2023
Comparison of two assessments of real‐world data and real‐world evidence for regulatory decision‐making
Yuan L, Rahman M, Concato J. Comparison of two assessments of real‐world data and real‐world evidence for regulatory decision‐making. Clinical And Translational Science 2023, 17: e13702. PMID: 38093484, PMCID: PMC10766019, DOI: 10.1111/cts.13702.Peer-Reviewed Original ResearchReal-world evidenceEuropean Medicines AgencyDrug approvalOpen-label extension studyNon-interventional studySingle-arm trialClinical trial implementationUnited States FoodInterventional trialsComparator armDrug AdministrationMedicines AgencyExtension studyStudy designUse of RWEStates FoodPharmacovigilance activitiesTrialsRegulatory agenciesApprovalLack of agreementTrial implementationLiterature reviewTherapeutic contextReal-world data
2013
Study Design and “Evidence” in Patient-oriented Research
Concato J. Study Design and “Evidence” in Patient-oriented Research. American Journal Of Respiratory And Critical Care Medicine 2013, 187: 1167-1172. PMID: 23725613, DOI: 10.1164/rccm.201303-0521oe.Peer-Reviewed Original ResearchConceptsRandomized trialsObservational studyPatient-oriented researchStudy designCritical care literatureEvidence-based medicineGeneral medicalCause-effect associationClinical careGold standard statusComparative effectivenessEvidence baseTrialsCare literatureIndividual studiesPatientsStudy resultsResearch designStudyMethodological designCareEvidence approach
2010
Observational Methods in Comparative Effectiveness Research
Concato J, Lawler EV, Lew RA, Gaziano JM, Aslan M, Huang GD. Observational Methods in Comparative Effectiveness Research. The American Journal Of Medicine 2010, 123: e16-e23. PMID: 21184862, DOI: 10.1016/j.amjmed.2010.10.004.Peer-Reviewed Original ResearchConceptsComparative effectiveness researchObservational studyGroup of patientsVeterans Health AdministrationEffectiveness researchSpecific medical conditionsPatient-oriented researchCorresponding study designPatient populationTreatment optionsMedical conditionsHealth AdministrationStudy designMedical ailmentsIndividual studiesAvailable optionsPatientsRCTsOptionsProminent featureStudyAdministrationTrials
2000
Randomized, Controlled Trials, Observational Studies, and the Hierarchy of Research Designs
Concato J, Shah N, Horwitz R. Randomized, Controlled Trials, Observational Studies, and the Hierarchy of Research Designs. New England Journal Of Medicine 2000, 342: 1887-1892. PMID: 10861325, PMCID: PMC1557642, DOI: 10.1056/nejm200006223422507.Peer-Reviewed Original ResearchConceptsCase-control studyObservational studyBacille Calmette-Guérin (BCG) vaccineCalmette-Guérin vaccineRandomized clinical trialsClinical topicsIndividual observational studiesEffect of vaccinationEffect of treatmentMEDLINE data baseActive tuberculosisControlled TrialsPercent confidence intervalsClinical trialsOdds ratioRelative riskSummary estimatesMajor medical journalsSame interventionTrialsResearch designConfidence intervalsHigh gradeTreatment effectsOriginal report
1993
Therapies for Benign Prostatic Hyperplasia
Concato J, Horwitz R, Feinstein A, Elmore J, Schiff S. Therapies for Benign Prostatic Hyperplasia. JAMA 1993, 269: 867-867. PMID: 7678874, DOI: 10.1001/jama.1993.03500070047017.Peer-Reviewed Original ResearchConceptsBenign prostatic hyperplasiaProstatic hyperplasiaOpen prostatectomyHigh mortalityYale-New Haven HospitalSurvival of patientsTime of surgeryT-testStudent's t-testTransurethral resectionTrial investigatorsTURPMortalityHyperplasiaPatientsProstatectomyResectionSurgeryHospitalTherapyProstateTrials
1992
Therapies for Benign Prostatic Hyperplasia-Reply
Concato J, Horwitz R, Feinstein A, Elmore J, Schiff S. Therapies for Benign Prostatic Hyperplasia-Reply. JAMA 1992, 268: 1269-1269. DOI: 10.1001/jama.1992.03490100063026.Peer-Reviewed Original Research