Efficiency of nonparametric superiority tests based on restricted mean survival time versus the log-rank test under proportional hazards
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比例风险下限制平均生存时间检验与对数秩检验的效率比较
- 研究问题
- 在比例风险成立的优效性随机试验中，非参数限制平均生存时间差检验相对对数秩检验的效率如何受事件率和删失分布影响？
- 方法与思路
- 作者在无协变量设定下，通过渐近分析和模拟，联合考察事件率与删失分布，比较两种检验，并提供若干说明性情形。
- 材料陈述的贡献
- 摘要称高事件率或广泛删失时，两法使用相同数据的相对效率接近一；低事件率且删失集中在窗口末端时，比例风险分析更占优。
- 阅读关注点
- 应核对限制时间的选择、删失设定、相同数据量的具体含义，以及效率结论对应的比例风险情形和事件率范围。
- 阅读边界
- 这是预印本，同行评审或期刊接收未经核实。摘要未给出具体效率数值或全部条件，结论不能直接推广到比例风险不成立的情形。
原文摘要
Background: For RCTs with time-to-event endpoints, proportional hazard (PH) models are typically used to estimate treatment effects and logrank tests are commonly used for hypothesis testing. There is growing support for replacing this approach with a model-free estimand and assumption-lean analysis method. One alternative is to base the analysis on the difference in restricted mean survival time (RMST) at a specific time, a single-number summary measure that can be defined without any restrictive assumptions on the outcome model. In a simple setting without covariates, an assumption-lean analysis can be achieved using nonparametric methods such as Kaplan Meier estimation. The main advantage of moving to a model-free summary measure and assumption-lean analysis is that the validity and interpretation of conclusions do not depend on the PH assumption. The potential disadvantage is that the nonparametric analysis may lose efficiency under PH. There is disagreement in recent literature on this issue. Methods: Asymptotic results and simulations are used to compare the efficiency of a log-rank test against a nonparametric analysis of the difference in RMST in a superiority trial under PH. Previous studies have separately examined the effect of event rates and the censoring distribution on relative efficiency. This investigation clarifies conflicting results from earlier research by exploring the joint effect of event rate and censoring distribution together. Several illustrative examples are provided. Results: In scenarios with high event rates and/or substantial censoring across a large proportion of the study window, and when both methods make use of the same amount of data, relative efficiency is close to unity. However, in cases with low event rates but when censoring is concentrated at the end of the study window, the PH analysis has a considerable efficiency advantage.