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Updated: Jul 10, 2026
06:05
The Participant-Reported Implementation Update and Score (PRIUS): A Novel Method for Capturing Implementation-Related Data Over Time
Published on: February 19, 2021
Interpreting and reporting results based on patient-reported outcomes.
Dennis A Revicki1, Pennifer A Erickson, Jeff A Sloan
1Center for Health Outcomes Research, United BioSource Corporation, Bethesda, MD, USA.
Summary
This article guides on interpreting and reporting patient-reported outcomes (PROs) in clinical trials for pharmaceutical claims. It emphasizes clear methods for assessing clinical significance and presenting PRO data effectively.
Area of Science:
- Clinical Trials Methodology
- Pharmaceutical Research
- Health Outcomes Research
Background:
- Patient-reported outcomes (PROs) are increasingly incorporated into clinical trials.
- Challenges exist in interpreting and reporting PRO data for pharmaceutical claims.
- Assessing the clinical significance of PROs is crucial for regulatory and clinical decision-making.
Purpose of the Study:
- To address methods for assessing clinical significance of PROs.
- To provide guidance on effectively presenting PRO data in regulatory submissions and publications.
- To highlight common pitfalls in PRO data interpretation and reporting.
Main Methods:
- Review of best practices for PRO data interpretation.
- Analysis of FDA application requirements for PRO evidence.
- Discussion of methods for assessing and reporting clinical significance of PRO measures.
Main Results:
- Identified key questions regarding PRO data assessment and presentation.
- Outlined the importance of clear specifications for clinical meaningfulness of PROs.
- Stressed the need for comprehensive reporting of PRO trial methods, measures, and results.
Conclusions:
- Standardized guidelines are needed for interpreting and reporting PROs.
- Instrument developers and psychometricians must define clinical meaningfulness.
- Comprehensive and clear reporting of PRO data is essential for all stakeholders.
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