2024
Randomized in error in pragmatic clinical trials
Tong G, Coronado G, Li C, Li F. Randomized in error in pragmatic clinical trials. Contemporary Clinical Trials 2024, 148: 107764. PMID: 39603383, DOI: 10.1016/j.cct.2024.107764.Peer-Reviewed Original ResearchPragmatic clinical trialsElectronic health record dataHealth record dataPatient-reported dataExclusion of participantsSelection biasPatients' medical recordsAverage treatment effectOutcomes of participantsUsual carePragmatic trialTreatment effectsIntervention effectsIntention-to-treatOutcomes frameworkPost-randomization exclusionsPotential outcomes frameworkRecord dataCovariate-adjusted estimatesMedical recordsParticipantsClinical trialsInterventionTrialsArm being
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 formulaA scoping review described diversity in methods of randomization and reporting of baseline balance in stepped-wedge cluster randomized trials
Nevins P, Davis-Plourde K, Pereira Macedo J, Ouyang Y, Ryan M, Tong G, Wang X, Meng C, Ortiz-Reyes L, Li F, Caille A, Taljaard M. A scoping review described diversity in methods of randomization and reporting of baseline balance in stepped-wedge cluster randomized trials. Journal Of Clinical Epidemiology 2023, 157: 134-145. PMID: 36931478, PMCID: PMC10546924, DOI: 10.1016/j.jclinepi.2023.03.010.Peer-Reviewed Original ResearchConceptsStepped-wedge clusterIndividual-level characteristicsMethod of randomizationCross-sectional designControl armBaseline imbalancesCohort designMedian numberElectronic searchPrimary analysisBaseline balanceStudy designPrimary reportsBaselineTrialsIntervention conditionSW-CRTsRandomizationReporting
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