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
2021
Comprehensive Comparative Effectiveness and Safety of First-Line β-Blocker Monotherapy in Hypertensive Patients
You S, Krumholz HM, Suchard MA, Schuemie MJ, Hripcsak G, Chen R, Shea S, Duke J, Pratt N, Reich CG, Madigan D, Ryan PB, Park R, Park S. Comprehensive Comparative Effectiveness and Safety of First-Line β-Blocker Monotherapy in Hypertensive Patients. Hypertension 2021, 77: 1528-1538. PMID: 33775125, PMCID: PMC8035236, DOI: 10.1161/hypertensionaha.120.16402.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 LettersPrevalence of Missing Data in the National Cancer Database and Association With Overall Survival
Yang DX, Khera R, Miccio JA, Jairam V, Chang E, Yu JB, Park HS, Krumholz HM, Aneja S. Prevalence of Missing Data in the National Cancer Database and Association With Overall Survival. JAMA Network Open 2021, 4: e211793. PMID: 33755165, PMCID: PMC7988369, DOI: 10.1001/jamanetworkopen.2021.1793.Peer-Reviewed Original ResearchConceptsNational Cancer DatabaseNon-small cell lung cancerOverall survivalCell lung cancerCancer DatabaseMedical recordsLung cancerProstate cancerBreast cancerPatient recordsComplete dataRetrospective cohort studyCohort studyCancer RegistryCommon cancerVariables of interestHigh prevalenceMAIN OUTCOMEPatientsClinical advancementReal-world data sourcesCancerPrevalenceSurvivalHeterogeneous differences
2020
Association of Ticagrelor vs Clopidogrel With Net Adverse Clinical Events in Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention
You SC, Rho Y, Bikdeli B, Kim J, Siapos A, Weaver J, Londhe A, Cho J, Park J, Schuemie M, Suchard MA, Madigan D, Hripcsak G, Gupta A, Reich CG, Ryan PB, Park RW, Krumholz HM. Association of Ticagrelor vs Clopidogrel With Net Adverse Clinical Events in Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention. JAMA 2020, 324: 1640-1650. PMID: 33107944, PMCID: PMC7592033, DOI: 10.1001/jama.2020.16167.Peer-Reviewed Original ResearchMeSH KeywordsAcute Coronary SyndromeAdultAgedAged, 80 and overAlgorithmsAspirinCase-Control StudiesCause of DeathClopidogrelDatabases, FactualDyspneaFemaleHemorrhageHumansIschemiaMaleMiddle AgedMyocardial InfarctionNetwork Meta-AnalysisPercutaneous Coronary InterventionPropensity ScorePurinergic P2Y Receptor AntagonistsRecurrenceRepublic of KoreaRetrospective StudiesStrokeTicagrelorUnited StatesConceptsNet adverse clinical eventsAcute coronary syndromePercutaneous coronary interventionAdverse clinical eventsHemorrhagic eventsIschemic eventsHazard ratioCause mortalityCoronary syndromeCoronary interventionClinical eventsRisk of NACEClinical practiceLarge randomized clinical trialsPrimary end pointRetrospective cohort studyPropensity-matched pairsSummary hazard ratioRandomized clinical trialsRoutine clinical practiceSignificant differencesP2Y12 platelet inhibitorsTicagrelor groupCohort studySecondary outcomesPrinciples of Large-scale Evidence Generation and Evaluation across a Network of Databases (LEGEND)
Schuemie MJ, Ryan PB, Pratt N, Chen R, You SC, Krumholz HM, Madigan D, Hripcsak G, Suchard MA. Principles of Large-scale Evidence Generation and Evaluation across a Network of Databases (LEGEND). Journal Of The American Medical Informatics Association 2020, 27: 1331-1337. PMID: 32909033, PMCID: PMC7481029, DOI: 10.1093/jamia/ocaa103.Peer-Reviewed Original ResearchConceptsNetwork of databasesLarge-scale Evidence GenerationObservational Health Data SciencesObservational health care databasesHealth Data SciencesHealth care dataElectronic health recordsData sciencePublication biasPatient-level informationGeneric overviewHealth recordsMethods addressAforementioned concernsHealth care databasesAnalytic codeNetworkNew paradigmSuch dataHackingEvidence generationDissemination of evidenceHypertension treatmentResidual confoundingAdministrative claimsLarge-scale evidence generation and evaluation across a network of databases (LEGEND): assessing validity using hypertension as a case study
Schuemie MJ, Ryan PB, Pratt N, Chen R, You SC, Krumholz HM, Madigan D, Hripcsak G, Suchard MA. Large-scale evidence generation and evaluation across a network of databases (LEGEND): assessing validity using hypertension as a case study. Journal Of The American Medical Informatics Association 2020, 27: 1268-1277. PMID: 32827027, PMCID: PMC7481033, DOI: 10.1093/jamia/ocaa124.Peer-Reviewed Original ResearchAssociation Between Subsequent Hospitalizations and Recurrent Acute Myocardial Infarction Within 1 Year After Acute Myocardial Infarction
Wang Y, Leifheit E, Normand S, Krumholz HM. Association Between Subsequent Hospitalizations and Recurrent Acute Myocardial Infarction Within 1 Year After Acute Myocardial Infarction. Journal Of The American Heart Association 2020, 9: e014907. PMID: 32172654, PMCID: PMC7335517, DOI: 10.1161/jaha.119.014907.Peer-Reviewed Original ResearchConceptsRecurrent acute myocardial infarctionAcute myocardial infarctionIndex acute myocardial infarctionClinical Classification SoftwareMyocardial infarctionDisease categoriesRisk of deathCox regression modelPost-acute careAcute care hospitalsOccurrence of hospitalizationLow recurrence riskUnplanned rehospitalizationSubsequent hospitalizationBackground PatientsHazard ratioPatient characteristicsSecondary preventionMedian timeService patientsChronic diseasesPatient riskOutcome measuresRehospitalizationHigh riskAttribution 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
Comprehensive comparative effectiveness and safety of first-line antihypertensive drug classes: a systematic, multinational, large-scale analysis
Suchard MA, Schuemie MJ, Krumholz HM, You SC, Chen R, Pratt N, Reich CG, Duke J, Madigan D, Hripcsak G, Ryan PB. Comprehensive comparative effectiveness and safety of first-line antihypertensive drug classes: a systematic, multinational, large-scale analysis. The Lancet 2019, 394: 1816-1826. PMID: 31668726, PMCID: PMC6924620, DOI: 10.1016/s0140-6736(19)32317-7.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAgedAngiotensin Receptor AntagonistsAngiotensin-Converting Enzyme InhibitorsAntihypertensive AgentsCalcium Channel BlockersChildCohort StudiesComparative Effectiveness ResearchDatabases, FactualDiureticsEvidence-Based MedicineFemaleHeart FailureHumansHypertensionMaleMiddle AgedMyocardial InfarctionStrokeYoung AdultConceptsNon-dihydropyridine calcium channel blockersCalcium channel blockersThiazide-like diureticsChannel blockersEnzyme inhibitorsDrug classesHazard ratioCurrent guidelinesFirst-line antihypertensive drug classesComparative effectivenessFirst-line drug classesNew-user cohort designDihydropyridine calcium channel blockerElectronic health record databaseFirst-line classesAngiotensin receptor blockersAntihypertensive drug classesAcute myocardial infarctionHealth record databaseReal-world evidenceMedical Research CouncilMillions of patientsAustralian National HealthOptimal monotherapyReceptor blockersCharacteristics, Management, and Outcomes of Patients Hospitalized for Heart Failure in China: The China PEACE Retrospective Heart Failure Study
Yu Y, Gupta A, Wu C, Masoudi FA, Du X, Zhang J, Krumholz HM, Li J, Group T. Characteristics, Management, and Outcomes of Patients Hospitalized for Heart Failure in China: The China PEACE Retrospective Heart Failure Study. Journal Of The American Heart Association 2019, 8: e012884. PMID: 31431117, PMCID: PMC6755852, DOI: 10.1161/jaha.119.012884.Peer-Reviewed Original ResearchConceptsHeart failureHF careSignificant healthcare resource utilizationBackground Heart failureGuideline-recommended medicationsLower inpatient mortalityAcute heart failureOutcomes of patientsHealthcare resource utilizationLower prescription ratesMedical record abstractionHeart Failure StudyTraditional Chinese medicineHospital mortalityConclusions PatientsInpatient mortalityPatient characteristicsTreatment withdrawalEjection fractionMedian agePrescription ratesRecord abstractionMedian lengthBiomarker testingInpatient settingAcute Kidney Injury Among Older Patients Undergoing Coronary Angiography for Acute Myocardial Infarction: The SILVER-AMI Study
Dodson JA, Hajduk A, Curtis J, Geda M, Krumholz HM, Song X, Tsang S, Blaum C, Miller P, Parikh CR, Chaudhry SI. Acute Kidney Injury Among Older Patients Undergoing Coronary Angiography for Acute Myocardial Infarction: The SILVER-AMI Study. The American Journal Of Medicine 2019, 132: e817-e826. PMID: 31170374, PMCID: PMC6891160, DOI: 10.1016/j.amjmed.2019.05.022.Peer-Reviewed Original ResearchMeSH KeywordsActivities of Daily LivingAcute Kidney InjuryAge FactorsAgedAged, 80 and overCohort StudiesCoronary AngiographyDatabases, FactualFemaleGeriatric AssessmentHospital MortalityHospitalizationHumansKaplan-Meier EstimateLogistic ModelsMaleMyocardial InfarctionOdds RatioPrognosisProportional Hazards ModelsRisk AssessmentSeverity of Illness IndexSurvival AnalysisConceptsAcute kidney injuryAcute myocardial infarctionAge-related conditionsKidney injuryBody mass indexCoronary angiographyRisk factorsMyocardial infarctionOlder patientsMean ageAcute kidney injury risk factorsAcute Myocardial Infarction StudyAcute myocardial infarction cohortOlder adultsGlobal Outcomes criteriaMyocardial Infarction StudyInjury risk factorsParticipants' mean ageSILVER-AMI StudyMultivariable adjustmentComorbid diseasesHeart failureIndependent predictorsGeriatric conditionsMass indexAssociation 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 capabilitiesHemopericardium and Cardiac Tamponade as a Complication of Vena Caval Filters: Systematic Review of the Published Literature and the MAUDE Database
Bikdeli B, Kirtane AJ, Jimenez D, Green P, Spencer FA, Kuo WT, Krumholz HM, Parikh SA. Hemopericardium and Cardiac Tamponade as a Complication of Vena Caval Filters: Systematic Review of the Published Literature and the MAUDE Database. Clinical And Applied Thrombosis/Hemostasis 2019, 25: 1076029619849111. PMID: 31088147, PMCID: PMC6714946, DOI: 10.1177/1076029619849111.Peer-Reviewed Original Research
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 levelDifferencesPatientsRegistryDefibrillatorICDClinical Outcomes of Plavix and Generic Clopidogrel for Patients Hospitalized With an Acute Coronary Syndrome
Ko DT, Krumholz HM, Tu JV, Austin PC, Stukel TA, Koh M, Chong A, de Melo JF, Jackevicius CA. Clinical Outcomes of Plavix and Generic Clopidogrel for Patients Hospitalized With an Acute Coronary Syndrome. Circulation Cardiovascular Quality And Outcomes 2018, 11: e004194. PMID: 29535091, DOI: 10.1161/circoutcomes.117.004194.Peer-Reviewed Original ResearchMeSH KeywordsAcute Coronary SyndromeAgedAged, 80 and overClopidogrelCost SavingsCost-Benefit AnalysisDatabases, FactualDrug CostsDrug SubstitutionDrugs, GenericFemaleHemorrhageHumansMaleOntarioPatient AdmissionPatient ReadmissionPlatelet Aggregation InhibitorsPurinergic P2Y Receptor AntagonistsRecurrenceRisk AssessmentRisk FactorsTime FactorsTreatment OutcomeConceptsAcute coronary syndromeGeneric clopidogrelClinical outcomesCoronary syndromePrimary outcomeRecurrent acute coronary syndromeSubstantial healthcare cost savingsPopulation-based observational studyPropensity-weighted cohortsComposite of deathTransient ischemic attackComposite end pointEffect of clopidogrelElevation myocardial infarctionHealthcare cost savingsCox proportional hazardsRate of deathIschemic attackACS hospitalizationCause readmissionBaseline characteristicsHospital dischargeRecurrent hospitalizationsMean ageMyocardial infarctionNational Trends in Nonstatin Use and Expenditures Among the US Adult Population From 2002 to 2013: Insights From Medical Expenditure Panel Survey
Salami JA, Warraich HJ, Valero‐Elizondo J, Spatz ES, Desai NR, Rana JS, Virani SS, Blankstein R, Khera A, Blaha MJ, Blumenthal RS, Katzen BT, Lloyd‐Jones D, Krumholz HM, Nasir K. National Trends in Nonstatin Use and Expenditures Among the US Adult Population From 2002 to 2013: Insights From Medical Expenditure Panel Survey. Journal Of The American Heart Association 2018, 7: e007132. PMID: 29358195, PMCID: PMC5850149, DOI: 10.1161/jaha.117.007132.Peer-Reviewed Original ResearchAdultAgedAtherosclerosisDatabases, FactualDrug CostsDrug PrescriptionsDyslipidemiasFemaleHealth Care SurveysHealth ExpendituresHealthcare DisparitiesHumansHydroxymethylglutaryl-CoA Reductase InhibitorsHypolipidemic AgentsLongitudinal StudiesMaleMedically UninsuredMiddle AgedPractice Patterns, Physicians'Racial GroupsRetrospective StudiesRisk FactorsSex FactorsSocioeconomic FactorsTime FactorsTreatment OutcomeUnited States
2017
With Great Power Comes Great Responsibility
Khera R, Krumholz HM. With Great Power Comes Great Responsibility. Circulation Cardiovascular Quality And Outcomes 2017, 10: e003846. PMID: 28705865, PMCID: PMC5728376, DOI: 10.1161/circoutcomes.117.003846.Peer-Reviewed Original ResearchDiscovery of temporal and disease association patterns in condition-specific hospital utilization rates
Haimovich JS, Venkatesh AK, Shojaee A, Coppi A, Warner F, Li SX, Krumholz HM. Discovery of temporal and disease association patterns in condition-specific hospital utilization rates. PLOS ONE 2017, 12: e0172049. PMID: 28355219, PMCID: PMC5371293, DOI: 10.1371/journal.pone.0172049.Peer-Reviewed Original Research
2016
Analysis of Machine Learning Techniques for Heart Failure Readmissions
Mortazavi BJ, Downing NS, Bucholz EM, Dharmarajan K, Manhapra A, Li SX, Negahban SN, Krumholz HM. Analysis of Machine Learning Techniques for Heart Failure Readmissions. Circulation Cardiovascular Quality And Outcomes 2016, 9: 629-640. PMID: 28263938, PMCID: PMC5459389, DOI: 10.1161/circoutcomes.116.003039.Peer-Reviewed Original Research