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Choosing a patient-reported outcome measure
Leah M McClimans1, John Browne
1Department of Philosophy, University of South Carolina, Columbia, SC 29208, USA. mccliman@mailbox.sc.edu
Theoretical Medicine and Bioethics
|November 27, 2010
Summary
This study examines the U.S. Food and Drug Administration (FDA) guidelines for patient-reported outcome measures. It argues for greater emphasis on patient judgment and understanding meaning in assessing these measures.
Area of Science:
- Health research methodology
- Psychometrics
- Regulatory science
Background:
- The hierarchy of evidence prioritizes study designs but less so outcome measures.
- Patient-reported outcome measures (PROMs) are crucial in clinical research.
- Assessing the psychometric adequacy of PROMs is vital for reliable results.
Purpose of the Study:
- To examine the U.S. Food and Drug Administration's (FDA) guidelines on assessing PROMs.
- To focus on recommendations for content validity and weighing psychometric evidence.
- To advocate for a more central role of judgment and meaning in PROM adequacy.
Main Methods:
- Analysis of the FDA's recently published guidelines for PROMs.
- Focus on specific recommendations regarding content validity.
- Examination of how to weigh cumulative psychometric evidence for PROM selection.
Main Results:
- The FDA guidelines provide a framework for assessing PROMs.
- Current guidelines may not sufficiently emphasize the role of patient judgment.
- There is a need to better integrate understanding of meaning into PROM evaluation.
Conclusions:
- Philosophical considerations of outcome measures warrant more attention.
- Patient judgment and understanding meaning are critical for PROM adequacy.
- The FDA's approach to PROMs can be enhanced by prioritizing these aspects.
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