2023
Integrating real-world data to assess cardiac ablation device outcomes in a multicenter study using the OMOP common data model for regulatory decisions: implementation and evaluation
Yu Y, Jiang G, Brandt E, Forsyth T, Dhruva S, Zhang S, Chen J, Noseworthy P, Doshi A, Collison-Farr K, Kim D, Ross J, Coplan P, Drozda J. Integrating real-world data to assess cardiac ablation device outcomes in a multicenter study using the OMOP common data model for regulatory decisions: implementation and evaluation. JAMIA Open 2023, 6: ooac108. PMID: 36632328, PMCID: PMC9831049, DOI: 10.1093/jamiaopen/ooac108.Peer-Reviewed Original ResearchOMOP Common Data ModelCommon data modelData modelMedical device dataObservational Medical Outcomes Partnership Common Data ModelReal-world dataReal-world evaluationData integrationMultiple healthcare systemsData transformationHealthcare systemElectronic health record dataDevice dataData sourcesChain databaseLoad processHealth record dataTest casesMercy HealthQA analysisMulticenter studyMayo ClinicPatient outcomesPatient encountersDevice outcomes
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