论文标题

比较复发事件速率的Andersen-Gill模型的样本量计算

Sample size calculation for the Andersen-Gill model comparing rates of recurrent events

论文作者

Tang, Yongqiang, Fitzpatrick, Ronan

论文摘要

在生物医学研究中,经常出现反复事件,在该研究中,受试者可能会多次经历相同类型的事件。 Andersen-Gill(AG)模型在分析复发事件中越来越流行,特别是在事件速率随着时间的流逝不变时。我们提出了一项程序,用于计算AG模型的强大WALD测试的功率和样本量,以优越性,非效率和等效性临床试验。数值示例证明了其性能。 SAS代码在补充材料中提供。

Recurrent events arise frequently in biomedical research, where the subject may experience the same type of events more than once. The Andersen-Gill (AG) model has become increasingly popular in the analysis of recurrent events particularly when the event rate is not constant over time. We propose a procedure for calculating the power and sample size for the robust Wald test from the AG model in superiority, noninferiority, and equivalence clinical trials. Its performance is demonstrated by numerical examples. Sample SAS code is provided in the Supplementary Material.

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