Testing Prioritized Composite Endpoint with Multiple Follow-up Time Examinations
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结合多个随访时点检验优先级复合终点
- 研究问题
- 当治疗效应随随访时间变化，或非致死终点的效应被高优先级死亡终点掩盖时，如何改进分层复合终点检验？
- 方法与思路
- 作者提出 ProFS，将多个随访时点的 Finkelstein–Schoenfeld 检验统计量取最大值，并扩展到组序贯监测设计。
- 材料陈述的贡献
- 摘要称模拟中 ProFS 在短期效应突出或次级终点效应被掩盖的情形提高检验功效，并以 SPRINT 临床试验展示应用。
- 阅读关注点
- 应核对多个时点统计量的联合分布、显著性水平控制、时点选择规则，以及序贯监测下的拒绝边界和功效比较。
- 阅读边界
- 这是 arXiv 预印本，同行评审与期刊接收未核实；摘要未说明具体校准方法和功效数值，不能将特定情形的优势推广到所有试验。
原文摘要
Composite endpoints are widely used in cardiovascular clinical trials. In recent years, hierarchical composite endpoints-particularly the win ratio approach and its predecessor, the Finkelstein-Schoenfeld (FS) test, also known as the unmatched win ratio test-have gained popularity. These methods involve comparing individuals across multiple endpoints, ranked by priority, with mortality typically assigned the highest priority in many applications. However, these methods have not accounted for varying treatment effects, known as non-constant hazards over time in the context of survival analysis. To address this limitation, we propose an adaptation of the FS test that incorporates progressive follow-up time, which we will refer to as ProFS. This proposed test can jointly evaluate treatment effects at various follow-up time points by incorporating the maximum of several FS test statistics calculated at those specific times. Moreover, ProFS also supports clinical trials with group sequential monitoring strategies, providing flexibility in trial design. As demonstrated through extensive simulations, ProFS offers increased statistical power in scenarios where the treatment effect is mainly in the short term or when the second (non-fatal) layer might be concealed by a lack of effect or weak effect on the top (fatal) layer. We also apply ProFS to the SPRINT clinical trial, illustrating how our proposed method improves the performance of FS.