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Sample size calculation for cluster randomized cross-over trials
B Giraudeau1, P Ravaud, A Donner
1INSERM, CIC 202, France. giraudeau@med.univ-tours.fr
Abstract:
The cluster randomized cross-over design has been proposed in particular because it prevents an imbalance that may bring into question the internal validity of parallel group cluster trials. We derived a sample size formula for continuous outcomes that takes into account both the intraclass correlation coefficient (representing the clustering effect) and the interperiod correlation (induced by the cross-over design).
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