Chen Liddy M, Ibrahim Joseph G, Chu Haitao
a Global Research Operation, Biostatistics, PAREXEL International , Durham , North Carolina , USA.
J Biopharm Stat. 2014;24(4):908-23. doi: 10.1080/10543406.2014.901346.
The frailty model is increasingly popular for analyzing multivariate time-to-event data. The most common model is the shared frailty model. Although study design consideration is as important as analysis strategies, sample size determination methodology in studies with multivariate time-to-event data is greatly lacking in the literature. In this article, we develop a sample size determination method for the shared frailty model to investigate the treatment effect on multivariate event times. We analyzed the data using both a parametric model and a piecewise model with unknown baseline hazard, and compare the empirical power with the calculated power. Last, we discuss the formula for testing the treatment effect on recurrent events.
脆弱模型在分析多变量事件发生时间数据方面越来越受欢迎。最常见的模型是共享脆弱模型。尽管研究设计考量与分析策略同样重要，但在多变量事件发生时间数据的研究中，样本量确定方法在文献中却极为匮乏。在本文中，我们开发了一种用于共享脆弱模型的样本量确定方法，以研究治疗对多变量事件时间的影响。我们使用参数模型和具有未知基线风险的分段模型来分析数据，并将经验功效与计算得到的功效进行比较。最后，我们讨论了用于检验对复发事件治疗效果的公式。
