2024
A review of current practice in the design and analysis of extremely small stepped-wedge cluster randomized trials.
Tong G, Nevins P, Ryan M, Davis-Plourde K, Ouyang Y, Pereira Macedo J, Meng C, Wang X, Caille A, Li F, Taljaard M. A review of current practice in the design and analysis of extremely small stepped-wedge cluster randomized trials. Clinical Trials 2024, 17407745241276137. PMID: 39377196, DOI: 10.1177/17407745241276137.Peer-Reviewed Original ResearchSmall-sample correctionsStepped-wedge cluster randomized trialCluster randomized trialSample size calculation methodGeneralized linear mixed modelsLongitudinal correlation structureSize calculation methodLinear mixed modelsPermutation testSample sizeBayesian approachRandomized trialsCorrelation structureMixed modelsBayesian analysisGeneralized estimating equationsPermutationMedian sample sizeIntervention conditionRandomization methodEquations
2023
Sample size considerations for assessing treatment effect heterogeneity in randomized trials with heterogeneous intracluster correlations and variances
Tong G, Taljaard M, Li F. Sample size considerations for assessing treatment effect heterogeneity in randomized trials with heterogeneous intracluster correlations and variances. Statistics In Medicine 2023, 42: 3392-3412. PMID: 37316956, DOI: 10.1002/sim.9811.Peer-Reviewed Original ResearchConceptsGroup treatment trialsTreatment effect modificationRandomized trialsTreatment trialsEffect modificationEffect modifiersIntracluster correlation coefficientIndividual-level effect modifiersStudy armsTreatment effect heterogeneityOutcome observationsContinuous outcomesTrialsGroup treatmentTreatment effectsOutcome varianceEffect heterogeneityIntracluster correlationSample sizeSample size formulaAccounting for expected attrition in the planning of cluster randomized trials for assessing treatment effect heterogeneity
Tong J, Li F, Harhay M, Tong G. Accounting for expected attrition in the planning of cluster randomized trials for assessing treatment effect heterogeneity. BMC Medical Research Methodology 2023, 23: 85. PMID: 37024809, PMCID: PMC10077680, DOI: 10.1186/s12874-023-01887-8.Peer-Reviewed Original ResearchConceptsSample size methodsSample size proceduresSize proceduresTreatment effect heterogeneityHeterogeneous treatment effectsSize methodMissingness ratesSample size formulaSample size estimationMissingness indicatorsEffect heterogeneityReal-world examplesSimulation studyIntracluster correlation coefficientInflation methodSize formulaAverage treatment effectResultsSimulation resultsSample size estimatesSize estimationMissingnessSample sizeClustersEstimationFormula
2021
Sample size and power considerations for cluster randomized trials with count outcomes subject to right truncation
Li F, Tong G. Sample size and power considerations for cluster randomized trials with count outcomes subject to right truncation. Biometrical Journal 2021, 63: 1052-1071. PMID: 33751620, PMCID: PMC9132617, DOI: 10.1002/bimj.202000230.Peer-Reviewed Original ResearchConceptsCluster Randomized TrialPrimary outcomeGroup-based interventionRandomized trialsHealth StudySuch trialsPublic health studiesRight truncationTrialsOutcomesVector-borne diseasesCountSample size formulaAnalysis of CRTsPower calculationPopulation-level effectsSample sizeSize formulaClosed-form sample size formulaMarginal modeling approachMalariaDisease