2024
Assessing treatment effect heterogeneity in the presence of missing effect modifier data in cluster-randomized trials
Blette B, Halpern S, Li F, Harhay M. Assessing treatment effect heterogeneity in the presence of missing effect modifier data in cluster-randomized trials. Statistical Methods In Medical Research 2024, 33: 909-927. PMID: 38567439, PMCID: PMC11041086, DOI: 10.1177/09622802241242323.Peer-Reviewed Original ResearchConceptsMultilevel multiple imputationHeterogeneous treatment effectsCluster randomized trialPotential effect modifiersMultiple imputationAssess treatment effect heterogeneityEffect modifiersTreatment effect heterogeneityComplete-case analysisMissingness mechanismIntracluster correlationSimulation studyUnder-coverageRandomized trialsEffect heterogeneityHealth StudyTreatment effectsContinuous outcomesClinical practiceImputationModel specificationMissingnessData methodsModified dataTrials
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 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 individualswdpwr: A SAS macro and an R package for power calculations in stepped wedge cluster randomized trials
Chen J, Zhou X, Li F, Spiegelman D. swdpwr: A SAS macro and an R package for power calculations in stepped wedge cluster randomized trials. Computer Methods And Programs In Biomedicine 2021, 213: 106522. PMID: 34818620, PMCID: PMC8665077, DOI: 10.1016/j.cmpb.2021.106522.Peer-Reviewed Original ResearchConceptsWedge clusterIntracluster correlation coefficientContinuous outcomesCross-sectional cohortBinary outcomesExchangeable correlation structureWedge designPublic health intervention evaluationsHealth services researchClosed cohort designPower calculationCohort designClosed cohortStudy designIntracluster correlationIntervention evaluationNeeds of investigatorsOutcomesTrialsCohortServices researchInvestigatorsPrevious studiesSWD