2025
Model‐Robust Standardization in Cluster‐Randomized Trials
Li F, Tong J, Fang X, Cheng C, Kahan B, Wang B. Model‐Robust Standardization in Cluster‐Randomized Trials. Statistics In Medicine 2025, 44: e70270. PMID: 40968363, DOI: 10.1002/sim.70270.Peer-Reviewed Original ResearchConceptsInformative cluster sizeWorking regression modelsJackknife variance estimatorTreatment effect parametersCluster randomized trialData generating processAverage treatment effectVariance estimationCoefficient estimatesGeneralized linear mixed modelsEstimandsR packageNatural testCluster averagesLinear mixed modelsEstimationTreatment effectsExtensive simulation experimentsCluster sizeInferenceRegression modelsGeneralized Estimating EquationsGeneration processMixed modelsEquations
2022
Assessing Exposure-Time Treatment Effect Heterogeneity in Stepped-Wedge Cluster Randomized Trials
Maleyeff L, Li F, Haneuse S, Wang R. Assessing Exposure-Time Treatment Effect Heterogeneity in Stepped-Wedge Cluster Randomized Trials. Biometrics 2022, 79: 2551-2564. PMID: 36416302, PMCID: PMC10203056, DOI: 10.1111/biom.13803.Peer-Reviewed Original ResearchConceptsTreatment effect heterogeneityEffect heterogeneityParameter increasesTreatment effect parametersParametric functional formModel choicePermutation testModel formulationSimulation studyPrecise averageNew model formulationFunctional formEffect parametersRandom effectsTreatment effect estimatesCategorical termsVariance componentsDesign 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 definition
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