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 ITrialsGuidelines 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 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 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
Randomized 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 beingMultiply robust estimation of principal causal effects with noncompliance and survival outcomes
Cheng C, Guo Y, Liu B, Wruck L, Li F, Li F. Multiply robust estimation of principal causal effects with noncompliance and survival outcomes. Clinical Trials 2024, 21: 553-561. PMID: 38813813, DOI: 10.1177/17407745241251773.Peer-Reviewed Original ResearchConceptsPrincipal strataRight-censored survival outcomesPrincipal causal effectsCausal effectsSensitivity analysis strategyPrincipal ignorabilityRobust estimationIdentification assumptionsCensoringPragmatic clinical trialsTreatment assignmentTreatment noncomplianceMonotonicityEstimationAssess treatment effectsCardiovascular diseaseClinical trialsMultipliersTreatment effectsAssumptionsNoncomplianceCausal interpretation of the hazard ratio in randomized clinical trials
Fay M, Li F. Causal interpretation of the hazard ratio in randomized clinical trials. Clinical Trials 2024, 21: 623-635. PMID: 38679930, PMCID: PMC11502288, DOI: 10.1177/17407745241243308.Peer-Reviewed Original ResearchProportional hazards assumptionHazard ratioHazards assumptionConstant hazard ratioRandomized clinical trialsMeasure of treatment effectTime-varying effectsEstimandsRate ratiosUntestable assumptionsIndividual-levelPopulation-level interpretationCausal effectsClinical trialistsIndividual-level interpretationsClinical trialsAssumptionsCausal interpretationAverage changeTreatment effectsPotential outcomes
2022
Pragmatic clinical trial design in emergency medicine: Study considerations and design types
Gettel CJ, Yiadom MYAB, Bernstein SL, Grudzen CR, Nath B, Li F, Hwang U, Hess EP, Melnick ER. Pragmatic clinical trial design in emergency medicine: Study considerations and design types. Academic Emergency Medicine 2022, 29: 1247-1257. PMID: 35475533, PMCID: PMC9790188, DOI: 10.1111/acem.14513.Peer-Reviewed Original ResearchConceptsPragmatic clinical trialsClinical trial designTrial designReal-world clinical practicePragmatic clinical trial designElectronic health recordsEmergency departmentClinical trialsStudy design typeClinical practiceStudy typeTrial componentsHealth recordsEmergency medicineEmergency medicine investigatorsHuman subjects concernsInvestigatorsStudy findingsStudy considerationsTrialistsTrialsGeneralizing Trial Evidence to Target Populations in Non-Nested Designs: Applications to AIDS Clinical Trials
Li F, Buchanan AL, Cole SR. Generalizing Trial Evidence to Target Populations in Non-Nested Designs: Applications to AIDS Clinical Trials. Journal Of The Royal Statistical Society Series C (Applied Statistics) 2022, 71: 669-697. PMID: 35968541, PMCID: PMC9367209, DOI: 10.1111/rssc.12550.Peer-Reviewed Original ResearchAIDS Clinical Trials GroupTarget populationClinical Trials GroupComparative effectiveness evidenceTreatment effectsRandomized trialsTrial evidenceClinical trialsTrial groupHIV interventionsACTG trialsTrial participantsTrial designPropensity scoreEffectiveness evidenceTrialsAIDS clinical trialsSpecified populationPopulationAverage treatment effectMost casesHIVEvidenceRegression
2021
Impact of complex, partially nested clustering in a three-arm individually randomized group treatment trial: A case study with the wHOPE trial
Tong G, Seal KH, Becker WC, Li F, Dziura JD, Peduzzi PN, Esserman DA. Impact of complex, partially nested clustering in a three-arm individually randomized group treatment trial: A case study with the wHOPE trial. Clinical Trials 2021, 19: 3-13. PMID: 34693748, PMCID: PMC8847260, DOI: 10.1177/17407745211051288.Peer-Reviewed Original ResearchConceptsGroup treatment trialsIntraclass correlation coefficientTreatment trialsTreatment sessionsHealth optionsEducation trialThree-armWhole health teamFuture trial designNumber of cliniciansGroup treatment designTrue intraclass correlation coefficientsGroup treatment sessionsTreatment armsClinical trialsClinician levelMultiple cliniciansBACKGROUND/Health teamsOutcome dataTreatment groupsTrial designGroup educationClinical scenariosDifferent clinicians
2020
Propensity score weighting for covariate adjustment in randomized clinical trials
Zeng S, Li F, Wang R, Li F. Propensity score weighting for covariate adjustment in randomized clinical trials. Statistics In Medicine 2020, 40: 842-858. PMID: 33174296, DOI: 10.1002/sim.8805.Peer-Reviewed Original ResearchStatistical Considerations for Embedded Pragmatic Clinical Trials in People Living with Dementia
Allore HG, Goldfeld KS, Gutman R, Li F, Monin JK, Taljaard M, Travison TG. Statistical Considerations for Embedded Pragmatic Clinical Trials in People Living with Dementia. Journal Of The American Geriatrics Society 2020, 68: s68-s73. PMID: 32589276, PMCID: PMC7396162, DOI: 10.1111/jgs.16616.Peer-Reviewed Original ResearchConceptsEmbedded Pragmatic Clinical TrialsPragmatic clinical trialsClinical trialsAlzheimer's diseaseImbedded Pragmatic Alzheimer's DiseaseIMPACT CollaboratoryOutcome ascertainmentPoint of careNonpharmacological interventionsReal-world settingComplex interventionsTrialsIntervention effectivenessVulnerable populationsPragmatic designHealthcare systemNational InstituteClinical scientistsSuch interventionsInterventionDementiaPLWDDiseaseCaregiversResearch prioritiesAn evidence mapping and analysis of registered COVID-19 clinical trials in China
Lu L, Li F, Wen H, Ge S, Zeng J, Luo W, Wang L, Tang C, Xu N. An evidence mapping and analysis of registered COVID-19 clinical trials in China. BMC Medicine 2020, 18: 167. PMID: 32493331, PMCID: PMC7268588, DOI: 10.1186/s12916-020-01612-y.Peer-Reviewed Original ResearchConceptsCOVID-19 clinical trialsCurrent Control TrialsClinical Trials RegistryNational Research RegisterTraditional Chinese medicinePrimary outcomeTrials RegistryClinical trialsAntiviral drugsCOVID-19 nucleic acid testInternational Clinical Trials Registry PlatformAustralian Clinical Trials RegistryClinical Trials Registry PlatformChinese Clinical Trial RegistryEvidence mappingPilot studyPhase 4 trialTrials Registry PlatformNucleic acid testCOVID-19 trialsData monitoring committeePublic Health DivisionMedian sample sizeBiological agentsType of intervention
2019
Predicting the Risk of Huntington’s Disease with Multiple Longitudinal Biomarkers
Li F, Li K, Li C, Luo S, Group P. Predicting the Risk of Huntington’s Disease with Multiple Longitudinal Biomarkers. Journal Of Huntington's Disease 2019, 8: 323-332. PMID: 31256145, PMCID: PMC6718328, DOI: 10.3233/jhd-190345.Peer-Reviewed Original ResearchConceptsEnroll-HDRisk of Huntington's diseasePREDICT-HDRisk of HDMultiple longitudinal markersTime to diagnosisHuntington's diseasePatient's risk categoryPrognostic indexPrognostic scorePrognostic modelHD diagnosisRisk predictionPublic health threatCox modelRisk categoriesLongitudinal measurementsHealth threatRiskLongitudinal biomarkersScoresBiomarker measurementsPatient selectionClinical trialsClinical biomarkers
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