Sample size calculation for cluster randomized cross-over trials.
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).
Giraudeau
B
B
INSERM, CIC 202, France. giraudeau@med.univ-tours.fr
Ravaud
P
P
Donner
A
A
D000465:Algorithms; D001786:Blood Glucose / Q000032:analysis*; D016000:Cluster Analysis; D018592:Cross-Over Studies; D003627:Data Interpretation, Statistical; D004360:Drug Therapy, Computer-Assisted; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D007328:Insulin / Q000008:administration & dosage*; D007362:Intensive Care Units; D015233:Models, Statistical; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D018401:Sample Size; D013997:Time Factors
D001786:Blood Glucose; D007004:Hypoglycemic Agents; D007328:Insulin