Interpretational challenges of the Win Ratio in analyzing Hierarchical Composite Endpoints in Chronic Kidney Disease
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慢性肾病分层复合终点分析中胜率比的解释难题
- 研究问题
- 随机临床试验使用胜率比分析分层复合终点时，如何界定其目标量与因果问题，并理解它作为治疗效应指标的局限？
- 方法与思路
- 作者通过慢性肾病背景下的简单例子，讨论胜率比对组成终点方差的依赖，以及不可折叠性和非传递性带来的解释问题。
- 材料陈述的贡献
- 摘要称梳理了胜率比的既有解释难题，强调目标量、因果问题和临床含义之间的联系，为其合理使用提供讨论。
- 阅读关注点
- 应核对各例子的终点层级、比较规则和目标量定义，并区分方差依赖、不可折叠性与非传递性各自影响的解释层面。
- 阅读边界
- 这是arXiv预印本，不能据此认定已获同行评审或接收。摘要未提供例子的具体设定，也不足以判断各问题的适用范围。
原文摘要
Win statistics based methods have gained traction as a method for analyzing Hierarchical Composite Endpoints (HCEs) in randomized clinical trials, particularly in cardiovascular and kidney disease research. HCEs offer several key advantages, including increased statistical power, mitigation of competing risks, and hierarchical ranking of clinical outcomes. While, as summary measures, the win ratio (WR) along with the Net Benefit (NB) and the Win Odds (WO) provide a structured approach to analyzing HCEs, several concerns regarding their interpretability remain. In this paper, we present known issues with the WR using simple examples designed to explore the implications for the clinical interpretability of the treatment effect measure in the chronic kidney disease setting. Specifically, we discuss the challenge of defining an appropriate estimand in the context of HCEs using the WR, the difficulties in formulating a relevant causal question underlying the WR, and the dependency of the WR on the variance of its components, which complicates its role as an effect measure. Additionally, we highlight the non-collapsibility and non-transitivity of the WR, further complicating its interpretation. While the WR remains a valuable tool in clinical trials, its inherent limitations must be acknowledged to ensure its proper use in regulatory and clinical decision-making.