2019
Validating the use of registries and claims data to support randomized trials: Rationale and design of the Extending Trial-Based Evaluations of Medical Therapies Using Novel Sources of Data (EXTEND) Study
Strom JB, Tamez H, Zhao Y, Valsdottir LR, Curtis J, Brennan JM, Shen C, Popma JJ, Mauri L, Yeh RW. Validating the use of registries and claims data to support randomized trials: Rationale and design of the Extending Trial-Based Evaluations of Medical Therapies Using Novel Sources of Data (EXTEND) Study. American Heart Journal 2019, 212: 64-71. PMID: 30953936, PMCID: PMC6535119, DOI: 10.1016/j.ahj.2019.02.007.Peer-Reviewed Original ResearchMeSH KeywordsAged, 80 and overDatabases, FactualDual Anti-Platelet TherapyElectronic Health RecordsFemaleHumansMaleMyocardial IschemiaMyocardial RevascularizationRandomized Controlled Trials as TopicRegistriesReproducibility of ResultsConceptsMedical therapyDual Antiplatelet Therapy StudyEnd pointEnd-point eventsClinical trial programEfficacy of therapyPatient-level dataClinical trial dataHealth system dataUse of registriesNew medical treatmentsProcedural registryRandomized trialsClaims databasePatient populationNational registryAdministrative claimsOutcome dataMedical treatmentTrial programTrial dataRegistryTrial informationTherapy studiesTrial results
2013
Survival of Patients Receiving a Primary Prevention Implantable Cardioverter-Defibrillator in Clinical Practice vs Clinical Trials
Al-Khatib SM, Hellkamp A, Bardy GH, Hammill S, Hall WJ, Mark DB, Anstrom KJ, Curtis J, Al-Khalidi H, Curtis LH, Heidenreich P, Peterson ED, Sanders G, Clapp-Channing N, Lee KL, Moss AJ. Survival of Patients Receiving a Primary Prevention Implantable Cardioverter-Defibrillator in Clinical Practice vs Clinical Trials. JAMA 2013, 309: 55-62. PMID: 23280225, PMCID: PMC3638257, DOI: 10.1001/jama.2012.157182.Peer-Reviewed Original ResearchConceptsPrimary prevention ICDsPrimary prevention clinical trialsTrial-eligible patientsSurvival of patientsPrevention clinical trialsClinical trialsICD RegistrySCD-HeFTClinical practiceRegistry patientsMADIT-IISimilar patientsNational Cardiovascular Data Registry ICD RegistryPrimary prevention implantable cardioverter defibrillatorsSurvival rateImplantable cardioverter-defibrillator therapyMADIT II criteriaMADIT II patientsSCD-HeFT criteriaCardioverter-defibrillator therapyClinical trial patientsLarge national registryRandomized clinical trialsProportional hazards modelImplantable cardioverter defibrillator
2004
Efficacy and safety of two unfractionated heparin dosing strategies with tenecteplase in acute myocardial infarction (results from Assessment of the Safety and Efficacy of a New Thrombolytic Regimens 2 and 3)
Curtis JP, Alexander JH, Huang Y, Wallentin L, Verheugt FW, Armstrong PW, Krumholz HM, Van de Werf F, Danays T, Cheeks M, Granger CB, Investigators A. Efficacy and safety of two unfractionated heparin dosing strategies with tenecteplase in acute myocardial infarction (results from Assessment of the Safety and Efficacy of a New Thrombolytic Regimens 2 and 3). The American Journal Of Cardiology 2004, 94: 279-283. PMID: 15276088, DOI: 10.1016/j.amjcard.2004.04.019.Peer-Reviewed Original ResearchMeSH KeywordsAgedConfidence IntervalsDose-Response Relationship, DrugDrug Administration ScheduleDrug Therapy, CombinationElectrocardiographyFemaleFollow-Up StudiesHeparin, Low-Molecular-WeightHumansIncidenceIntracranial HemorrhagesMaleMiddle AgedMultivariate AnalysisMyocardial InfarctionMyocardial IschemiaPartial Thromboplastin TimeProbabilityRandomized Controlled Trials as TopicRisk AssessmentSeverity of Illness IndexSurvival RateTenecteplaseThrombolytic TherapyTissue Plasminogen ActivatorTreatment OutcomeConceptsWeight-adjusted heparinST-elevation myocardial infarctionASSENT-3Myocardial infarctionASSENT-2Major bleedingIntracranial hemorrhageSmall doseFull-dose tenecteplaseLess major bleedingNew thrombolytic regimenOutcomes of patientsAcute myocardial infarctionPartial thromboplastin timeSimilar ratesRefractory ischemiaThrombolytic regimenRecurrent infarctionBaseline characteristicsHemorrhagic complicationsUnfractionated heparinThromboplastin timePatientsInfarctionTenecteplaseModulation of the renin-angiotensin-aldosterone system for the secondary prevention of stroke
Sokol SI, Portnay EL, Curtis JP, Nelson MA, Hebert PR, Setaro JF, Foody JM. Modulation of the renin-angiotensin-aldosterone system for the secondary prevention of stroke. Neurology 2004, 63: 208-213. PMID: 15277610, DOI: 10.1212/01.wnl.0000130360.21618.d0.Peer-Reviewed Original ResearchMeSH KeywordsAgedAngiotensin-Converting Enzyme InhibitorsAnimalsBrainChronic DiseaseDouble-Blind MethodDrug Evaluation, PreclinicalEndothelium, VascularFibrinolysisHemostasisHumansInflammationMiddle AgedNerve RegenerationRandomized Controlled Trials as TopicRatsReceptor, Angiotensin, Type 1Receptor, Angiotensin, Type 2Renin-Angiotensin SystemSecondary PreventionStrokeTreatment OutcomeConceptsRenin angiotensin aldosterone systemRAAS modulationRecurrent strokeAldosterone systemCerebrovascular eventsStroke preventionSecondary preventionACE inhibitorsCerebrovascular diseaseAngiotensin II type 1 receptor blocker therapiesBlood pressure-independent mechanismsMajor public health concernReceptor blocker therapyRecurrent cerebrovascular eventsRecurrent stroke preventionAngiotensin aldosterone systemBlood pressure reductionSecondary stroke preventionRecurrent cardiac eventsPressure-independent mechanismsVascular structural changesOngoing clinical trialsNew treatment strategiesPublic health concernBlocker therapy
2002
β-Blocker Therapy and Symptoms of Depression, Fatigue, and Sexual Dysfunction
Ko DT, Hebert PR, Coffey CS, Sedrakyan A, Curtis JP, Krumholz HM. β-Blocker Therapy and Symptoms of Depression, Fatigue, and Sexual Dysfunction. JAMA 2002, 288: 351-357. PMID: 12117400, DOI: 10.1001/jama.288.3.351.Peer-Reviewed Original ResearchMeSH KeywordsAdrenergic beta-AntagonistsCardiovascular AgentsDepressionFatigueFemaleHeart FailureHumansHypertensionMaleMyocardial InfarctionRandomized Controlled Trials as TopicRiskSexual Dysfunction, PhysiologicalConceptsBeta-blocker therapySexual dysfunctionDepressive symptomsSymptoms of depressionAdverse eventsHeart failureMyocardial infarctionSignificant annual increaseAdditional reportsLipid solubilityAdverse effectsWithdrawal of therapyΒ-blocker therapyPatient-reported symptomsNumber of patientsEnglish-language articlesInclusion of trialsPlacebo groupMortality benefitRandomized trialsStudy treatmentCardiac patientsPlacebo controlRisk of fatigueClinical trials