4.5 Article

A note on sample size calculations for cluster randomised crossover trials with a fixed number of clusters

Journal

STATISTICS IN MEDICINE
Volume 38, Issue 18, Pages 3342-3345

Publisher

WILEY
DOI: 10.1002/sim.8191

Keywords

cluster randomised crossover clinical trial; experimental design; sample size calculation

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Girardeau, Ravaud and Donner in 2008 presented a formula for sample size calculations for cluster randomised crossover trials, when the intracluster correlation coefficient, interperiod correlation coefficient and mean cluster size are specified in advance. However, in many randomised trials, the number of clusters is constrained in some way, but the mean cluster size is not. We present a version of the Girardeau formula for sample size calculations for cluster randomised crossover trials when the number of clusters is fixed. Formulae are given for the minimum number of clusters, the maximum cluster size and the relationship between the correlation coefficients when there are constraints on both the number of clusters and the cluster size. Our version of the formula may aid the efficient planning and design of cluster randomised crossover trials.

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