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The win ratio in cardiology trials: lessons learnt, new developments, and wise future use.
Stuart J Pocock1, John Gregson1, Timothy J Collier1
1Medical Statistics Department, London School of Hygiene and Tropical Medicine, London, WC1E 7HT, UK.
European Heart Journal
|October 15, 2024
Summary
The win ratio method offers a robust way to analyze composite clinical outcomes, particularly in cardiovascular research. This perspective reviews its application, advantages, and potential challenges for better trial design and interpretation.
Area of Science:
- Cardiology
- Clinical Trials
- Biostatistics
Background:
- Composite outcomes are increasingly used in clinical trials, especially in cardiovascular research.
- The win ratio method is gaining popularity for analyzing hierarchical composite outcomes.
- Conventional composite outcomes have limitations that the win ratio method aims to address.
Purpose of the Study:
- To provide a comprehensive perspective on the win ratio method's application in clinical trials.
- To discuss the advantages, limitations, and practical considerations of using the win ratio.
- To offer guidance on implementing and interpreting the win ratio for composite outcomes.
Main Methods:
- Review of the win ratio methodology and its statistical underpinnings.
- Analysis of its application and performance in cardiovascular trials.
- Discussion of extensions including win difference, subgroup analysis, and covariate adjustment.
Main Results:
- The win ratio provides a nuanced analysis of hierarchical composite outcomes.
- Guidance is offered on selecting appropriate outcome hierarchies and displaying results.
- Methods for sample size determination and handling of specific trial designs are presented.
Conclusions:
- The win ratio method is a valuable tool for analyzing composite outcomes in clinical trials.
- Recommendations are provided for its appropriate use and to avoid potential misuses.
- Further research and statistical software development are encouraged for wider adoption.
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