2022
A RANDOMIZED CLINICAL TRIAL OF SCREENING FOR ATRIAL FIBRILLATION WITH A 14-DAY PATCH MONITOR: ANALYSIS OF ECG RECORDINGS FROM THE GUARD-AF STUDY
Singer D, Atlas S, Go A, Lopes R, Lubitz S, McManus D, Revkin J, Mills D, Crosson L, Lenane J, Aronson R. A RANDOMIZED CLINICAL TRIAL OF SCREENING FOR ATRIAL FIBRILLATION WITH A 14-DAY PATCH MONITOR: ANALYSIS OF ECG RECORDINGS FROM THE GUARD-AF STUDY. Journal Of The American College Of Cardiology 2022, 79: 28. DOI: 10.1016/s0735-1097(22)01019-1.Peer-Reviewed Original Research
2016
Traditional and new composite endpoints in heart failure clinical trials: facilitating comprehensive efficacy assessments and improving trial efficiency
Anker SD, Schroeder S, Atar D, Bax JJ, Ceconi C, Cowie MR, Crisp A, Dominjon F, Ford I, Ghofrani H, Gropper S, Hindricks G, Hlatky MA, Holcomb R, Honarpour N, Jukema JW, Kim AM, Kunz M, Lefkowitz M, Le Floch C, Landmesser U, McDonagh TA, McMurray JJ, Merkely B, Packer M, Prasad K, Revkin J, Rosano GM, Somaratne R, Stough WG, Voors AA, Ruschitzka F. Traditional and new composite endpoints in heart failure clinical trials: facilitating comprehensive efficacy assessments and improving trial efficiency. European Journal Of Heart Failure 2016, 18: 482-489. PMID: 27071916, DOI: 10.1002/ejhf.516.Peer-Reviewed Original ResearchConceptsHeart failure clinical trialsComposite endpointClinical trialsNew composite endpointHeart failureHeart failure treatmentEffect of therapyHealth system perspectiveOverall treatment effectRepeat hospitalizationPlanned trialsFunctional statusFailure treatmentOutcome eventsPatient burdenEfficacy assessmentPatient experienceNew treatmentsTrialsAdverse effectsEfficiency of trialsEndpointTrial efficiencyTreatment effectsPrimary measure
2012
Rate of change in carotid intima–media thickness and vascular events
Bots ML, Taylor AJ, Kastelein JJ, Peters SA, Ruijter H, Tegeler CH, Baldassarre D, Stein JH, O’Leary D, Revkin JH, Grobbee DE. Rate of change in carotid intima–media thickness and vascular events. Journal Of Hypertension 2012, 30: 1690-1696. PMID: 22895014, DOI: 10.1097/hjh.0b013e32835644dc.Peer-Reviewed Original ResearchConceptsCarotid intima-media thicknessIntima-media thicknessFuture cardiovascular disease riskCardiovascular disease riskTherapy-induced changesCardiovascular drug developmentDifferent risk profilesVascular eventsPrimary outcomeVascular riskMeta-regression techniquesHeterogeneous efficacyCardiovascular treatmentPharmaceutical interventionsDisease riskRisk profileDrug developmentTrialsEcologic fallacyTreatmentLack of powerRisk
2010
Surrogate endpoints in randomized cardiovascular clinical trials
Domanski M, Pocock S, Bernaud C, Borer J, Geller N, Revkin J, Zannad F. Surrogate endpoints in randomized cardiovascular clinical trials. Fundamental & Clinical Pharmacology 2010, 25: 411-413. PMID: 20698890, DOI: 10.1111/j.1472-8206.2010.00865.x.Peer-Reviewed Original Research