2016
Gender differences in physical activity following acute myocardial infarction in adults: A prospective, observational study
Minges KE, Strait KM, Owen N, Dunstan DW, Camhi SM, Lichtman J, Geda M, Dreyer RP, Bueno H, Beltrame JF, Curtis JP, Krumholz HM. Gender differences in physical activity following acute myocardial infarction in adults: A prospective, observational study. European Journal Of Preventive Cardiology 2016, 24: 192-203. PMID: 27885060, DOI: 10.1177/2047487316679905.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAustraliaCardiac RehabilitationChi-Square DistributionExerciseExercise TherapyFemaleHealth BehaviorHealth Knowledge, Attitudes, PracticeHumansMaleMiddle AgedMyocardial InfarctionOdds RatioPatient ComplianceProspective StudiesRisk FactorsSex FactorsSpainTime FactorsTreatment OutcomeUnited StatesYoung AdultConceptsAcute myocardial infarctionPost-acute myocardial infarctionMyocardial infarctionPhysical activityRegular physical activity participationYoung AMI Patients (VIRGO) studyPhysical activity recommendationsAmerican Heart AssociationPhysical activity trajectoriesNon-white raceMyocardial infarction recoveryPhysical activity participationGender differencesHospital dischargeHeart AssociationLifestyle behaviorsActivity recommendationsObservational studyInfarctionAustralian hospitalsTargeted interventionsOne monthPatientsTime pointsLonger duration
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