Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research
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1) To compare the Food and Drug Administration's (FDA's) Risk Evaluation and Mitigation Strategies (REMS) and European Medicines Agency's (EMA's) Risk Management Plan (RMP) guidances and 2) to compare REMS and RMPs for specific chemical entities and biological products. ⋯ Both REMS and RMPs provide positive guidance for identification, monitoring, and minimization of risk to patient safety. Currently, neither agency provides specific guidance on how risk should be related to benefit either qualitatively or quantitatively.
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Comparative Study
Comparison of generic, condition-specific, and mapped health state utility values for multiple myeloma cancer.
Resource allocation informed by cost-utility analysis requires that the benefits be comparable across patient groups and interventions. One option is to recommend the use of one generic utility measure, but this raises the issue of comparability when the preferred measure is inappropriate or unavailable. Many cancer trials do not include generic measures such as the EuroQol five-dimensional (EQ-5D) questionnaire and instead include condition-specific measures and use these to generate utility estimates. We analyze the comparability of generic, condition-specific, and mapped utility values for a multiple myeloma cancer patient data set. ⋯ Our findings suggest that condition-specific EORTC-8D or mapped EQ-5D utility estimates are broadly comparable to directly obtained EQ-5D utilities for a multiple myeloma patient data set. However, EORTC-8D estimates captured changes in quality of life for patients in mild health states that were not captured by the EQ-5D, but estimated lower utility gains than did the use of the EQ-5D directly.
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Develop and validate a health-related quality-of-life (measure for patients with acute and chronic leukemia. ⋯ The FACT-Leu scale is a valid, reliable, and efficient measure of leukemia-specific health-related quality of life for acute and chronic disease.
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To design cost-effective health services it is important to understand why people adopt particular symptom management strategies. ⋯ People value self-care, supported self-care, and general practitioner consultation differently depending on the type of symptoms. Manipulating costs to users and waiting times for different services could allow policymakers to influence the services people choose when managing symptoms.
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In an effort to sustainably strengthen orthopaedic trauma care in Haiti, a 2-year Orthopaedic Trauma Care Specialist (OTCS) program for Haitian physicians has been developed. The program will provide focused training in orthopaedic trauma surgery and fracture care utilizing a train-the-trainer approach. The purpose of this analysis was to calculate the cost-effectiveness of the program relative to its potential to decrease disability in the Haitian population. ⋯ The current economic analysis suggests the OTCS program to be a highly cost-effective intervention. Probabilistic sensitivity analysis demonstrates that the conclusions remain stable even when considering the joint uncertainty of the cost and DALY estimates.