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具有治疗前和治疗后测量的随机临床试验:重复测量与协方差分析模型。

Randomized clinical trials with a pre- and a post-treatment measurement: repeated measures versus ANCOVA models.

作者信息

Winkens Bjorn, van Breukelen Gerard J P, Schouten Hubert J A, Berger Martijn P F

机构信息

Department of Methodology and Statistics, University of Maastricht, P.O. Box 616, 6200 MD Maastricht, The Netherlands.

出版信息

Contemp Clin Trials. 2007 Nov;28(6):713-9. doi: 10.1016/j.cct.2007.04.002. Epub 2007 Apr 21.

Abstract

Repeated measures (RM) and ANCOVA models are compared with respect to treatment effect estimation in randomized clinical trials with a pre- and a post-treatment measure. The covariance matrices of repeated measures are assumed to be I) homogeneous or II) heterogeneous across groups. In situation I, ANCOVA is preferred to RM, because the estimated variance of the treatment effect estimator is unbiased for ANCOVA and biased downwards for RM. In situation II, RM with Kenward and Roger's adjustment is preferred to ANCOVA, because the ANCOVA variance estimator does not correct for unknown pre-treatment expectation. The results are illustrated with an example.

摘要

在具有治疗前和治疗后测量的随机临床试验中,就治疗效果估计而言,对重复测量(RM)模型和协方差分析(ANCOVA)模型进行了比较。重复测量的协方差矩阵假定为:I)各组间同质或II)各组间异质。在情况I中,ANCOVA优于RM,因为治疗效果估计量的估计方差对于ANCOVA是无偏的,而对于RM则向下有偏。在情况II中,采用肯沃德和罗杰调整的RM优于ANCOVA,因为ANCOVA方差估计量未对未知的治疗前期望进行校正。通过一个例子对结果进行了说明。

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