2025
Selecting the optimal longitudinal cluster randomized design with a continuous outcome: Parallel-arm, crossover, or stepped-wedge.
Liu J, Li F, Sutcliffe S, Colditz G. Selecting the optimal longitudinal cluster randomized design with a continuous outcome: Parallel-arm, crossover, or stepped-wedge. Statistical Methods In Medical Research 2025, 9622802251360409. PMID: 40785501, DOI: 10.1177/09622802251360409.Peer-Reviewed Original ResearchSW-CRTsLongitudinal cluster randomized trialsStepped wedge cluster randomized trialCluster-period sizesTreatment effect estimatesCluster randomized trialContinuous outcomesGeneralized Estimating EquationsOptimal designCluster randomized designEffect estimatesFixed budgetCluster randomized trial designFormulaEquationsAlgorithmOptimal numberCross-sectional designGlobal optimal designEstimationRandomized trial designRandomized trialsStepped-wedgeCRXO trialsOD algorithmAssessing Mediation in Cross‐Sectional Stepped Wedge Cluster Randomized Trials
Cao Z, Li F. Assessing Mediation in Cross‐Sectional Stepped Wedge Cluster Randomized Trials. Statistics In Medicine 2025, 44: e70175. PMID: 40662697, DOI: 10.1002/sim.70175.Peer-Reviewed Original ResearchConceptsStepped wedge cluster randomized trialSW-CRTsTreatment effect heterogeneityCluster randomized trialSW-CRTBinary mediatorEffect heterogeneityGeneralized linear mixed modelsNatural indirect effectLinear mixed modelsEstimationEffective structureExamplesMixed modelsType combinationsMediation proportionPractical implementationPower calculation for cross-sectional stepped wedge cluster randomized trials with a time-to-event endpoint
Baumann M, Esserman D, Taljaard M, Li F. Power calculation for cross-sectional stepped wedge cluster randomized trials with a time-to-event endpoint. Biometrics 2025, 81: ujaf074. PMID: 40557765, PMCID: PMC12188223, DOI: 10.1093/biomtc/ujaf074.Peer-Reviewed Original ResearchConceptsSW-CRTsCluster randomized trialStepped wedge cluster randomized trialTime-to-event endpointsTime-to-event outcomesRobust sandwich varianceMarginal Cox modelSandwich varianceWithin-periodElectronic reminder systemSW-CRTRandomized trialsBinary outcomesPower calculationsPower formulaReminder systemR Shiny applicationHospital settingCorrelation parametersSample sizePlanned trialsCox modelWaldFormulaTrials
2023
A 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
Marginal modeling of cluster-period means and intraclass correlations in stepped wedge designs with binary outcomes
Li F, Yu H, Rathouz PJ, Turner EL, Preisser JS. Marginal modeling of cluster-period means and intraclass correlations in stepped wedge designs with binary outcomes. Biostatistics 2021, 23: 772-788. PMID: 33527999, PMCID: PMC9291643, DOI: 10.1093/biostatistics/kxaa056.Peer-Reviewed Original ResearchConceptsPopulation-averaged interpretationFinite sample inferenceMarginal inferenceMarginal meansRigorous justificationBinary outcomesComputational burdenIndividual-level observationsMarginal modelsInterval estimationMarginal modelingCorrelated binary outcomesCluster-period sizesJoint estimationEquationsLinear modelEstimating EquationsSW-CRTsFlexible toolFast pointInferenceEstimationAdditional mappingModelApproach
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