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 devicesAdvancing patient-centric care: integrating patient reported outcomes for tolerability assessment in early phase clinical trials – insights from an expert virtual roundtable
Yap C, Aiyegbusi O, Alger E, Basch E, Bell J, Bhatnagar V, Cella D, Collis P, Dueck A, Gilbert A, Gnanasakthy A, Greystoke A, Hansen A, Kamudoni P, Kholmanskikh O, King-Kallimanis B, Krumholz H, Minchom A, O'Connor D, Petrie J, Piccinin C, Rantell K, Rauz S, Retzer A, Rizk S, Wagner L, Sasseville M, Seymour L, Weber H, Wilson R, Calvert M, Peipert J. Advancing patient-centric care: integrating patient reported outcomes for tolerability assessment in early phase clinical trials – insights from an expert virtual roundtable. EClinicalMedicine 2024, 76: 102838. PMID: 39386161, PMCID: PMC11462221, DOI: 10.1016/j.eclinm.2024.102838.Peer-Reviewed Original ResearchEarly phase trialsPatient-reported outcomesPhase trialsInvestigator-reported adverse eventsEarly phase clinical trialsTolerability assessmentsPhase clinical trialsIntegration of patient-reported outcomesAdverse eventsClinical trialsPatient-centred careDosing decisionsDiverse clinical areasTherapy risksLaboratory assessmentPatientsTrialsPatient advocatesClinical areasOutcomesSafety alertsPharmaceutical representativesVirtual roundtableRiskTirzepatide and blood pressure reduction: stratified analyses of the SURMOUNT-1 randomised controlled trial
Krumholz H, de Lemos J, Sattar N, Linetzky B, Sharma P, Mast C, Ahmad N, Bunck M, Stefanski A. Tirzepatide and blood pressure reduction: stratified analyses of the SURMOUNT-1 randomised controlled trial. Heart 2024, 110: 1165-1171. PMID: 39084707, PMCID: PMC11420724, DOI: 10.1136/heartjnl-2024-324170.Peer-Reviewed Original ResearchBlood pressure reductionBlood pressure subgroupBlood pressurePost hoc analysisPressure reductionTirzepatide groupsAdverse eventsDiastolic blood pressure reductionHoc analysisAssociated with reduced blood pressureEffects of tirzepatideWeight-related complicationsOverall blood pressureLower blood pressure levelsWeight lossNormal blood pressureDiastolic blood pressureLower blood pressureBlood pressure levelsRandomised controlled trialsMediation analysisTirzepatideClinical subgroupsControlled hypertensionPlacebo
2023
Clinical Phenotyping with an Outcomes-driven Mixture of Experts for Patient Matching and Risk Estimation
Hurley N, Dhruva S, Desai N, Ross J, Ngufor C, Masoudi F, Krumholz H, Mortazavi B. Clinical Phenotyping with an Outcomes-driven Mixture of Experts for Patient Matching and Risk Estimation. ACM Transactions On Computing For Healthcare 2023, 4: 1-18. PMID: 37908872, PMCID: PMC10613929, DOI: 10.1145/3616021.Peer-Reviewed Original ResearchRelationship Between In-Hospital Adverse Events and Hospital Performance on 30-Day All-cause Mortality and Readmission for Patients With Heart Failure
Wang Y, Eldridge N, Metersky M, Rodrick D, Eckenrode S, Mathew J, Galusha D, Peterson A, Hunt D, Normand S, Krumholz H. Relationship Between In-Hospital Adverse Events and Hospital Performance on 30-Day All-cause Mortality and Readmission for Patients With Heart Failure. Circulation Cardiovascular Quality And Outcomes 2023, 16: e009573. PMID: 37463255, PMCID: PMC10351904, DOI: 10.1161/circoutcomes.122.009573.Peer-Reviewed Original ResearchConceptsMore adverse eventsAdverse eventsHeart failureCause mortalityReadmission ratesHigh riskMedicare Patient Safety Monitoring SystemHospital-acquired adverse eventsIn-Hospital Adverse EventsHospital adverse eventsRate of patientsPatient Safety DatabasePerformance categoriesAdverse event dataCross-sectional studyUnited States CentersHospital performanceHospital characteristicsReadmission dataPatient riskMAIN OUTCOMEPatientsWorst hospitalsHospitalHigh mortality
2022
Trends in Adverse Event Rates in Hospitalized Patients, 2010-2019
Eldridge N, Wang Y, Metersky M, Eckenrode S, Mathew J, Sonnenfeld N, Perdue-Puli J, Hunt D, Brady PJ, McGann P, Grace E, Rodrick D, Drye E, Krumholz HM. Trends in Adverse Event Rates in Hospitalized Patients, 2010-2019. JAMA 2022, 328: 173-183. PMID: 35819424, PMCID: PMC9277501, DOI: 10.1001/jama.2022.9600.Peer-Reviewed Original ResearchMeSH KeywordsAccidental FallsAdultAgedAged, 80 and overCross InfectionCross-Sectional StudiesDrug-Related Side Effects and Adverse ReactionsFemaleHeart FailureHospitalizationHumansMaleMedicareMiddle AgedMyocardial InfarctionPatient SafetyPneumoniaPostoperative ComplicationsPressure UlcerRisk AssessmentSurgical Procedures, OperativeUnited StatesConceptsMajor surgical proceduresAcute myocardial infarctionAdverse event ratesGeneral adverse eventsAdverse eventsHeart failureAdverse drug eventsAcute care hospitalsMyocardial infarctionHospital-acquired infectionsSurgical proceduresEvent ratesHospital dischargeCare hospitalDrug eventsMedicare Patient Safety Monitoring SystemSerial cross-sectional studyPatient safetyUS acute care hospitalsHospital adverse eventsSignificant decreaseSurgical procedure groupsCross-sectional studyRisk-adjusted ratesAdult patientsAssociation of Neighborhood-Level Material Deprivation With Atrial Fibrillation Care in a Single-Payer Health Care System: A Population-Based Cohort Study
Abdel-Qadir H, Akioyamen LE, Fang J, Pang A, Ha ACT, Jackevicius CA, Alter DA, Austin PC, Atzema CL, Bhatia RS, Booth GL, Johnston S, Dhalla I, Kapral MK, Krumholz HM, McNaughton CD, Roifman I, Tu K, Udell JA, Wijeysundera HC, Ko DT, Schull MJ, Lee DS. Association of Neighborhood-Level Material Deprivation With Atrial Fibrillation Care in a Single-Payer Health Care System: A Population-Based Cohort Study. Circulation 2022, 146: 159-171. PMID: 35678171, PMCID: PMC9287095, DOI: 10.1161/circulationaha.122.058949.Peer-Reviewed Original ResearchConceptsYears of ageCohort studyUniversal health careAF-related adverse eventsNeighbourhood-level material deprivationPopulation-based cohort studyPrimary care physician visitsCause-specific hazards regressionRhythm control interventionsHigh cardiovascular disease burdenCardiovascular disease burdenHealth careAtrial fibrillation careNeighborhood material deprivationSingle-payer health care systemMaterial deprivation quintileAtrial fibrillation diagnosisHealth care systemNoncardiovascular comorbiditiesAdverse eventsHeart failurePhysician visitsHazards regressionAdverse outcomesDeprivation quintileAnalysis of Hospital-Level Readmission Rates and Variation in Adverse Events Among Patients With Pneumonia in the United States
Wang Y, Eldridge N, Metersky ML, Rodrick D, Faniel C, Eckenrode S, Mathew J, Galusha DH, Tasimi A, Ho SY, Jaser L, Peterson A, Normand ST, Krumholz HM. Analysis of Hospital-Level Readmission Rates and Variation in Adverse Events Among Patients With Pneumonia in the United States. JAMA Network Open 2022, 5: e2214586. PMID: 35639379, PMCID: PMC9157270, DOI: 10.1001/jamanetworkopen.2022.14586.Peer-Reviewed Original ResearchConceptsRisk-standardized readmission ratesMedicare Patient Safety Monitoring SystemCause readmission rateAdverse eventsReadmission ratesHigh riskHospital-level readmission ratesHigher patient riskHospital adverse eventsAdverse event dataCross-sectional studyHospital performanceIndex hospitalizationMedian ageHospital characteristicsMedical recordsReadmission dataPatient riskHospital careMAIN OUTCOMEPneumoniaHospital levelPatientsReadmissionGreater risk
2021
Toward Dynamic Risk Prediction of Outcomes After Coronary Artery Bypass Graft
Mori M, Durant TJS, Huang C, Mortazavi BJ, Coppi A, Jean RA, Geirsson A, Schulz WL, Krumholz HM. Toward Dynamic Risk Prediction of Outcomes After Coronary Artery Bypass Graft. Circulation Cardiovascular Quality And Outcomes 2021, 14: e007363. PMID: 34078100, PMCID: PMC8635167, DOI: 10.1161/circoutcomes.120.007363.Peer-Reviewed Original ResearchConceptsCoronary artery bypass graftArtery bypass graftIntraoperative variablesBypass graftLogistic regression modelsOperative mortalityC-statisticCoronary artery bypass graft casesThoracic Surgeons Adult Cardiac Surgery DatabaseAdult Cardiac Surgery DatabaseMean patient ageGood c-statisticCardiac Surgery DatabaseBrier scoreRisk restratificationDynamic risk predictionIntraoperative deathsPostoperative complicationsPostoperative eventsAdverse eventsPatient agePreoperative variablesRegression modelsGraft casesSurgery Database
2020
Association Between Medicare Expenditures and Adverse Events for Patients With Acute Myocardial Infarction, Heart Failure, or Pneumonia in the United States
Wang Y, Eldridge N, Metersky ML, Sonnenfeld N, Rodrick D, Fine JM, Eckenrode S, Galusha DH, Tasimi A, Hunt DR, Bernheim SM, Normand ST, Krumholz HM. Association Between Medicare Expenditures and Adverse Events for Patients With Acute Myocardial Infarction, Heart Failure, or Pneumonia in the United States. JAMA Network Open 2020, 3: e202142. PMID: 32259263, PMCID: PMC7139276, DOI: 10.1001/jamanetworkopen.2020.2142.Peer-Reviewed Original ResearchConceptsAcute myocardial infarctionMedicare Patient Safety Monitoring SystemAdverse event ratesAdverse eventsHeart failureMedicare expendituresService patientsMyocardial infarctionMedicare feeEvent ratesHigher adverse event ratesCare expendituresRisk-standardized ratesPatients 65 yearsAdverse event dataAcute care hospitalsCross-sectional studyFinal study sampleInpatient care expendituresRate of occurrenceDates of analysisPatient characteristicsCare hospitalMean ageInpatient careAttribution 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 treatment
2019
Myocardial infarction with non-obstructive coronary arteries as compared with myocardial infarction and obstructive coronary disease: outcomes in a Medicare population
Dreyer RP, Tavella R, Curtis JP, Wang Y, Pauspathy S, Messenger J, Rumsfeld JS, Maddox TM, Krumholz HM, Spertus JA, Beltrame JF. Myocardial infarction with non-obstructive coronary arteries as compared with myocardial infarction and obstructive coronary disease: outcomes in a Medicare population. European Heart Journal 2019, 41: 870-878. PMID: 31222249, PMCID: PMC7778433, DOI: 10.1093/eurheartj/ehz403.Peer-Reviewed Original ResearchConceptsMajor adverse cardiac eventsAcute myocardial infarctionHeart failureMyocardial infarctionCoronary angiographyComponents of MACENational Cardiovascular Data Registry CathPCI RegistryNon-obstructive coronary arteriesObstructive coronary artery diseaseAdverse cardiac eventsMajor adverse eventsObservational cohort studyObstructive coronary diseasePrognosis of patientsCoronary artery diseaseMACE componentsMINOCA patientsAdjusted riskCause mortalityPrimary endpointSecondary endpointsAdverse eventsCardiac eventsCathPCI RegistryCohort studyDigoxin 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 trendsAssociation Between Medication Adherence and 1‐Year Major Cardiovascular Adverse Events After Acute Myocardial Infarction in China
Shang P, Liu GG, Zheng X, Ho PM, Hu S, Li J, Jiang Z, Li X, Bai X, Gao Y, Xing C, Wang Y, Normand S, Krumholz HM. Association Between Medication Adherence and 1‐Year Major Cardiovascular Adverse Events After Acute Myocardial Infarction in China. Journal Of The American Heart Association 2019, 8: e011793. PMID: 31057004, PMCID: PMC6512098, DOI: 10.1161/jaha.118.011793.Peer-Reviewed Original ResearchConceptsAcute myocardial infarctionMedication adherencePoor adherenceGood adherenceAdverse eventsMyocardial infarctionGuideline-directed medical therapyMajor cardiovascular adverse eventsCardiovascular adverse eventsCardiovascular event riskLow education levelMore comorbiditiesCardiovascular eventsCardiovascular medicationsSecondary preventionCommon medicationsMedical therapyAMI outcomesAMI patientsCommon reasonCox modelLower riskMedicationsPatientsEvent riskEducation level and outcomes after acute myocardial infarction in China
Huo X, Khera R, Zhang L, Herrin J, Bai X, Wang Q, Lu Y, Nasir K, Hu S, Li J, Li X, Zheng X, Masoudi FA, Spertus JA, Krumholz HM, Jiang L. Education level and outcomes after acute myocardial infarction in China. Heart 2019, 105: 946. PMID: 30661037, PMCID: PMC6582708, DOI: 10.1136/heartjnl-2018-313752.Peer-Reviewed Original ResearchConceptsMajor adverse cardiovascular eventsLow educational attainmentAcute myocardial infarction (AMI) outcomesAdverse cardiovascular eventsFuture healthcare interventionsMyocardial infarction outcomesCardiovascular risk factorsRisk-adjusted analysisAcute myocardial infarctionMedian participant ageCardiovascular eventsCause mortalityAdverse eventsConsecutive patientsAMI outcomesChina PatientUnadjusted analysesMyocardial infarctionRisk factorsChinese cohortHigh riskEducational attainmentEducational attainment groupsHealthcare interventionsPatients
2018
Is Posthospital Syndrome a Result of Hospitalization-Induced Allostatic Overload?
Goldwater DS, Dharmarajan K, McEwan BS, Krumholz HM. Is Posthospital Syndrome a Result of Hospitalization-Induced Allostatic Overload? Journal Of Hospital Medicine 2018, 13 PMID: 29813141, DOI: 10.12788/jhm.2986.Peer-Reviewed Original ResearchConceptsPosthospital syndromeAllostatic overloadAutonomic nervous systemMultiple organ systemsHospital dischargeInflammatory markersAdverse eventsHospital readmissionAdrenal axisAdverse outcomesPlausible etiologyPathophysiologic consequencesElevated riskNervous systemNarrative reviewOrgan systemsEnhanced vulnerabilityElevated levelsHospital environmentTraditional hospital environmentSyndromeMaladaptive statesOverloadOutcomesPossible mechanism
2017
Prediction of Adverse Events in Patients Undergoing Major Cardiovascular Procedures
Mortazavi B, Desai N, Zhang J, Coppi A, Warner F, Krumholz H, Negahban S. Prediction of Adverse Events in Patients Undergoing Major Cardiovascular Procedures. IEEE Journal Of Biomedical And Health Informatics 2017, 21: 1719-1729. PMID: 28287993, DOI: 10.1109/jbhi.2017.2675340.Peer-Reviewed Original ResearchConceptsMajor cardiovascular proceduresElectronic health recordsRespiratory failureAdverse eventsCardiovascular proceduresYale-New Haven HospitalPostoperative respiratory failurePatient cohortHospital costsPatient outcomesSpecific patientPatientsHealth recordsCohort-specific modelsCharacteristic curveInfectionFailureHospitalCohortCliniciansComparison 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
Association Between Hospital Performance on Patient Safety and 30‐Day Mortality and Unplanned Readmission for Medicare Fee‐for‐Service Patients With Acute Myocardial Infarction
Wang Y, Eldridge N, Metersky ML, Sonnenfeld N, Fine JM, Pandolfi MM, Eckenrode S, Bakullari A, Galusha DH, Jaser L, Verzier NR, Nuti SV, Hunt D, Normand S, Krumholz HM. Association Between Hospital Performance on Patient Safety and 30‐Day Mortality and Unplanned Readmission for Medicare Fee‐for‐Service Patients With Acute Myocardial Infarction. Journal Of The American Heart Association 2016, 5: e003731. PMID: 27405808, PMCID: PMC5015406, DOI: 10.1161/jaha.116.003731.Peer-Reviewed Original ResearchMeSH KeywordsAgedAged, 80 and overCause of DeathCenters for Medicare and Medicaid Services, U.S.Fee-for-Service PlansFemaleHospitalsHospitals, RuralHospitals, VoluntaryHumansMaleMedicareMortalityMyocardial InfarctionPatient ReadmissionPatient SafetyPrognosisUnited StatesUnited States Agency for Healthcare Research and QualityConceptsAcute myocardial infarctionUnplanned readmission rateMedicare Patient Safety Monitoring SystemRisk-standardized mortalityAdverse eventsReadmission ratesService patientsMedicare feeUnplanned readmissionMyocardial infarctionMedicare patientsPatient safetyHospital performanceMore adverse eventsAdverse event ratesAcute care hospitalsPatient safety dataHospital mortalityAdverse event measuresCause mortalityOccurrence rateCare hospitalHospital characteristicsReadmission dataPatient safety performance