Randomized two-stage optimal design for interval-censored data.

Randomized two-stage optimal design for interval-censored data.
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DOI:
10.1080/10543406.2021.2009499
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发表时间:
2022-03
影响因子:
1.1
通讯作者:
Shan, Guogen
Shan, Guogen
中科院分区:
医学4区
文献类型:
--
作者:
Shan, Guogen

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区间删失数据发生在一项研究中,其中未观察到每个参与者的确切事件时间,但已知其在一定的时间间隔内。对这些数据提出了多种检验,包括Sun的对数秩检验、Finkelstein的比例风险检验以及Peto和Peto的Wilcoxon型检验。我们提出了基于这些测试的并行一阶段或两阶段设计的样本量计算。当满足比例风险假设时,比例风险检验和对数秩检验需要的样本量比Wilcoxon型检验小,样本量节省相当大。但是,当比例风险假设不成立时,这种趋势就会逆转,并且使用Wilcoxon型检验的样本量节省相当大。肺癌临床试验的一个例子是用来说明所提出的样本量计算的应用。
Interval-censored data occur in a study where the exact event time of each participant is not observed but it is known to be within a certain time interval. Multiple tests were proposed for such data, including the logrank test by Sun, the proportional hazard test by Finkelstein, and the Wilcoxon-type test by Peto and Peto. We propose sample size calculations based on these tests for a parallel one-stage or two-stage design. When the proportional hazard assumption is met, the proportional hazard test and the logrank test need smaller sample size than the Wilcoxon-type test, and the sample size savings are substantial. But this trend is reversed when the proportional hazard assumption does not hold, and the sample size savings using the Wilcoxon-type test are sizable. An example from a lung cancer clinical trial is used to illustrate the application of the proposed sample size calculations.
DOI: 10.1080/10543406.2020.1730869
发表时间: 2020-02-28
影响因子: 1.1
作者:
Shan, Guogen
通讯作者: Shan, Guogen
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