Testing for baseline balance in clinical trials

1994/09/15 by Stephen Senn · 1 voice · 8 citations
Mathematics · Economics, Econometrics and Finance · Decision Sciences · #Statistical Methods in Clinical Trials #Health Systems, Economic Evaluations, Quality of Life #Meta-analysis and systematic reviews

paper · 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).

Citations

• On the Principle of Total Evidence

Cited by

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• Comparison of the ability of double‐robust estimators to correct bias in propensity score matching analysis. <scp>A M</scp>onte <scp>C</scp>arlo simulation study
• Double propensity-score adjustment: A solution to design bias or bias due to incomplete matching
• Guidelines for estimating causal effects in pragmatic randomized trials

Discussions

• 6) P-values in Table 1 of randomised trials Random fluctuations in the balance between groups in baseline characteristics of the trial are not a threat to the validity of the trial results. There is [bsky, 37 points, 5 comments]

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