2024
Use of Sensitivity Analyses to Assess Uncontrolled Confounding from Unmeasured Variables in Observational, Active Comparator Pharmacoepidemiologic Studies: A Systematic Review
Latour C, Delgado M, Su I, Wiener C, Acheampong C, Poole C, Edwards J, Quinto K, Stürmer T, Lund J, Li J, Lopez N, Concato J, Funk M. Use of Sensitivity Analyses to Assess Uncontrolled Confounding from Unmeasured Variables in Observational, Active Comparator Pharmacoepidemiologic Studies: A Systematic Review. American Journal Of Epidemiology 2024, kwae234. PMID: 39098826, DOI: 10.1093/aje/kwae234.Peer-Reviewed Original ResearchUncontrolled confoundingEpidemiology journalsResidual confoundingSystematic reviewRobustness of studiesComparative cohort studyActive comparator cohort studyMedical journal articlesCohort studyConfoundingJournal articlesPharmacoepidemiological studiesSensitivity analysisPotential biasAssess robustnessMeasured variablesUnmeasured variablesPotential concernReview articleStudyJournalsVariablesQualitative Analysis of Inquiries Received by FDA Regarding Conduct of Clinical Trials during the Covid-19 Public Health Emergency
Kambere M, Vu H, Kappel D, Oh K, Budashewitz P, Concato J. Qualitative Analysis of Inquiries Received by FDA Regarding Conduct of Clinical Trials during the Covid-19 Public Health Emergency. Therapeutic Innovation & Regulatory Science 2024, 58: 987-995. PMID: 38913114, PMCID: PMC11335776, DOI: 10.1007/s43441-024-00674-x.Peer-Reviewed Original ResearchCOVID-19 public health emergencyPublic health emergencyFood and Drug AdministrationTrial participantsHealth emergencyClinical practice guidelinesAnalysis of inquirySafety of trial participantsClinical trialsTrial-related activityPractice guidelinesCOVID-19Industry trade associationsConduction of clinical trialsU.S. Food and Drug AdministrationClinical practiceInterested partiesTrade associationsPartiesMedical productsBackgroundThis reportRelated guidanceParticipantsQualitative methodsDrug AdministrationCorrelates of suicidal behaviors and genetic risk among United States veterans with schizophrenia or bipolar I disorder
Bigdeli T, Barr P, Rajeevan N, Graham D, Li Y, Meyers J, Gorman B, Peterson R, Sayward F, Radhakrishnan K, Natarajan S, Nielsen D, Wilkinson A, Malhotra A, Zhao H, Brophy M, Shi Y, O’Leary T, Gleason T, Przygodzki R, Pyarajan S, Muralidhar S, Gaziano J, Huang G, Concato J, Siever L, DeLisi L, Kimbrel N, Beckham J, Swann A, Kosten T, Fanous A, Aslan M, Harvey P. Correlates of suicidal behaviors and genetic risk among United States veterans with schizophrenia or bipolar I disorder. Molecular Psychiatry 2024, 29: 2399-2407. PMID: 38491344, DOI: 10.1038/s41380-024-02472-1.Peer-Reviewed Original ResearchBipolar I disorderSuicidal behaviorElectronic health recordsPolygenic scoresVeterans Health AdministrationSelf-reported SBColumbia-Suicide Severity Rating ScaleBipolar I disorder patientsCorrelates of suicidal behaviorClasses of psychotropic medicationsSelf-injurious behaviorHealth recordsSeverity Rating ScaleDiagnosed mental illnessAssociated with clinical variablesElectronic health record codesEHR domainDepressive disorderC-SSRSLifetime diagnosisSubstance-relatedPsychotropic medicationsSuicidal ideationExternalizing behaviorsSuicide attemptsClinical Interviewing: An Essential but Neglected Method of Medicine
Fava G, Sonino N, Aron D, Balon R, Montiel C, Cao J, Concato J, Eory A, Horwitz R, Rafanelli C, Schnyder U, Wang H, Wise T, Wright J, Zipfel S, Patierno C. Clinical Interviewing: An Essential but Neglected Method of Medicine. Psychotherapy And Psychosomatics 2024, 93: 94-99. PMID: 38382481, DOI: 10.1159/000536490.Peer-Reviewed Original ResearchClinical interviewIncrease patient motivationHealthy behaviorsMethods of medicineSelf-managementClinical encountersPatient motivationClinical processesPatient informationQuality of interviewsEducational trainingLack cost effectivenessClinical domainsPresenting complaintMedical historyInterviewsPhysiciansLife settingsTime pressureQuality of dataPersonal attitudesPatientsCost-effectiveExpensive testsDecision making
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 dataMetformin prescription for U.S. veterans with prediabetes, 2010–2019
Gulanski B, Goulet J, Radhakrishnan K, Ko J, Li Y, Rajeevan N, Lee K, Heberer K, Lynch J, Streja E, Mutalik P, Cheung K, Concato J, Shih M, Lee J, Aslan M. Metformin prescription for U.S. veterans with prediabetes, 2010–2019. Journal Of Investigative Medicine 2023, 72: 139-150. PMID: 37668313, DOI: 10.1177/10815589231201141.Peer-Reviewed Original ResearchConceptsBody mass indexVeterans Health AdministrationIncident prediabetesHigh riskHealth AdministrationRetrospective observational cohort studyType 2 diabetes mellitusUse of metforminObservational cohort studyProportion of veteransMetformin prescribingGestational diabetesCohort studyMetformin prescriptionDiabetes mellitusDiabetes preventionMass indexCardiovascular diseaseMultivariable modelPrediabetesSubset of individualsMetforminU.S. veteransHealthcare systemVeteransDecisions on Non-oncology Breakthrough Therapy Designation Requests in 2017–2019
Poddar A, Raggio M, Concato J. Decisions on Non-oncology Breakthrough Therapy Designation Requests in 2017–2019. Therapeutic Innovation & Regulatory Science 2023, 58: 214-221. PMID: 37926768, PMCID: PMC10764372, DOI: 10.1007/s43441-023-00589-z.Peer-Reviewed Original ResearchConceptsBreakthrough therapy statusTherapy statusInsufficient treatment effectNon-oncology drugsReview of requestsUnmet medical needInadequate study designBreakthrough therapy designationConclusionsThis analysisCommon reasonInvestigational drugsUS FoodMedical needOrphan diseaseStudy designDrug evaluationMarketing approvalCorresponding drugsDrugsApproval statusTreatment effectsDrug developmentFDA processDesignation programStatusReal-World Evidence for Neonatal Drug Development: Challenges and Opportunities
Singh K, Concato J, Davis J. Real-World Evidence for Neonatal Drug Development: Challenges and Opportunities. The Journal Of Pediatrics 2023, 265: 113806. PMID: 37918517, DOI: 10.1016/j.jpeds.2023.113806.Peer-Reviewed Original ResearchWhen can real‐world data generate real‐world evidence?
Rahman M, Dal Pan G, Stein P, Levenson M, Kraus S, Chakravarty A, Rivera D, Forshee R, Concato J. When can real‐world data generate real‐world evidence? Pharmacoepidemiology And Drug Safety 2023, 33: e5715. PMID: 37855046, DOI: 10.1002/pds.5715.Peer-Reviewed Original ResearchGenome-wide association studies and cross-population meta-analyses investigating short and long sleep duration
Austin-Zimmerman I, Levey D, Giannakopoulou O, Deak J, Galimberti M, Adhikari K, Zhou H, Denaxas S, Irizar H, Kuchenbaecker K, McQuillin A, Concato J, Buysse D, Gaziano J, Gottlieb D, Polimanti R, Stein M, Bramon E, Gelernter J. Genome-wide association studies and cross-population meta-analyses investigating short and long sleep duration. Nature Communications 2023, 14: 6059. PMID: 37770476, PMCID: PMC10539313, DOI: 10.1038/s41467-023-41249-y.Peer-Reviewed Original ResearchConceptsAssociation studiesGenome-wide association studiesGenetic correlationsWide association studyLinkage disequilibrium scorePositive genetic correlationSleep traitsIndependent lociMillion Veteran ProgramTraitsAncestryUK BiobankVeteran ProgramMendelian randomisationLociHeritabilitySNPsPhenotypeEast AsiansSimilar patternCardiometabolic phenotypesEarly predictors of chronic posttraumatic stress disorder symptom trajectories in U.S. Army soldiers deployed to the Iraq war zone
Vasterling J, Franz M, Lee L, Kaiser A, Proctor S, Marx B, Schnurr P, Ko J, Concato J, Aslan M. Early predictors of chronic posttraumatic stress disorder symptom trajectories in U.S. Army soldiers deployed to the Iraq war zone. Journal Of Traumatic Stress 2023, 36: 955-967. PMID: 37608526, DOI: 10.1002/jts.22964.Peer-Reviewed Original ResearchPosttraumatic stress disorderSymptom coursePosttraumatic stress disorder symptom trajectoriesGrowth mixture modelingU.S. Army soldiersLong-term followPrimary outcome variableArmy soldiersPTSD symptom courseProspective studyMild symptomsEarly predictorSummary scoresBiopsychosocial factorsAsymptomatic classSymptomatic classesSymptom classMilitary populationSymptom trajectoriesUnderstanding of predictors
2021
Genomic and Phenomic Correlates of Suicidality Among US Veterans With Schizophrenia or Bipolar Disorder
Bigdeli T, Peterson R, Khankari N, Rajeevan N, Swann A, Sayward F, Meyers J, Li Y, Nielsen D, Wilkinson A, Graham D, O'Leary T, Zhao H, Cheung K, Mane S, Miller P, Brophy M, Program M, Przygodszki R, Siever L, Pyarajan S, Gleason T, Muralidhar S, Gaziano J, Concato J, Huang G, Fanous A, Aslan M, Kosten T, Harvey P. Genomic and Phenomic Correlates of Suicidality Among US Veterans With Schizophrenia or Bipolar Disorder. Biological Psychiatry 2021, 89: s237-s238. DOI: 10.1016/j.biopsych.2021.02.596.Peer-Reviewed Original Research
2020
Randomized, observational, interventional, and real‐world—What's in a name?
Concato J, Stein P, Dal Pan G, Ball R, Corrigan‐Curay J. Randomized, observational, interventional, and real‐world—What's in a name? Pharmacoepidemiology And Drug Safety 2020, 29: 1514-1517. PMID: 32940401, DOI: 10.1002/pds.5123.Peer-Reviewed Original Research
2018
159. GWAS of PTSD Re-experiencing Symptoms in the VA Million Veteran Program
Stein M, Gelernter J, Zhao H, Sun N, Pietrzak R, Harrington K, Cho K, Honerlaw J, Quaden R, Gaziano J, Concato J, MVP M. 159. GWAS of PTSD Re-experiencing Symptoms in the VA Million Veteran Program. Biological Psychiatry 2018, 83: s64-s65. DOI: 10.1016/j.biopsych.2018.02.177.Peer-Reviewed Original Research
2015
Million Veteran Program: A mega-biobank to study genetic influences on health and disease
Gaziano JM, Concato J, Brophy M, Fiore L, Pyarajan S, Breeling J, Whitbourne S, Deen J, Shannon C, Humphries D, Guarino P, Aslan M, Anderson D, LaFleur R, Hammond T, Schaa K, Moser J, Huang G, Muralidhar S, Przygodzki R, O'Leary TJ. Million Veteran Program: A mega-biobank to study genetic influences on health and disease. Journal Of Clinical Epidemiology 2015, 70: 214-223. PMID: 26441289, DOI: 10.1016/j.jclinepi.2015.09.016.Peer-Reviewed Original ResearchConceptsMillion Veteran ProgramVeterans Affairs Health Care SystemObservational cohort studyVA electronic health recordVeteran ProgramHealth care deliverySelf-reported raceHealth care systemElectronic health recordsCohort studyAfrican American populationBlood samplesPeer-reviewed research studiesCare deliveryClinical decisionGenetic testingStudy designRecruiting sitesCare systemHealth recordsMost participantsPrecision medicineGenetic influencesAmerican populationParticipants
2014
Development and validation of a prognostic index for fracture risk in older men undergoing prostate cancer treatment.
Graham-Steed T, Soulos P, Dearing N, Concato J, Tinetti M, Gross C. Development and validation of a prognostic index for fracture risk in older men undergoing prostate cancer treatment. Journal Of Clinical Oncology 2014, 32: 5056-5056. DOI: 10.1200/jco.2014.32.15_suppl.5056.Peer-Reviewed Original Research
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 approachDesign of “Neuropsychological and Mental Health Outcomes of Operation Iraqi Freedom: A Longitudinal Cohort Study”
Aslan M, Concato J, Peduzzi P, Proctor S, Schnurr P, Marx B, McFall M, Gleason T, Huang G, Vasterling J. Design of “Neuropsychological and Mental Health Outcomes of Operation Iraqi Freedom: A Longitudinal Cohort Study”. Journal Of Investigative Medicine 2013, 61: 569. DOI: 10.231/jim.0b013e31828407ff.Peer-Reviewed Original ResearchNeurocognition Deployment Health StudyPosttraumatic stress disorderOperation Iraqi FreedomStudy designVA Cooperative Studies ProgramSubsequent posttraumatic stress disorderLongitudinal cohort studyStatistical analysis planTraumatic brain injuryMental health disordersTarget sample sizeCooperative Studies ProgramIraqi FreedomTiming of assessmentMental health outcomesCurrent study dataUS Army soldiersCohort studyBrain injuryStudy populationHealth StudyPostdeployment assessmentsHealth disordersNeuropsychological changesHealth outcomesProbability, uncertainty, and prostate cancer.
Concato J. Probability, uncertainty, and prostate cancer. Annals Of Internal Medicine 2013, 158: 211-212. PMID: 23381041, DOI: 10.7326/0003-4819-158-3-201302050-00012.Peer-Reviewed Original Research
2012
Investigating the Healthy User Effect: Correlating CPAP Use and Medication Adherence
Dieffenbach P, Bravata D, Ferguson J, McClain V, Austin C, Struve F, Li X, Williams L, Sico J, Fragoso C, Burrus N, Concato J, Kim N, Yaggi H. Investigating the Healthy User Effect: Correlating CPAP Use and Medication Adherence. CHEST Journal 2012, 142: 1053a-1053c. DOI: 10.1378/chest.1386770.Peer-Reviewed Original Research