2024
Effectiveness of glucose-lowering medications on cardiovascular outcomes in patients with type 2 diabetes at moderate cardiovascular risk
McCoy R, Herrin J, Swarna K, Deng Y, Kent D, Ross J, Umpierrez G, Galindo R, Crown W, Borah B, Montori V, Brito J, Neumiller J, Mickelson M, Polley E. Effectiveness of glucose-lowering medications on cardiovascular outcomes in patients with type 2 diabetes at moderate cardiovascular risk. Nature Cardiovascular Research 2024, 3: 431-440. PMID: 38846711, PMCID: PMC11156225, DOI: 10.1038/s44161-024-00453-9.Peer-Reviewed Original ResearchAdverse cardiovascular eventsGlucose-lowering medicationsType 2 diabetesCardiovascular diseaseGLP-1RACardiovascular eventsGlucagon-like peptide-1 receptor agonistsSodium-glucose cotransporter 2 inhibitorsPeptide-1 receptor agonistsDipeptidyl peptidase-4 inhibitorsPeptidase-4 inhibitorsRetrospective cohort studyCardiovascular disease risk reductionGlucose-lowering agentsModerate cardiovascular riskCardiovascular risk reductionReceptor agonistsEffects of glucose-lowering medicationsRisk reductionCardiovascular riskCohort studyCardiovascular outcomesHigh riskBaseline riskModerate riskIntegrating 4 methods to evaluate physical function in patients with cancer (In4M): protocol for a prospective cohort study
Thanarajasingam G, Kluetz P, Bhatnagar V, Brown A, Cathcart-Rake E, Diamond M, Faust L, Fiero M, Huntington S, Jeffery M, Jones L, Noble B, Paludo J, Powers B, Ross J, Ritchie J, Ruddy K, Schellhorn S, Tarver M, Dueck A, Gross C. Integrating 4 methods to evaluate physical function in patients with cancer (In4M): protocol for a prospective cohort study. BMJ Open 2024, 14: e074030. PMID: 38199641, PMCID: PMC10806877, DOI: 10.1136/bmjopen-2023-074030.Peer-Reviewed Original ResearchConceptsPhysical function assessmentPhysical functionFunctional assessmentEvaluation of physical functionElectronic health record dataEvaluate physical functionHealth record dataSpanish-speaking patientsDigital health technologiesBreast cancerProspective cohort studyClinician-reported outcomesCancer clinical trialsClinical decision-makingStudy questionnairePatient-centred evaluationHealth technologiesMeasure symptomsOncology practiceCohort studyRecord dataPatient's impressionMayo ClinicEnglish-speakingWearable sensors
2023
Therapeutic value of first versus supplemental indications of drugs in US and Europe (2011-20): retrospective cohort study
Vokinger K, Glaus C, Kesselheim A, Serra-Burriel M, Ross J, Hwang T. Therapeutic value of first versus supplemental indications of drugs in US and Europe (2011-20): retrospective cohort study. The BMJ 2023, 382: e074166. PMID: 37407074, PMCID: PMC10320829, DOI: 10.1136/bmj-2022-074166.Peer-Reviewed Original ResearchConceptsEuropean Medicines AgencyRetrospective cohort studyCohort studyTherapeutic valueSupplemental indicationsIndication approvalsHigh therapeutic valueAvailable treatmentsDrug AdministrationUS FoodMedicines AgencyFDA approvalHealth authoritiesCancer disordersSimilar findingsTherapeutic ratingFirst indicationDrugsIndicationsApprovalFDAPatientsLarge subsetProportionPhysicians
2022
Safety and Effectiveness of a Catheter With Contact Force and 6-Hole Irrigation for Ablation of Persistent Atrial Fibrillation in Routine Clinical Practice
Dhruva SS, Zhang S, Chen J, Noseworthy PA, Doshi AA, Agboola KM, Herrin J, Jiang G, Yu Y, Cafri G, Farr K, Ervin KR, Ross JS, Coplan PM, Drozda JP. Safety and Effectiveness of a Catheter With Contact Force and 6-Hole Irrigation for Ablation of Persistent Atrial Fibrillation in Routine Clinical Practice. JAMA Network Open 2022, 5: e2227134. PMID: 35976649, PMCID: PMC9386540, DOI: 10.1001/jamanetworkopen.2022.27134.Peer-Reviewed Original ResearchConceptsPersistent AF ablationRoutine clinical practiceMercy HealthAF ablationMayo ClinicSafety outcomesClinical practiceCatheter groupCohort studyCatheter ablationPersistent AFParoxysmal atrial fibrillation ablationThermocool SmartTouch catheterComposite of deathPrimary safety outcomeAtrial fibrillation ablationPersistent atrial fibrillationElectronic health record dataHealth system dataHealth record dataHealth care systemSmartTouch catheterThromboembolic eventsFibrillation ablationProcedural complicationsAcute pain pathways: protocol for a prospective cohort study
Jeffery MM, Ahadpour M, Allen S, Araojo R, Bellolio F, Chang N, Ciaccio L, Emanuel L, Fillmore J, Gilbert GH, Koussis P, Lee C, Lipkind H, Mallama C, Meyer T, Moncur M, Nuckols T, Pacanowski MA, Page DB, Papadopoulos E, Ritchie JD, Ross JS, Shah ND, Soukup M, St. Clair CO, Tamang S, Torbati S, Wallace DW, Zhao Y, Heckmann R. Acute pain pathways: protocol for a prospective cohort study. BMJ Open 2022, 12: e058782. PMID: 35790333, PMCID: PMC9258513, DOI: 10.1136/bmjopen-2021-058782.Peer-Reviewed Original ResearchConceptsAcute painOpioid analgesicsMulticentre prospective observational studyLittle high-quality evidenceNon-cancer painOpioid analgesic useResolution of painProspective cohort studyProspective observational studyPatient-centered outcomesElectronic health record dataEvidence-based guidelinesHigh-quality evidenceHealth record dataDiverse clinical settingsLong-term useClinician prescribingLeftover opioidsAnalgesic usePain controlCohort studyPain conditionsPain managementPain treatmentCommon diagnosis
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 populationUS Food and Drug Administration utilization of postmarketing requirements and postmarketing commitments, 2009–2018
Skydel JJ, Zhang AD, Dhruva SS, Ross JS, Wallach JD. US Food and Drug Administration utilization of postmarketing requirements and postmarketing commitments, 2009–2018. Clinical Trials 2021, 18: 488-499. PMID: 33863236, PMCID: PMC8292154, DOI: 10.1177/17407745211005044.Peer-Reviewed Original ResearchConceptsClinical studiesPostmarketing requirementsUS FoodDrug AdministrationNew therapeuticsClinical evidenceNew prospective cohort studyProspective cohort studyCross-sectional studyDrug Administration approvalCohort studyRetrospective studyUnapproved indicationsAdministration approvalClinical indicationsClinical trialsBACKGROUND/Median numberDisease populationTherapeutic safetyTherapeutic indicationsSecondary analysisNovel therapeuticsSmall molecule drugsOriginal approval
2020
Association between FDA and EMA expedited approval programs and therapeutic value of new medicines: retrospective cohort study
Hwang TJ, Ross JS, Vokinger KN, Kesselheim AS. Association between FDA and EMA expedited approval programs and therapeutic value of new medicines: retrospective cohort study. The BMJ 2020, 371: m3434. PMID: 33028575, PMCID: PMC7537471, DOI: 10.1136/bmj.m3434.Peer-Reviewed Original ResearchConceptsEuropean Medicines AgencyRetrospective cohort studyTherapeutic valueHigh therapeutic valueNew drugsCohort studyLow therapeutic valueEMA approvalUS FoodDrug AdministrationMedicines AgencyFDA approvalDrugsFDARegulatory approvalApproval programsNew medicinesAssociationGreater proportionApprovalProportionAdministrationComparative Effectiveness of Generic vs Brand-Name Levothyroxine in Achieving Normal Thyrotropin Levels
Brito JP, Ross JS, Sangaralingham L, Dutcher SK, Graham DJ, Wang Z, Wu Y, Yao X, Smallridge RC, Bernet V, Shah ND, Lipska KJ. Comparative Effectiveness of Generic vs Brand-Name Levothyroxine in Achieving Normal Thyrotropin Levels. JAMA Network Open 2020, 3: e2017645. PMID: 32997127, PMCID: PMC7527873, DOI: 10.1001/jamanetworkopen.2020.17645.Peer-Reviewed Original ResearchConceptsNormal thyrotropin levelsPropensity score-matched patientsThyrotropin levelsLevothyroxine prescriptionsThyrotropin valuesProportion of patientsAdministrative claims databaseMonths of initiationMIU/LMild thyroid dysfunctionLongitudinal cohort studyMedicare Advantage enrolleesNormal thyrotropin valuesEligible patientsInitial therapyLevothyroxine formulationsCohort studyThyroid dysfunctionClaims databaseGeneric levothyroxineLevothyroxineMAIN OUTCOMENormal rangePatientsNormal vsAggregating multiple real-world data sources using a patient-centered health-data-sharing platform
Dhruva SS, Ross JS, Akar JG, Caldwell B, Childers K, Chow W, Ciaccio L, Coplan P, Dong J, Dykhoff HJ, Johnston S, Kellogg T, Long C, Noseworthy PA, Roberts K, Saha A, Yoo A, Shah ND. Aggregating multiple real-world data sources using a patient-centered health-data-sharing platform. Npj Digital Medicine 2020, 3: 60. PMID: 32352038, PMCID: PMC7170944, DOI: 10.1038/s41746-020-0265-z.Peer-Reviewed Original ResearchElectronic health recordsCatheter-based atrial fibrillation ablationPatient-reported outcome measures (PROMs) dataAdditional health systemsPost-procedure recoveryProspective cohort studyTertiary care hospitalU.S. tertiary care hospitalDisease-specific symptomsAtrial fibrillation ablationOutcome measure dataDigital weight scaleBariatric surgeryCohort studyCare hospitalFibrillation ablationPharmacy dataWalgreens pharmaciesReal-world data sourcesActivity monitorHealth systemPatientsHealth recordsEHR dataWeight scaleAssociation of Use of an Intravascular Microaxial Left Ventricular Assist Device vs Intra-aortic Balloon Pump With In-Hospital Mortality and Major Bleeding Among Patients With Acute Myocardial Infarction Complicated by Cardiogenic Shock
Dhruva SS, Ross JS, Mortazavi BJ, Hurley NC, Krumholz HM, Curtis JP, Berkowitz A, Masoudi FA, Messenger JC, Parzynski CS, Ngufor C, Girotra S, Amin AP, Shah ND, Desai NR. Association of Use of an Intravascular Microaxial Left Ventricular Assist Device vs Intra-aortic Balloon Pump With In-Hospital Mortality and Major Bleeding Among Patients With Acute Myocardial Infarction Complicated by Cardiogenic Shock. JAMA 2020, 323: 734-745. PMID: 32040163, PMCID: PMC7042879, DOI: 10.1001/jama.2020.0254.Peer-Reviewed Original ResearchMeSH KeywordsAgedCause of DeathExtracorporeal Membrane OxygenationFemaleHeart ArrestHeart-Assist DevicesHemorrhageHospital MortalityHumansIntra-Aortic Balloon PumpingMaleMatched-Pair AnalysisMiddle AgedMyocardial InfarctionPercutaneous Coronary InterventionPropensity ScoreRegistriesRetrospective StudiesShock, CardiogenicST Elevation Myocardial InfarctionConceptsMicroaxial left ventricular assist deviceIntra-aortic balloon pumpLeft ventricular assist deviceAcute myocardial infarctionPercutaneous coronary interventionNational Cardiovascular Data RegistryCardiogenic shockHemodynamic supportMyocardial infarctionRegistry-based retrospective cohort studyCardiology-National Cardiovascular Data RegistryChest Pain-MI RegistryST-elevation myocardial infarctionMechanical circulatory support devicesGreater hemodynamic supportHospital major bleedingRetrospective cohort studyPropensity-matched pairsCirculatory support devicesVentricular assist deviceClinical laboratory dataHospital mortalityMajor bleedingHospital deathCohort studyClinical 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
Medicare Prescription Drug Plan Formulary Restrictions After Postmarket FDA Black Box Warnings.
Solotke MT, Ross JS, Shah ND, Karaca-Mandic P, Dhruva SS. Medicare Prescription Drug Plan Formulary Restrictions After Postmarket FDA Black Box Warnings. Journal Of Managed Care & Specialty Pharmacy 2019, 25: 1201-1217. PMID: 31663461, PMCID: PMC10397710, DOI: 10.18553/jmcp.2019.25.11.1201.Peer-Reviewed Original ResearchConceptsBlack box warningFDA black box warningBox warningFormulary restrictionsFormulary coverageMean percentageNew black box warningsMain outcome measuresPrecision Health EconomicsNational InstituteOutcomes Research InstituteBlue Cross Blue Shield AssociationHealth care qualityCohort studyBoxed warningUnsafe medicationsDrug therapyStep therapy requirementsMayo ClinicFormulary changeOutcome measuresBlue Shield AssociationJohn Arnold FoundationDrug AdministrationFormulary managementHome Health Care After Skilled Nursing Facility Discharge Following Heart Failure Hospitalization
Weerahandi H, Bao H, Herrin J, Dharmarajan K, Ross JS, Jones S, Horwitz LI. Home Health Care After Skilled Nursing Facility Discharge Following Heart Failure Hospitalization. Journal Of The American Geriatrics Society 2019, 68: 96-102. PMID: 31603248, PMCID: PMC6964248, DOI: 10.1111/jgs.16179.Peer-Reviewed Original ResearchConceptsSkilled nursing facilitiesHF hospitalizationReadmission ratesReadmission riskHeart failure readmission ratesDays of dischargeHeart failure hospitalizationRetrospective cohort studyHospital discharge practicesMore functional impairmentHome health careFailure hospitalizationHF patientsUnplanned readmissionCohort studyHospital dischargePrimary outcomeRestorative therapySNF stayFunctional impairmentHome healthcare servicesService Medicare dataAdjusted modelCox modelNursing facilitiesRates of Physician Coprescribing of Opioids and Benzodiazepines After the Release of the Centers for Disease Control and Prevention Guidelines in 2016
Jeffery MM, Hooten WM, Jena AB, Ross JS, Shah ND, Karaca-Mandic P. Rates of Physician Coprescribing of Opioids and Benzodiazepines After the Release of the Centers for Disease Control and Prevention Guidelines in 2016. JAMA Network Open 2019, 2: e198325. PMID: 31373650, PMCID: PMC6681551, DOI: 10.1001/jamanetworkopen.2019.8325.Peer-Reviewed Original ResearchConceptsLong-term opioid useOpioid usePrevention guidelinesMA groupDisease controlCoprescription of opioidsRetrospective cohort studyUS national databaseInsurance groupsMedicare AdvantageSickle cell diseaseGuideline releasePrescription daysPrescribed opioidsBenzodiazepine prescriptionsCohort studyMedian agePharmacy claimsChronic painCell diseaseCoprescriptionMAIN OUTCOMESame clinicianClaims dataHospice careRisk of Readmission After Discharge From Skilled Nursing Facilities Following Heart Failure Hospitalization: A Retrospective Cohort Study
Weerahandi H, Li L, Bao H, Herrin J, Dharmarajan K, Ross JS, Kim KL, Jones S, Horwitz LI. Risk of Readmission After Discharge From Skilled Nursing Facilities Following Heart Failure Hospitalization: A Retrospective Cohort Study. Journal Of The American Medical Directors Association 2019, 20: 432-437. PMID: 30954133, PMCID: PMC6486375, DOI: 10.1016/j.jamda.2019.01.135.Peer-Reviewed Original ResearchConceptsSkilled nursing facilitiesSNF dischargeRetrospective cohort studySNF lengthHeart failureHF hospitalizationComposite outcomeCohort studyNursing facilitiesService beneficiaries 65Heart failure hospitalizationRisk of readmissionHazard rate ratiosFailure hospitalizationUnplanned readmissionHF diagnosisHospital dischargePostdischarge outcomesSNF stayMedicare patientsMedicare feeHome transitionPatientsReadmissionDay 3Association of a Risk Evaluation and Mitigation Strategy Program With Transmucosal Fentanyl Prescribing
Fleischman W, Auth D, Shah ND, Agrawal S, Ross JS. Association of a Risk Evaluation and Mitigation Strategy Program With Transmucosal Fentanyl Prescribing. JAMA Network Open 2019, 2: e191340. PMID: 30924899, PMCID: PMC6450314, DOI: 10.1001/jamanetworkopen.2019.1340.Peer-Reviewed Original ResearchConceptsMedicare Part D beneficiariesPart D beneficiariesOpioid toleranceClock opioid analgesicsMitigation strategy programAccess programOpioid prescribing trendsPercentage of prescriptionsInterrupted time series analysisREMS implementationBreakthrough painCohort studyPrescribing trendsOpioid analgesicsCancer definitionsMAIN OUTCOMECancer statusPatientsUS FoodDrug AdministrationPrescribingCancerFentanyl drugsPrescriptionMonthly decrease
2018
Registration, 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 drugsDrugsAssociation of Racial and Socioeconomic Disparities With Outcomes Among Patients Hospitalized With Acute Myocardial Infarction, Heart Failure, and Pneumonia
Downing NS, Wang C, Gupta A, Wang Y, Nuti SV, Ross JS, Bernheim SM, Lin Z, Normand ST, Krumholz HM. Association of Racial and Socioeconomic Disparities With Outcomes Among Patients Hospitalized With Acute Myocardial Infarction, Heart Failure, and Pneumonia. JAMA Network Open 2018, 1: e182044. PMID: 30646146, PMCID: PMC6324513, DOI: 10.1001/jamanetworkopen.2018.2044.Peer-Reviewed Original ResearchMeSH KeywordsAgedAged, 80 and overBlack PeopleCohort StudiesFee-for-Service PlansFemaleHealth Status DisparitiesHeart FailureHospitalizationHospitalsHumansMaleMedicareMiddle AgedMyocardial InfarctionOutcome Assessment, Health CarePneumoniaRacial GroupsRetrospective StudiesSocial ClassUnited StatesWhite PeopleConceptsAcute myocardial infarctionRisk-standardized mortality ratesRisk-standardized readmission ratesReadmission ratesHeart failureMyocardial infarctionMortality rateIntraclass correlation coefficientAnalysis cohortBlack patientsHospital proportionSocioeconomic disparitiesHospital analysisRisk-standardized outcomesRisk-standardized ratesRetrospective cohort studySocioeconomic statusNeighborhood income levelHospital performanceHospital outcomesCohort studyNumber of hospitalsBroader systemic effectsPatient raceMAIN OUTCOMESpeed of Adoption of Immune Checkpoint Inhibitors of Programmed Cell Death 1 Protein and Comparison of Patient Ages in Clinical Practice vs Pivotal Clinical Trials
O’Connor J, Fessele KL, Steiner J, Seidl-Rathkopf K, Carson KR, Nussbaum NC, Yin ES, Adelson KB, Presley CJ, Chiang AC, Ross JS, Abernethy AP, Gross CP. Speed of Adoption of Immune Checkpoint Inhibitors of Programmed Cell Death 1 Protein and Comparison of Patient Ages in Clinical Practice vs Pivotal Clinical Trials. JAMA Oncology 2018, 4: e180798-e180798. PMID: 29800974, PMCID: PMC6143052, DOI: 10.1001/jamaoncol.2018.0798.Peer-Reviewed Original ResearchMeSH KeywordsAgedAntibodies, Monoclonal, HumanizedCarcinoma, Non-Small-Cell LungCarcinoma, Renal CellClinical Trials as TopicFemaleFollow-Up StudiesHumansKidney NeoplasmsLung NeoplasmsMaleMiddle AgedNivolumabPractice Patterns, Physicians'PrognosisProgrammed Cell Death 1 ReceptorRetrospective StudiesConceptsNon-small cell lung cancerPivotal clinical trialsRenal cell carcinomaCell death 1 proteinEligible patientsImmune checkpoint inhibitorsDeath 1 proteinClinical trialsClinical practiceFDA approvalAgent treatmentCheckpoint inhibitorsAnti-PD-1 agentsFlatiron Health networkRetrospective cohort studyAge of patientsCell lung cancerClinical trial participantsCohort studyPatient ageYounger patientsMore patientsSuch patientsTrial evidenceCell carcinoma