2022
Development and validation of an automated algorithm for end point adjudication for a large U.S. national registry
Friedman DJ, Pierre D, Wang Y, Gambone L, Koutras C, Segawa C, Farb A, Vemulapalli S, Varosy PD, Masoudi FA, Lansky A, Curtis JP, Freeman JV. Development and validation of an automated algorithm for end point adjudication for a large U.S. national registry. American Heart Journal 2022, 254: 102-111. PMID: 36007567, DOI: 10.1016/j.ahj.2022.08.006.Peer-Reviewed Original ResearchConceptsEnd point adjudicationCEC adjudicationEnd pointLarge registriesClinical trialsNational Cardiovascular Data RegistryMajor vascular complicationsU.S. National RegistryPost-discharge eventsAgreement rateMajor bleedingNeurologic eventsVascular complicationsNational registryEvent adjudicationData registryRegistryCommittee's evaluationsPercent agreementGold standardAgreement thresholdHospitalTrialsFurther confirmationBleeding
2020
Clinical Outcome Event Adjudication in a 10-Year Prospective Study of Nucleos(t)ide Analogue Therapy for Chronic Hepatitis B
Lim JK, Chang AY, Zaman A, Martin P, Fernandez-Rodriguez CM, Korkmaz M, Rossi S, Ford JM, Noonan T, Cooney E, Navarro V, Colombato L. Clinical Outcome Event Adjudication in a 10-Year Prospective Study of Nucleos(t)ide Analogue Therapy for Chronic Hepatitis B. Journal Of Clinical And Translational Hepatology 2020, 8: 377-384. PMID: 33447520, PMCID: PMC7782110, DOI: 10.14218/jcth.2020.00039.Peer-Reviewed Original ResearchClinical outcome eventsHepatocellular carcinomaDiagnostic criteriaChronic hepatitis B virus infectionHepatitis B virus infectionPrimary study outcome measureHBV disease progressionNon-HCC malignanciesChronic hepatitis BB virus infectionStudy outcome measuresDisease progression eventsEvent adjudication committeePotential adverse effectsRandomized therapyAnalogue therapyHepatitis BProspective studyAdjudicated diagnosisAdjudication committeeMalignant neoplasmsDisease progressionEvent adjudicationOutcome eventsVirus infection
2019
Comparison of Clinical Trials and Administrative Claims to Identify Stroke Among Patients Undergoing Aortic Valve Replacement
Strom JB, Zhao Y, Faridi KF, Tamez H, Butala NM, Valsdottir LR, Curtis J, Brennan JM, Shen C, Boulware M, Popma JJ, Yeh RW. Comparison of Clinical Trials and Administrative Claims to Identify Stroke Among Patients Undergoing Aortic Valve Replacement. Circulation Cardiovascular Interventions 2019, 12: e008231. PMID: 31694411, PMCID: PMC7212938, DOI: 10.1161/circinterventions.119.008231.Peer-Reviewed Original ResearchMeSH KeywordsAdministrative Claims, HealthcareAgedAged, 80 and overAortic ValveAortic Valve StenosisBrain IschemiaClinical Trials as TopicDatabases, FactualFemaleHeart Valve Prosthesis ImplantationHumansIschemic Attack, TransientMaleMedicareRisk AssessmentRisk FactorsStrokeTime FactorsTranscatheter Aortic Valve ReplacementTreatment OutcomeUnited StatesConceptsNegative predictive valueAortic valve replacementCerebrovascular eventsInternational ClassificationPositive predictive valuePredictive valueValve replacementNinth RevisionClinical trialsTenth RevisionBilling codesKaplan-Meier estimatesMedicare inpatient claimsSURTAVI trialClinical event adjudicationDevastating complicationIschemic strokeNeurological eventsCerebrovascular diseaseBilling claimsInpatient claimsEvent adjudicationAdministrative claimsHigh riskTrial participantsProtocol for serious fall injury adjudication in the Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) study
Ganz DA, Siu AL, Magaziner J, Latham NK, Travison TG, Lorenze NP, Lu C, Wang R, Greene EJ, Stowe CL, Harvin LN, Araujo KLB, Gurwitz JH, Agrawal Y, Correa-De-Araujo R, Peduzzi P, Gill TM. Protocol for serious fall injury adjudication in the Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) study. Injury Epidemiology 2019, 6: 14. PMID: 31245263, PMCID: PMC6582694, DOI: 10.1186/s40621-019-0190-2.Peer-Reviewed Original ResearchSerious fall injuriesPrimary care providersFall injuriesPrimary outcomeMedical recordsMedical attentionFull-text medical recordsMulticenter pragmatic clinical trialHealth systemAdministrative dataMedical record reviewIndividualized care plansPragmatic clinical trialsPrimary care practicesMedical record dataParticipant's primary care providerUnderlying riskUS health systemOvernight hospitalizationRecord reviewHead injuryElders StudyClinical trialsEvent adjudicationJoint dislocation
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