The win ratio: a new approach to the analysis of composite endpoints in clinical trials based on clinical priorities
The win ratio: a new approach to the analysis of composite endpoints in clinical trials based on clinical priorities
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DOI：
10.1093/eurheartj/ehr352
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发表时间：
2012-01-01
影响因子：
39.3
通讯作者：
Wang, Duolao
中科院分区：
文献类型：
--
作者：
Pocock, Stuart J.;Ariti, Cono A.;Wang, Duolao
临床试验中对复合终点的常规报道有其固有的局限性，因为它强调每个患者的第一个事件，这通常是临床重要性较低的结果。为了解决这个问题，我们引入了报告复合端点的胜率的概念。新的治疗组和对照组的患者根据他们的风险特征被配对。在心力衰竭试验中考虑一个主要的复合终点，例如心血管(CV)死亡和心力衰竭住院(HF Hosp)。对于每一对匹配的患者，新治疗的患者会被贴上“赢家”或“输家”的标签，这取决于谁先死了一份简历。如果不知道这一点，只有到那时，他们才会被贴上“赢家”或“输家”的标签，这取决于谁先患上了HF Hosp。否则，他们被认为是平局。胜率是赢家总数除以输家总数。容易获得95%的可信区间和胜率的P值。如果形成匹配对是不切实际的，则可以通过比较所有可能的不匹配对来获得可选的胜率。这种方法通过对重点-HF、伙伴B和魅力测试的重新分析来说明。Win Ratio是一种新的报告复合终点的方法，它易于使用，并适当优先考虑临床上更重要的事件，如死亡率。我们鼓励在未来的试验报告中使用它。
The conventional reporting of composite endpoints in clinical trials has an inherent limitation in that it emphasizes each patient's first event, which is often the outcome of lesser clinical importance. To overcome this problem, we introduce the concept of the win ratio for reporting composite endpoints. Patients in the new treatment and control groups are formed into matched pairs based on their risk profiles. Consider a primary composite endpoint, e.g. cardiovascular (CV) death and heart failure hospitalization (HF hosp) in heart failure trials. For each matched pair, the new treatment patient is labelled a 'winner' or a 'loser' depending on who had a CV death first. If that is not known, only then they are labelled a 'winner' or 'loser' depending on who had a HF hosp first. Otherwise they are considered tied. The win ratio is the total number of winners divided by the total numbers of losers. A 95% confidence interval and P-value for the win ratio are readily obtained. If formation of matched pairs is impractical then an alternative win ratio can be obtained by comparing all possible unmatched pairs. This method is illustrated by re-analyses of the EMPHASIS-HF, PARTNER B, and CHARM trials. The win ratio is a new method for reporting composite endpoints, which is easy to use and gives appropriate priority to the more clinically important event, e. g. mortality. We encourage its use in future trial reports.