2025
Burden and care time for dementia caregivers in the LIVE@Home.Path trial.
Berge LI, Angeles RC, Gedde MH, Fæø SE, Mannseth J, Vislapuu M, Søyland Puaschitz NG, Hillestad E, Aarsland D, Achterberg WP, Allore H, Ballard C, Li F, Selbæk G, Vahia IV, Husebo BS. Burden and care time for dementia caregivers in the LIVE@Home.Path trial. Alzheimers Dement 2025, 21: e14622. PMID: 40042468, DOI: 10.1002/alz.14622.Peer-Reviewed Original ResearchAnalysis of Cohort Stepped Wedge Cluster-Randomized Trials With Nonignorable Dropout via Joint Modeling.
Gasparini A, Crowther MJ, Hoogendijk EO, Li F, Harhay MO. Analysis of Cohort Stepped Wedge Cluster-Randomized Trials With Nonignorable Dropout via Joint Modeling. Stat Med 2025, 44: e10347. PMID: 39963907, DOI: 10.1002/sim.10347.Peer-Reviewed Original ResearchDepression 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 RP, Li F, Spatz ES, Caraballo C, Mahajan S, Raparelli V, Leifheit EC, Lu Y, Krumholz HM, Spertus JA, D'Onofrio G, Pilote L, Lichtman JH. 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. Biopsychosoc Sci Med 2025, 87: 129-137. PMID: 39909011, DOI: 10.1097/PSY.0000000000001363.Peer-Reviewed Original ResearchWeighting methods for truncation by death in cluster-randomized trials.
Isenberg D, Harhay MO, Mitra N, Li F. Weighting methods for truncation by death in cluster-randomized trials. Stat Methods Med Res 2025, 9622802241309348. PMID: 39885759, DOI: 10.1177/09622802241309348.Peer-Reviewed Original ResearchPrioritizing 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 BC, Li F, Harhay MO, Auriemma CL. 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, DOI: 10.1186/s13063-024-08673-x.Peer-Reviewed Original ResearchBlood 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, 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 CR, Fink DS, Rudolph KE, Harhay MO, Rentsch CT, Fiellin DA, Gonsalves GS. Four targets: an enhanced framework for guiding causal inference from observational data. Int J Epidemiol 2024, 54 PMID: 39868475, 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, 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 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 coefficientUsing 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, Pereira 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, 17407745241276137. PMID: 39377196, 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 methodEquationsBayesian 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 mediatorsBrainHow 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 modelsModel‐assisted analysis of covariance estimators for stepped wedge cluster randomized experiments
Chen X, Li F. Model‐assisted analysis of covariance estimators for stepped wedge cluster randomized experiments. Scandinavian Journal Of Statistics 2024 DOI: 10.1111/sjos.12755.Peer-Reviewed Original ResearchCluster-randomized experimentANCOVA estimatesFinite population central limit theoremAnalysis of covariance estimatorCentral limit theoremLimit theoremPotential outcomes frameworkCovariance estimationRandomized experimentTarget estimandEstimandsRandomization schemeCovariate adjustmentEstimationTheoremData structureOutcomes frameworkMultilevel data structureCovariatesRobust methodClassEvaluating analytic models for individually randomized group treatment trials with complex clustering in nested and crossed designs
Moyer J, Li F, Cook A, Heagerty P, Pals S, Turner E, Wang R, Zhou Y, Yu Q, Wang X, Murray D. Evaluating analytic models for individually randomized group treatment trials with complex clustering in nested and crossed designs. Statistics In Medicine 2024, 43: 4796-4818. PMID: 39225281, DOI: 10.1002/sim.10206.Peer-Reviewed Original ResearchGroup treatmentRandomized group treatment trialsTreatment trialsDeliver treatmentNominal type I error rateData generating mechanismRating inflationType I error rateMultiple membershipsType I error rate inflationParticipantsAgent settingMultiple agentsOutcome measuresSingle agent settingTrial armsSimulation studyStudy designTherapistsStudy armsEvaluate analytical modelsContinuous outcomesA Multimodal Video-Based AI Biomarker for Aortic Stenosis Development and Progression
Oikonomou E, Holste G, Yuan N, Coppi A, McNamara R, Haynes N, Vora A, Velazquez E, Li F, Menon V, Kapadia S, Gill T, Nadkarni G, Krumholz H, Wang Z, Ouyang D, Khera R. A Multimodal Video-Based AI Biomarker for Aortic Stenosis Development and Progression. JAMA Cardiology 2024, 9: 534-544. PMID: 38581644, PMCID: PMC10999005, DOI: 10.1001/jamacardio.2024.0595.Peer-Reviewed Original ResearchCardiac magnetic resonanceAortic valve replacementCardiac magnetic resonance imagingAV VmaxSevere ASAortic stenosisCohort studyPeak aortic valve velocityCohort study of patientsAortic valve velocityCohort of patientsTraditional cardiovascular risk factorsAssociated with faster progressionStudy of patientsCedars-Sinai Medical CenterAssociated with AS developmentCardiovascular risk factorsCardiovascular imaging modalitiesIndependent of ageModerate ASEjection fractionEchocardiographic studiesValve replacementRisk stratificationCardiac structureOptimal designs using generalized estimating equations in cluster randomized crossover and stepped wedge trials.
Liu J, Li F. Optimal designs using generalized estimating equations in cluster randomized crossover and stepped wedge trials. Stat Methods Med Res 2024, 9622802241247717. PMID: 38813761, DOI: 10.1177/09622802241247717.Peer-Reviewed Original ResearchMaintaining the validity of inference from linear mixed models in stepped-wedge cluster randomized trials under misspecified random-effects structures
Ouyang Y, Taljaard M, Forbes A, Li F. Maintaining the validity of inference from linear mixed models in stepped-wedge cluster randomized trials under misspecified random-effects structures. Statistical Methods In Medical Research 2024, 33: 1497-1516. PMID: 38807552, PMCID: PMC11499024, DOI: 10.1177/09622802241248382.Peer-Reviewed Original ResearchRandom effects structureVariance estimationComplex correlation structureRobust variance estimationFixed effects parametersDegrees of freedom correctionCluster randomized trialEstimates of standard errorsCorrelation structureRandom effectsStepped-wedge cluster randomized trialComprehensive simulation studyLinear mixed modelsStatistical inferenceRandom intercept modelSimulation studyMixed modelsMisspecificationValidity of inferencesRandom interceptContinuous outcomesEstimationComputational challengesIntercept modelStandard error