Design and analysis of cluster randomized trials with time‐to‐event outcomes under the additive hazards mixed model
Blaha O, Esserman D, Li F. Design and analysis of cluster randomized trials with time‐to‐event outcomes under the additive hazards mixed model. Statistics In Medicine 2022, 41: 4860-4885. PMID: 35908796, PMCID: PMC9588628, DOI: 10.1002/sim.9541.Peer-Reviewed Original ResearchConceptsSample size formulaCluster sizeNew sample size formulaSample size proceduresSize formulaEffect parametersSandwich variance estimatorStatistical inferenceCluster size variationEvent outcomesRandomization-based testsImproved inferenceSize proceduresTreatment effect parametersVariance estimatorSmall sample biasesAnalysis of clustersSimulation studyUnequal cluster sizesFrailty termVariance inflation factorFailure timeSample size requirementsMixed modelsAppropriate definitionClustered restricted mean survival time regression
Chen X, Harhay MO, Li F. Clustered restricted mean survival time regression. Biometrical Journal 2022, 65: e2200002. PMID: 35593026, DOI: 10.1002/bimj.202200002.Peer-Reviewed Original ResearchConceptsSandwich variance estimatorVariance estimatorValid inferencesRegression coefficient estimatesSmall sample scenariosContinuous functionsCluster correlationEffects of covariatesEstimatorHazard functionTarget parametersCoefficient estimatesMultilevel observational studyTime regressionRegression coefficientsInferenceEvent outcomesEquationsRegression modelsModelCritical assumptionsSufficient numberSimulationsFunctionAssumption