Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research
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Health promotion (HP) interventions have outcomes that go beyond health. Such broader nonhealth outcomes are usually neglected in economic evaluation studies. To allow for their consideration, insights are needed into the types of nonhealth outcomes that HP interventions produce and their relative importance compared with health outcomes. This study explored consumer preferences for health and nonhealth outcomes of HP in the context of lifestyle behavior change. ⋯ Health outcomes and nonhealth outcomes of lifestyle behavior change were both important to consumers in this study. Decision makers should respond to consumer preferences and consider nonhealth outcomes when deciding about HP interventions.
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Comparative Study
Responsiveness of the EQ-5D health-related quality-of-life instrument in assessing low back pain.
To compare the responsiveness of the EuroQol five-dimensional questionnaire (EQ-5D) generic quality-of-life instrument with that of specific instruments-the Brief Pain Inventory (BPI) and the Oswestry Disability Index (ODI)-in assessing low back pain. ⋯ The EQ-5D index is less responsive than instruments specific to pain measurement, although it is capable of indicating clinically important changes. The lower responsiveness arises from EQ-5D's more limited gradation of severity and its multidimensionality.
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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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Randomized Controlled Trial Multicenter Study
Unidimensional 12-item Zarit Caregiver Burden Interview for the assessment of dementia caregivers' burden obtained by item response theory.
To develop a one-dimensional version of the 22-item Zarit Caregiver Burden Interview (ZBI) by applying item response theory approaches. ⋯ The reduced 12-item ZBI fits a one-dimensional latent variable of burden. Further psychometric studies, focusing on its equivalence for different populations, sensitivity to change, and minimal important difference are warranted.
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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.