2025
Model‐Robust Standardization in Cluster‐Randomized Trials
Li F, Tong J, Fang X, Cheng C, Kahan B, Wang B. Model‐Robust Standardization in Cluster‐Randomized Trials. Statistics In Medicine 2025, 44: e70270. PMID: 40968363, DOI: 10.1002/sim.70270.Peer-Reviewed Original ResearchConceptsInformative cluster sizeWorking regression modelsJackknife variance estimatorTreatment effect parametersCluster randomized trialData generating processAverage treatment effectVariance estimationCoefficient estimatesGeneralized linear mixed modelsEstimandsR packageNatural testCluster averagesLinear mixed modelsEstimationTreatment effectsExtensive simulation experimentsCluster sizeInferenceRegression modelsGeneralized Estimating EquationsGeneration processMixed modelsEquationsSelecting 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 algorithmA Bayesian nonparametric approach to mediation and spillover effects with multiple mediators in cluster-randomized trials
Ohnishi Y, Li F. A Bayesian nonparametric approach to mediation and spillover effects with multiple mediators in cluster-randomized trials. Journal Of The American Statistical Association 2025, 1-20. DOI: 10.1080/01621459.2025.2544366.Peer-Reviewed Original ResearchAssessing 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 implementationIdentification and multiply robust estimation in causal mediation analysis across principal strata
Cheng C, Li F. Identification and multiply robust estimation in causal mediation analysis across principal strata. Journal Of The Royal Statistical Society Series B Statistical Methodology 2025, qkaf037. DOI: 10.1093/jrsssb/qkaf037.Peer-Reviewed Original ResearchRobust estimationPrincipal strataJoint potential valuesEfficient influence functionNuisance modelsData examplesEfficient estimationInfluence functionIdentification assumptionsEfficient inferenceEstimationInferenceMisspecificationEstimandsCausal mediation analysisExamplesAssumptionsPosttreatment eventsPermutation tests for detecting treatment effect heterogeneity in cluster randomized trials
Maleyeff L, Li F, Haneuse S, Wang R. Permutation tests for detecting treatment effect heterogeneity in cluster randomized trials. Statistical Methods In Medical Research 2025, 34: 1617-1632. PMID: 40525570, PMCID: PMC12365356, DOI: 10.1177/09622802251348999.Peer-Reviewed Original ResearchCluster randomized trialDetect treatment effect heterogeneityTreatment effect heterogeneityEffect heterogeneityNominal type I error rateRandomized trialsType I error rateTreatment-covariate interactionsAssess treatment effect heterogeneityTests of interaction termsPermutation testAverage treatment effectPain programEvaluation of intervention strategiesParametric assumptionsEffect modificationHealthcare ResearchActive copingSimulation studyTreatment effectsIntervention strategiesTrial contextPermutationInteraction termsTrialsPeer and Patient Feedback to Increase Adherence to Postoperative Opioid Prescribing Guidelines: A Stepped-Wedge Cluster Randomized Clinical Trial.
Agarwal AK, Ebert JP, Xiong R, Ali ZS, Lee D, Shofer F, Gitelman Y, Do D, Spencer EA, Grenader EM, Li F, Harhay MO, Delgado MK. Peer and Patient Feedback to Increase Adherence to Postoperative Opioid Prescribing Guidelines: A Stepped-Wedge Cluster Randomized Clinical Trial. JAMA Surg 2025 PMID: 40498501, DOI: 10.1001/jamasurg.2025.1672.Peer-Reviewed Original ResearchRevisiting representativeness
Lu H, Zivich P, Rudolph J, Liew Z, Mukherjee B, Li F. Revisiting representativeness. International Journal Of Epidemiology 2025, 54: dyaf109. PMID: 40587415, PMCID: PMC12208074, DOI: 10.1093/ije/dyaf109.Peer-Reviewed Original ResearchA Bayesian Approach to the G‐Formula via Iterative Conditional Regression
Liu R, Hu L, Wilson F, Warren J, Li F. A Bayesian Approach to the G‐Formula via Iterative Conditional Regression. Statistics In Medicine 2025, 44: e70123. PMID: 40476299, PMCID: PMC12184534, DOI: 10.1002/sim.70123.Peer-Reviewed Original ResearchConceptsCausal effect estimationTime-varying covariatesModel misspecification biasBayesian approachReal world data examplesG-formulaAverage causal effect estimationTime-varying treatmentsBayesian additive regression treesAverage causal effectAdditive regression treesConditional expectationOutcome regressionConditional distributionJoint distributionData examplesPosterior distributionMisspecification biasParametric regressionSimulation studyEffect estimatesSampling algorithmAlgorithm formulaCausal effectsFlexible machine learning techniquesA Pilot Study to Capture Provider Perspectives on Clinically Relevant Effects in Thoracic Transplant Trials.
Cantu E, Isenberg D, Marquis A, Alcudia A, Yusuf S, Saleh A, Raevsky A, Li F, Harhay MO. A Pilot Study to Capture Provider Perspectives on Clinically Relevant Effects in Thoracic Transplant Trials. Am J Respir Crit Care Med 2025, 211: 1079-1082. PMID: 40106820, DOI: 10.1164/rccm.202408-1535RL.Commentaries, Editorials and LettersWhat Is a Stepped-Wedge Cluster Randomized Trial?
Li F, Wang B, Heagerty P. What Is a Stepped-Wedge Cluster Randomized Trial? JAMA Internal Medicine 2025, 185: 593-594. PMID: 40063042, PMCID: PMC12052484, DOI: 10.1001/jamainternmed.2024.8216.Peer-Reviewed Original ResearchHow Should Parallel Cluster Randomized Trials With a Baseline Period be Analyzed?—A Survey of Estimands and Common Estimators
Lee K, Li F. How Should Parallel Cluster Randomized Trials With a Baseline Period be Analyzed?—A Survey of Estimands and Common Estimators. Biometrical Journal 2025, 67: e70052. PMID: 40302411, PMCID: PMC12041842, DOI: 10.1002/bimj.70052.Peer-Reviewed Original ResearchConceptsInformative cluster sizeIndependence estimating equationsCluster-period sizesParallel cluster randomized trialsTreatment effect estimatesCluster randomized trialInconsistent estimatesSimulation studyEstimandsEstimating EquationsCluster sizeContinuous outcomesEstimationTreatment effectsEffect estimatesImprove mental healthRandomized trialsConvergenceEquationsRural eastern IndiaMental healthMixed-effects modelsYouth teamsEvidence-based personalised medicine in critical care: a framework for quantifying and applying individualised treatment effects in patients who are critically ill
Munroe E, Spicer A, Castellvi-Font A, Zalucky A, Dianti J, Linck E, Talisa V, Urner M, Angus D, Baedorf-Kassis E, Blette B, Bos L, Buell K, Casey J, Calfee C, Del Sorbo L, Estenssoro E, Ferguson N, Giblon R, Granholm A, Harhay M, Heath A, Hodgson C, Houle T, Jiang C, Kramer L, Lawler P, Leligdowicz A, Li F, Liu K, Maiga A, Maslove D, McArthur C, McAuley D, Neto A, Oosthuysen C, Perner A, Prescott H, Rochwerg B, Sahetya S, Samoilenko M, Schnitzer M, Seitz K, Shah F, Shankar-Hari M, Sinha P, Slutsky A, Qian E, Webb S, Young P, Zampieri F, Zarychanski R, Fan E, Semler M, Churpek M, Goligher E, investigators P, Group E. Evidence-based personalised medicine in critical care: a framework for quantifying and applying individualised treatment effects in patients who are critically ill. The Lancet Respiratory Medicine 2025, 13: 556-568. PMID: 40250459, PMCID: PMC12362495, DOI: 10.1016/s2213-2600(25)00054-2.Peer-Reviewed Original ResearchConceptsAverage treatment effectCritical careHeterogeneity of treatment effectsTreatment decisionsTreatment effectsCritical care syndromesResponse to treatmentClinical careRandomised clinical trialsCareRandomised trialsEffects of treatmentTreatment responseClinical trialsAggregate differencesPatientsOutcomesPersonalised medicineTreatmentEffect ITrialsA flexible Bayesian g-formula for causal survival analyses with time-dependent confounding
Chen X, Hu L, Li F. A flexible Bayesian g-formula for causal survival analyses with time-dependent confounding. Lifetime Data Analysis 2025, 31: 394-421. PMID: 40227517, DOI: 10.1007/s10985-025-09652-3.Peer-Reviewed Original ResearchConceptsG-formulaBalance scoresHealth system electronic health recordDiscrete survival dataTime-to-event outcomesPosterior sampling algorithmParametric g-formulaElectronic health recordsBayesian additive regression treesTime-varying treatmentsHypothetical intervention scenariosAdditive regression treesLongitudinal observational studyGeneral classModel misspecificationHealth recordsEmpirical performanceSampling algorithmObservational studySurvival dataIntervention scenariosScoresTreatment strategiesMisspecificationCausality analysisPower 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 modelWaldFormulaTrialsBurden and care time for dementia caregivers in the LIVE@Home.Path trial
Berge L, Angeles R, Gedde M, Fæø S, Mannseth J, Vislapuu M, Puaschitz N, Hillestad E, Aarsland D, Achterberg W, Allore H, Ballard C, Li F, Selbæk G, Vahia I, Husebo B. Burden and care time for dementia caregivers in the LIVE@Home.Path trial. Alzheimer's & Dementia 2025, 21: e14622. PMID: 40042468, PMCID: PMC11881633, DOI: 10.1002/alz.14622.Peer-Reviewed Original ResearchConceptsRelative Stress ScaleInformal care timeCaregiver burdenLiving interventionsCare timeIntervention periodStepped wedge randomized controlled trialVolunteer supportHome-dwelling peopleStepped-wedge trialPersonal activitiesDementia caregiversRandomized Controlled TrialsIntention-to-treatStress ScaleMunicipal coordinatorCaregiversPersonal supportRandomized dyadsDementiaControlled TrialsPrimary outcomeControl periodInterventionPositive changesGuidelines for the content of statistical analysis plans in clinical trials: protocol for an extension to cluster randomized trials
Hemming K, Thompson J, Hooper R, Ukoumunne O, Li F, Caille A, Kahan B, Leyrat C, Grayling M, Mohammed N, Thompson J, Giraudeau B, Turner E, Watson S, Goulão B, Kasza J, Forbes A, Copas A, Taljaard M. Guidelines for the content of statistical analysis plans in clinical trials: protocol for an extension to cluster randomized trials. Trials 2025, 26: 72. PMID: 40011934, PMCID: PMC11866560, DOI: 10.1186/s13063-025-08756-3.Peer-Reviewed Original ResearchAnalysis of Cohort Stepped Wedge Cluster‐Randomized Trials With Nonignorable Dropout via Joint Modeling
Gasparini A, Crowther M, Hoogendijk E, Li F, Harhay M. Analysis of Cohort Stepped Wedge Cluster‐Randomized Trials With Nonignorable Dropout via Joint Modeling. Statistics In Medicine 2025, 44: e10347. PMID: 39963907, PMCID: PMC11833761, DOI: 10.1002/sim.10347.Peer-Reviewed Original ResearchConceptsStepped wedge cluster randomized trialDropout processNonignorable missing outcomesParallel-arm cluster-randomized trialsCluster randomized trialNonignorable dropoutsJoint longitudinal-survival modelLongitudinal submodelData-generating scenariosMissingness patternsJoint modeling methodologyCorrelation structureMonte Carlo simulationsLongitudinal outcomesJoint modelEffective parametrizationPrimary care practicesGeriatric care modelsCarlo simulationsFrail older adultsAssociation structureSubmodelsCare modelUsual careCare practicesCorrecting for bias due to mismeasured exposure in mediation analysis with a survival outcome
Cheng C, Spiegelman D, Li F. Correcting for bias due to mismeasured exposure in mediation analysis with a survival outcome. Journal Of The Royal Statistical Society Series C (Applied Statistics) 2025, 74: 969-993. PMID: 40837827, PMCID: PMC12364547, DOI: 10.1093/jrsssc/qlaf010.Peer-Reviewed Original ResearchExposure-mediator interactionProtective effect of physical activityHealth Professionals Follow-up StudyEffects of physical activityReduced body mass indexExposure measurement errorRisk of cardiovascular diseaseBody mass indexPhysical activityMismeasured exposureMass indexRare outcomesFollow-up studyCardiovascular diseaseMediation analysisCox regressionOutcomesBias formulaSurvival outcomesHealthDepression and Low Social Support Mediate the Association of Marital Stress and 12-Month Cardiac-Specific Quality of Life in Young Adults With Acute Myocardial Infarction
Zhu C, Dreyer R, Li F, Spatz E, Caraballo C, Mahajan S, Raparelli V, Leifheit E, Lu Y, Krumholz H, Spertus J, D’Onofrio G, Pilote L, Lichtman J. Depression and Low Social Support Mediate the Association of Marital Stress and 12-Month Cardiac-Specific Quality of Life in Young Adults With Acute Myocardial Infarction. Biopsychosocial Science And Medicine 2025, 87: 129-137. PMID: 39909011, DOI: 10.1097/psy.0000000000001363.Peer-Reviewed Original ResearchConceptsLow social supportCardiac-specific quality of lifeNatural direct effectSocial supportMonths post-AMIQuality of lifeAcute myocardial infarctionMarital stressComprehensive secondary preventive strategySignificant depressive symptomsPost-AMISecondary prevention strategiesYoung adultsMyocardial infarctionSociodemographic factorsDepressive symptomsAMI survivorsCovariate adjustmentPrevention strategiesSelf-ReportContinuous scoresQoLBaseline QOLCategorical depressionDepression
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