Good Research Practices for Establishing and Reporting Evidence of the Content Validity of Patient-Reported Outcomes Instruments

Chair: Donald L. Patrick PhD, MSPH, Department of Health Services, University of Washington, Seattle, WA, USA

Leadership Team:
Laurie B. Burke RPh, MPH, Director, Study Endpoints and Label Developments, Office of New Drugs, CDER, FDA, Washington, DC, USA
Chad Gwaltney PhD, Assistant Professor (Research), Department of Community Health, Brown University, Providence, RI, USA and Scientific Consultant, PRO Consulting, Pittsburgh, PA, USA
Nancy Kline Leidy PhD, Senior Vice President of Scientific Affairs, United BioSource, Bethesda, MD, USA
Mona L. Martin RN, MPA, Executive Director, Health Research Associates, Inc, Seattle, WA, USA
Lena Ring PhD, Associate Professor, Pharmaceutical Outcomes Research, Department of Pharmacy, Uppsala University and Senior Outcomes Research Scientist, HEOR, R&D, AstraZeneca, Södertälje, Sweden

Background and Project Description:
Content validity is the extent to which an assessment instrument measures the important aspects of the concept assessed.   A patient reported outcome (PRO) instrument measures a concept relevant and important to the patient’s condition and its treatment.  For PRO instruments, items and domains as reflected in the scores of an instrument should be important to the target population of patients and comprehensive with respect to patient concerns concerning the concept being assessed.  Documentation of target patient population input in item generation, as well as evaluation of patient understanding through cognitive interviewing, can provide the evidence for content validity.

Background and Project Description continued…

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