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, 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 beingEvaluating 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 outcomes
2022
Ethical considerations within pragmatic randomized controlled trials in dementia: Results from a literature survey
Nicholls SG, Carroll K, Nix HP, Li F, Hey SP, Mitchell SL, Weijer C, Taljaard M. Ethical considerations within pragmatic randomized controlled trials in dementia: Results from a literature survey. Alzheimer's & Dementia: Translational Research & Clinical Interventions 2022, 8: e12287. PMID: 35509502, PMCID: PMC9060321, DOI: 10.1002/trc2.12287.Peer-Reviewed Original ResearchEthical considerationsEthical protectionsVulnerable participantsConsent approachResearch participantsResearch participationPatient's capacityAlzheimer's diseaseEthics approvalSearch of MEDLINEHealth care professionalsCapacity assessmentStudy populationEligible reportsTrial settingsConsentVulnerable groupsDementiaTwo-thirdsConsiderationDiseaseTrialsParticipantsExtracted informationMention