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

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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of patient-reported outcome measures (PROs) has been a focus of debate since the 2006 publication of the U.S. FDA Draft Guidance for Industry in Patient Reported Outcome Measurement.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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Computer adaptive testing


Confirmatory factor analysis


Differential item functioning


United States Food and Drug Administration


Item response theory


International Society for Quality of Life Research


International Society for Pharmacoeconomics and Outcomes Research


National Institutes of Health


Patient-reported outcome


Patient Reported Outcomes Measurement Information System


Structural equation modeling


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This work was funded by the National Institutes of Health through the NIH Roadmap for Medical Research, Grant (1U01-AR052177). This manuscript was reviewed by PROMIS reviewers, Paul Pilkonis, Arthur Stone, and Paul Crane, before submission for external peer review. Laurie Burke also provided thoughtful comments on an early draft.

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Correspondence to Susan Magasi.

Appendix 1: Conference participants

Appendix 1: Conference participants

Nancy Amicangelo (patient representative); Dagmar Amtmann, PhD, University of Washington; Meryl Brod, PhD, The Brod Group; Maarten Boers, MD, PhD, Vrije Universiteit; Laurie B. Burke, RPh, MPH OND/CDER/FDA; David Cella, PhD, Northwestern University; Jill Cyranowski, PhD, University of Pittsburgh Medical Center; Susan Czajkowski, PhD, National Institutes of Health; Darren DeWalt, MD, MPH. University of North Carolina; Jacqueline Dunbar-Jacob, PhD, RN, FAAN, University of Pittsburg; Sofia Garcia, PhD, Northwestern University; Richard Gershon, PhD, Northwestern University; Ari Gnanasakthy, PhD, Novartis Pharmaceuticals Corporation; Ron D. Hays, PhD, University of California at Los Angeles; Thomas Hilton, PhD, National Institute on Drug Abuse; Laura Lee Johnson, PhD, National Center for Complementary and Alternative Medicine; Nancy Kline Leidy, PhD, United BioSource Corporation; Eswat Krishnan, MD, Stanford University; William Lenderking, PhD, United BioSource Corporation (ISOQOL Representative); Amye Leong, MBA (Patient Representative); Mary Lynn, PhD, University of North Carolina at Chapel Hill; Susan Magasi, PhD, Northwestern University; Richard Moxley III, MD, University of Rochester Medical Center; Bhash Parasuramen, PhD, AstraZeneca Pharmaceuticals; Donald Patrick, PhD, University of Washington; Charles D. Petrie, PhD, Pfizer Global Development Headquarters (ISOPOR representative); Theodore Pincus, MD, NYU-Hospital for Joint Disease; Louis Quatrano, PhD, National Institute of Child Health and Human Development; Kenneth Rasinski, PhD, University of Chicago; Bryce Reeve, PhD, National Cancer Institute; William Riley, PhD, National Institute of Mental Health; Dennis Revicki, PhD, United BioSource Corporation; Margaret Rothman, PhD, Johnson & Johnson Pharmaceutical Services, LLC; Nan Rothrock, PhD, Northwestern University; Gery Ryan, PhD, Rand Corporation; Jane Scott, PhD, Mapi Values (ISOQOL Representative); Claire Snyder, PhD, Johns Hopkins School of Medicine; Ruth E.K. Stein, MD, AECOM/CHAM; Arthur Stone, PhD, Stony Brook University; Philip Tonkins, MS, DrPH; Peter Tugwell, MD; University of Ottawa; John Ware, QualityMetric Incorporated; Kevin Weinfurt, PhD; Duke University; Gordon Willis, PhD, National Cancer Institute; James P. Witter, MD, PhD NIAMS; Albert Wu, MD, MPH; Susan Yount, PhD, Northwestern University.

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Magasi, S., Ryan, G., Revicki, D. et al. Content validity of patient-reported outcome measures: perspectives from a PROMIS meeting. Qual Life Res 21, 739–746 (2012).

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