Propensity score to detect baseline imbalance in cluster randomized trials: the role of the c-statistic

BMC Medical Research Methodology
C LeyratB Giraudeau

Abstract

Despite randomization, baseline imbalance and confounding bias may occur in cluster randomized trials (CRTs). Covariate imbalance may jeopardize the validity of statistical inferences if they occur on prognostic factors. Thus, the diagnosis of a such imbalance is essential to adjust statistical analysis if required. We developed a tool based on the c-statistic of the propensity score (PS) model to detect global baseline covariate imbalance in CRTs and assess the risk of confounding bias. We performed a simulation study to assess the performance of the proposed tool and applied this method to analyze the data from 2 published CRTs. The proposed method had good performance for large sample sizes (n =500 per arm) and when the number of unbalanced covariates was not too small as compared with the total number of baseline covariates (≥40% of unbalanced covariates). We also provide a strategy for pre selection of the covariates needed to be included in the PS model to enhance imbalance detection. The proposed tool could be useful in deciding whether covariate adjustment is required before performing statistical analyses of CRTs.

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Citations

May 19, 2017·American Journal of Public Health·Elizabeth L TurnerDavid M Murray
Jan 18, 2021·Journal of the American Medical Directors Association·Elizabeth M GalikErik Barr
Jun 23, 2021·Clinical Trials : Journal of the Society for Clinical Trials·K HemmingL Middleton
Jul 18, 2021·Cardiovascular Diabetology·Ferdinando Carlo SassoUNKNOWN NID-2 Study Group Investigators

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