How do Orthopaedic Devices Change After Their Initial FDA Premarket Approval?
Samuel AM, Rathi VK, Grauer JN, Ross JS. How do Orthopaedic Devices Change After Their Initial FDA Premarket Approval? Clinical Orthopaedics And Related Research® 2015, 474: 1053-1068. PMID: 26584802, PMCID: PMC4773325, DOI: 10.1007/s11999-015-4634-x.Peer-Reviewed Original ResearchMeSH KeywordsCross-Sectional StudiesDatabases, FactualDevice ApprovalEquipment DesignHumansMedical Device RecallsOrthopedic EquipmentOrthopedic ProceduresPatient SafetyProduct Surveillance, PostmarketingRetrospective StudiesRisk FactorsSafety-Based Medical Device WithdrawalsTime FactorsUnited StatesUnited States Food and Drug AdministrationDifferences in Colonoscopy Quality Among Facilities: Development of a Post-Colonoscopy Risk-Standardized Rate of Unplanned Hospital Visits
Ranasinghe I, Parzynski CS, Searfoss R, Montague J, Lin Z, Allen J, Vender R, Bhat K, Ross JS, Bernheim S, Krumholz HM, Drye EE. Differences in Colonoscopy Quality Among Facilities: Development of a Post-Colonoscopy Risk-Standardized Rate of Unplanned Hospital Visits. Gastroenterology 2015, 150: 103-113. PMID: 26404952, DOI: 10.1053/j.gastro.2015.09.009.Peer-Reviewed Original ResearchConceptsUnplanned hospital visitsDay of colonoscopyHospital visitsOutpatient facilitiesColonoscopy qualityHealthcare costsRisk-standardized ratesHospital outpatient departmentsUtilization Project dataAmbulatory surgery centersLogistic regression modelsHierarchical logistic regressionQuality improvement effortsPrior arrhythmiaAbdominal painElectrolyte imbalanceOutpatient departmentSurgery centersCommon causeHospital careOutcome measuresPsychiatric disordersColonoscopyUtilization ProjectPatient choiceEfficacy And Safety Concerns Are Important Reasons Why The FDA Requires Multiple Reviews Before Approval Of New Drugs
Ross JS, Dzara K, Downing NS. Efficacy And Safety Concerns Are Important Reasons Why The FDA Requires Multiple Reviews Before Approval Of New Drugs. Health Affairs 2015, 34: 681-688. PMID: 25847652, DOI: 10.1377/hlthaff.2014.1160.Peer-Reviewed Original Research