2023
Assessing the use of observational methods and real-world data to emulate ongoing randomized controlled trials
Wallach J, Deng Y, Polley E, Dhruva S, Herrin J, Quinto K, Gandotra C, Crown W, Noseworthy P, Yao X, Jeffery M, Lyon T, Ross J, McCoy R. Assessing the use of observational methods and real-world data to emulate ongoing randomized controlled trials. Clinical Trials 2023, 20: 689-698. PMID: 37589143, PMCID: PMC10843567, DOI: 10.1177/17407745231193137.Peer-Reviewed Original ResearchConceptsBaseline participant characteristicsParticipant characteristicsPrimary endpointSecondary endpointsTrial publicationsMajor adverse cardiovascular eventsPropensity score-matched participantsFirst major adverse cardiovascular eventAdverse cardiovascular eventsBaseline patient characteristicsNonfatal myocardial infarctionOptumLabs Data WarehouseElectronic health record dataRepresentative patient populationHealth record dataCardiovascular eventsClinical characteristicsPatient characteristicsPatient populationMyocardial infarctionExclusion criteriaDrug effectivenessTrialsRecord dataEndpointComparative effectiveness of second line glucose lowering drug treatments using real world data: emulation of a target trial
Deng Y, Polley E, Wallach J, Herrin J, Ross J, McCoy R. Comparative effectiveness of second line glucose lowering drug treatments using real world data: emulation of a target trial. BMJ Medicine 2023, 2: e000419. PMID: 37577025, PMCID: PMC10414064, DOI: 10.1136/bmjmed-2022-000419.Peer-Reviewed Original ResearchYear cumulative incidence rateCumulative incidence rateType 2 diabetesLiraglutide armMetabolic failureSitagliptin armGlycaemic controlInsulin glargineMedian timeIncidence rateComparative effectivenessCox proportional hazards regressionPropensity scoreTarget trialsInsulin glargine armProportional hazards regressionOptumLabs Data WarehouseTarget trial emulationStatistical analysis planMetformin monotherapyMacrovascular complicationsMicrovascular outcomesStudy drugStudy armsTrial emulationIdentifying 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 ResearchConceptsOral 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
Association Between Generic-to-Generic Levothyroxine Switching and Thyrotropin Levels Among US Adults
Brito JP, Deng Y, Ross JS, Choi NH, Graham DJ, Qiang Y, Rantou E, Wang Z, Zhao L, Shah ND, Lipska KJ. Association Between Generic-to-Generic Levothyroxine Switching and Thyrotropin Levels Among US Adults. JAMA Internal Medicine 2022, 182: 418-425. PMID: 35226058, PMCID: PMC8886450, DOI: 10.1001/jamainternmed.2022.0045.Peer-Reviewed Original ResearchConceptsComparative effectiveness research studyIndex dateProportion of patientsTSH levelsNormal TSH levelsMIU/LThyrotropin levelsLevothyroxine productsGeneric levothyroxineNational administrative claims databasePropensity-matched patient pairsBaseline TSH levelsMean TSH levelsThyroid replacement therapyAdministrative claims databaseCurrent guideline recommendationsSerum thyrotropin levelsOptumLabs Data WarehouseStandardized mean differenceLevothyroxine doseLevothyroxine prescriptionsPropensity matchingGuideline recommendationsClaims databaseReplacement therapy
2021
Second-Line Therapy for Type 2 Diabetes Management: The Treatment/Benefit Paradox of Cardiovascular and Kidney Comorbidities.
McCoy RG, Van Houten HK, Karaca-Mandic P, Ross JS, Montori VM, Shah ND. Second-Line Therapy for Type 2 Diabetes Management: The Treatment/Benefit Paradox of Cardiovascular and Kidney Comorbidities. Diabetes Care 2021, 44: 2302-2311. PMID: 34348996, PMCID: PMC8929191, DOI: 10.2337/dc20-2977.Peer-Reviewed Original ResearchSodium-glucose cotransporter 2 inhibitorsGLP-1RAsHeart failureRelative risk ratiosDPP-4iMyocardial infarctionOlder patientsCerebrovascular diseaseCardiovascular diseaseGlucagon-like peptide-1 receptor agonistsPeptide-1 receptor agonistsDipeptidyl peptidase-4 inhibitorsType 2 diabetes managementDPP-4i therapySecond-line therapyCotransporter 2 inhibitorsPrior myocardial infarctionPeptidase-4 inhibitorsOptumLabs Data WarehouseType 2 diabetesMedicare Advantage beneficiariesMedication classesSGLT2i therapyClinical factorsRisk ratio
2020
Catheter-related complications and mortality of atrial fibrillation ablation following introduction of contact force-sensing technology
Akar JG, Hummel JP, Yao X, Sangaralingham L, Dhruva S, Dong J, Ward R, Shah ND, Ross J, Noseworthy PA. Catheter-related complications and mortality of atrial fibrillation ablation following introduction of contact force-sensing technology. BMJ Surgery Interventions & Health Technologies 2020, 2: e000058. PMID: 35047796, PMCID: PMC8647613, DOI: 10.1136/bmjsit-2020-000058.Peer-Reviewed Original ResearchContact force-sensing catheterForce-sensing catheterAcute care useAtrial fibrillation ablationCatheter-related complicationsFibrillation ablationCare useAtrial fibrillationStroke/transient ischemic attackTransient ischemic attackRetrospective cohort analysisEmergency department visitsInverse probability treatment weightsOptumLabs Data WarehouseCatheter complicationsIschemic attackBaseline characteristicsComplication rateDepartment visitsAtrioesophageal fistulaEsophageal injuryCohort analysisContact force monitoringClinical practiceCatheter
2016
Trends of Anti-Vascular Endothelial Growth Factor Use in Ophthalmology Among Privately Insured and Medicare Advantage Patients
Parikh R, Ross JS, Sangaralingham LR, Adelman RA, Shah ND, Barkmeier AJ. Trends of Anti-Vascular Endothelial Growth Factor Use in Ophthalmology Among Privately Insured and Medicare Advantage Patients. Ophthalmology 2016, 124: 352-358. PMID: 27890437, DOI: 10.1016/j.ophtha.2016.10.036.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAngiogenesis InhibitorsBevacizumabCohort StudiesDatabases, FactualDiabetic RetinopathyDrug UtilizationFemaleHumansInsurance, HealthIntravitreal InjectionsMacular DegenerationMaleMedicare Part CMiddle AgedOphthalmologyPrivate SectorRanibizumabReceptors, Vascular Endothelial Growth FactorRecombinant Fusion ProteinsRetinal Vein OcclusionRetrospective StudiesUnited StatesVascular Endothelial Growth Factor AYoung AdultConceptsAge-related macular degenerationDiabetic retinal diseaseAnti-VEGF injectionsIntravitreal anti-VEGF injectionsRetinal vein occlusionAdministrative claims dataRetinal diseasesOphthalmic diseasesVein occlusionClaims dataUse of bevacizumabCurrent Procedural Terminology codesPatients 18 yearsRetrospective cohort studyMedicare Advantage patientsOptumLabs Data WarehouseDrug Administration approvalProcedural Terminology codesGrowth factor useRanibizumab useBevacizumab useAvailable medicationsCohort studyMedication useCommon medicationsIntensive Treatment and Severe Hypoglycemia Among Adults With Type 2 Diabetes
McCoy RG, Lipska KJ, Yao X, Ross JS, Montori VM, Shah ND. Intensive Treatment and Severe Hypoglycemia Among Adults With Type 2 Diabetes. JAMA Internal Medicine 2016, 176: 969-78. PMID: 27273792, PMCID: PMC5380118, DOI: 10.1001/jamainternmed.2016.2275.Peer-Reviewed Original ResearchConceptsType 2 diabetesHigh clinical complexityRisk-adjusted probabilitySevere hypoglycemiaIntensive treatmentClinical complexityStandard treatmentIntensive glucose-lowering treatmentEnd-stage renal diseasePatient clinical complexityGlucose-lowering medicationsGlucose-lowering treatmentUse of insulinRisk of hypoglycemiaOptumLabs Data WarehouseAdults 18 yearsSerious chronic conditionsEligible patientsHbA1c levelsRenal diseaseHbA1c testEmergency departmentChronic conditionsPractice guidelinesRetrospective analysis