2023
Availability of Unique Device Identifiers for Class I Medical Device Recalls From 2018 to 2022
Mooghali M, Ross J, Kadakia K, Dhruva S. Availability of Unique Device Identifiers for Class I Medical Device Recalls From 2018 to 2022. JAMA Internal Medicine 2023, 183: 735-737. PMID: 37184854, PMCID: PMC10186206, DOI: 10.1001/jamainternmed.2023.0727.Peer-Reviewed Original Research
2022
Renewing the Call for Reforms to Medical Device Safety—The Case of Penumbra
Kadakia KT, Beckman AL, Ross JS, Krumholz HM. Renewing the Call for Reforms to Medical Device Safety—The Case of Penumbra. JAMA Internal Medicine 2022, 182: 59-65. PMID: 34842892, DOI: 10.1001/jamainternmed.2021.6626.Commentaries, Editorials and LettersConceptsReperfusion catheterClinical evidenceClass IPenumbra reperfusion catheterSingle-arm trialUser Facility Device Experience (MAUDE) databaseAdverse event reportsPostmarket surveillanceHealth policy makersMedical device reportsPenumbra deviceClinical evaluationPatient deathDevice safetyMedicine recommendationsAnimal dataCatheterFDA databaseFDA medical device regulationsClinical literatureSmall sample sizeDevice reportsEvent reportsPublic healthExperience database
2021
Identification of Hospitals That Care for a High Proportion of Patients With Social Risk Factors
Matty R, Heckmann R, George E, Barthel AB, Suter LG, Ross JS, Bernheim SM. Identification of Hospitals That Care for a High Proportion of Patients With Social Risk Factors. JAMA Health Forum 2021, 2: e211323. PMID: 35977204, PMCID: PMC8796989, DOI: 10.1001/jamahealthforum.2021.1323.Peer-Reviewed Original ResearchConceptsSocial risk factorsIdentification of hospitalsProportion of patientsRisk factorsCross-sectional studyHospital performance measuresPatient populationHospital Readmissions Reduction ProgramAfrican American raceProportion of hospitalsDisadvantaged patient populationsReadmissions Reduction ProgramHigher proportionSocioeconomic status scoresSame hospitalStatus scoreCrowded householdsMAIN OUTCOMEMedicaid coverageAmerican racePatientsHospitalHealthcare ResearchDisadvantaged populationsSuch hospitalsPhysician variation in the de‐adoption of ineffective statin and fibrate therapy
Everhart A, Desai NR, Dowd B, Herrin J, Higuera L, Jeffery MM, Jena AB, Ross JS, Shah ND, Smith LB, Karaca‐Mandic P. Physician variation in the de‐adoption of ineffective statin and fibrate therapy. Health Services Research 2021, 56: 919-931. PMID: 33569804, PMCID: PMC8522575, DOI: 10.1111/1475-6773.13630.Peer-Reviewed Original ResearchMeSH KeywordsAgedDiabetes Mellitus, Type 2Drug Therapy, CombinationDrug UtilizationFemaleFibric AcidsGuideline AdherenceHumansHydroxymethylglutaryl-CoA Reductase InhibitorsHypoglycemic AgentsHypolipidemic AgentsLongitudinal StudiesMaleMedicare Part CMiddle AgedPractice Guidelines as TopicPractice Patterns, Physicians'Risk FactorsUnited StatesConceptsMedicare Advantage patientsType 2 diabetic patientsACCORD lipid trialFibrate useAdvantage patientsCommercial patientsPhysician characteristicsLIPID trialFibrate therapyDiabetic patientsPhysician variationDiabetes careType 2 diabetes diagnosisContinuous insurance enrollmentPatient diabetes carePhysician random effectsGlucose-lowering drugsElectronic health record dataHealth record dataReal-world data assetConcurrent statinCardiovascular eventsStatin usersClinical evidenceManagement visitsUse of Mechanical Circulatory Support Devices Among Patients With Acute Myocardial Infarction Complicated by Cardiogenic Shock
Dhruva SS, Ross JS, Mortazavi BJ, Hurley NC, Krumholz HM, Curtis JP, Berkowitz AP, Masoudi FA, Messenger JC, Parzynski CS, Ngufor CG, Girotra S, Amin AP, Shah ND, Desai NR. Use of Mechanical Circulatory Support Devices Among Patients With Acute Myocardial Infarction Complicated by Cardiogenic Shock. JAMA Network Open 2021, 4: e2037748. PMID: 33616664, PMCID: PMC7900859, DOI: 10.1001/jamanetworkopen.2020.37748.Peer-Reviewed Original ResearchMeSH KeywordsAgedAssisted CirculationCross-Sectional StudiesExtracorporeal Membrane OxygenationFemaleHeart ArrestHeart-Assist DevicesHospitals, High-VolumeHospitals, Low-VolumeHospitals, TeachingHumansIntra-Aortic Balloon PumpingMaleMiddle AgedMyocardial InfarctionPercutaneous Coronary InterventionRisk FactorsShock, CardiogenicConceptsMicroaxial left ventricular assist deviceIntra-aortic balloon pumpLeft ventricular assist devicePercutaneous coronary interventionAcute myocardial infarctionMechanical circulatory support devicesCardiogenic shockHospital-level variationSignificant hospital-level variationCirculatory support devicesMCS devicesUse of IABPDevice useMedian proportionAcute Myocardial Infarction ComplicatedCardiology-National Cardiovascular Data RegistryChest Pain-MI RegistryLimited clinical trial evidenceNational Cardiovascular Data RegistryMyocardial Infarction ComplicatedFirst medical contactSupport devicesClinical trial evidenceExtracorporeal membrane oxygenationCoronary artery stenosis
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 groupsPatientsAttribution 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
Association of Inferior Vena Cava Filter Use With Mortality Rates in Older Adults With Acute Pulmonary Embolism
Bikdeli B, Wang Y, Jimenez D, Ross JS, Monreal M, Goldhaber SZ, Krumholz HM. Association of Inferior Vena Cava Filter Use With Mortality Rates in Older Adults With Acute Pulmonary Embolism. JAMA Internal Medicine 2019, 179: 263-265. PMID: 30535318, PMCID: PMC6439651, DOI: 10.1001/jamainternmed.2018.5287.Peer-Reviewed Original Research
2018
Variation in the Diagnosis of Aspiration Pneumonia and Association with Hospital Pneumonia Outcomes
Lindenauer PK, Strait KM, Grady JN, Ngo CK, Parisi ML, Metersky M, Ross JS, Bernheim SM, Dorsey K. Variation in the Diagnosis of Aspiration Pneumonia and Association with Hospital Pneumonia Outcomes. Annals Of The American Thoracic Society 2018, 15: 562-569. PMID: 29298090, DOI: 10.1513/annalsats.201709-728oc.Peer-Reviewed Original ResearchConceptsAspiration pneumoniaHospital mortalityHospital patientsMortality rateLower risk-standardized mortality ratesRisk-standardized mortality ratesRisk-standardized ratesPatients 65 yearsHospital readmission ratesNational mortality ratesPneumonia cohortPneumonia outcomesHospital outcomesReadmission ratesHospital differencesPrincipal diagnosisOutcome measuresReadmission measuresHospital codingMedicare feePneumoniaService claimsPatientsMedian proportionMortality
2017
Opioid Prescribing for Opioid-Naive Patients in Emergency Departments and Other Settings: Characteristics of Prescriptions and Association With Long-Term Use
Jeffery MM, Hooten WM, Hess EP, Meara ER, Ross JS, Henk HJ, Borgundvaag B, Shah ND, Bellolio MF. Opioid Prescribing for Opioid-Naive Patients in Emergency Departments and Other Settings: Characteristics of Prescriptions and Association With Long-Term Use. Annals Of Emergency Medicine 2017, 71: 326-336.e19. PMID: 28967517, PMCID: PMC6295192, DOI: 10.1016/j.annemergmed.2017.08.042.Peer-Reviewed Original ResearchConceptsLong-term opioid useNon-ED settingsOpioid-naive patientsLong-term useOpioid prescriptionsOpioid useCharacteristics of prescriptionsPrescription opioid useLow daily dosesAdministrative claims dataRate of progressionDisabled Medicare beneficiariesMedicare Advantage beneficiariesED prescriptionGuideline concordancePatients 56Patients 58Opioid prescribingCDC guidelinesPrevention guidelinesDaily dosesEmergency departmentCDC recommendationsDays' supplyInclusion criteriaComparison of two independent systematic reviews of trials of recombinant human bone morphogenetic protein-2 (rhBMP-2): the Yale Open Data Access Medtronic Project
Low J, Ross JS, Ritchie JD, Gross CP, Lehman R, Lin H, Fu R, Stewart LA, Krumholz HM. Comparison of two independent systematic reviews of trials of recombinant human bone morphogenetic protein-2 (rhBMP-2): the Yale Open Data Access Medtronic Project. Systematic Reviews 2017, 6: 28. PMID: 28196521, PMCID: PMC5310069, DOI: 10.1186/s13643-017-0422-x.Peer-Reviewed Original ResearchConceptsParticipant-level dataSystematic reviewSummary estimatesRecombinant human bone morphogenetic protein-2Inclusion criteriaCenter BIndividual participant-level dataMeta-analysis inclusion criteriaHuman bone morphogenetic protein-2Trial inclusion criteriaMulti-site clinical trialMain outcome measuresMost clinical outcomesStatistical methodsConcurrent systematic reviewIndependent systematic reviewsProtein 2Bone morphogenetic protein-2Summary efficacyMorphogenetic protein-2Adverse eventsClinical outcomesSurgical approachTrial inclusionClinical trials
2016
Intensive 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 analysisImpact 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 sampleAdherenceAdherentYearsProportionCohort
2015
How do Orthopaedic Devices Change After Their Initial FDA Premarket Approval?
Samuel AM, Rathi VK, Grauer JN, Ross JS. How do Orthopaedic Devices Change After Their Initial FDA Premarket Approval? Clinical Orthopaedics And Related Research® 2015, 474: 1053-1068. PMID: 26584802, PMCID: PMC4773325, DOI: 10.1007/s11999-015-4634-x.Peer-Reviewed Original ResearchMeSH KeywordsCross-Sectional StudiesDatabases, FactualDevice ApprovalEquipment DesignHumansMedical Device RecallsOrthopedic EquipmentOrthopedic ProceduresPatient SafetyProduct Surveillance, PostmarketingRetrospective StudiesRisk FactorsSafety-Based Medical Device WithdrawalsTime FactorsUnited StatesUnited States Food and Drug AdministrationNational assessment of early β-blocker therapy in patients with acute myocardial infarction in China, 2001-2011: The China Patient-centered Evaluative Assessment of Cardiac Events (PEACE)–Retrospective AMI Study
Zhang H, Masoudi FA, Li J, Wang Q, Li X, Spertus JA, Ross JS, Desai NR, Krumholz HM, Jiang L, Group C. National assessment of early β-blocker therapy in patients with acute myocardial infarction in China, 2001-2011: The China Patient-centered Evaluative Assessment of Cardiac Events (PEACE)–Retrospective AMI Study. American Heart Journal 2015, 170: 506-515.e1. PMID: 26385034, PMCID: PMC5459420, DOI: 10.1016/j.ahj.2015.05.012.Peer-Reviewed Original ResearchConceptsΒ-blocker therapyAcute myocardial infarctionΒ-blocker useCardiogenic shockRisk factorsAbsolute contraindicationMyocardial infarctionEarly β-blocker useLower systolic blood pressureHours of admissionMedical record reviewSystolic blood pressureClinical practice guidelinesLower heart rateQuality of careChest discomfortCardiac eventsBlood pressureRecord reviewChina PatientIdeal patientPractice guidelinesHeart rateHigh riskPatterns of useRegional-Level Correlations in Inappropriate Imaging Rates for Prostate and Breast Cancers: Potential Implications for the Choosing Wisely Campaign
Makarov DV, Soulos PR, Gold HT, Yu JB, Sen S, Ross JS, Gross CP. Regional-Level Correlations in Inappropriate Imaging Rates for Prostate and Breast Cancers: Potential Implications for the Choosing Wisely Campaign. JAMA Oncology 2015, 1: 185-194. PMID: 26181021, PMCID: PMC4707944, DOI: 10.1001/jamaoncol.2015.37.Peer-Reviewed Original ResearchMeSH KeywordsAgedAged, 80 and overBreast NeoplasmsCatchment Area, HealthChi-Square DistributionDiagnostic ImagingFemaleGuideline AdherenceHumansLogistic ModelsMaleMedicareMultivariate AnalysisPractice Guidelines as TopicPractice Patterns, Physicians'Predictive Value of TestsProstatic NeoplasmsResidence CharacteristicsRetrospective StudiesRisk FactorsSEER ProgramUnited StatesUnnecessary ProceduresConceptsLow-risk prostate cancerProstate cancerBreast cancerProstate cancer imagingFourth quartileLow-risk breast cancerBreast cancer imagingLow-risk prostateEnd Results-MedicareRetrospective cohort studyMultivariable logistic regressionChoosing Wisely campaignPatient-level analysisAppropriateness of careHospital referral regionsCancer imagingQuality of careInappropriate imagingCohort studyWisely campaignHealth care spendingLowest quartileOdds ratioPatient levelHRR level
2014
Place of Residence and Outcomes of Patients With Heart Failure
Bikdeli B, Wayda B, Bao H, Ross JS, Xu X, Chaudhry SI, Spertus JA, Bernheim SM, Lindenauer PK, Krumholz HM. Place of Residence and Outcomes of Patients With Heart Failure. Circulation Cardiovascular Quality And Outcomes 2014, 7: 749-756. PMID: 25074375, PMCID: PMC5323058, DOI: 10.1161/circoutcomes.113.000911.Peer-Reviewed Original ResearchConceptsNeighborhood socioeconomic statusIndividual socioeconomic statusOutcomes of patientsHeart failureHigher SES neighborhoodsSocioeconomic statusClinical factorsHeart Failure Outcomes trialPrimary end pointPatient-level factorsUS internal medicineCause mortalityCause readmissionMultivariable adjustmentOutcome trialsMedical chartsPatient interviewsLow-SES neighborhoodsCardiology practiceMortality ratePatientsPlace of residenceInternal medicineReadmissionEnd pointUsual Source of Care and Outcomes Following Acute Myocardial Infarction
Spatz ES, Sheth SD, Gosch KL, Desai MM, Spertus JA, Krumholz HM, Ross JS. Usual Source of Care and Outcomes Following Acute Myocardial Infarction. Journal Of General Internal Medicine 2014, 29: 862-869. PMID: 24553957, PMCID: PMC4026492, DOI: 10.1007/s11606-014-2794-0.Peer-Reviewed Original ResearchConceptsAcute myocardial infarctionUsual sourceMyocardial infarctionMortality rateBaseline risk factorsAcute clinical eventsMain outcome measuresAMI severityAMI patientsMultivariable analysisKey ResultsAmongClinical eventsSocio-demographic characteristicsRisk factorsOutcome measuresReadmissionHigh mortalityPatientsMortalityCareMonthsInfarctionAdultsOutcomesAssociation