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合并多个临床试验死亡比例时的效率问题。

Issues of efficiency in combining proportions of deaths from several clinical trials.

作者信息

Buyse M, Ryan L M

机构信息

Department of Biostatistics, Harvard School of Public Health, Boston, Massachusetts.

出版信息

Stat Med. 1987 Jul-Aug;6(5):565-76. doi: 10.1002/sim.4780060505.

Abstract

The Mantel-Haenszel test provides a straightforward method to combine results from several clinical trials when only summary information, such as the proportion of deaths, is available for each trial. More efficient tests, such as the stratified logrank test, should be used if the survival and censoring times are known for all individuals, but in practice, the cost and effort of obtaining this information may be prohibitive. The purpose of this paper is to derive a general expression for the asymptotic relative efficiency (ARE) of the Mantel-Haenszel test with respect to the stratified logrank test, and to compute the ARE in situations which are likely to be of practical interest. The results show that under realistic assumptions about the survival distribution, losses to follow-up and duration of accrual, the ARE frequently exceeds 80 per cent. An example is given to show the usefulness of the approach when combining proportions of deaths from several cancer clinical trials.

摘要

当每个临床试验仅能获取诸如死亡比例等汇总信息时,Mantel-Haenszel检验提供了一种将多个临床试验结果合并的直接方法。如果已知所有个体的生存和截尾时间,则应使用更有效的检验方法,如分层对数秩检验,但在实际中,获取这些信息的成本和工作量可能过高。本文的目的是推导Mantel-Haenszel检验相对于分层对数秩检验的渐近相对效率(ARE)的一般表达式,并在可能具有实际意义的情况下计算ARE。结果表明,在关于生存分布、随访失访和入组持续时间的现实假设下,ARE经常超过80%。给出了一个示例,以说明在合并多个癌症临床试验的死亡比例时该方法的实用性。

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