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Quantifying the impact of fixed effects modeling of clusters in multiple imputation for cluster randomized trials

โœ Scribed by Rebecca R. Andridge


Publisher
John Wiley and Sons
Year
2011
Tongue
English
Weight
270 KB
Volume
53
Category
Article
ISSN
0323-3847

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โœฆ Synopsis


In cluster randomized trials (CRTs), identifiable clusters rather than individuals are randomized to study groups. Resulting data often consist of a small number of clusters with correlated observations within a treatment group. Missing data often present a problem in the analysis of such trials, and multiple imputation (MI) has been used to create complete data sets, enabling subsequent analysis with well-established analysis methods for CRTs. We discuss strategies for accounting for clustering when multiply imputing a missing continuous outcome, focusing on estimation of the variance of group means as used in an adjusted t-test or ANOVA. These analysis procedures are congenial to (can be derived from) a mixed effects imputation model; however, this imputation procedure is not yet available in commercial statistical software. An alternative approach that is readily available and has been used in recent studies is to include fixed effects for cluster, but the impact of using this convenient method has not been studied. We show that under this imputation model the MI variance estimator is positively biased and that smaller intraclass correlations (ICCs) lead to larger overestimation of the MI variance. Analytical expressions for the bias of the variance estimator are derived in the case of data missing completely at random, and cases in which data are missing at random are illustrated through simulation. Finally, various imputation methods are applied to data from the Detroit Middle School Asthma Project, a recent school-based CRT, and differences in inference are compared.


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Cluster-randomized, crossover trial of t
โœ P. M. Nthumba; E. Stepita-Poenaru; D. Poenaru; P. Bird; B. Allegranzi; D. Pittet ๐Ÿ“‚ Article ๐Ÿ“… 2010 ๐Ÿ› John Wiley and Sons ๐ŸŒ English โš– 138 KB ๐Ÿ‘ 1 views

## Abstract ## Background The aim of this cluster-randomized, crossover trial was to compare the efficacy of plain soap and water with an alcohol-based handrub for surgical hand preparation and prevention of surgical-site infection (SSI) in a Kenyan rural hospital. ## Methods A total of 3317 pat