2023
Designing individually randomized group treatment trials with repeated outcome measurements using generalized estimating equations
Wang X, Turner E, Li F. Designing individually randomized group treatment trials with repeated outcome measurements using generalized estimating equations. Statistics In Medicine 2023, 43: 358-378. PMID: 38009329, PMCID: PMC10939061, DOI: 10.1002/sim.9966.Peer-Reviewed Original ResearchConceptsSample size proceduresConstant treatment effectCorrelation structureSize proceduresMarginal mean modelClosed-form sample size formulaCorrelation parametersSandwich variance estimatorGroup treatment trialsEquation approachExchangeable correlation structureSample size formulaBinary outcomesVariance estimatorEmpirical powerLinear timeMean modelCorrelation matrixDifferent correlation parametersEstimating EquationsSize formulaEquationsSample size calculationDifferent assumptionsProper sample size calculationDesigning multicenter individually randomized group treatment trials
Tong G, Tong J, Li F. Designing multicenter individually randomized group treatment trials. Biometrical Journal 2023, 66: e2200307. PMID: 37768850, DOI: 10.1002/bimj.202200307.Peer-Reviewed Original ResearchSample 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 formula
2021
Methodological challenges in pragmatic trials in Alzheimer’s disease and related dementias: Opportunities for improvement
Taljaard M, Li F, Qin B, Cui C, Zhang L, Nicholls SG, Carroll K, Mitchell SL. Methodological challenges in pragmatic trials in Alzheimer’s disease and related dementias: Opportunities for improvement. Clinical Trials 2021, 19: 86-96. PMID: 34841910, PMCID: PMC8847324, DOI: 10.1177/17407745211046672.Peer-Reviewed Original ResearchConceptsPragmatic trialAlzheimer's diseasePrimary outcomeSample size calculationGroup treatment trialsPairs of reviewersDementia researchSize calculationCluster Randomized TrialGroup treatment designRandomized trialsTreatment trialsIntracluster correlationMethodological qualityTrial reportsBaseline assessmentDiseaseTrialsDementiaKey methodological characteristicsOutcomesType IMethodological quality indicatorsUnique methodological challengesSame individualImpact of complex, partially nested clustering in a three-arm individually randomized group treatment trial: A case study with the wHOPE trial
Tong G, Seal KH, Becker WC, Li F, Dziura JD, Peduzzi PN, Esserman DA. Impact of complex, partially nested clustering in a three-arm individually randomized group treatment trial: A case study with the wHOPE trial. Clinical Trials 2021, 19: 3-13. PMID: 34693748, PMCID: PMC8847260, DOI: 10.1177/17407745211051288.Peer-Reviewed Original ResearchConceptsGroup treatment trialsIntraclass correlation coefficientTreatment trialsTreatment sessionsHealth optionsEducation trialThree-armWhole health teamFuture trial designNumber of cliniciansGroup treatment designTrue intraclass correlation coefficientsGroup treatment sessionsTreatment armsClinical trialsClinician levelMultiple cliniciansBACKGROUND/Health teamsOutcome dataTreatment groupsTrial designGroup educationClinical scenariosDifferent clinicians