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Interpretation of patient-reported outcomes
Joseph C Cappelleri1, Andrew G Bushmakin2
1Pfizer Inc, Groton, CT, USA joseph.c.cappelleri@pfizer.com.
Statistical Methods in Medical Research
|February 22, 2013
Summary
Interpreting patient-reported outcome (PRO) scores is crucial for healthcare research and policy. This review clarifies anchor-based, distribution-based, and mediation analysis methods for better PRO score understanding.
Area of Science:
- Health Outcomes Research
- Clinical Epidemiology
- Biostatistics
Background:
- Patient-reported outcomes (PROs) are vital health status reports directly from patients.
- Meaningful interpretation of PRO scores is essential for study design, intervention evaluation, consumer education, and health policy.
- Understanding PRO scores is often hindered by insufficient data or lack of clinical expertise.
Purpose of the Study:
- To provide an updated review of methods for enhancing the understanding and interpretation of PRO scores.
- To elucidate the application of anchor-based, distribution-based, and mediation analysis approaches for PRO interpretation.
Main Methods:
- Review of anchor-based methods: threshold percentages, criterion-group interpretation, content-based interpretation, and clinical important difference.
- Review of distribution-based methods: effect size, probability of relative benefit, responder analysis, and cumulative proportions.
- Highlighting mediation analysis as a novel strategy to contextualize PROs within intervention mechanisms.
Main Results:
- The article details the logic and rationale of anchor-based, distribution-based, and mediation analysis.
- It integrates recent applications of these methodologies, demonstrating real-world implications.
- Mediation analysis is presented as a developing approach for deeper PRO score interpretation.
Conclusions:
- Understanding PRO scores is fundamental for their effective use in healthcare.
- Anchor-based, distribution-based, and mediation analysis offer valuable frameworks for interpreting PRO data.
- This integrated review provides practical insights into applying these diverse methodologies.
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