2024
Information Disclosure, Medical Device Regulation, and Device Safety: The Case of Cook Celect IVC Filters.
Kadakia K, Bikdeli B, Gupta A, Dhruva S, Ross J, Krumholz H. Information Disclosure, Medical Device Regulation, and Device Safety: The Case of Cook Celect IVC Filters. Annals Of Internal Medicine 2024 PMID: 39556835, DOI: 10.7326/annals-24-00089.Peer-Reviewed Original ResearchMedical device regulationDetect adverse eventsDevice regulationInferior vena cavaPatient safetyFood and Drug AdministrationDevice safetyOutcome definitionsStudy protocolPatient deathClinical study protocolAdverse eventsProfessional societiesCourt documentsClinical practiceRegulatory reformCliniciansInferior vena cava perforationDevice labelingPrevention of pulmonary embolismPublished literaturePublic recordsInaccurate informationCelect IVC filtersMedical devices
2022
Characterization of multi-domain postoperative recovery trajectories after cardiac surgery using a digital platform
Mori M, Dhruva S, Geirsson A, Krumholz H. Characterization of multi-domain postoperative recovery trajectories after cardiac surgery using a digital platform. Npj Digital Medicine 2022, 5: 192. PMID: 36564550, PMCID: PMC9789027, DOI: 10.1038/s41746-022-00736-0.Peer-Reviewed Original ResearchPatient-reported outcome measuresCardiac surgeryProspective cohort studyPROM data collectionPostoperative complicationsCohort studyPostoperative recoveryTertiary centerPatients' perceptionsOutcome measuresClinical practicePatientsSurgeryRecovery progressionRecovery trajectoriesTrajectory membershipComplicationsOverall recoveryDaysAnxiety trajectoriesRecoveryProgressionCareClinical decision support in cardiovascular medicine
Lu Y, Melnick ER, Krumholz HM. Clinical decision support in cardiovascular medicine. The BMJ 2022, 377: e059818. PMID: 35613721, DOI: 10.1136/bmj-2020-059818.Peer-Reviewed Original ResearchConceptsCardiovascular diseaseCardiovascular careEffectiveness of CDSRisk factor modificationClinical decision support toolQuality of careClinical decision supportClinical outcomesFactor modificationHealth information technologyClinical practicePatient careDiseaseCardiovascular medicineCDS effectivenessCareEffectiveness of deliveryMissed opportunityTreatmentFailureProper evidenceHealthcare processesMedicineEvidencePrevention
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 outcomes
2019
Digoxin Use and Associated Adverse Events Among Older Adults
Angraal S, Nuti SV, Masoudi FA, Freeman JV, Murugiah K, Shah ND, Desai NR, Ranasinghe I, Wang Y, Krumholz HM. Digoxin Use and Associated Adverse Events Among Older Adults. The American Journal Of Medicine 2019, 132: 1191-1198. PMID: 31077654, DOI: 10.1016/j.amjmed.2019.04.022.Peer-Reviewed Original ResearchConceptsRate of hospitalizationDigoxin useDigoxin toxicityNational Prescription AuditMedicare feeService beneficiariesDigoxin prescriptionAssociated adverse eventsAdverse eventsCohort studyAdverse outcomesSecondary diagnosisNational cohortPrescription auditPrescription trendsClinical guidelinesHospitalizationMortality rateClinical practiceOlder adultsSubsequent outcomesOutcomesToxicityPrescriptionNational-level trends
2018
Will research preprints improve healthcare for patients?
Krumholz HM, Ross JS, Otto CM. Will research preprints improve healthcare for patients? The BMJ 2018, 362: k3628. PMID: 30249719, DOI: 10.1136/bmj.k3628.Commentaries, Editorials and LettersAge of Data at the Time of Publication of Contemporary Clinical Trials
Welsh J, Lu Y, Dhruva SS, Bikdeli B, Desai NR, Benchetrit L, Zimmerman CO, Mu L, Ross JS, Krumholz HM. Age of Data at the Time of Publication of Contemporary Clinical Trials. JAMA Network Open 2018, 1: e181065-e181065. PMID: 30646100, PMCID: PMC6324269, DOI: 10.1001/jamanetworkopen.2018.1065.Peer-Reviewed Original ResearchConceptsClinical trialsFinal data collectionParticipant enrollmentInternal medicineMultivariable linear regression analysisFirst participant enrollmentPrimary end pointMultivariable regression analysisContemporary clinical trialsClinical trial dataJAMA Internal MedicineRegression analysisCross-sectional analysisTime of publicationMedian timeTrial characteristicsOutcome measuresMAIN OUTCOMENew England JournalClinical practiceLinear regression analysisTrial dataEnd pointTrial resultsTrialsNational and Regional Trends in Deep Vein Thrombosis Hospitalization Rates, Discharge Disposition, and Outcomes for Medicare Beneficiaries
Minges KE, Bikdeli B, Wang Y, Attaran RR, Krumholz HM. National and Regional Trends in Deep Vein Thrombosis Hospitalization Rates, Discharge Disposition, and Outcomes for Medicare Beneficiaries. The American Journal Of Medicine 2018, 131: 1200-1208. PMID: 29753792, PMCID: PMC7040884, DOI: 10.1016/j.amjmed.2018.04.033.Peer-Reviewed Original ResearchConceptsDeep vein thrombosisHospitalization ratesVein thrombosisBlack patientsMedicare Standard Analytic FilesProportion of patientsPrincipal discharge diagnosisStandard Analytic FilesSecondary prevention effortsDischarge dispositionHospital lengthInpatient managementReadmission ratesDischarge diagnosisService patientsAdjusted outcomesOutpatient careAnalytic FilesMedicare feeMedicare beneficiariesMortality rateClinical practiceHospitalizationPatientsThrombosis
2017
The primary health-care system in China
Li X, Lu J, Hu S, Cheng K, De Maeseneer J, Meng Q, Mossialos E, Xu DR, Yip W, Zhang H, Krumholz HM, Jiang L, Hu S. The primary health-care system in China. The Lancet 2017, 390: 2584-2594. PMID: 29231837, DOI: 10.1016/s0140-6736(17)33109-4.Peer-Reviewed Original ResearchConceptsPrimary health care systemHealth care systemChronic non-communicable diseasesEvidence-based performance indicatorsNon-communicable diseasesEveryday clinical practiceQuality of careHealth information technology systemsRisk factorsClinical practiceCare deliveryVillage doctorsHealth care reformInadequate educationCost savingsWorld populationPopulationPrevalenceDiseasePostmarket Safety Events Among Novel Therapeutics Approved by the US Food and Drug Administration Between 2001 and 2010
Downing NS, Shah ND, Aminawung JA, Pease AM, Zeitoun JD, Krumholz HM, Ross JS. Postmarket Safety Events Among Novel Therapeutics Approved by the US Food and Drug Administration Between 2001 and 2010. JAMA 2017, 317: 1854-1863. PMID: 28492899, PMCID: PMC5815036, DOI: 10.1001/jama.2017.5150.Peer-Reviewed Original ResearchConceptsNovel therapeuticsSafety eventsAccelerated approvalTherapeutic characteristicsUS FoodDrug AdministrationFDA approvalInitial regulatory approvalClinician decision makingNew safety risksMedian followCohort studyMedian timeMultivariable analysisBoxed warningDrug classesMAIN OUTCOMEClinical practicePostmarket periodPsychiatric diseasesPriority reviewTherapeutic areasOrphan statusPsychiatric therapeuticsBiologics
2015
Achieving best outcomes for patients with cardiovascular disease in China by enhancing the quality of medical care and establishing a learning health-care system
Jiang L, Krumholz HM, Li X, Li J, Hu S. Achieving best outcomes for patients with cardiovascular disease in China by enhancing the quality of medical care and establishing a learning health-care system. The Lancet 2015, 386: 1493-1505. PMID: 26466053, PMCID: PMC5323019, DOI: 10.1016/s0140-6736(15)00343-8.Peer-Reviewed Original ResearchDevelopment of a Hospital Outcome Measure Intended for Use With Electronic Health Records
McNamara RL, Wang Y, Partovian C, Montague J, Mody P, Eddy E, Krumholz HM, Bernheim SM. Development of a Hospital Outcome Measure Intended for Use With Electronic Health Records. Medical Care 2015, 53: 818-826. PMID: 26225445, DOI: 10.1097/mlr.0000000000000402.Peer-Reviewed Original ResearchConceptsElectronic health recordsOutcome measuresClinical dataMortality rateClinical practiceFuture quality improvement measuresRisk-standardized mortality ratesHospital risk-standardized mortality ratesLow-mortality hospitalsHealth recordsSystolic blood pressureOdds of mortalityClinical registry dataAcute myocardial infarctionHigh-mortality hospitalsHospital outcome measuresEHR dataFinal risk modelCurrent clinical practiceStandard clinical practiceFirst outcome measureNational Quality ForumCurrent electronic health recordsQuality improvement measuresChart abstraction
2013
Centers for Cardiovascular Outcomes Research
Cook NL, Bonds DE, Kiefe CI, Curtis JP, Krumholz HM, Kressin NR, Peterson ED. Centers for Cardiovascular Outcomes Research. Circulation Cardiovascular Quality And Outcomes 2013, 6: 223-228. PMID: 23481526, PMCID: PMC3684990, DOI: 10.1161/circoutcomes.0b013e31828e8d5c.Peer-Reviewed Original ResearchMeSH KeywordsCardiovascular DiseasesContinuity of Patient CareCooperative BehaviorHealth Care ReformHealth Services ResearchHealthcare DisparitiesHumansInterdisciplinary CommunicationInterinstitutional RelationsMulticenter Studies as TopicNational Heart, Lung, and Blood Institute (U.S.)Organizational ObjectivesOutcome Assessment, Health CareProgram DevelopmentProgram EvaluationQuality Indicators, Health CareQuality of LifeTreatment OutcomeUnited StatesConceptsCardiovascular Outcomes ResearchOutcomes research programsBlood InstituteNational HeartCardiovascular conditionsCross-program collaborationOutcomes researchAcute coronary syndromeBetter patient outcomesQuality of lifeCoronary syndromeVenous thromboembolismClinical eventsCare transitionsPatient outcomesDisparate careEarly-stage investigatorsClinical practiceTranslational gapLungNational InstituteHealthcare deliveryOutcomesHeartCareEthical Oversight: Serving the Best Interests of Patients
Selby JV, Krumholz HM. Ethical Oversight: Serving the Best Interests of Patients. The Hastings Center Report 2013, 43: s34-s36. PMID: 23315893, DOI: 10.1002/hast.138.Peer-Reviewed Original Research
2011
Operator Experience and Carotid Stenting Outcomes in Medicare Beneficiaries
Nallamothu BK, Gurm HS, Ting HH, Goodney PP, Rogers MA, Curtis JP, Dimick JB, Bates ER, Krumholz HM, Birkmeyer JD. Operator Experience and Carotid Stenting Outcomes in Medicare Beneficiaries. JAMA 2011, 306: 1338-1343. PMID: 21954477, PMCID: PMC3208144, DOI: 10.1001/jama.2011.1357.Peer-Reviewed Original ResearchMeSH KeywordsAge FactorsAgedAged, 80 and overAtherosclerosisCarotid StenosisCenters for Medicare and Medicaid Services, U.S.Clinical CompetenceFee-for-Service PlansFemaleHospital MortalityHumansInsurance CoverageMaleMedicarePhysiciansQuality of Health CareRetrospective StudiesStentsStrokeTime FactorsTreatment OutcomeUnited StatesConceptsAnnual operator volumeCarotid stentingOperator volumeMedicare beneficiariesNational coverage decisionHigh riskOperator experienceStudy periodThirty-day mortalityEmbolic protection devicesHigh-volume operatorsLow-volume operatorsService Medicare beneficiariesLow annual volumeMultivariable adjustmentOlder patientsRate of failureClinical trialsCoverage decisionsObservational studyMAIN OUTCOMEPatientsClinical practiceStentingMore procedures
2007
Impact of the Food and Drug Administration’s Public Health Notification on the Adoption of Drug-Eluting Stents
Curtis JP, Cohen DJ, Jones PG, Bach RG, Spertus JA, Krumholz HM. Impact of the Food and Drug Administration’s Public Health Notification on the Adoption of Drug-Eluting Stents. The American Journal Of Cardiology 2007, 99: 1227-1229. PMID: 17478147, DOI: 10.1016/j.amjcard.2006.12.031.Peer-Reviewed Original ResearchConceptsPublic health notificationDrug-eluting stentsDES useDrug Administration Public Health NotificationsUse of DESDrug Administration NotificationProspective registryMyocardial infarctionDES safetyClinical practiceStudy periodStentsRelative decreaseTemporary effectInfarctionPatientsNotificationFoodRegistryDramatic increase
2005
Diagnosis, Evaluation, and Treatment of Childhood Obesity in Pediatric Practice
Dorsey KB, Wells C, Krumholz HM, Concato J. Diagnosis, Evaluation, and Treatment of Childhood Obesity in Pediatric Practice. JAMA Pediatrics 2005, 159: 632-638. PMID: 15996996, DOI: 10.1001/archpedi.159.7.632.Peer-Reviewed Original ResearchConceptsBody mass indexRisk of overweightHospital-based clinicsHealth maintenance visitsRate of diagnosisType of treatmentComorbid diseasesMass indexOverweight childrenChildhood obesityMedical recordsTreatment recommendationsHigh burdenPediatric practiceRoutine screeningOverweightClinical practiceMaintenance visitsDiagnosisEncounter notesFormal diagnosisTreatmentChildrenSingle-parent householdsRiskReport of the National Heart, Lung, and Blood Institute Working Group on Outcomes Research in Cardiovascular Disease
Krumholz HM, Peterson ED, Ayanian JZ, Chin MH, DeBusk RF, Goldman L, Kiefe CI, Powe NR, Rumsfeld JS, Spertus JA, Weintraub WS. Report of the National Heart, Lung, and Blood Institute Working Group on Outcomes Research in Cardiovascular Disease. Circulation 2005, 111: 3158-3166. PMID: 15956152, DOI: 10.1161/circulationaha.105.536102.Peer-Reviewed Original ResearchConceptsCardiovascular diseaseNational HeartOutcomes researchBlood Institute Working GroupReal-world effectivenessNational surveillance projectPatient-centered careClinical decision makingWorking GroupBlood InstitutePatient outcomesClinical practiceSurveillance projectCost of interventionHealthcare deliveryLungDiseaseCareCV conditionsResearch investigatorsGroupBasic scienceResearch prioritiesHeart
2004
Prognostic Value of Health Status in Patients With Heart Failure After Acute Myocardial Infarction
Soto GE, Jones P, Weintraub WS, Krumholz HM, Spertus JA. Prognostic Value of Health Status in Patients With Heart Failure After Acute Myocardial Infarction. Circulation 2004, 110: 546-551. PMID: 15262843, DOI: 10.1161/01.cir.0000136991.85540.a9.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAmericasCardiovascular DiseasesCohort StudiesComorbidityDisease-Free SurvivalEplerenoneEuropeFemaleHealth Status IndicatorsHeart FailureHospitalizationHumansMaleMiddle AgedMineralocorticoid Receptor AntagonistsMyocardial InfarctionPrognosisProspective StudiesRisk FactorsSeverity of Illness IndexSpironolactoneConceptsKansas City Cardiomyopathy QuestionnaireAcute myocardial infarctionHeart failureKCCQ-OSMyocardial infarctionHealth statusKCCQ scoresCardiovascular mortalityPrognostic valueDisease-specific health status instrumentRecent acute myocardial infarctionSubsequent cardiovascular eventsEvent-free survivalOutpatient clinical practiceFirst outpatient visitHealth status instrumentsPatients' health statusQuality of lifeCardiovascular eventsClinical characteristicsOutpatient visitsMultivariable modelInternational cohortFunctional limitationsClinical practice
2003
Is there evidence of implicit exclusion criteria for elderly subjects in randomized trials? Evidence from the GUSTO-1 study
Krumholz HM, Gross CP, Peterson ED, Barron HV, Radford MJ, Parsons LS, Every NR. Is there evidence of implicit exclusion criteria for elderly subjects in randomized trials? Evidence from the GUSTO-1 study. American Heart Journal 2003, 146: 839-847. PMID: 14597933, DOI: 10.1016/s0002-8703(03)00408-3.Peer-Reviewed Original ResearchConceptsCooperative Cardiovascular ProjectRandomized trialsExclusion criteriaEligibility criteriaMortality rateClinical practiceKillip class III/IVClass III/IVOccluded Coronary Arteries (GUSTO-I) trialCoronary Arteries trialHospital mortality rateMyocardial infarction careTrial eligibility criteriaHigh mortality rateRetrospective registryBaseline characteristicsClinical characteristicsElderly patientsOlder patientsCCP patientsClinical presentationClinical eventsMyocardial infarctionHealthy cohortHospital characteristics