2025
Public 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 remitAssessing 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
Medicare 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 populationMedical 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 evidenceConcordanceEndpointTemporary FDA Advisory Committee Members, Recommendations, and Agency Actions, 2017-2021
Chaudhry N, Zhang A, Schwartz J, Ramachandran R, Ross J. Temporary FDA Advisory Committee Members, Recommendations, and Agency Actions, 2017-2021. JAMA Network Open 2024, 7: e2436789. PMID: 39352702, PMCID: PMC11445682, DOI: 10.1001/jamanetworkopen.2024.36789.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 measurementsComparative 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, PMCID: PMC12045554, 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 modelPremarket 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 J, Ross J, Bai G. Unveiling the Adoption and Barriers of Telemedicine in US Hospitals: A Comprehensive Analysis (2017–2022). Journal Of General Internal Medicine 2024, 39: 2438-2445. PMID: 38985409, PMCID: PMC11436691, DOI: 10.1007/s11606-024-08853-0.Peer-Reviewed Original ResearchConceptsElectronic health information exchangeHealth information exchangePercentage of hospitalsUS hospitalsTelemedicine servicesNational sample of US hospitalsHealth IT developmentAdoption of telemedicine servicesBarriers of telemedicineHealthcare delivery modelsAmerican Hospital AssociationUrban-rural disparitiesSample of US hospitalsComprehensive policy interventionsEHR vendorsTelehealth adoptionHealthcare deliveryHospital AssociationHospital typePatient encountersTelemedicine adoptionDelivery modelsInstitutional challengesU.S. hospitalsStudy participantsReporting 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 managementReporting 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 transparencyHarmReportsGuidelinesOutcomesEndpointThe Integration of Clinical Trials With the Practice of Medicine
Angus D, Huang A, Lewis R, Abernethy A, Califf R, Landray M, Kass N, Bibbins-Domingo K, Abbasi A, Abebe K, Abernethy A, Adam S, Angus D, Ard J, Berkwits M, Bender Ignacio R, Berry S, Bhatt D, Bibbins-Domingo K, Bonow R, Bonten M, Brangman S, Brownstein J, Buntin M, Butte A, Califf R, Campbell M, Cappola A, Chiang A, Cook D, Cummings S, Curfman G, Esserman L, Fleisher L, Franklin J, Gonzalez R, Grossman C, Haddad T, Herbst R, Hernandez A, Holder D, Horn L, Huang G, Huang A, Kass N, Khera R, Koroshetz W, Krumholz H, Landray M, Lewis R, Lieu T, Malani P, Martin C, McClellan M, McDermott M, Morain S, Murphy S, Nicholls S, Nicholls S, O'Dwyer P, Patel B, Peterson E, Prindiville S, Ross J, Rowan K, Rubenfeld G, Seymour C, Taylor R, Waldstreicher J, Wang T. The Integration of Clinical Trials With the Practice of Medicine. JAMA 2024, 332: 153-162. PMID: 38829654, PMCID: PMC12045079, DOI: 10.1001/jama.2024.4088.Peer-Reviewed Original ResearchConceptsHealth care delivery enterpriseHealth care deliveryCare deliveryIntegrity of clinical trialsRandomized clinical trialsHealth careOptimal health care deliveryHealth care delivery systemCare delivery systemLearning health systemElectronic health recordsPractice of medicineHealth recordsImplementation scienceHealth systemHealth dataOptimal careQuality improvementCareNonfinancial incentivesVulnerable populationsPoor accessStudy designClinical trialsHealthAltmetric 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 ResearchElectronic PrescribingHumansAssessing Real-World Data From Electronic Health Records for Health Technology Assessment: The SUITABILITY Checklist: A Good Practices Report of an ISPOR Task Force
Fleurence R, Kent S, Adamson B, Tcheng J, Balicer R, Ross J, 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 In Health 2024, 27: 692-701. PMID: 38871437, PMCID: PMC11182651, DOI: 10.1016/j.jval.2024.01.019.Peer-Reviewed Original ResearchConceptsElectronic health recordsHealth technology assessmentElectronic health record dataEHR-derived dataHealth record dataTechnology assessmentHealth technology assessment agenciesHealth recordsGenerative artificial intelligenceData provenanceLanguage modelEvidence gapsPractice reportArtificial intelligenceRecord dataISPOR Task ForceData characteristicsData governanceReal worldEvidence developmentTask ForceReal World DataISPORChecklistRelevant itemsA Public Option for Clinical Trials? Lessons from Convalescent Plasma.
Roy V, Ross J, Ramachandran R. A Public Option for Clinical Trials? Lessons from Convalescent Plasma. The Journal Of Law, Medicine & Ethics 2024, 52: 98-100. PMID: 38818610, DOI: 10.1017/jme.2024.57.Peer-Reviewed Original ResearchAssociations Between Surrogate Markers and Clinical Outcomes for Nononcologic Chronic Disease Treatments
Wallach J, Yoon S, Doernberg H, Glick L, Ciani O, Taylor R, Mooghali M, Ramachandran R, Ross J. Associations Between Surrogate Markers and Clinical Outcomes for Nononcologic Chronic Disease Treatments. JAMA 2024, 331: 1646-1654. PMID: 38648042, PMCID: PMC11036312, DOI: 10.1001/jama.2024.4175.Peer-Reviewed Original ResearchConceptsMeta-analysesChronic diseasesFood and Drug AdministrationMeta-regression analysisMeta-analyses of observational studiesSurrogate markerClinical outcomesClinical trialsMeta-analysisEvidence of associationPublished meta-analysesStrength of associationMeta-analyses of clinical trialsChronic disease treatmentFood and Drug Administration tableResults of meta-regression analysisOutcome pairsFood and Drug Administration approvalMain OutcomesData extractionSystematic reviewStatistically significant resultsObservational studyPooled analysisDrug Administration
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