Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research
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Patient-reported outcomes (PROs) are the consequences of disease and/or its treatment as reported by the patient. The importance of PRO measures in clinical trials for new drugs, biological agents, and devices was underscored by the release of the US Food and Drug Administration's draft guidance for industry titled "Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims." The intent of the guidance was to describe how the FDA will evaluate the appropriateness and adequacy of PRO measures used as effectiveness end points in clinical trials. In response to the expressed need of ISPOR members for further clarification of several aspects of the draft guidance, ISPOR's Health Science Policy Council created three task forces, one of which was charged with addressing the implications of the draft guidance for the collection of PRO data using electronic data capture modes of administration (ePRO). The objective of this report is to present recommendations from ISPOR's ePRO Good Research Practices Task Force regarding the evidence necessary to support the comparability, or measurement equivalence, of ePROs to the paper-based PRO measures from which they were adapted. ⋯ The electronic administration of PRO measures offers many advantages over paper administration. We provide a general framework for decisions regarding the level of evidence needed to support modifications that are made to PRO measures when they are migrated from paper to ePRO devices. The key issues include: 1) the determination of the extent of modification required to administer the PRO on the ePRO device and 2) the selection and implementation of an effective strategy for testing the measurement equivalence of the two modes of administration. We hope that these good research practice recommendations provide a path forward for researchers interested in migrating PRO measures to electronic data collection platforms.
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Comparative Study
Women's preferences for attributes of first-trimester miscarriage management: a stated preference discrete-choice experiment.
To elicit women's preferences for attributes of alternative management options for first-trimester miscarriage. ⋯ The preference results generated by this study suggest that many women undergoing management of first-trimester miscarriage would value being offered alternatives to expectant management. The data from this study should be considered by decision-makers in conjunction with the clinical and cost-effectiveness evidence base in this area as well as consideration of the budgets available to them for such services.
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The objective of this study was to investigate the interchangeability of the EuroQol 5D (EQ-5D) and the Short Form 6D (SF-6D) in individuals with long-lasting low back pain to guide the optimal choice of instrument and to inform decision-makers about any between-measure discrepancy, which require careful interpretation of the results of cost-utility evaluations. ⋯ Although the EQ-5D and the SF-6D are both psychometrically valid for generic outcome assessment in long-lasting low back pain, it appears that they cannot generally be used interchangeably for measurement of preference values. Sensitivity analysis examining the impact of between-measure discrepancy thus remains a necessary condition for the interpretation of the results of cost-utility evaluations.