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01-06-2012 | Review

Content validity of patient-reported outcome measures: perspectives from a PROMIS meeting

Auteurs: Susan Magasi, Gery Ryan, Dennis Revicki, William Lenderking, Ron D. Hays, Meryl Brod, Claire Snyder, Maarten Boers, David Cella

Gepubliceerd in: Quality of Life Research | Uitgave 5/2012

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Abstract

Content validity of patient-reported outcome measures (PROs) has been a focus of debate since the 2006 publication of the U.S. FDA Draft Guidance for Industry in Patient Reported Outcome Measurement. Under the auspices of the Patient Reported Outcomes Measurement Information System (PROMIS) initiative, a working meeting on content validity was convened with leading PRO measurement experts. Platform presentations and participant discussion highlighted key issues in the content validity debate, including inconsistency in the definition and evaluation of content validity, the need for empirical research to support methodological approaches to the evaluation of content validity, and concerns that continual re-evaluation of content validity slows the pace of science and leads to the proliferation of study-specific PROs. We advocate an approach to the evaluation of content validity, which includes meticulously documented qualitative and advanced quantitative methods. To advance the science of content validity in PROs, we recommend (1) development of a consensus definition of content validity; (2) development of content validity guidelines that delineate the role of qualitative and quantitative methods and the integration of multiple perspectives; (3) empirical evaluation of generalizability of content validity across applications; and (4) use of generic measures as the foundation for PROs assessment.
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Metagegevens
Titel
Content validity of patient-reported outcome measures: perspectives from a PROMIS meeting
Auteurs
Susan Magasi
Gery Ryan
Dennis Revicki
William Lenderking
Ron D. Hays
Meryl Brod
Claire Snyder
Maarten Boers
David Cella
Publicatiedatum
01-06-2012
Uitgeverij
Springer Netherlands
Gepubliceerd in
Quality of Life Research / Uitgave 5/2012
Print ISSN: 0962-9343
Elektronisch ISSN: 1573-2649
DOI
https://doi.org/10.1007/s11136-011-9990-8

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