The win ratio in cardiology trials: lessons learnt, new developments, and wise future use

作者：Stuart Pocock, John Gregson, Timothy J. Collier, João Pedro Ferreira, Gregg W. Stone · 发表于：European Heart Journal · 年份：2024 · DOI：10.1093/eurheartj/ehae647 · 被引用次数：106 · 研究领域：Statistical Methods in Clinical Trials、Health Systems, Economic Evaluations, Quality of Life、Advanced Causal Inference Techniques

The win ratio method for analysing a composite clinical hierarchy of outcomes is growing in popularity especially in cardiovascular trials. This article gives a perspective on its use so far and the issues derived from that experience. Specifically, it focuses on the limitations of a conventional composite outcome; how does the win ratio work, what does it mean, and how to display its findings; guidance on choosing an appropriate clinical hierarchy of outcomes including clinical events, quantitative outcomes, and other options; the additional value of the win difference as a measure of absolute benefit: extension to stratified win ratio, subgroup analysis, matched win ratio, and covariate adjustment; determining trial size for a win ratio outcome; specific insights such as adaptive designs, use of repeat events, and use of margins and time averages for quantitative outcomes; a critique of potential misuses; availability of statistical software; and a statistical appendix on the methodological details. Throughout, each principle is illustrated by examples from specific cardiology trials. The article concludes with a set of recommendations for future use of the win ratio.