2008
Validation of an Automated Safety Surveillance System with Prospective, Randomized Trial Data
Matheny M, Morrow D, Ohno-Machado L, Cannon C, Sabatine M, Resnic F. Validation of an Automated Safety Surveillance System with Prospective, Randomized Trial Data. Medical Decision Making 2008, 29: 247-256. PMID: 19015285, PMCID: PMC2743924, DOI: 10.1177/0272989x08327110.Peer-Reviewed Original ResearchMeSH KeywordsBayes TheoremData Interpretation, StatisticalDecision Support TechniquesFibrinolytic AgentsHumansIntracranial HemorrhagesMulticenter Studies as TopicMyocardial InfarctionRandomized Controlled Trials as TopicReproducibility of ResultsRetrospective StudiesSafety ManagementSentinel SurveillanceConceptsIntervention armMortality rateEvent ratesTrial BTrial AMajor bleeding ratesOutcomes Surveillance SystemIntracranial hemorrhage rateCumulative event rateRandomized trial dataEvent-rate analysisSafety surveillance systemSurveillance systemAdverse eventsMulticenter trialHemorrhage rateMonth 14Bleeding rateControl armClinical trialsTrial B.Trial dataTrialsObserved event ratesMonths
2005
Monitoring Device Safety in Interventional Cardiology
Matheny M, Ohno-Machado L, Resnic F. Monitoring Device Safety in Interventional Cardiology. Journal Of The American Medical Informatics Association 2005, 13: 180-187. PMID: 16357356, PMCID: PMC1447549, DOI: 10.1197/jamia.m1908.Peer-Reviewed Original Research
2004
Exploration of a Bayesian Updating Methodology to Monitor the Safety of Interventional Cardiovascular Procedures
Resnic F, Zou K, Do D, Apostolakis G, Ohno-Machado L. Exploration of a Bayesian Updating Methodology to Monitor the Safety of Interventional Cardiovascular Procedures. Medical Decision Making 2004, 24: 399-407. PMID: 15271278, DOI: 10.1177/0272989x04267012.Peer-Reviewed Original ResearchConceptsConventional statistical methodsPrior probability distributionProbability distributionStatistical methodsBayesian updatingMedical device safety evaluationStable estimatesPatient risk groupsInterventional cardiology proceduresInterventional cardiovascular proceduresBayesianClinical outcomesPatient groupRotational atherectomyRisk groupsCardiovascular proceduresClinical practiceMethodologyCardiology proceduresEstimationEvent ratesSafety experienceEstimation of riskFrameworkNovel approach