2023
Using real-world data from health systems to evaluate the safety and effectiveness of a catheter to treat ischemic ventricular tachycardia
Dhruva S, Zhang S, Chen J, Noseworthy P, Doshi A, Agboola K, Herrin J, Jiang G, Yu Y, Cafri G, Farr K, Mbwana M, Ross J, Coplan P, Drozda J. Using real-world data from health systems to evaluate the safety and effectiveness of a catheter to treat ischemic ventricular tachycardia. Journal Of Interventional Cardiac Electrophysiology 2023, 66: 1817-1825. PMID: 36738387, DOI: 10.1007/s10840-023-01496-x.Peer-Reviewed Original ResearchConceptsIschemic ventricular tachycardiaVentricular tachycardiaHealth system dataVT ablationSTSF catheterComposite outcomeHealth systemRisk differencePre-specified performance goalComposite safety outcomeReal-world safetyRoutine clinical practiceDrug Administration approvalAverage risk differenceThromboembolic eventsTotal patientsHeart failureProcedural complicationsMethodsAmong patientsAdministration approvalMayo ClinicSafety outcomesEffectiveness outcomesClinical practiceCatheter
2022
Safety and Effectiveness of a Catheter With Contact Force and 6-Hole Irrigation for Ablation of Persistent Atrial Fibrillation in Routine Clinical Practice
Dhruva SS, Zhang S, Chen J, Noseworthy PA, Doshi AA, Agboola KM, Herrin J, Jiang G, Yu Y, Cafri G, Farr K, Ervin KR, Ross JS, Coplan PM, Drozda JP. Safety and Effectiveness of a Catheter With Contact Force and 6-Hole Irrigation for Ablation of Persistent Atrial Fibrillation in Routine Clinical Practice. JAMA Network Open 2022, 5: e2227134. PMID: 35976649, PMCID: PMC9386540, DOI: 10.1001/jamanetworkopen.2022.27134.Peer-Reviewed Original ResearchConceptsPersistent AF ablationRoutine clinical practiceMercy HealthAF ablationMayo ClinicSafety outcomesClinical practiceCatheter groupCohort studyCatheter ablationPersistent AFParoxysmal atrial fibrillation ablationThermocool SmartTouch catheterComposite of deathPrimary safety outcomeAtrial fibrillation ablationPersistent atrial fibrillationElectronic health record dataHealth system dataHealth record dataHealth care systemSmartTouch catheterThromboembolic eventsFibrillation ablationProcedural complications
2016
Characterisation of trials where marketing purposes have been influential in study design: a descriptive study
Barbour V, Burch D, Godlee F, Heneghan C, Lehman R, Perera R, Ross JS, Schroter S. Characterisation of trials where marketing purposes have been influential in study design: a descriptive study. Trials 2016, 17: 31. PMID: 26792624, PMCID: PMC4720997, DOI: 10.1186/s13063-015-1107-1.Peer-Reviewed Original ResearchConceptsMedian numberDrug trialsGeneral medical journalsComposite primary outcome measureStudy designTerms of blindingPrimary outcome measureTrials of drugsHigh-impact general medical journalsKey trial characteristicsIndustry-funded trialsMedical journalsAdverse eventsCategories of trialsTrial characteristicsOutcome measuresStudy populationSafety outcomesBlinded researcherStudy characteristicsDescriptive studyTrial documentationTrialsSignificant differencesMarketing trials