2025
Evidence-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, 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 ITrialsPrioritizing 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 approach
2024
Prepare Romania: study protocol for a randomized controlled trial of an intervention to promote pre-exposure prophylaxis adherence and persistence among gay, bisexual, and other men who have sex with men
Lelutiu-Weinberger C, Filimon M, Zavodszky A, Lixandru M, Hanu L, Fierbinteanu C, Patrascu R, Streinu-Cercel A, Luculescu S, Bora M, Filipescu I, Jianu C, Heightow-Weidman L, Rochelle A, Yi B, Buckner N, Golub S, van Dyk I, Burger J, Li F, Pachankis J. Prepare Romania: study protocol for a randomized controlled trial of an intervention to promote pre-exposure prophylaxis adherence and persistence among gay, bisexual, and other men who have sex with men. Trials 2024, 25: 470. PMID: 38987812, PMCID: PMC11238350, DOI: 10.1186/s13063-024-08313-4.Peer-Reviewed Original ResearchConceptsGBMSM livingPrEP adherenceRandomized controlled trial designMobile health interventionsRollout of PrEPMonths post-randomizationPre-exposure prophylaxisPre-exposure prophylaxis adherenceSelf-report surveyRandomized controlled trialsPromotion interventionsPrescribed PrEPEfficacy of toolsHealth interventionsNational rolloutHealth systemPrEP rolloutDiscussionThe knowledgeIntervention efficacyEffectiveness trialBlood spot testingPost-randomizationHigh-risk groupHIV transmissionDried blood spot testingAssessing treatment effect heterogeneity in the presence of missing effect modifier data in cluster-randomized trials
Blette B, Halpern S, Li F, Harhay M. Assessing treatment effect heterogeneity in the presence of missing effect modifier data in cluster-randomized trials. Statistical Methods In Medical Research 2024, 33: 909-927. PMID: 38567439, PMCID: PMC11041086, DOI: 10.1177/09622802241242323.Peer-Reviewed Original ResearchConceptsMultilevel multiple imputationHeterogeneous treatment effectsCluster randomized trialPotential effect modifiersMultiple imputationAssess treatment effect heterogeneityEffect modifiersTreatment effect heterogeneityComplete-case analysisMissingness mechanismIntracluster correlationSimulation studyUnder-coverageRandomized trialsEffect heterogeneityHealth StudyTreatment effectsContinuous outcomesClinical practiceImputationModel specificationMissingnessData methodsModified dataTrials
2023
Group sequential two‐stage preference designs
Liu R, Li F, Esserman D, Ryan M. Group sequential two‐stage preference designs. Statistics In Medicine 2023, 43: 315-341. PMID: 38010193, PMCID: PMC12171965, DOI: 10.1002/sim.9962.Peer-Reviewed Original Research
2021
Electronic health record alerts for acute kidney injury: multicenter, randomized clinical trial
Wilson FP, Martin M, Yamamoto Y, Partridge C, Moreira E, Arora T, Biswas A, Feldman H, Garg AX, Greenberg JH, Hinchcliff M, Latham S, Li F, Lin H, Mansour SG, Moledina DG, Palevsky PM, Parikh CR, Simonov M, Testani J, Ugwuowo U. Electronic health record alerts for acute kidney injury: multicenter, randomized clinical trial. The BMJ 2021, 372: m4786. PMID: 33461986, PMCID: PMC8034420, DOI: 10.1136/bmj.m4786.Peer-Reviewed Original ResearchConceptsAcute kidney injuryElectronic health record alertsKidney injuryPrimary outcomeMedical recordsYale New Haven Health SystemCare practicesGlobal Outcomes creatinine criteriaLarge tertiary care centerComposite of progressionDays of randomizationReceipt of dialysisPrespecified secondary outcomesTertiary care centerPatients' medical recordsSmall community hospitalNon-teaching hospitalsElectronic health recordsCreatinine criteriaUsual careSecondary outcomesAdult inpatientsKidney diseaseClinical centersWorse outcomes
2018
Power and sample size requirements for GEE analyses of cluster randomized crossover trials
Li F, Forbes AB, Turner EL, Preisser JS. Power and sample size requirements for GEE analyses of cluster randomized crossover trials. Statistics In Medicine 2018, 38: 636-649. PMID: 30298551, PMCID: PMC6461037, DOI: 10.1002/sim.7995.Peer-Reviewed Original Research
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