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U.S. FDA Draft Guidance for Industry in Patient Reported Outcome Measurement.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.
U.S. FDA Draft Guidance for Industry in Patient Reported Outcome Measurement.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.
- Content Type Journal Article
- Category Review
- Pages 1-8
- DOI 10.1007/s11136-011-9990-8
- Authors
- Susan Magasi, Department of Medical Social Sciences, Feinberg School of Medicine Northwestern University, 625 Michigan Ave., Suite 2700, Chicago, IL Il 60611, USA
- Gery Ryan, Rand Corporation, Santa Monica, CA, USA
- Dennis Revicki, United BioSource Corporation, Bethesda, MD, USA
- William Lenderking, United BioSource Corporation, Bethesda, MD, USA
- Ron D. Hays, Department of Medicine, University of California, Los Angeles, Los Angeles, CA, USA
- Meryl Brod, The Brod Group, Mill Valley, CA, USA
- Claire Snyder, Division of General Internal Medicine, Johns Hopkins School of Medicine, Baltimore, MD, USA
- Maarten Boers, Department of Epidemiology and Biostatistics, Vrije Universiteit (VU) University Medical Center, Amsterdam, The Netherlands
- David Cella, Department of Medical Social Sciences, Feinberg School of Medicine Northwestern University, 625 Michigan Ave., Suite 2700, Chicago, IL Il 60611, USA
- Journal Quality of Life Research
- Online ISSN 1573-2649
- Print ISSN 0962-9343