 16321387;Abstract: Objectives: This study investigated Belgian hospital nurses' perceptions on work environment and workforce issues, quality of care, job satisfaction and professional decision making. Methods: All eligible nurses in a selection of 22 hospitals received the BELIMAGE questionnaire for a total of 13,958 potential respondents. Of these, 9941 returned study materials (response rate=71.2%) of which 9638 were valid and useable for statistical analysis (valid response rate=69.1%). Results: The study identified several areas of tension in the nursing profession. The commitment to being competent providers of quality care was remarkably strong among the nurses, but they also perceived the barriers in the work environment to be multiple and complex. Concerns about the quality of leadership and management, insufficient staff, time demands and stressful work environment are experienced as obstacles in providing good nursing care. Four out of ten nurses (39.2%) would not choose nursing again as a career and more than half of the nurses (54.3%) have contemplated leaving the profession at some point in time. Conclusions: To effectively tackle the professional and workforce issues in nursing, investments should focus on redesigning a work environment that supports nurses in providing comprehensive professional care. © 2005 Elsevier Ltd. All rights reserved.
• Milisen, K., Abraham, I., Siebens, K., Darras, E., Dierckx de Casterlé, B., & , B. g. (2006). Work environment and workforce problems: a cross-sectional questionnaire survey of hospital nurses in Belgium. International journal of nursing studies, 43(6), 745-54.
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  This study investigated Belgian hospital nurses' perceptions on work environment and workforce issues, quality of care, job satisfaction and professional decision making.
• Siebens, K., Casterlé, B. D., Abraham, I., Dierckx, K., Braes, T., Darras, E., Dubois, Y., Milisen, K., & , r. t. (2006). The professional self-image of nurses in Belgian hospitals: a cross-sectional questionnaire survey. International journal of nursing studies, 43(1), 71-82.
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  This paper reports data on the professional self-image of 9638 nurses employed in 22 Belgian general hospitals with the goal of identifying problems affecting recruitment and retention. Nurses reported having a positive self-image. Most were proud to be a nurse and considered themselves competent health professionals having great responsibility. Although they reported that an ideal practice requires effective teamwork, supportive management, societal recognition, and sufficient time to perform their duties, they also felt that these essential conditions were absent in daily practice.
• Siebens, K., Casterlé, B. D., Abraham, I., Dierckx, K., Braes, T., Darras, E., Dubois, Y., Milisen, K., Aubry, C., Buellens, J., Claessens, P., Dekeyser, L., Leonard, S., Simons, J., Stinglhamber, B., Peeters, G., Vandenberghe, A., & Vanschoor, M. (2006). The professional self-image of nurses in Belgian hospitals: A cross-sectional questionnaire survey. International Journal of Nursing Studies, 43(Issue 1). doi:10.1016/j.ijnurstu.2005.04.004
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  This paper reports data on the professional self-image of 9638 nurses employed in 22 Belgian general hospitals with the goal of identifying problems affecting recruitment and retention. Nurses reported having a positive self-image. Most were proud to be a nurse and considered themselves competent health professionals having great responsibility. Although they reported that an ideal practice requires effective teamwork, supportive management, societal recognition, and sufficient time to perform their duties, they also felt that these essential conditions were absent in daily practice. © 2005 Elsevier Ltd. All rights reserved.
• Siebens, K., Dierckx, B., Abraham, I., Dierckx, K., Braes, T., Darras, E., Dubois, Y., Milisen, K., Aubry, C., Buellens, J., Claessens, P., Dekeyser, L., Leonard, S., Simons, J., Stinglhamber, B., Peeters, G., Vandenberghe, A., & Vanschoor, M. (2006). The professional self-image of nurses in Belgian hospitals: A cross-sectional questionnaire survey. International Journal of Nursing Studies, 43(1), 71-82.
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  PMID: 15972211;Abstract: This paper reports data on the professional self-image of 9638 nurses employed in 22 Belgian general hospitals with the goal of identifying problems affecting recruitment and retention. Nurses reported having a positive self-image. Most were proud to be a nurse and considered themselves competent health professionals having great responsibility. Although they reported that an ideal practice requires effective teamwork, supportive management, societal recognition, and sufficient time to perform their duties, they also felt that these essential conditions were absent in daily practice. © 2005 Elsevier Ltd. All rights reserved.
• Steeman, E., Moons, P., Milisen, K., Bal, N. D., Geest, S. D., Froidmont, C. D., Tellier, V., Gosset, C., & Abraham, I. (2006). Implementation of discharge management for geriatric patients at risk of readmission or institutionalization. International Journal for Quality in Health Care, 18(5), 352-358.
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  PMID: 16861721;Abstract: Objective. To evaluate whether implementation of discharge management by trained social workers or nurses reduces hospital readmissions and institutionalizations of geriatric patients in a real-world setting. De sign. Quasi-experimental design. Setting. Six general hospitals in Belgium. Participants. A representative sample of 824 patients, 355 of whom were assigned to the experimental group receiving comprehensive discharge management and 469 to the control group receiving usual care. Inclusion criteria were patients admitted to a geriatric, rehabilitation, or internal medicine ward, not residing in a nursing home, and showing risk of readmission or institutionalization on admission in the hospital. Intervention. In-hospital discharge planning according to a case management protocol allowing for adjustment to participating hospitals' case mix and patients' and families' specific needs. Main outcome measures. Hospital readmission within 15 and 90 days post discharge; institutionalization at discharge and within 15 and 90 days post discharge. Results. Discharge management resulted in fewer institutionalizations (n = 53; 14.9%) compared with usual care (n = 130; 23.7%) (adjusted odds ratio = 0.47; CI 95% = 0.31-0.70). Readmission rates between the intervention and usual care group were not significantly different. Conclusions. This implementation project showed that a discharge planning intervention can reduce institutionalization rates of elderly patients in real-life settings. © 2006 Oxford University Press.
• Steeman, E., Moons, P., Milisen, K., De Bal, N., De Geest, S., De Froidmont, C., Tellier, V., Gosset, C., & Abraham, I. (2006). Implementation of discharge management for geriatric patients at risk of readmission or institutionalization. International Journal for Quality in Health Care, 18(Issue 5). doi:10.1093/intqhc/mzl026
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  Objective. To evaluate whether implementation of discharge management by trained social workers or nurses reduces hospital readmissions and institutionalizations of geriatric patients in a real-world setting. De sign. Quasi-experimental design. Setting. Six general hospitals in Belgium. Participants. A representative sample of 824 patients, 355 of whom were assigned to the experimental group receiving comprehensive discharge management and 469 to the control group receiving usual care. Inclusion criteria were patients admitted to a geriatric, rehabilitation, or internal medicine ward, not residing in a nursing home, and showing risk of readmission or institutionalization on admission in the hospital. Intervention. In-hospital discharge planning according to a case management protocol allowing for adjustment to participating hospitals' case mix and patients' and families' specific needs. Main outcome measures. Hospital readmission within 15 and 90 days post discharge; institutionalization at discharge and within 15 and 90 days post discharge. Results. Discharge management resulted in fewer institutionalizations (n = 53; 14.9%) compared with usual care (n = 130; 23.7%) (adjusted odds ratio = 0.47; CI 95% = 0.31-0.70). Readmission rates between the intervention and usual care group were not significantly different. Conclusions. This implementation project showed that a discharge planning intervention can reduce institutionalization rates of elderly patients in real-life settings. © 2006 Oxford University Press.
• Steeman, E., Moons, P., Milisen, K., De Bal, N., De Geest, S., De Froidmont, C., Tellier, V., Gosset, C., & Abraham, I. (2006). Implementation of discharge management for geriatric patients at risk of readmission or institutionalization. International journal for quality in health care : journal of the International Society for Quality in Health Care / ISQua, 18(5), 352-8.
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  To evaluate whether implementation of discharge management by trained social workers or nurses reduces hospital readmissions and institutionalizations of geriatric patients in a real-world setting.
• Fulmer, T., Paveza, G., VandeWeerd, C., Guadagno, L., Fairchild, S., Norman, R., Abraham, I., & Bolton-Blatt, M. (2005). Neglect assessment in urban emergency departments and confirmation by an expert clinical team. Journals of Gerontology - Series A Biological Sciences and Medical Sciences, 60(8), 1002-1006.
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  PMID: 16127103;Abstract: Background. Elder neglect accounts for over 70% of all adull protective services reports in the nation annually, and it has been estimated that there are over 70,000 new cases each year. The purpose of this study was to conduct elder neglect research in the emergency department (ED), using a dyadic vulnerability/risk-profiling framework for elder neglect. Methods. Patients were recruited through four EDs in New York and Tampa from the beginning of February 2001 through the end of September 2003. Demographics, a Mini-Mental Status Examination score, and an initial elder assessment screen were collected. The diagnosis of neglect was then made by a Neglect Assessment Team (NAT) comprising a nurse, physician, and social worker, with extensive clinical experience in elder neglect. Results. Of the 3664 ED screens of adults 70 years and older, 405 (11%) met the inclusion criteria and agreed to participate. Neglect was diagnosed by the NAT in 86 of the 405 cases reviewed. Demographic differences between neglect versus no neglect cases were examined using Fisher's exact test, and differences emerged between the 2 groups. Conclusion. This study documents the underreporting of cases of neglect as evidenced by differences in diagnoses by screeners versus experts. The research assistants screened positive for neglect in 5% (N = 22) of the 405 cases. The NAT made the diagnosis of neglect in 22% (86/389) of the cases. This markedly different rate of neglect may mean that ED screens are important but may underestimate the true number of cases. Conversely, an NAT may make the diagnosis of neglect in an older adult more often given a higher sensitivity and a more robust knowledge base of the problem. Copyright 2005 by The Gerontological Society of America.
• Fulmer, T., Paveza, G., VandeWeerd, C., Guadagno, L., Fairchild, S., Norman, R., Abraham, I., & Bolton-Blatt, M. (2005). Neglect assessment in urban emergency departments and confirmation by an expert clinical team. Journals of Gerontology - Series A Biological Sciences and Medical Sciences, 60(Issue 8). doi:10.1093/gerona/60.8.1002
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  Background. Elder neglect accounts for over 70% of all adull protective services reports in the nation annually, and it has been estimated that there are over 70,000 new cases each year. The purpose of this study was to conduct elder neglect research in the emergency department (ED), using a dyadic vulnerability/risk-profiling framework for elder neglect. Methods. Patients were recruited through four EDs in New York and Tampa from the beginning of February 2001 through the end of September 2003. Demographics, a Mini-Mental Status Examination score, and an initial elder assessment screen were collected. The diagnosis of neglect was then made by a Neglect Assessment Team (NAT) comprising a nurse, physician, and social worker, with extensive clinical experience in elder neglect. Results. Of the 3664 ED screens of adults 70 years and older, 405 (11%) met the inclusion criteria and agreed to participate. Neglect was diagnosed by the NAT in 86 of the 405 cases reviewed. Demographic differences between neglect versus no neglect cases were examined using Fisher's exact test, and differences emerged between the 2 groups. Conclusion. This study documents the underreporting of cases of neglect as evidenced by differences in diagnoses by screeners versus experts. The research assistants screened positive for neglect in 5% (N = 22) of the 405 cases. The NAT made the diagnosis of neglect in 22% (86/389) of the cases. This markedly different rate of neglect may mean that ED screens are important but may underestimate the true number of cases. Conversely, an NAT may make the diagnosis of neglect in an older adult more often given a higher sensitivity and a more robust knowledge base of the problem. Copyright 2005 by The Gerontological Society of America.
• Fulmer, T., Paveza, G., Vandeweerd, C., Guadagno, L., Fairchild, S., Norman, R., Abraham, I., & Bolton-Blatt, M. (2005). Neglect assessment in urban emergency departments and confirmation by an expert clinical team. The journals of gerontology. Series A, Biological sciences and medical sciences, 60(8), 1002-6.
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  Elder neglect accounts for over 70% of all adult protective services reports in the nation annually, and it has been estimated that there are over 70,000 new cases each year. The purpose of this study was to conduct elder neglect research in the emergency department (ED), using a dyadic vulnerability/risk-profiling framework for elder neglect.
• Milisen, K., Foreman, M. D., Hendrickx, A., Godderis, J., Abraham, I. L., Broos, P. L., & De Geest, S. (2005). Psychometric properties of the Flemish translation of the NEECHAM Confusion Scale. BMC Psychiatry, 5(Issue). doi:10.1186/1471-244x-5-16
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  Background: Determination of a patient's cognitive status by use of a valid and reliable screening instrument is of major importance as early recognition and accurate diagnosis of delirium is necessary for effective management. This study determined the reliability, validity and diagnostic value of the Flemish translation of the NEECHAM Confusion Scale. Methods: A sample of 54 elderly hip fracture patients with a mean age of 80.9 years (SD = 7.85) were included. To test the psychometric properties of the NEECHAM Confusion Scale, performance on the NEECHAM was compared to the Confusion Assessment Method (CAM) and the Mini-Mental State Examination (MMSE), by using aggregated data based on 5 data collection measurement points (repeated measures). The CAM and MMSE served as gold standards. Results: The alpha coefficient for the total NEECHAM score was high (0.88). Principal components analysis yielded a two-component solution accounting for 70.8% of the total variance. High correlations were found between the total NEECHAM scores and total MMSE (0.75) and total CAM severity scores (-0.73), respectively. Diagnostic values using the CAM algorithm as gold standard showed 76.9% sensitivity, 64.6% specificity, 13.5% positive and 97.5% negative predictive values, respectively. Conclusion: This validation of the Flemish version of the NEECHAM Confusion Scale adds to previous evidence suggesting that this scale holds promise as a valuable screening instrument for delirium in clinical practice. Further validation studies in diverse clinical populations; however, are needed. © 2005 Millsen et al; licensee BioMed Central Ltd.
• Milisen, K., Foreman, M. D., Hendrickx, A., Godderis, J., Abraham, I. L., Broos, P. L., & De Geest, S. (2005). Psychometric properties of the Flemish translation of the NEECHAM Confusion Scale. BMC psychiatry, 5, 16.
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  Determination of a patient's cognitive status by use of a valid and reliable screening instrument is of major importance as early recognition and accurate diagnosis of delirium is necessary for effective management. This study determined the reliability, validity and diagnostic value of the Flemish translation of the NEECHAM Confusion Scale.
• Milisen, K., Foreman, M. D., Hendrickx, A., Godderis, J., Abraham, I. L., Broos, P. L., & Geest, S. D. (2005). Psychometric properties of the Flemish translation of the NEECHAM Confusion Scale. BMC Psychiatry, 5.
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  PMID: 15792498;PMCID: PMC1079887;Abstract: Background: Determination of a patient's cognitive status by use of a valid and reliable screening instrument is of major importance as early recognition and accurate diagnosis of delirium is necessary for effective management. This study determined the reliability, validity and diagnostic value of the Flemish translation of the NEECHAM Confusion Scale. Methods: A sample of 54 elderly hip fracture patients with a mean age of 80.9 years (SD = 7.85) were included. To test the psychometric properties of the NEECHAM Confusion Scale, performance on the NEECHAM was compared to the Confusion Assessment Method (CAM) and the Mini-Mental State Examination (MMSE), by using aggregated data based on 5 data collection measurement points (repeated measures). The CAM and MMSE served as gold standards. Results: The alpha coefficient for the total NEECHAM score was high (0.88). Principal components analysis yielded a two-component solution accounting for 70.8% of the total variance. High correlations were found between the total NEECHAM scores and total MMSE (0.75) and total CAM severity scores (-0.73), respectively. Diagnostic values using the CAM algorithm as gold standard showed 76.9% sensitivity, 64.6% specificity, 13.5% positive and 97.5% negative predictive values, respectively. Conclusion: This validation of the Flemish version of the NEECHAM Confusion Scale adds to previous evidence suggesting that this scale holds promise as a valuable screening instrument for delirium in clinical practice. Further validation studies in diverse clinical populations; however, are needed. © 2005 Millsen et al; licensee BioMed Central Ltd.
• Rothberg, M. B., Abraham, I., Lindenauer, P. K., & Rose, D. N. (2005). Improving nurse-to-patient staffing ratios as a cost-effective safety intervention. Medical Care, 43(8), 785-791.
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  PMID: 16034292;Abstract: Background: Responding to research confirming the link between nurse staffing and patient outcomes, 14 states have introduced legislation to limit patient-to-nurse ratios. However, increased staffing places a considerable financial burden on hospitals. Objective: We sought to determine the cost-effectiveness of various nurse staffing ratios. Research Design: This was a cost-effectiveness analysis from the institutional perspective comparing patient-to-nurse ratios ranging from 8:1 to 4:1. Cost estimates were drawn from the medical literature and the Bureau of Labor Statistics. Patient mortality and length of stay data for different ratios were based on 2 large hospital level studies. Incremental cost-effectiveness was calculated for each ratio and sensitivity and Monte Carlo analyses performed. Subjects: The study included general medical and surgical patients. Measures: We sought to measure costs per life saved in 2003 US dollars. Results of Base Case Analysis: Eight patients per nurse was the least expensive ratio but was associated with the highest patient mortality. Decreasing the number of patients per nurse improved mortality and increased costs, becoming progressively less cost-effective as the ratio declined from 8:1 to 4:1. Nonetheless, the incremental cost-effectiveness did not exceed $136,000 (95% CI $53,000-402,000) per life saved. Results of Sensitivity Analysis: The model was most sensitive to the effects of patient-to-nurse ratios on mortality. Lower ratios were most cost-effective when lower ratios shortened length of stay, and hourly wages were low. However, throughout the ranges of all these variables, the incremental cost-effectiveness of limiting the ratio to 4:1 never exceeded $449,000 per life saved. Conclusions: As a patient safety intervention, patient-to-nurse ratios of 4:1 are reasonably cost-effective and in the range of other commonly accepted interventions. Copyright © 2005 by Lippincott Williams & Wilkins.
• Rothberg, M. B., Abraham, I., Lindenauer, P. K., & Rose, D. N. (2005). Improving nurse-to-patient staffing ratios as a cost-effective safety intervention. Medical Care, 43(Issue 8). doi:10.1097/01.mlr.0000170408.35854.fa
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  Background: Responding to research confirming the link between nurse staffing and patient outcomes, 14 states have introduced legislation to limit patient-to-nurse ratios. However, increased staffing places a considerable financial burden on hospitals. Objective: We sought to determine the cost-effectiveness of various nurse staffing ratios. Research Design: This was a cost-effectiveness analysis from the institutional perspective comparing patient-to-nurse ratios ranging from 8:1 to 4:1. Cost estimates were drawn from the medical literature and the Bureau of Labor Statistics. Patient mortality and length of stay data for different ratios were based on 2 large hospital level studies. Incremental cost-effectiveness was calculated for each ratio and sensitivity and Monte Carlo analyses performed. Subjects: The study included general medical and surgical patients. Measures: We sought to measure costs per life saved in 2003 US dollars. Results of Base Case Analysis: Eight patients per nurse was the least expensive ratio but was associated with the highest patient mortality. Decreasing the number of patients per nurse improved mortality and increased costs, becoming progressively less cost-effective as the ratio declined from 8:1 to 4:1. Nonetheless, the incremental cost-effectiveness did not exceed $136,000 (95% CI $53,000-402,000) per life saved. Results of Sensitivity Analysis: The model was most sensitive to the effects of patient-to-nurse ratios on mortality. Lower ratios were most cost-effective when lower ratios shortened length of stay, and hourly wages were low. However, throughout the ranges of all these variables, the incremental cost-effectiveness of limiting the ratio to 4:1 never exceeded $449,000 per life saved. Conclusions: As a patient safety intervention, patient-to-nurse ratios of 4:1 are reasonably cost-effective and in the range of other commonly accepted interventions. Copyright © 2005 by Lippincott Williams & Wilkins.
• Rothberg, M. B., Abraham, I., Lindenauer, P. K., & Rose, D. N. (2005). Improving nurse-to-patient staffing ratios as a cost-effective safety intervention. Medical care, 43(8), 785-91.
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  Responding to research confirming the link between nurse staffing and patient outcomes, 14 states have introduced legislation to limit patient-to-nurse ratios. However, increased staffing places a considerable financial burden on hospitals.
• Guadagno, L., Vandeweerd, C., Stevens, D., Abraham, I., Paveza, G. J., & Fulmer, T. (2004). Using PDAs for data collection. Applied Nursing Research, 17(4), 283-291.
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  PMID: 15573337;Abstract: Advances in handheld computer technology are making data collection faster, easier, and more accurate. In this article, the use of personal digital assistants (PDAs) to collect data for a study on elder neglect is described and evaluated. Methods for integrating this technology into a research study are discussed as are suggestions for increasing the performance of data collectors using these devices. The authors offer some practical solutions for researchers and clinicians planning to use PDAs in their research. © 2004 Elsevier Inc. All rights reserved.
• Guadagno, L., Vandeweerd, C., Stevens, D., Abraham, I., Paveza, G. J., & Fulmer, T. (2004). Using PDAs for data collection. Applied Nursing Research, 17(Issue 4). doi:10.1016/j.apnr.2004.09.008
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  Advances in handheld computer technology are making data collection faster, easier, and more accurate. In this article, the use of personal digital assistants (PDAs) to collect data for a study on elder neglect is described and evaluated. Methods for integrating this technology into a research study are discussed as are suggestions for increasing the performance of data collectors using these devices. The authors offer some practical solutions for researchers and clinicians planning to use PDAs in their research. © 2004 Elsevier Inc. All rights reserved.
• Milisen, K., Cremers, S., Foreman, M. D., Vandevelde, E., Haspeslagh, M., Geest, S. D., & Abraham, I. (2004). The Strain of Care for Delirium Index: a new instrument to assess nurses' strain in caring for patients with delirium. International journal of nursing studies, 41(7), 775-83.
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  This study evaluated content validity, internal consistency and construct validity of the Strain of Care for Delirium Index (SCDI), a newly constructed instrument to measure the strain nurses experience in caring for patients with delirium. Content validity, evaluated by eight experts, reduced the initial pool of items from 38 to 28. Using a convenience sample of 190 nurses, Cronbach's alpha for the 28-item version was 0.88. Using non-linear principal components analysis another eight items were eliminated and a four-factor structure was identified. The proportion of variance explained by the remaining 20 items was 61.51%. Preliminary psychometric evaluation of the SCDI supported content validity, internal consistency and construct validity; however additional psychometric evaluation is warranted.
• Milisen, K., Cremers, S., Foreman, M. D., Vandevelde, E., Haspeslagh, M., Geest, S. D., & Abraham, I. (2004). The strain of care for Delirium Index: A new instrument to assess nurses' strain in caring for patients with delirium. International Journal of Nursing Studies, 41(Issue 7). doi:10.1016/j.ijnurstu.2004.03.005
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  This study evaluated content validity, internal consistency and construct validity of the Strain of Care for Delirium Index (SCDI), a newly constructed instrument to measure the strain nurses experience in caring for patients with delirium. Content validity, evaluated by eight experts, reduced the initial pool of items from 38 to 28. Using a convenience sample of 190 nurses, Cronbach's α for the 28-item version was 0.88. Using non-linear principal components analysis another eight items were eliminated and a four-factor structure was identified. The proportion of variance explained by the remaining 20 items was 61.51%. Preliminary psychometric evaluation of the SCDI supported content validity, internal consistency and construct validity; however additional psychometric evaluation is warranted. © 2004 Elsevier Ltd. All rights reserved.
• Milisen, K., Cremers, S., Foreman, M. D., Vandevelde, E., Haspeslagh, M., Geest, S. D., & Abraham, I. (2004). The strain of care for Delirium Index: A new instrument to assess nurses' strain in caring for patients with delirium. International Journal of Nursing Studies, 41(7), 775-783.
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  PMID: 15288800;Abstract: This study evaluated content validity, internal consistency and construct validity of the Strain of Care for Delirium Index (SCDI), a newly constructed instrument to measure the strain nurses experience in caring for patients with delirium. Content validity, evaluated by eight experts, reduced the initial pool of items from 38 to 28. Using a convenience sample of 190 nurses, Cronbach's α for the 28-item version was 0.88. Using non-linear principal components analysis another eight items were eliminated and a four-factor structure was identified. The proportion of variance explained by the remaining 20 items was 61.51%. Preliminary psychometric evaluation of the SCDI supported content validity, internal consistency and construct validity; however additional psychometric evaluation is warranted. © 2004 Elsevier Ltd. All rights reserved.
• Abraham, I., Baglioni, A. J., Fulmer, T., Guadagno, L., Paveza, G. J., & Vandeweerd, C. (2003). Erratum: Profiles of Older Adults Who Screen Positive for Neglect during an Emergency Department Visit (Journal of Elder Abuse & Neglect (2002) 14:1 (49-60)). Journal of Elder Abuse & Neglect, 15(2), 103-116. doi:10.1300/j084v15n02_06
• Denhaerynck, K., Abraham, I., Gourley, G., Drent, G., De Vleeschouwer, P., Papajcik, D., Lince, E., & De Geest, S. (2003). Validity testing of the Long-Term Medication Behavior Self-Efficacy Scale. Journal of nursing measurement, 11(3), 267-82.
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  Self-efficacy is an important determinant of health behavior that can be targeted for intervention. Little effort has been given to the development of valid measures for self-efficacy with medication taking for adherence research. The purpose of this study was to determine the criterion validity of the Long-Term Medication Behavior Self-Efficacy Scale (LTMBSES). Individual patient data from 6 existing adherence studies in transplant, hyperlipidemia, and AIDS/HIV patients (n = 1021) were pooled. Validity was determined by assessing the relation between the LTMBSES score and medication adherence--both self-reported and electronically monitored. A weak relationship was found between the LTMBSES score and adherence, which can possibly be attributed to a ceiling effect, caused by a too homogeneous population and/or a failure of the scale to challenge patients. Generalized Estimating Equations revealed that the total average self-efficacy score predicted reported medication adherence (p < .0001). The Receiver Operating Characteristic curve revealed the area under the curve was 0.67, indicating a significant (p < .0001), but poor predictive capability. Evidence for criterion validity of the Long-Term Medication Behavior Self-Efficacy Scale is not yet convincing. Future research should focus on: (1) validation in a population with a more heterogenous level of adherence, and (2) making the scale more challenging by referring to "always taking the medication without exception."
• Denhaerynck, K., Abraham, I., Gourley, G., Drent, G., Vleeschouwer, P. D., Papajcik, D., Lince, E., & Geest, S. D. (2003). Validity testing of the long-term medication behavior self-efficacy scale. Journal of Nursing Measurement, 11(3), 267-282.
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  PMID: 15633781;Abstract: Self-efficacy is an important determinant of health behavior that can be targeted for intervention. Little effort has been given to the development of valid measures for self-efficacy with medication taking for adherence research. The purpose of this study was to determine the criterion validity of the Long-Term Medication Behavior Self-Efficacy Scale (LTMBSES). Individual patient data from 6 existing adherence studies in transplant, hyperlipidemia, and AIDS/HIV patients (n = 1021) were pooled. Validity was determined by assessing the relation between the LTMBSES score and medication adherence - both self-reported and electronically monitored. A weak relationship was found between the LTMBSES score and adherence, which can possibly be attributed to a ceiling effect, caused by a too homogeneous population and/or a failure of the scale to challenge patients. Generalized Estimating Equations revealed that the total average self-efficacy score predicted reported medication adherence (p < .0001). The Receiver Operating Characteristic curve revealed the area under the curve was 0.67, indicating a significant (p < .0001), but poor predictive capability. Evidence for criterion validity of the Long-Term Medication Behavior Self-Efficacy Scale is not yet convincing. Future research should focus on: (1) validation in a population with a more heterogenous level of adherence, and (2) making the scale more challenging by referring to "always taking the medication without exception.".
• Rosencher, N., Kerkkamp, H. E., Macheras, G., Munuera, L. M., Menichella, G., Barton, D. M., Cremers, S., & Abraham, I. L. (2003). Orthopedic surgery transfusion hemoglobin european overview (OSTHEO) study: Blood management in elective knee and hip arthroplasty in Europe. Transfusion, 43(4), 459-469.
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  PMID: 12662278;Abstract: BACKGROUND: The purpose of this study was to assess current practices in blood management in elective orthopedic surgery in Europe. STUDY DESIGN AND METHODS: For this 225-center prospective survey, data were collected on 3996 patients. Actual perioperative blood loss was compared to preoperative estimates. Differences in Hb levels and other outcome variables for patients receiving allogeneic versus autologous transfusions were evaluated. The probability of allogeneic transfusion based on selected predictor variables was estimated. RESULTS: A total of 2640 (67%) hip and 1305 (33%) knee arthroplasty patients were evaluated. Estimated blood loss (median, 750 mL) was significantly lower than computed blood loss (median, 1944 mL). A total of 2762 (69%) patients received transfusions, including 1393 (35%) autologous-only and 1024 (25%) allogeneic-only. The probability of allogeneic transfusion decreased with increasing baseline Hb, but differentially so for men and women. Transfusion triggers were Hb levels of 8.93 ± 1.83 g per dL for allogeneic transfusions, and 21 percent of these occurred when the Hb level was greater than 10 g per dL. Autologous blood transfusion was associated with a significantly lower rate (1%) of wound infections than allogeneic blood transfusion (4.2%). CONCLUSION: Accurate assessment of preoperative Hb levels, better estimation of perioperative blood loss, efficient use of autologous blood, adherence to transfusion guidelines, and pharmacologic alternatives contribute to effective and comprehensive blood and anemia management.
• Rosencher, N., Kerkkamp, H. E., Macheras, G., Munuera, L. M., Menichella, G., Barton, D. M., Cremers, S., & Abraham, I. L. (2003). Orthopedic surgery transfusion hemoglobin european overview (OSTHEO) study: Blood management in elective knee and hip arthroplasty in Europe. Transfusion, 43(Issue 4). doi:10.1046/j.1537-2995.2003.00348.x
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  BACKGROUND: The purpose of this study was to assess current practices in blood management in elective orthopedic surgery in Europe. STUDY DESIGN AND METHODS: For this 225-center prospective survey, data were collected on 3996 patients. Actual perioperative blood loss was compared to preoperative estimates. Differences in Hb levels and other outcome variables for patients receiving allogeneic versus autologous transfusions were evaluated. The probability of allogeneic transfusion based on selected predictor variables was estimated. RESULTS: A total of 2640 (67%) hip and 1305 (33%) knee arthroplasty patients were evaluated. Estimated blood loss (median, 750 mL) was significantly lower than computed blood loss (median, 1944 mL). A total of 2762 (69%) patients received transfusions, including 1393 (35%) autologous-only and 1024 (25%) allogeneic-only. The probability of allogeneic transfusion decreased with increasing baseline Hb, but differentially so for men and women. Transfusion triggers were Hb levels of 8.93 ± 1.83 g per dL for allogeneic transfusions, and 21 percent of these occurred when the Hb level was greater than 10 g per dL. Autologous blood transfusion was associated with a significantly lower rate (1%) of wound infections than allogeneic blood transfusion (4.2%). CONCLUSION: Accurate assessment of preoperative Hb levels, better estimation of perioperative blood loss, efficient use of autologous blood, adherence to transfusion guidelines, and pharmacologic alternatives contribute to effective and comprehensive blood and anemia management.
• Rosencher, N., Kerkkamp, H. E., Macheras, G., Munuera, L. M., Menichella, G., Barton, D. M., Cremers, S., Abraham, I. L., & , O. I. (2003). Orthopedic Surgery Transfusion Hemoglobin European Overview (OSTHEO) study: blood management in elective knee and hip arthroplasty in Europe. Transfusion, 43(4), 459-69.
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  The purpose of this study was to assess current practices in blood management in elective orthopedic surgery in Europe.
• Fulmer, T., Guadagno, L., Pavesa, G. J., VandeWeerd, C., Baglioni Jr., A. J., & Abraham, I. (2002). Profiles of Older Adults Who Screen Positive for Neglect During an Emergency Department Visit. Journal of Elder Abuse and Neglect, 14(1), 49-60.
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  Abstract: The purpose of this paper is to describe how elder mistreatment (EM) assessment has been conducted in emergency departments in an ongoing study on elder neglect and to present profiles of older adults who are assessed as neglected by domestic caregivers. Data from 334 patients, which include 22 neglect cases, are presented in order to examine the demographic profile of the sample and the differences between the neglect and non-neglect groups. Results suggest that, although there are no differences in the basic demographic variables of the two groups, differences exist in regards to the type of caregiver, the reason for the patient's emergency department visit, and the elder's functional and dependency status. © 2002 by The Haworth Press, Inc. All rights reserved.
• Fulmer, T., Mezey, M., Bottrell, M., Abraham, I., Sazant, J., Grossman, S., & Grisham, E. (2002). Nurses Improving Care for Healthsystem Elders (NICHE): Using outcomes and Benchmarks for evidence-based practice. Geriatric Nursing, 23(3), 121-127.
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  PMID: 12075275;Abstract: This article describes Nurses Improving Care for Healthsystem Elders (NICHE), a project begun in 1992 with four pilot hospitals. These pilot hospitals gathered baseline data using a geriatric institutional assessment profile (GIAP) with a pre- and postdesign to capture changes in staff attitudes, knowledge, and perceptions of the care of older adults. Based on the success of the pilot effort, NICHE, now in its eight year, has evolved into a program that involves 32 health systems comprising 105 hospitals nationally. To date, more than 10,000 GIAPs have been collected by NICHE hospital staff. All NICHE settings are able to benchmark their GIAP data against comparable institutions (eg, urban, rural, university, community settings) to understand how they compare and then interpret the data at their unique sites. The opportunities for continuous quality improvement through the NICHE program are described.
• Fulmer, T., Mezey, M., Bottrell, M., Abraham, I., Sazant, J., Grossman, S., & Grisham, E. (2002). Nurses Improving Care for Healthsystem Elders (NICHE): Using outcomes and Benchmarks for evidence-based practice. Geriatric Nursing, 23(Issue 3). doi:10.1067/mgn.2002.125423
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  This article describes Nurses Improving Care for Healthsystem Elders (NICHE), a project begun in 1992 with four pilot hospitals. These pilot hospitals gathered baseline data using a geriatric institutional assessment profile (GIAP) with a pre- and postdesign to capture changes in staff attitudes, knowledge, and perceptions of the care of older adults. Based on the success of the pilot effort, NICHE, now in its eight year, has evolved into a program that involves 32 health systems comprising 105 hospitals nationally. To date, more than 10,000 GIAPs have been collected by NICHE hospital staff. All NICHE settings are able to benchmark their GIAP data against comparable institutions (eg, urban, rural, university, community settings) to understand how they compare and then interpret the data at their unique sites. The opportunities for continuous quality improvement through the NICHE program are described.
• Milisen, K., & Abraham, I. (2002). Care for the elderly: A vision from the professional caregiver. Tijdschrift voor Geneeskunde, 58(5), 303-314.
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  Abstract: This manuscript will explore the meaning of care for the elderly viewed from a nursing perspective, but taking into account all interdisciplinary care characteristics. We will first review the demographic changes in Belgium before going into more detail into the objectives of the care for the elderly. Further, issues concerning the stereotype of ageing, differentiation among age categories in the elderly, the importance of research, and the interplay between long term and acute care will be addressed. In addition to demographic trends a broad framework describing other major trends in health care and society (i.e. epidemiological shifts, knowledge explosion, introduction of new technologies, changes in consumer preferences, changes in lifestyle and culture, socio-economic changes and budgetary restrictions in health care) will allow to understand the complexity of care for the elderly.
• Milisen, K., & Abraham, I. (2002). Care for the elderly: A vision from the professional caregiver. Tijdschrift voor Geneeskunde, 58(Issue 5). doi:10.2143/tvg.58.5.5001278
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  This manuscript will explore the meaning of care for the elderly viewed from a nursing perspective, but taking into account all interdisciplinary care characteristics. We will first review the demographic changes in Belgium before going into more detail into the objectives of the care for the elderly. Further, issues concerning the stereotype of ageing, differentiation among age categories in the elderly, the importance of research, and the interplay between long term and acute care will be addressed. In addition to demographic trends a broad framework describing other major trends in health care and society (i.e. epidemiological shifts, knowledge explosion, introduction of new technologies, changes in consumer preferences, changes in lifestyle and culture, socio-economic changes and budgetary restrictions in health care) will allow to understand the complexity of care for the elderly.
• Milisen, K., Foreman, M. D., Wouters, B., Driesen, R., Godderis, J., Abraham, I. L., & Broos, P. L. (2002). Documentation of delirium in elderly patients with hip fracture. Journal of gerontological nursing, 28(11), 23-9.
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  This study determined the accuracy of diagnosis and documentation of delirium in the medical and nursing records of 55 elderly patients with hip fracture (mean age = 78.4, SD = 8.4). These records were reviewed retrospectively on a patient's discharge for diagnosis of delirium, and for description of clinical indicators or symptoms of delirium. Additionally, all patients were monitored by one of the research members on days 1, 3, 5, 8, and 12 postoperatively for signs of delirium, as measured by the Confusion Assessment Method (CAM). Clinicians were blinded to the purpose of the study. According to the CAM criteria, the incidence of delirium was 14.5% on postoperative Day 1; 9.1% on postoperative Day 3; 10.9% on postoperative Day 5; 7.7% on postoperative Day 8; and 5.6% on postoperative Day 12. For those same days, no formal diagnosis of delirium or a description of clinical indicators was found in the medical records. In the nursing records, a false-positive documentation of 8.5%, 4%, 4.1%, 4.2%, and 5.9%, respectively was noted. False-negative documentation was found in 87.5%, 80%, 66.7%, 75%, and 50% of the cases on the respective days. Documentation of essential symptoms--namely onset and course of the syndrome--and disturbances in consciousness, attention, and cognition, were seldom or never found in the nursing records. However, behaviors of the hyperactive variant of delirium and which are known to interfere with nursing care were documented more often (e.g., 13.4% restless, 10.3% fidget with materials, 7.2% annoying behavior). Both medical and nursing records showed poor documentation and under-diagnosis of delirium. However, a correct diagnosis and early recognition of delirium may enhance the management of this syndrome.
• Milisen, K., Foreman, M. D., Wouters, B., Driesen, R., Godderis, J., Abraham, I. L., & Broos, P. L. (2002). Documentation of delirium in elderly patients with hip fracture.. Journal of gerontological nursing, 28(Issue 11). doi:10.3928/0098-9134-20021101-07
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  This study determined the accuracy of diagnosis and documentation of delirium in the medical and nursing records of 55 elderly patients with hip fracture (mean age = 78.4, SD = 8.4). These records were reviewed retrospectively on a patient's discharge for diagnosis of delirium, and for description of clinical indicators or symptoms of delirium. Additionally, all patients were monitored by one of the research members on days 1, 3, 5, 8, and 12 postoperatively for signs of delirium, as measured by the Confusion Assessment Method (CAM). Clinicians were blinded to the purpose of the study. According to the CAM criteria, the incidence of delirium was 14.5% on postoperative Day 1; 9.1% on postoperative Day 3; 10.9% on postoperative Day 5; 7.7% on postoperative Day 8; and 5.6% on postoperative Day 12. For those same days, no formal diagnosis of delirium or a description of clinical indicators was found in the medical records. In the nursing records, a false-positive documentation of 8.5%, 4%, 4.1%, 4.2%, and 5.9%, respectively was noted. False-negative documentation was found in 87.5%, 80%, 66.7%, 75%, and 50% of the cases on the respective days. Documentation of essential symptoms--namely onset and course of the syndrome--and disturbances in consciousness, attention, and cognition, were seldom or never found in the nursing records. However, behaviors of the hyperactive variant of delirium and which are known to interfere with nursing care were documented more often (e.g., 13.4% restless, 10.3% fidget with materials, 7.2% annoying behavior). Both medical and nursing records showed poor documentation and under-diagnosis of delirium. However, a correct diagnosis and early recognition of delirium may enhance the management of this syndrome.
• Milisen, K., Foreman, M. D., Wouters, B., Driesen, R., Godderis, J., Abraham, I. L., & L, P. (2002). Documentation of delirium in elderly patients with hip fracture.. Journal of gerontological nursing, 28(11), 23-29.
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  PMID: 12465199;Abstract: This study determined the accuracy of diagnosis and documentation of delirium in the medical and nursing records of 55 elderly patients with hip fracture (mean age = 78.4, SD = 8.4). These records were reviewed retrospectively on a patient's discharge for diagnosis of delirium, and for description of clinical indicators or symptoms of delirium. Additionally, all patients were monitored by one of the research members on days 1, 3, 5, 8, and 12 postoperatively for signs of delirium, as measured by the Confusion Assessment Method (CAM). Clinicians were blinded to the purpose of the study. According to the CAM criteria, the incidence of delirium was 14.5% on postoperative Day 1; 9.1% on postoperative Day 3; 10.9% on postoperative Day 5; 7.7% on postoperative Day 8; and 5.6% on postoperative Day 12. For those same days, no formal diagnosis of delirium or a description of clinical indicators was found in the medical records. In the nursing records, a false-positive documentation of 8.5%, 4%, 4.1%, 4.2%, and 5.9%, respectively was noted. False-negative documentation was found in 87.5%, 80%, 66.7%, 75%, and 50% of the cases on the respective days. Documentation of essential symptoms--namely onset and course of the syndrome--and disturbances in consciousness, attention, and cognition, were seldom or never found in the nursing records. However, behaviors of the hyperactive variant of delirium and which are known to interfere with nursing care were documented more often (e.g., 13.4% restless, 10.3% fidget with materials, 7.2% annoying behavior). Both medical and nursing records showed poor documentation and under-diagnosis of delirium. However, a correct diagnosis and early recognition of delirium may enhance the management of this syndrome.
• Reel, S. J., Morgan-Judge, T., Peros, D. S., & Abraham, I. L. (2002). School-based rural case management: a model to prevent and reduce risk. Journal of the American Academy of Nurse Practitioners, 14(7), 291-6.
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  To describe the development of the School-Based Rural Case Management: A Model to Prevent and Reduce Risk in a primary health care academic nursing center practice in West Virginia.
• Reel, S. J., Morgan-Judge, T., Peros, D. S., & Abraham, I. L. (2002). School-based rural case management: a model to prevent and reduce risk.. Journal of the American Academy of Nurse Practitioners, 14(7), 291-296.
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  PMID: 12138523;Abstract: PURPOSE: To describe the development of the School-Based Rural Case Management: A Model to Prevent and Reduce Risk in a primary health care academic nursing center practice in West Virginia. DATA SOURCES: Selected nursing and anthropological literature, regional health planning documents, and case examples. CONCLUSIONS: The model guides identification of health risks and the provision of health service, health education, and support to students, families, and communities. IMPLICATIONS FOR PRACTICE: As primary health care services are developed within rural schools, a school-based case management system assists matching appropriate services to the client, as well as supports program success.
• Reel, S. J., Morgan-Judge, T., Peros, D. S., & Abraham, I. L. (2002). School-based rural case management: a model to prevent and reduce risk.. Journal of the American Academy of Nurse Practitioners, 14(Issue 7). doi:10.1111/j.1745-7599.2002.tb00128.x
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  PURPOSE: To describe the development of the School-Based Rural Case Management: A Model to Prevent and Reduce Risk in a primary health care academic nursing center practice in West Virginia. DATA SOURCES: Selected nursing and anthropological literature, regional health planning documents, and case examples. CONCLUSIONS: The model guides identification of health risks and the provision of health service, health education, and support to students, families, and communities. IMPLICATIONS FOR PRACTICE: As primary health care services are developed within rural schools, a school-based case management system assists matching appropriate services to the client, as well as supports program success.
• Macdougall, I. C., Hörl, W., Jacobs, C., Valderrábano, F., Parrondo, I., Abraham, I. L., & Peterson, A. E. (2001). The European Survey on Anaemia Management (ESAM): Indicators of current practices of anaemia care in patients with end-stage renal disease. Erythropoiesis: New Dimensions in the Treatment of Anaemia, 11(1), 3-14.
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  Abstract: There is persistent variability in the practice patterns of anaemia management in patients with end-stage renal disease. In an effort to document existing practice patterns before the introduction of the European Best Practice Guidelines (EBPG), the European Survey on Anaemia Management (ESAM) was launched in 14 Western European countries. Data were collected longitudinally for 6 months. Findings are reported on 14 527 patients, of which 13 121 (90.3%) were receiving haemodialysis and 1406 (9.7%) were receiving peritoneal dialysis. The ESAM found that epoetin treatment is most often initiated after dialysis has begun, with haemoglobin (Hb) levels (mean = 8.7 g/dl) lower than the EBPG recommendation. For target Hb, the vast majority of patients were allocated values at or exceeding the EBPG recommended level, yet in only 53.6% of patients were these targets reached at 6 months. During any given month of the survey, between 15% and 22% of haemodialysis patients and between 41% and 45% of peritoneal dialysis patients had absolute iron deficiency; however, almost 19% of haemodialysis patients and 34% of peritoneal dialysis patients received no iron supplementation during the 6-month study. The ESAM documents the significant shortfall between EBPG recommendations and de facto clinical management of anaemia in end-stage renal disease. Patients are being treated with epoetin too late in the course of their anaemia, iron supplementation is underused and target Hb levels are not being achieved.
• Milisen, K., Foreman, M. D., Abraham, I. L., De Geest, S., Godderis, J., Vandermeulen, E., Fischler, B., Delooz, H. H., Spiessens, B., & Broos, P. L. (2001). A nurse-led interdisciplinary intervention program for delirium in elderly hip-fracture patients. Journal of the American Geriatrics Society, 49(Issue 5). doi:10.1046/j.1532-5415.2001.49109.x
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  OBJECTIVES: To develop and test the effect of a nurse-led interdisciplinary intervention program for delirium on the incidence and course (severity and duration) of delirium, cognitive functioning, functional rehabilitation, mortality, and length of stay in older hip-fracture patients. DESIGN: Longitudinal prospective before/after design (sequential design). SETTING: The emergency room and two traumatological units of an academic medical center located in an urban area in Belgium. PARTICIPANTS: 60 patients in an intervention cohort (81.7% females, median age = 82, interquartile range (IQR) = 13) and another 60 patients in a usual care/nonintervention cohort (80% females, median age = 80, IQR = 12). INTERVENTION: (1) Education of nursing staff, (2) systematic cognitive screening, (3) consultative services by a delirium resource nurse, a geriatric nurse specialist, or a psychogeriatrician, and (4) use of a scheduled pain protocol. MEASUREMENTS: All patients were monitored for signs of delirium, as measured by the Confusion Assessment Method (CAM). Severity of delirium was assessed using a variant of the CAM. Cognitive and functional status were measured by the Mini-Mental State Examination (MMSE) (including subscales of memory, linguistic ability, concentration, and psychomotor executive skills) and the Katz Index of activities of daily living (ADLs), respectively. RESULTS: Although there was no significant effect on the incidence of delirium (23.3% in the control vs 20.0% in the intervention cohort; P = .82), duration of delirium was shorter (P = .03) and severity of delirium was less (P = .0049) in the intervention cohort. Further, clinically higher cognitive functioning was observed for the delirious patients in the intervention cohort compared with the nonintervention cohort. Additionally, a trend toward decreased length of stay postoperatively was noted for the delirious patients in the intervention cohort. Despite these positive intervention effects, no effect on ADL rehabilitation was found. Results for risk of mortality were inconclusive. CONCLUSIONS: This study demonstrated the beneficial effects of an intervention program focusing on early recognition and treatment of delirium in older hip-fracture patients and confirms the reversibility of the syndrome in view of the delirium's duration and severity.
• Milisen, K., Foreman, M. D., Abraham, I. L., Geest, S. D., Godderis, J., Vandermeulen, E., Fischler, B., Delooz, H. H., Spiessens, B., & L., P. (2001). A nurse-led interdisciplinary intervention program for delirium in elderly hip-fracture patients. Journal of the American Geriatrics Society, 49(5), 523-532.
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  PMID: 11380743;Abstract: OBJECTIVES: To develop and test the effect of a nurse-led interdisciplinary intervention program for delirium on the incidence and course (severity and duration) of delirium, cognitive functioning, functional rehabilitation, mortality, and length of stay in older hip-fracture patients. DESIGN: Longitudinal prospective before/after design (sequential design). SETTING: The emergency room and two traumatological units of an academic medical center located in an urban area in Belgium. PARTICIPANTS: 60 patients in an intervention cohort (81.7% females, median age = 82, interquartile range (IQR) = 13) and another 60 patients in a usual care/nonintervention cohort (80% females, median age = 80, IQR = 12). INTERVENTION: (1) Education of nursing staff, (2) systematic cognitive screening, (3) consultative services by a delirium resource nurse, a geriatric nurse specialist, or a psychogeriatrician, and (4) use of a scheduled pain protocol. MEASUREMENTS: All patients were monitored for signs of delirium, as measured by the Confusion Assessment Method (CAM). Severity of delirium was assessed using a variant of the CAM. Cognitive and functional status were measured by the Mini-Mental State Examination (MMSE) (including subscales of memory, linguistic ability, concentration, and psychomotor executive skills) and the Katz Index of activities of daily living (ADLs), respectively. RESULTS: Although there was no significant effect on the incidence of delirium (23.3% in the control vs 20.0% in the intervention cohort; P = .82), duration of delirium was shorter (P = .03) and severity of delirium was less (P = .0049) in the intervention cohort. Further, clinically higher cognitive functioning was observed for the delirious patients in the intervention cohort compared with the nonintervention cohort. Additionally, a trend toward decreased length of stay postoperatively was noted for the delirious patients in the intervention cohort. Despite these positive intervention effects, no effect on ADL rehabilitation was found. Results for risk of mortality were inconclusive. CONCLUSIONS: This study demonstrated the beneficial effects of an intervention program focusing on early recognition and treatment of delirium in older hip-fracture patients and confirms the reversibility of the syndrome in view of the delirium's duration and severity.
• Moons, P., De Geest, S., Versteven, K., Abraham, I., Vlaminck, H., Moens, G., & Waer, M. (2001). Psychometric properties of the "Modified Transplant Symptom Occurrence and Symptom Distress Scale". Journal of Nursing Measurement, 9(Issue 2). doi:10.1891/1061-3749.9.2.115
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  The aim of this study was to assess key aspects of the reliability and validity of the "Modified Transplant Symptom Occurrence and Distress Scale," an instrument measuring symptom experience associated with side effects of triple drug therapy in transplant patients. This cross-sectional, comparative study included 108 renal transplant recipients (61% men; 39% women) with a median age of 47 years and a median posttransplant status of 5.5 years. Renal transplant patients were matched by age and gender with 108 healthy control persons not taking immunosuppressive drugs. Content validity, construct validity and discriminant validity of the instrument were substantiated. Internal consistency reliability was not useful to assess in this instrument, as the conditions for calculating Cronbach's alpha were not satisfied. These findings document the validity of the "Modified Transplant Symptom Occurrence and Symptom Distress Scale" as an instrument to measure symptom experience with immunosuppressive drugs.
• Moons, P., Geest, S. D., Versteven, K., Abraham, I., Vlaminck, H., Moens, G., & Waer, M. (2001). Psychometric properties of the "Modified Transplant Symptom Occurrence and Symptom Distress Scale". Journal of Nursing Measurement, 9(2), 115-134.
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  PMID: 11696937;Abstract: The aim of this study was to assess key aspects of the reliability and validity of the "Modified Transplant Symptom Occurrence and Distress Scale," an instrument measuring symptom experience associated with side effects of triple drug therapy in transplant patients. This cross-sectional, comparative study included 108 renal transplant recipients (61% men; 39% women) with a median age of 47 years and a median posttransplant status of 5.5 years. Renal transplant patients were matched by age and gender with 108 healthy control persons not taking immunosuppressive drugs. Content validity, construct validity and discriminant validity of the instrument were substantiated. Internal consistency reliability was not useful to assess in this instrument, as the conditions for calculating Cronbach's alpha were not satisfied. These findings document the validity of the "Modified Transplant Symptom Occurrence and Symptom Distress Scale" as an instrument to measure symptom experience with immunosuppressive drugs.
• Moons, P., Siebens, K., De Geest, S., Abraham, I., Budts, W., & Gewillig, M. (2001). A pilot study of expenditures on, and utilization of resources in, health care in adults with congenital heart disease. Cardiology in the Young, 11(Issue 3). doi:10.1017/s1047951101000336
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  Background: Congenital cardiac disease may be a chronic condition, necessitating life-long follow-up for a substantial proportion of the patients. Such patients, therefore, are often presumed to be high users of resources for health care. Information on utilization of resources in adults with congenital heart disease, however, is scarce. Methods: This retrospective pilot study, performed in Belgium, investigated 192 adults with congenital heart disease to measure the annual expenditures and utilization of health care and compared the findings with data from the general population. We also sought to explore demographic and clinical parameters as predictors for the expenditures. Results: Hospitalization was documented in 20.3% of the patients, with a median length of stay of 5 days. The overall payment by health insurance associations in 1997 was 1794.5 ECU per patient, while patients paid on average 189.5 ECU out-of-pocket. For medication, the average reimbursement and out-of-pocket expenses were estimated at 78 ECU and 20 ECU, respectively. Expenditures for patients with congenital heart disease were considerably higher than the age and gender-corrected expenditures for the general population (411.7 ECU), though this difference was accounted for by only one-eighth of the cohort of those with congenital heart disease. In general, higher expenditures were associated with abnormal left ventricular end-diastolic diameter, female gender, functional impairment and higher age, although the explained variance was limited. Conclusion: Our study has provided pilot data on the economic outcomes for patients with congenital heart diseases. We have identified parameters that could predict expenditure, but which will have to be examined in future research. This is needed to develop guidelines for health insurance for those with congenital heart diseases. © Greenwich Medical Media Ltd.
• Moons, P., Siebens, K., Geest, S. D., Abraham, I., Budts, W., & Gewillig, M. (2001). A pilot study of expenditures on, and utilization of resources in, health care in adults with congenital heart disease. Cardiology in the Young, 11(3), 301-313.
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  PMID: 11388625;Abstract: Background: Congenital cardiac disease may be a chronic condition, necessitating life-long follow-up for a substantial proportion of the patients. Such patients, therefore, are often presumed to be high users of resources for health care. Information on utilization of resources in adults with congenital heart disease, however, is scarce. Methods: This retrospective pilot study, performed in Belgium, investigated 192 adults with congenital heart disease to measure the annual expenditures and utilization of health care and compared the findings with data from the general population. We also sought to explore demographic and clinical parameters as predictors for the expenditures. Results: Hospitalization was documented in 20.3% of the patients, with a median length of stay of 5 days. The overall payment by health insurance associations in 1997 was 1794.5 ECU per patient, while patients paid on average 189.5 ECU out-of-pocket. For medication, the average reimbursement and out-of-pocket expenses were estimated at 78 ECU and 20 ECU, respectively. Expenditures for patients with congenital heart disease were considerably higher than the age and gender-corrected expenditures for the general population (411.7 ECU), though this difference was accounted for by only one-eighth of the cohort of those with congenital heart disease. In general, higher expenditures were associated with abnormal left ventricular end-diastolic diameter, female gender, functional impairment and higher age, although the explained variance was limited. Conclusion: Our study has provided pilot data on the economic outcomes for patients with congenital heart diseases. We have identified parameters that could predict expenditure, but which will have to be examined in future research. This is needed to develop guidelines for health insurance for those with congenital heart diseases. © Greenwich Medical Media Ltd.
• Rosencher, N., Boucebci, K. J., Menichella, G., Kerkkamp, H., Macheras, G., Munuera, L., Barton, D., Cremers, S., & Abraham, I. (2001). Orthopaedic Surgery Transfusion Haemoglobin European Overview: The OSTEO study. Transfusion Clinique et Biologique, 8(3), 211-213.
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  PMID: 11499960;
• Rosencher, N., Boucebci, K. J., Menichella, G., Kerkkamp, H., Macheras, G., Munuera, L., Barton, D., Cremers, S., & Abraham, I. (2001). Orthopaedic surgery transfusion haemoglobin european overview: The OSTEO study (extended abstract). Transfusion Clinique et Biologique, 8(Issue 3). doi:10.1016/s1246-7820(01)00124-0
• Fulmer, T., Paveza, G., Abraham, I., & Fairchild, S. (2000). Elder neglect assessment in the emergency department. Journal of Emergency Nursing, 26(5), 436-443.
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  PMID: 11015061;
• Fulmer, T., Paveza, G., Abraham, I., & Fairchild, S. (2000). Elder neglect assessment in the emergency department. Journal of Emergency Nursing, 26(Issue 5). doi:10.1067/men.2000.110621
• Hyer, K., Fairchild, S., Abraham, I., Mezey, M., & Fulmer, T. (2000). Measuring attitudes related to interdisciplinary training: Revisiting the Heinemann, Schmitt and Farrell 'attitudes toward health care teams' scale. Journal of Interprofessional Care, 14(Issue 3). doi:10.1080/713678570
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  Findings from an exploratory factor analysis on the 21 item 'attitudes towards health care teams' (Heinemann et al., 1999) are reported. Using data collected as part of an innovative educational program on geriatric team training program in the United States we report an exploratory factor analyses for 913 student trainees. The geriatric interdisciplinary team training (GITT) program funded by a United States philanthropic foundation, The John A. Hartford Foundation of New York City, requires medicine, nursing, and social work students to learn about geriatric teams. A 3-factor solution with all 21-items is obtained. These factors are labeled to reflect normative team constructs: team value, team efficiency and shared leadership. Though conceptually these factors map onto those identified by Heinemann et al. (1999), some important philosophical and methodological differences are noted. Implications for interdisciplinary education and for the construct validity of this scale are discussed.
• Hyer, K., Fairchild, S., Abraham, I., Mezey, M., & Fulmer, T. (2000). Measuring attitudes related to interdisciplinary training: Revisiting the Heinemann, Schmitt and Farrell 'attitudes toward health care teams' scale. Journal of Interprofessional Care, 14(3), 249-258.
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  Abstract: Findings from an exploratory factor analysis on the 21 item 'attitudes towards health care teams' (Heinemann et al., 1999) are reported. Using data collected as part of an innovative educational program on geriatric team training program in the United States we report an exploratory factor analyses for 913 student trainees. The geriatric interdisciplinary team training (GITT) program funded by a United States philanthropic foundation, The John A. Hartford Foundation of New York City, requires medicine, nursing, and social work students to learn about geriatric teams. A 3-factor solution with all 21-items is obtained. These factors are labeled to reflect normative team constructs: team value, team efficiency and shared leadership. Though conceptually these factors map onto those identified by Heinemann et al. (1999), some important philosophical and methodological differences are noted. Implications for interdisciplinary education and for the construct validity of this scale are discussed.
• Jacobs, C., Horl, W. H., Macdougall, I. C., Valderrabano, F., Parrondo, I., Abraham, I. L., & Segner, A. (2000). European best practice guidelines 9-13: Anaemia management. Nephrology Dialysis Transplantation, 15(Issue 4). doi:10.1093/ndt/15.suppl_3.33
• Jacobs, C., Horl, W. H., Macdougall, I. C., Valderrabano, F., Parrondo, I., Abraham, I. L., & Segner, A. (2000). European best practice guidelines 9-13: Anaemia management. Nephrology Dialysis Transplantation, 15(SUPPL. 4), 33-42.
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  PMID: 11052147;
• Jacobs, C., Horl, W. H., Macdougall, I. C., Valderrabano, F., Parrondo, I., Segner, A., & Abraham, I. L. (2000). European best practice guidelines 5: Target haemoglobin. Nephrology Dialysis Transplantation, 15(SUPPL. 4), 15-19.
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  PMID: 11052145;
• Jacobs, C., Hörl, W. H., Macdougall, I. C., Valderrábano, F., Parrondo, I., Abraham, I. L., & Segner, A. (2000). European best practice guidelines 9-13: anaemia management. Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association, 15 Suppl 4, 33-42.
• Jacobs, C., Hörl, W. H., Macdougall, I. C., Valderrábano, F., Parrondo, I., Segner, A., & Abraham, I. L. (2000). European best practice guidelines 5: target haemoglobin. Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association, 15 Suppl 4, 15-9.
• Valderrabano, F., Horl, W. H., Jacobs, C., Macdougall, I. C., Parrondo, I., Cremers, S., & Abraham, I. L. (2000). European best practice guidelines 1-4: Evaluating anaemia and initiating treatment. Nephrology Dialysis Transplantation, 15(SUPPL. 4), 8-14.
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  PMID: 11052144;
• Valderrábano, F., Hörl, W. H., Jacobs, C., Macdougall, I. C., Parrondo, I., Cremers, S., & Abraham, I. L. (2000). European best practice guidelines 1-4: evaluating anaemia and initiating treatment. Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association, 15 Suppl 4, 8-14.
• Abraham, I. L., Bottrell, M. M., Dash, K. R., Fulmer, T. T., Mezey, M. D., O'Donnell, L., & Vince-Whitman, C. (1999). Profiling care and benchmarking best practice in care of hospitalized elderly: the Geriatric Institutional Assessment Profile.. The Nursing clinics of North America, 34(Issue 1).
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  This article reports on a new instrument, the Geriatric Institutional Assessment Profile (GIAP), developed to assess (1) hospital workers' knowledge, attitudes, and perceptions regarding care of geriatric patients, and (2) the perceived adequacy of an institutional environment to serve geriatric patients' needs. Findings are reported from 303 questionnaires completed by health care employees from a 658-bed academic medical center. Internal consistency estimates were consistently high for the various components of the GIAP. Factor analysis was performed to examine underlying dimensions of knowledge and institutional environment. The GIAP has the potential to narrow the gap between actual and best practice in geriatric care by identifying staff information needs and concerns, as well as institutional barriers and facilitators to providing quality geriatric hospital care.
• Abraham, I. L., Bottrell, M. M., Dash, K. R., Fulmer, T. T., Mezey, M. D., O'Donnell, L., & Vince-Whitman, C. (1999). Profiling care and benchmarking best practice in care of hospitalized elderly: the Geriatric Institutional Assessment Profile.. The Nursing clinics of North America, 34(1), 237-255.
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  PMID: 9922290;Abstract: This article reports on a new instrument, the Geriatric Institutional Assessment Profile (GIAP), developed to assess (1) hospital workers' knowledge, attitudes, and perceptions regarding care of geriatric patients, and (2) the perceived adequacy of an institutional environment to serve geriatric patients' needs. Findings are reported from 303 questionnaires completed by health care employees from a 658-bed academic medical center. Internal consistency estimates were consistently high for the various components of the GIAP. Factor analysis was performed to examine underlying dimensions of knowledge and institutional environment. The GIAP has the potential to narrow the gap between actual and best practice in geriatric care by identifying staff information needs and concerns, as well as institutional barriers and facilitators to providing quality geriatric hospital care.
• Abraham, I., Bollen, S., Geest, S. D., Indenkleef, S., Milisen, K., Moons, P., Steeman, E., & Wouters, B. (1999). Functional and Psychosocial Determinants of Rehospitalization in Elderly Cardiovascular Patients. European Heart Journal Supplements, 20, 547-547.
• Abraham, I., Broos, P., Delooz, H., Fischler, B., Foreman, M. D., Geest, S. D., Godderis, J., Milisen, K., & Vandermeulen, E. (1999). Early detection of delirium in elderly hip fracture patients: An intervention study. Journal of the American Geriatrics Society, 47(9).
• Abraham, I., Dunbar-jacob, J., Geest, S. D., & Vanhaecke, J. (1999). Behavioral determinants and strategies to enhance long-term survival after solid organ transplantation. Nephrology Dialysis Transplantation, 14(7), 1809-1825.
• Borgermans, L. A., Abraham, I. L., Milisen, K., Steeman, E., Dejace, A. M., Gosset, C., Rondal, P. M., & Moons, P. (1999). Case management for geriatric patients and their families: The clinical model of Belgian projects. Tijdschrift voor Geneeskunde, 55(6), 427-435.
• Hillewaere, L., Ghyselen, K., Moons, P., Steeman, E., Geest, S. D., & Abraham, I. (1999). Case management: A feasible assistance model in Belgian mental health care. Acta Hospitalia, 39(4), 33-44+85.
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  Abstract: A critical dimension of innovation in mental health care is to provide integrated care for specific target groups. This requires a vision of shared care across the facilities. Case management as an alternative care model provides a framework for guiding patients through a network of services. The practical implementation of case management depends on the specific needs of the target group and the degree in which the local facilities are fulfilling these needs. This article discusses the different case-management models described in the literature and considers the feasibility and advisability of case management in the Belgian Mental Health Care.
• Moons, P., Steeman, E., Wouters, B., Indenkleef, S., Bollen, S., Manhaeve, D., Milisen, K., Smets, K., Geest, S. D., & Abraham, I. (1999). The effectiveness of discharge management in Belgian health care: Research results of general hospitals. Acta Hospitalia, 39(4), 45-56+86.
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  Abstract: The reduction of length of stay in hospitals and the increasing trend towards extramural health care has led to emphasis being placed on the development of health care models promoting continuity of care. 'Discharge management' is structured and patient-oriented preparation for hospital discharge that expands the interdisciplinary collaboration among hospital professionals and between intra- and extramural health care workers. This study examines the effectiveness of discharge management in Belgian general hospitals in preventing rehospitalisation and institutionalisation of geriatric patients. This quasi-experimental study included 825 geriatric patients (n = 356 in the experimental group; n = 469 in the control group). For the experimental patients, discharge management was applied during hospitalisation, while the control patients received the standard preparation for discharge. Variables were measured at hospital admission, at discharge, at 14 days, and at 90 days after discharge. In the experimental group, significantly more patients were discharged to home and fewer were institutionalised than in the control group. This difference between the experimental and the control group was also observed at 14 and 90 days after discharge. Multivariate analysis showed that discharge management was, indeed, a factor in the prevention of institutionalisation. The number of rehospitalisations was not reduced. This study demonstrated that discharge management is able to reduce the rate of institutionalisation. Therefore, discharge management should be implemented for this frail patient population.
• Neese, J. B., Abraham, I. L., & Buckwalter, K. C. (1999). Utilization of mental health services among rural elderly. Archives of Psychiatric Nursing, 13(1), 30-40.
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  PMID: 10069100;Abstract: Rural elders are an undeserved and vulnerable population with compromised access to health and human services leading to premature institutionalization. Even though elders living in rural areas have psychiatric illnesses that would prompt them to use mental health services, their use of these services remains low. This study developed predictive models of psychiatric hospitalization, use of mental health services, and use of crisis intervention by rural elders participating in an outreach case-management program. A combination of demographic, health status, and organizational variables were used in stepwise multiple regression. Being married and having supplemental insurance in addition to Medicare predicted 23% of the variance for utilization of psychiatric hospitalization. Only one variable, Medicaid, predicted 14% of the variance for use of mental health services. Type of caregiver, marital status, household composition, and Medicaid insurance accounted for 23% of the variance in utilization of crisis intervention by rural elders. Overall, the two variables that most likely predicted use of psychiatric mental health services were marital status and type of insurance. Copyright © 1999 by W.B. Saunders Company.
• Neese, J. B., Abraham, I. L., & Buckwalter, K. C. (1999). Utilization of mental health services among rural elderly. Archives of Psychiatric Nursing, 13(Issue 1). doi:10.1016/s0883-9417(99)80015-6
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  Rural elders are an undeserved and vulnerable population with compromised access to health and human services leading to premature institutionalization. Even though elders living in rural areas have psychiatric illnesses that would prompt them to use mental health services, their use of these services remains low. This study developed predictive models of psychiatric hospitalization, use of mental health services, and use of crisis intervention by rural elders participating in an outreach case-management program. A combination of demographic, health status, and organizational variables were used in stepwise multiple regression. Being married and having supplemental insurance in addition to Medicare predicted 23% of the variance for utilization of psychiatric hospitalization. Only one variable, Medicaid, predicted 14% of the variance for use of mental health services. Type of caregiver, marital status, household composition, and Medicaid insurance accounted for 23% of the variance in utilization of crisis intervention by rural elders. Overall, the two variables that most likely predicted use of psychiatric mental health services were marital status and type of insurance. Copyright © 1999 by W.B. Saunders Company.
• Abraham, I., Broos, P., Milisen, K., & Wouters, B. (1998). Documentation of delirium in the nursing and medical records of elderly hip fracture patients. Journal of the American Geriatrics Society, 46(9), 117-117.
• Abraham, I., Fulmer, T., & Milisen, K. (1998). Geriatric nursing - Preface. Nursing Clinics of North America, 33(3).
• Borgermans, L. A., Abraham, I. L., Milisen, K., Dejace, A. M., Gosset, C., & Rondal, P. M. (1998). Nursing case management for psychogeriatric patients and their families: description of a clinical model.. The Nursing clinics of North America, 33(3), 529-542.
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  PMID: 9719696;Abstract: A theoretical model of clinical case management for psychogeriatric patients and their families is described. Psychogeriatric patients often have complex health care needs, requiring specific nursing interventions. The increasing frailty of these patients over time, together with the risk for institutionalization, make professional nursing contribution to their care even more desirable. Nursing case management is described by means of a conceptual-operational continuum. On the conceptual site, the continuum includes a geriatric definition and core principles of case management. On the operational site, case management is described as a clinical system, a process, a technology, and a role. The process of case management is a deliberate, intellectual activity whereby the practice of nursing is approached in an orderly, systematic manner. It includes components of assessment, diagnosis, planning, implementation, and evaluation. The case management approach requires nurses to assume an active role in designing care maps and to work collaboratively with members of a multidisciplinary team.
• De Geest, S., Abraham, I., Moons, P., Vandeputte, M., Van Cleemput, J., Evers, G., Daenen, W., & Vanhaecke, J. (1998). Late acute rejection and subclinical noncompliance with cyclosporine therapy in heart transplant recipients. Journal of Heart and Lung Transplantation, 17(Issue 9).
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  Background: Although noncompliance with immunosuppressive medication is recognized as a critical behavioral risk factor for late acute rejection episodes and graft loss after transplantation, little is known about the degree of subclinical cyclosporine noncompliance, its associated risk for acute late rejection episodes (>1 year after transplantation), and its determinants in heart transplant recipients. Methods: The convenience sample of this longitudinal study included 101 European heart transplant recipients (87 men and 14 women), with a median age of 56 (Q1 = 50, Q3 = 61) and a median posttransplantation status of 3 (range 1 to 6) years. Subclinical cyclosporine noncompliance was measured during a 3-month period with electronic event monitoring. Selected sociodemographic, behavioral, cognitive, emotional, health, and treatment-related determinants of medication noncompliance were measured by using instruments with established psychometric properties or by patient interviews. With the use of iterative partitioning methods of cluster analysis, including nonstandardized electronic event monitoring compliance parameters, patients were categorized by degree of subclinical cyclosporine noncompliance into a 3-cluster solution. Results: Overall compliance was high, with a median medication taking compliance of 99.4%. The 3 derived clusters, that is, excellent compliers (84%), minor subclinical noncompliers (7%), and moderate subclinical noncompliers (9%), differed significantly by degree of subclinical noncompliance (p < .0001) and showed a 1.19%, 14.28%, and 22.22% incidence of late acute rejections (p = .01), respectively. The 3 groups also differed in terms of former medication noncompliance (p = .02), appointment noncompliance (p = .03), and perceived self-efficacy with medication taking (p = .04). Conclusions: Although in absolute numbers cyclosporine compliance in this sample was high, minor deviations from dosing schedule were associated with an increased risk for acute late rejection episodes. This suggests a pivotal role of patient compliance in successful long-term outcome after transplantation.
• Fulmer, T., & Abraham, I. L. (1998). Rethinking geriatric nursing.. The Nursing clinics of North America, 33(3), 387-394.
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  PMID: 9719686;Abstract: Geriatric nursing has radically progressed in the past 2 decades, moving from a custodial approach, to one that is anticipatory, evidenced-based, and proactive. This article provides a brief overview on the new thinking that is shaping geriatric nursing practice. Active interventions are discussed within the interdisciplinary mandate.
• Geest, S. D., Abraham, I., Moons, P., Vandeputte, M., Cleemput, J. V., Evers, G., Daenen, W., & Vanhaecke, J. (1998). Late acute rejection and subclinical noncompliance with cyclosporine therapy in heart transplant recipients. Journal of Heart and Lung Transplantation, 17(9), 854-863.
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  PMID: 9773856;Abstract: Background: Although noncompliance with immunosuppressive medication is recognized as a critical behavioral risk factor for late acute rejection episodes and graft loss after transplantation, little is known about the degree of subclinical cyclosporine noncompliance, its associated risk for acute late rejection episodes (>1 year after transplantation), and its determinants in heart transplant recipients. Methods: The convenience sample of this longitudinal study included 101 European heart transplant recipients (87 men and 14 women), with a median age of 56 (Q1 = 50, Q3 = 61) and a median posttransplantation status of 3 (range 1 to 6) years. Subclinical cyclosporine noncompliance was measured during a 3-month period with electronic event monitoring. Selected sociodemographic, behavioral, cognitive, emotional, health, and treatment-related determinants of medication noncompliance were measured by using instruments with established psychometric properties or by patient interviews. With the use of iterative partitioning methods of cluster analysis, including nonstandardized electronic event monitoring compliance parameters, patients were categorized by degree of subclinical cyclosporine noncompliance into a 3-cluster solution. Results: Overall compliance was high, with a median medication taking compliance of 99.4%. The 3 derived clusters, that is, excellent compliers (84%), minor subclinical noncompliers (7%), and moderate subclinical noncompliers (9%), differed significantly by degree of subclinical noncompliance (p < .0001) and showed a 1.19%, 14.28%, and 22.22% incidence of late acute rejections (p = .01), respectively. The 3 groups also differed in terms of former medication noncompliance (p = .02), appointment noncompliance (p = .03), and perceived self-efficacy with medication taking (p = .04). Conclusions: Although in absolute numbers cyclosporine compliance in this sample was high, minor deviations from dosing schedule were associated with an increased risk for acute late rejection episodes. This suggests a pivotal role of patient compliance in successful long-term outcome after transplantation.
• Geest, S. D., Renteln-Kruse, W. v., Steeman, E., Degraeve, S., & Abraham, I. L. (1998). Compliance issues with the geriatric population: complexity with aging.. The Nursing clinics of North America, 33(3), 467-480.
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  PMID: 9719692;Abstract: Nonadherence with the prescribed treatment regimen is a major issue in health care. This article focuses specifically on adherence issues in the geriatric population. The strengths and weaknesses of measurement methods to assess nonadherence with medication regimens are discussed. Determinants of noncompliance with special emphasis on risk factors for geriatric patients are described. Finally, an overview of preventative and restorative compliance interventions is given.
• Milisen, K., Abraham, I. L., & Broos, P. L. (1998). Postoperative variation in neurocognitive and functional status in elderly hip fracture patients. Journal of Advanced Nursing, 27(Issue 1). doi:10.1046/j.1365-2648.1998.00491.x
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  Regaining independence in the performance of activities of daily living (ADL) is a nursing priority in the postoperative care of hip fracture patients, though often impeded by a temporary yet reversible decrease in cognitive status postoperatively. This study investigated the incidence and evolution of decreased cognitive status in geriatric hip fracture patients from admission through to the fifth postoperative day, and the relationship between cognitive abilities and functional (ADL) status. Twenty-six elderly hip fracture patients (f: 21, m: 5) with a mean age of 79·5 years (SD = 8·2) admitted to the emergency room of an academic medical centre were monitored longitudinally from admission until the fifth postoperative day regarding neurocognitive status and ADL status, as measured by the mini-mental state exam (MMSE; including subscales of memory, linguistic ability, concentration and psychomotor executive skills) and an adapted version of the Katz ADL-scale, respectively. Patients were categorized on the basis of cognitive status as follows: no cognitive impairment (MMSE≥24), moderate (MMSE≤23 but ≥ 18) and severe impairment (MMSE≤17). Nineteen of the 26 patients (73·1%) showed cognitive impairment (MMSE≥23) at some point in time before and/or after surgery. Some improvement in cognitive status was observed yet only selectively across patient cohorts and neurocognitive dimensions. Cognitive status, especially memorial ability and psychomotor executive skills, seemed to be most vulnerable to becoming impaired after hip fracture surgery. A relationship was found between cognitive and functional status, specifically, strong associations between memory and psychomotor skills relative to ADL and modest associations between linguistic ability and concentration relative to ADL. Further, patients with decreased cognitive status postoperatively remained more ADL-dependent than non-impaired patients. This study underscores the importance of a systematic assessment of the cognitive status of elderly hip fracture patients and linking these observations to functional ability in order to enhance the postoperative rehabilitation of this patient group.
• Milisen, K., Abraham, I. L., & L., P. (1998). Postoperative variation in neurocognitive and functional status in elderly hip fracture patients. Journal of Advanced Nursing, 27(1), 59-67.
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  PMID: 9515609;Abstract: Regaining independence in the performance of activities of daily living (ADL) is a nursing priority in the postoperative care of hip fracture patients, though often impeded by a temporary yet reversible decrease in cognitive status postoperatively. This study investigated the incidence and evolution of decreased cognitive status in geriatric hip fracture patients from admission through to the fifth postoperative day, and the relationship between cognitive abilities and functional (ADL) status. Twenty-six elderly hip fracture patients (f: 21, m: 5) with a mean age of 79·5 years (SD = 8·2) admitted to the emergency room of an academic medical centre were monitored longitudinally from admission until the fifth postoperative day regarding neurocognitive status and ADL status, as measured by the mini-mental state exam (MMSE; including subscales of memory, linguistic ability, concentration and psychomotor executive skills) and an adapted version of the Katz ADL-scale, respectively. Patients were categorized on the basis of cognitive status as follows: no cognitive impairment (MMSE≥24), moderate (MMSE≤23 but ≥ 18) and severe impairment (MMSE≤17). Nineteen of the 26 patients (73·1%) showed cognitive impairment (MMSE≥23) at some point in time before and/or after surgery. Some improvement in cognitive status was observed yet only selectively across patient cohorts and neurocognitive dimensions. Cognitive status, especially memorial ability and psychomotor executive skills, seemed to be most vulnerable to becoming impaired after hip fracture surgery. A relationship was found between cognitive and functional status, specifically, strong associations between memory and psychomotor skills relative to ADL and modest associations between linguistic ability and concentration relative to ADL. Further, patients with decreased cognitive status postoperatively remained more ADL-dependent than non-impaired patients. This study underscores the importance of a systematic assessment of the cognitive status of elderly hip fracture patients and linking these observations to functional ability in order to enhance the postoperative rehabilitation of this patient group.
• Milisen, K., Foreman, M. D., Godderis, J., Abraham, I. L., & Broos, P. L. (1998). Delirium in the hospitalized elderly: nursing assessment and management.. The Nursing clinics of North America, 33(3), 417-439.
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  PMID: 9719689;Abstract: Delirium is a serious health problem with significant negative consequences which is experienced by many hospitalized elderly patients. Because of its clinical impact and potential reversibility, prompt treatment of delirium is essential. Therefore an understanding of delirium, its manifestations, methods of detection, prevention, and treatment in hospitalized elderly patients is needed. This article provides an overview of the diagnostic and therapeutic dilemmas of delirium.
• Moons, P., De Geest, S., Abraham, I., Van Cleemput, J., & Vanhaecke, J. (1998). Symptom experience associated with maintenance immunosuppression after heart transplantation: Patients' appraisal of side effects. Heart and Lung: Journal of Acute and Critical Care, 27(Issue 5). doi:10.1016/s0147-9563(98)90052-8
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  OBJECTIVE: To evaluate symptom experience related to side effects of immunosuppressive therapy in heart transplant recipients. METHODS: This descriptive, cross-sectional study included 105 heart transplant recipients (90 men; 15 women) with a median age of 56 years. Maintenance immunosuppression consisted of triple therapy (cyclosporine, corticosteroids, azathioprine). Symptom frequency and symptom distress were assessed by an adapted version of the Transplant Symptom Frequency and Symptom Distress Scale, which includes 27 symptoms associated with side effects of immunosuppressive therapy. RESULTS: The most frequent symptom for both sexes was increased hair growth. Impotence and painful menstruation were experienced as the most distressing symptoms for men and women, respectively. Women reported a significantly higher level of symptom experience. The majority of the most frequent and most distressing symptoms were corticosteroid associated. CONCLUSIONS: Patients' Perception of side effects completes the symptomatologic profile of immunosuppressive therapy. A gender- specific evaluation is indicated because symptom experience differs between the sexes.
• Moons, P., Geest, S. D., Abraham, I., Cleemput, J. V., & Vanhaecke, J. (1998). Symptom experience associated with maintenance immunosuppression after heart transplantation: Patients' appraisal of side effects. Heart and Lung: Journal of Acute and Critical Care, 27(5), 315-325.
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  PMID: 9777377;Abstract: OBJECTIVE: To evaluate symptom experience related to side effects of immunosuppressive therapy in heart transplant recipients. METHODS: This descriptive, cross-sectional study included 105 heart transplant recipients (90 men; 15 women) with a median age of 56 years. Maintenance immunosuppression consisted of triple therapy (cyclosporine, corticosteroids, azathioprine). Symptom frequency and symptom distress were assessed by an adapted version of the Transplant Symptom Frequency and Symptom Distress Scale, which includes 27 symptoms associated with side effects of immunosuppressive therapy. RESULTS: The most frequent symptom for both sexes was increased hair growth. Impotence and painful menstruation were experienced as the most distressing symptoms for men and women, respectively. Women reported a significantly higher level of symptom experience. The majority of the most frequent and most distressing symptoms were corticosteroid associated. CONCLUSIONS: Patients' Perception of side effects completes the symptomatologic profile of immunosuppressive therapy. A gender- specific evaluation is indicated because symptom experience differs between the sexes.
• Onega, L. L., & Abraham, I. L. (1998). Differentiated nursing assessment of depressive symptoms in community-dwelling elders.. The Nursing clinics of North America, 33(3), 407-416.
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  PMID: 9719688;Abstract: Because of the complexity in assessing elders for depressive symptoms, we recommend that nurses use a differentiated approach as an adjunct to clinical judgment and other assessment strategies. Based on our research and clinical experience, we advocate the joint use of the Hamilton Rating Scale for Depression and the Dementia Mood Assessment Scale, and propose a two-tiered assessment process. The first differentiation in this process is made by means of a cut-off score to determine whether or not depressive symptoms exist. If depressive symptoms are present, a second system of differentiation may be employed to identify discrete symptom factors. Application of this differentiated approach will enable the nurse to better understand and design interventions for each elder's specific presentation of depressive symptoms.
• Smith, M., Buckwalter, K. C., Hirsch, M., Abraham, I., Mitchell, S., & Kreiter, C. (1998). From the rural midwest to the rural Southeast: Evaluation of the generalizability of a successful geriatric mental health training program. Journal of Mental Health and Aging, 4(Issue 1).
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  The care of mentally ill persons residing in long-term-care (LTC) facilities is a matter of great and on-going concern. Day-to-day care providers in nursing homes and other LTC settings too often lack skills to understand and manage behavioral symptoms. Geriatric mental health training programs that address the diverse needs of staff and patients are needed to improve the quality of care provided. This project explored the generalizability of a geriatric mental health training program that was used successfully with a culturally homogeneous group of LTC providers in the rural Midwest. Program materials and training approaches, including both a direct-training and a train-the-trainer format, were further evaluated with culturally and educationally diverse LTC staff in the rural Southeast. Findings suggest that the training materials were perceived as useful and relevant, but that the training methods used to train staff must be tailored to the population's individual needs.
• Holroyd, S., Currie, L., Thompson-Heisterman, A., & Abraham, I. (1997). A descriptive study of elderly community-dwelling alcoholic patients in the rural South. American Journal of Geriatric Psychiatry, 5(3), 221-228.
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  PMID: 9209564;Abstract: Alcohol-related disorders, estimated to be more prevalent in the South, are associated with serious comorbid disorders, such as depression and suicide. In a rural outreach program, the authors examined patients with a diagnosis of alcoholism and compared them with nonalcoholic patients on various demographic and descriptive variables. Of 166 patients referred to the program, 35 (21.1%) had an alcohol-related disorder. Alcoholism was significantly associated with male gender and younger age, but nearly half of the alcoholic subjects were women. Alcoholism is associated with inappropriate health care utilization; alcohol-related disorders produced significantly more emergency room visits and somewhat more hospital admission; these patients were less likely to have a primary care physician. No patient was receiving treatment for alcoholism.
• Holroyd, S., Currie, L., Thompson-Heisterman, A., & Abraham, I. (1997). A descriptive study of elderly community-dwelling alcoholic patients in the rural South. American Journal of Geriatric Psychiatry, 5(Issue 3). doi:10.1097/00019442-199700530-00006
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  Alcohol-related disorders, estimated to be more prevalent in the South, are associated with serious comorbid disorders, such as depression and suicide. In a rural outreach program, the authors examined patients with a diagnosis of alcoholism and compared them with nonalcoholic patients on various demographic and descriptive variables. Of 166 patients referred to the program, 35 (21.1%) had an alcohol-related disorder. Alcoholism was significantly associated with male gender and younger age, but nearly half of the alcoholic subjects were women. Alcoholism is associated with inappropriate health care utilization; alcohol-related disorders produced significantly more emergency room visits and somewhat more hospital admission; these patients were less likely to have a primary care physician. No patient was receiving treatment for alcoholism.
• Kresevic, D. M., Mezey, M., Abraham, I., Amella, E., Bottrell, M., Ebersole, P., Fletcher, K., Foreman, M. D., Fulmer, T., Lee, A., Mion, L., Naylor, M. D., Vince, C., Walker, M., & Wykle, M. (1997). Assessment of function: Critically important to acute care of elders. Geriatric Nursing, 18(5), 216-222.
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  PMID: 9362663;Abstract: Assessment of functional status in hospitalized elders provides essential information that can assist maintenance or restoration of self-care. Nurses in acute care settings are in a pivotal position to assess function and target interventions to prevent loss of function and maintain an individual's self-care ability. This article discusses critical issues in the functional assessment of hospitalized elders and provides a clinical practice protocol that includes nursing care strategies to prevent functional decline during hospitalisation and assist with discharge planning.
• Kresevic, D. M., Mezey, M., Abraham, I., Amella, E., Bottrell, M., Ebersole, P., Fletcher, K., Foreman, M. D., Fulmer, T., Lee, A., Mion, L., Naylor, M. D., Vince, C., Walker, M., & Wykle, M. (1997). Assessment of function: Critically important to acute care of elders. Geriatric Nursing, 18(Issue 5). doi:10.1016/s0197-4572(97)90095-1
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  Assessment of functional status in hospitalized elders provides essential information that can assist maintenance or restoration of self-care. Nurses in acute care settings are in a pivotal position to assess function and target interventions to prevent loss of function and maintain an individual's self-care ability. This article discusses critical issues in the functional assessment of hospitalized elders and provides a clinical practice protocol that includes nursing care strategies to prevent functional decline during hospitalisation and assist with discharge planning.
• Kurlowicz, L. H., Abraham, I., Amella, E. J., Bottrell, M., Ebersole, P., Fletcher, K., Foreman, M. D., Fulmer, T., Kresevic, D. M., Lee, A., Mezey, M., Mion, L. C., Naylor, M. D., Simon, L., Vince, C., Walker, M., & Wykle, M. (1997). Nursing standard of practice protocol: Depression in elderly patients. Geriatric Nursing, 18(5), 192-200.
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  PMID: 9362660;Abstract: Depression is a highly prevalent but underrecognized and undertreated mental health problem in community-dwelling, medically ill, and institutionalized older adults. Untreated depression is associated with serious negative consequences for the elderly patient. Nurses in various practice settings can reduce the negative effects of depression through early recognition, intervention, and referral of patients with depression. This article presents an overview of depression in late life with emphasis on age-related assessment considerations, clinical decision-making, and nursing intervention strategies for elders with depression. A standard of practice protocol for use by nurses in a variety of practice settings is also presented.
• Kurlowicz, L. H., Abraham, I., Amella, E. J., Bottrell, M., Ebersole, P., Fletcher, K., Foreman, M. D., Fulmer, T., Kresevic, D. M., Lee, A., Mezey, M., Mion, L. C., Naylor, M. D., Simon, L., Vince, C., Walker, M., & Wykle, M. (1997). Nursing standard of practice protocol: Depression in elderly patients. Geriatric Nursing, 18(Issue 5). doi:10.1016/s0197-4572(97)90092-6
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  Depression is a highly prevalent but underrecognized and undertreated mental health problem in community-dwelling, medically ill, and institutionalized older adults. Untreated depression is associated with serious negative consequences for the elderly patient. Nurses in various practice settings can reduce the negative effects of depression through early recognition, intervention, and referral of patients with depression. This article presents an overview of depression in late life with emphasis on age-related assessment considerations, clinical decision-making, and nursing intervention strategies for elders with depression. A standard of practice protocol for use by nurses in a variety of practice settings is also presented.
• Neese, J. B., & Abraham, I. L. (1997). Cluster analysis of psychogeriatric characteristics and service use among rural elders. Issues in Mental Health Nursing, 18(1), 1-18.
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  PMID: 9052097;Abstract: In developing models of psychiatric service delivery, nurses must be able to target groups on the basis of their health status and service needs. This investigation attempted to develop profiles of rural elderly, a significant risk population, by subjecting data on the psychogeriatric nursing status and health services utilization of 125 subjects to cluster-analytic methods. The cluster analysis yielded a three-cluster model: Cluster 1 (n = 39) predominantly comprised unmarried women in moderate health, but with a high degree of health service utilization; Cluster 2 (n = 53) had rural elders with moderate physical impairments, self-perceptions of poor health, and moderate health service utilization; and Cluster 3 (n = 33) comprised elders with severe cognitive and physical impairments and high health service utilization. Cluster 2 subjects were judged to be mild users of services because they were younger and married without a regular source of health care. Because subjects in Cluster 1 tended to be unmarried women who lived alone, with mild to moderate physical impairments and a regular source of health care, these subjects were assessed as moderate users of services. Cluster 3, which comprised the oldest and most impaired, both physically and cognitively, were judged to be intensive users of services.
• Neese, J. B., & Abraham, I. L. (1997). Cluster analysis of psychogeriatric characteristics and service use among rural elders. Issues in Mental Health Nursing, 18(Issue 1). doi:10.3109/01612849709006536
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  In developing models of psychiatric service delivery, nurses must be able to target groups on the basis of their health status and service needs. This investigation attempted to develop profiles of rural elderly, a significant risk population, by subjecting data on the psychogeriatric nursing status and health services utilization of 125 subjects to cluster-analytic methods. The cluster analysis yielded a three-cluster model: Cluster 1 (n = 39) predominantly comprised unmarried women in moderate health, but with a high degree of health service utilization; Cluster 2 (n = 53) had rural elders with moderate physical impairments, self-perceptions of poor health, and moderate health service utilization; and Cluster 3 (n = 33) comprised elders with severe cognitive and physical impairments and high health service utilization. Cluster 2 subjects were judged to be mild users of services because they were younger and married without a regular source of health care. Because subjects in Cluster 1 tended to be unmarried women who lived alone, with mild to moderate physical impairments and a regular source of health care, these subjects were assessed as moderate users of services. Cluster 3, which comprised the oldest and most impaired, both physically and cognitively, were judged to be intensive users of services.
• Onega, L. L., & Abraham, I. L. (1997). Factor structure of the Hamilton rating scale for depression in a cohort of community-dwelling elderly. International Journal of Geriatric Psychiatry, 12(7), 760-764.
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  PMID: 9251940;Abstract: We examined the factor structure of the 17-item Hamilton Rating Scale for Depression (HRS-D) in 206 community-dwelling elderly patients. Using principal components analysis and quartimax rotation, a four-factor structure involving all 17 items and accounting for 57.7% of the variance was derived. The factors represented the following dimensions of depressive symptomatology and illness: depressed affect, vegetative symptoms, anxiety, and agitation/insight. This factor structure reflects the presentation of depressive symptomatology and depressive illness in this population. Findings suggest that the HRS-D can be used for clinical assessment of depressive symptomatology along major dimensions of depressive illness in community-dwelling elderly.
• Onega, L. L., & Abraham, I. L. (1997). Factor structure of the Hamilton rating scale for depression in a cohort of community-dwelling elderly. International Journal of Geriatric Psychiatry, 12(Issue 7). doi:10.1002/(sici)1099-1166(199707)12:7<760::aid-gps636>3.0.co;2-p
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  We examined the factor structure of the 17-item Hamilton Rating Scale for Depression (HRS-D) in 206 community-dwelling elderly patients. Using principal components analysis and quartimax rotation, a four-factor structure involving all 17 items and accounting for 57.7% of the variance was derived. The factors represented the following dimensions of depressive symptomatology and illness: depressed affect, vegetative symptoms, anxiety, and agitation/insight. This factor structure reflects the presentation of depressive symptomatology and depressive illness in this population. Findings suggest that the HRS-D can be used for clinical assessment of depressive symptomatology along major dimensions of depressive illness in community-dwelling elderly.
• Onega, L. L., & Abraham, I. L. (1997). Factor structure of the dementia mood assessment scale in a cohort of community-dwelling elderly. International Psychogeriatrics, 9(4), 449-457.
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  PMID: 9549594;Abstract: We examined the factor structure of the 28-item Dementia Mood Assessment Scale (DMAS), an instrument to assess depressive symptoms in older adults with cognitive impairment, in a cohort of 165 community-dwelling elderly with varying degrees of cognitive impairment. Factor analysis using principal components analysis and varimax rotation was performed to explore the presence of subscales and examine construct validity. A five-factor structure involving all 28 items accounting for 63.2% of the variance in the DMAS scores was derived. Factors were named: Depressed Affect, Environmental Interaction, DiurnalPattems, Agitation/Suspicion, and Somatic Indicators. This factor structure reflects the often differing presentations of depressive symptoms in older adults with varying degrees of cognitive function and establishes the construct validity of the DMAS in this population. We conclude that the DMAS may be used for differentiated clinical assessment of depressive symptoms along major dimensions of depressive illness in this cohort of elderly.
• Onega, L. L., & Abraham, I. L. (1997). Factor structure of the dementia mood assessment scale in a cohort of community-dwelling elderly. International Psychogeriatrics, 9(Issue 4). doi:10.1017/s1041610297004584
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  We examined the factor structure of the 28-item Dementia Mood Assessment Scale (DMAS), an instrument to assess depressive symptoms in older adults with cognitive impairment, in a cohort of 165 community-dwelling elderly with varying degrees of cognitive impairment. Factor analysis using principal components analysis and varimax rotation was performed to explore the presence of subscales and examine construct validity. A five-factor structure involving all 28 items accounting for 63.2% of the variance in the DMAS scores was derived. Factors were named: Depressed Affect, Environmental Interaction, DiurnalPattems, Agitation/Suspicion, and Somatic Indicators. This factor structure reflects the often differing presentations of depressive symptoms in older adults with varying degrees of cognitive function and establishes the construct validity of the DMAS in this population. We conclude that the DMAS may be used for differentiated clinical assessment of depressive symptoms along major dimensions of depressive illness in this cohort of elderly.
• Steeman, E., Abraham, I. L., & Godderis, J. (1997). Risk profiles for institutionalization in a cohort of elderly people with dementia or depression. Archives of Psychiatric Nursing, 11(6), 295-303.
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  PMID: 9419921;Abstract: Seventy-five elderly persons with dementia or depression, served by a nursing outreach assessment and case management service in Belgium, were entered in a risk profiling study. Cluster analysis yielded three clusters, each presenting a different risk profile for institutionalization: (1) High Risk Profile, with subjects of moderately advanced age, highly dependent for activities of daily living (ADL), with severe cognitive impairment, poor communication skills, and behavioral problems; (2) Moderate Risk Profile, with subjects of advanced age, limited ADL-dependency, yet high care demands for Instrumental ADL (IADL), moderate to severe cognitive impairment, adequate communication competency, and some behavioral problems; and (3) Low Risk Profile, consisting of relatively young elderly, partially ADL and IADL-dependent, mild or no cognitive impairment, good communication abilities, and no particular behavioral problems. Copyright © 1997 by W.B. Saunders Company.
• Talsma, A., & Abraham, I. L. (1997). Nursing and health care for an aging society: the case of The Netherlands.. Journal of gerontological nursing, 23(9), 37-44.
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  PMID: 9355483;Abstract: 1. Demographic developments in European and western countries are not unique. Nurses should embrace the opportunity to learn from each others' care and research initiatives for the elderly population. 2. Current transitions in health care systems should be seized as an opportunity to further establish and develop the nursing profession, for example, through joining and initiating multidisciplinary initiatives. 3. The aging population is the fastest growing population in a number of countries. The training, recruitment, and retainment of nursing staff are key to continuously provide high quality care for the elderly.
• Borgermans, L., Milisen, K., Dejace, A., Gosset, C., Rondal, P., & Abraham, I. (1996). Case management for psychogeriatric patients: The case manager. Acta Hospitalia, 36(4), 19-27.
• Borgermans, L., Milisen, K., Dejace, A., Gosset, C., Rondal, P., & Abraham, I. (1996). Case management for psychogeriatric patients: Theoretical aspects of a demonstration project for nursing personnel. Acta Hospitalia, 36(4), 5-18.
• Chalifoux, Z., Neese, J. B., Buckwalter, K. C., Litwak, E., & Abraham, I. L. (1996). Mental health services for rural elderly: Innovative service strategies. Community Mental Health Journal, 32(5), 463-480.
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  PMID: 8891413;Abstract: This paper reviews issues in planning and delivering mental health services to rural dwelling elderly. First, comparative data on the prevalence of mental illness among rural elderly, and the availability and accessibility of mental health services in rural areas are presented to provide a basis for subsequent discussion. Next, several strategies for improving the development and delivery of geriatric mental health services to rural areas are discussed. These include: increasing the number and quality of rural mental health providers; adapting or developing diagnostic techniques to improve case identification among rural elderly; providing culturally sensitive mental health services; strengthening informal and formal care linkages in rural communities; developing innovative service delivery models building upon the strengths of rural settings; and emphasizing fluidity as well as continuity in treatment models.
• De Geest, S., Abraham, I., & Dunbar-Jacob, J. (1996). Measuring Transplant Patients' Compliance with Immunosuppressive Therapy. Western Journal of Nursing Research, 18(Issue 5). doi:10.1177/019394599601800509
• Geest, S. D., Abraham, I., & Dunbar-Jacob, J. (1996). Measuring Transplant Patients' Compliance with Immunosuppressive Therapy. Western Journal of Nursing Research, 18(5), 595-605.
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  PMID: 8918210;
• Goossen, W. T., Epping, P. J., & Abraham, I. L. (1996). Classification systems in nursing: Formalizing nursing knowledge and implications for nursing information systems. Methods of Information in Medicine, 35(1), 59-71.
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  PMID: 8992226;Abstract: The development of nursing information systems (NIS) is often hampered by the fact that nursing lacks a unified nursing terminology and classification system. Currently there exist various initiatives in this area. We address the question as to how current initiatives in the development of nursing terminology and classification systems can contribute towards the development of NIS. First, the rationale behind the formalization of nursing knowledge is discussed. Next, using a framework for nursing information processing, the most important developments in the field of nursing on formalization, terminology and classification are critically reviewed. The initiatives discussed include nursing terminology projects in several countries, and the International Classification of Nursing Practice. Suggestions for further developments in the area are discussed. Finally, implications for NIS are presented, as well as the relationships of these components to other sections of an integrated computerized patient record.
• Goossen, W. T., Epping, P. J., & Abraham, I. L. (1996). Classification systems in nursing: Formalizing nursing knowledge and implications for nursing information systems. Methods of Information in Medicine, 35(Issue 1). doi:10.1055/s-0038-1634633
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  The development of nursing information systems (NIS) is often hampered by the fact that nursing lacks a unified nursing terminology and classification system. Currently there exist various initiatives in this area. We address the question as to how current initiatives in the development of nursing terminology and classification systems can contribute towards the development of NIS. First, the rationale behind the formalization of nursing knowledge is discussed. Next, using a framework for nursing information processing, the most important developments in the field of nursing on formalization, terminology and classification are critically reviewed. The initiatives discussed include nursing terminology projects in several countries, and the International Classification of Nursing Practice. Suggestions for further developments in the area are discussed. Finally, implications for NIS are presented, as well as the relationships of these components to other sections of an integrated computerized patient record.
• Goossen, W. T., Epping, P. J., Abraham, I. L., Dassen, T. W., & Hasman, A. (1996). Problems with nursing information systems: Are there solutions?. Studies in Health Technology and Informatics, 34, 872-876.
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  Abstract: The use of information systems in health care is widespread in the Netherlands, and nurses are confronted with these systems on many sites and occasions. However, the computerised support of the nursing process - the core of nursing care delivering activities - is limited to a few sites. This situation calls for an analysis of the problems that exist in the development and use of Nursing Information Systems (NISs). Possible solutions are suggested for an adequate use of information systems by Dutch nurses. A reference model for a proper course of action in the development and use of NISs is proposed. © The authors 1996.
• Holroyd, S., Currie, L. J., & Abraham, I. L. (1996). Aggression in a rural psychogeriatric outreach program. International Journal of Geriatric Psychiatry, 11(6), 529-533.
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  Abstract: A rural, community-dwelling group of elders referred to a psychogeriatric outreach program were examined for presence of aggressive behaviors. Aggressive patients were compared to non-aggressive patients on the following variables: age, sex, presence of hallucinations and delusions, alcohol use, cognition score, score on Hamilton Depression Scale, physical and instrumental activity of daily living (ADL) scores, general health and quality of life. Of one hundred and fifty-eight patients, 19 (12%) exhibited aggressive behavior. Aggression was significantly associated with presence of hallucinations (p < 0.0001), delusions (p = 0.004), lower physical (p = 0.004), instrumental activity of daily living scores (p < 0.0001) and diagnosis of dementia versus other psychiatric diagnoses. However, lower cognitive score, depressive symptoms, age, gender, alcohol use, quality of life and general health did not differ between aggressive and non-aggressive patients. Aggression is not uncommon in community-dwelling elders in a rural psychogeriatric program. Careful evaluation for treatment of psychotic symptoms should be done in aggressive elders.
• Holroyd, S., Currie, L. J., & Abraham, I. L. (1996). Aggression in a rural psychogeriatric outreach program. International Journal of Geriatric Psychiatry, 11(Issue 6). doi:10.1002/(sici)1099-1166(199606)11:6<529::aid-gps353>3.0.co;2-w
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  A rural, community-dwelling group of elders referred to a psychogeriatric outreach program were examined for presence of aggressive behaviors. Aggressive patients were compared to non-aggressive patients on the following variables: age, sex, presence of hallucinations and delusions, alcohol use, cognition score, score on Hamilton Depression Scale, physical and instrumental activity of daily living (ADL) scores, general health and quality of life. Of one hundred and fifty-eight patients, 19 (12%) exhibited aggressive behavior. Aggression was significantly associated with presence of hallucinations (p < 0.0001), delusions (p = 0.004), lower physical (p = 0.004), instrumental activity of daily living scores (p < 0.0001) and diagnosis of dementia versus other psychiatric diagnoses. However, lower cognitive score, depressive symptoms, age, gender, alcohol use, quality of life and general health did not differ between aggressive and non-aggressive patients. Aggression is not uncommon in community-dwelling elders in a rural psychogeriatric program. Careful evaluation for treatment of psychotic symptoms should be done in aggressive elders.
• Milisen, K., Borgermans, L., Dejace, A., Gosset, C., Steeman, E., Indenkleef, S., Rondal, P., & Abraham, I. (1996). Case management for psychogeriatric patients: Health condition of these elderly patients and the burden for their caretakers. Acta Hospitalia, 36(4), 29-40.
• Wasserbauer, L. I., Arrington, D. T., & Abraham, I. L. (1996). Using elderly volunteers to care for the elderly: opportunities for nursing.. Nursing economic$, 14(4), 232-238.
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  PMID: 8826311;Abstract: A growing population of educated and skilled younger retirees may help provide volunteer services to the growing population of frail elderly in homes, hospitals, and community agencies. Nursing professionals are in key positions to provide insight and guidance in the development of programs that offer new opportunities for older volunteers. Program structures that encourage collaboration, cooperation, and innovation among professionals and volunteers have the potential to increase health care services while decreasing economic challenges.
• Abraham, I. L., Chalifoux, Z. L., Evers, G. C., & De Geest, S. (1995). Conditions, interventions, and outcomes in nursing research: a comparative analysis of North American and European/ International journals (1981-1990). International Journal of Nursing Studies, 32(Issue 2). doi:10.1016/0020-7489(94)00030-n
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  This study compared the conceptual foci and methodological characteristics of research projects which tested the effects of nursing interventions, published in four general nursing research journals with predominantly North American, and two with predominantly European/International authorship and readership. Dimensions and variables of comparison included: nature of subjects, design issues, statistical methodology, statistical power, and types of interventions and outcomes. Although some differences emerged, the most striking and consistent finding was that there were no statistically significant differences (and thus similarities) in the content foci and methodological parameters of the intervention studies published in both groups of journals. We conclude that European/International and North American nursing intervention studies, as reported in major general nursing research journals, are highly similar in the parameters studied, yet in need of overall improvement. Certainly, there is no empirical support for the common (explicit or implicit). © 1995.
• Abraham, I. L., Chalifoux, Z. L., Evers, G. C., & Geest, S. D. (1995). Conditions, interventions, and outcomes in nursing research: a comparative analysis of North American and European/ International journals (1981-1990). International Journal of Nursing Studies, 32(2), 173-187.
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  PMID: 7790157;Abstract: This study compared the conceptual foci and methodological characteristics of research projects which tested the effects of nursing interventions, published in four general nursing research journals with predominantly North American, and two with predominantly European/International authorship and readership. Dimensions and variables of comparison included: nature of subjects, design issues, statistical methodology, statistical power, and types of interventions and outcomes. Although some differences emerged, the most striking and consistent finding was that there were no statistically significant differences (and thus similarities) in the content foci and methodological parameters of the intervention studies published in both groups of journals. We conclude that European/International and North American nursing intervention studies, as reported in major general nursing research journals, are highly similar in the parameters studied, yet in need of overall improvement. Certainly, there is no empirical support for the common (explicit or implicit). © 1995.
• Abraham, I., & Borgermans, L. (1995). Coordinating community care. Multidisciplinary teams and care management. Health Policy, 33(3), 234-236. doi:10.1016/0168-8510(95)90045-4
• De Geest, S., Borgermans, L., Gemoets, H., Abraham, I., Vlaminck, H., Evers, G., & Vanrenterghem, Y. (1995). Incidence, determinants, and consequences of subclinical noncompliance with immunosuppressive therapy in renal transplant recipients. Transplantation, 59(Issue 3). doi:10.1097/00007890-199502150-00006
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  In this descriptive cross-sectional study, we investigated the incidence, determinants, and consequences of subclinical noncompliance with immunosuppressive therapy in 150 adult renal transplant recipients with more than one year posttransplant status. Symptom frequency and symptom distress, and self-care agency were measured by the Transplant Symptom Frequency and Symptom Distress Scale, and the Appraisal for Self-Care Agency Scale, respectively. The Long-Term Medication Behavior Self-Efficacy Scale and a renal transplant knowledge questionnaire were developed as part of this study to measure perceived self-efficacy and knowledge of the therapeutic regimen. Demographic variables were also measured. The incidence of subclinical noncompliance with immunosuppressive therapy as assessed by interview was 22.3%. Compliers and noncompliers differed significantly on the variables of marital status (P=0.03), situational-operational knowledge (P=0.02), self-care agency (P=0.03), and perceived self-efficacy related to long-term medication intake (P=0.048). A logistic regression model using gender, marital status, perceived self-efficacy, self-care agency, knowledge about medication administration and signs of infection, and situational operational knowledge as predictor variables, revealed a 78.6% correct classification of compliers versus noncompliers and a sensitivity ratio of 95.9% There were significantly more acute late rejection episodes (P=0.003) in the noncompliant group. Graft survival at 5 years in this group was also significantly low'er (P=0.03) than the compliant patients. No significant difference was found in terms of the occurrence of chronic rejection episodes or in terms of patient survival at 5 years. Because noncompliance is a risk factor for negative clinical outcome in renal transplant recipients, it is of utmost importance to develop intervention strategies to enhance compliance in this population by using determinants identified in exploratory studies. © 1995 by Williams & Wilkins.
• Geest, S. D., Borgermans, L., Gemoets, H., Abraham, I., Vlaminck, H., Evers, G., & Vanrenterghem, Y. (1995). Incidence, determinants, and consequences of subclinical noncompliance with immunosuppressive therapy in renal transplant recipients. Transplantation, 59(3), 340-347.
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  PMID: 7871562;Abstract: In this descriptive cross-sectional study, we investigated the incidence, determinants, and consequences of subclinical noncompliance with immunosuppressive therapy in 150 adult renal transplant recipients with more than one year posttransplant status. Symptom frequency and symptom distress, and self-care agency were measured by the Transplant Symptom Frequency and Symptom Distress Scale, and the Appraisal for Self- Care Agency Scale, respectively. The Long-Term Medication Behavior Self- Efficacy Scale and a renal transplant knowledge questionnaire were developed as part of this study to measure perceived self-efficacy and knowledge of the therapeutic regimen. Demographic variables were also measured. The incidence of subclinical noncompliance with immunosuppressive therapy as assessed by interview was 22.3%. Compliers and noncompliers differed significantly on the variables of marital status (P=0.03), situational-operational knowledge (P=0.02), self-care agency (P=0.03), and perceived self-efficacy related to long-term medication intake (P=0.048). A logistic regression model using gender, marital status, perceived self-efficacy, self-care agency, knowledge about medication administration and signs of infection, and situational operational knowledge as predictor variables, revealed a 78.6% correct classification of compliers versus noncompliers and a sensitivity ratio of 95.9%. There were significantly more acute late rejection episodes (P=0.003) in the noncompliant group. Graft survival at 5 years in this group was also significantly lower (P=0.03) than the compliant patients. No significant difference was found in terms of the occurrence of chronic rejection episodes or in terms of patient survival at 5 years. Because noncompliance is a risk factor for negative clinical outcome in renal transplant recipients, it is of utmost importance to develop intervention strategies to enhance compliance in this population by using determinants identified in exploratory studies.
• Abraham, I. L. (1994). Does Suboptimal Measurement Reliability Constrain the Explained Variance in Regression?. Western Journal of Nursing Research, 16(Issue 4). doi:10.1177/019394599401600409
• Abraham, I. L. (1994). Does suboptimal measurement reliability constrain the explained variance in regression?. Western journal of nursing research, 16(4), 447-452.
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  PMID: 7941490;
• Abraham, I. L., & Buckwalter, K. C. (1994). Geropsychiatric nursing: a clinical knowledge base in community and institutional settings.. Journal of psychosocial nursing and mental health services, 32(4), 20-26.
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  PMID: 8035363;Abstract: 1. The term clinical knowledge base refers to the foundations and areas of knowledge that are integral to an independent and interdependent clinical discipline. 2. The clinical content essential to establish a research base in geropsychiatric nursing includes normal and abnormal aging, nature and magnitude of geriatric mental health problems, diagnostic categories, caregiver and family roles, and cultural determinants of mental health problems and care. 3. The clinical knowledge base for geropsychiatric nursing care in both community and institutional settings consists of the components identified above and the logical integration of each. Integration can be achieved by including these themes in the theoretical and clinical training of nurses.
• Abraham, I. L., Buckwalter, K. C., Harper, M. S., & Hight, V. A. (1994). Geropsychiatric Nursing: Bringing Advances in Practice and Research to Education. Journal of Psychosocial Nursing and Mental Health Services, 32(4), 5-5. doi:10.3928/0279-3695-19940401-03
• Abraham, I. L., Buckwalter, K. C., Neese, J. B., & Fox, J. C. (1994). Mental health of rural elderly: a research agenda for nursing.. Issues in mental health nursing, 15(3), 203-213.
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  PMID: 7829311;Abstract: Only recently have the health sciences, including nursing, begun to focus on the dynamics of mental health and aging. Reports on rural initiatives, are beginning to appear; these developments have occurred without the benefit of context and direction, however, especially in terms of how these issues apply in rural areas. The article reviews selected issues in the interface of aging and mental health in rural areas. It offers a research agenda comprising descriptive, intervention, and utilization studies as a context to guide research and knowledge development in mental health nursing of rural elderly.
• Abraham, I. L., Currie, L. J., Neese, J. B., Yi, E. S., & Thompson-Heisterman, A. A. (1994). Risk profiles for nursing home placement of rural elderly: A cluster analysis of psychogeriatric indicators. Archives of Psychiatric Nursing, 8(4), 262-271.
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  PMID: 7979559;Abstract: In an effort to better understand the clinical and functional status of pattients served by our Rural Elder Outreach Program, more effectively identify risk groups, and more efficiently target services, we performed a cluster analysis on 92 older adults served by our program. The first cluster included patients with very poor health, mild cognitive impairment, very high care demands, and migrating toward active risk for institutionalization. The second cluster included patients with poor physical but good mental health, intact cognition, high care demands, and at passive risk. The third cluster comprised patients with high functional, physical, and cognitive impairment, intensive care demands, moderate mental health problems, poor insight into their situation, and at active risk for institutionalization. © 1994.
• Abraham, I. L., Currie, L. J., Neese, J. B., Yi, E. S., & Thompson-Heisterman, A. A. (1994). Risk profiles for nursing home placement of rural elderly: A cluster analysis of psychogeriatric indicators. Archives of Psychiatric Nursing, 8(Issue 4). doi:10.1016/0883-9417(94)90068-x
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  In an effort to better understand the clinical and functional status of pattients served by our Rural Elder Outreach Program, more effectively identify risk groups, and more efficiently target services, we performed a cluster analysis on 92 older adults served by our program. The first cluster included patients with very poor health, mild cognitive impairment, very high care demands, and migrating toward active risk for institutionalization. The second cluster included patients with poor physical but good mental health, intact cognition, high care demands, and at passive risk. The third cluster comprised patients with high functional, physical, and cognitive impairment, intensive care demands, moderate mental health problems, poor insight into their situation, and at active risk for institutionalization. © 1994.
• Abraham, I. L., Holroyd, S., Snustad, D. G., Manning, C. A., Brashear, H. R., Diamond, P. T., & Thompson-Heisterman, A. (1994). Multidisciplinary assessment of patients with Alzheimer's disease.. Nursing Clinics of North America, 29(1), 113-128.
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  PMID: 8121815;Abstract: The complexity of AD necessitates that multiple disciplines interface effectively in the assessment of patient, caregiver, and family. This multidisciplinary effort should not be focused on the mere exchange of data. As this article emphasized, just from the perspective of nursing, it is critical that the various disciplines involved know about the purpose, focus, and process of assessment approaches used by each in the convergent effort to comprehensively evaluate the disease and its possible changes, as well as its impact on function, cognition, behavior, and emotion. From this article, it should be apparent that effective multidisciplinary assessment is not exchange of data but rather purposive interchange of clinical information to achieve the clinical goals of assessment, diagnosis, explanation, intervention, prognosis, and evaluation.
• Abraham, I. L., Manning, C. A., Snustad, D. G., Brashear, H. R., Newman, M. C., & Wofford, A. B. (1994). Cognitive Screening of Nursing Home Residents: Factor Structures of the Mini‐Mental State Examination. Journal of the American Geriatrics Society, 42(Issue 7). doi:10.1111/j.1532-5415.1994.tb06536.x
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  OBJECTIVE: To examine factor structures of the Mini‐Mental State Examination, attempting first to replicate any of previously proposed 2‐factor solutions; and to explore, secondly, the presence of clinically more differentiated and statistically stable factor structures representing common neurocognitive dimensions. DESIGN: Factor analytic investigation of descriptive dataset collected on nursing home residents. Two factor analyses were performed, one in which the number of factors was fixed at 2 in an effort to replicate previous studies, and one in which the number of factors to retain was determined by the scree test. Both factor analyses used established methods for judging the adequacy of the correlation matrix and the significance of factor loadings, and both applied principal components analysis for initial factor extraction and the equamax criterion for orthogonal rotation. SETTING: Seven nursing homes with a total of 894 beds. PARTICIPANTS: 922 assessments on nursing home residents were performed, of which 892 were complete and entered into the factor analyses. The observation‐to‐variable ratio exceeded 81:1, assuring the statistical stability of factor solutions derived. MEASUREMENT: The Mini‐Mental State Examination, with standardization of words to be recalled and the inverted spelling of “world” as the mental reversal task. MAIN RESULTS: Two factor structures were derived. A 2‐factor solution, explaining 36.5% of the variance and statistically and conceptually different from those obtained in previous studies, distinguished between Perceptual‐Organizational and Psychomotor skills. A 4‐factor solution, which explained 56.1% of the variance, included a factor named Executing Psychomotor Commands, while also further differentiating the perceptual‐organizational processes into the factors of Memory, Concentration, and Language. CONCLUSION: The 2‐factor solution shows that, notwithstanding previous claims to the contrary, the MMSE can make stable and independent distinctions between psychomotor and perceptual‐organizational processes. However, this solution is statistically and conceptually limited and, therefore, of limited clinical and scientific relevance. The 4‐factor solution of the MMSE maps well onto commonly recognized dimensions of neurocognitive ability. It offers a stable, intuitively sound, and statistically supported framework for clinical differentiation of cognitive screening data into independent clinical dimensions of neurocognitive functioning. Thus, it offers clinicians and researchers a 4‐dimensional framework for interpreting data obtained by means of the MMSE. Studies with other populations of cognitively impaired and intact elderly are recommended to validate and extend the present findings. 1994 The American Geriatrics Society
• Abraham, I. L., Manning, C. A., Snustad, D. G., Brashear, H. R., Newman, M. C., & Wofford, A. B. (1994). Cognitive screening of nursing home residents: Factor structures of the mini-mental state examination. Journal of the American Geriatrics Society, 42(7), 750-756.
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  PMID: 8014351;Abstract: OBJECTIVE: To examine factor structures of the Mini-Mental State Examination, attempting first to replicate any of previously proposed 2- factor solutions; and to explore, secondly, the presence of clinically more differentiated and statistically stable factor structures representing common neurocognitive dimensions. DESIGN: Factor analytic investigation of descriptive dataset collected on nursing home residents. Two factor analyses were performed, one in which the number of factors was fixed at 2 in an effort to replicate previous studies, and one in which the number of factors to retain was determined by the screen test. Both factor analyses used established methods for judging the adequacy of the correlation matrix and the significance of factor loadings, and both applied principal components analysis for initial factor extraction and the equamax criterion for orthogonal rotation. SETTING: Seven nursing homes with a total of 894 beds. PARTICIPANTS: 922 assessments on nursing home residents were performed, of which 892 were complete and entered into the factor analyses. The observation-to-variable ratio exceeded 81:1, assuring the statistical stability of factor solutions derived. MEASUREMENT: The Mini-Mental State Examination, with standardization of words to be recalled and the inverted spelling of 'world' as the mental reversal task. MAIN RESULTS: Two factor structures were derived. A 2-factor solution, explaining 36.5% of the variance and statistically and conceptually different from those obtained in previous studies, distinguished between Perceptual-Organizational and Psychomotor skills. A 4-factor solution, which explained 56.1% of the variance, included a factor named Executing Psychomotor Commands, while also further differentiating the perceptual-organizational processes into the factors of Memory, Concentration, and Language. CONCLUSION: The 2-factor solution shows that, notwithstanding previous claims to the contrary, the MMSF can make stable and independent distinctions between psychomotor and perceptual-organizational processes. However, this solution is statistically and conceptually limited and, therefore, of limited clinical and scientific relevance. The 4-factor solution of the MMSE maps well onto commonly recognized dimensions of neurocognitive ability. It offers a stable, intuitively sound, and statistically supported framework for clinical differentiation of cognitive screening data into independent clinical dimensions of neurocognitive functioning. Thus, it offers clinicians and researchers a 4-dimensional framework for interpreting data obtained by means of the MMSE. Studies with other populations of cognitively impaired and intact elderly are recommended to validate and extend the present findings.
• Abraham, I. L., Neese, J. B., Snustad, D. G., & Thompson-heisterman, A. A. (1994). Chapter Seven: Mental Health Outreach to Rural Elderly: Service Delivery to a Forgotten Risk Group. Clinical Gerontologist, 14(1), 95-111. doi:10.1300/j018v14n01_08
• Abraham, I. L., Onega, L. L., Chalifoux, Z. L., & Maes, M. J. (1994). Care environments for patients with Alzheimer's disease.. Nursing Clinics of North America, 29(1), 157-172.
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  PMID: 8121818;Abstract: Alzheimer's disease creates various demands in terms of community-based and institutional long-term care resources and services needed for patients, caregivers, and families. Nurses play a pivotal role in helping patients, caregivers, and families decide what resources and services are needed. The determinants involved in the decision-making process related to short-term and long-term care options are described. Next, the home, community, and institutional care environments are reviewed. Finally, policy recommendations related to care environments for Alzheimer's patients are discussed.
• Abraham, I. L., Wofford, A. B., Lichtenberg, P. A., & Holroyd, S. (1994). Factor structure of the geriatric depression scale in a cohort of depressed nursing home residents. International Journal of Geriatric Psychiatry, 9(8), 611-617.
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  Abstract: We examined factor structures of the 30-item Geriatric Depression Scale in a sample of depressed nursing home residents at various levels of cognitive functioning (N = 917; observation-to-variable ratio 30.6:1). Using principal components analysis and orthogonal varimax rotation, a six-factor structure involving 26 of the 30 items was derived. This solution, which explained 55.1% of the variance, consisted of the following factors: life dissatisfaction dysphoria, hopelessness/decreased self-attitude, rumination/anxiety, social withdrawal/decreased motivation and decreased cognition. This factor solution shows that a screening test for depression like the GDS may be able to make stable and independent distinctions between various dimensions associated with depressed mood in nursing home residents. The factors derived map well onto commonly recognized dimensions of depressed mood in frail older adults residing in long-term care facilities. The proposed six-factor solution offers a stable, intuitively sound and statistically supported framework for differentiation of depressive screening data into independent dimensions. This, in turn, offers opportunities for clinical differentiation in both practice and research efforts using the GDS.
• Abraham, I. L., Wofford, A. B., Lichtenberg, P. A., & Holroyd, S. (1994). Factor structure of the geriatric depression scale in a cohort of depressed nursing home residents. International Journal of Geriatric Psychiatry, 9(Issue 8). doi:10.1002/gps.930090804
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  We examined factor structures of the 30‐item Geriatric Depression Scale in a sample of depressed nursing home residents at various levels of cognitive functioning (N=917; observation‐to‐variable ratio 30.6:1). Using principal components analysis and orthogonal varimax rotation, a six‐factor structure involving 26 of the 30 items was derived. This solution, which explained 55.1% of the variance, consisted of the following factors: life dissatisfaction, dysphoria, hopelessness/decreased self‐attitude, rumination/anxiety, social withdrawal/decreased motivation and decreased cognition. This factor solution shows that a screening test for depression like the GDS may be able to make stable and independent distinctions between various dimensions associated with depressed mood in nursing home residents. The factors derived map well onto commonly recognized dimensions of depressed mood in frail older adults residing in long‐term care facilities. The proposed six‐factor solution offers a stable, intuitively sound and statistically supported framework for differentiation of depressive screening data into independent dimensions. This, in turn, offers opportunities for clinical differentiation in both practice and research efforts using the GDS. Copyright © 1994 John Wiley & Sons, Ltd.
• Geest, S. D., Abraham, I., Gemoets, H., & Evers, G. (1994). Development of the long-term medication behaviour self-efficacy scale: qualitative study for item development.. Journal of advanced nursing, 19(2), 233-238.
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  PMID: 8188953;Abstract: There are no published instruments of patient self-efficacy related to medication behaviour, yet understanding and promoting medication compliance are central to nursing practice. The purpose of this quanlitative study was to explore patient perceptions, experiences and practices associated with long-term medication behaviour in order to establish an instrument measuring self-efficacy in medication behaviour. In-depth interviews were conducted with 14 patients with lifelong dependency on medicine. Using a phenomenological method of analysis the following themes emerged, all of which could be integrated within Bandura's conceptualization of dimensions of self-efficacy. The dimension of personal attributes comprised the themes of emotional distress, confidence in the physician, perceived health status, and normalcy. Environmental factors included the themes of routine, distraction, social support and cost of medication. The third dimension of self-efficacy, task-related and behavioural factors was composed of themes of side-effects, drug delivery system, medication aids, medication schedule, and knowledge. Based on these themes, items for the Long-Term Medication Behaviour Self-Efficacy Scale, were developed and integrated into a version that is currently being submitted to further psychometric work.
• Goddaer, J., & Abraham, I. L. (1994). Effects of relaxing music on agitation during meals among nursing home residents with severe cognitive impairment. Archives of Psychiatric Nursing, 8(3), 150-158.
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  PMID: 8080303;Abstract: Relaxing music was hypothesized to buffer the general nolse level typically found in dining rooms of nursing homes, exert a calming effect, and thus reduce agitated behaviors among residents with severe cognitive impairment. Twenty-nine nursing home residents with severe cognitive deficits participated in a 4-week protocol in which, following baseline observations (week 1), relaxing music was introduced (week 2), removed (week 3), and reintroduced (week 4). Subjects were observed in terms of total number of behaviors of the Cohen-Mansfield Agitation Inventory present during a given week, and the number of behaviors present on the subscales of aggressive, physically nonaggressive, verbally agitated, and hiding/hoarding behaviors. Significant reductions were observed on the cumulative incidence of total agitated behaviors (63.4%); as well as the cumulative incidence of physically nonaggressive behaviors (56.3%) and verbally agitated behaviors (74.5%). No significant reductions were noted in terms of aggressive behaviors and hiding/hoarding behaviors. Where significant reductions were achieved, a distinct pattern was observed. Agitation decreased during week 2, increased again during week 3, only to decrease again in week 4. In addition, variance effects were noted as well, as ranges and standard deviations of agitated behaviors narrowed over time. These findings are interpreted within Hall and Buckwalter's (1988) model of a progressively lowered stress threshold among dementia patients. © 1994.
• Goddaer, J., & Abraham, I. L. (1994). Effects of relaxing music on agitation during meals among nursing home residents with severe cognitive impairment. Archives of Psychiatric Nursing, 8(Issue 3). doi:10.1016/0883-9417(94)90048-5
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  Relaxing music was hypothesized to buffer the general nolse level typically found in dining rooms of nursing homes, exert a calming effect, and thus reduce agitated behaviors among residents with severe cognitive impairment. Twenty-nine nursing home residents with severe cognitive deficits participated in a 4-week protocol in which, following baseline observations (week 1), relaxing music was introduced (week 2), removed (week 3), and reintroduced (week 4). Subjects were observed in terms of total number of behaviors of the Cohen-Mansfield Agitation Inventory present during a given week, and the number of behaviors present on the subscales of aggressive, physically nonaggressive, verbally agitated, and hiding/hoarding behaviors. Significant reductions were observed on the cumulative incidence of total agitated behaviors (63.4%); as well as the cumulative incidence of physically nonaggressive behaviors (56.3%) and verbally agitated behaviors (74.5%). No significant reductions were noted in terms of aggressive behaviors and hiding/hoarding behaviors. Where significant reductions were achieved, a distinct pattern was observed. Agitation decreased during week 2, increased again during week 3, only to decrease again in week 4. In addition, variance effects were noted as well, as ranges and standard deviations of agitated behaviors narrowed over time. These findings are interpreted within Hall and Buckwalter's (1988) model of a progressively lowered stress threshold among dementia patients. © 1994.
• Yi, E. S., Abraham, I. L., & Holroyd, S. (1994). Alzheimer's disease and nursing. New scientific and clinical insights.. Nursing Clinics of North America, 29(1), 85-99.
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  PMID: 8121829;Abstract: This article aimed to provide an orientation to major new insights in the causes, pathogenesis, and management of AD. This article certainly does not offer a comprehensive overview, and this was not the intent. Instead, the aim was to provide an orientation to the major issues in the complex debate over "causes and cures," and to so serve as a foundation for further study as well as platform for this issue of Nursing Clinics of North America on AD.
• Abraham, I. (1993). Beyond continuity and towards fluidity of care. Rethinking long-term care for an aging society. Acta Hospitalia, 33(4), 71-75+123.
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  Abstract: The need for continuity of care in the case for the elderly - as also in other kinds of care - is constantly being stressed. In this article, the author considers continuity of care to be a concept and places it in a structural and process context. The author stresses that the present perception of the concept is limited to the structure of the care and that an equally important operational perspective is lacking. Thus, the concept of 'continuity of care' is insufficient for the formulation of an adequate and flexible care policy that meets the needs and demands of the elderly. The author develops his position on two levels. First, an expansion of the concept of continuity of care in four dimensions (locus of care, care providers, substitution, and specialization of provisions) means a rethinking of the structure of care for the elderly. In addition, he examines how the structure of continuous care can be formalized in operational care models that are more attuned to the care process.
• Abraham, I. (1993). Beyond continuity and towards fluidity of care. Rethinking long-term care for an aging society. Acta Hospitalia, 33(Issue 4).
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  The need for continuity of care in the case for the elderly - as also in other kinds of care - is constantly being stressed. In this article, the author considers continuity of care to be a concept and places it in a structural and process context. The author stresses that the present perception of the concept is limited to the structure of the care and that an equally important operational perspective is lacking. Thus, the concept of 'continuity of care' is insufficient for the formulation of an adequate and flexible care policy that meets the needs and demands of the elderly. The author develops his position on two levels. First, an expansion of the concept of continuity of care in four dimensions (locus of care, care providers, substitution, and specialization of provisions) means a rethinking of the structure of care for the elderly. In addition, he examines how the structure of continuous care can be formalized in operational care models that are more attuned to the care process.
• Abraham, I. L. (1993). A Problem-Solving Approach to Technical Research Issues. Western Journal of Nursing Research, 15(Issue 6). doi:10.1177/019394599301500610
• Abraham, I. L. (1993). A problem-solving approach to technical research issues.. Western journal of nursing research, 15(6), 784-787.
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  PMID: 8284935;
• Abraham, I. L. (1993). Mental healthcare for seniors.. Health progress (Saint Louis, Mo.), 74(6), 9-.
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  PMID: 10127340;
• Abraham, I. L. (1993). Mental healthcare for seniors.. Health progress (Saint Louis, Mo.), 74(Issue 6).
• Abraham, I. L., Beck, C. K., Buckwalter, K. C., Chalifoux, Z. L., Evers, G. C., Fulmer, T., & Snustad, D. G. (1993). Beyond the Role of ExtenderIndependent and Interdependent Contributions of Nursing to Geriatric Rehabilitation.. NeuroRehabilitation, 3(1), 12-25. doi:10.3233/nre-1993-3104
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  Too often, the role of nursing in geriatric neurorehabilitation is defined in terms of extending the care of other disciplines and assuring continuity of selected aspects of care over 24 hours. This article argues that nursing has made significant clinical and scientific progress in contributing, independently and interdependently, to quality rehabilitation care for older adults; and that the role of nursing clearly exceeds the realm of mere extension and continuity of care. Reviewed are nursing's innovations in the areas of promoting comprehensive assessment; fostering functional independence, self-care, and self-care agency; enhancing communication; encouraging family involvement; improving cognitive status; and assuring quality physical care. We conclude with a discussion of the relationship of nursing to other disciplines, and how nursing's contributions can be optimized within the broader context of multidisciplinary geriatric rehabilitation.
• Abraham, I. L., Buckwalter, C., Snustad, D. G., Smullen, D. E., Thompson-Heisterman, A., Neese, J. B., & Smith, M. (1993). Psychogeriatric outreach to rural families: The Iowa and Virginia models. International Psychogeriatrics, 5(2), 203-211.
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  PMID: 8292773;Abstract: Elderly residents of rural areas are at significant risk for mental health problems, yet have less access to mental health services. Thus, most mental health problems among rural elderly remain either undiagnosed or untreated. We describe two models of mental health outreach programs to rural elderly in Iowa and Virginia, serving demographically, culturally, and epidemiologically different populations in geographically and economically dissimilar regions. Programs are compared on the basis of initiation, community partnerships, target population, target region, clinical disciplines involved, coordinating discipline, referral sources, operational model, initial home assessment, care planning, sustainability, cost, patient demographics, and primary and secondary diagnoses. Outreach programs are argued to be effective models of delivering services to geographically and/or socially isolated elderly populations. The experiences of our programs, though limited to rural populations, may be of relevance to any outreach program attempting to serve elderly presenting with or at risk for mental health problems.
• Abraham, I. L., Buckwalter, K. C., Snustad, D. G., Smullen, D. E., Thompson-Heisterman, A. A., Neese, J. B., & Smith, M. (1993). Psychogeriatric Outreach To Rural Families: The Iowa and Virginia Models. International Psychogeriatrics, 5(Issue 2). doi:10.1017/s104161029300153x
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  Elderly residents of rural areas are at significant risk for mental health problems, yet have less access to mental health services. Thus, most mental health problems among rural elderly remain either undiagnosed or untreated. We describe two models of mental health outreach programs to rural elderly in Iowa and Virginia, serving demographically, culturally, and epidemiologically different populations in geographically and economically dissimilar regions. Programs are compared on the basis of initiation, community partnerships, target population, target region, clinical disciplines involved, coordinating discipline, referral sources, operational model, initial home assessment, care planning, sustainability, cost, patient demographics, and primary and secondary diagnoses. Outreach programs are argued to be effective models of delivering services to geographically and/or socially isolated elderly populations. The experiences of our programs, though limited to rural populations, may be of relevance to any outreach program attempting to serve elderly presenting with or at risk for mental health problems. © 1994, Cambridge University Press. All rights reserved.
• Abraham, I. L., Manning, C. A., Boyd, M. R., Neese, J. B., Newman, M. C., Plowfield, L. A., & Reel, S. J. (1993). Cognitive screening of nursing home residents: Factor structure of the modified mini-mental state (3MS) examination. International Journal of Geriatric Psychiatry, 8(2), 133-138.
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  Abstract: We examined factor structures of the Modified Mini-Mental State Examination in a sample of nursing home residents (N = 892; observation-to-variable ratio 59.5:1). Using principal components analysis and orthogonal equamax rotation, a five-factor structure was derived. This solution, which explained 58.9% of the variance, consisted of the following factors: psychomotor skills, memory, identification and association, orientation, and concentration and calculation. This factor solution shows that, notwithstanding previous claims to the contrary, cognitive screening tests may be able to make stable and independent distinctions between psychomotor and perceptual-organizational processes. The factors derived map well onto commonly recognized dimensions of neurocognitive ability. The proposed five-factor solution offers a stable, intuitively sound, and statistically supported framework for differentiation of cognitive screening data into independent dimensions.
• Abraham, I., Neese, J. B., Snustad, D. G., & Thompson-heisterman, A. A. (1993). Mental health outreach to rural elderly: service delivery to a forgotten risk group. Clinical Gerontologist, 14(1), 95-111.
• Baker, F. M., Robinson, B. H., Stewart, B., Espino, D. V., Soniat, B. A., Pollack, M., McDougall, G. J., Smith, G. C., Tobin, S. S., Jacobson, S., Kropf, N. P., Snustad, D. G., Thompson-Heisterman, A., Neese, J. B., & Abraham, I. L. (1993). The forgotten aged: Ethnic, psychiatric, and societal minorities. Clinical Gerontologist, 14(1), 1-111.
• Buckwalter, K. C., Abraham, I. L., Smith, M., & Smullen, D. E. (1993). Nursing outreach to rural elderly people who are mentally ill. Hospital and Community Psychiatry, 44(9), 821-823.
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  PMID: 8225291;
• Dzurec, L. C., & Abraham, I. L. (1993). The nature of inquiry: linking quantitative and qualitative research.. ANS. Advances in nursing science, 16(1), 73-79.
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  PMID: 8311427;Abstract: Views of research that dichotomize qualitative and quantitative methods and the paradigms in which they are couched reflect a limited interpretation of the process of inquiry. In this article, the authors propose that inquiry, regardless of the inquirer's chosen paradigm or method, is governed by six pursuits that integrate qualitative and quantitative research methods. Recognition of the synthetic nature of inquiry is essential to fuller explanation and understanding of questions and problems relevant to nursing.
• Dzurec, L. C., & Abraham, I. L. (1993). The nature of inquiry: linking quantitative and qualitative research.. ANS. Advances in nursing science, 16(Issue 1). doi:10.1097/00012272-199309000-00009
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  Views of research that dichotomize qualitative and quantitative methods and the paradigms in which they are couched reflect a limited interpretation of the process of inquiry. In this article, the authors propose that inquiry, regardless of the inquirer's chosen paradigm or method, is governed by six pursuits that integrate qualitative and quantitative research methods. Recognition of the synthetic nature of inquiry is essential to fuller explanation and understanding of questions and problems relevant to nursing.
• Abraham, I. L. (1992). Longitudinal reliability of the Life Satisfaction Index (Short Form) with nursing home residents: a cautionary note.. Perceptual and Motor Skills, 75(2), 665-666.
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  PMID: 1408633;Abstract: We administered the Life Satisfaction Index (Short Form) 18 times over a 39-wk. period to an initial sample of 76 old, frail, multiply impaired, and depressed nursing home residents participating in a longitudinal quasi-experimental study of the effects of cognitive group interventions on cognition and depression. As no changes over time were observed on the outcome variable of life satisfaction, the stability of the instrument's internal consistency could be examined. Kuder-Richardson KR-20 coefficients ranged from .11 to .60, with a mean of .42 (SD = .11). We conclude that caution should be used when applying this instrument to measure life satisfaction in frail nursing home residents.
• Abraham, I. L. (1992). Longitudinal reliability of the Life Satisfaction Index (Short Form) with nursing home residents: a cautionary note.. Perceptual and motor skills, 75(Issue 2). doi:10.2466/pms.1992.75.2.665
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  We administered the Life Satisfaction Index (Short Form) 18 times over a 39-wk. period to an initial sample of 76 old, frail, multiply impaired, and depressed nursing home residents participating in a longitudinal quasi-experimental study of the effects of cognitive group interventions on cognition and depression. As no changes over time were observed on the outcome variable of life satisfaction, the stability of the instrument's internal consistency could be examined. Kuder-Richardson KR-20 coefficients ranged from .11 to .60, with a mean of .42 (SD = .11). We conclude that caution should be used when applying this instrument to measure life satisfaction in frail nursing home residents.
• Abraham, I. L. (1992). Quality improvement of nursing care of the elderly. Acta Hospitalia, 32(1), 5-14+78.
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  Abstract: The relation between quality improvement and science is central in this contribution on quality improvement of nursinq care of the elderly. It is set out how research methods can be used for assessing nursing care models and generalizing their results. This is done on the basis of a concrete example, namely the research and development project 'Rural elder outreach program'. In this project, which is under the direction of the author, a nursing care model has been developed for the benefit of a vulnerable high risk group of old people in Virginia, U.S.A. An attempt is also made to assess the model that has been developed, by means of an extended multidisciplinary research program founded both scientifically and conceptually. This project is financed by the W.K. Kellogg Foundation and the National Institute of Mental Health, Rockville, Maryland, U.S.A.
• Abraham, I. L. (1992). Quality improvement of nursing care of the elderly. Acta Hospitalia, 32(Issue 1).
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  The relation between quality improvement and science is central in this contribution on quality improvement of nursinq care of the elderly. It is set out how research methods can be used for assessing nursing care models and generalizing their results. This is done on the basis of a concrete example, namely the research and development project 'Rural elder outreach program'. In this project, which is under the direction of the author, a nursing care model has been developed for the benefit of a vulnerable high risk group of old people in Virginia, U.S.A. An attempt is also made to assess the model that has been developed, by means of an extended multidisciplinary research program founded both scientifically and conceptually. This project is financed by the W.K. Kellogg Foundation and the National Institute of Mental Health, Rockville, Maryland, U.S.A.
• Abraham, I. L., & Reel, S. J. (1992). Cognitive nursing interventions with long-term care residents: Effects on neurocognitive dimensions. Archives of Psychiatric Nursing, 6(6), 356-365.
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  PMID: 1476463;Abstract: We recently reported that cognitive nursing interventions-such as cognitive-behavioral group therapy and focused visual imagery group therapy-administered over time may produce significant and lasting improvements in overall cognitive status in nursing home residents with slight to moderate cognitive impairment, when compared with subjects participating in educational discussion groups. To further elucidate the cognitive gains made by subjects, we reanalyzed the data focusing on the 15 neurocognitive parameters tested by means of the Modified Mini-Mental State Examination. Main effects for intervention were noted on neurocognitive operations involving abstraction and conceptual thinking, concentration and linguistic manipulation, and execution of auditorily presented language skills. Main effects for time were observed on short and medium term recall, fluency of category retrieval, abstraction and conceptual thinking, concentration and linguistic manipulation, and execution of visually presented commands. Intervention and time were found to produce interaction effects on subjects' ability to visually and linguistically identify objects and their praxic ability to recognize and redraw simple but intersecting geometric figures. From a functional brain perspective, these effects involved brain functions at higher cortical and subcortical/limbic levels, and lower and more basic cortical functions were not affected. These findings underscore the role of psychogeriatric nursing in maintaining or restoring cognitive function in nursing home residents with mild to moderate cognitive impairment, not only for the sake of cognition itself but also for the (corollary) sake of promoting functional independence and self-care in a high-risk population. © 1992.
• Abraham, I. L., & Reel, S. J. (1992). Cognitive nursing interventions with long-term care residents: Effects on neurocognitive dimensions. Archives of Psychiatric Nursing, 6(Issue 6). doi:10.1016/0883-9417(92)90088-z
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  We recently reported that cognitive nursing interventions-such as cognitive-behavioral group therapy and focused visual imagery group therapy-administered over time may produce significant and lasting improvements in overall cognitive status in nursing home residents with slight to moderate cognitive impairment, when compared with subjects participating in educational discussion groups. To further elucidate the cognitive gains made by subjects, we reanalyzed the data focusing on the 15 neurocognitive parameters tested by means of the Modified Mini-Mental State Examination. Main effects for intervention were noted on neurocognitive operations involving abstraction and conceptual thinking, concentration and linguistic manipulation, and execution of auditorily presented language skills. Main effects for time were observed on short and medium term recall, fluency of category retrieval, abstraction and conceptual thinking, concentration and linguistic manipulation, and execution of visually presented commands. Intervention and time were found to produce interaction effects on subjects' ability to visually and linguistically identify objects and their praxic ability to recognize and redraw simple but intersecting geometric figures. From a functional brain perspective, these effects involved brain functions at higher cortical and subcortical/limbic levels, and lower and more basic cortical functions were not affected. These findings underscore the role of psychogeriatric nursing in maintaining or restoring cognitive function in nursing home residents with mild to moderate cognitive impairment, not only for the sake of cognition itself but also for the (corollary) sake of promoting functional independence and self-care in a high-risk population. © 1992.
• Abraham, I. L., Currie, L. J., & Neundorfer, M. M. (1992). Effects of Cognitive Group Iterventions on Depression and Cognition Among Elderly Women in Long-Term Care.. Journal of women & aging, 4(1), 5-24. doi:10.1300/j074v04n01_02
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  The effects of cognitive-behavioral group therapy and focused visual imagery group therapy on cognition and depression in frail women residing in nursing homes were examined.' Twenty-four (24) women participated in a 24-week protocol of cognitive- behavioral group therapy and twenty-one (21) in a protocol of visual imagery group therapy of similar duration. Eleven (11) women in a comparison condition participated in a 24 week series of educational discussion group sessions. Data on cognition and depression are reported for four time points: 4 weeks before treatment initiation, 8 and 20 weeks after treatment initiation, and 4 weeks after treatment termination. Subjects in the cognitive-behavioral and visual imagery groups experienced a significant improvement in cognition over the duration of the study, while subjects in the educational discussion groups did not. There was no effect for any of the interventions on depression. This lack of effect may indicate the tenacity of depression among female nursing home residents and.
• Abraham, I. L., Fox, J. C., & Cohen, B. T. (1992). Integrating the bio into the biopsychosocial: Understanding and treating biological phenomena in psychiatric-mental health nursing. Archives of Psychiatric Nursing, 6(5), 296-305.
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  PMID: 1476457;Abstract: Advances in neuroscientific understandings of the interrelationships between brain, behavior, emotion, and cognition offer new opportunities for psychiatricmental health nursing. Yet, even though the discipline conceptually embraces a biopsychosocial perspective as part of its holistic mandate, the factual integration of biological sciences into practice, research, and education is limited. Integrating the biological perspective into a holistic paradigm and progressing toward a discipline in which the biological, psychological, and social interact coherently and interdependently requires a dual focus on understanding and treating patients and their social and physical environments. We describe how in the past the discipline has strived toward understanding and treating patients from predominantly psychological and social perspectives. We also show how progress in the biology of mental health and illness provides new avenues for understanding and treating patients' responses to actual and potential health problems. This in turn will contribute to the emergence of a truly holistic discipline of psychiatric-mental health nursing. © 1992.
• Abraham, I. L., Fox, J. C., & Cohen, B. T. (1992). Integrating the bio into the biopsychosocial: Understanding and treating biological phenomena in psychiatric-mental health nursing. Archives of Psychiatric Nursing, 6(Issue 5). doi:10.1016/0883-9417(92)90041-g
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  Advances in neuroscientific understandings of the interrelationships between brain, behavior, emotion, and cognition offer new opportunities for psychiatricmental health nursing. Yet, even though the discipline conceptually embraces a biopsychosocial perspective as part of its holistic mandate, the factual integration of biological sciences into practice, research, and education is limited. Integrating the biological perspective into a holistic paradigm and progressing toward a discipline in which the biological, psychological, and social interact coherently and interdependently requires a dual focus on understanding and treating patients and their social and physical environments. We describe how in the past the discipline has strived toward understanding and treating patients from predominantly psychological and social perspectives. We also show how progress in the biology of mental health and illness provides new avenues for understanding and treating patients' responses to actual and potential health problems. This in turn will contribute to the emergence of a truly holistic discipline of psychiatric-mental health nursing. © 1992.
• Abraham, I. L., Neundorfer, M. M., & Currie, L. J. (1992). Effects of group interventions on cognition and depression in nursing home residents. Nursing Research, 41(Issue 4). doi:10.1097/00006199-199207000-00002
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  The effects of cognitive-behavioral group therapy, focused visual imagery group therapy, and education-discussion groups on cognition, depression, hopelessness, and dissatisfaction with life were studied among depressed nursing home residents. Seventy-six depressed subjects with mild to moderate cognitive decline participated in nurse-led 24-week protocols. Data were collected 4 weeks before the interventions, 8 and 20 weeks after treatment initiation, and 4 weeks after treatment termination. There were no significant changes in depression, hopelessness, or life satisfaction scores for any of the three conditions. Participants in the cognitive-behavioral and focused visual imagery groups showed a significant improvement beginning 8 weeks after treatment initiation on cognitive scores. These findings are encouraging indications that cognitive-behavioral and focused visual imagery group therapies may reduce cognitive impairment in depressed nursing home residents with mild to moderate cognitive decline. © Lippincott-Raven Publishers.
• Abraham, I. L., Neundorfer, M. M., & Currie, L. J. (1992). Effects of group interventions on cognition and depression in nursing home residents.. Nursing Research, 41(4), 196-202.
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  PMID: 1383947;Abstract: The effects of cognitive-behavioral group therapy, focused visual imagery group therapy, and education-discussion groups on cognition, depression, hopelessness, and dissatisfaction with life were studied among depressed nursing home residents. Seventy-six depressed subjects with mild to moderate cognitive decline participated in nurse-led 24-week protocols. Data were collected 4 weeks before the interventions, 8 and 20 weeks after treatment initiation, and 4 weeks after treatment termination. There were no significant changes in depression, hopelessness, or life satisfaction scores for any of the three conditions. Participants in the cognitive-behavioral and focused visual imagery groups showed a significant improvement beginning 8 weeks after treatment initiation on cognitive scores. These findings are encouraging indications that cognitive-behavioral and focused visual imagery group therapies may reduce cognitive impairment in depressed nursing home residents with mild to moderate cognitive decline.
• Abraham, I. L., Smullen, D. E., & Thompson-Heisterman, A. (1992). Assessing geropsychiatric patients.. Journal of psychosocial nursing and mental health services, 30(9), 13-19.
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  PMID: 1404011;Abstract: Although other disciplines involved in the care of geriatric patients with psychiatric or neurobehavioral problems have established assessment procedures, this is not the case for nursing. Some approaches to assessing geropsychiatric patients from a nursing perspective have been proposed (Baldwin, 1987; Burnside, 1981; Ninos, 1985), but they have been limited in scope (Abraham, 1990b). However, with nursing assuming an increasingly central role in the multidisciplinary care of geropsychiatric patients and their families, a comprehensive and accepted method of multidimensional geropsychiatric nursing assessment is necessary. This method enables nurses to provide the best possible nursing care to patients and families while contributing effectively to multidisciplinary assessment and intervention. To this end, Abraham and associates (Abraham, 1990a; Thompson-Heisterman, 1992) developed the Psychogeriatric Nursing Assessment Protocol (PNAP). Previous articles have described the rationale and content of the PNAP (Abraham, 1990a; Thompson-Heisterman, 1992). This article will draw on the authors' clinical experience in using the PNAP and will offer practical clinical strategies for assessment within the PNAP framework. The PNAP is presented in the Figure, and readers are referred to previous articles for detailed descriptions of the various aspects of the PNAP. A rating form has been developed for use with the PNAP that permits quantification of clinical observations and the determination of selected clinical scores.
• Abraham, I. L., Smullen, D. E., & Thompson-Heisterman, A. A. (1992). Assessing geropsychiatric patients.. Journal of psychosocial nursing and mental health services, 30(Issue 9).
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  Although other disciplines involved in the care of geriatric patients with psychiatric or neurobehavioral problems have established assessment procedures, this is not the case for nursing. Some approaches to assessing geropsychiatric patients from a nursing perspective have been proposed (Baldwin, 1987; Burnside, 1981; Ninos, 1985), but they have been limited in scope (Abraham, 1990b). However, with nursing assuming an increasingly central role in the multidisciplinary care of geropsychiatric patients and their families, a comprehensive and accepted method of multidimensional geropsychiatric nursing assessment is necessary. This method enables nurses to provide the best possible nursing care to patients and families while contributing effectively to multidisciplinary assessment and intervention. To this end, Abraham and associates (Abraham, 1990a; Thompson-Heisterman, 1992) developed the Psychogeriatric Nursing Assessment Protocol (PNAP). Previous articles have described the rationale and content of the PNAP (Abraham, 1990a; Thompson-Heisterman, 1992). This article will draw on the authors' clinical experience in using the PNAP and will offer practical clinical strategies for assessment within the PNAP framework. The PNAP is presented in the Figure, and readers are referred to previous articles for detailed descriptions of the various aspects of the PNAP. A rating form has been developed for use with the PNAP that permits quantification of clinical observations and the determination of selected clinical scores.
• Currie, L. J., & Abraham, I. L. (1992). A clinical and research database management system for a geriatric nursing outreach program to rural elderly: purpose and general structure.. Proceedings / the . Annual Symposium on Computer Application [sic] in Medical Care. Symposium on Computer Applications in Medical Care, 729-733.
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  PMID: 1482967;PMCID: PMC2248020;Abstract: The need to systematically and comprehensively manage data to support nursing services asserts itself in all areas and contexts where nursing services are delivered to patients and families. While most applications have targeted inpatient nursing services, several systems to sustain ambulatory nursing care have been proposed as well. In this paper, we outline the purpose and general structure of a custom-designed computerized database management system to support the clinical, administrative, and research operations of a geriatric nursing outreach program in rural Virginia.
• Currie, L. J., & Abraham, I. L. (1992). A clinical and research database management system for a geriatric nursing outreach program to rural elderly: purpose and general structure.. Proceedings / the ... Annual Symposium on Computer Application [sic] in Medical Care. Symposium on Computer Applications in Medical Care.
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  The need to systematically and comprehensively manage data to support nursing services asserts itself in all areas and contexts where nursing services are delivered to patients and families. While most applications have targeted inpatient nursing services, several systems to sustain ambulatory nursing care have been proposed as well. In this paper, we outline the purpose and general structure of a custom-designed computerized database management system to support the clinical, administrative, and research operations of a geriatric nursing outreach program in rural Virginia.
• Abraham, I. L. (1991). The Geriatric Depression Scale and Hopelessness Index: longitudinal psychometric data on frail nursing home residents.. Perceptual and Motor Skills, 72(3 Pt 1), 875-880.
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  PMID: 1891325;Abstract: We administered the Geriatric Depression Scale and the Hopelessness Index 18 times over a 39-wk. period to an initial sample of 76 old, frail, multiply impaired, and depressed nursing home residents participating in a longitudinal quasi-experimental study on the effects of cognitive group interventions on cognition, depression , hopelessness, and life satisfaction. As no changes over time were observed on the outcome variables of geriatric depression and hopelessness, the stability of the instruments' internal consistency was examined longitudinally. For the Geriatric Depression Scale, Kuder-Richardson KR-20 coefficients ranged from .69 to .88, with a mean of .82 (SD = .05). Coefficients for the Hopelessness Index were between .72 and .86, with a mean of .80 (SD = .04). We conclude that both instruments give reliable measurements of geriatric depression and hopelessness in old, frail, and depressed nursing home residents.
• Abraham, I. L. (1991). The Geriatric Depression Scale and Hopelessness Index: longitudinal psychometric data on frail nursing home residents.. Perceptual and motor skills, 72(Issue 3). doi:10.2466/pms.1991.72.3.875
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  We administered the Geriatric Depression Scale and the Hopelessness Index 18 times over a 39-wk. period to an initial sample of 76 old, frail, multiply impaired, and depressed nursing home residents participating in a longitudinal quasi-experimental study on the effects of cognitive group interventions on cognition, depression , hopelessness, and life satisfaction. As no changes over time were observed on the outcome variables of geriatric depression and hopelessness, the stability of the instruments' internal consistency was examined longitudinally. For the Geriatric Depression Scale, Kuder-Richardson KR-20 coefficients ranged from .69 to .88, with a mean of .82 (SD = .05). Coefficients for the Hopelessness Index were between .72 and .86, with a mean of .80 (SD = .04). We conclude that both instruments give reliable measurements of geriatric depression and hopelessness in old, frail, and depressed nursing home residents.
• Abraham, I. L., & Fox, J. C. (1991). Designing continuing care retirement communities: Toward a partnership of formal and informal care providers. Family & Community Health, 14(2), 68-80. doi:10.1097/00003727-199107000-00009
• Abraham, I. L., & Williams, B. M. (1991). Hypertensive Elders' Perceptions and Management of Their Disease: Health Beliefs or Health Decisions?. The Journal of Applied Gerontology, 10(Issue 4). doi:10.1177/073346489101000406
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  This study attempted to validate the Health Belief Model (HBM) as a model for explaining health behavior among elderly people diagnosed with hypertension. Using the construct validation perspective within psychometric theory, factor analysis with principal axis factoring and orthogonal varimax rotation was performed on data obtained from 275 elderly patients seen for hypertension in outpatient clinics. The structure of the HBM as originally proposed by Rosenstock (1966) was not confirmed. Instead, a six-factor structure reflecting a decision-making perspective as opposed to a belief perspective was obtained This factor structure accounted for 100% of the variance and was established on the basis of eigenvalues meeting more than one criterion for factor retention. The six factors are (a) inference of susceptibility, (b) understanding of hypertension, (c) use of health services, (d) inference of illness, (e) likelihood of disease-related complications, and (f) health locus of control. This study reveals patients' need to process information about their illness and health, to apply their cognitive-inferential skills to analyze and draw conclusions from this information, and to use these inferences to chart their course of behavioral response to their illness and its management. © 1991, The Southern Gerontological Society. All rights reserved.
• Abraham, I. L., & Williams, B. M. (1991). Hypertensive elders' perceptions and management of their disease: Health beliefs or health decisions?. Journal of Applied Gerontology, 10(4), 444-454.
• Abraham, I. L., Neese, J. B., & Westerman, P. S. (1991). Depression. Nursing implications of a clinical and social problem.. Nursing Clinics of North America, 26(3), 527-544.
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  PMID: 1891390;Abstract: Depression is a phenomenon with concurrent personal, social, and clinical dimensions. Each person is affected by depression differently and expresses depressive symptomatology in a unique manner. Socially, the incidence of depressive illness in the general population is three times that of schizophrenia. The cost of depression in terms of lost days at work and treatment is estimated to be $29 billion in 1991. Diagnosing and treating depressive illnesses depend on the clinical manifestations of the illness and the assessment skills of the practitioner. Different treatment modalities such as psychotherapy, psychopharmacology, and electroconvulsive treatments can be effective singularly or in combination to assist the patient in regaining his or her functionality in daily life.
• Abraham, I. L., Niles, S. A., Thiel, B. P., Siarkowski, K. I., & 3rd., W. C. (1991). Therapeutic group work with depressed elderly.. Nursing Clinics of North America, 26(3), 635-650.
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  PMID: 1891398;Abstract: This article presents several approaches to therapeutic group work with the elderly, drawing from experience in designing and implementing several group interventions for frail nursing home residents. What is important to recognize is that the common preconception that the elderly, in general, and the frail, in particular, cannot participate in therapy and groups is a misconception at least, if not a prejudice.
• Abraham, I. L., Thompson-Heisterman, A. A., Harrington, D. P., Smullen, D. E., Onega, L. L., Droney, E. G., Westerman, P. S., Manning, C. A., & Lichtenberg, P. A. (1991). Outpatient psychogeriatric nursing services: An integrative model. Archives of Psychiatric Nursing, 5(3), 151-164.
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  PMID: 1929564;Abstract: The complex needs of psychogeriatric patients and their families require specialized outpatient psychogeriatric services. The interaction of physical and mental health and the need for coordinated care places important responsibilities on nursing because it contributes to integrated, multidisciplinary care delivery to these patients and their families. This article presents a model of outpatient psychogeriatric nursing services focused on the community integration of patients and families. Experiences in the development of the Geriatric Neuropsychiatry Clinic at the University of Virginia, Charlottesville, are used as the point of departure from which to describe a model of outpatient psychogeriatric nursing care delivery that is multidisciplinary, clinically innovative, and epidemiologically justified. © 1991.
• Abraham, I., & Fletcher, K. (1991). Foreword. Family and Community Health, 14(2). doi:10.1097/00003727-199107000-00002
• Abraham, I., Evers, G., Hasman, A., Tanghe, H., Silkens, R., & Hein, F. (1991). A summer institute on computer applications for nursing management: background, curriculum, and evaluation.. Journal of continuing education in nursing, 22(4), 136-142.
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  PMID: 1906478;Abstract: Nursing managers are faced with a growing number of computer applications for nursing management, yet they may lack the educational preparation to assist them in using these technologies for problem-solving and decision-making. This article describes a Summer Institute on informatics applications for nursing management taught by an international and multidisciplinary team of faculty members, and offered at the University of Limburg (Maastricht, The Netherlands). A discussion of professional, scientific, and educational issues serves as the foundation for curriculum content and instructional format. Evaluation data from both offerings are reviewed and underscore the professional relevance and didactic quality of the Summer Institute. The Summer Institute is presented as a possible model of continuing education in computer applications for nursing management transferable to Western European and North American countries.
• Abraham, I., Evers, G., Hasman, A., Tanghe, H., Silkens, R., & Hein, F. (1991). A summer institute on computer applications for nursing management: background, curriculum, and evaluation.. Journal of continuing education in nursing, 22(Issue 4).
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  Nursing managers are faced with a growing number of computer applications for nursing management, yet they may lack the educational preparation to assist them in using these technologies for problem-solving and decision-making. This article describes a Summer Institute on informatics applications for nursing management taught by an international and multidisciplinary team of faculty members, and offered at the University of Limburg (Maastricht, The Netherlands). A discussion of professional, scientific, and educational issues serves as the foundation for curriculum content and instructional format. Evaluation data from both offerings are reviewed and underscore the professional relevance and didactic quality of the Summer Institute. The Summer Institute is presented as a possible model of continuing education in computer applications for nursing management transferable to Western European and North American countries.
• Snustad, D., Lee, V., Abraham, I., Alexander, C., Bella, D., & Cumming, C. (1991). Dietary fiber in hospitalized geriatric patients: Too soft a solution for too hard a problem?. Journal of Nutrition for the Elderly, 10(2), 49-63.
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  PMID: 1849571;
• Abraham, I. L., & Neundorfer, M. M. (1990). Alzheimer's: A decade of progress, a future of nursing challenges. Geriatric Nursing, 11(Issue 3). doi:10.1016/s0197-4572(06)80094-7
• Abraham, I. L., & Neundorfer, M. M. (1990). Alzheimer's: A decade of progress, a future of nursing challenges. Geriatric Nursing, 11(3), 116-119.
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  PMID: 2163943;
• Abraham, I. L., Fox, J. M., Harrington, D. P., Snustad, D. G., Steiner, D. A., Abraham, L. H., & Brashear, H. R. (1990). A psychogeriatric nursing assessment protocol for use in multidisciplinary practice. Archives of Psychiatric Nursing, 4(4), 242-259.
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  PMID: 2241244;Abstract: The assessment of geriatric patients with psychiatric or neurobehavioral problems demands a multidisciplinary approach linking nursing, psychiatry, neurology, geriatrics, and internal medicine. While the medical disciplines have relatively well-established approaches to assessing psychogeriatric patients, nursing lacks a comprehensive assessment strategy that supports both nursing and multidisciplinary practice. This article describes the Psychogeriatric Nursing Assessment Protocol (Abraham, 1989) developed for use in a multidisciplinary geriatric neuropsychiatric outpatient clinic. The relationship of the protocol to psychiatric, neurological, geriatric, and medical assessments is discussed in an attempt to clarify the linkages of knowledge and care required for successful service delivery to geriatric patients with psychiatric or neurobehavioral problems, as well as to their families and formal and informal caregivers. © 1990.
• Abraham, I. L., Fox, J. M., Harrington, D. P., Snustad, D. G., Steiner, D. A., Abraham, L. H., & Robert Brashear, H. (1990). A psychogeriatric nursing assessment protocol for use in multidisciplinary practice. Archives of Psychiatric Nursing, 4(Issue 4). doi:10.1016/0883-9417(90)90039-n
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  The assessment of geriatric patients with psychiatric or neurobehavioral problems demands a multidisciplinary approach linking nursing, psychiatry, neurology, geriatrics, and internal medicine. While the medical disciplines have relatively well-established approaches to assessing psychogeriatric patients, nursing lacks a comprehensive assessment strategy that supports both nursing and multidisciplinary practice. This article describes the Psychogeriatric Nursing Assessment Protocol (Abraham, 1989) developed for use in a multidisciplinary geriatric neuropsychiatric outpatient clinic. The relationship of the protocol to psychiatric, neurological, geriatric, and medical assessments is discussed in an attempt to clarify the linkages of knowledge and care required for successful service delivery to geriatric patients with psychiatric or neurobehavioral problems, as well as to their families and formal and informal caregivers. © 1990.
• Abraham, I. L., Neundorfer, M. M., Cowling, W. R., & Sutorius, S. D. (1990). Changes in resident mix in nursing homes: Cognitive and sensory data from a (redesigned) sampling plan. Psychological Reports, 66(2), 547-550.
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  PMID: 2349346;Abstract: In planning and implementing a study, we unintentionally and serendipitously obtained data about changes in resident mix over a 2.8-yr. period. We screened residents of a 184-bed nursing home for cognition and sensorium in October 1984 to assess sampling feasibility for a grant proposal in preparation. At that time, 65.2% of the residents met the sampling criteria. However, in July/August 1987, after award of funding, only 5.4% of residents of the same nursing home met the cognitive and sensory criteria. We were forced to recruit from an additional six nursing homes, in which only 9.3% of residents met the sampling criteria.
• Abraham, I. L., Neundorfer, M. M., Cowling, W. R., & Sutorius, S. D. (1990). Changes in resident mix in nursing homes: Cognitive and sensory data from a (redesigned) sampling plan. Psychological Reports, 66(Issue 2). doi:10.2466/pr0.1990.66.2.547
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  In planning and implementing a study, we unintentionally and serendipitously obtained data about changes in resident mix over a 2.8-yr. period. We screened residents of a 184-bed nursing home for cognition and sensorium in October 1984 to assess sampling feasibility for a grant proposal in preparation. At that time, 65.2% of the residents met the sampling criteria. However, in July/August 1987, after award of funding, only 5.4% of residents of the same nursing home met the cognitive and sensory criteria. We were forced to recruit from an additional six nursing homes, in which only 9.3% of residents met the sampling criteria.
• Fitzpatrick, J. J., Abraham, I. L., & Pressler, J. L. (1989). Developing scientific relationships through leadership. Nurse Educator, 14(Issue 1). doi:10.1097/00006223-198901000-00009
• Fitzpatrick, J. J., Abraham, I. L., & Pressler, J. L. (1989). Developing scientific relationships through leadership.. Nurse educator, 14(1), 6-7.
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  PMID: 2927747;
• Zielstorff, R. D., Abraham, I. L., Werley, H. H., Saba, V. K., & Schwirian, P. M. (1989). Guidelines for reporting innovations in computer-based information systems for nursing.. Computers in nursing, 7(5), 203-208.
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  PMID: 2804794;Abstract: Inconsistent, incomplete reporting of computer applications in nursing is a barrier to building a knowledge base in the field. Progress in building this knowledge base might be accelerated if system developers could use the available literature to build upon work previously done and to profit from lessons already learned. This article presents guidelines for developing articles and reports on computer applications in nursing. Important topics include statement of the problem, proposed solution, description of the system, system impact, relationship to previous work, problems encountered, lessons learned, professional issues, transferability, and future plans. A checklist is provided. The authors welcome comments on these guidelines.
• Abraham, I., Buckwalter, K. C., & Neundorfer, M. M. (1988). Alzheimers-Disease - Urinary-Incontinence in the Elderly - Preface. Nursing Clinics of North America, 23(1).
• Buckwalter, K. C., Abraham, I. L., & Neundorfer, M. M. (1988). Alzheimer's disease. Involving nursing in the development and implementation of health care for patients and families.. The Nursing clinics of North America, 23(1), 1-9.
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  PMID: 3279403;Abstract: This article focuses on integrating nurses into the development, implementation, and evaluation of clinical, inpatient, community-based, and in-home services for patients with Alzheimer's disease and for their families.
• Buckwalter, K. C., Buckwalter, K. C., Abraham, I. L., Abraham, I. L., Neundorfer, M. M., & Neundorfer, M. M. (1988). Alzheimer's disease. Involving nursing in the development and implementation of health care for patients and families. Nursing Clinics of North America, 23(Issue 1).
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  This article focuses on integrating nurses into the development, implementation, and evaluation of clinical, inpatient, community-based, and in-home services for patients with Alzheimer's disease and for their families.
• Abraham, I. L. (1987). Linking health care and information technology: the future of computer applications in nursing.. NLN publications, 125-130.
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  PMID: 3648663;
• Abraham, I. L. (1987). Linking health care and information technology: the future of computer applications in nursing.. NLN publications.
• Abraham, I. L., & Fitzpatrick, J. J. (1987). KNOWING FOR NURSING PRACTICE: PATTERNS OF KNOWLEDGE AND THEIR EMULATION IN EXPERT SYSTEMS.. Proceedings - Annual Symposium on Computer Applications in Medical Care, 88-92.
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  Abstract: The authors address the issue of clinical knowledge in nursing, and the feasibility of emulating this knowledge in expert system technology. The perspective on patterns of knowing for nursing practice, advanced by B. A. Carper (1978), serves as the point of departure. The four patterns of knowing--empirics, esthetics, ethics, personal knowledge--are evaluated as to the extent to which they can be emulated in clinical expert systems, given constraints imposed by the current technology of these systems.
• Buckwalter, K. C., & Abraham, I. L. (1987). Alleviating the discharge crisis: the effects of a cognitive-behavioral nursing intervention for depressed patients and their families.. Archives of psychiatric nursing, 1(5), 350-358.
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  PMID: 3662621;
• Buckwalter, K. C., & Abraham, I. L. (1987). Alleviating the discharge crisis: the effects of a cognitive-behavioral nursing intervention for depressed patients and their families.. Archives of psychiatric nursing, 1(Issue 5).
• Fitzpatrick, J. J., & Abraham, I. L. (1987). Toward the socialization of scholars and scientists. Nurse Educator, 12(Issue 3). doi:10.1097/00006223-198705000-00009
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  Why do we need research and scholarship? What is quality research? How can we encourage scholarship? The authors discuss these questions and suggest ways to advance scholarship among nursing faculty and doctoral students © Lippincott-Raven Publishers.
• Fitzpatrick, J. J., & Abraham, I. L. (1987). Toward the socialization of scholars and scientists.. Nurse educator, 12(3), 23-25.
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  PMID: 3648532;
• Glazer, G., & Abraham, I. (1987). Obstetrical complications checklist: Description, factor analysis, and reliability. Health Care for Women International, 8(5-6). doi:10.1080/07399338709515796
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  This article reports on the development, initial validation, and testing of an instrument to measure obstetrical complications associated with maternal anxiety. Ninety-nine obstetrical complications reported in the literature were rated for clinical-conceptual relevance by 39 experts. Complications with high interrater reliability were subsequently included in a factor analysis. Estimates of internal consistency reliability were obtained. Five factors with a total of 39 items were retained. Loadings ranged from .37 to .92. In order to maximize parsimony and conceptual meaningfulness, a second item reduction was performed and yielded 31 items. Coefficient a for the total instrument was .95, and ranged from .77 to .96 for the sub-scales. The development of the Glazer and Abraham Obstetrical Complications Checklist is an initial step in providing an objective, uniform expert-referenced instrument to measure obstetrical complications. © Taylor & Francis Group, LLC.
• Jewell, J. A., Abraham, I. L., & Fitzpartrick, J. J. (1987). SELECTING AN APPROPRIATE PROBLEM FOR NURSING EXPERT SYSTEM DEVELOPMENT.. Proceedings - Annual Symposium on Computer Applications in Medical Care, 85-87.
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  Abstract: The process of translating the knowledge base of the expert critical care nurse clinicians (knowledge engineering) into an expert system that will serve as a support for decision-making for the selected problem is discussed. The specific components of the subproblem area of decisions regarding the use of restraints to prevent extubation (and thereby maintain the airway) are being explored by the knowledge engineer. The rationale for decisions of expert nurses applied to use of restraints to prevent extubation are being imbedded within the expert system program.
• 2nd., S. S., & Abraham, I. L. (1986). Computer use and nursing research. Interfacing microcomputers and nursing research--II. Dissemination of research findings and project management.. Western journal of nursing research, 8(4), 473-477.
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  PMID: 3643688;
• Abraham, I. L. (1986). Diagnostic discrepancy and clinical inference: a social-cognitive analysis.. Genetic, social, and general psychology monographs, 112(1), 41-102.
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  PMID: 3732786;Abstract: This review posits that clinical inference be studied as an instance of human inference. Normative rules for clinical inference may be derived from those for human inference in general, but clinicians choose not to adhere to them, relying instead on possibly biasing and suboptimal methods. A seven-phase model of clinical inference, with each phase containing particular tasks, is presented. Performance on these tasks depends on the effect of cognitive and environmental influences and the application of cognitive strategies, with erroneous performance leading to impaired clinical inference.
• Abraham, I. L. (1986). Diagnostic discrepancy and clinical inference: a social-cognitive analysis.. Genetic, social, and general psychology monographs, 112(Issue 1).
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  This review posits that clinical inference be studied as an instance of human inference. Normative rules for clinical inference may be derived from those for human inference in general, but clinicians choose not to adhere to them, relying instead on possibly biasing and suboptimal methods. A seven-phase model of clinical inference, with each phase containing particular tasks, is presented. Performance on these tasks depends on the effect of cognitive and environmental influences and the application of cognitive strategies, with erroneous performance leading to impaired clinical inference.
• Abraham, I. L., & 2nd., S. S. (1986). Computer use and nursing research: interfacing microcomputers and nursing research--I. Management and analysis of research data.. Western journal of nursing research, 8(3), 386-391.
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  PMID: 3639681;
• Abraham, I. L., & Krowchuk, H. v. (1986). Unemployment and health. Health promotion for the jobless male. Nursing Clinics of North America, 21(1), 37-47.
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  PMID: 3513133;Abstract: Unemployment and joblessness are two distinctly different yet interrelated issues. Unemployment is an economic statistic that indicates how bad the economy is. Joblessness, in contrast, is a psychosocial experience with pervasive effects on physical and mental health and quality of life. This article reviews these effects and suggests comprehensive strategies for health promotion among the jobless. Although the focus of this review is on the jobless male, his family and immediate social environment are also important concerns since both are likley to be affected.
• Abraham, I. L., & Schultz, S. (1986). Computer use and nursing research: Interfacing Microcomputers and Nursing Research-1. Management and Analysis of Research Data. Western Journal of Nursing Research, 8(Issue 3). doi:10.1177/019394598600800314
• Abraham, I. L., Fitzpatrick, J. J., & Jane, L. H. (1986). Computers in critical care nursing: Yet another technology?. Dimensions of Critical Care Nursing, 5(Issue 6). doi:10.1097/00003465-198611000-00001
• Abraham, I. L., Fitzpatrick, J. J., & Jane, L. H. (1986). Computers in critical care nursing: yet another technology?. Dimensions of critical care nursing : DCCN, 5(6), 325-326.
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  PMID: 3640691;
• McCain, N. L., Smith, M. C., & Abraham, I. L. (1986). Meta-Analyses of Nursing Interventions: The Codebook as a Research Instrument. Western Journal of Nursing Research, 8(Issue 2). doi:10.1177/019394598600800203
• McCain, N. L., Smith, M. C., & Abraham, I. L. (1986). Meta-analyses of nursing interventions: the codebook as a research instrument.. Western journal of nursing research, 8(2), 155-167.
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  PMID: 3638062;
• Musil, C. M., & Abraham, I. L. (1986). Coping, thinking, and mental health nursing: Cognitions and their application to psychosocial intervention. Issues in Mental Health Nursing, 8(Issue 3). doi:10.3109/01612848609014565
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  This article presents a cognitive perspective on coping. It is advanced that cognitions play a central role in coping since they reflect as well as influence how and with what people cope. Coping is seen as the aggregate of efforts aimed at modifying and regulating the impact and consequences of particular situations and events, the ultimate goal being the control of one's experiences. Three cognitive control efforts are discussed: making attributions, selecting attainable outcomes, and finding meaning in an experience. A review of strategies for psychosocial intervention based on these three cognitive processes concludes this article. © 1986 Informa UK Ltd All rights reserved: reproduction in whole or part not permitted.
• Musil, C. M., & Abraham, I. L. (1986). Coping, thinking, and mental health nursing: cognitions and their application to psychosocial intervention.. Issues in mental health nursing, 8(3), 191-201.
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  PMID: 3647954;
• Wood, J. E., Tiedje, L. B., & Abraham, I. L. (1986). Practicing Autonomously: A Comparison of Nurses. Public Health Nursing, 3(Issue 3). doi:10.1111/j.1525-1446.1986.tb00482.x
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  Forty‐five subjects including community health nurses with baccalaureate nursing degrees, senior‐level generic nursing students, and registered nurses in a baccalaureate nursing program were compared on age, years of employment in nursing, and three variables of professional autonomy: nurses' rights and responsibilities, the nurse‐patient relationship, and nurses' role in health care delivery. It was predicted that nurses from baccalaureate programs and those practicing in community health nursing would perceive themselves as more autonomous and that age and years of employment in nursing would not appreciably alter perceptions of autonomy. An analysis of variance confirmed the initial prediction at the 0.01 level of significance or better for nurses' rights and responsibilities and their role in health care delivery. A significant negative correlation was obtained between age and nurses' rights and responsibilities for the community health nurses; a significant positive correlation was obtained between years of work experience and nurses' rights and responsibilities for only the registered nurses. This study is perceived as an initial step in a lengthy process aimed at identifying factors that influence nurses' perceptions about professional autonomy. Copyright © 1986, Wiley Blackwell. All rights reserved
• Wood, J. E., Tiedje, L. B., & Abraham, I. L. (1986). Practicing autonomously: A comparison of nurses. Public Health Nursing, 3(3), 130-139.
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  PMID: 3639492;Abstract: Forty-five subjects including community health nurses with baccalaureate nursing degrees, senior-level generic nursing students, and registered nurses in a baccalaureate nursing program were compared on age, years of employment in nursing, and three variables of professional autonomy: nurses' rights and responsibilities, the nurse-patient relationship, and nurses' role in health care delivery. It was predicted that nurses from baccalaureate programs and those practicing in community health nursing would perceive themselves as more autonomous and that age and years of employment in nursing would not appreciably alter perceptions of autonomy. An analysis of variance confirmed the initial prediction at the 0.01 level of significance or better for nurses' rights and responsibilities and their role in health care delivery. A significant negative correlation was obtained between age and nurses' rights and responsibilities for the community health nurses; a significant positive correlation was obtained between years of work experience and nurses' rights and responsibilities for only the registered nurses. This study is perceived as an initial step in a lengthy process aimed at identifying factors that influence nurses' perceptions about professional autonomy.
• Abraham, I. L. (1985). Causal attributions of depression: Reliability of the 'causal dimension scale' in research on clinical inference. Psychological Reports, 56(Issue 2). doi:10.2466/pr0.1985.56.2.415
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  This article presents estimates of internal consistency for the Causal Dimension Scale, recently developed to measure causal attributions in terms of attributions of locus, stability, and controllability of the causes. In a study of the clinical inference of depression, alpha coefficients ranging from .68 to .96 were noted for the whole test and the subscales. The scale may prove helpful in the study of causal attributions about the mental health of others.
• Abraham, I. L. (1985). Causal attributions of depression: Reliability of the 'causal dimension scale' in research on clinical inference. Psychological Reports, 56(2), 415-418.
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  PMID: 4001248;Abstract: This article presents estimates of internal consistency for the Causal Dimension Scale, recently developed to measure causal attributions in terms of attributions of locus, stability, and controllability of the causes. In a study of the clinical inference of depression, alpha coefficients ranging from .68 to .96 were noted for the whole test and the subscales. The scale may prove helpful in the study of causal attributions about the mental health of others.
• Abraham, I. L., & Fitzpatrick, J. J. (1985). RESEARCH ENVIRONMENTS IN NURSING: RATIONALE AND REQUIREMENTS FOR COMPUTING.. Proceedings - Annual Symposium on Computer Applications in Medical Care, 814-818.
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  Abstract: The authors present the development and implementation of computing facilities at the Bolton School of Nursing. The approach differs from previous descriptions of school-based computing facilities in that it presents the professional and scientific context within which the system was conceived; the expected outcomes, direct and indirect, of investing in computing facilities; and the scientific and technical requirements to maximize its relevance to the mission and goals of the institution. A functional perspective of research development and facilitation among faculty and doctoral students is emphasized. The model system described is organized as a local area network of microcomputers with additional mainframe access.
• Nicoll, L. H., Meyer, P. A., & Abraham, I. L. (1985). Critique: external comparison of conceptual nursing models.. ANS. Advances in nursing science, 7(4), 1-9.
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  PMID: 3927824;Abstract: Research by Jacobson on development of a semantic differential for external comparison of conceptual nursing models was reported in 1984. The present article critiques the philosophical stance and the research methods presented in the Jacobson report. Methods of analysis and evaluation of conceptual nursing models are reviewed, and the influences of conceptual nursing models on the structure of the discipline are examined in light of the purposes of the Jacobson study. Issues related to the investigation and use of models in the development of nursing knowledge are discussed.
• Nicoll, L. H., Meyer, P. A., & Abraham, I. L. (1985). Critique: external comparison of conceptual nursing models.. ANS. Advances in nursing science, 7(Issue 4). doi:10.1097/00012272-198507000-00003
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  Research by Jacobson on development of a semantic differential for external comparison of conceptual nursing models was reported in 1984. The present article critiques the philosophical stance and the research methods presented in the Jacobson report. Methods of analysis and evaluation of conceptual nursing models are reviewed, and the influences of conceptual nursing models on the structure of the discipline are examined in light of the purposes of the Jacobson study. Issues related to the investigation and use of models in the development of nursing knowledge are discussed.
• Ozbolt, J. G., II, S. S., Swain, M. A., & Abraham, I. L. (1985). A proposed expert system for nursing practice - A springboard to nursing science. Journal of Medical Systems, 9(1-2), 57-68.
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  PMID: 3839835;Abstract: The knowledge on which nursing practice is based comes largely from traditional sources, expert nurses passing on the wisdom of their experience to novices. Nursing research, although increasing, is usually parallel to nursing practice, and its findings, at best, are implemented only after long delays. Consequently, the most effective nursing responses to a particular client problem may be undiscovered or unknown. Nursing information systems reflect the nature and usage of nursing knowledge. They offer standard care plans, but the knowledge and decision structures for individualizing care remain exclusively in the mind of the nurse. Nurses may have great freedom to enter information into the information system, but the information is rarely retrievable in a form suitable for evaluation or research. Nursing practice, and the knowledge on which it is based, could be enhanced through the use of a novel expert system. This paper describes how such a system could be developed, with examples from the authors' prototype programs. Taxonomies of data, diagnoses, objectives, and interventions would make it possible to compare patients and to determine the relative effectiveness of nursing interventions. A built-in evaluation component would provide feedback and correction. Everyday nursing practice would become a field for research, and the knowledge gained from research would immediately be fed back into practice. In its development and in its implementation, this kind of system would help to build nursing science. © 1985 Plenum Publishing Corporation.
• Ozbolt, J. G., II, S. S., Swain, M. A., & Abraham, I. L. (1985). PROPOSED EXPERT SYSTEM FOR NURSING PRACTICE: A SPRINGBOARD TO NURSING SCIENCE.. Proceedings of the Hawaii International Conference on System Science, 289-302.
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  Abstract: Nursing practice, and the knowledge on which it is based, could be enhanced through the use of a novel expert system. This paper describes how such a system could be developed, with examples from the authors' prototype programs. Taxonomies of data, diagnoses, objectives, and interventions would make it possible to compare patients and to determine the relative effectiveness of nursing interventions. A built-in evaluation component would provide feedback and correction. Everyday nursing practice would become a field for research, and the knowledge gained from research would immediately be fed back into practice. In its development and in its implementation, this kind of system would help to build nursing science.
• Ozbolt, J. G., Schultz, S., Swain, M. A., & Abraham, I. L. (1985). A proposed expert system for nursing practice - A springboard to nursing science. Journal of Medical Systems, 9(Issue 1-2). doi:10.1007/bf00992522
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  The knowledge on which nursing practice is based comes largely from traditional sources, expert nurses passing on the wisdom of their experience to novices. Nursing research, although increasing, is usually parallel to nursing practice, and its findings, at best, are implemented only after long delays. Consequently, the most effective nursing responses to a particular client problem may be undiscovered or unknown. Nursing information systems reflect the nature and usage of nursing knowledge. They offer standard care plans, but the knowledge and decision structures for individualizing care remain exclusively in the mind of the nurse. Nurses may have great freedom to enter information into the information system, but the information is rarely retrievable in a form suitable for evaluation or research. Nursing practice, and the knowledge on which it is based, could be enhanced through the use of a novel expert system. This paper describes how such a system could be developed, with examples from the authors' prototype programs. Taxonomies of data, diagnoses, objectives, and interventions would make it possible to compare patients and to determine the relative effectiveness of nursing interventions. A built-in evaluation component would provide feedback and correction. Everyday nursing practice would become a field for research, and the knowledge gained from research would immediately be fed back into practice. In its development and in its implementation, this kind of system would help to build nursing science. © 1985 Plenum Publishing Corporation.
• Abraham, I. L., & Foley, T. S. (1984). The Work Environment Scale and the Ward Atmosphere Scale (short forms): psychometric data.. Perceptual and Motor Skills, 58(1), 319-322.
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  PMID: 6718198;Abstract: Alpha coefficients of internal consistency for the Short Forms of the Work Environment Scale and Ward Atmosphere Scale, their major dimensions and their subscales are presented. Although some exceptions were noted, the indices reported here attest to the adequate reliability of the short forms of the two scales, which was previously documented for the unabridged forms. The few exceptions are hypothesized to be attributable to either sampling error or the fact that each factor is comprised of only 4 items. The need for further reliability testing of these short forms is emphasized.
• Abraham, I. L., & Foley, T. S. (1984). The Work Environment Scale and the Ward Atmosphere Scale (short forms): psychometric data.. Perceptual and motor skills, 58(Issue 1). doi:10.2466/pms.1984.58.1.319
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  Alpha coefficients of internal consistency for the Short Forms of the Work Environment Scale and Ward Atmosphere Scale, their major dimensions and their subscales are presented. Although some exceptions were noted, the indices reported here attest to the adequate reliability of the short forms of the two scales, which was previously documented for the unabridged forms. The few exceptions are hypothesized to be attributable to either sampling error or the fact that each factor is comprised of only 4 items. The need for further reliability testing of these short forms is emphasized.
• Abraham, I. L., Schultz, S., Ozbolt, J. G., & Ann, M. (1984). MULTIVARIATE MATHEMATICAL ALGORITHM FOR DIAGNOSTIC INFORMATION SYSTEMS: II. PROCEDURES FOR CLINICAL INFERENCE.. Proceedings - Annual Symposium on Computer Applications in Medical Care, 107-111.
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  Abstract: For Pt. I, see Proc. Eur. Fed. for Medical Informatics (1984). The procedures for clinical inference of a multivariate algorithm for diagnostic information systems are presented. This complements the description given in Pt. I of procedures for data acquisition and storage of the proposed algorithm. Clinical inference is viewed as a twofold process of (1) acquiring and sampling information, and organizing it in a fashion conducive to subsequent analysis; and (2) deciding about the normality or abnormality of functional health domains. Normality is defined as being within the limits of a population criterion interval. The mathematical explication of clinical inference as used in the algorithm is emphasized.
• Ozbolt, J. G., Schultz, S., Ann, M., Abraham, I. L., & Farchaus-Stein, K. (1984). DEVELOPING AN EXPERT SYSTEM FOR NURSING PRACTICE.. Proceedings - Annual Symposium on Computer Applications in Medical Care, 654-657.
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  Abstract: The American Nurses Association has set eight standards of nursing practice related to the nursing process. Computer-aided information systems intended to facilitate the nursing process must be designed to promote adherence to these professional standards. For each of the eight standards, the authors describe how a hypothetical expert system could help nurses meet the standard. A prototype of such an expert system is being developed. Issues in conceptualizing clinical decision-making and developing decision strategies for the prototype system are discussed. The process of developing the prototype system is also described.
• Abraham, I. L., & 2nd., S. S. (1983). Univariate statistical models for meta-analysis.. Nursing Research, 32(5), 312-315.
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  PMID: 6554622;
• Abraham, I. L., & Hagerty, B. K. (1983). Development and initial reliability testing of an instrument to measure attitudes toward in-service programming among psychiatric hospital staff. Psychological Reports, 53(2), 589-590.
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  PMID: 6647706;Abstract: An instrument to determine clinical staff's perceptions and valuations of in-service programming, the Staff Development Evaluation Questionnaire, is presented. Initial testing on sample of 55 psychiatric nursing staff in a quasi-experimental one-group pretest-posttest design yielded alpha coefficients of .83 for both the pretest and the posttest and a test-retest coefficient of temporal stability of .81. The need for further assessment of reliability is emphasized, a process currently being undertaken.
• Abraham, I. L., & Hagerty, B. K. (1983). Development and initial reliability testing of an instrument to measure attitudes toward in-service programming among psychiatric hospital staff. Psychological Reports, 53(Issue 2). doi:10.2466/pr0.1983.53.2.589
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  An instrument to determine clinical staff's perceptions and valuations of in-service programming, the Staff Development Evaluation Questionnaire, is presented. Initial testing on sample of 55 psychiatric nursing staff in a quasi-experimental one-group pretest-posttest design yielded alpha coefficients of .83 for both the pretest and the posttest and a test-retest coefficient of temporal stability of .81. The need for further assessment of reliability is emphasized, a process currently being undertaken.
• Abraham, I. L., & Schultz, S. (1983). Univariate statistical models for meta-analysis. Nursing Research, 32(Issue 5). doi:10.1097/00006199-198309000-00012
• Abraham, I. L. (1982). Support groups for nursing students in psychiatric rotation. Issues in Mental Health Nursing, 4(Issue 3). doi:10.3109/01612848209141052
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  The content and process of a support group for undergraduate nursing students in clinical rotation in an inpatient psychiatric setting is presented and analyzed. This analysis provides the basis for a discussion on the potential of integrating experiential learning about groups into undergraduate nursing curricula. It is argued that such curriculum change will allow student nurses to establish a personal practice-oriented knowledge base about group processes and about their own patterns of group participation. It is also asserted that this knowledge will prepare them to build group programs into their clinical practice. Finally, it is argued that the group participation itself serves also an immediate function in that it provides student nurses to emotionally deal with the psychological demands of nursing practice. © 1982 Informa UK Ltd All rights reserved: reproduction in whole or part not permitted.
• Abraham, I. L. (1982). Support groups for nursing students in psychiatric rotation.. Issues in mental health nursing, 4(3), 159-165.
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  PMID: 6926410;
• Hagerty, B. K., & Abraham, I. L. (1982). The attitudes of psychiatric nursing staff toward staff development programs: A quasi-experimental analysis. Issues in Mental Health Nursing, 4(Issue 4). doi:10.3109/01612848209141063
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  This study investigated psychiatric nursing staff's attitudes toward in-service education; how these attitudes may change; and the factors promoting such changes. A sample of 55 psychiatric nursing staff at a major midwestern academic hospital were administered the Staff Development Evaluation Survey (DES) (Hagerty and Abraham, 1982-reliability: Cronbach's alpha ==.83, test-retest coefficient ==.81) before and after their participation in a comprehensive in-service educational program. Although attitudes were consistently favorable, this quasi-experimental, one-group, pretest-posttest study revealed a general trend of decreasing attitudes after program implementation. Yet this trend was found to be a function of the professional responsibilities, educational backgrounds, and work settings. Moreover, this trend could be explained as the result of a significant decrease on one dimension of the SDES: the administrative issues related to staff development. The implications for nursing administrators and educators are discussed. © 1982 Informa UK Ltd All rights reserved: reproduction in whole or part not permitted.
• Hagerty, B. K., & Abraham, I. L. (1982). The attitudes of psychiatric nursing staff toward staff development programs: a quasi-experimental analysis.. Issues in mental health nursing, 4(4), 317-329.
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  PMID: 6927618;

Proceedings Publications

• Abraham, I. L., McBride, A., Slack, M. K., & Alrawashdh, N. (2020, Winter). Economic evaluation of ibrutinib versus acalabrutinib versus zanubrutinib for patients with relapsed or refractory mantle cell lymphoma.. In Blood, 136, 9-10.
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• Abraham, I., Bime, C., Camp, S. M., Carter, D., Casanova, N. G., Dessap, A. M., Downs, C. A., Garcia, J. G., Lussier, Y. A., Lynn, H., Miller, E. J., Ndukum, J., & Oita, R. C. (2020). A Prognostic Biomarker-Based Panel for Patient Stratification in Adults with Acute Respiratory Distress Syndrome. In A104. LUNGS, BUGS, AND THE DIAPHRAGM: TRANSLATIONAL STUDIES IN THE ICU.
• Alrawashdh, N., Almutairi, A. R., McBride, A., & Abraham, I. L. (2020, Winter). Economic evaluation of daratumumab and pomalidomide and dexamethasone versus isatuximab and pomalidomide and dexamethasone for patients with relapsed or refractory multiple myeloma. In Blood, 136 (Suppl 1), 19-20.
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• Bahn, C., Valsvik, K., Arredondo, A., Notbohm, A., Kumar, A., Cranmer, L., Kraft, A., Abraham, I. L., & McBride, A. (2020, Spring). Transitioning adriamycin ifosfamide mesna (AIM) chemotherapy in sarcoma patients to the outpatient setting: evaluation of outpatient chemotherapy in an oncology care model setting.. In Journal of Clinical Oncology, 38 (Suppl), e19149.
• Bartels, T., Moore, L., Persky, D. O., Kumar, A., Abraham, I. L., & McBride, A. (2020, Spring). Utilizing a novel four-drug regimen to reduce the incidence of infusion-related reactions for first-dose rituximab infusions: an institutional review of rituximab infusion-related reactions in lymphoma patients.. In Journal of Clinical Oncology, 38 (Suppl), e19148.
• Bin Riaz, I., Almutairi, A. R., Lang, D. K., Ashgar, N., Riaz, A., Yao, Y., Sipra, Q., Ryu, A. J., Alkhatib, N., Oh, M., Abraham, I. L., Murad, M. H., & Kohli, M. (2020, Spring). Cost-effectiveness of novel antiandrogens (AAs) for treatment of nonmetastatic castrate-resistant prostate cancer (nmCRPC). In Journal of Clinical Oncology, 38 (Suppl 6), 5583.
• Bin Riaz, I., Lang, D. K., Yao, Y., Riaz, A., Almutairi, A. R., Wang, Z., Abraham, I. L., Murad, M. H., & Kohli, M. (2020, Spring). A systematic review and network meta-analysis of FDA approved treatment options in men with nonmetastatic, castration-resistant prostate cancer (M0CRPC).. In Journal of Clinical Oncology, 38 (Suppl 6), 335.
• Combs, D., Edgin, J. O., Klewer, S., Barber, B. J., Morgan, W. J., Hsu, C. H., Abraham, I., & Parthasarathy, S. (2020). OSA and Neurocognitive Impairment in Children With Congenital Heart Disease. In Pediatrics Something, 158.
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  Background: Children with congenital heart disease (CHD) have an increased risk of neurocognitive impairment. No prior studies have evaluated the role of OSA, which is associated with neurocognitive impairment in children without CHD. Research Question: Is OSA is associated with neurocognitive impairment in children with CHD? Study Design and Methods: Children aged 6 to 17 years with corrected moderate to complex CHD without syndromes that may affect neurocognition were recruited from the pediatric cardiology clinic. Participants underwent home sleep testing and neurocognitive testing, including a validated Intellectual Quotient (IQ) test as well as validated tests of memory (Paired Associates Learning test), executive function (Intra-Extra Dimensional set shift test), and attention (Simple Reaction Test) from the CANTAB neurocognitive testing battery. Results: Complete results were available for 30 children. Seventeen children (57%) were found to have OSA. Total IQ was markedly lower in children with CHD and comorbid OSA compared with children with CHD without comorbid OSA (mean, 86 ± 12 vs 98 ± 11; P = .01). Children with CHD and OSA did significantly worse on the Paired Associates Learning test, with a median of eight total errors (interquartile range [IQR], 2.25-15) compared with children with CHD without OSA (median total errors, 2, IQR, 1-8; P = .02). Interpretation: Children with CHD and comorbid OSA have impaired neurocognition compared with children with CHD without comorbid OSA. OSA may be a reversible cause of neurocognitive impairment in children with CHD. Further research is needed to evaluate the effects of OSA treatment on neurocognitive impairment in children with CHD.
• McBride, A., MacDonald, K., & Abraham, I. L. (2020, Spring). Simulation modeling of budget-neutral expanded access to antineoplastic therapy from cost-savings derived from conversion to biosimilar pegfilgrastim-cbqv for the prophylaxis of chemotherapy-induced (febrile) neutropenia (CIN/FN) in early-stage breast cancer.. In Journal of Clinical Oncology, 38 (Suppl), e19371.
• McBride, A., MacDonald, K., & Abraham, I. L. (2020, Spring). Simulation modeling of cost-savings from conversion of pegfilgrastim to biosimilar pegfilgrastim-cbqv for the prophylaxis of chemotherapy-induced (febrile) neutropenia (CIN/FN) and expanded access to biosimilar prophylaxis.. In Journal of Clinical Oncology, 38 (Suppl), e19372.
• McBride, A., MacDonald, K., & Abraham, I. L. (2020, Winter). Conversion to biosimilar pegfilgrastim-jmdb from pegfilgrastim with on-body injector device in diffuse large b-cell lymphoma: simulation modeling of cost-savings and budget-neutral expanded access to prophylaxis and anti-neoplastic therapy considering device failure rate.. In Blood, 136 (Suppl 1), 22.
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• McBride, A., MacDonald, K., & Abraham, I. L. (2020, Winter). Simulation modeling of cost-savings from conversion to biosimilar pegfilgrastim-cbqv for the prophylaxis of chemotherapy-induced neutropenia, and budget-neutral expanded access to prophylaxis and anti-neoplastic therapy from derived cost-savings in non-Hodgkin lymphoma.. In Blood, 136 (Suppl 1), 24-25.
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• AlRawashdh, N., Oh, M., Almutairi, A., Alkhatib, N., Babiker, H., MacDonald, K., McBride, A., & Abraham, I. (2019, Summer). 30-year extrapolations of overall survival and metastasis-free survival from the SPCG-4 trial of radical prostatectomy versus watchful waiting in patients with early prostate cancer. (abstract). In Journal of Clinical Oncology, 37 (Suppl), e16597.
• Algotar, A., Hsu, C. H., Chow, H. H., Dougherty, S., Babiker, H., Marrero, D. G., Abraham, I., Kumar, R., Ligibel, J. A., Courtney, K. S., & Thomson, C. A. (2019, Spring). Comprehensive lifestyle improvement program for prostate cancer (CLIPP): a feasibility study in men with prostate cancer on ADT. (abstract). In Journal of Clinical Oncology.
• Alkhatib, N., Choi, B., Pae, E., Babiker, H., Garland, L., Henglefelt, A., McBride, A., & Abraham, I. (2019, Summer). Economic evaluation of anaplastic lymphoma kinase inhibitors brigatinib, alectinib and crizotinib in non-small cell lung cancer: analysis for intracranial metastasis-related progression free survival (abstract). In Journal of Clinical Oncology, 37 (Suppl), e20515.
• Alkhushaym, N., Almutairi, A., Fallatah, S., Altaghafi, A., Oh, M., Babiker, H., & Abraham, I. (2019, Summer). Proton pump inhibitor (PPI) exposure and risk of pancreatic cancer (PC): meta-analysis. (abstract). In Journal of Clinical Oncology, 37 (Suppl), e15755.
• Almutairi, A., McBride, A., Garland, L., & Abraham, I. (2019, Summer). PD-1 versus PD-L1 inhibitors for previously treated advanced non-small cell lung cancer: Bayesian network meta-analysis (abstract). In Journal of Clinical Oncology, 37 (Suppl), e20511.
• Almutairi, A., McBride, A., Sundararajan, S., & Abraham, I. (2019, Summer). Immune-related adverse events of mono-, combination, and sequential therapy regimens of ipilimumab, nivolumab, and pembrolizumab for advanced melanoma. (abstract). In Journal of Clinical Oncology, 37 (Suppl), e21011.
• Barqawi, Y., Borrego, M., Roberts, M., & Abraham, I. (2019, Spring). Cost effectiveness analysis comparing enzalutamide, abiraterone plus prednisone and cabazitaxel plus predinsone for the treatment of visceral metastatic castration resistant prostate cancer post docetaxel failure. (abstract). In Value in Health, 22, S75.
• Choi, B., Alkhatib, N., Pae, E., Babiker, H., Garland, L., Henglefelt, A., McBride, A., & Abraham, I. (2019, Summer). Economic evaluation of crizotinib, alectinib and brigatinib in anaplastic lymphoma kinase positive non-small cell lung cancer. (abstract). In Journal of Clinical Oncology, 37 (Suppl), e20714.
• Combs, D., Abraham, I. L., Hsu, C., Morgan, W. J., Patel, S. I., & Parthasarathy, S. (2019, December). Comparison of parent and child treatment preferences for obstructive sleep apnea. In Chest.
• Oh, M., Marini, B., Perissinotti, A., Benitez, L., Burke, P. W., Bixby, D. L., Pettit, K. M., Abraham, I., & McBride, A. (2019, Summer). Bayesian network meta-analysis of complete remission without or with incomplete hematologic recovery to CPX-351, FLAG, and standard 7+3 chemotherapy in the treatment of newly diagnosed secondary acute myeloid leukemia. (abstract). In Journal of Clinical Oncology, 37 (Suppl), e18514.
• Oh, M., Patanwala, S., Alsaid, N., Almutairi, A., Abraham, I., & Erstad, B. (2019, Summer). Cost analysis of adjunctive hydrocortisone therapy for septic shock from the US payer perspective. (abstract). In Critical Care Medicine, 47, 800.
• Perloff, T., Dawkins, M., Crews, J. R., Gregg, J. P., Abraham, I., & Schwartzberg, L. (2019, Spring). A multi-specialty approach to immune-oncology education for community providers. (abstract). In Journal of Clinical Oncology, 37, 80.
• AlRawahdh, N., McBride, A., Lee, C., Diri, R., Bagalagel, A., Bakhsh, H., Babiker, H. M., MacDonald, K., & Abraham, I. L. (2018, Spring). Outcomes of pegfilgrastim administration on the same day vs the day after chemotherapy in the prophylaxis of chemotherapy-induced (febrile) neutropenia: systematic review and meta-analysis. In Journal of Clinical Oncology, 36(Suppl), e14510.
• Alhifany, A., McBride, A., Almutairi, A., Babiker, H. M., MacDonald, K., & Abraham, I. L. (2018, Spring). Efficacy of thalidomide, neurokinin-1 receptor antagonist, and olanzapine in combination with palonosetron plus dexamethasone in preventing chemotherapy-induced nausea and vomiting induced by highly emetogenic chemotherapy: Bayesian network meta-analysis. In Journal of Clinical Oncology, 36(Suppl), e14514.
• Almutairi, A., Alsaid, N., Martin, J., Babiker, H. M., McBride, A., & Abraham, I. L. (2018, Spring). Comparative efficacy and safety of immunotherapies targeting PD-1/PD-L1 pathway for previously treated advanced non-small cell lung cancer: Bayesian network meta-analysis. In Journal of Clinical Oncology, 36(Suppl), e21012.
• Almutairi, A., Alsaid, N., Oh, M., Babiker, H. M., McBride, A., & Abraham, I. L. (2018, Spring). Economic evaluation of the combination of talimogene laherparepvec plus ipilimumab versus ipilimumab in patients with advanced unresectable melanoma. In Journal of Clinical Oncology, 36(Suppl), e21545.
• Alsaid, N., McBride, A., Persky, D., Anwer, F., Andritsos, L., Kumar, A., Yun, S., Babiker, H. M., & Abraham, I. L. (2018, Spring). Economic evaluation for the US of venetoclax versus ibrutinib versus allogeneic hematopoietic stem-cell transplantation for patients with relapsed or refractory chronic lymphocytic leukemia with 17p deletion. In Journal of Clinical Oncology, 36(Suppl), 7527.
• Bin Riaz, I., Almutairi, A., Zeeshan, A., Alhifany, A., Bhattacharjee, S., Abraham, I. L., & Kohli, M. (2018, February). Abiraterone acetate or docetaxel in metastatic castration-sensitive prostate cancer: a systematic review and network meta-analysis of randomized controlled trials.. In Journal of Clinical Oncology, 36(Suppl 6S), 243.
• Combs, D., Abraham, I. L., Hsu, C., Morgan, W. J., Bailey, O., & Parthasarathy, S. (2018, Spring). Parent treatment preferences for mild obstructive sleep apnea in children. In American Journal of Respiratory and Critical Care Medicine, 197, A2005.
• Combs, D., Edgin, J. O., Barber, B. J., Klewer, S. E., Morgan, W. J., Hsu, C., Abraham, I. L., & Parthasarathy, S. (2018, Fall). Obstructive sleep apnea is a novel risk factor for neurocognitive impairment in children with congenital heart disease. In Circulation, 138(Suppl 1), 14956.
• Combs, D., Edgin, J. O., Barber, B. J., Morgan, W. J., Hsu, C., Abraham, I. L., & Parthasarathy, S. (2018, Fall). Sleep-disordered breathing is associated with neurocognitive impairment in children with congenital heart disease. In Sleep, 41, A277.
• Fletcher, S., Alsaid, N., Katragadda, C., Martin, J. R., Babiker, H. M., Algotar, A., McBride, A., MacDonald, K., & Abraham, I. L. (2018, Spring). Risk of biochemical recurrence in prostate cancer patients with perineural invasion: systematic review and meta-analysis.. In Journal of Clinical Oncology, 36(Suppl), e21671..
• Garcia, A., Frahm, C., Jeter, J., Abraham, I. L., Chambers, S., Cragun, J., & McBride, A. (2018, Spring). Incidence of hypersensitivity reactions to carboplatin or paclitaxel in patients with ovarian, fallopian tube, or primary peritoneal cancer with or without BRCA1 or BRCA2 mutations. In Journal of Clinical Oncology, 36(Suppl), e18758.
• Hinchman, A., Abraham, I. L., Almutairi, A., Sundararajan, S., Lattimore, L., Babiker, H. M., & McBride, A. (2018, Spring). Clinical experience with talimogene laherparepvec (Imlygic®) in a melanoma population at a university based cancer center. In Journal of Clinical Oncology, 36(Suppl), e21547.
• McBride, A., Abraham, I. L., MacDonald, K., Campbell, K., Bikkina, M., & Balu, S. (2017, June). Cost savings of conversion from Neupogen or Neulasta to biosimilar Zarxio for chemotherapy-induced (febrile) neutropenia prophylaxis and expanded access to biosimilar GCSF on a budget neutral basis.. In Jounal of Clinical Oncology, 35(Suppl), e18344.
• McBride, A., Balu, S., Campbell, K., MacDonald, K., & Abraham, I. L. (2018, Winter). Subcutaneous versus intravenous rituximab in non-Hodgkin’s lymphoma treated with R-CHOP: economic modeling for the US. In Blood, 132(Suppl 1):, 4776.
• McBride, A., Campbell, K., Bikkina, M., MacDonald, K., Abraham, I. L., & Balu, S. (2018, Winter). Cost-efficiency of chemotherapy-induced (febrile) neutropenia prophylaxis with biosimilar ZARXIO® over NEUPOGEN®, NEULASTA®, and NEULASTA/ONPRO®: breast cancer case study.. In Cancer Research, 78(Suppl 1), 3380.
• McBride, A., Krenduykov, A., Mathieson, N., Campbell, K., Balu, S., MacDonald, K., & Abraham, I. L. (2018, Fall). Cost simulation for the US febrile neutropenia hospitalization due to pegfilgrastim on-body injector failure compared to single-injection pegfilgrastim and daily injections with reference and biosimilar in lung cancer.. In Annals of Oncology, 29(Suppl 9), ix133.
• McBride, A., Krenduykov, A., Mathieson, N., Campbell, K., Balu, S., MacDonald, K., & Abraham, I. L. (2018, Winter). Cost simulation for febrile neutropenia hospiyalization in the US due to pegfilgrastim on-body injector failure compared to single-injection pegfilgrastim and daily injections with reference and biosimilar in non-Hodgkin lymphoma.. In Blood, 132(Suppl 1):, 2251.
• Oh, M., Aljadeed, R., Al Khushaym, N., Althagfi, A., Fallatah, S., Babiker, H. M., McBride, A., & Abraham, I. L. (2018, Spring). The association of BRCA1 and BRCA2 mutations on prostate cancer risk, frequency, and mortality: systematic review and meta-analysis.. In Journal of Clinical Oncology, 36(Suppl), 5060.
• Oh, M., Almutairi, A., Alsaid, N., Babiker, H. M., McBride, A., & Abraham, I. L. (2018, Spring). Progression-free and overall survival in treatment of BRAF mutation-positive metastatic melanoma: Bayesian network meta-analysis. In Journal of Clinical Oncology, 36(Suppl), e21532.
• Oh, M., McBride, A., Yun, S., Bhattacharjee, S., Slack, M., Martin, J., Jeter, J., & Abraham, I. L. (2018, January). BRCA1 and BRCA2 gene mutations and colorectal cancer risk: systematic review and meta-analysis.. In Journal of Clinical Oncology, 36(Suppl. 4S), 605.
• Recio Boiles, A., Alkhatib, N., McBride, A., Abraham, I. L., & Elquza, E. (2018, Winter). Recurrent venous thromboembolism, major bleeding, and associated cost of treatment with low molecular weight heparin or direct oral anticoagulant in patients with gastrointestinal malignancies: retrospective real-world analysis at a comprehensive cancer center. In Blood, 132(Suppl 1):, 5057.
• Tompkinson, M., Fine, K., Gruber, D., Abraham, I. L., Babiker, H. M., & McBride, A. (2018, Spring). A survey of perceptions of healthcare workers on the cost and safety of oral oncolytic agents in practice. In Journal of Clinical Oncology, 36(Suppl), e14510.
• Aapro, M., Bokemeyer, C., Boccadoro, M., Gascon, P., Denhaerynck, K., Krendyokov, A., Abraham, I., MacDonald, K., & Ludwig, H. (2017, November). Chemotherapy-induced (febrile) neutropenia prophylaxis with biosimilar filgrastim in solid tumours versus haematological malignancies: patterns, outcomes and determinants (MONITOR-GCSF study).. In Annals of Oncology, 28(Suppl 10).
• Abraham, I., Katragadda, C., Katz, M., Erstad, B., MacDonald, K., & Ojo, A. (2017, November). Forecasts for 2030 for the end-stage renal disease (ESRD)/dialysis workforce in the US.. In Journal of the American Society of Nephrology, 28 (Abstract edition), 606.
• Alsaid, N., McBride, A., Agarwal, A., Al Mutairi, A., Anwer, F., & Abraham, I. (2017, June). Economic evaluation of carfilzomib, ixazomib, elotuzumab, or daratumumab with lenalidomide and dexamethasone (LEN+DEX) vs LEN and DEX in relapsed/refractory multiple myeloma (R/R MM).. In Journal of Clinical Oncology 2017, 35, 8030.
• Alsaid, N., McBride, A., Kim, H., Oh, M., Andritsos, L., Anwer, F., Persky, D., Kumar, A., Yun, S., & Abraham, I. (2017, December). Economic evaluation for the US of ibrutinib versus allogeneic hematopoietic stem-cell transplantation for patients with relapsed or refractory chronic lymphocytic leukemia with 17p deletion.. In Blood, 130(Suppl 1), 4679.
• Alsaid, N., McBride, A., Oh, M., Persky, D., Anwer, F., Andritsos, L., Kumar, A., Yun, S., & Abraham, I. (2017, December). Economic evaluation for the US of venetoclax versus allogeneic hematopoietic stem-cell transplantation for patients with relapsed or refractory chronic lymphocytic leukemia with 17p deletion.. In Blood, 130(Suppl 1), 4680.
• Alsaid, N., Sweitzer, N., Ramos, K., Erstad, B., Slack, M., & Abraham, I. (2017, November). Classification of causes of hospitalization for heart failure patients in cost-effectiveness and cost-utility evaluations of pharmacotherapeutic, surgical, and managed-care interventions: systematic review.. In Value in Health, 20, A740.
• Balu, S., McBride, A., Campbell, K., Bikkina, M., MacDonald, K., & Abraham, I. (2017, May). Comparative cost-efficiency of filgrastim, biosimilar filgrastim-sndz, and pegfilgrastim for the prophylaxis of chemotherapy-induced (febrile) neutropenia in the US.. In Supportive Care in Cancer, 25(Suppl 2), S143.
• Bokemeyer, C., Aapro, M., Gascon, P., Boccadoro, M., Ludwig, H., Krendyokov, A., MacDonald, K., & Abraham, I. (2017, November). Proof-of-concept of a risk calculator of chemotherapy induced (febrile) neutropenia based on real-world evidence (MONITOR-GCSF study).. In Annals of Oncology, 28(Suppl 10).
• Dellanna, F., Goldsmith, D., Mann, J., Zaoui, P., Combe, C., Krendyukov, A., MacDonald, K., & Abraham, I. (2017, November). Predictive hierarchical modeling of determinants of outcomes of anemia management with Binocrit®, a biosimilar epoetin alfa, in the hemodialysis setting (MONITOR-CKD5 study).. In Journal of the American Society of Nephrology, 28 (Abstract edition), 891.
• Gharaibeh, M., Alsaid, N., & Abraham, I. (2017, November). An algorithm to quantitatively estimate extrapolated lifetime survival curves for economic evaluation of cancer treatments when only aggregrated patient data are available; with application to metastatic pancreatic cancer.. In Value in Health, 20, A733-A734.
• Maiese, E., Graham, C., Have, E., Le Moine, J., Abraham, I., & Senbetta, M. (2017, December). Cost-effectiveness of daratumumab plus bortezomib and dexamethasone versus bortezomib and dexamethasone for treatment of patients with multiple myeloma who have received at least one prior therapy: an analysis of the CASTOR trial.. In Blood, 130(Suppl 1).
• Maiese, E., Graham, C., Have, E., Le Moine, J., Abraham, I., & Senbetta, M. (2017, December). Cost-effectiveness of daratumumab plus lenalidomide and dexamethasone versus lenalidomide and dexamethasone for treatment of patients with multiple myeloma who have received at least one prior therapy: an analysis of the CASTOR trial.. In Blood, 130(Suppl 1).
• McBride, A., Abraham, I., MacDonald, K., Campbell, K., Bikkina, M., & Balu, S. (2017, June). Cost savings of conversion from Neupogen or Neulasta to biosimilar Zarxio for chemotherapy-induced (febrile) neutropenia prophylaxis and expanded access to biosimilar GCSF on a budget neutral basis.. In Journal of Clinical Oncology, 35(Suppl).
• McBride, A., Campbell, K., Bikkina, M., MacDonald, K., Abraham, I. L., & Balu, S. (2017, December). Cost-efficiency of chemotherapy-induced (febrile) neutropenia prophylaxis with biosimilar ZARXIO® over NEUPOGEN®, NEULASTA®, and NEULASTA/ONPRO®: breast cancer case study.. In Cancer Research.
• McBride, A., Campbell, K., Bikkina, M., MacDonald, K., Abraham, I. L., & Balu, S. (2017, December). Expanded access to obinutuzumab from cost-savings generated from biosimilar filgrastim-sndz in the prophylaxis of chemotherapy-induced (febrile) neutropenia: US simulation study.. In Blood, 130(Suppl 1), 3380.
• McBride, A., Campbell, K., Bikkina, M., MacDonald, K., Abraham, I., & Balu, S. (2017, November). Expanded access to pembrolizumab from cost-savings generated from biosimilar filgrastim-sndz in the prophylaxis of chemotherapy-induced (febrile) neutropenia: simulation study.. In Value in Health, 20, A443.
• McBride, A., Katragadda, C., & Abraham, I. (2017, June). Safety and efficacy of direct oral anticoagulants in cancer patients: meta-analysis of randomized controlled trials.. In Journal of Clinical Oncology, 35(Suppl), e18264.
• Mushtaq, A., Kapoor, V., Iftikhar, A., Zafar, R., Warraich, F., Sami, W., McBride, A., Tenet, P., Russ, A., Razkak, D., Halajian, M., Abraham, I., & Anwer, F. (2017, December). Efficacy and safety profile of carfilzomib based regimens for treatment of multiple myeloma, a systematic review. In Blood, 130(Suppl 1), 5413.
• Gascon, P., Aapro, M., Ludwig, H., Boccadoro, M., Bokemeyer, C., Turner, M., Muenzberg, M., Abraham, I. L., Denhaerynck, K., & MacDonald, K. (2015, Spring). Prophylaxis of chemotherapy-induced febrile neutropenia with biosimilar filgrastim: description of patients, treatment patterns and outcomes in the MONITOR-GCSF study in the breast cancer cohort.. In Cancer Research.
• Gharaibeh, M., McBride, A., Bootman, J. L., Cranmer, L., & Abraham, I. (2015, May). Economic evaluation for the United States (US) of gemcitabine (GEM), nab-paclitaxel plus gemcitabine (NAB-P+GEM), and FOLFIRINOX as first-line treatment for metastatic pancreatic cancer (MPC). Journal of Clinical Oncology.. In Journal of Clinical Oncology.
• Abraham, I. L., Aapro, M., Ludwig, H., Gascon, P., Boccadoro, M., Bokemeyer, C., Turner, M., Muenzberg, M., Abraham, I., Denhaerynck, K., & MacDonald, K. (2014, Summer). Prophylaxis of chemotherapy-induced febrile neutropenia with biosimilar filgrastim: description of patients, treatment patterns and outcomes in the MONITOR-GCSF study. (Abstract). In Supportive Care in Cancer, 22(Suppl 1), S221.
• Abraham, I. L., Goldsmith, D., Combe, C., Covic, A., Dellanna, F., Gesualdo, L., London, G. M., Mann, J. F., Zaoui, P., Turner, M., Abraham, I., & MacDonald, K. (2014, Fall). Effectiveness of biosimilar epoetin alfa (HX575): interim results from the MONITOR CKD-5 study of anemia in hemodialysis. (Abstract). In Journal of the American Society of Nephrology, 25, 974A.
• Alomi, Y., Alharbi, E., Alshayban, D., Khoshaim, M., Alhowasi, M., Zamakhshary, M., Alhumaida, A., Alesseimi, M., & Abraham, I. L. (2014, November). Population-based cost-efficiency simulation of partial versus complete thromboprophylaxis in hospitalized patients in Saudi Arabia: application of a British model.. In Value in Health, 17, A533.
• Sun, D., Gharaibeh, M., Altyar, A., MacDonald, K., Martin, J., & Abraham, I. L. (2014, Fall). Economic evaluation of primary prophylaxis using filgrastim versus pegfilgrastim in patients with solid tumor cancer: a systematic literature review. (Abstract). In Value in Health, 17, A736.
• Goossen, W. T., Epping, P. J., Abraham, I. L., Dassen, T. W., & Hasman, A. (1996). Problems with nursing information systems: Are there solutions?. In MedInfo Europe.
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  The use of information systems in health care is widespread in the Netherlands, and nurses are confronted with these systems on many sites and occasions. However, the computerised support of the nursing process - the core of nursing care delivering activities - is limited to a few sites. This situation calls for an analysis of the problems that exist in the development and use of Nursing Information Systems (NISs). Possible solutions are suggested for an adequate use of information systems by Dutch nurses. A reference model for a proper course of action in the development and use of NISs is proposed. © The authors 1996.
• Abraham, I. L., & Fitzpatrick, J. J. (1987). KNOWING FOR NURSING PRACTICE: PATTERNS OF KNOWLEDGE AND THEIR EMULATION IN EXPERT SYSTEMS.. In Proceedings - The Eleventh Annual Symposium on Computer Applications in Medical Care..
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  The authors address the issue of clinical knowledge in nursing, and the feasibility of emulating this knowledge in expert system technology. The perspective on patterns of knowing for nursing practice, advanced by B. A. Carper (1978), serves as the point of departure. The four patterns of knowing--empirics, esthetics, ethics, personal knowledge--are evaluated as to the extent to which they can be emulated in clinical expert systems, given constraints imposed by the current technology of these systems.
• Jewell, J. A., Abraham, I. L., & Fitzpartrick, J. J. (1987). SELECTING AN APPROPRIATE PROBLEM FOR NURSING EXPERT SYSTEM DEVELOPMENT.. In Proceedings - The Eleventh Annual Symposium on Computer Applications in Medical Care..
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  The process of translating the knowledge base of the expert critical care nurse clinicians (knowledge engineering) into an expert system that will serve as a support for decision-making for the selected problem is discussed. The specific components of the subproblem area of decisions regarding the use of restraints to prevent extubation (and thereby maintain the airway) are being explored by the knowledge engineer. The rationale for decisions of expert nurses applied to use of restraints to prevent extubation are being imbedded within the expert system program.
• Abraham, I. L., & Fitzpatrick, J. J. (1985). RESEARCH ENVIRONMENTS IN NURSING: RATIONALE AND REQUIREMENTS FOR COMPUTING.. In Proceedings - Ninth Annual Symposium on Computer Applications in Medical Care..
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  The authors present the development and implementation of computing facilities at the Bolton School of Nursing. The approach differs from previous descriptions of school-based computing facilities in that it presents the professional and scientific context within which the system was conceived; the expected outcomes, direct and indirect, of investing in computing facilities; and the scientific and technical requirements to maximize its relevance to the mission and goals of the institution. A functional perspective of research development and facilitation among faculty and doctoral students is emphasized. The model system described is organized as a local area network of microcomputers with additional mainframe access.
• Ozbolt, J. G., Schultz, S., Swain, M. A., & Abraham, I. L. (1985). PROPOSED EXPERT SYSTEM FOR NURSING PRACTICE: A SPRINGBOARD TO NURSING SCIENCE.. In Proceedings of the Eighteenth Hawaii International Conference on System Sciences 1985. Volume 3: Medical Information Processing. Proceedings of the Hawaii International Conference on System Science 18th, Distributed by Western Periodicals Co.
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  Nursing practice, and the knowledge on which it is based, could be enhanced through the use of a novel expert system. This paper describes how such a system could be developed, with examples from the authors' prototype programs. Taxonomies of data, diagnoses, objectives, and interventions would make it possible to compare patients and to determine the relative effectiveness of nursing interventions. A built-in evaluation component would provide feedback and correction. Everyday nursing practice would become a field for research, and the knowledge gained from research would immediately be fed back into practice. In its development and in its implementation, this kind of system would help to build nursing science.
• Abraham, I. L., Abraham, I. L., Schultz, S., Schultz, S., Ozbolt, J. G., Ozbolt, J. G., Swain, M. A., & Swain, M. A. (1984). MULTIVARIATE MATHEMATICAL ALGORITHM FOR DIAGNOSTIC INFORMATION SYSTEMS: II. PROCEDURES FOR CLINICAL INFERENCE.. In Proceedings - Eighth Annual Symposium on Computer Applications in Medical Care..
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  For Pt. I, see Proc. Eur. Fed. for Medical Informatics (1984). The procedures for clinical inference of a multivariate algorithm for diagnostic information systems are presented. This complements the description given in Pt. I of procedures for data acquisition and storage of the proposed algorithm. Clinical inference is viewed as a twofold process of (1) acquiring and sampling information, and organizing it in a fashion conducive to subsequent analysis; and (2) deciding about the normality or abnormality of functional health domains. Normality is defined as being within the limits of a population criterion interval. The mathematical explication of clinical inference as used in the algorithm is emphasized.
• Ozbolt, J. G., Schultz, S., Swain, M. A., Abraham, I. L., & Farchaus-Stein, K. (1984). DEVELOPING AN EXPERT SYSTEM FOR NURSING PRACTICE.. In Proceedings - Eighth Annual Symposium on Computer Applications in Medical Care..
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  The American Nurses Association has set eight standards of nursing practice related to the nursing process. Computer-aided information systems intended to facilitate the nursing process must be designed to promote adherence to these professional standards. For each of the eight standards, the authors describe how a hypothetical expert system could help nurses meet the standard. A prototype of such an expert system is being developed. Issues in conceptualizing clinical decision-making and developing decision strategies for the prototype system are discussed. The process of developing the prototype system is also described.

Presentations

• AlRawashdh, N., McBride, A., & Abraham, I. L. (2022). Cost-effectiveness analyses of first line ibrutinib versus acalabrutinib versus zanubrutinib followed by second line venetoclax plus rituximab in previously untreated chronic lymphocytic leukemia patients.. American Society of Hematology.
• Abraham, I. L. (2021). Assessing the value of new treatments: the "classical" landscape. AZBioPEERSAZ Bio.
• Abraham, I. L. (2021). Convincing payers and buyer: calculating your product budget impact. AZBioPeersAZ Bio.
• Abraham, I. L. (2020, Spring). The immuno-oncology landscape: trends and value. ACCC 47th Annual Meeting & Cancer Center Business Summit. Washington DC: Association of Community Cancer Centers.
• Abraham, I. L. (2018, Fall). Big data, deep analytics, better outcomes. Association of Community Cancer Centers. Washington, DC: Association of Community Cancer Centers.
• Abraham, I. L. (2018, Fall). Biosimilars. Pharmacoeconomics Training Course. Tucson, AZ: University of Arizona Center for Health Outcomes and PharmacoEconomic Research.
• Abraham, I. L. (2018, Fall). Economic evaluation of cancer treatments: metastatic pancreatic cancer. West Virginia University Cancer Institute - West Virginia University School of Pharmacy. Morgantown, WV: West Virginia University.
• Abraham, I. L. (2018, Fall). Judy Kandzari Memorial Lecture - Better real-world evidence: conceptual and methodological issues in outcomes and effectiveness research. West Virginia University School of Nursing. Morgantown, WV: West Virginia University.
• Abraham, I. L. (2018, Fall). Writing for publication: tips, tricks, trials, and tribulations. West Virginia University School of Nursing. Morgantown, WV: West Virginia University.
• Abraham, I. L. (2018, February). Economic evaluation of cancer treatments: metastatic pancreas cancer. Cutting Edge Research Seminar. Tucson, AZ: University of Arizona College of Nursing.
• Abraham, I. L. (2018, Spring). Biosimilars: cost-efficiencies and expanded access. Jordan Food and Drug Administration. Amman, Jordan: Jordan Food and Drug Administration.
• Abraham, I. L. (2018, Spring). Biosimilars: scientific and economic opportunities. Jordan Food and Drug Administration. Amman, Jordan: Jordan Food and Drug Administration.
• Abraham, I. L. (2018, Spring). Issues in the economic evaluation of immunotherapies in cancer. Association of Community Cancer Centers. Washington, DC: Association of Community Cancer Centers.
• Abraham, I. L. (2018, Spring). Real-world evidence: clinical and economic outcomes of pharmacotherapy. Mutah University International Dead Sea Conference on Pharmacotherapy. Ishtar, Jordan: Jordan University of Science and Technology.
• Abraham, I. L. (2018, Spring). The economics of pharmacotherapy: from small molecules to complex biologicals. Jordan University of Science and Technology. Irbed, Jordan: Jordan University of Science and Technology.
• Abraham, I. L. (2018, Sprint). Value of meta-analysis: why do it?. Meta-Analysis Course. Tucson, AZ: University of Arizona Center for Health Outcomes and PharmacoEconomic Research.
• Abraham, I. L., & Almutairi, A. (2018, Spring). Indirect comparison and network meta-analysis. Meta-Analysis Course. Tucson, AZ: University of Arizona Center for Health Outcomes and PharmacoEconomic Research.
• AlRawashdeh, N., Alsaid, N., Persky, D. O., McBride, A., & Abraham, I. L. (2018, Winter). Economic evaluation for the US of ibrutinib versus acalabrutinib for patients with relapsed or refractory mantle cell lymphoma. American Society of Hematology. San Diego, CA: American Society of Hematology.
• Abraham, I. (2017, April). Pharmaceutical dollars and sense - some (intern)national perspectives and comments. Invited Lecture - University of Arizona Regulatory Science Series. Tucson, AZ.
• Abraham, I. (2017, June). Meta-analysis - why do it?. HOPE Center Meta-analysis Course. Tucson, AZ.
• Abraham, I. (2017, March). Better real-world evidence: some conceptual and methodological issues.. HOPE Center Workshop on Real-World Evidence. Tucson, AZ.
• Abraham, I. (2017, March). Biosimilars: new questions for old products. HOPE Center Workshop on Real-World Evidence. Tucson, AZ.
• Abraham, I. (2017, March). Looking for superiority in a non-inferior world. HOPE Center Workshop on Real-World Evidence. Tucson, AZ.
• Abraham, I. (2017, March). Osteonecrosis of the jaw. HOPE Center Workshop on Real-World Evidence. Tucson, AZ.
• Abraham, I. (2017, March). When real-world evidence can be surprising ... and difficult to digest. HOPE Center Workshop on Real-World Evidence. Tucson, AZ.
• Abraham, I. (2017, September). An Overview of Methods in Health Technology Assessment: Algorithm, Value Framework, and Individual Study Simulation. Invited Lecture, Sungkyunkwan University. Seoul, Korea.
• Abraham, I. (2017, September). Design studies of complex interventions. Invited Lecture - University of Hyogo. Kobe, Japan.
• Abraham, I. (2017, September). Invited Lecture - Writing for publication - tips, tricks, trials, and tribulations. Catholic University of Korea. Seoul, Korea.
• Sun, D., & Abraham, I. (2017, March). Latent variable models. HOPE Center Workshop on Real-World Evidence. Tucson, AZ.
• Gharaibeh, M. L. (2016, February). Pharmacoeconomics and the value of cancer care - Metastatic pancreas cancer as an example. Invited Lecture, College of Pharmacy, University of Houston. Houston, TX: College of Pharmacy, University of Houston.
• Abraham, I. L. (2015, January). Beyond the legacy: the HOPE center. 2014-2015 Academic Research Fellows Program - American Association of Colleges of Pharmacy. Tucson, AZ: American Association of Colleges of Pharmacy.
• Abraham, I. L., Alomi, Y., Alshayban, D., Alyami, M., & Bootman, J. (2015, March). The E3O (Expertise and Evidence in Pharmaco-Economics and Outcomes) partnership of the University of Arizona and the Ministry of Health, Kingdom of Saudi Arabia. 7th International Conference on Health Issues in Arab Communities. Muscat, Oman.
• Abraham, I. L. (2014, January). Beyond the legacy: the HOPE center. 2013-2014 Academic Research Fellows Program - American Association of Colleges of Pharmacy. Tucson, AZ: American Association of Colleges of Pharmacy.
• Abraham, I. L. (2014, October). Pharmacoeconomics and reimbursement approvals in Europe.. 1st Saudi International Conference on Pharmaceutical Policy, Economics, and Outcomes.. Riyadh, Saudi Arabia.
• Abraham, I. L. (2014, September). The cost of drug development. World Congress of the FIP International Pharmaceutical Federation. Bangkok, Thailand: FIP.
• Abraham, I. L., & Grizzle, A. (2014, April). Introduction to pharmacoeconomics.. Annual Forum on Supportive Medical Services, Ministry of Health. Riyadh, Saudi Arabia.
• Abraham, I. L., & Lee, C. (2014, April). Introduction to meta-analysis.. Annual Forum on Supportive Medical Services, Ministry of Health. Riyadh, Saudi Arabia.
• Abraham, I. L., & MacDonald, K. (2014, March). Outcomes and effectiveness research on medication safety interventions: conceptual and methodological issues.. First International Conference on Medication Safety. Al Ahsa, Saudi Arabia.
• Abraham, I. L., & MacDonald, K. M. (2014, October). Better evidence: enhancing outcomes and effectiveness studies.. 1st Saudi International Conference on Pharmaceutical Policy, Economics, and Outcomes.. Riyadh, Saudi Arabia.
• Abraham, I. L., & MacDonald, K. M. (2014, October). Conceptual and methodological issues in outcomes and effectiveness research.. 1st Saudi International Conference on Pharmaceutical Policy, Economics, and Outcomes.. Riyadh, Saudi Arabia.
• Abraham, I. L., & Sun, D. (2014, April). Pharmacists contributions to the health of patients and populations: systematic reviews and meta-analyses.. Annual Forum on Supportive Medical Services, Ministry of Health. Riyadh, Saudi Arabia.
• Abraham, I. L., MacDonald, K., & Denhaerynck, K. (2014, March). How to evaluate guidelines.. Thirteenth Annual Conference on Anaemia, Neutropenia, Thombosis and Cancer.. Vienna, Austria: European School of Oncology.
• Abraham, I. L., Sun, D., & Schneider, P. (2014, March). The role of nursing in medication safety.. First International Conference on Medication Safety. Al Ahsa, Saudi Arabia.

Poster Presentations

• Abraham, I. L. (2024). Treatment patterns in first-line treatment of metastatic gastroenteropancreatic neuroendocrine tumors: analysis of US claims data.. Academy of Managed Care Pharmacy. Las Vegas, NV: AMCP.
• Almutairi, A., Authors, M., Abraham, I. L., & Authors, E. M. (2023). Real-world effectiveness of osimertinib in non-small cell lung cancer with EGFR mutation: systematic review and meta-analysis. . Value in Health.
• Aqel, O., Authors, M., & Abraham, I. L. (2023). Economic evaluation for the US of durvalumab plus gemcitabine and cisplatin in advanced biliary tract cancer. . Journal of Clinical Oncology.
• Aqel, O., Authors, M., & Abraham, I. L. (2023). Economic evaluation for the US of relatlimab and nivolumab versus nivolumab monotherapy in untreated advanced melanoma. . Journal of Clinical Oncology.
• Kreutzfeldt, J., Authors, M., Abraham, I. L., & Reccio-Boiles, A. (2023). Overall survival, efficacy, and safety outcomes beyond front-line modern therapies in metastatic clear-cell renal cell carcinoma.. Journal of Clinical Oncology.
• MacDonald, K., Authors, M., & Abraham, I. L. (2023). Cost-efficiency and expanded access modeling of ranibizumab-ranq biosimilar versus originator in patients with neovascular age-related macular degeneration and diabetic macular edema. . Journal of Managed Care and Specialty Pharmacy.
• Obeng-Kusi, M., Authors, M., Abraham, I. L., Obeng-Kusi, M., Authors, M., & Abraham, I. L. (2023). Cost-effectiveness analysis of later-line therapies for metastatic colorectal cancer based on a novel methodology of network meta-analysis of survival curves.. Journal of Clinical Oncology.
• Oguzulgen, I. K., Authors, M., & Abraham, I. L. (2023). Real-world patient-level cost-effectiveness analysis of omalizumab in patients with severe allergic asthma. 
  . European Respiratory Journal.
• Stocking, J., Multiple, A., & Abraham, I. L. (2023). A LASSO-derived predictive model for postoperative respiratory failure in a heterogeneous adult elective surgery patient population.. CHEST.
• Abraham, I. L., Xue, W., Chen, X., Zhou, J., & Huang, H. (2022). Conversion from subcutaneous trastuzumab to trastuzumab-dkst in metastatic breast cancer: comparative cost-efficiency modelling between US and France. Value in Health.
• Abraham, I. L., Xue, W., Chen, X., Zhou, J., & Huang, H. (2022). Economic impact of trilaciclib for chemotherapy-induced myelosuppression (CIM) in extensive-stage small cell lung cancer (ES-SCLC): economic evaluation from the provider and patient-caregiver perspectives in the United States. International Society for PharmacoEconomics and Outcomes Research.
• AlRawashdh, N., McBride, A., & Abraham, I. L. (2022). Racial/ethnic, sex, and income disparities in overall survival in chronic lymphocytic leukemia patients in the era of targeted therapy: Surveillance, Epidemiology, and End Results (SEER) registry analysis (2009-2019)
  
  . American Society of Hematology.
• Calamia, M., MacDonald, K., Walden, P., Geller, R., & Abraham, I. L. (2022). Ex ante budget impact analysis of the PD-1 inhibitor toripalimab plus pemetrexed and platinum versus pembrolizumab in previously untreated advanced non-squamous non-small lung cancer.
  
  . Academy of Managed Care Pharmacy.
• MacDonald, K., Abraham, I. L., Fuentes-Alburo, A., Austrup, H., & Moebius, J. (2022). Conversion from subcutaneous trastuzumab to trastuzumab-dkst in metastatic breast cancer: comparative cost-efficiency modelling between US and France
  
  . Value in Health.
• MacDonald, K., Walden, P., Geller, R., & Abraham, I. L. (2022). Cost-efficiency and budget-neutral expanded access modeling of PD-1 inhibitor toripalimab plus gemcitabine-cisplatin over a simulated parallel pembrolizumab regimen for treatment of recurrent or metastatic naso-pharyngeal cancer
  
  . Academy of Managed Care Pharmacy.
• MacDonald, K., Walden, P., Geller, R., Abraham, I. L., Calamia, M., Walden, P., Geller, R., MacDonald, K., & Abraham, I. L. (2022). Cost-efficiency and budget-neutral expanded access modeling of toripalimab over pembrolizumab in previously untreated advanced squamous NSCLC. North American Lung Cancer Conference.
• Obeng-Kusi, M., Erstad, B., Roe, R. D., & Abraham, I. L. (2022). Value-based pricing of an ebola vaccine in resource-constrained countries based on cost-effectiveness analysis
  
  . International Society for Pharmacoeconomics and Outcomes Research.
• Obeng-Kusi, M., Erstad, B., Roe, R. D., & Abraham, I. L. (2022). Value-based pricing of an ebola vaccine in resource-constrained countries based on cost-effectiveness analysis
  
  . Value in Health.
• Reccio-Boiles, A., Aqel, O., Obeng-Kusi, M., & Abraham, I. L. (2022). Network meta-analysis of second-line treatment options in metastatic renal cell carcinoma. 
  
  . American Society of Clinical Oncology.
• Abraham, I. L., MacDonald, K., Fuentes-Alburo, A., & McBride, A. (2021). Biosimilar trastuzumab mono- and pertuzumab combination therapy in metastatic breast cancer: cost-efficiency and expanded access modeling.. International Society of Pharmacoeconomics and Outcomes Research Annual MeetingInternational Society of Pharmacoeconomics and Outcomes Research.
• Alrawashdh, N., McBride, A., & Abraham, I. L. (2021). Meta-analysis of chemotherapy-induced (febrile) neutropenia and chemotherapy disruptions associated with same-day versus standard (24-72h) pegfilgrastim administration in non-Hodgkin lymphoma patients. American Society of Hematology Annual MeetingAmerican Society of Hematology.
• Alrawashdh, N., McBride, A., Persky, D. O., Sweasy, J., Erstad, B. L., & Abraham, I. L. (2021). Survival trends in chronic lymphocytic leukemia across treatment eras: SEER database analyses (1985 to 2017).. American Society of Clinical Oncology Annual MeetingAmerican Society of Clinical Oncology.
• Bahn, C., Arredondo, A., Notbohm, K., Valsvik, K., Ortega, A., Sanders, L., Recio, A., Kraft, A., Babiker, H., Do, B., Persky, D., Abraham, I. L., & McBride, A. (2021). Transitioning ifosfamide based chemotherapy to the outpatient setting: a model of implementation of transitioning chemotherapy outpatient in a safety net hospital.. American Society of Clinical Oncology Annual MeetingAmerican Society of Clinical Oncology.
• Choi, B., Alrawashdh, N., McBride, A., & Abraham, I. L. (2021). Cost evaluation of adjunctive osimertinib use in resected epidermal growth factor receptor-positive non-small cell lung cancer.. American Society of Clinical Oncology Annual MeetingAmerican Society of Clinical Oncology.
• Choi, B., Alrawashdh, N., Vraney, J., McBride, A., & Abraham, I. L. (2021). Institutional chart review on same-day pegfilgrastim administration in small cell lung cancer (SCLC) patients receiving myelotoxic chemotherapy.. American Society of Clinical Oncology Quality ForumAmerican Society of Clinical Oncology.
• Little, N. G., McBride, A., Henry, N., MacDonald, K., & Abraham, I. L. (2021). Comparative cost-efficiency analysis of trilaciclib, a novel CDK4/6 inhibitor, in the prophylaxis of chemotherapy-induced myelosuppression. American Society of Hematology Annual MeetingAmerican Society of Hematology.
• McBride, A., MacDonald, K., & Abraham, I. L. (2021). Cost-efficiency and budget-neutral expanded access to antineoplastic therapy from cost-savings derived from conversion to biosimilar pegfilgrastim-cbqv for the prophylaxis of chemotherapy-induced (febrile) neutropenia: simulation modeling metastatic pancreatic cancer. American Society of Clinical Oncology Gastro-intestinal ConferenceAmerican Society of Clinical Oncology.
• Obeng-Kusi, M., Arku, D., Alrawashdh, N., Choi, B., Alkhatib, N., McBride, A., & Abraham, I. L. (2021). Ixazomib, carfilzomib, elotuzumab, or daratumumab with lenalidomide and dexamethasone (LEN+DEX) versus LEN+DEX only in relapsed/refractory multiple myeloma: a comparative cost-effectiveness analysis.. American Society of Clinical Oncology Annual MeetingAmerican Society of Clinical Oncology.
• Obeng-Kusi, M., MacDonald, K., van Lierde, M. A., & Abraham, I. L. (2021). Novel application of Kaplan-Meier methods to model tolerance for nonadherence to imatinib in patients with chronic myeloid leukemia in the ADAGIO study.. American Society of Clinical Oncology Annual MeetingAmerican Society of Clinical Oncology.
• Alrawashdh, N., Almutairi, A. R., McBride, A., & Abraham, I. L. (2020, Winter). Economic evaluation of daratumumab and pomalidomide and dexamethasone versus isatuximab and pomalidomide and dexamethasone for patients with relapsed or refractory multiple myeloma. Annual Meeting - American Society of Hematology. Virtual: American Society of Hematology.
  More info

  Virtual poster
• Alrawashdh, N., McBride, A., Slack, M. K., & Abraham, I. L. (2020, Winter). Economic evaluation of ibrutinib versus acalabrutinib versus zanubrutinib for patients with relapsed or refractory mantle cell lymphoma.. Annual Meeting - American Society of Hematology. Virtual: American Society of Hematology.
  More info

  Virtual poster
• Bin Riaz, I., Almutairi, A. R., Lang, D. K., Ashgar, N., Riaz, A., Yao, Y., Sipra, Q., Ryu, A. J., Alkhatib, N., Oh, M., Abraham, I. L., Murad, M. H., & Kohli, M. (2020, Spring). Cost-effectiveness of novel antiandrogens (AAs) for treatment of nonmetastatic castrate-resistant prostate cancer (nmCRPC). American Society of Clinical Oncology - Annual Meeting. Virtual: American Society of Clinical Oncology.
• Bin Riaz, I., Lang, D. K., Yao, Y., Riaz, A., Almutairi, A. R., Wang, Z., Abraham, I. L., Murad, M. H., & Kohli, M. (2020, Spring). A systematic review and network meta-analysis of FDA approved treatment options in men with nonmetastatic, castration-resistant prostate cancer (M0CRPC).. American Society of Clinical Oncology - Genito-urinary Symposium. San Francisco, CA: American Society of Clinical Oncology.
• McBride, A., MacDonald, K., & Abraham, I. L. (2020, Winter). Conversion to biosimilar pegfilgrastim-jmdb from pegfilgrastim with on-body injector device in diffuse large b-cell lymphoma: simulation modeling of cost-savings and budget-neutral expanded access to prophylaxis and anti-neoplastic therapy considering device failure rate.. Annual Meeting - American Society of Hematology. Virtual: American Society of Hematology.
  More info

  Virtual poster
• McBride, A., MacDonald, K., & Abraham, I. L. (2020, Winter). Simulation modeling of cost-savings from conversion to biosimilar pegfilgrastim-cbqv for the prophylaxis of chemotherapy-induced neutropenia, and budget-neutral expanded access to prophylaxis and anti-neoplastic therapy from derived cost-savings in non-Hodgkin lymphoma.. Annual Meeting - American Society of Hematology. Virtual: American Society of Hematology.
  More info

  Virtual poster
• Algotar, A., Algotar, A., Hsu, C., Hsu, C., Chow, H., Chow, H., Abraham, I. L., Abraham, I. L., Babiker, H. M., Babiker, H. M., Marrero, D., Marrero, D., Dougherty, S., Dougherty, S., Babiker, H. M., Babiker, H. M., Kumar, R., Kumar, R., Ligibel, J., , Ligibel, J., et al. (2019, Spring). Comprehensive lifestyle improvement program for prostate cancer (CLIPP): A feasibility study in men with prostate cancer on ADT.. ASCO Genitourinary Cancers Symposium.
• Barqawi, Y., Borrego, M., Roberts, M., & Abraham, I. (2019, Spring). Cost effectiveness analysis comparing enzalutamide, abiraterone plus prednisone and cabazitaxel plus predinsone for the treatment of visceral metastatic castration resistant prostate cancer post docetaxel failure. (abstract). ISPOR.
• Combs, D., Abraham, I. L., Hsu, C., Morgan, W. J., Patel, S. I., & Parthasarathy, S. (2019, December). Comparison of parent and child treatment preferences for obstructive sleep apnea. 2019 meeting of the Associated Professional Sleep Societies. San Antonio, TX.
• Oh, M., Patanwala, S., Alsaid, N., Almutairi, A., Abraham, I., & Erstad, B. (2019, Spring). Cost analysis of adjunctive hydrocortisone therapy for septic shock from the US payer perspective. (abstract). SCCM.
• Parthasarathy, S., Patel, S. I., Morgan, W. J., Hsu, C., Abraham, I. L., & Combs, D. (2019, December). Comparison of parent and child treatment preferences for obstructive sleep apnea. 2019 meeting of the Associated Professional Sleep Societies. San Antonio, TX.
• Perloff, T., Dawkins, M., Crews, J. R., Gregg, J. P., Abraham, I., & Schwartzberg, L. (2019, Spring). A multi-specialty approach to immune-oncology education for community providers. (abstract). ASCO SITC Immune-Oncology Conference.
• Thomson, C. A., Courneya, K. S., Ligibel, J., Kumar, R., Babiker, H. M., Dougherty, S., Marrero, D., Babiker, H. M., Abraham, I. L., Chow, H., Hsu, C., & Algotar, A. (2019, Spring). Comprehensive lifestyle improvement program for prostate cancer (CLIPP): A feasibility study in men with prostate cancer on ADT.. Genitourinary Cancers Symposium.
• Alsaid, N., McBride, A., Persky, D., Anwer, F., Andritsos, L., Kumar, A., Yun, S., Babiker, H. M., & Abraham, I. L. (2018, Spring). Economic evaluation for the US of venetoclax versus ibrutinib versus allogeneic hematopoietic stem-cell transplantation for patients with relapsed or refractory chronic lymphocytic leukemia with 17p deletion. Journal of Clinical OncologyAmerican Society of Clinical Oncology.
• Bin Riaz, I., Almutairi, A., Zeeshan, A., Alhifany, A., Bhattacharjee, S., Abraham, I. L., & Kohli, M. (2018, February). Abiraterone acetate or docetaxel in metastatic castration-sensitive prostate cancer: a systematic review and network meta-analysis of randomized controlled trials.. ASCO Genitourinary Symposium. San Francisco, CA: ASCO.
• Combs, D., Abraham, I. L., Hsu, C., Morgan, W. J., Bailey, O., & Parthasarathy, S. (2018, Spring). Parent treatment preferences for mild obstructive sleep apnea in children. American Thoracic SocietyAmerican Thoracic Society.
• Combs, D., Edgin, J. O., Barber, B. J., Klewer, S. E., Morgan, W. J., Hsu, C., Abraham, I. L., & Parthasarathy, S. (2018, Fall). Obstructive sleep apnea is a novel risk factor for neurocognitive impairment in children with congenital heart disease. American Heart AssociationAmerican Heart Association.
• Combs, D., Edgin, J. O., Barber, B. J., Morgan, W. J., Hsu, C., Abraham, I. L., & Parthasarathy, S. (2018, Fall). Sleep-disordered breathing is associated with neurocognitive impairment in children with congenital heart disease. Sleep Research SocietySleep Research Society.
• Gupta, S., MacDonald, K., & Abraham, I. (2017, September). Pill count (% of prescribed pills not taken) is an independent predictor of achieving complete cytogenetic response and European LeukemiaNet optimal response in patients with chronic myeloid leukemia treated with imatinib. International Pharmaceutical Federation. Seoul (South Korea).
• McBride, A., Balu, S., Campbell, K., MacDonald, K., & Abraham, I. L. (2018, Winter). Subcutaneous versus intravenous rituximab in non-Hodgkin’s lymphoma treated with R-CHOP: economic modeling for the US. American Society of Hematology. San Diego, CA: American Society of Hematology.
• McBride, A., Campbell, K., Bikkina, M., MacDonald, K., Abraham, I. L., & Balu, S. (2018, Winter). Cost-efficiency of chemotherapy-induced (febrile) neutropenia prophylaxis with biosimilar ZARXIO® over NEUPOGEN®, NEULASTA®, and NEULASTA/ONPRO®: breast cancer case study.. San Antonio Breast Cancer Symposium. San Antonio, TX: San Antonio Breast Cancer Symposium.
• McBride, A., Krenduykov, A., Mathieson, N., Campbell, K., Balu, S., MacDonald, K., & Abraham, I. L. (2018, Fall). Cost simulation for the US febrile neutropenia hospitalization due to pegfilgrastim on-body injector failure compared to single-injection pegfilgrastim and daily injections with reference and biosimilar in lung cancer.. European Society of Medical Oncology - Asia. Singapore: European Society of Medical Oncology.
• McBride, A., Krenduykov, A., Mathieson, N., Campbell, K., Balu, S., MacDonald, K., & Abraham, I. L. (2018, Winter). Cost simulation for febrile neutropenia hospiyalization in the US due to pegfilgrastim on-body injector failure compared to single-injection pegfilgrastim and daily injections with reference and biosimilar in non-Hodgkin lymphoma.. American Society of Hematology. San Diego, CA: American Society of Hematology.
• Oh, M., Aljadeed, R., Al Khushaym, N., Althagfi, A., Fallatah, S., Babiker, H. M., McBride, A., & Abraham, I. L. (2018, Spring). The association of BRCA1 and BRCA2 mutations on prostate cancer risk, frequency, and mortality: systematic review and meta-analysis.. Journal of Clinical OncologyAmerican Society of Clinical Oncology.
• Oh, M., Slack, M. K., McBride, A., Yun, S., Bhattacharjee, S., Jeter, J. M., & Abraham, I. L. (2018, Spring). BRCA1 and BRCA2 gene mutations and colorectal cancer risk: Systematic review and meta-analysis. 2018 ASCO Gastrointestinal Cancers Symposium. San Francisco: American Society of Clinical Oncology.
• Aapro, M., Bokemeyer, C., Boccadoro, M., Gascon, P., Denhaerynck, K., Krendyokov, A., Abraham, I., MacDonald, K., & Ludwig, H. (2017, November). Chemotherapy-induced (febrile) neutropenia prophylaxis with biosimilar filgrastim in solid tumours versus haematological malignancies: patterns, outcomes and determinants (MONITOR-GCSF study).. European Society of Medical Oncology. Madrid, Spain.
• Abraham, I. L., Kumar, A., Persky, D. O., & Anwar, F. (2017, December/Winter). 4678 Economic Evaluation for the US of Venetoclax Versus Allogeneic Hematopoietic Stem-Cell Transplantation for Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia with 17p Deletion. ASH Annual Meeting. Atllanta, GA: ASH.
• Abraham, I. L., Kumar, A., Persky, D. O., & Anwar, F. (2017, December/Winter). 4679 Economic Evaluation for the US of Ibrutinib Versus Allogeneic Hematopoietic Stem-Cell Transplantation for Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia with 17p Deletion. ASH Annual Conference. Atlanta GA: ASH.
• Abraham, I., Katragadda, C., Katz, M., Erstad, B., MacDonald, K., & Ojo, A. (2017, November). Forecasts for 2030 for the end-stage renal disease (ESRD)/dialysis workforce in the US.. American Society of Nephrology. New Orleans, LA.
• Alsaid, N., McBride, A., Agarwal, A., Al Mutairi, A., Anwer, F., & Abraham, I. (2017, June). Economic evaluation of carfilzomib, ixazomib, elotuzumab, or daratumumab with lenalidomide and dexamethasone (LEN+DEX) vs LEN and DEX in relapsed/refractory multiple myeloma (R/R MM).. American Society of Clinical Oncology. Chicago, IL.
• Alsaid, N., McBride, A., Kim, H., Oh, M., Andritsos, L., Anwer, F., Persky, D., Kumar, A., Yun, S., & Abraham, I. (2017, December). Economic evaluation for the US of ibrutinib versus allogeneic hematopoietic stem-cell transplantation for patients with relapsed or refractory chronic lymphocytic leukemia with 17p deletion.. American Society of Hematology. Atlanta, GA.
• Alsaid, N., McBride, A., Oh, M., Persky, D., Anwer, F., Andritsos, L., Kumar, A., Yun, S., & Abraham, I. (2017, December). Economic evaluation for the US of venetoclax versus allogeneic hematopoietic stem-cell transplantation for patients with relapsed or refractory chronic lymphocytic leukemia with 17p deletion.. American Society of Hematology. Atlanta, GA.
• Alsaid, N., Sweitzer, N., Ramos, K., Erstad, B., Slack, M., & Abraham, I. (2017, November). Classification of causes of hospitalization for heart failure patients in cost-effectiveness and cost-utility evaluations of pharmacotherapeutic, surgical, and managed-care interventions: systematic review.. International Society for Pharmacoeconomics and Outcomes Research. Glasgow, UK.
• Balu, S., McBride, A., Campbell, K., Bikkina, M., MacDonald, K., & Abraham, I. (2017, June). Comparative cost-efficiency of filgrastim, biosimilar filgrastim-sndz, and pegfilgrastim for the prophylaxis of chemotherapy-induced (febrile) neutropenia in the US.. Multinational Association for Supportive Cancer Care. Washington, DC.
• Bokemeyer, C., Aapro, M., Gascon, P., Boccadoro, M., Ludwig, H., Krendyokov, A., MacDonald, K., & Abraham, I. (2017, November). Proof-of-concept of a risk calculator of chemotherapy induced (febrile) neutropenia based on real-world evidence (MONITOR-GCSF study).. European Society of Medical Oncology.
• Cranmer, L., Al Yami, M., Alsaid, N., Loggers, E., Pollack, S., & Abraham, I. (2017, November). Therapy of advanced soft tissue sarcomas using olaratumab/doxorubicin versus doxorubicin/ifosfamide: a network meta-analysis.. Connective Tissue Oncology Society. Maui, HI.
• Dellanna, F., Goldsmith, D., Mann, J., Zaoui, P., Combe, C., Krendyukov, A., MacDonald, K., & Abraham, I. (2017, November). Predictive hierarchical modeling of determinants of outcomes of anemia management with Binocrit®, a biosimilar epoetin alfa, in the hemodialysis setting (MONITOR-CKD5 study).. American Society of Nephrology. New Orleans, LA.
• Gharaibeh, M., Alsaid, N., & Abraham, I. (2017, November). An algorithm to quantitatively estimate extrapolated lifetime survival curves for economic evaluation of cancer treatments when only aggregrated patient data are available; with application to metastatic pancreatic cancer.. International Society for Pharmacoeconomics and Outcomes Research. Glasgow, UK.
• Maiese, E., Graham, C., Hawe, E., Le Moine, J., Abraham, I., & Senbetta, M. (2017, December). Cost-effectiveness of daratumumab plus bortezomib and dexamethasone versus bortezomib and dexamethasone for treatment of patients with multiple myeloma who have received at least one prior therapy: an analysis of the CASTOR trial.. American Society of Hematology. Atlanta, GA.
• Maiese, E., Graham, C., Hawe, E., Le Moine, J., Abraham, I., & Senbetta, M. (2017, December). Cost-effectiveness of daratumumab plus lenalidomide and dexamethasone versus lenalidomide and dexamethasone for treatment of patients with multiple myeloma who have received at least one prior therapy: an analysis of the CASTOR trial.. American Society of Hematology. Atlanta, GA.
• McBride, A., Abraham, I., MacDonald, K., Campbell, K., Bikkina, M., & Balu, S. (2017, June). Cost savings of conversion from Neupogen or Neulasta to biosimilar Zarxio for chemotherapy-induced (febrile) neutropenia prophylaxis and expanded access to biosimilar GCSF on a budget neutral basis.. American Society of Clinical Oncology. Chicago, IL.
• McBride, A., Campbell, K., Bikkina, M., MacDonald, K., Abraham, I. L., & Balu, S. (2017, December). Cost-efficiency of chemotherapy-induced (febrile) neutropenia prophylaxis with biosimilar ZARXIO® over NEUPOGEN®, NEULASTA®, and NEULASTA/ONPRO®: breast cancer case study.. San Antonio Breast Cancer Symposium. San Antonio, TX.
• McBride, A., Campbell, K., Bikkina, M., MacDonald, K., Abraham, I. L., & Balu, S. (2017, December). Expanded access to obinutuzumab from cost-savings generated from biosimilar filgrastim-sndz in the prophylaxis of chemotherapy-induced (febrile) neutropenia: US simulation study.. American Society of Hematology. Atlanta, GA.
• McBride, A., Campbell, K., Bikkina, M., MacDonald, K., Abraham, I., & Balu, S. (2017, November). Expanded access to pembrolizumab from cost-savings generated from biosimilar filgrastim-sndz in the prophylaxis of chemotherapy-induced (febrile) neutropenia: simulation study.. International Society for Pharmacoeconomics and Outcomes Research. Atlanta, GA.
• McBride, A., Katragadda, C., & Abraham, I. (2017, June). Safety and efficacy of direct oral anticoagulants in cancer patients: meta-analysis of randomized controlled trials.. American Society of Clinical Oncology. Chicago, IL.
• Mushtaq, A., Kapoor, V., Iftikhar, A., Zafar, R., Warraich, F., Sami, W., McBride, A., Tenet, P., Russ, A., Razkak, D., Halajian, M., Abraham, I., & Anwer, F. (2017, December). Efficacy and safety profile of carfilzomib based regimens for treatment of multiple myeloma, a systematic review. American Society of Hematology. Atlanta, GA.
• Gharaibeh, M., McBride, A., Bootman, J. L., Cranmer, L., & Abraham, I. (2015, May). Economic evaluation for the United States (US) of gemcitabine (GEM), nab-paclitaxel plus gemcitabine (NAB-P+GEM), and FOLFIRINOX as first-line treatment for metastatic pancreatic cancer (MPC). Journal of Clinical Oncology.. Journal of Clinical Oncology. Chicago, IL: American Society of Clinical Oncology.
• Aapro, M., Ludwig, H., Gascon, P., Boccadoro, M., Bokemeyer, C., Turner, M., Muenzberg, M., Denhaerynck, K., MacDonald, K., & Abraham, I. L. (2014, Summer). Prophylaxis of chemotherapy-induced febrile neutropenia with biosimilar filgrastim: description of patients, treatment patterns and outcomes in the MONITOR-GCSF study.. MASCC.
• Abraham, I. L., Goldsmith, D., Combe, C., Covic, A., Dellanna, F., Gesualdo, L., London, G. M., Mann, J. F., Zaoui, P., Turner, M., Abraham, I., & MacDonald, K. (2014, Fall). Effectiveness of biosimilar epoetin alfa (HX575): interim results from the MONITOR CKD-5 study of anemia in hemodialysis.. American Society of Nephrology.
• Alomi, Y., Alharbi, E., Alshayban, D., Khoshaim, M., Alhowasi, M., Zamakhshary, M., Alhumaida, A., Alesseimi, M., & Abraham, I. L. (2014, November). Population-based cost-efficiency simulation of partial versus complete thromboprophylaxis in hospitalized patients in Saudi Arabia: application of a British model.. ISPOR Europe. Amsterdam, The Netherlands.
• Gascon, P., Aapro, M., Ludwig, H., Boccadoro, M., Bokemeyer, C., Turner, M., Muenzberg, M., Abraham, I. L., Denhaerynck, K., & MacDonald, K. (2014, Fall). Prophylaxis of chemotherapy-induced febrile neutropenia with biosimilar filgrastim: description of patients, treatment patterns and outcomes in the MONITOR-GCSF study in the breast cancer cohort.. San Antonio Breast Cancer Symposium.
• Sun, D., Gharaibeh, M., Altyar, A., MacDonald, K., Martin, J., & Abraham, I. L. (2014, Fall). Economic evaluation of primary prophylaxis using filgrastim versus pegfilgrastim in patients with solid tumor cancer: a systematic literature review.. ISPOR Asia. Beijing, China: ISPOR.

Reviews

• Abraham, I. L. (2020. Big data, deep analytics, better outcomes.. Immuno-Oncology Insights.
• Abraham, I., Alhossan, A., Lee, C. S., Kutbi, H., & MacDonald, K. (2015. "Real-life" effectiveness studies of omalizumab in adult patients with severe allergic asthma: systematic review.
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  We reviewed 24 'real-life' effectiveness studies of omalizumab in the treatment of severe allergic asthma that included 4117 unique patients from 32 countries with significant heterogeneity in patients, clinicians, and settings. The evidence underscores the short- and long-term benefit of anti-IgE therapy in terms of: improving lung function; achieving asthma control and reducing symptomatology, severe exacerbations, and associated work/school days lost; reducing healthcare resource utilizations, in particular hospitalizations, hospital lengths-of-stay, and accident specialist or emergency department visits; and reducing or discontinuing other asthma medications; and improving quality of life - thus confirming, complementing, and extending evidence from randomized trials. Thus omalizumab therapy is associated with signal improvements across the full objective and subjective burden of illness chain of severe allergic asthma. Benefits of omalizumab may extend up to 2 to 4 years and the majority of omalizumab-treated patients may benefit for many years. Omalizumab has positive short- and long-term safety profiles similar to what is known from randomized clinical trials. Initiated patients should be monitored for treatment response at 16 weeks. Those showing positive response at that time are highly likely to show sustained treatment response and benefit in terms of clinical, quality of life, and health resource utilization outcomes. This article is protected by copyright. All rights reserved.

Others

• Devogelaer, J., Geusens, P., Daci, E., Gielen, E., Denhaerynck, K., Macdonald, K., Hermans, C., Vancayzeele, S., Abraham, I., & Boonen, S. (2014, June). Remission over 3 years in patients with Paget disease of bone treated with a single intravenous infusion of 5 mg zoledronic acid. Calcified tissue international.
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  Using data from the Belgian Paget's Disease Registry of 142 patients treated with a 5 mg intravenous infusion of zoledronic acid, we examined disease remission over 3 years in 98 patients with Paget disease of bone (PDB) seen in routine practice. Median age was 76 years, most patients (60.2 %) were male, and all were Caucasian. Median time since PDB diagnosis was 11.5 years, few patients (5.1 %) had a family history of PDB, and 32.6 % had received prior bisphosphonate and/or other treatments. The most common pagetic locations were pelvis, spine, femur, tibia, and skull. The most common symptoms included pain, impaired mobility, bone deformities, and joint disease: 36.7 % of patients had comorbid osteoarthritis and 16.3 % comorbid osteoporosis. Response rates were 93.3 % at 1 year, 89.5 % at 2 years, and 91.6 % at 3 years, statistically similar to an extension study of the original zoledronic acid trials. Twenty-one patients experienced a relapse over the 3-year period at a median of 20.7 months posttreatment; of these, 13 regained remission by the end of the observation period. Relapse was not associated with osteoarthritis, osteoporosis, or other comorbidities. Safety data were similar to those reported elsewhere. In summary, in this somewhat frailer sample of patients with PDB, effectiveness and safety data were similar to those observed in the original trial populations. These findings, which are the first on the use of zoledronic acid for PDB in routine clinical practice, underscore the therapeutic benefits and relative safety of zoledronic acid in the management of PDB in "real-world" clinical settings.
• Herman, P. M., Dodds, S. E., Logue, M. D., Abraham, I., Rehfeld, R. A., Grizzle, A. J., Urbine, T. F., Horwitz, R., Crocker, R. L., & Maizes, V. H. (2014). IMPACT--Integrative Medicine PrimAry Care Trial: protocol for a comparative effectiveness study of the clinical and cost outcomes of an integrative primary care clinic model. BMC complementary and alternative medicine.
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  Integrative medicine (IM) is a patient-centered, healing-oriented clinical paradigm that explicitly includes all appropriate therapeutic approaches whether they originate in conventional or complementary medicine (CM). While there is some evidence for the clinical and cost-effectiveness of IM practice models, the existing evidence base for IM depends largely on studies of individual CM therapies. This may in part be due to the methodological challenges inherent in evaluating a complex intervention (i.e., many interacting components applied flexibly and with tailoring) such as IM.
• Delforge, M., Selleslag, D., Triffet, A., Mineur, P., Bries, G., Graux, C., Trullemans, F., MacDonald, K., Abraham, I., Pluymers, W., & Ravoet, C. (2011). Iron status and treatment modalities in transfusion-dependent patients with myelodysplastic syndromes. Annals of hematology.
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  Transfusion dependency and iron overload are common among patients with myelodysplastic syndromes (MDS) treated with red blood cell (RBC) transfusions. Transfusion dependency is associated with leukemic progression and shorter survival. Guidelines recommend iron chelation therapy to manage iron overload, however little is known about the chelation patterns in daily clinical practice. The objective of this multicenter, retrospective, cross-sectional, observational study was to evaluate iron status and its management in transfusion-dependent MDS patients. A total of 193 patient records from 29 centers were eligible for inclusion. Median patient age was 76, and median age at diagnosis of MDS was 74. Patients had received an average of 13.4 ± 7.6 RBC units in the past 4 months; 44% had received more than 50 units since their MDS diagnosis. Medium serum ferritin was 1,550 μg/L. Ninety patients (46.6%) received iron chelation therapy with either deferoxamine (41%), deferasirox (36%), and deferoxamine followed by deferasirox (23%). There were no statistically significant differences between chelated and nonchelated patients in terms of International Prognostic Scoring System (IPSS), French-American-British (FAB), and/or World Health Organization (WHO) status, though chelated patients had received more RBC transfusions (p = 0.014). Iron chelation therapy may be underutilized in transfusion-dependent patients. Undertreatment can be reduced by complementing sound clinical judgment with the generally accepted guidelines of a serum ferritin level >1,000 μg/L and/or two or more RBC transfusions per month for the past year; considering patients on the basis of their IPSS, FAB, and/or WHO status; and individually tailored treatment regimens. Prospective randomized trials are necessary to establish causally the efficacy of iron chelation therapy in MDS.
• Van Erps, J., Aapro, M., MacDonald, K., Soubeyran, P., Turner, M., Warrinnier, H., Albrecht, T., & Abraham, I. (2010). Promoting evidence-based management of anemia in cancer patients: concurrent and discriminant validity of RESPOND, a web-based clinical guidance system based on the EORTC guidelines for supportive care in cancer. Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer.
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  The goal of this study is to test the validity of RESPOND, a web-based decision support system to assess and manage anemia in cancer patients as per the European Organisation for Research and Treatment of Cancer (EORTC) guidelines. The intraclass correlation metrics for the algorithmic definitions were reported previously. Reported here are the concurrent validity, the extent to which clinicians' anemia management is guidelines-congruent when using the system; and discriminant validity, the extent to which clinicians practice in congruence with guidelines when vs. when not using the system.
• Noens, L., van Lierde, M., De Bock, R., Verhoef, G., Zachée, P., Berneman, Z., Martiat, P., Mineur, P., Van Eygen, K., MacDonald, K., De Geest, S., Albrecht, T., & Abraham, I. (2009). Prevalence, determinants, and outcomes of nonadherence to imatinib therapy in patients with chronic myeloid leukemia: the ADAGIO study. Blood.
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  Imatinib mesylate (imatinib) has been shown to be highly efficacious in the treatment of chronic myeloid leukemia (CML). Continuous and adequate dosing is essential for optimal outcomes and with imatinib treatment possibly being lifelong, patient adherence is critical. The ADAGIO (Adherence Assessment with Glivec: Indicators and Outcomes) study aimed to assess prospectively over a 90-day period the prevalence of imatinib nonadherence in patients with CML; to develop a multivariate canonical correlation model of how various determinants may be associated with various measures of nonadherence; and to examine whether treatment response is associated with adherence levels. A total of 202 patients were recruited from 34 centers in Belgium, of whom 169 were evaluable. One-third of patients were considered to be nonadherent. Only 14.2% of patients were perfectly adherent with 100% of prescribed imatinib taken. On average, patients with suboptimal response had significantly higher mean percentages of imatinib not taken (23.2%, standard deviation [SD] = 23.8) than did those with optimal response (7.3%, SD = 19.3, P = .005; percentages calculated as proportions x 100). Nonadherence is more prevalent than patients, physicians, and family members believe it is, and therefore should be assessed routinely. It is associated with poorer response to imatinib. Several determinants may serve as alert signals, many of which are clinically modifiable.
• Guadagno, L., VandeWeerd, C., Stevens, D., Abraham, I., Paveza, G. J., & Fulmer, T. (2004). Using PDAs for data collection. Applied nursing research : ANR.
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  Advances in handheld computer technology are making data collection faster, easier, and more accurate. In this article, the use of personal digital assistants (PDAs) to collect data for a study on elder neglect is described and evaluated. Methods for integrating this technology into a research study are discussed as are suggestions for increasing the performance of data collectors using these devices. The authors offer some practical solutions for researchers and clinicians planning to use PDAs in their research.