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Published on: February 19, 2021
Methods for interpreting change over time in patient-reported outcome measures
K W Wyrwich1, J M Norquist, W R Lenderking
1United BioSource Corporation, 7101 Wisconsin Avenue, Suite 600, Bethesda, MD 20814, USA. kathy.wyrwich@unitedbiosource.com
Summary
Interpreting patient-reported outcome (PRO) change scores requires clear guidelines. Anchor-based methods are crucial for defining meaningful thresholds to assess intervention efficacy and communicate results effectively.
Area of Science:
- Health Outcomes Research
- Clinical Trial Methodology
- Patient-Reported Outcomes
Background:
- Patient-reported outcome (PRO) measures are vital for evaluating intervention efficacy and communicating results to various stakeholders.
- The 2009 FDA Guidance provides recommendations for interpreting PRO change scores in medical product development.
- Clear interpretation guidelines are essential for PRO change scores.
Purpose of the Study:
- To review the evolution of methods and terminology for communicating meaningful PRO change score thresholds.
- To discuss the role of anchor-based and distribution-based methods in PRO interpretation.
- To highlight the FDA's emphasis on patient global assessments as an anchor-based method.
Main Methods:
- Literature review of methods for PRO change score interpretation.
- Analysis of anchor-based and distribution-based approaches.
- Discussion of the FDA's recommendations, including the cumulative distribution function (CDF).
Main Results:
- Anchor- and distribution-based methods are important for interpreting PRO change scores.
- The FDA emphasizes patient global assessments for defining responder status.
- The CDF is proposed by the FDA for depicting treatment effects across populations.
Conclusions:
- Cumulative distribution functions (CDFs) are useful but should not replace anchor-based methods for defining responder thresholds.
- Thorough investigation using anchor-based methods is necessary to establish relevant thresholds for interpreting PRO changes over time.
- Stakeholder communication regarding PRO interpretation requires robust, evidence-based thresholds.
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