2012
Regulatory Review of Novel Therapeutics — Comparison of Three Regulatory Agencies
Downing NS, Aminawung JA, Shah ND, Braunstein JB, Krumholz HM, Ross JS. Regulatory Review of Novel Therapeutics — Comparison of Three Regulatory Agencies. New England Journal Of Medicine 2012, 366: 2284-2293. PMID: 22591257, PMCID: PMC3504361, DOI: 10.1056/nejmsa1200223.Peer-Reviewed Original ResearchConceptsNovel therapeutic agentsEuropean Medicines AgencyHealth CanadaTherapeutic agentsNew therapeutic agentsMedian lengthTherapeutic comparisonsDrug AdministrationMedicines AgencyNew drug applicationsPrescription Drug User Fee ActNovel therapeuticsDrug applicationFDAUnique agentUnited StatesTotal review timeFirst reviewRegulatory agenciesReview timeDaysAgentsReviewRegulatory reviewVast majority
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
2002
Representation of the elderly, women, and minorities in heart failure clinical trials.
Heiat A, Gross CP, Krumholz HM. Representation of the elderly, women, and minorities in heart failure clinical trials. JAMA Internal Medicine 2002, 162: 1682-8. PMID: 12153370, DOI: 10.1001/archinte.162.15.1682.Peer-Reviewed Original ResearchConceptsClinical trialsHF RCTsHeart failure clinical trialsCharacteristics of patientsSystolic ejection fractionFuture clinical trialsInvasive diagnostic testsCharacteristics of participantsType of interventionChronic HFHF trialsEjection fractionHF populationExclusion criteriaGeneralizability of evidenceRCTsAdditional trialsPatientsDiagnostic testsTrialsOriginal reportMore participantsPrincipal investigatorWomenPublication year