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
2017
Postmarket 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 ResearchMeSH KeywordsBiological ProductsCohort StudiesDrug ApprovalDrug-Related Side Effects and Adverse ReactionsHumansProduct Surveillance, PostmarketingRiskSafetyUnited StatesUnited States Food and Drug AdministrationConceptsNovel 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
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 ResearchMeSH KeywordsAlgorithmsCross InfectionDrug-Related Side Effects and Adverse ReactionsFemaleHeart FailureHospital MortalityHospitalizationHumansMaleMedicareMyocardial InfarctionPatient SafetyPneumoniaPoisson DistributionPostoperative ComplicationsSurgical Procedures, OperativeUnited StatesConceptsCongestive 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