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 devicesHospital COVID-19 Burden and Adverse Event Rates
Metersky M, Rodrick D, Ho S, Galusha D, Timashenka A, Grace E, Marshall D, Eckenrode S, Krumholz H. Hospital COVID-19 Burden and Adverse Event Rates. JAMA Network Open 2024, 7: e2442936. PMID: 39495512, PMCID: PMC11581512, DOI: 10.1001/jamanetworkopen.2024.42936.Peer-Reviewed Original ResearchConceptsCOVID-19 burdenHospital admissionPatient safetyRelative riskCohort studyStudy of hospital admissionsAcute care hospitalsRisk-adjustment variablesRisk-adjusted ratesMedicare hospital admissionsCOVID-19 pandemicStaffing shortagesHospital characteristicsMain OutcomesHospital resilienceSurge capacityMedicare patientsCare hospitalHighest burdenPrevent declinesPatient admissionsStudy sampleElixhauser comorbiditiesCOVID-19Low burdenModernizing Medical Device Regulation: Challenges and Opportunities for the 510(k) Clearance Process.
Kadakia K, Rathi V, Dhruva S, Ross J, Krumholz H. Modernizing Medical Device Regulation: Challenges and Opportunities for the 510(k) Clearance Process. Annals Of Internal Medicine 2024, 177: 1558-1565. PMID: 39374526, DOI: 10.7326/annals-24-00728.Peer-Reviewed Original ResearchClass I Recalls of Cardiovascular Devices Between 2013 and 2022 : A Cross-Sectional Analysis.
See C, Mooghali M, Dhruva S, Ross J, Krumholz H, Kadakia K. Class I Recalls of Cardiovascular Devices Between 2013 and 2022 : A Cross-Sectional Analysis. Annals Of Internal Medicine 2024, 177: 1499-1508. PMID: 39284187, DOI: 10.7326/annals-24-00724.Peer-Reviewed Original ResearchCross-sectional studyCross-sectional analysisAdverse health consequencesPatient safetyClinical testingClass IHealth consequencesClinical evidenceFDA summariesPostapproval studiesDecision summariesFood and Drug AdministrationU.S. Food and Drug AdministrationEnd-point selectionPremarket approvalMultiple class IClinical studiesPostmarketing surveillanceSummaryDrug AdministrationMedical device recall databaseRecallPatientsFDAPostmarketing
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 patients
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
2014
National Trends in Patient Safety for Four Common Conditions, 2005–2011
Wang Y, Eldridge N, Metersky ML, Verzier NR, Meehan TP, Pandolfi MM, Foody JM, Ho SY, Galusha D, Kliman RE, Sonnenfeld N, Krumholz HM, Battles J. National Trends in Patient Safety for Four Common Conditions, 2005–2011. New England Journal Of Medicine 2014, 370: 341-351. PMID: 24450892, PMCID: PMC4042316, DOI: 10.1056/nejmsa1300991.Peer-Reviewed Original ResearchConceptsCongestive heart failureAcute myocardial infarctionMore adverse eventsProportion of patientsAdverse event ratesAdverse eventsHeart failureMyocardial infarctionRate of occurrenceCommon medical conditionsMedical recordsMedicare patientsMedical conditionsPatientsSurgeryInfarctionPneumoniaHospitalizationPatient safetyNational trendsMonitoring System dataSignificant declineFailureProportionRate