2024
Direct oral anticoagulant approvals by four major regulatory agencies: a cross-sectional analysis of premarket and postmarket evidence
Mooghali M, Zhou T, Ross J. Direct oral anticoagulant approvals by four major regulatory agencies: a cross-sectional analysis of premarket and postmarket evidence. BMJ Open 2024, 14: e090376. PMID: 39461853, PMCID: PMC11529451, DOI: 10.1136/bmjopen-2024-090376.Peer-Reviewed Original ResearchConceptsPhase 2 trialPhase 3 trialBox warningAtrial fibrillation patientsPostmarketing evidenceEvidence of safetyOral anticoagulantsFibrillation patientsPostmarketing studiesCross-sectional analysisDegree of concordanceStroke preventionStudy requirementsPostmarketingEfficacy evidenceRegulatory agenciesDrugPostmarketing requirementsInterpretation of resultsEfficacyHealth CanadaSample sizeSafety evidenceConcordanceEndpoint
2023
Physician responses to apple watch-detected irregular rhythm alerts
Demkowicz P, Dhruva S, Spatz E, Beatty A, Ross J, Khera R. Physician responses to apple watch-detected irregular rhythm alerts. American Heart Journal 2023, 262: 29-37. PMID: 37084933, PMCID: PMC10988207, DOI: 10.1016/j.ahj.2023.04.008.Peer-Reviewed Original ResearchConceptsAtrial fibrillationPrimary careEmergency medicinePhysician responsesDiagnostic testingUse of antiarrhythmicsClinical practice guidelinesMeasurement of BNPFurther diagnostic testingCase-based surveyLarge academic centerAF alertsAsymptomatic patientsPatient demographicsClinical symptomsTreatment optionsMedical historyPatient referralPhysician specialtyPractice guidelinesPhysician differencesRhythm monitoringAcademic centersUS FoodClinical complexityIdentifying treatment heterogeneity in atrial fibrillation using a novel causal machine learning method
Ngufor C, Yao X, Inselman J, Ross J, Dhruva S, Graham D, Lee J, Siontis K, Desai N, Polley E, Shah N, Noseworthy P, MN; New Haven C. Identifying treatment heterogeneity in atrial fibrillation using a novel causal machine learning method. American Heart Journal 2023, 260: 124-140. PMID: 36893934, PMCID: PMC10615250, DOI: 10.1016/j.ahj.2023.02.015.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, OralAgedAnticoagulantsAtrial FibrillationDabigatranFemaleHumansIschemic StrokePyridonesRivaroxabanStrokeWarfarinConceptsOral anticoagulantsAtrial fibrillationPatient subgroupsComposite outcomeIschemic strokeEffect of OACsLifelong oral anticoagulationNonvitamin K antagonistNew oral anticoagulantsNonvalvular atrial fibrillationPrimary composite outcomeGlomerular filtration rateFuture prospective studiesOptumLabs Data WarehousePopulation-level effectivenessOAC useOral anticoagulationVASc scoreCause mortalityK antagonistsPrimary endpointWarfarin usersRenal functionAF patientsEntire cohort
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 ResearchMeSH KeywordsAgedAtrial FibrillationCatheter AblationCathetersCohort StudiesFemaleHumansMaleMiddle AgedRetrospective StudiesTreatment OutcomeConceptsPersistent 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 complicationsAssessment of Hypothetical Out-of-Pocket Costs of Guideline-Recommended Medications for the Treatment of Older Adults With Multiple Chronic Conditions, 2009 and 2019
Zhou T, Liu P, Dhruva SS, Shah ND, Ramachandran R, Berg KM, Ross JS. Assessment of Hypothetical Out-of-Pocket Costs of Guideline-Recommended Medications for the Treatment of Older Adults With Multiple Chronic Conditions, 2009 and 2019. JAMA Internal Medicine 2022, 182: 185-195. PMID: 34982097, PMCID: PMC8728660, DOI: 10.1001/jamainternmed.2021.7457.Peer-Reviewed Original ResearchMeSH KeywordsAgedAtrial FibrillationChronic DiseaseCross-Sectional StudiesDiabetes Mellitus, Type 2Drug CostsHealth ExpendituresHeart FailureHumansHypercholesterolemiaHypertensionMedicare Part CMedicare Part DMultiple Chronic ConditionsOsteoarthritisOsteoporosisPrescription DrugsPulmonary Disease, Chronic ObstructiveRetrospective StudiesUnited StatesConceptsCommon chronic diseasesGuideline-recommended medicationsGuideline-recommended managementPrescription drug plansCross-sectional studyChronic conditionsChronic diseasesPocket costsOlder adultsOutpatient medicationsMedicare prescription drug plansInitial treatmentMedicare Advantage plansRetrospective cross-sectional studyMultiple chronic conditionsMedicare Part D plansPart D plansSubstantial financial burdenAtrial fibrillationMAIN OUTCOMEExclusion criteriaMedicare beneficiariesAnnual outHypothetical patientsMedications
2021
Heart Watch Study: protocol for a pragmatic randomised controlled trial
Dhruva SS, Shah ND, Vemulapalli S, Deshmukh A, Beatty AL, Gamble GM, Freeman JV, Hummel JP, Piccini JP, Akar JG, Ervin K, Arges KL, Emanuel L, Noseworthy PA, Hu T, Bartlett V, Ross JS. Heart Watch Study: protocol for a pragmatic randomised controlled trial. BMJ Open 2021, 11: e054550. PMID: 35234659, PMCID: PMC8719216, DOI: 10.1136/bmjopen-2021-054550.Peer-Reviewed Original ResearchConceptsHealthcare utilisationSecondary outcomesAtrial fibrillationAtrial flutterDuke University Health SystemRoutine clinical care settingsAtrial Fibrillation EffectLife global scoresTime of cardioversionAdditional secondary outcomesPopulation of patientsPatient-reported outcomesClinical care settingsUniversity Health SystemQuality of lifeInstitutional review boardMulticentre pragmaticPeer-reviewed journalsPrimary outcomePatients' qualityTrial protocolClinical trialsMayo ClinicECG featuresCare settingsClinician Trends in Prescribing Direct Oral Anticoagulants for US Medicare Beneficiaries
Wheelock KM, Ross JS, Murugiah K, Lin Z, Krumholz HM, Khera R. Clinician Trends in Prescribing Direct Oral Anticoagulants for US Medicare Beneficiaries. JAMA Network Open 2021, 4: e2137288. PMID: 34870678, PMCID: PMC8649845, DOI: 10.1001/jamanetworkopen.2021.37288.Peer-Reviewed Original ResearchConceptsDOAC useAnticoagulant prescriptionOral anticoagulantsUS cliniciansMedicare beneficiariesNational clinical practice guidelinesElevated bleeding riskOral anticoagulant prescriptionsRetrospective cohort studyDirect oral anticoagulantsClinical practice guidelinesUS Medicare beneficiariesInternal medicine physiciansNumber of cliniciansAnticoagulant prescribingDOAC prescriptionsUnique cliniciansBleeding riskCohort studyAnticoagulant strategiesPrescription claimsPractice guidelinesMAIN OUTCOMEMost indicationsMedicare populationPhysician Network Connections Associated With Faster De-Adoption of Dronedarone for Permanent Atrial Fibrillation
Stecher C, Everhart A, Smith LB, Jena A, Ross JS, Desai NR, Shah N, Karaca-Mandic P. Physician Network Connections Associated With Faster De-Adoption of Dronedarone for Permanent Atrial Fibrillation. Circulation Cardiovascular Quality And Outcomes 2021, 14: e008040. PMID: 34555928, PMCID: PMC8530939, DOI: 10.1161/circoutcomes.121.008040.Peer-Reviewed Original Research
2020
Comparative Effectiveness and Safety of Oral Anticoagulants Across Kidney Function in Patients With Atrial Fibrillation
Yao X, Inselman JW, Ross JS, Izem R, Graham DJ, Martin DB, Thompson AM, Ross Southworth M, Siontis KC, Ngufor CG, Nath KA, Desai NR, Nallamothu BK, Saran R, Shah ND, Noseworthy PA. Comparative Effectiveness and Safety of Oral Anticoagulants Across Kidney Function in Patients With Atrial Fibrillation. Circulation Cardiovascular Quality And Outcomes 2020, 13: e006515. PMID: 33012172, PMCID: PMC7580213, DOI: 10.1161/circoutcomes.120.006515.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, OralAgedAged, 80 and overAnticoagulantsAntithrombinsAtrial FibrillationComparative Effectiveness ResearchDabigatranDatabases, FactualFactor Xa InhibitorsFemaleGlomerular Filtration RateHemorrhageHumansKidneyMaleMiddle AgedPyrazolesPyridonesRenal Insufficiency, ChronicRetrospective StudiesRisk AssessmentRisk FactorsRivaroxabanTime FactorsTreatment OutcomeUnited StatesWarfarinConceptsGlomerular filtration rateKidney functionMajor bleedingAtrial fibrillationOral anticoagulantsLower riskFiltration rateComparative effectivenessGlomerular filtration rate categoriesUS administrative claims databaseFalsification end pointsKidney function declineReduced kidney functionProportion of patientsAdministrative claims databaseSubstantial residual confoundingBaseline characteristicsFunction declineClaims databaseComparative safetyResidual confoundingTreatment weightingSimilar riskTreatment groupsPatientsPatient and provider-level factors associated with changes in utilization of treatments in response to evidence on ineffectiveness or harm
Smith LB, Desai NR, Dowd B, Everhart A, Herrin J, Higuera L, Jeffery MM, Jena AB, Ross JS, Shah ND, Karaca-Mandic P. Patient and provider-level factors associated with changes in utilization of treatments in response to evidence on ineffectiveness or harm. International Journal Of Health Economics And Management 2020, 20: 299-317. PMID: 32350680, PMCID: PMC7725279, DOI: 10.1007/s10754-020-09282-2.Peer-Reviewed Original ResearchConceptsPermanent atrial fibrillationType 2 diabetesAtrial fibrillationPermanent atrial fibrillation patientsProvider-level factorsAtrial fibrillation patientsEffective new therapiesPrimary care providersUse of medicationsProvider-level characteristicsUtilization of treatmentHigh-quality health careDronedarone useInterrupted time-series regression modelsFibrillation patientsMedication useDiabetes patientsProvider characteristicsCare providersMedicare feeNew therapiesService claimsFemale providersPatientsMedicationsClinical Outcomes With Beta-Blocker Use in Patients With Recent History of Myocardial Infarction
Jackevicius CA, Krumholz HM, Ross JS, Koh M, Chong A, Austin PC, Stukel TA, Azizi P, Ko DT. Clinical Outcomes With Beta-Blocker Use in Patients With Recent History of Myocardial Infarction. Canadian Journal Of Cardiology 2020, 36: 1633-1640. PMID: 32416066, DOI: 10.1016/j.cjca.2020.01.024.Peer-Reviewed Original ResearchConceptsPrior myocardial infarctionMyocardial infarctionStable patientsPopulation-based observational studyAngina 1 yearDeath/hospitalizationHistory of revascularisationBeta-blocker useMajor cardiovascular eventsHospital discharge diagnosisUse of BBsIndividual end pointsContemporary clinical trialsYears of ageCardiovascular eventsIndex dateCohort studyComposite outcomeBB useHeart failureMedian agePrimary outcomeClinical outcomesAtrial fibrillationDischarge diagnosis
2019
Evolution of Medicare Formulary Coverage Changes for Antithrombotic Therapies After Guideline Updates
Dayoub EJ, Ross JS, Shah ND, Dhruva SS. Evolution of Medicare Formulary Coverage Changes for Antithrombotic Therapies After Guideline Updates. Circulation 2019, 140: 1227-1230. PMID: 31567008, DOI: 10.1161/circulationaha.119.040580.Peer-Reviewed Original Research