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 considerationsTrialistsTrialsStepped Wedge Cluster Randomized Trials: A Methodological Overview
Li F, Wang R. Stepped Wedge Cluster Randomized Trials: A Methodological Overview. World Neurosurgery 2022, 161: 323-330. PMID: 35505551, PMCID: PMC9074087, DOI: 10.1016/j.wneu.2021.10.136.Peer-Reviewed Original ResearchConceptsStepped wedge designStepped wedge cluster randomized trialIntervention programsSample size determinationDelivery of patient careWedge designStepped wedge trial designHealth intervention programsCluster randomized trialRandomized trialsPatient careStudy designPragmatic settingSize determinationTrial designGeneralizing 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