2025
308-OR: Risk of New Cancer Diagnoses with GLP-1 Receptor Agonist, SGLT2 Inhibitor, DPP-4 Inhibitor, and Sulfonylurea Use in Type 2 Diabetes
SKLEPINSKI S, HERRIN J, SINDHU SWARNA K, NEUMILLER J, GALINDO R, UMPIERREZ G, ROSS J, DENG Y, POLLEY E, MICKELSON M, MCCOY R. 308-OR: Risk of New Cancer Diagnoses with GLP-1 Receptor Agonist, SGLT2 Inhibitor, DPP-4 Inhibitor, and Sulfonylurea Use in Type 2 Diabetes. Diabetes 2025, 74 DOI: 10.2337/db25-308-or.Peer-Reviewed Original ResearchDipeptidyl peptidase-4 inhibitorsIncident cancer riskSodium-glucose cotransporter 2 inhibitorsIncident cancerGLP-1RACancer riskHigher risk of incident cancerType 2 diabetesRisk of incident cancerHigh riskReceptor agonistsMedicare fee-for-serviceFemale breast cancerFee-for-serviceGlucagon-like peptide-1 receptor agonistsPeptide-1 receptor agonistsGLP-1 receptor agonistsPropensity score inverse probabilityTarget trial emulationModerate CVD riskCox proportional hazards modelsOptumLabs Data WarehousePeptidase-4 inhibitorsIncidence of melanomaAdverse cardiovascular events779-P: Cardiovascular Outcomes Associated with Dulaglutide, Exenatide, Liraglutide, and Semaglutide in Adults with Type 2 Diabetes at Moderate Cardiovascular Risk
SKLEPINSKI S, HERRIN J, SINDHU SWARNA K, NEUMILLER J, GALINDO R, UMPIERREZ G, ROSS J, DENG Y, POLLEY E, MARON B, MCCOY R. 779-P: Cardiovascular Outcomes Associated with Dulaglutide, Exenatide, Liraglutide, and Semaglutide in Adults with Type 2 Diabetes at Moderate Cardiovascular Risk. Diabetes 2025, 74 DOI: 10.2337/db25-779-p.Peer-Reviewed Original ResearchModerate CVD riskCVD riskType 2 diabetesCardiovascular diseaseAssociated with lower hazardRisk of cardiovascular outcomesCardiovascular disease outcomesCox proportional hazards modelsCardiovascular outcomesGlucagon-like peptide-1 receptor agonistsModerate cardiovascular riskCardiovascular risk reductionDigestive and Kidney DiseasesPeptide-1 receptor agonistsPropensity score inverse probabilityProportional hazards modelHazard of deathDepartment visitsNational Institute of DiabetesHazard of MACETrial emulationMedicare AdvantageMedicare plansComparative riskHazards model780-P: Comparative Risk of Adverse Pancreatic Events with Second-Line Glucose-Lowering Therapies in Adults with Type 2 Diabetes at Moderate Cardiovascular Disease Risk
KALATHIYA U, HERRIN J, SINDHU SWARNA K, NEUMILLER J, GALINDO R, UMPIERREZ G, ROSS J, DENG Y, POLLEY E, MICKELSON M, MCCOY R. 780-P: Comparative Risk of Adverse Pancreatic Events with Second-Line Glucose-Lowering Therapies in Adults with Type 2 Diabetes at Moderate Cardiovascular Disease Risk. Diabetes 2025, 74 DOI: 10.2337/db25-780-p.Peer-Reviewed Original ResearchSodium-glucose cotransporter 2 inhibitorsGLP-1RAAcute pancreatitisPancreatic cancerType 2 diabetesRisk of pancreatic cancerIncident acute pancreatitisMedicare fee-for-servicePancreatitis eventsComparative riskAssociated with lower riskFee-for-serviceCardiovascular disease riskGlucagon-like peptide-1 receptor agonistsModerate cardiovascular disease riskSecond-line glucose-lowering therapyAssociated with increased riskAssociated with higher riskRisk of acute pancreatitisPeptide-1 receptor agonistsPropensity score inverse probabilityDipeptidyl peptidase-4 inhibitorsOptumLabs Data WarehouseGLP-1RA therapyModerate cardiovascular riskRepresentation of Women, Older Adults, and Racial and Ethnic Minoritized Patients in Pivotal Trials for US Food and Drug Administration Novel Oncology Therapeutic Approvals, 2012-2021: Bright Spot Trials and Trends Over Time.
Miller J, Pelletiers W, Gross C, Mello M, Ramachandran R, Schwartz J, Suttiratana S, Varma T, Ross J. Representation of Women, Older Adults, and Racial and Ethnic Minoritized Patients in Pivotal Trials for US Food and Drug Administration Novel Oncology Therapeutic Approvals, 2012-2021: Bright Spot Trials and Trends Over Time. JCO Oncology Practice 2025, op2400563. PMID: 40493876, DOI: 10.1200/op-24-00563.Peer-Reviewed Original ResearchFood and Drug AdministrationOncology therapeuticsLatino patientsBlack patientsTherapeutic approvalsOlder adultsRetrospective cross-sectional studyUS Food and Drug AdministrationTrial characteristicsMinoritized patientsUS patient populationSpot trialsPivotal trialsPatient demographicsPatient populationRepresentative patientsTrial enrollmentUS Census dataDrug AdministrationPatientsStudy of trialsTrialsOncologyWomenClinical trial diversityPublic Health Implications of Legal Challenges to the FDA’s Regulation of Laboratory-Developed Tests
Kadakia K, Ross J, Ramachandran R. Public Health Implications of Legal Challenges to the FDA’s Regulation of Laboratory-Developed Tests. JAMA Health Forum 2025, 6: e252233. PMID: 40540283, DOI: 10.1001/jamahealthforum.2025.2233.Peer-Reviewed Original ResearchConceptsLaboratory-developed testsFood and Drug AdministrationPublic health implicationsEastern District of TexasSupreme Court's recent decisionAssociation of Molecular PathologyCourt's recent decisionUS District CourtClinical evidence of safetyRegulate laboratory-developed testsFood and Drug Administration regulationsUS Food and Drug AdministrationPublic health concernPublic health emergencyMedical Devices AuthorityChevron doctrineDistrict CourtAgency interpretationsClinical careHealth technologiesImplementing statutesComplex molecular testsLegal challengesAmendment ActRegulatory remitShareholder Payouts Among Large Publicly Traded Health Care Companies
Roy V, Amana V, Ross J, Gross C. Shareholder Payouts Among Large Publicly Traded Health Care Companies. JAMA Internal Medicine 2025, 185: 466-468. PMID: 39928316, PMCID: PMC11811864, DOI: 10.1001/jamainternmed.2024.7687.Peer-Reviewed Original ResearchReaffirming the JAMA Network Commitment to the Health of Patients and the Public
Bibbins-Domingo K, Bonow R, Bressler N, Brubaker L, Christakis D, Christiansen S, Curfman G, Disis M, Flanagin A, Galea S, Inouye S, Josephson S, Kibbe M, Lieu T, Malani P, McDermott M, Muth C, Öngür D, Park H, Piccirillo J, Perencevich E, Perlis R, Ross J, Shinkai K, Walter K. Reaffirming the JAMA Network Commitment to the Health of Patients and the Public. JAMA 2025, 333: 1121-1122. PMID: 39977264, DOI: 10.1001/jama.2025.2405.Peer-Reviewed Original ResearchOnline Advertising of Compounded Glucagon-Like Peptide-1 Receptor Agonists
Chetty A, Chillakanti M, Ramachandran R, Ross J, Chen A. Online Advertising of Compounded Glucagon-Like Peptide-1 Receptor Agonists. JAMA Health Forum 2025, 6: e245018. PMID: 39820389, PMCID: PMC11742527, DOI: 10.1001/jamahealthforum.2024.5018.Peer-Reviewed Original ResearchAssessing Medicare’s Coverage With Evidence Development Program
Mooghali M, Moneer O, Janda G, Dhruva S, Ross J, Ramachandran R. Assessing Medicare’s Coverage With Evidence Development Program. Health Affairs 2025, 44: 32-39. PMID: 39761464, DOI: 10.1377/hlthaff.2024.00814.Peer-Reviewed Original Research
2024
Representativeness of Studies Required Under Medicare’s Coverage With Evidence Development Program
Mooghali M, Dhruva S, Ross J, Ramachandran R. Representativeness of Studies Required Under Medicare’s Coverage With Evidence Development Program. JAMA 2024, 332: 1943-1945. PMID: 39535767, PMCID: PMC11561719, DOI: 10.1001/jama.2024.20493.Peer-Reviewed Original ResearchHealth and the 2024 US Election
Brubaker L, Curfman G, Ross J, Bibbins-Domingo K. Health and the 2024 US Election. JAMA 2024, 332: 1791-1793. PMID: 39432399, DOI: 10.1001/jama.2024.21511.Peer-Reviewed Original ResearchMedicare Local Coverage Determinations: Evidence Quality Is Stronger For Covered Indications
Moneer O, Mooghali M, Moosa K, Ramachandran R, Ross J, Dhruva S. Medicare Local Coverage Determinations: Evidence Quality Is Stronger For Covered Indications. Health Affairs 2024, 43: 1712-1718. PMID: 39626147, DOI: 10.1377/hlthaff.2024.00182.Peer-Reviewed Original ResearchConceptsCentury Cures ActLocal coverage determinationsCures ActQuality of evidenceHigh-risk devicesCoverage decisionsPatient ageClinical evidenceClinical studiesCoverage determinationMedical literatureTherapeutic drugsSixty-fiveCoverage databaseEvidence strengthEvidence qualityEvidence summaryActMedicare coverage decisionsMedicare beneficiary populationRetraction of publications in Spain: A retrospective analysis using the Retraction Watch database
Candal-Pedreira C, Ross J, Rey-Brandariz J, Ruano-Ravina A. Retraction of publications in Spain: A retrospective analysis using the Retraction Watch database. Medicina Clínica (English Edition) 2024, 163: 626-633. DOI: 10.1016/j.medcle.2024.07.015.Peer-Reviewed Original ResearchFeasibility of Multi-Modal Physical Function Data Collection to Assess Treatment Tolerability in Patients with Lymphoma
Paludo J, Dueck A, Bhatnagar V, Brown A, Cathcart-Rake E, Copley D, Diamond M, Faust L, Fiero M, Huntington S, Jeffery M, Jones L, Noble B, Power B, Ritchie J, Ross J, Ruddy K, Schellhorn S, Tarver M, Torre L, Wood W, Gross C, Kluetz P, Thanarajasingam G. Feasibility of Multi-Modal Physical Function Data Collection to Assess Treatment Tolerability in Patients with Lymphoma. Blood 2024, 144: 387-387. DOI: 10.1182/blood-2024-194607.Peer-Reviewed Original ResearchEastern Cooperative Oncology GroupPhysical functionPatient reportsTreatment toleranceCompletion ratesBaseline 6MWTExit surveyInterquartile rangeAssess treatment tolerancePost-treatment follow-upAssessment of PFCooperative Oncology GroupMedian wear timeUnique implementation challengesWearable sensor dataWalk testCytotoxic chemotherapyNon-Hispanic/LatinoNo standard approachOncology GroupAlaska NativesPerformance statusPF measuresFull-time employmentMedian timeMedical Devices Applying for Outpatient Medicare Supplemental Payments
Moneer O, Johnston J, Rathi V, Ross J, Dhruva S. Medical Devices Applying for Outpatient Medicare Supplemental Payments. JAMA Health Forum 2024, 5: e244016. PMID: 39546305, PMCID: PMC11568453, DOI: 10.1001/jamahealthforum.2024.4016.Peer-Reviewed Original ResearchConceptsCenters for Medicare & Medicaid ServicesMedicare beneficiariesUS Centers for Medicare & Medicaid ServicesCross-sectional studyCross-sectional analysisPatient demographic characteristicsClinical decision-makingMedicaid ServicesMain OutcomesHispanic patientsClinical evidence requirementsPremarket clinical studyOutpatient settingOutpatient paymentsTraditional pathwaysMedicareSupplemental paymentsFiscal yearTransitional pass-through paymentsReimbursementDemographic dataEffectiveness end pointPathway applicationClinical studiesAuthorization pathwaysAdoption of the voluntary conflict of interest statement on PubMed
Rogus S, Ross J, Lurie P. Adoption of the voluntary conflict of interest statement on PubMed. PLOS ONE 2024, 19: e0308782. PMID: 39475909, PMCID: PMC11524491, DOI: 10.1371/journal.pone.0308782.Peer-Reviewed Original ResearchDirect oral anticoagulant approvals by four major regulatory agencies: a cross-sectional analysis of premarket and postmarket evidence
Mooghali M, Zhou T, Ross J. Direct oral anticoagulant approvals by four major regulatory agencies: a cross-sectional analysis of premarket and postmarket evidence. BMJ Open 2024, 14: e090376. PMID: 39461853, PMCID: PMC11529451, DOI: 10.1136/bmjopen-2024-090376.Peer-Reviewed Original ResearchConceptsPhase 2 trialPhase 3 trialBox warningAtrial fibrillation patientsPostmarketing evidenceEvidence of safetyOral anticoagulantsFibrillation patientsPostmarketing studiesCross-sectional analysisDegree of concordanceStroke preventionStudy requirementsPostmarketingEfficacy evidenceRegulatory agenciesDrugPostmarketing requirementsInterpretation of resultsEfficacyHealth CanadaSample sizeSafety evidenceConcordanceEndpointKidney Outcomes with Glucagon-Like Peptide-1 Receptor Agonists, Sodium-Glucose Cotransporter 2 Inhibitors, Dipeptidyl Peptidase-4 Inhibitors, and Sulfonylureas in Type 2 Diabetes and Moderate Cardiovascular Risk
Neumiller J, Herrin J, Swarna K, Polley E, Galindo R, Umpierrez G, Deng Y, Ross J, Mickelson M, McCoy R. Kidney Outcomes with Glucagon-Like Peptide-1 Receptor Agonists, Sodium-Glucose Cotransporter 2 Inhibitors, Dipeptidyl Peptidase-4 Inhibitors, and Sulfonylureas in Type 2 Diabetes and Moderate Cardiovascular Risk. Clinical Journal Of The American Society Of Nephrology 2024, 20: 206-217. PMID: 39729347, PMCID: PMC11835155, DOI: 10.2215/cjn.0000000587.Peer-Reviewed Original ResearchSodium-glucose co-transporter 2 inhibitorsGlucagon-like peptide-1 receptor agonistsSodium-glucose co-transporter 2Dipeptidyl peptidase-4 inhibitorsGlucagon-like peptide-1Dipeptidyl peptidase-4Receptor agonistsPrimary composite outcomeKidney replacement therapyChronic kidney diseaseComposite outcomeSecondary composite outcomeType 2 diabetesGLP-1 receptor agonist therapyCVD riskCardiovascular diseaseModerate CVD riskPrescribed glucose-lowering agentsBaseline CVD riskHigh-risk patientsAssociated with risk reductionCKD stage 3Retrospective observational studyGlucose-lowering agentsModerate cardiovascular riskModernizing Medical Device Regulation: Challenges and Opportunities for the 510(k) Clearance Process.
Kadakia K, Rathi V, Dhruva S, Ross J, Krumholz H. Modernizing Medical Device Regulation: Challenges and Opportunities for the 510(k) Clearance Process. Annals Of Internal Medicine 2024, 177: 1558-1565. PMID: 39374526, DOI: 10.7326/annals-24-00728.Peer-Reviewed Original ResearchAt-Home Testing for Survivors of Sexual Assault—Empowerment or Exploitation?
Kadakia K, Ross J, Ramachandran R. At-Home Testing for Survivors of Sexual Assault—Empowerment or Exploitation? JAMA Internal Medicine 2024, 184: 1153-1155. PMID: 39133501, DOI: 10.1001/jamainternmed.2024.2883.Peer-Reviewed Original Research
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