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在临床试验中测试基线平衡。

Testing for baseline balance in clinical trials.

作者信息

Senn S

机构信息

Medicine and Clinical Development Department, CIBA, Basle, Switzerland.

出版信息

Stat Med. 1994 Sep 15;13(17):1715-26. doi: 10.1002/sim.4780131703.

Abstract

Once the data from a clinical trial are available for analysis it is common practice to carry out 'tests of baseline homogeneity' on prognostic covariates before proceeding to analyse the effects of treatment on outcome variables. It is argued that this practice is philosophically unsound, of no practical value and potentially misleading. Instead it is recommended that prognostic variables be identified in the trial-plan and fitted in an analysis of covariance regardless of their baseline distribution (statistical significance).

摘要

一旦来自临床试验的数据可供分析,在着手分析治疗对结局变量的影响之前,对预后协变量进行“基线同质性检验”是常见的做法。有人认为这种做法在理论上站不住脚,没有实际价值,而且可能会产生误导。相反,建议在试验计划中确定预后变量,并在协方差分析中进行拟合,而不考虑其基线分布(统计显著性)。

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