2025
Medical therapy and outcomes in REVIVED-BCIS2 and STICHES: an individual patient data analysis
Ryan M, Petrie M, Kontopantelis E, Dodd M, Tong G, Marquis-Gravel G, Docherty K, Clayton T, Lansky A, Mamas M, Rouleau J, Velazquez E, Perera D. Medical therapy and outcomes in REVIVED-BCIS2 and STICHES: an individual patient data analysis. European Heart Journal 2025, 46: 2052-2062. PMID: 40048661, PMCID: PMC12146480, DOI: 10.1093/eurheartj/ehaf080.Peer-Reviewed Original ResearchCoronary Artery Bypass GraftingPercutaneous coronary interventionMedical therapyPrimary outcome eventFollow-upPrimary outcomePatients treated with coronary artery bypass graftingOutcome eventsIndividual patient data analysisCoronary artery bypass graft surgeryIschaemic left ventricular dysfunctionMedian Follow-UpMulticentre randomized trialLeft ventricular dysfunctionOutcomes of patientsBenefit of coronary artery bypass graftingCompleteness of follow-upArtery Bypass GraftingCoronary artery diseasePatient data analysisIschaemic cardiomyopathyVentricular dysfunctionSurgical treatmentHeart failurePooled analysis
2023
Borderzone Infarcts and Recurrent Cerebrovascular Events in Symptomatic Intracranial Arterial Stenosis: A Systematic Review and Meta-Analysis
Das S, Shu L, Morgan R, Shah A, Fayad F, Goldstein E, Chahien D, Maglinger B, Bokka S, Owens C, Abbasi M, Kvernland A, Siegler J, Mac Grory B, Nguyen T, Furie K, Khatri P, Mistry E, Prabhakaran S, Liebeskind D, Romano J, de Havenon A, Palaiodimou L, Tsivgoulis G, Yaghi S. Borderzone Infarcts and Recurrent Cerebrovascular Events in Symptomatic Intracranial Arterial Stenosis: A Systematic Review and Meta-Analysis. Journal Of Stroke 2023, 25: 223-232. PMID: 37282372, PMCID: PMC10250880, DOI: 10.5853/jos.2023.00185.Peer-Reviewed Original ResearchBorderzone infarctsIntracranial arterial stenosisRisk ratioNeurological deteriorationSystematic reviewRecurrent strokeInfarct patternsArterial stenosisAnterior circulation stroke patientsSymptomatic intracranial arterial stenosisRecurrent cerebrovascular eventsPosterior circulation strokeSymptomatic ICACerebrovascular eventsStroke recurrenceTerritorial infarctsDistal perfusionRecurrence rateStroke patientsSubgroup analysisThrombus embolizationOutcome eventsPlaque progressionInclusion criteriaHigh risk
2022
Choice and application of time scale selection for Cox proportional hazards regression model in cohort studies
Li Z, Shen Q, Tuo J, Tang D, Xiao Y, Zhao L, Xiang Y. Choice and application of time scale selection for Cox proportional hazards regression model in cohort studies. Chinese Journal Of Epidemiology 2022, 43: 2002-2007. PMID: 36572476, DOI: 10.3760/cma.j.cn112338-20220720-00644.Peer-Reviewed Original ResearchConceptsCohort study dataCox proportional hazards regression modelsProportional hazards regression modelsHazards regression modelsShanghai Women's Health StudyCox modelRisk of liver cancerWomen's Health StudyRegression modelsStudy dataHealth StudyCentral obesityData analysisCohort studyTime-to-event data analysisCoxOutcome eventsTime scalesLiver cancerResidual stroke risk despite oral anticoagulation in patients with atrial fibrillation
Carlisle M, Shrader P, Fudim M, Pieper K, Blanco R, Fonarow G, Naccarelli G, Gersh B, Reiffel J, Kowey P, Steinberg B, Freeman J, Ezekowitz M, Singer D, Allen L, Chan P, Pokorney S, Peterson E, Piccini J, Patients and Investigators O. Residual stroke risk despite oral anticoagulation in patients with atrial fibrillation. Heart Rhythm O2 2022, 3: 621-628. PMID: 36589908, PMCID: PMC9795305, DOI: 10.1016/j.hroo.2022.09.018.Peer-Reviewed Original ResearchTransient ischemic attackPermanent atrial fibrillationOral anticoagulationAtrial fibrillationVASc scoreIschemic attackThromboembolic eventsFemale sexPrevious stroke/transient ischemic attackStroke/transient ischemic attackTransient ischemic attack eventsCox proportional hazard modelingResidual riskResidual stroke riskBetter Informed TreatmentRisk of thromboembolismProportional hazard modelingSystemic embolismPrevious strokeStroke riskOutcomes RegistryMean ageRisk markersOutcome eventsThromboembolismCentral vs site outcome adjudication in the IRIS trial
Forman R, Viscoli CM, Bath PM, Furie KL, Guarino P, Inzucchi SE, Young L, Kernan WN. Central vs site outcome adjudication in the IRIS trial. Journal Of Stroke And Cerebrovascular Diseases 2022, 31: 106667. PMID: 35901589, DOI: 10.1016/j.jstrokecerebrovasdis.2022.106667.Peer-Reviewed Original ResearchConceptsCentral adjudicationHazard ratioStroke definitionsRecent transient ischemic attackInsulin Resistance InterventionMain secondary outcomesShorter symptom durationTransient ischemic attackPrevention of strokeNormal brain imagingClinical trial researchIschemic attackIschemic strokeSecondary outcomesSymptom durationPrimary outcomeStroke trialsIRIS trialMyocardial infarctionOutcome definitionsStroke typeOutcome eventsAdjudicated eventsOutcome adjudicationResistance Intervention
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 infectionComparison of Cardiovascular and Safety Outcomes of Chlorthalidone vs Hydrochlorothiazide to Treat Hypertension
Hripcsak G, Suchard MA, Shea S, Chen R, You SC, Pratt N, Madigan D, Krumholz HM, Ryan PB, Schuemie MJ. Comparison of Cardiovascular and Safety Outcomes of Chlorthalidone vs Hydrochlorothiazide to Treat Hypertension. JAMA Internal Medicine 2020, 180: 542-551. PMID: 32065600, PMCID: PMC7042845, DOI: 10.1001/jamainternmed.2019.7454.Peer-Reviewed Original ResearchConceptsComposite outcome eventsHeart failureMyocardial infarctionOutcome eventsSafety outcomesComposite cardiovascular disease outcomeLarge-scale Evidence GenerationType 2 diabetes mellitusSignificant cardiovascular benefitsAcute renal failureAbnormal weight gainChronic kidney diseaseComposite cardiovascular outcomeFirst-line therapyAdministrative claims databaseComparative cohort studyCardiovascular disease outcomesSudden cardiac deathInpatient care episodesAcute myocardial infarctionPropensity score stratificationComparison of CardiovascularElectronic health recordsAntihypertensive monotherapyChlorthalidone use
2018
The Competing Risk of Death in Longitudinal Geriatric Outcomes
Murphy TE, Gill TM, Leo‐Summers L, Gahbauer EA, Pisani MA, Ferrante LE. The Competing Risk of Death in Longitudinal Geriatric Outcomes. Journal Of The American Geriatrics Society 2018, 67: 357-362. PMID: 30537050, PMCID: PMC6367003, DOI: 10.1111/jgs.15697.Peer-Reviewed Original ResearchConceptsFall-related hospitalizationsRisk of deathProspective cohort studyPersons 70 yearsLong-term followPrecipitating Events ProjectCommunity-based dataLongitudinal studyGeriatric outcomesCohort studyFried phenotypeFunctional recoveryTotal disabilityOutcome eventsDaily livingClinical scenariosSecondary analysisOlder personsVision impairmentDeathBasic activitiesOutcomesDisabilityDecedentsRiskImpact of Cardiovascular Risk on the Relative Benefit and Harm of Intensive Treatment of Hypertension
Phillips RA, Xu J, Peterson LE, Arnold RM, Diamond JA, Schussheim AE. Impact of Cardiovascular Risk on the Relative Benefit and Harm of Intensive Treatment of Hypertension. Journal Of The American College Of Cardiology 2018, 71: 1601-1610. PMID: 29525494, DOI: 10.1016/j.jacc.2018.01.074.Peer-Reviewed Original ResearchConceptsSignificant serious adverse eventsPrimary outcome eventIntensive treatment groupCVD riskOutcome eventsHarm ratioIntensive treatmentTreatment groupsTreatment guidelinesAmerican CollegeCardiology/American Heart AssociationFuture cardiovascular disease riskCox proportional hazards modelBaseline CVD riskQuartiles of baselineSerious adverse eventsBlood pressure treatmentCardiovascular disease riskAmerican Heart AssociationProportional hazards modelLower ratesSPRINT populationAdverse eventsCardiovascular riskPrimary outcome
2017
Approaches to Predicting Outcomes in Patients with Acute Kidney Injury
Saly D, Yang A, Triebwasser C, Oh J, Sun Q, Testani J, Parikh CR, Bia J, Biswas A, Stetson C, Chaisanguanthum K, Wilson FP. Approaches to Predicting Outcomes in Patients with Acute Kidney Injury. PLOS ONE 2017, 12: e0169305. PMID: 28122032, PMCID: PMC5266278, DOI: 10.1371/journal.pone.0169305.Peer-Reviewed Original ResearchConceptsAcute kidney injuryLength of stayKidney injuryReceiver operator characteristic curveOutcomes of interestOperator characteristic curveValidation cohortClinical eventsAccurate prognosticationOutcome eventsPredicting OutcomePrognostic modelDeath predictionLab valuesCharacteristic curveGood discrimination abilityPatientsStayInjuryDialysisModel discriminationOutcomesDaysMedicationsMorbidity
2016
Traditional and new composite endpoints in heart failure clinical trials: facilitating comprehensive efficacy assessments and improving trial efficiency
Anker SD, Schroeder S, Atar D, Bax JJ, Ceconi C, Cowie MR, Crisp A, Dominjon F, Ford I, Ghofrani H, Gropper S, Hindricks G, Hlatky MA, Holcomb R, Honarpour N, Jukema JW, Kim AM, Kunz M, Lefkowitz M, Le Floch C, Landmesser U, McDonagh TA, McMurray JJ, Merkely B, Packer M, Prasad K, Revkin J, Rosano GM, Somaratne R, Stough WG, Voors AA, Ruschitzka F. Traditional and new composite endpoints in heart failure clinical trials: facilitating comprehensive efficacy assessments and improving trial efficiency. European Journal Of Heart Failure 2016, 18: 482-489. PMID: 27071916, DOI: 10.1002/ejhf.516.Peer-Reviewed Original ResearchConceptsHeart failure clinical trialsComposite endpointClinical trialsNew composite endpointHeart failureHeart failure treatmentEffect of therapyHealth system perspectiveOverall treatment effectRepeat hospitalizationPlanned trialsFunctional statusFailure treatmentOutcome eventsPatient burdenEfficacy assessmentPatient experienceNew treatmentsTrialsAdverse effectsEfficiency of trialsEndpointTrial efficiencyTreatment effectsPrimary measure
2014
Incidental Pancreatic Cystic Lesions: Is There a Relationship with the Development of Pancreatic Adenocarcinoma and All-Cause Mortality?
Chernyak V, Flusberg M, Haramati L, Rozenblit A, Bellin E. Incidental Pancreatic Cystic Lesions: Is There a Relationship with the Development of Pancreatic Adenocarcinoma and All-Cause Mortality? Radiology 2014, 274: 161-9. PMID: 25117591, PMCID: PMC4334243, DOI: 10.1148/radiol.14140796.Peer-Reviewed Original ResearchConceptsIncidental pancreatic cystsPancreatic cystsPancreatic adenocarcinomaInitial CTCharlson scoreHazard ratioMR examinationsTertiary care medical centerMR imagingRespective mean agesPancreatic ductal adenocarcinomaCox hazard modelInstitutional review boardMagnetic resonanceCause mortalityOverall mortalityAbdominal CTMean agePancreatic cancerDuctal adenocarcinomaHospital databaseOutcome eventsMedical CenterStudy populationHazards model
2003
Efficient Bayesian Sample Size Calculation for Designing a Clinical Trial with Multi‐Cluster Outcome Data
Zou K, Resnic F, Gogate A, Ondategui‐Parra S, Ohno‐Machado L. Efficient Bayesian Sample Size Calculation for Designing a Clinical Trial with Multi‐Cluster Outcome Data. Biometrical Journal 2003, 45: 826-836. DOI: 10.1002/bimj.200390052.Peer-Reviewed Original ResearchBayesian methodsSample size calculation methodBeta prior distributionBeta-binomial modelBayesian beta-binomial modelBayesian sample size calculationsPrior distributionSample size calculationNecessary sample sizePosterior intervalsHierarchical data structureMain outcome eventPercutaneous coronary interventionHealth care utilizationLength criterionSize calculationCoronary interventionCare utilizationMajor complicationsClinical trialsOutcome eventsOutcome dataOutcome studiesCalculation methodHealth providers
1999
Drugs and Falls in Older People: A Systematic Review and Meta‐analysis: I. Psychotropic Drugs
Leipzig R, Cumming R, Tinetti M. Drugs and Falls in Older People: A Systematic Review and Meta‐analysis: I. Psychotropic Drugs. Journal Of The American Geriatrics Society 1999, 47: 30-39. PMID: 9920227, DOI: 10.1111/j.1532-5415.1999.tb01898.x.Peer-Reviewed Original ResearchConceptsPsychotropic drugsNeuroleptic useOlder peopleLong acting benzodiazepinesDuration of therapyIncidence of fallsNumber of fallersAdverse outcome eventsPooled odds ratioEnglish-language articlesIncreased fallsAntidepressant useHypnotic useMore fallsActing benzodiazepineBenzodiazepine useMean agePsychotropic usePooled ORsOdds ratioOutcome eventsTCA useExclusion criteriaEligibility criteriaResponse rate
1998
Randomized trial of cerebrospinal fluid shunt valve design in pediatric hydrocephalus.
Drake J, Kestle J, Milner R, Cinalli G, Boop F, Piatt J, Haines S, Schiff S, Cochrane D, Steinbok P, MacNeil N. Randomized trial of cerebrospinal fluid shunt valve design in pediatric hydrocephalus. Neurosurgery 1998, 43: 294-303; discussion 303-5. PMID: 9696082, DOI: 10.1097/00006123-199808000-00068.Peer-Reviewed Original ResearchConceptsShunt obstructionDifferential pressure valvesShunt failurePediatric hydrocephalusCerebrospinal fluid shunt failuresCerebrospinal fluid shunt insertionTreatment failure rateShunt failure ratesOrbis-Sigma valvePediatric neurosurgical centersUpright positionCerebrospinal fluid shuntsIndependent case reviewShunt insertionCerebral ventricleDelta valvesHydrocephalic childrenFailure rateNeurosurgical centersOutcome eventsCase reviewPatientsObstructionShunt valveInfection
1995
Assessing Risk for the Onset of Functional Dependence Among Older Adults: The Role of Physical Performance
Gill T, Williams C, Tinetti M. Assessing Risk for the Onset of Functional Dependence Among Older Adults: The Role of Physical Performance. Journal Of The American Geriatrics Society 1995, 43: 603-609. PMID: 7775716, DOI: 10.1111/j.1532-5415.1995.tb07192.x.Peer-Reviewed Original ResearchConceptsCommunity-dwelling adultsBasic ADLPhysical performanceOlder adultsMain outcome eventTimed testsPhysical performance testsChair standNew disabilityBaseline interviewOutcome eventsCohort membersDaily livingHigh riskRepresentative cohortRate of dependenceOlder personsRisk assessment strategiesADLRapid gaitBasic activitiesComplete dataAdultsRiskOnsetSex differences in mortality after myocardial infarction. Is there evidence for an increased risk for women?
Vaccarino V, Krumholz H, Berkman L, Horwitz R. Sex differences in mortality after myocardial infarction. Is there evidence for an increased risk for women? Circulation 1995, 91: 1861-71. PMID: 7882498, DOI: 10.1161/01.cir.91.6.1861.Peer-Reviewed Original ResearchConceptsMyocardial infarctionMortality rateIncreased early mortalitySex differencesUnadjusted mortality ratesHigh mortality rateEnglish-language literatureEarly phaseImproved survivalPatient seriesEarly mortalityFemale sexRisk factorsOutcome eventsCrude rateMEDLINE searchInfarctionSurvival rateOlder ageMortalityWomenAgeMenNumber of studiesLower survival
1993
Analysis as‐randomized and the problem of non‐adherence: An example from the veterans affairs randomized trial of coronary artery bypass surgery
Peduzzi P, Wittes J, Detre K, Holford T. Analysis as‐randomized and the problem of non‐adherence: An example from the veterans affairs randomized trial of coronary artery bypass surgery. Statistics In Medicine 1993, 12: 1185-1195. PMID: 8210821, DOI: 10.1002/sim.4780121302.Peer-Reviewed Original ResearchConceptsCoronary artery bypass surgeryArtery bypass surgeryTreatment groupsAlternative treatment groupBypass surgeryTreatment changesVeterans Administration Cooperative StudyTime of randomizationRandomized clinical trialsTreat analysisClinical trialsOutcome eventsRandom treatment assignmentCooperative StudyVeterans AffairsTreatment assignmentTherapySurgeryTrialsGroupPatients
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