2024
Use of electronic health records to characterize patients with uncontrolled hypertension in two large health system networks
Lu Y, Keeley E, Barrette E, Cooper-DeHoff R, Dhruva S, Gaffney J, Gamble G, Handke B, Huang C, Krumholz H, McDonough C, Schulz W, Shaw K, Smith M, Woodard J, Young P, Ervin K, Ross J. Use of electronic health records to characterize patients with uncontrolled hypertension in two large health system networks. BMC Cardiovascular Disorders 2024, 24: 497. PMID: 39289597, PMCID: PMC11409735, DOI: 10.1186/s12872-024-04161-x.Peer-Reviewed Original ResearchConceptsElectronic health recordsHealth recordsHealth systemUncontrolled hypertensionUse of electronic health recordsHypertension managementElectronic health record systemsOneFlorida Clinical Research ConsortiumElectronic health record dataYale New Haven Health SystemBP measurementsICD-10-CM codesHealth system networkPublic health priorityICD-10-CMIncidence rate of deathElevated BP measurementsElevated blood pressure measurementsHealthcare visitsAmbulatory careHealth priorityRetrospective cohort studyEHR dataOneFloridaBlood pressure measurements
2023
Pivotal Trial Demographic Representation and Clinical Development Times for Oncology Therapeutics
Wong A, Miller J, Mooghali M, Ramachandran R, Ross J, Wallach J. Pivotal Trial Demographic Representation and Clinical Development Times for Oncology Therapeutics. JAMA 2023, 330: 2392-2394. PMID: 38079163, PMCID: PMC10714278, DOI: 10.1001/jama.2023.21958.Peer-Reviewed Original Research
2021
Clinician Trends in Prescribing Direct Oral Anticoagulants for US Medicare Beneficiaries
Wheelock KM, Ross JS, Murugiah K, Lin Z, Krumholz HM, Khera R. Clinician Trends in Prescribing Direct Oral Anticoagulants for US Medicare Beneficiaries. JAMA Network Open 2021, 4: e2137288. PMID: 34870678, PMCID: PMC8649845, DOI: 10.1001/jamanetworkopen.2021.37288.Peer-Reviewed Original ResearchConceptsDOAC useAnticoagulant prescriptionOral anticoagulantsUS cliniciansMedicare beneficiariesNational clinical practice guidelinesElevated bleeding riskOral anticoagulant prescriptionsRetrospective cohort studyDirect oral anticoagulantsClinical practice guidelinesUS Medicare beneficiariesInternal medicine physiciansNumber of cliniciansAnticoagulant prescribingDOAC prescriptionsUnique cliniciansBleeding riskCohort studyAnticoagulant strategiesPrescription claimsPractice guidelinesMAIN OUTCOMEMost indicationsMedicare population
2020
Comparative Effectiveness and Safety of Oral Anticoagulants Across Kidney Function in Patients With Atrial Fibrillation
Yao X, Inselman JW, Ross JS, Izem R, Graham DJ, Martin DB, Thompson AM, Ross Southworth M, Siontis KC, Ngufor CG, Nath KA, Desai NR, Nallamothu BK, Saran R, Shah ND, Noseworthy PA. Comparative Effectiveness and Safety of Oral Anticoagulants Across Kidney Function in Patients With Atrial Fibrillation. Circulation Cardiovascular Quality And Outcomes 2020, 13: e006515. PMID: 33012172, PMCID: PMC7580213, DOI: 10.1161/circoutcomes.120.006515.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, OralAgedAged, 80 and overAnticoagulantsAntithrombinsAtrial FibrillationComparative Effectiveness ResearchDabigatranDatabases, FactualFactor Xa InhibitorsFemaleGlomerular Filtration RateHemorrhageHumansKidneyMaleMiddle AgedPyrazolesPyridonesRenal Insufficiency, ChronicRetrospective StudiesRisk AssessmentRisk FactorsRivaroxabanTime FactorsTreatment OutcomeUnited StatesWarfarinConceptsGlomerular filtration rateKidney functionMajor bleedingAtrial fibrillationOral anticoagulantsLower riskFiltration rateComparative effectivenessGlomerular filtration rate categoriesUS administrative claims databaseFalsification end pointsKidney function declineReduced kidney functionProportion of patientsAdministrative claims databaseSubstantial residual confoundingBaseline characteristicsFunction declineClaims databaseComparative safetyResidual confoundingTreatment weightingSimilar riskTreatment groupsPatientsAttribution of Adverse Events Following Coronary Stent Placement Identified Using Administrative Claims Data
Dhruva SS, Parzynski CS, Gamble GM, Curtis JP, Desai NR, Yeh RW, Masoudi FA, Kuntz R, Shaw RE, Marinac‐Dabic D, Sedrakyan A, Normand S, Krumholz HM, Ross JS. Attribution of Adverse Events Following Coronary Stent Placement Identified Using Administrative Claims Data. Journal Of The American Heart Association 2020, 9: e013606. PMID: 32063087, PMCID: PMC7070203, DOI: 10.1161/jaha.119.013606.Peer-Reviewed Original ResearchMeSH KeywordsAdministrative Claims, HealthcareAgedAged, 80 and overCoronary RestenosisCoronary ThrombosisDatabases, FactualDrug-Eluting StentsFemaleHumansMaleMedicareMyocardial InfarctionPercutaneous Coronary InterventionProduct Surveillance, PostmarketingRegistriesRetreatmentRisk AssessmentRisk FactorsTime FactorsTreatment OutcomeUnited StatesConceptsIndex percutaneous coronary interventionPercutaneous coronary interventionSame coronary arteryDrug-eluting stentsNCDR CathPCI RegistrySubsequent percutaneous coronary interventionAcute myocardial infarctionCoronary arteryClaims dataCathPCI RegistryAdverse eventsIndex procedureMyocardial infarctionRepeat percutaneous coronary interventionReal-world registry dataTarget vessel revascularizationCoronary stent placementAdministrative claims dataLong-term safetyLongitudinal claims dataPotential safety eventsVessel revascularizationCoronary interventionDES placementStent thrombosisClinical Outcomes With Beta-Blocker Use in Patients With Recent History of Myocardial Infarction
Jackevicius CA, Krumholz HM, Ross JS, Koh M, Chong A, Austin PC, Stukel TA, Azizi P, Ko DT. Clinical Outcomes With Beta-Blocker Use in Patients With Recent History of Myocardial Infarction. Canadian Journal Of Cardiology 2020, 36: 1633-1640. PMID: 32416066, DOI: 10.1016/j.cjca.2020.01.024.Peer-Reviewed Original ResearchConceptsPrior myocardial infarctionMyocardial infarctionStable patientsPopulation-based observational studyAngina 1 yearDeath/hospitalizationHistory of revascularisationBeta-blocker useMajor cardiovascular eventsHospital discharge diagnosisUse of BBsIndividual end pointsContemporary clinical trialsYears of ageCardiovascular eventsIndex dateCohort studyComposite outcomeBB useHeart failureMedian agePrimary outcomeClinical outcomesAtrial fibrillationDischarge diagnosis
2019
Evolution of the American College of Cardiology and American Heart Association Cardiology Clinical Practice Guidelines: A 10‐Year Assessment
DuBose‐Briski V, Yao X, Dunlay SM, Dhruva SS, Ross JS, Shah ND, Noseworthy PA. Evolution of the American College of Cardiology and American Heart Association Cardiology Clinical Practice Guidelines: A 10‐Year Assessment. Journal Of The American Heart Association 2019, 8: e012065. PMID: 31566106, PMCID: PMC6806052, DOI: 10.1161/jaha.119.012065.Peer-Reviewed Original ResearchConceptsValvular heart diseaseClinical practice guidelinesAmerican Heart AssociationLevel of evidenceAmerican CollegeLOE BHeart failureHeart AssociationHeart diseasePractice guidelinesCardiology/American Heart Association (ACC/AHA) guideline recommendationsCardiology/American Heart Association guidelinesCardiology/American Heart AssociationMedian proportionCardiology clinical practice guidelinesAmerican Heart Association guidelinesHeart Association guidelinesClass of recommendationLOE AGuideline recommendationsResults ThirtyAssociation guidelinesMedian numberStable ischemiaLevel ISharing of clinical trial data and results reporting practices among large pharmaceutical companies: cross sectional descriptive study and pilot of a tool to improve company practices
Miller J, Ross JS, Wilenzick M, Mello MM. Sharing of clinical trial data and results reporting practices among large pharmaceutical companies: cross sectional descriptive study and pilot of a tool to improve company practices. The BMJ 2019, 366: l4217. PMID: 31292127, PMCID: PMC6614834, DOI: 10.1136/bmj.l4217.Peer-Reviewed Original ResearchConceptsClinical trial dataTrial dataDrug approvalSectional descriptive studyPharmaceutical companiesFDA drug approvalsLarge pharmaceutical companiesClinical trialsDrug levelsNew drug approvalsUS FoodDrug AdministrationNew drug applicationsFDA approvalPatientsNovel drugsDescriptive studyDrug applicationTrialsDrugsExternal investigatorsSharing scoreDrug companiesTrial transparencyStudy measuresGeneric and Brand-Name Thyroid Hormone Drug Use Among Commercially Insured and Medicare Beneficiaries, 2007 Through 2016
Ross JS, Rohde S, Sangaralingham L, Brito JP, Choi L, Dutcher SK, Graham DJ, Jenkins MR, Lipska KJ, Mendoza M, Qiang Y, Wang Z, Wu Y, Yao X, Shah ND. Generic and Brand-Name Thyroid Hormone Drug Use Among Commercially Insured and Medicare Beneficiaries, 2007 Through 2016. The Journal Of Clinical Endocrinology & Metabolism 2019, 104: 2305-2314. PMID: 30690529, DOI: 10.1210/jc.2018-02197.Peer-Reviewed Original ResearchConceptsBrand-name useDrug useMedicare AdvantageThyroid hormone replacement therapyLarge administrative claims databaseBeneficiary populationAdministrative claims databaseHormone replacement therapyCertain patient characteristicsMedicare Part DPrescriber specialtyPatient characteristicsPrescriber characteristicsClaims databaseReplacement therapyGeneric levothyroxineWhite raceHealth plansOlder adultsHormone drugsInsurance coverageProduct useLevothyroxineNational dataPart D
2018
Timeliness of Postmarket Studies for New Pharmaceuticals Approved Between 2009 and 2012: a Cross-Sectional Analysis
Wallach JD, Egilman AC, Ross JS, Woloshin S, Schwartz LM. Timeliness of Postmarket Studies for New Pharmaceuticals Approved Between 2009 and 2012: a Cross-Sectional Analysis. Journal Of General Internal Medicine 2018, 34: 492-495. PMID: 30543020, PMCID: PMC6445841, DOI: 10.1007/s11606-018-4779-x.Peer-Reviewed Original ResearchCoverage of Novel Therapeutic Agents by Medicare Prescription Drug Plans Following FDA Approval
Shaw DL, Dhruva SS, Ross JS. Coverage of Novel Therapeutic Agents by Medicare Prescription Drug Plans Following FDA Approval. Journal Of Managed Care & Specialty Pharmacy 2018, 24: 10.18553/jmcp.2018.24.12.1230. PMID: 30479199, PMCID: PMC10397592, DOI: 10.18553/jmcp.2018.24.12.1230.Peer-Reviewed Original ResearchConceptsNovel therapeutic agentsPrescription drug plansOrphan drug statusFDA approvalYear of approvalTherapeutic agentsNovel therapeuticsPrior authorizationNovel therapiesPriority reviewStep therapyMedicare prescription drug plansDrug plansDrug coverageNational InstituteDrug statusPart D prescription drug benefitMedicaid ServicesDrug characteristicsTherapeutic areasCross-sectional studyDrug benefit coverageHealth insurance payerBlue Cross Blue Shield AssociationPrescription drug benefitRegistration, results reporting, and publication bias of clinical trials supporting FDA approval of neuropsychiatric drugs before and after FDAAA: a retrospective cohort study
Zou CX, Becker JE, Phillips AT, Garritano JM, Krumholz HM, Miller JE, Ross JS. Registration, results reporting, and publication bias of clinical trials supporting FDA approval of neuropsychiatric drugs before and after FDAAA: a retrospective cohort study. Trials 2018, 19: 581. PMID: 30352601, PMCID: PMC6199729, DOI: 10.1186/s13063-018-2957-0.Peer-Reviewed Original ResearchConceptsRetrospective cohort studyPublication biasNeuropsychiatric indicationsCohort studyClinical trialsRelative riskEfficacy trialsFDA approvalPositive trialsFisher's exact testRecent FDA approvalDrug Administration Amendments ActClinical trial publicationsTRIAL REGISTRATIONMAIN OUTCOMEProportion of trialsNeuropsychiatric drugsNew drug approvalsTrial publicationsExact testMedical interventionsTrialsDrug approvalNew drugsDrugsAdherence to the International Committee of Medical Journal Editors’ (ICMJE) prospective registration policy and implications for outcome integrity: a cross-sectional analysis of trials published in high-impact specialty society journals
Gopal AD, Wallach JD, Aminawung JA, Gonsalves G, Dal-Ré R, Miller JE, Ross JS. Adherence to the International Committee of Medical Journal Editors’ (ICMJE) prospective registration policy and implications for outcome integrity: a cross-sectional analysis of trials published in high-impact specialty society journals. Trials 2018, 19: 448. PMID: 30134950, PMCID: PMC6106722, DOI: 10.1186/s13063-018-2825-y.Peer-Reviewed Original ResearchConceptsPrimary outcome dataOutcome dataCross-sectional analysisUnregistered trialsTrial characteristicsClinical trialsFavorable findingsProfessional medical societiesMedical societiesIndustry-funded trialsFrequency of registrationPrimary outcomeRegistered trialsEnrollment siteProspective fashionChi-square analysisProportion of trialsOriginal research reportsInitial ascertainmentTrialsHigh-impact journalsMedical Journal EditorsRegistration timingRetrospective registrationLower ratesAge of Data at the Time of Publication of Contemporary Clinical Trials
Welsh J, Lu Y, Dhruva SS, Bikdeli B, Desai NR, Benchetrit L, Zimmerman CO, Mu L, Ross JS, Krumholz HM. Age of Data at the Time of Publication of Contemporary Clinical Trials. JAMA Network Open 2018, 1: e181065-e181065. PMID: 30646100, PMCID: PMC6324269, DOI: 10.1001/jamanetworkopen.2018.1065.Peer-Reviewed Original ResearchConceptsClinical trialsFinal data collectionParticipant enrollmentInternal medicineMultivariable linear regression analysisFirst participant enrollmentPrimary end pointMultivariable regression analysisContemporary clinical trialsClinical trial dataJAMA Internal MedicineRegression analysisCross-sectional analysisTime of publicationMedian timeTrial characteristicsOutcome measuresMAIN OUTCOMENew England JournalClinical practiceLinear regression analysisTrial dataEnd pointTrial resultsTrialsPublication and Dissemination of Results in Clinical Trials of Neurology
Sreekrishnan A, Mampre D, Ormseth C, Miyares L, Leasure A, Ross JS, Sheth KN. Publication and Dissemination of Results in Clinical Trials of Neurology. JAMA Neurology 2018, 75: 890-891. PMID: 29710083, PMCID: PMC6145765, DOI: 10.1001/jamaneurol.2018.0674.Peer-Reviewed Original ResearchPostmarket studies required by the US Food and Drug Administration for new drugs and biologics approved between 2009 and 2012: cross sectional analysis
Wallach JD, Egilman AC, Dhruva SS, McCarthy ME, Miller JE, Woloshin S, Schwartz LM, Ross JS. Postmarket studies required by the US Food and Drug Administration for new drugs and biologics approved between 2009 and 2012: cross sectional analysis. The BMJ 2018, 361: k2031. PMID: 29794072, PMCID: PMC5967364, DOI: 10.1136/bmj.k2031.Peer-Reviewed Original ResearchConceptsProspective cohort studyCohort studyClinical trialsPostmarketing requirementsTimeliness of registrationNew drugsUS FoodDrug AdministrationFDA approvalStudy designNumber of patientsSectional analysisPostmarket studiesFirst approvalRegistrySecondary analysisTrialsBiologicsDrugsComparator typeAdministrationApprovalFDAFDA's authorityStatewide Inferior Vena Cava Filter Placement, Complications, and Retrievals
Charalel RA, Durack JC, Mao J, Ross JS, Meltzer AJ, Sedrakyan A. Statewide Inferior Vena Cava Filter Placement, Complications, and Retrievals. Medical Care 2018, 56: 260-265. PMID: 29356721, DOI: 10.1097/mlr.0000000000000867.Peer-Reviewed Original ResearchConceptsIVC filter placementFilter placementIVC filtersFilter retrievalIVC filter-related complicationsProphylactic IVC filter placementInferior vena cava filter placementVena cava filter placementFilter-related complicationsPulmonary embolism riskAverage patient ageDrug Administration (FDA) safety communicationRetrospective cohort studyCava filter placementKaplan-Meier analysisAge-adjusted ratesIVC filter retrievalCohort studyPatient agePE occurrencePE ratePE eventsCumulative riskPopulation-level trendsClinical practiceFactors Associated With Postmarketing Research for Approved Indications for Novel Medicines Approved by Both the FDA and EMA Between 2005 and 2010: A Multivariable Analysis
Zeitoun J, Ross JS, Atal I, Vivot A, Downing NS, Baron G, Ravaud P. Factors Associated With Postmarketing Research for Approved Indications for Novel Medicines Approved by Both the FDA and EMA Between 2005 and 2010: A Multivariable Analysis. Clinical Pharmacology & Therapeutics 2018, 104: 1000-1007. PMID: 29377075, DOI: 10.1002/cpt.1038.Peer-Reviewed Original Research
2017
Opioid Prescribing for Opioid-Naive Patients in Emergency Departments and Other Settings: Characteristics of Prescriptions and Association With Long-Term Use
Jeffery MM, Hooten WM, Hess EP, Meara ER, Ross JS, Henk HJ, Borgundvaag B, Shah ND, Bellolio MF. Opioid Prescribing for Opioid-Naive Patients in Emergency Departments and Other Settings: Characteristics of Prescriptions and Association With Long-Term Use. Annals Of Emergency Medicine 2017, 71: 326-336.e19. PMID: 28967517, PMCID: PMC6295192, DOI: 10.1016/j.annemergmed.2017.08.042.Peer-Reviewed Original ResearchConceptsLong-term opioid useNon-ED settingsOpioid-naive patientsLong-term useOpioid prescriptionsOpioid useCharacteristics of prescriptionsPrescription opioid useLow daily dosesAdministrative claims dataRate of progressionDisabled Medicare beneficiariesMedicare Advantage beneficiariesED prescriptionGuideline concordancePatients 56Patients 58Opioid prescribingCDC guidelinesPrevention guidelinesDaily dosesEmergency departmentCDC recommendationsDays' supplyInclusion criteriaRegulatory Review of New Therapeutic Agents — FDA versus EMA, 2011–2015
Downing NS, Zhang AD, Ross JS. Regulatory Review of New Therapeutic Agents — FDA versus EMA, 2011–2015. New England Journal Of Medicine 2017, 376: 1386-1387. PMID: 28379798, DOI: 10.1056/nejmc1700103.Peer-Reviewed Original Research