2023
Use of Recalled Devices in New Device Authorizations Under the US Food and Drug Administration’s 510(k) Pathway and Risk of Subsequent Recalls
Kadakia K, Dhruva S, Caraballo C, Ross J, Krumholz H. Use of Recalled Devices in New Device Authorizations Under the US Food and Drug Administration’s 510(k) Pathway and Risk of Subsequent Recalls. JAMA 2023, 329: 136-143. PMID: 36625810, PMCID: PMC9857464, DOI: 10.1001/jama.2022.23279.Peer-Reviewed Original Research
2022
Retracted papers originating from paper mills: cross sectional study
Candal-Pedreira C, Ross J, Ruano-Ravina A, Egilman D, Fernández E, Pérez-Ríos M. Retracted papers originating from paper mills: cross sectional study. The BMJ 2022, 379: e071517. PMID: 36442874, PMCID: PMC9703783, DOI: 10.1136/bmj-2022-071517.Peer-Reviewed Original ResearchSpontaneous reporting of post-market safety signals: what evidence should support regulatory action?
Dhodapkar MM, Ross JS, Ramachandran R. Spontaneous reporting of post-market safety signals: what evidence should support regulatory action? The BMJ 2022, 379: o2409. PMID: 36198410, DOI: 10.1136/bmj.o2409.Commentaries, Editorials and Letters
2021
Implementation of 21st Century Cures Act Expanded Access Policies Requirements
Kang S, Chang S, Ross JS, Miller JE. Implementation of 21st Century Cures Act Expanded Access Policies Requirements. Clinical Pharmacology & Therapeutics 2021, 110: 1579-1584. PMID: 34431083, DOI: 10.1002/cpt.2401.Peer-Reviewed Original ResearchLeveraging Open Science to Accelerate Research
Kadakia KT, Beckman AL, Ross JS, Krumholz HM. Leveraging Open Science to Accelerate Research. New England Journal Of Medicine 2021, 384: e61. PMID: 33761227, DOI: 10.1056/nejmp2034518.Commentaries, Editorials and Letters
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 groupsPatientsComparative Effectiveness of Generic vs Brand-Name Levothyroxine in Achieving Normal Thyrotropin Levels
Brito JP, Ross JS, Sangaralingham L, Dutcher SK, Graham DJ, Wang Z, Wu Y, Yao X, Smallridge RC, Bernet V, Shah ND, Lipska KJ. Comparative Effectiveness of Generic vs Brand-Name Levothyroxine in Achieving Normal Thyrotropin Levels. JAMA Network Open 2020, 3: e2017645. PMID: 32997127, PMCID: PMC7527873, DOI: 10.1001/jamanetworkopen.2020.17645.Peer-Reviewed Original ResearchConceptsNormal thyrotropin levelsPropensity score-matched patientsThyrotropin levelsLevothyroxine prescriptionsThyrotropin valuesProportion of patientsAdministrative claims databaseMonths of initiationMIU/LMild thyroid dysfunctionLongitudinal cohort studyMedicare Advantage enrolleesNormal thyrotropin valuesEligible patientsInitial therapyLevothyroxine formulationsCohort studyThyroid dysfunctionClaims databaseGeneric levothyroxineLevothyroxineMAIN OUTCOMENormal rangePatientsNormal vsPatient 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 providersPatientsMedicationsImpact 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 ResearchMeSH KeywordsAgedDatabases, FactualFemaleHeart FailureHeart TransplantationHeart-Assist DevicesHumansMaleMyocardial InfarctionPatient ReadmissionRiskConceptsLeft 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 supportPatientsAttribution 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 thrombosis
2019
Characteristics of Recent Generic Drug Approvals by the US Food and Drug Administration
Jiao K, Gupta R, Fox E, Kesselheim A, Ross JS. Characteristics of Recent Generic Drug Approvals by the US Food and Drug Administration. JAMA Network Open 2019, 2: e1913029. PMID: 31603482, PMCID: PMC6804024, DOI: 10.1001/jamanetworkopen.2019.13029.Peer-Reviewed Original ResearchUse of Mechanical Cardiopulmonary Resuscitation Devices for Out-of-Hospital Cardiac Arrest, 2010-2016
Kahn PA, Dhruva SS, Rhee TG, Ross JS. Use of Mechanical Cardiopulmonary Resuscitation Devices for Out-of-Hospital Cardiac Arrest, 2010-2016. JAMA Network Open 2019, 2: e1913298. PMID: 31617923, PMCID: PMC6806423, DOI: 10.1001/jamanetworkopen.2019.13298.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAge FactorsAgedAged, 80 and overBlack or African AmericanCardiopulmonary ResuscitationCross-Sectional StudiesDatabases, FactualEmergency Medical ServicesFemaleHispanic or LatinoHumansIncomeMaleMiddle AgedNew EnglandOut-of-Hospital Cardiac ArrestRetrospective StudiesSex FactorsSuburban Health ServicesWhite PeopleYoung AdultConceptsHospital cardiac arrestMechanical cardiopulmonary resuscitationMechanical CPR deviceAdjusted odds ratioCardiac arrestCardiopulmonary resuscitationManual cardiopulmonary resuscitationCPR deviceOdds ratioNational Emergency Medical Services Information System dataUse of CPRRetrospective cross-sectional studyMechanical cardiopulmonary resuscitation devicesEMS professionalsRisk-standardized ratesPatient demographic characteristicsPrior clinical trialsCross-sectional studyEvidence of benefitCardiopulmonary resuscitation devicesEmergency medical services (EMS) professionalsNortheast census regionMultivariable analysisClinical trialsPrehospital settingClaims-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 DatabaseAssociation Between Food and Drug Administration Advisory Committee Recommendations and Agency Actions, 2008–2015
ZHANG AD, SCHWARTZ JL, ROSS JS. Association Between Food and Drug Administration Advisory Committee Recommendations and Agency Actions, 2008–2015. Milbank Quarterly 2019, 97: 796-819. PMID: 31304643, PMCID: PMC6739629, DOI: 10.1111/1468-0009.12403.Peer-Reviewed Original ResearchAssociation Between Insurance Status and Access to Hospital Care in Emergency Department Disposition
Venkatesh AK, Chou SC, Li SX, Choi J, Ross JS, D’Onofrio G, Krumholz HM, Dharmarajan K. Association Between Insurance Status and Access to Hospital Care in Emergency Department Disposition. JAMA Internal Medicine 2019, 179: 686-693. PMID: 30933243, PMCID: PMC6503571, DOI: 10.1001/jamainternmed.2019.0037.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAsthmaCritical CareCross-Sectional StudiesDatabases, FactualEmergency Service, HospitalFemaleHealth Services AccessibilityHospitalizationHumansInsurance CoverageInsurance, HealthLung DiseasesMaleMedicaidMedically UninsuredMiddle AgedPatient DischargePatient TransferPneumoniaPulmonary Disease, Chronic ObstructiveUnited StatesConceptsNational Emergency Department SampleEmergency Department SampleCommon medical conditionsUninsured patientsCritical care capabilitiesED dischargeED visitsED transfersPulmonary diseaseCare capabilitiesInsurance statusHigher oddsMedicaid beneficiariesMedical conditionsChronic obstructive pulmonary diseaseAcute pulmonary diseaseEmergency department transfersAdult ED visitsHospital admission ratesObstructive pulmonary diseaseEmergency department dispositionPatient insurance statusPatient case mixHospital ownership statusIntensive care capabilities
2018
Quantifying the utilization of medical devices necessary to detect postmarket safety differences: A case study of implantable cardioverter defibrillators
Bates J, Parzynski CS, Dhruva SS, Coppi A, Kuntz R, Li S, Marinac‐Dabic D, Masoudi FA, Shaw RE, Warner F, Krumholz HM, Ross JS. Quantifying the utilization of medical devices necessary to detect postmarket safety differences: A case study of implantable cardioverter defibrillators. Pharmacoepidemiology And Drug Safety 2018, 27: 848-856. PMID: 29896873, PMCID: PMC6436550, DOI: 10.1002/pds.4565.Peer-Reviewed Original ResearchConceptsAdverse event ratesSafety differencesEvent ratesMedical device utilizationICD utilizationRate ratioNational Cardiovascular Data RegistryICD modelsImplantable cardioverter defibrillatorEvent rate ratioMost patientsCardioverter defibrillatorProportion of individualsAmerican CollegeData registryRoutine surveillanceSample size estimatesAverage event rateDevice utilizationSignificance levelDifferencesPatientsRegistryDefibrillatorICDAvailability of Investigational Medicines Through the US Food and Drug Administration’s Expanded Access and Compassionate Use Programs
Puthumana J, Miller JE, Kim J, Ross JS. Availability of Investigational Medicines Through the US Food and Drug Administration’s Expanded Access and Compassionate Use Programs. JAMA Network Open 2018, 1: e180283-e180283. PMID: 30646072, PMCID: PMC6324420, DOI: 10.1001/jamanetworkopen.2018.0283.Peer-Reviewed Original ResearchConceptsCompassionate use programInvestigational medicinesFDA approvalNew drug application submissionAccess programExpanded AccessUS FoodAvailable FDA documentsLife-threatening conditionCross-sectional studyEvidence of safetyProtection of patientsUse programClinical trialsMAIN OUTCOMEDrug AdministrationInfectious diseasesDrug accessClinical development periodsFDA documentsApplication submissionPatientsDiseaseApprovalMonthsNetwork Optimization And The Continuity Of Physicians In Medicaid Managed Care
Ndumele CD, Staiger B, Ross JS, Schlesinger MJ. Network Optimization And The Continuity Of Physicians In Medicaid Managed Care. Health Affairs 2018, 37: 929-935. PMID: 29863934, DOI: 10.1377/hlthaff.2017.1410.Peer-Reviewed Original ResearchMeSH KeywordsChronic DiseaseContinuity of Patient CareCost ControlDatabases, FactualDelivery of Health CareFemaleHealth ExpendituresHealth Maintenance OrganizationsHealth Services AccessibilityHumansMaleManaged Care ProgramsMedicaidPhysiciansPractice Patterns, Physicians'Retrospective StudiesUnited StatesFactors Associated With Postmarketing Research for Approved Indications for Novel Medicines Approved by Both the FDA and EMA Between 2005 and 2010: A Multivariable Analysis
Zeitoun J, Ross JS, Atal I, Vivot A, Downing NS, Baron G, Ravaud P. Factors Associated With Postmarketing Research for Approved Indications for Novel Medicines Approved by Both the FDA and EMA Between 2005 and 2010: A Multivariable Analysis. Clinical Pharmacology & Therapeutics 2018, 104: 1000-1007. PMID: 29377075, DOI: 10.1002/cpt.1038.Peer-Reviewed Original Research
2017
Incremental Revisions across the Life Span of Ophthalmic Devices after Initial Food and Drug Administration Premarket Approval, 1979–2015
Gopal AD, Rathi VK, Teng CC, Del Priore L, Ross JS. Incremental Revisions across the Life Span of Ophthalmic Devices after Initial Food and Drug Administration Premarket Approval, 1979–2015. Ophthalmology 2017, 124: 1237-1246. PMID: 28501378, DOI: 10.1016/j.ophtha.2017.03.040.Peer-Reviewed Original Research