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
2007
Failure to Rescue
Horwitz LI, Cuny JF, Cerese J, Krumholz HM. Failure to Rescue. Medical Care 2007, 45: 283-287. PMID: 17496710, DOI: 10.1097/01.mlr.0000250226.33094.d4.Peer-Reviewed Original ResearchConceptsChart reviewQuality Patient Safety IndicatorsRetrospective chart reviewPatient safety indicatorsRate of deathAdministrative dataHospital complicationsComplication typePatient agePatient characteristicsPrimary outcomeNonsurgical casesInsurance statusComplicationsHealthcare ResearchPatientsMortalityConsortium institutionsAgeSafety indicatorsFailureReviewHospitalizationAdmissionCases
2005
The generalizability of observational data to elderly patients was dependent on the research question in a systematic review
Gross CP, Garg PP, Krumholz HM. The generalizability of observational data to elderly patients was dependent on the research question in a systematic review. Journal Of Clinical Epidemiology 2005, 58: 130-137. PMID: 15680745, DOI: 10.1016/j.jclinepi.2004.10.001.Peer-Reviewed Original ResearchConceptsCooperative Cardiovascular ProjectIntracranial hemorrhageSystematic reviewBeta-blocker useElderly patientsAngiography useCommunity patientsAtrial fibrillationRisk factorsObservational studyOutcome measuresRCT dataPresentation delayGlobal UtilizationT-PAPatientsSimilar predictorsTreatment variationStudy questionsCCP dataGUSTOHemorrhageReviewFibrillationAbsolute rate