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 dataEndpoint
2021
Real-world Cardiovascular Outcomes Associated With Degarelix vs Leuprolide for Prostate Cancer Treatment
Wallach JD, Deng Y, McCoy RG, Dhruva SS, Herrin J, Berkowitz A, Polley EC, Quinto K, Gandotra C, Crown W, Noseworthy P, Yao X, Shah ND, Ross JS, Lyon TD. Real-world Cardiovascular Outcomes Associated With Degarelix vs Leuprolide for Prostate Cancer Treatment. JAMA Network Open 2021, 4: e2130587. PMID: 34677594, PMCID: PMC8536955, DOI: 10.1001/jamanetworkopen.2021.30587.Peer-Reviewed Original ResearchConceptsMajor adverse cardiovascular eventsSecondary end pointsMyocardial infarctionClinical trialsCardiovascular diseaseProstate cancerCardiovascular eventsEnd pointRisk of MACELarge US administrative claims databasePropensity-matched cohort studyUS administrative claims databasePropensity score-matched patientsAdverse cardiovascular eventsPrimary end pointAdministrative claims databaseProportional hazards regressionRandomized clinical trialsAdministrative claims dataTrial eligibility criteriaMedicare Advantage beneficiariesProstate cancer treatmentReal-world evidenceElectronic health recordsCardiovascular outcomesSecond-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 ratioCardiovascular outcomes and rates of fractures and falls among patients with brand-name versus generic L-thyroxine use
Brito JP, Ross JS, Deng Y, Sangaralingham L, Graham DJ, Qiang Y, Wang Z, Yao X, Zhao L, Smallridge RC, Bernet V, Shah ND, Lipska KJ. Cardiovascular outcomes and rates of fractures and falls among patients with brand-name versus generic L-thyroxine use. Endocrine 2021, 74: 592-602. PMID: 34089480, PMCID: PMC9210353, DOI: 10.1007/s12020-021-02779-x.Peer-Reviewed Original ResearchConceptsCongestive heart failureRate of fracturesCardiovascular outcomesL-thyroxineRate of fallHeart failureHip fractureAtrial fibrillationMyocardial infarctionNational administrative claims databasePropensity-matched patientsAdministrative claims databaseRate of hospitalizationMIU/L.Main outcome measuresSignificant differencesDose subgroupsHospitalization ratesClaims databaseThyroid cancerInpatient settingBaseline thyroidHormone levelsOutcome measuresPatients
2020
Impact of left ventricular assist devices and heart transplants on acute myocardial infarction and heart failure mortality and readmission measures
Brandt EJ, Ross JS, Grady JN, Ahmad T, Pawar S, Bernheim SM, Desai NR. Impact of left ventricular assist devices and heart transplants on acute myocardial infarction and heart failure mortality and readmission measures. PLOS ONE 2020, 15: e0230734. PMID: 32214363, PMCID: PMC7098556, DOI: 10.1371/journal.pone.0230734.Peer-Reviewed Original ResearchConceptsLeft ventricular assist deviceHeart transplantation patientsRisk-standardized mortalityHeart transplantationTransplantation patientsAMI cohortReadmission cohortHF cohortVentricular assist deviceAMI mortalityAssist deviceHeart failure mortalityAcute myocardial infarctionHF mortalityLVAD indicationHF patientsLVAD patientsReadmission ratesHeart transplantMyocardial infarctionPrimary diagnosisReadmission measuresMedicare feeChronic supportPatientsAssociation of Use of an Intravascular Microaxial Left Ventricular Assist Device vs Intra-aortic Balloon Pump With In-Hospital Mortality and Major Bleeding Among Patients With Acute Myocardial Infarction Complicated by Cardiogenic Shock
Dhruva SS, Ross JS, Mortazavi BJ, Hurley NC, Krumholz HM, Curtis JP, Berkowitz A, Masoudi FA, Messenger JC, Parzynski CS, Ngufor C, Girotra S, Amin AP, Shah ND, Desai NR. Association of Use of an Intravascular Microaxial Left Ventricular Assist Device vs Intra-aortic Balloon Pump With In-Hospital Mortality and Major Bleeding Among Patients With Acute Myocardial Infarction Complicated by Cardiogenic Shock. JAMA 2020, 323: 734-745. PMID: 32040163, PMCID: PMC7042879, DOI: 10.1001/jama.2020.0254.Peer-Reviewed Original ResearchMeSH KeywordsAgedCause of DeathExtracorporeal Membrane OxygenationFemaleHeart ArrestHeart-Assist DevicesHemorrhageHospital MortalityHumansIntra-Aortic Balloon PumpingMaleMatched-Pair AnalysisMiddle AgedMyocardial InfarctionPercutaneous Coronary InterventionPropensity ScoreRegistriesRetrospective StudiesShock, CardiogenicST Elevation Myocardial InfarctionConceptsMicroaxial left ventricular assist deviceIntra-aortic balloon pumpLeft ventricular assist deviceAcute myocardial infarctionPercutaneous coronary interventionNational Cardiovascular Data RegistryCardiogenic shockHemodynamic supportMyocardial infarctionRegistry-based retrospective cohort studyCardiology-National Cardiovascular Data RegistryChest Pain-MI RegistryST-elevation myocardial infarctionMechanical circulatory support devicesGreater hemodynamic supportHospital major bleedingRetrospective cohort studyPropensity-matched pairsCirculatory support devicesVentricular assist deviceClinical laboratory dataHospital mortalityMajor bleedingHospital deathCohort studyAttribution of Adverse Events Following Coronary Stent Placement Identified Using Administrative Claims Data
Dhruva SS, Parzynski CS, Gamble GM, Curtis JP, Desai NR, Yeh RW, Masoudi FA, Kuntz R, Shaw RE, Marinac‐Dabic D, Sedrakyan A, Normand S, Krumholz HM, Ross JS. Attribution of Adverse Events Following Coronary Stent Placement Identified Using Administrative Claims Data. Journal Of The American Heart Association 2020, 9: e013606. PMID: 32063087, PMCID: PMC7070203, DOI: 10.1161/jaha.119.013606.Peer-Reviewed Original ResearchMeSH KeywordsAdministrative Claims, HealthcareAgedAged, 80 and overCoronary RestenosisCoronary ThrombosisDatabases, FactualDrug-Eluting StentsFemaleHumansMaleMedicareMyocardial InfarctionPercutaneous Coronary InterventionProduct Surveillance, PostmarketingRegistriesRetreatmentRisk AssessmentRisk FactorsTime FactorsTreatment OutcomeUnited StatesConceptsIndex percutaneous coronary interventionPercutaneous coronary interventionSame coronary arteryDrug-eluting stentsNCDR CathPCI RegistrySubsequent percutaneous coronary interventionAcute myocardial infarctionCoronary arteryClaims dataCathPCI RegistryAdverse eventsIndex procedureMyocardial infarctionRepeat percutaneous coronary interventionReal-world registry dataTarget vessel revascularizationCoronary stent placementAdministrative claims dataLong-term safetyLongitudinal claims dataPotential safety eventsVessel revascularizationCoronary interventionDES placementStent thrombosisUpdating insights into rosiglitazone and cardiovascular risk through shared data: individual patient and summary level meta-analyses
Wallach JD, Wang K, Zhang AD, Cheng D, Grossetta Nardini HK, Lin H, Bracken MB, Desai M, Krumholz HM, Ross JS. Updating insights into rosiglitazone and cardiovascular risk through shared data: individual patient and summary level meta-analyses. The BMJ 2020, 368: l7078. PMID: 32024657, PMCID: PMC7190063, DOI: 10.1136/bmj.l7078.Peer-Reviewed Original ResearchConceptsIndividual patient-level dataCardiovascular related deathsCardiovascular riskMyocardial infarctionRelated deathsSummary-level dataHeart failureOdds ratioSystematic reviewIncreased cardiovascular riskMore myocardial infarctionsHeart failure eventsCochrane Central RegistryAcute myocardial infarctionMyocardial infarction eventsPatient-level dataRandom-effects modelWeb of ScienceAnalysis of trialsEligible trialsComposite outcomeAdverse eventsContinuity correctionControlled TrialsRosiglitazone treatmentClinical 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
Adoption of New Glucose-Lowering Medications in the U.S.—The Case of SGLT2 Inhibitors: Nationwide Cohort Study
McCoy R, Dykhoff HJ, Sangaralingham L, Ross JS, Karaca-Mandic P, Montori VM, Shah N. Adoption of New Glucose-Lowering Medications in the U.S.—The Case of SGLT2 Inhibitors: Nationwide Cohort Study. Diabetes Technology & Therapeutics 2019, 21: 702-712. PMID: 31418588, PMCID: PMC7207017, DOI: 10.1089/dia.2019.0213.Peer-Reviewed Original ResearchConceptsSodium-glucose cotransporter 2 inhibitorsGlucose-lowering medicationsHeart failureKidney diseaseMyocardial infarctionHigh-quality diabetes careMedicare Advantage insurancePrevalent adverse effectsRenal protective benefitsTreatment-risk paradoxNationwide cohort studyCotransporter 2 inhibitorsGlucose-lowering therapyPrior myocardial infarctionGlucose lowering medicationsChronic diabetes complicationsMultivariable logistic regressionNon-black patientsType 2 diabetesDiabetes type 1Insurance-related factorsCommercial health insuranceAppropriateness of usePrior hypoglycemiaSGLT2i initiationClaims-based cardiovascular outcome identification for clinical research: Results from 7 large randomized cardiovascular clinical trials
Brennan JM, Wruck L, Pencina MJ, Clare RM, Lopes RD, Alexander JH, O'Brien S, Krucoff M, Rao SV, Wang TY, Curtis LH, Newby LK, Granger CB, Patel M, Mahaffey K, Ross JS, Normand SL, Eloff BC, Caños DA, Lokhnygina YV, Roe MT, Califf RM, Marinac-Dabic D, Peterson ED. Claims-based cardiovascular outcome identification for clinical research: Results from 7 large randomized cardiovascular clinical trials. American Heart Journal 2019, 218: 110-122. PMID: 31726314, DOI: 10.1016/j.ahj.2019.09.002.Peer-Reviewed Original ResearchMeSH KeywordsAgedBiomedical ResearchCardiovascular DiseasesCoronary Artery BypassData AccuracyDatabases, FactualFee-for-Service PlansFemaleFollow-Up StudiesHumansInpatientsInsurance Claim ReviewKaplan-Meier EstimateMaleMedical Record LinkageMedicareMulticenter Studies as TopicMyocardial InfarctionMyocardial RevascularizationRandomized Controlled Trials as TopicRetrospective StudiesStrokeUnited StatesConceptsCardiovascular clinical trialsMyocardial infarctionEvent ratesClinical researchRandomized cardiovascular clinical trialsClinical trialsTrial participantsClinical events committee’s adjudicationsOverall cardiovascular event ratesTreatment effectsAnnual event rateCardiovascular event ratesMedicare inpatient claimsClinical trial dataOutcomes of interestSite-reported eventsCase concordanceCardiovascular outcomesRetrospective studyHigher event ratesInpatient claimsClinical dataMedicare claimsClaims dataDuke Database
2018
Association of Racial and Socioeconomic Disparities With Outcomes Among Patients Hospitalized With Acute Myocardial Infarction, Heart Failure, and Pneumonia
Downing NS, Wang C, Gupta A, Wang Y, Nuti SV, Ross JS, Bernheim SM, Lin Z, Normand ST, Krumholz HM. Association of Racial and Socioeconomic Disparities With Outcomes Among Patients Hospitalized With Acute Myocardial Infarction, Heart Failure, and Pneumonia. JAMA Network Open 2018, 1: e182044. PMID: 30646146, PMCID: PMC6324513, DOI: 10.1001/jamanetworkopen.2018.2044.Peer-Reviewed Original ResearchMeSH KeywordsAgedAged, 80 and overBlack PeopleCohort StudiesFee-for-Service PlansFemaleHealth Status DisparitiesHeart FailureHospitalizationHospitalsHumansMaleMedicareMiddle AgedMyocardial InfarctionOutcome Assessment, Health CarePneumoniaRacial GroupsRetrospective StudiesSocial ClassUnited StatesWhite PeopleConceptsAcute myocardial infarctionRisk-standardized mortality ratesRisk-standardized readmission ratesReadmission ratesHeart failureMyocardial infarctionMortality rateIntraclass correlation coefficientAnalysis cohortBlack patientsHospital proportionSocioeconomic disparitiesHospital analysisRisk-standardized outcomesRisk-standardized ratesRetrospective cohort studySocioeconomic statusNeighborhood income levelHospital performanceHospital outcomesCohort studyNumber of hospitalsBroader systemic effectsPatient raceMAIN OUTCOME
2017
Quality of Care in the United States Territories, 1999–2012
Nuti SV, Wang Y, Masoudi FA, Nunez-Smith M, Normand ST, Murugiah K, Rodríguez-Vilá O, Ross JS, Krumholz HM. Quality of Care in the United States Territories, 1999–2012. Medical Care 2017, 55: 886-892. PMID: 28906314, PMCID: PMC6482857, DOI: 10.1097/mlr.0000000000000797.Peer-Reviewed Original ResearchConceptsAcute myocardial infarctionHeart failureHospitalization ratesMedicare beneficiariesMortality rateService Medicare beneficiariesQuality of careRecent study periodPneumonia hospitalizationsMyocardial infarctionPatient outcomesMillions of AmericansMedicare feeHealth outcomesPneumoniaService beneficiariesHospital reimbursementUnique beneficiariesHealth equityStudy periodPatient paymentsInpatient paymentsHealth careMortalityCareAge Differences in Hospital Mortality for Acute Myocardial Infarction: Implications for Hospital Profiling.
Dharmarajan K, McNamara RL, Wang Y, Masoudi FA, Ross JS, Spatz EE, Desai NR, de Lemos JA, Fonarow GC, Heidenreich PA, Bhatt DL, Bernheim SM, Slattery LE, Khan YM, Curtis JP. Age Differences in Hospital Mortality for Acute Myocardial Infarction: Implications for Hospital Profiling. Annals Of Internal Medicine 2017, 167: 555-564. PMID: 28973634, PMCID: PMC9359429, DOI: 10.7326/m16-2871.Peer-Reviewed Original ResearchConceptsRisk-standardized mortality ratesAcute myocardial infarctionOlder patientsYounger patientsMyocardial infarctionAge groupsHospital risk-standardized mortality ratesRetrospective cohort studyHospital mortality rankingsNational Quality ForumHospital mortalityMedian hospitalHospital outcomesCohort studyACTION RegistryAMI mortalityAmerican CollegeMedicare beneficiariesAMI hospitalizationPatientsMortality rateHospitalQuality ForumHospital ValueHospital profilingAssociation of Changing Hospital Readmission Rates With Mortality Rates After Hospital Discharge
Dharmarajan K, Wang Y, Lin Z, Normand ST, Ross JS, Horwitz LI, Desai NR, Suter LG, Drye EE, Bernheim SM, Krumholz HM. Association of Changing Hospital Readmission Rates With Mortality Rates After Hospital Discharge. JAMA 2017, 318: 270-278. PMID: 28719692, PMCID: PMC5817448, DOI: 10.1001/jama.2017.8444.Peer-Reviewed Original ResearchConceptsRisk-adjusted readmission ratesRisk-adjusted mortality ratesAcute myocardial infarctionHeart failureReadmission ratesMortality rateMyocardial infarctionMedicare feeService beneficiariesHospital readmission ratesMean hospitalHospital mortalityPostdischarge mortalityHospital dischargeHospital readmissionRetrospective studyAffordable Care ActReadmission reductionMAIN OUTCOMEPneumoniaHospitalSecondary analysisWeighted Pearson correlation coefficientMortalityCare Act
2016
Association Between Hospital Penalty Status Under the Hospital Readmission Reduction Program and Readmission Rates for Target and Nontarget Conditions
Desai NR, Ross JS, Kwon JY, Herrin J, Dharmarajan K, Bernheim SM, Krumholz HM, Horwitz LI. Association Between Hospital Penalty Status Under the Hospital Readmission Reduction Program and Readmission Rates for Target and Nontarget Conditions. JAMA 2016, 316: 2647-2656. PMID: 28027367, PMCID: PMC5599851, DOI: 10.1001/jama.2016.18533.Peer-Reviewed Original ResearchConceptsHospital Readmissions Reduction ProgramAcute myocardial infarctionReadmission ratesReadmissions Reduction ProgramHeart failurePenalty statusNontarget conditionsMedicare feeMean readmission rateThirty-day riskRetrospective cohort studyUnplanned readmission rateReduction programsHRRP announcementHRRP implementationPenalized hospitalsCohort studyService patientsMyocardial infarctionMAIN OUTCOMEExcess readmissionsMedicare beneficiariesService beneficiariesHospitalPatientsHospital Use of Observation Stays
Venkatesh AK, Wang C, Ross JS, Altaf FK, Suter LG, Vellanky S, Grady JN, Bernheim SM. Hospital Use of Observation Stays. Medical Care 2016, 54: 1070-1077. PMID: 27579906, PMCID: PMC5850934, DOI: 10.1097/mlr.0000000000000601.Peer-Reviewed Original ResearchConceptsRisk-standardized readmission ratesAcute myocardial infarctionObservation staysHeart failureReadmission measuresHospital useHospital risk-standardized readmission ratesCross-sectional analysisModest inverse correlationPostdischarge periodReadmission ratesHospital observationMyocardial infarctionMedicare feeStayPneumoniaService beneficiariesMeasures of qualityMedicaid ServicesHospitalInverse correlationModest correlationReadmissionPublic reportingFailureA Nationwide Assessment of the Association of Smoking Bans and Cigarette Taxes With Hospitalizations for Acute Myocardial Infarction, Heart Failure, and Pneumonia
Ho V, Ross JS, Steiner CA, Mandawat A, Short M, Ku-Goto MH, Krumholz HM. A Nationwide Assessment of the Association of Smoking Bans and Cigarette Taxes With Hospitalizations for Acute Myocardial Infarction, Heart Failure, and Pneumonia. Medical Care Research And Review 2016, 74: 687-704. PMID: 27624634, PMCID: PMC5665160, DOI: 10.1177/1077558716668646.Peer-Reviewed Original ResearchConceptsHeart failure hospitalizationAcute myocardial infarctionHospitalization ratesSmoking bansFailure hospitalizationMyocardial infarctionCigarette taxesPneumonia hospitalization ratesPublic place smoking banComprehensive smoking banHigher cigarette taxesPersons age 60Pneumonia hospitalizationsHeart failureContemporaneous controlsProvider characteristicsHospitalizationAge 60State cigarette taxesHospitalization countsMultiple studiesLocal healthInfarctionNational studyAssociationImpact of Hospitalization for Acute Myocardial Infarction on Adherence to Statins Among Older Adults
Kronish IM, Ross JS, Zhao H, Muntner P. Impact of Hospitalization for Acute Myocardial Infarction on Adherence to Statins Among Older Adults. Circulation Cardiovascular Quality And Outcomes 2016, 9: 364-371. PMID: 27220368, PMCID: PMC4956547, DOI: 10.1161/circoutcomes.115.002418.Peer-Reviewed Original ResearchMeSH KeywordsAdministrative Claims, HealthcareAgedAged, 80 and overDatabases, FactualDyslipidemiasFemaleHealth Knowledge, Attitudes, PracticeHospitalizationHumansHydroxymethylglutaryl-CoA Reductase InhibitorsMaleMedicareMedication AdherenceMyocardial InfarctionRisk AssessmentRisk FactorsTherapeuticsTime FactorsUnited StatesConceptsAcute myocardial infarctionImpact of hospitalizationAMI hospitalizationMyocardial infarctionProportion of patientsPatients adherentStatin adherentNonadherent patientsAdherent patientsMedicare patientsHospitalizationAdministrative claimsStatinsMedicare beneficiariesPatientsPneumoniaSubsequent adherenceOlder adultsInfarctionRandom sampleAdherenceAdherentYearsProportionCohortAssociation of Admission to Veterans Affairs Hospitals vs Non–Veterans Affairs Hospitals With Mortality and Readmission Rates Among Older Men Hospitalized With Acute Myocardial Infarction, Heart Failure, or Pneumonia
Nuti SV, Qin L, Rumsfeld JS, Ross JS, Masoudi FA, Normand SL, Murugiah K, Bernheim SM, Suter LG, Krumholz HM. Association of Admission to Veterans Affairs Hospitals vs Non–Veterans Affairs Hospitals With Mortality and Readmission Rates Among Older Men Hospitalized With Acute Myocardial Infarction, Heart Failure, or Pneumonia. JAMA 2016, 315: 582-592. PMID: 26864412, PMCID: PMC5459395, DOI: 10.1001/jama.2016.0278.Peer-Reviewed Original ResearchConceptsAcute myocardial infarctionNon-VA hospitalsReadmission ratesHeart failureVA hospitalsMortality rateVeterans AffairsMyocardial infarctionOlder menMedicare Standard Analytic FilesRisk-standardized mortality ratesCause readmission rateCause mortality ratesHigher readmission ratesStandard Analytic FilesVeterans Affairs hospitalRisk-standardized readmission ratesAdministrative claims dataAcute care hospitalsAssociation of admissionLittle contemporary informationLower mortality rateCross-sectional analysisAnalysis cohortCare hospital