2025
What 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 PMID: 40063042, DOI: 10.1001/jamainternmed.2024.8216.Peer-Reviewed Original ResearchBurden 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, qlaf010. 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. 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 depressionDepressionWeighting methods for truncation by death in cluster-randomized trials
Isenberg D, Harhay M, Mitra N, Li F. Weighting methods for truncation by death in cluster-randomized trials. Statistical Methods In Medical Research 2025, 34: 473-489. PMID: 39885759, DOI: 10.1177/09622802241309348.Peer-Reviewed Original ResearchConceptsSurvivor average causal effectAverage causal effectCluster randomized trialAsymptotic variance estimatorsSubgroup treatment effectsCausal effectsPrincipal stratification frameworkFinite-sampleVariance estimationDistributional assumptionsIdentification assumptionsStratification frameworkPatient-centered outcomesNon-mortality outcomesOutcome modelQuality of lifeRandomized trialsIll patient populationMeasurement time pointsTruncationEstimationLength of hospital stayAssumptionsSurvivorsPatient populationPrioritizing attributes of approaches to analyzing patient-centered outcomes that are truncated due to death in critical care clinical trials: a Delphi study
Bahti M, Kahan B, Li F, Harhay M, Auriemma C. Prioritizing attributes of approaches to analyzing patient-centered outcomes that are truncated due to death in critical care clinical trials: a Delphi study. Trials 2025, 26: 15. PMID: 39794867, PMCID: PMC11721323, DOI: 10.1186/s13063-024-08673-x.Peer-Reviewed Original ResearchConceptsCritical care clinical trialsPatient-centerednessDelphi roundsConsensus thresholdModified Delphi processCritical care trialsPatient-centered outcomesInvited individualsCare trialsExperience expertsDelphi processDelphi panelDelphi studyClinical trialsResearch teamResponse rateResultsThirty-oneClinical relevancePersonal experienceTrialsRespondentsCritical attributesDeathOutcomesAnalysis approachAddressing selection bias in cluster randomized experiments via weighting
Papadogeorgou G, Liu B, Li F, Li F. Addressing selection bias in cluster randomized experiments via weighting. Biometrics 2025, 81: ujaf013. PMID: 40052595, DOI: 10.1093/biomtc/ujaf013.Peer-Reviewed Original ResearchConceptsCluster-randomized experimentCluster randomized trialAverage treatment effectSelection biasInverse probability weightingOverall populationTreatment effectsCo-paymentControl armRecruited populationProbability weightingRandomized experimentRandomized trialsPopulationEstimation strategyTreatment assignmentIndividualsRecruitment assumptionR packageOverallAnalysis approachInterventionRecruitmentBlood Pressure Targets for Adults with Vasodilatory Shock - An Individual Patient Data Meta-Analysis.
Angriman F, Momenzade N, Adhikari NKJ, Mouncey PR, Asfar P, Yarnell CJ, Ong SWX, Pinto R, Doidge JC, Shankar-Hari M, Harhay MO, Masse MH, Harrison DA, Rowan KM, Li F, Carter F, Camirand-Lemyre F, Lamontagne F. Blood Pressure Targets for Adults with Vasodilatory Shock - An Individual Patient Data Meta-Analysis. NEJM Evid 2025, 4: EVIDoa2400359. PMID: 39556565, DOI: 10.1056/EVIDoa2400359.Peer-Reviewed Original Research
2024
Early, Individualized Recommendations for Hospitalized Patients With Acute Kidney Injury
Aklilu A, Menez S, Baker M, Brown D, Dircksen K, Dunkley K, Gaviria S, Farrokh S, Faulkner S, Jones C, Kadhim B, Le D, Li F, Makhijani A, Martin M, Moledina D, Coronel-Moreno C, O’Connor K, Shelton K, Shvets K, Srialluri N, Tan J, Testani J, Corona-Villalobos C, Yamamoto Y, Parikh C, Wilson F, Sundararajan A, Wang A, Schretlen C, Singel D, Moss E, Aune F, Iantosca G, Zou G, Chernova I, Bitzel J, Hernandez J, Lindsley J, Dane K, Orias M, Mehta P, Zassman-Isner S, Wen Y, Freeman N. Early, Individualized Recommendations for Hospitalized Patients With Acute Kidney Injury. JAMA 2024, 332: 2081-2090. PMID: 39454050, PMCID: PMC11669049, DOI: 10.1001/jama.2024.22718.Peer-Reviewed Original ResearchElectronic health recordsUsual careHealth recordsAction teamsClinicians of patientsHospitalized patientsFinal follow-upIntervention groupHealth systemStudy pharmacistsStudy physiciansMain OutcomesAssociated with adverse outcomesAcute kidney injuryRandomized clinical trialsPrimary outcomeIndividualized recommendationsNew HavenAdverse outcomesAKI detectionCareRhode IslandComposite outcomeFollow-upInterventionFour targets: an enhanced framework for guiding causal inference from observational data
Lu H, Li F, Lesko C, Fink D, Rudolph K, Harhay M, Rentsch C, Fiellin D, Gonsalves G. Four targets: an enhanced framework for guiding causal inference from observational data. International Journal Of Epidemiology 2024, 54: dyaf003. PMID: 39868475, PMCID: PMC11769716, DOI: 10.1093/ije/dyaf003.Peer-Reviewed Original ResearchRandomized 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, PMCID: PMC11752791, 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 beingTreatment Effect Heterogeneity in Acute Kidney Injury Incidence Following Intravenous Antihypertensive Administration for Severe Blood Pressure Elevation During Hospitalization
Ghazi L, Chen X, Harhay M, Hu L, Biswas A, Peixoto A, Li F, Wilson F. Treatment Effect Heterogeneity in Acute Kidney Injury Incidence Following Intravenous Antihypertensive Administration for Severe Blood Pressure Elevation During Hospitalization. American Journal Of Kidney Diseases 2024, 85: 442-453. PMID: 39580068, DOI: 10.1053/j.ajkd.2024.09.011.Peer-Reviewed Original ResearchAcute kidney injuryAcute kidney injury incidenceSevere hypertensionIV antihypertensivesAntihypertensive treatmentBlood pressureRisk of acute kidney injuryAbstractText Label="SETTINGS &Blood pressure elevationSevere blood pressure elevationSystolic blood pressureIdentifying treatment optionsAntihypertensive administrationKidney injuryAbstractText Label="RATIONALETreatment optionsAntihypertensive effectBP elevationPressure elevationPatient characteristicsDiastolic BPPatientsKidney failureAntihypertensivesHospital admissionEstimates of intra-cluster correlation coefficients from 2018 USA Medicare data to inform the design of cluster randomized trials in Alzheimer’s and related dementias
Ouyang Y, Li F, Li X, Bynum J, Mor V, Taljaard M. Estimates of intra-cluster correlation coefficients from 2018 USA Medicare data to inform the design of cluster randomized trials in Alzheimer’s and related dementias. Trials 2024, 25: 732. PMID: 39478608, PMCID: PMC11523597, DOI: 10.1186/s13063-024-08404-2.Peer-Reviewed Original ResearchConceptsIntra-cluster correlation coefficientIntra-cluster correlation coefficient estimationSample size calculationED visitsMedicare dataMedicare fee-for-service beneficiariesEmergency departmentFee-for-service beneficiariesSize calculationDiagnosis of ADRDNational Medicare dataCluster randomized trialHospital referral regionsHospital service areasHealth care systemBackgroundCluster randomized trialsPopulation-level dataRandomized trialsDesign of cluster randomized trialsEvaluate interventionsReferral regionsCare systemICC estimatesADRDCorrelation coefficientInverting estimating equations for causal inference on quantiles
Cheng C, Li F. Inverting estimating equations for causal inference on quantiles. Biometrika 2024, 112: asae058. DOI: 10.1093/biomet/asae058.Peer-Reviewed Original ResearchUsing Overlap Weights to Address Extreme Propensity Scores in Estimating Restricted Mean Counterfactual Survival Times
Cao Z, Ghazi L, Mastrogiacomo C, Forastiere L, Wilson F, Li F. Using Overlap Weights to Address Extreme Propensity Scores in Estimating Restricted Mean Counterfactual Survival Times. American Journal Of Epidemiology 2024, kwae416. PMID: 39489504, DOI: 10.1093/aje/kwae416.Peer-Reviewed Original ResearchInverse probability of censoring weightingProbability of censoring weightingOverlap weightingCensoring processVariance estimationInterval coverageInverse probability of treatment weightingTarget estimandInverse probabilityBinary outcomesPropensity scoreRMSTProbability of treatment weightingPropensity score weightingEstimationEstimandsLogistic regressionTreatment comparisonsVarianceA review of current practice in the design and analysis of extremely small stepped-wedge cluster randomized trials
Tong G, Nevins P, Ryan M, Davis-Plourde K, Ouyang Y, Macedo J, Meng C, Wang X, Caille A, Li F, Taljaard M. A review of current practice in the design and analysis of extremely small stepped-wedge cluster randomized trials. Clinical Trials 2024, 22: 45-56. PMID: 39377196, PMCID: PMC11810615, DOI: 10.1177/17407745241276137.Peer-Reviewed Original ResearchSmall-sample correctionsStepped-wedge cluster randomized trialCluster randomized trialSample size calculation methodGeneralized linear mixed modelsLongitudinal correlation structureSize calculation methodLinear mixed modelsPermutation testSample sizeBayesian approachRandomized trialsCorrelation structureMixed modelsBayesian analysisGeneralized estimating equationsPermutationMedian sample sizeIntervention conditionRandomization methodEquationsHow to achieve model-robust inference in stepped wedge trials with model-based methods?
Wang B, Wang X, Li F. How to achieve model-robust inference in stepped wedge trials with model-based methods? Biometrics 2024, 80: ujae123. PMID: 39499239, PMCID: PMC11536888, DOI: 10.1093/biomtc/ujae123.Peer-Reviewed Original ResearchConceptsTreatment effect estimandsWorking correlation structureSandwich variance estimatorExchangeable working correlation structureFunction of calendar timeEffect estimandsVariance estimationLink functionStepped wedge trialEstimandsTheoretical resultsCorrelation structureWedge trialsEstimating equationsCluster randomized trialG-computationLinear mixed modelsInferencePotential outcomesMisspecificationEstimationEffective structureModel-based methodsGeneralized estimating equationsMixed modelsBayesian pathway analysis over brain network mediators for survival data
Tian X, Li F, Shen L, Esserman D, Zhao Y. Bayesian pathway analysis over brain network mediators for survival data. Biometrics 2024, 80: ujae132. PMID: 39530270, PMCID: PMC11555425, DOI: 10.1093/biomtc/ujae132.Peer-Reviewed Original ResearchConceptsAccelerated failure time modelFailure time modelBrain connectivityAlzheimer's Disease Neuroimaging Initiative studyMaximum information extractionResponse regressionBayesian approachInformation extractionTime modelSurvival dataNoisy componentsUnique edgeWhite matter fiber tractsNetwork configurationBrain networksInterconnection networksNetworkNetwork mediatorsBrain
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