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协方差分析与基线变化:随机研究中效能更高,非随机研究中偏差更大[已修正]

ANCOVA versus change from baseline: more power in randomized studies, more bias in nonrandomized studies [corrected].

作者信息

Van Breukelen Gerard J P

机构信息

Department of Methodology & Statistics, Research Institute Caphri, Maastricht University, P.O. Box 616, 6200 MD Maastricht, The Netherlands.

出版信息

J Clin Epidemiol. 2006 Sep;59(9):920-5. doi: 10.1016/j.jclinepi.2006.02.007. Epub 2006 Jun 23.

Abstract

BACKGROUND AND OBJECTIVE

For inferring a treatment effect from the difference between a treated and untreated group on a quantitative outcome measured before and after treatment, current methods are analysis of covariance (ANCOVA) of the outcome with the baseline as covariate, and analysis of variance (ANOVA) of change from baseline. This article compares both methods on power and bias, for randomized and nonrandomized studies.

METHODS

The methods are compared by writing both as a regression model and as a repeated measures model, and are applied to a nonrandomized study of preventing depression.

RESULTS

In randomized studies both methods are unbiased, but ANCOVA has more power. If treatment assignment is based on the baseline, only ANCOVA is unbiased. In nonrandomized studies with preexisting groups differing at baseline, the two methods cannot both be unbiased, and may contradict each other. In the study of depression, ANCOVA suggests absence, but ANOVA of change suggests presence, of a treatment effect. The methods differ because ANCOVA assumes absence of a baseline difference.

CONCLUSION

In randomized studies and studies with treatment assignment depending on the baseline, ANCOVA must be used. In nonrandomized studies of preexisting groups, ANOVA of change seems less biased than ANCOVA, but two control groups and two baseline measurements are recommended.

摘要

背景与目的

为了根据治疗组与未治疗组在治疗前后所测量的定量结果差异推断治疗效果,当前的方法是将结果与基线作为协变量进行协方差分析(ANCOVA),以及对基线变化进行方差分析(ANOVA)。本文针对随机和非随机研究,比较了这两种方法在检验效能和偏倚方面的差异。

方法

通过将两种方法都写成回归模型和重复测量模型来进行比较,并将其应用于一项预防抑郁症的非随机研究。

结果

在随机研究中,两种方法均无偏倚,但ANCOVA的检验效能更高。如果治疗分配基于基线,只有ANCOVA无偏倚。在基线时存在差异的非随机研究中,两种方法不可能都无偏倚,且可能相互矛盾。在抑郁症研究中,ANCOVA表明不存在治疗效果,但变化的ANOVA表明存在治疗效果。这两种方法存在差异是因为ANCOVA假定不存在基线差异。

结论

在随机研究以及治疗分配取决于基线的研究中,必须使用ANCOVA。在基线时存在差异的非随机研究中,变化的ANOVA似乎比ANCOVA的偏倚更小,但建议设置两个对照组和进行两次基线测量。

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