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

BACKGROUND: 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 stat...

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Autores principales: Leyrat, Clémence, Caille, Agnès, Foucher, Yohann, Giraudeau, Bruno
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4724161/
https://www.ncbi.nlm.nih.gov/pubmed/26801083
http://dx.doi.org/10.1186/s12874-015-0100-4
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author Leyrat, Clémence
Caille, Agnès
Foucher, Yohann
Giraudeau, Bruno
author_facet Leyrat, Clémence
Caille, Agnès
Foucher, Yohann
Giraudeau, Bruno
author_sort Leyrat, Clémence
collection PubMed
description BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSION: The proposed tool could be useful in deciding whether covariate adjustment is required before performing statistical analyses of CRTs. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s12874-015-0100-4) contains supplementary material, which is available to authorized users.
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spelling pubmed-47241612016-01-24 Propensity score to detect baseline imbalance in cluster randomized trials: the role of the c-statistic Leyrat, Clémence Caille, Agnès Foucher, Yohann Giraudeau, Bruno BMC Med Res Methodol Research Article BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSION: The proposed tool could be useful in deciding whether covariate adjustment is required before performing statistical analyses of CRTs. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s12874-015-0100-4) contains supplementary material, which is available to authorized users. BioMed Central 2016-01-22 /pmc/articles/PMC4724161/ /pubmed/26801083 http://dx.doi.org/10.1186/s12874-015-0100-4 Text en © Leyrat et al. 2015 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License(http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Research Article
Leyrat, Clémence
Caille, Agnès
Foucher, Yohann
Giraudeau, Bruno
Propensity score to detect baseline imbalance in cluster randomized trials: the role of the c-statistic
title Propensity score to detect baseline imbalance in cluster randomized trials: the role of the c-statistic
title_full Propensity score to detect baseline imbalance in cluster randomized trials: the role of the c-statistic
title_fullStr Propensity score to detect baseline imbalance in cluster randomized trials: the role of the c-statistic
title_full_unstemmed Propensity score to detect baseline imbalance in cluster randomized trials: the role of the c-statistic
title_short Propensity score to detect baseline imbalance in cluster randomized trials: the role of the c-statistic
title_sort propensity score to detect baseline imbalance in cluster randomized trials: the role of the c-statistic
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4724161/
https://www.ncbi.nlm.nih.gov/pubmed/26801083
http://dx.doi.org/10.1186/s12874-015-0100-4
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