2024
Kidney Outcomes with GLP-1RAs, SGLT2 Inhibitors, DPP-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 GLP-1RAs, SGLT2 Inhibitors, DPP-4 Inhibitors, and Sulfonylureas in Type 2 Diabetes and Moderate Cardiovascular Risk. Clinical Journal Of The American Society Of Nephrology 2024 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 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 ResearchUse 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 measurementsClass I Recalls of Cardiovascular Devices Between 2013 and 2022 : A Cross-Sectional Analysis.
See C, Mooghali M, Dhruva S, Ross J, Krumholz H, Kadakia K. Class I Recalls of Cardiovascular Devices Between 2013 and 2022 : A Cross-Sectional Analysis. Annals Of Internal Medicine 2024 PMID: 39284187, DOI: 10.7326/annals-24-00724.Peer-Reviewed Original ResearchCross-sectional studyCross-sectional analysisAdverse health consequencesPatient safetyClinical testingClass IHealth consequencesClinical evidenceFDA summariesPostapproval studiesDecision summariesFood and Drug AdministrationU.S. Food and Drug AdministrationEnd-point selectionPremarket approvalMultiple class IClinical studiesPostmarketing surveillanceSummaryDrug AdministrationMedical device recall databaseRecallPatientsFDAPostmarketingRetraction 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 2024 PMID: 39277442, DOI: 10.1016/j.medcli.2024.07.003.Peer-Reviewed Original ResearchComparative Effectiveness of Second-Line Antihyperglycemic Agents for Cardiovascular Outcomes A Multinational, Federated Analysis of LEGEND-T2DM
Khera R, Aminorroaya A, Dhingra L, Thangaraj P, Pedroso Camargos A, Bu F, Ding X, Nishimura A, Anand T, Arshad F, Blacketer C, Chai Y, Chattopadhyay S, Cook M, Dorr D, Duarte-Salles T, DuVall S, Falconer T, French T, Hanchrow E, Kaur G, Lau W, Li J, Li K, Liu Y, Lu Y, Man K, Matheny M, Mathioudakis N, McLeggon J, McLemore M, Minty E, Morales D, Nagy P, Ostropolets A, Pistillo A, Phan T, Pratt N, Reyes C, Richter L, Ross J, Ruan E, Seager S, Simon K, Viernes B, Yang J, Yin C, You S, Zhou J, Ryan P, Schuemie M, Krumholz H, Hripcsak G, Suchard M. Comparative Effectiveness of Second-Line Antihyperglycemic Agents for Cardiovascular Outcomes A Multinational, Federated Analysis of LEGEND-T2DM. Journal Of The American College Of Cardiology 2024, 84: 904-917. PMID: 39197980, DOI: 10.1016/j.jacc.2024.05.069.Peer-Reviewed Original ResearchConceptsGLP-1 RAsSecond-line agentsGLP-1Antihyperglycemic agentsCardiovascular diseaseMACE riskGlucagon-like peptide-1 receptor agonistsSodium-glucose cotransporter 2 inhibitorsPeptide-1 receptor agonistsDipeptidyl peptidase-4 inhibitorsEffects of SGLT2isType 2 diabetes mellitusPeptidase-4 inhibitorsAdverse cardiovascular eventsCox proportional hazards modelsRandom-effects meta-analysisCardiovascular risk reductionTarget trial emulationProportional hazards modelFloods and cause-specific mortality in the United States during 2001-2020
Chu L, Warren J, Spatz E, Lowe S, Lu Y, Ma X, Ross J, Krumholz H, Chen K. Floods and cause-specific mortality in the United States during 2001-2020. ISEE Conference Abstracts 2024, 2024 DOI: 10.1289/isee.2024.1705.Peer-Reviewed Original ResearchPremarket Pivotal Trial End Points and Postmarketing Requirements for FDA Breakthrough Therapies
Mooghali M, Wallach J, Ross J, Ramachandran R. Premarket Pivotal Trial End Points and Postmarketing Requirements for FDA Breakthrough Therapies. JAMA Network Open 2024, 7: e2430486. PMID: 39190303, PMCID: PMC11350476, DOI: 10.1001/jamanetworkopen.2024.30486.Peer-Reviewed Original ResearchConceptsFood and Drug Administration tableFood and Drug AdministrationSurrogate end pointsSurrogate markerPostmarketing studiesEnd pointsTraditional approvalCross-sectional studyClinical benefitAccelerated approvalTherapy designClinically significant end pointsReview of therapeuticsPrimary end pointUS Food and Drug AdministrationTrial end pointsSignificant end pointsPostmarketing requirementsPreliminary clinical evidenceApproval pathwayPivotal trialsClinical evidenceBreakthrough therapiesDrug AdministrationTherapyUnveiling the Adoption and Barriers of Telemedicine in US Hospitals: A Comprehensive Analysis (2017-2022).
Jiang JX, Ross JS, Bai G. Unveiling the Adoption and Barriers of Telemedicine in US Hospitals: A Comprehensive Analysis (2017-2022). J Gen Intern Med 2024 PMID: 38985409, DOI: 10.1007/s11606-024-08853-0.Peer-Reviewed Original ResearchReporting of surrogate endpoints in randomised controlled trial reports (CONSORT-Surrogate): extension checklist with explanation and elaboration
Manyara A, Davies P, Stewart D, Weir C, Young A, Blazeby J, Butcher N, Bujkiewicz S, Chan A, Dawoud D, Offringa M, Ouwens M, Hróbjartsson A, Amstutz A, Bertolaccini L, Bruno V, Devane D, Faria C, Gilbert P, Harris R, Lassere M, Marinelli L, Markham S, Powers J, Rezaei Y, Richert L, Schwendicke F, Tereshchenko L, Thoma A, Turan A, Worrall A, Christensen R, Collins G, Ross J, Taylor R, Ciani O. Reporting of surrogate endpoints in randomised controlled trial reports (CONSORT-Surrogate): extension checklist with explanation and elaboration. The BMJ 2024, 386: e078524. PMID: 38981645, PMCID: PMC11231881, DOI: 10.1136/bmj-2023-078524.Peer-Reviewed Original ResearchConceptsRandomised controlled trial reportsTrial reportsRandomised controlled trialsControlled trial reportsIntervention treatment effectsResearch wasteTrial findingsTreatment effectsControlled trialsTarget outcomesChecklistAdequate informationSurrogate endpointsInterventionCONSORTItemsTrialsImprove transparencyHarmReportsGuidelinesOutcomesEndpointReporting of surrogate endpoints in randomised controlled trial protocols (SPIRIT-Surrogate): extension checklist with explanation and elaboration
Manyara A, Davies P, Stewart D, Weir C, Young A, Blazeby J, Butcher N, Bujkiewicz S, Chan A, Dawoud D, Offringa M, Ouwens M, Hróbjartsson A, Amstutz A, Bertolaccini L, Bruno V, Devane D, Faria C, Gilbert P, Harris R, Lassere M, Marinelli L, Markham S, Powers J, Rezaei Y, Richert L, Schwendicke F, Tereshchenko L, Thoma A, Turan A, Worrall A, Christensen R, Collins G, Ross J, Taylor R, Ciani O. Reporting of surrogate endpoints in randomised controlled trial protocols (SPIRIT-Surrogate): extension checklist with explanation and elaboration. The BMJ 2024, 386: e078525. PMID: 38981624, PMCID: PMC11231880, DOI: 10.1136/bmj-2023-078525.Peer-Reviewed Original ResearchConceptsTrial protocolRandomised controlled trial protocolTarget outcomesReduce research wasteStandard Protocol ItemsRandomised controlled trialsIntervention effectsProtocol ItemsInterpretation of findingsResearch wasteImprove reportingPrimary outcome(sIntervention trialsControlled trialsChecklistSurrogate endpointsInterventionItemsIncreasing callsTrialsGuidelinesOutcomesLimited informationOutcome(sHarmUse of Muscle Relaxants After Surgery in Traditional Medicare Part D Enrollees
Bongiovanni T, Gan S, Finlayson E, Ross J, Harrison J, Boscardin J, Steinman M. Use of Muscle Relaxants After Surgery in Traditional Medicare Part D Enrollees. Drugs & Aging 2024, 41: 615-622. PMID: 38980644, PMCID: PMC11249446, DOI: 10.1007/s40266-024-01124-x.Peer-Reviewed Original ResearchConceptsMuscle relaxant prescriptionsOlder adultsSpine proceduresPain controlMuscle relaxationRisk of prolonged useProlonged useMedication-related problemsDecreased opioid useRates of prescribingMuscle relaxant useResultsThe study cohortPostoperative pain managementPrescribed to patientsYears of agePostoperative prescribingStudy DesignUsingNonopioid medicationsOpioid useOpioid prescribingMedicare Part DPostoperative periodMedicare Part D enrolleesRetrospective analysisPain managementThe Integration of Clinical Trials With the Practice of Medicine: Repairing a House Divided.
Angus DC, Huang AJ, Lewis RJ, Abernethy AP, Califf RM, Landray M, Kass N, Bibbins-Domingo K, JAMA Summit on Clinical Trials Participants. The Integration of Clinical Trials With the Practice of Medicine: Repairing a House Divided. JAMA 2024, 332: 153-162. PMID: 38829654, DOI: 10.1001/jama.2024.4088.Commentaries, Editorials and LettersAltmetric Attention Scores and Citations of Published Research With or Without Preprints
Zissette S, Gautam A, Krumholz H, Ross J, Wallach J. Altmetric Attention Scores and Citations of Published Research With or Without Preprints. JAMA Network Open 2024, 7: e2424732. PMID: 39058492, PMCID: PMC11282438, DOI: 10.1001/jamanetworkopen.2024.24732.Peer-Reviewed Original ResearchPrescription Digital Therapeutics: The Authors Reply
Kumar A, Redberg R, Dhruva S, Ross J. Prescription Digital Therapeutics: The Authors Reply. Health Affairs 2024, 43: 898-898. PMID: 38830149, DOI: 10.1377/hlthaff.2024.00278.Peer-Reviewed Original ResearchHPR109 Evaluation of Evidence Informing Medicare’s Coverage With Evidence Development Decision Updates
Mooghali M, Moneer O, Janda G, Dhruva S, Ross J, Ramachandran R. HPR109 Evaluation of Evidence Informing Medicare’s Coverage With Evidence Development Decision Updates. Value In Health 2024, 27: s214. DOI: 10.1016/j.jval.2024.03.1178.Peer-Reviewed Original ResearchAssessing Real-World Data From Electronic Health Records for Health Technology Assessment: The SUITABILITY Checklist: A Good Practices Report of an ISPOR Task Force.
Fleurence RL, Kent S, Adamson B, Tcheng J, Balicer R, Ross JS, Haynes K, Muller P, Campbell J, Bouée-Benhamiche E, García Martí S, Ramsey S. Assessing Real-World Data From Electronic Health Records for Health Technology Assessment: The SUITABILITY Checklist: A Good Practices Report of an ISPOR Task Force. Value Health 2024, 27: 692-701. PMID: 38871437, DOI: 10.1016/j.jval.2024.01.019.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsIntegrating 4 Methods (In4M) to evaluate physical function in patients with cancer: Results of a comprehensive digital health study.
Thanarajasingam G, Dueck A, Bhatnagar V, Brown A, Cathcart-Rake E, Diamond M, Faust L, Fiero M, Huntington S, Jeffery M, Jones L, Paludo J, Power B, Ross J, Ruddy K, Schellhorn S, Tarver M, Wood W, Gross C, Kluetz P. Integrating 4 Methods (In4M) to evaluate physical function in patients with cancer: Results of a comprehensive digital health study. Journal Of Clinical Oncology 2024, 42: 1564-1564. DOI: 10.1200/jco.2024.42.16_suppl.1564.Peer-Reviewed Original ResearchPhysical functionPF measuresDaily stepsClinically meaningful change scoresAverage daily stepsEvaluate physical functionDigital health studiesMeasures of PFWearable dataHealth StudyWalk testWeekend daysCore outcomeChange scoresPerformance statusTreatment toleranceDetect changesPearson correlationECOG performance statusBreast cancerEvaluate feasibilityCancer trialsSignificant declineData collectionBaselineRetracted papers originating from paper mills: a cross-sectional analysis of references and citations
Candal-Pedreira C, Guerra-Tort C, Ruano-Ravina A, Freijedo-Farinas F, Rey-Brandariz J, Ross J, Pérez-Ríos M. Retracted papers originating from paper mills: a cross-sectional analysis of references and citations. Journal Of Clinical Epidemiology 2024, 172: 111397. PMID: 38815634, DOI: 10.1016/j.jclinepi.2024.111397.Peer-Reviewed Original Research