2015
Characteristics of Clinical Studies Conducted Over the Total Product Life Cycle of High-Risk Therapeutic Medical Devices Receiving FDA Premarket Approval in 2010 and 2011
Rathi VK, Krumholz HM, Masoudi FA, Ross JS. Characteristics of Clinical Studies Conducted Over the Total Product Life Cycle of High-Risk Therapeutic Medical Devices Receiving FDA Premarket Approval in 2010 and 2011. JAMA 2015, 314: 604-612. PMID: 26262798, DOI: 10.1001/jama.2015.8761.Peer-Reviewed Original ResearchConceptsPrimary effectiveness end pointEffectiveness end pointPostmarket studiesClinical studiesClinical evidencePMA pathwayPremarket studiesEnd pointAvailable FDA documentsInitial marketing approvalPremarket approval pathwayTherapeutic devicesMedian durationMedian enrollmentHigh-risk medical devicesMAIN OUTCOMEPatientsDrug AdministrationUS FoodFDA approvalMarketing approvalLonger durationFDA documentsMonthsPostmarket
2012
Duration of resuscitation efforts and survival after in-hospital cardiac arrest: an observational study
Goldberger ZD, Chan PS, Berg RA, Kronick SL, Cooke CR, Lu M, Banerjee M, Hayward RA, Krumholz HM, Nallamothu BK, Investigators F. Duration of resuscitation efforts and survival after in-hospital cardiac arrest: an observational study. The Lancet 2012, 380: 1473-1481. PMID: 22958912, PMCID: PMC3535188, DOI: 10.1016/s0140-6736(12)60862-9.Peer-Reviewed Original ResearchConceptsHospital cardiac arrestSpontaneous circulationCardiac arrestResuscitation attemptsMedian durationResuscitation effortsGuidelines-Resuscitation registryDuration of resuscitationRisk-adjusted survivalHigh-risk populationAmerican Heart AssociationPrimary endpointHospital dischargeHeart AssociationObservational studyPatientsUS hospitalsClinical Scholars ProgramSurvival rateHospitalResuscitationHigher survival rateSurvivalNational InstituteHigher likelihood
2009
What are covering doctors told about their patients? Analysis of sign-out among internal medicine house staff
Horwitz LI, Moin T, Krumholz HM, Wang L, Bradley EH. What are covering doctors told about their patients? Analysis of sign-out among internal medicine house staff. BMJ Quality & Safety 2009, 18: 248. PMID: 19651926, PMCID: PMC2722040, DOI: 10.1136/qshc.2008.028654.Peer-Reviewed Original Research