Redfors Björn, Gregson John, Crowley Aaron, McAndrew Thomas, Ben-Yehuda Ori, Stone Gregg W, Pocock Stuart J
Clinical Trials Center, Cardiovascular Research Foundation, New York, NY, USA.
Division of Cardiology, NewYork-Presbyterian Hospital/Columbia University Irving Medical Center, New York, NY, USA.
Eur Heart J. 2020 Dec 7;41(46):4391-4399. doi: 10.1093/eurheartj/ehaa665.
The win ratio was introduced in 2012 as a new method for examining composite endpoints and has since been widely adopted in cardiovascular (CV) trials. Improving upon conventional methods for analysing composite endpoints, the win ratio accounts for relative priorities of the components and allows the components to be different types of outcomes. For example, the win ratio can combine the time to death with the number of occurrences of a non-fatal outcome such as CV-related hospitalizations (CVHs) in a single hierarchical composite endpoint. The win ratio can provide greater statistical power to detect and quantify a treatment difference by using all available information contained in the component outcomes. The win ratio can also incorporate quantitative outcomes such as exercise tests or quality-of-life scores. There is a need for more practical guidance on how best to design trials using the win ratio approach. This manuscript provides an overview of the principles behind the win ratio and provides insights into how to implement the win ratio in CV trial design and reporting, including how to determine trial size.
胜率于2012年作为一种用于检查复合终点的新方法被引入，此后在心血管（CV）试验中得到广泛应用。与分析复合终点的传统方法相比，胜率考虑了各组成部分的相对优先级，并允许各组成部分为不同类型的结局。例如，胜率可以在单个分层复合终点中将死亡时间与非致命结局（如心血管相关住院（CVH））的发生次数相结合。胜率可以通过利用组成结局中包含的所有可用信息，提供更大的统计效力来检测和量化治疗差异。胜率还可以纳入定量结局，如运动测试或生活质量评分。对于如何最好地使用胜率方法设计试验，需要更实用的指导。本手稿概述了胜率背后的原理，并深入探讨了如何在CV试验设计和报告中应用胜率，包括如何确定试验规模。
