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Good Research Practices on New PRO Instruments – Assessing Respondent Understanding

Content Validity—Establishing and Reporting the Evidence in Newly Developed Patient-Reported Outcomes (PRO) Instruments for Medical Product Evaluation: ISPOR PRO Good Research Practices Task Force Report: Part 2 — Assessing Respondent Understanding

The citation for this report is:
Patrick DL, Burke LB, Gwaltney CJ, et al. Content validity - Establishing and reporting the evidence in newly-developed patient-reported outcomes (PRO) Instruments for medical product evaluation: ISPOR PRO good research practices task force report: Part 2 – Assessing respondent understanding. Value Health 2011;14; 978-988.  [Epub October 13, 2011]

For Content validity - Establishing and reporting the evidence in newly-developed patient-reported outcomes (PRO) Instruments for medical product evaluation: ISPOR PRO good research practices task force report: Part 1 - Eliciting concepts for a new PRO instrument please see: http://www.ispor.org/workpaper/Content-Validity-New-PRO-Eliciting-Concepts-for-a-New-PRO-Instrument.asp

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

Leadership Team:
Laurie B. Burke RPh, MPH, Director, Study Endpoints and Labeling Development, 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 Senior Scientist, 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
Elizabeth Molsen RN
, Director, ISPOR Initiatives, ISPOR, Lawrenceville, NJ
Lena Ring PhD, Principal Scientist in PRO Strategy, HEOR, R&D, AstraZeneca, Södertälje, Sweden and Associate Professor, Pharmaceutical Outcomes Research, Department of Pharmacy, Uppsala University, Sweden

Background
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 continued…

Activities:
Establishing the Content Validity of Patient-Reported Outcome (PRO) Instruments
May 2011 - ISPOR 16th Annual International Meeting, Short Course, Baltimore, MD, USA
Content Validity In Newly Developed PRO Instruments for Medical Product Evaluation: What Is Sufficient for Regulatory Submissions?
May 2011 - ISPOR 16th Annual International Meeting, Forum Presentation, Baltimore, MD, USA
Establishing the Content Validity of Patient-Reported Outcome (PRO) Instruments
May 2010 - ISPOR 15th Annual International Meeting, Short Course, Atlanta,Georgia, USA
ISPOR Good Research Practices Recommendations on the FDA’s Guidance for Industry Patient Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims
May 2010 – ISPOR 15th Annual International Meeting Forum Presentation, Atlanta, GA, USA


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