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 ResearchConceptsNovel 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
2005
The Year in Epidemiology, Health Services, and Outcomes Research
Krumholz HM. The Year in Epidemiology, Health Services, and Outcomes Research. Journal Of The American College Of Cardiology 2005, 46: 1362-1370. PMID: 16198857, DOI: 10.1016/j.jacc.2005.06.060.Peer-Reviewed Original Research
2000
Role of Exercise Stress Testing and Safety Monitoring for Older Persons Starting an Exercise Program
Gill TM, DiPietro L, Krumholz HM. Role of Exercise Stress Testing and Safety Monitoring for Older Persons Starting an Exercise Program. JAMA 2000, 284: 342-349. PMID: 10891966, DOI: 10.1001/jama.284.3.342.Peer-Reviewed Original ResearchConceptsExercise stress testingAdverse cardiac eventsExercise programOlder personsCardiac eventsStress testingPhysical activityRoutine exercise stress testingSedentary older personsSymptomatic cardiovascular diseasePharmacological stress testingCurrent physician practiceRelative exercise intensityMajority of personsUnproven benefitPhysical functionCurrent guidelinesCardiovascular diseaseExercise intensityPhysician practicesSafety monitoringRiskExercisePersonsTesting