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- Title
Recommendations on evidence needed to support measurement equivalence between electronic and paper-based patient-reported outcome (PRO) measures: ISPOR ePRO Good Research Practices Task Force report.
- Authors
Coons, Stephen Joel; Gwaltney, Chad J; Hays, Ron D; Lundy, J Jason; Sloan, Jeff A; Revicki, Dennis A; Lenderking, William R; Cella, David; Basch, Ethan; ISPOR ePRO Task Force
- Abstract
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for new drugs, biological agents, and devices was underscored by the release of the US Food and Drug Administration's draft guidance for industry titled "Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims."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 In response to the expressed need of ISPOR members for further clarification of several aspects of the draft guidance, ISPOR's Health Science Policy Council created three task forces, one of which was charged with addressing the implications of the draft guidance for the collection of PRO data using electronic data capture modes of administration (ePRO).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.
- Publication
Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research, 2009, Vol 12, Issue 4, p419
- ISSN
1524-4733
- Publication type
Journal Article
- DOI
10.1111/j.1524-4733.2008.00470.x