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基于比例比较的样本量计算在对数秩检验中的适用性。

Applicability of sample size calculations based on a comparison of proportions for use with the logrank test.

作者信息

Gail M H

出版信息

Control Clin Trials. 1985 Jun;6(2):112-9. doi: 10.1016/0197-2456(85)90116-3.

Abstract

The asymptotic relative efficiency of a test of proportions versus the logrank test is calculated for various clinical trial designs that are used to compare the survival of two treatment groups. The asymptotic relative efficiency is shown to be a reasonable guide to the relative sample sizes required for the logrank and proportions test. It is shown that the efficiency of the proportions test is near 1.0 for designs corresponding to typical studies of cardiovascular disease, for which the duration of the experiment is short compared to mean survival. This result is of practical importance, because sample size calculations based on the comparison of proportions are available to cover many contingencies, including a delay in the onset of full treatment effectiveness, whereas similar calculations have not been published for the logrank statistic. On the other hand, the efficiency of the proportions test can drop to 72% or less for trials in which the accrual period exceeds the mean survival, as is often the case in trials to treat cancer. In such cases, sample size calculations for the proportions test would be [(1/0.72) - 1] = 39% larger than required for the logrank test. Thus, power calculations specifically tailored to the logrank test should be used for studies with a duration comparable to mean survival, if one intends to employ the logrank statistic.

摘要

针对用于比较两个治疗组生存率的各种临床试验设计,计算了比例检验相对于对数秩检验的渐近相对效率。结果表明,渐近相对效率是对数秩检验和比例检验所需相对样本量的合理指南。结果显示,对于与心血管疾病典型研究相对应的设计,比例检验的效率接近1.0,在这类研究中,与平均生存期相比,实验持续时间较短。这一结果具有实际重要性,因为基于比例比较的样本量计算可涵盖许多意外情况,包括完全治疗效果出现延迟的情况,而对数秩统计量的类似计算尚未发表。另一方面,对于入组期超过平均生存期的试验,比例检验的效率可能降至72%或更低,治疗癌症的试验通常就是这种情况。在这种情况下,比例检验的样本量计算将比对数秩检验所需的样本量大[(1/0.72) - 1] = 39%。因此,如果打算使用对数秩统计量,对于持续时间与平均生存期相当的研究,应使用专门针对对数秩检验的效能计算。

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