2025
Permutation 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. Stat Methods Med Res 2025, 9622802251348999. PMID: 40525570, DOI: 10.1177/09622802251348999.Peer-Reviewed Original ResearchPeer 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 ResearchA Bayesian Approach to the G-Formula via Iterative Conditional Regression.
Liu R, Hu L, Perry Wilson F, Warren JL, Li F. A Bayesian Approach to the G-Formula via Iterative Conditional Regression. Stat Med 2025, 44: e70123. PMID: 40476299, DOI: 10.1002/sim.70123.Peer-Reviewed Original ResearchHow Should Parallel Cluster Randomized Trials With a Baseline Period be Analyzed?-A Survey of Estimands and Common Estimators.
Lee KM, Li F. How Should Parallel Cluster Randomized Trials With a Baseline Period be Analyzed?-A Survey of Estimands and Common Estimators. Biom J 2025, 67: e70052. PMID: 40302411, DOI: 10.1002/bimj.70052.Peer-Reviewed Original ResearchEvidence-based personalised medicine in critical care: a framework for quantifying and applying individualised treatment effects in patients who are critically ill.
Munroe ES, Spicer A, Castellvi-Font A, Zalucky A, Dianti J, Graham Linck E, Talisa V, Urner M, Angus DC, Baedorf-Kassis E, Blette B, Bos LD, Buell KG, Casey JD, Calfee CS, Del Sorbo L, Estenssoro E, Ferguson ND, Giblon R, Granholm A, Harhay MO, Heath A, Hodgson C, Houle T, Jiang C, Kramer L, Lawler PR, Leligdowicz A, Li F, Liu K, Maiga A, Maslove D, McArthur C, McAuley DF, Serpa Neto A, Oosthuysen C, Perner A, Prescott HC, Rochwerg B, Sahetya S, Samoilenko M, Schnitzer ME, Seitz KP, Shah F, Shankar-Hari M, Sinha P, Slutsky AS, Qian ET, Webb SA, Young PJ, Zampieri FG, Zarychanski R, Fan E, Semler MW, Churpek M, Goligher EC, Platform of Randomized Adaptive Clinical Trials in Critical Illness (PRACTICAL) investigators, Evidence-based Individualized Treatment Effects (EvITE) Group. Evidence-based personalised medicine in critical care: a framework for quantifying and applying individualised treatment effects in patients who are critically ill. Lancet Respir Med 2025, 13: 556-568. PMID: 40250459, DOI: 10.1016/S2213-2600(25)00054-2.Peer-Reviewed Original ResearchA 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 LettersA 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 Anal 2025, 31: 394-421. PMID: 40227517, DOI: 10.1007/s10985-025-09652-3.Peer-Reviewed Original ResearchWhat 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 being
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