2024
Medical 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 evidenceConcordanceEndpointPremarket 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 AdministrationTherapyIntravascular Microaxial Left Ventricular Assist Device Manufacturer Payments to Cardiologists and Use of Devices
Dhruva S, Ross J, Steinman M, Gan S, Muluk S, Anderson T. Intravascular Microaxial Left Ventricular Assist Device Manufacturer Payments to Cardiologists and Use of Devices. JAMA 2024, 331: 1499-1501. PMID: 38598231, PMCID: PMC11007652, DOI: 10.1001/jama.2024.4682.Peer-Reviewed Original ResearchMeSH KeywordsAdultCardiologistsCross-Sectional StudiesFemaleHeart FailureHeart-Assist DevicesHumansMaleMedicare Part BMiddle AgedUnited States
2023
Studies Of Prescription Digital Therapeutics Often Lack Rigor And Inclusivity
Kumar A, Ross J, Patel N, Rathi V, Redberg R, Dhruva S. Studies Of Prescription Digital Therapeutics Often Lack Rigor And Inclusivity. Health Affairs 2023, 42: 1559-1567. PMID: 37931187, DOI: 10.1377/hlthaff.2023.00384.Peer-Reviewed Original ResearchConceptsPrescription digital therapeuticDigital therapeuticsClinical studiesRetrospective cross-sectional analysisCross-sectional analysisStrong evidence baseHalf of studiesUpper age limitPremarket studiesDrug AdministrationClinician's prescriptionClinical useClinical researchEvidence baseTherapeuticsOne-thirdTrends in the Use of Gabapentinoids and Opioids in the Postoperative Period Among Older Adults
Bongiovanni T, Gan S, Finlayson E, Ross J, Harrison J, Boscardin W, Steinman M. Trends in the Use of Gabapentinoids and Opioids in the Postoperative Period Among Older Adults. JAMA Network Open 2023, 6: e2318626. PMID: 37326989, PMCID: PMC10276300, DOI: 10.1001/jamanetworkopen.2023.18626.Peer-Reviewed Original ResearchMeSH KeywordsAgedAnalgesics, OpioidCross-Sectional StudiesDrug PrescriptionsFemaleHumansMaleMedicarePainPractice Patterns, Physicians'Retrospective StudiesUnited StatesConceptsPostoperative periodCross-sectional studyGabapentinoid prescribingSurgical proceduresConcomitant prescribingGabapentinoid prescriptionOlder adultsPostoperative prescribingProcedure typeSerial cross-sectional studyPatients 66 yearsUse of gabapentinoidsProportion of patientsTotal study cohortAdverse drug eventsCommon surgical procedureConcurrent prescribingMultimodal painPostoperative opioidsOpioid prescribingOpioid usePain SocietyStudy cohortMean ageDrug eventsUS Food and Drug Administration regulatory reviewer disagreements and postmarket safety actions among new therapeutics
Eadie A, MacGregor A, Wallach J, Ross J, Herder M. US Food and Drug Administration regulatory reviewer disagreements and postmarket safety actions among new therapeutics. BMJ Evidence-Based Medicine 2023, 28: 151-156. PMID: 36944478, DOI: 10.1136/bmjebm-2022-112005.Peer-Reviewed Original ResearchMeSH KeywordsCommunicationCross-Sectional StudiesHumansProduct Surveillance, PostmarketingUnited StatesUnited States Food and Drug AdministrationConceptsNovel therapeuticsNew therapeuticsUS FoodReviewer disagreementTherapeutic approvalsFDA safety communicationCross-sectional studyBlack box warningPatient populationBox warningDrug AdministrationDrug approvalFDA reviewSafety actionsRegulatory approvalTherapeuticsFDAApprovalMarket approvalFDA reviewersReviewersInstances of disagreementReviewActionAdministrationFinancial conflicts of interest among US physician authors of 2020 clinical practice guidelines: a cross-sectional study
Mooghali M, Glick L, Ramachandran R, Ross J. Financial conflicts of interest among US physician authors of 2020 clinical practice guidelines: a cross-sectional study. BMJ Open 2023, 13: e069115. PMID: 36690402, PMCID: PMC9872463, DOI: 10.1136/bmjopen-2022-069115.Peer-Reviewed Original ResearchUse of Recalled Devices in New Device Authorizations Under the US Food and Drug Administration’s 510(k) Pathway and Risk of Subsequent Recalls
Kadakia K, Dhruva S, Caraballo C, Ross J, Krumholz H. Use of Recalled Devices in New Device Authorizations Under the US Food and Drug Administration’s 510(k) Pathway and Risk of Subsequent Recalls. JAMA 2023, 329: 136-143. PMID: 36625810, PMCID: PMC9857464, DOI: 10.1001/jama.2022.23279.Peer-Reviewed Original ResearchPrimary care institutional characteristics associated with hypertension awareness, treatment, and control in the China PEACE-Million Persons Project and primary health-care survey: a cross-sectional study
Group C, Zhou T, Wang Y, Zhang H, Wu C, Tian N, Cui J, Bai X, Yang Y, Zhang X, Lu Y, Spatz E, Ross J, Krumholz H, Lu J, Li X, Hu S. Primary care institutional characteristics associated with hypertension awareness, treatment, and control in the China PEACE-Million Persons Project and primary health-care survey: a cross-sectional study. The Lancet Global Health 2023, 11: e83-e94. PMID: 36521957, DOI: 10.1016/s2214-109x(22)00428-4.Peer-Reviewed Original ResearchMeSH KeywordsAntihypertensive AgentsChinaCross-Sectional StudiesHumansHypertensionPrimary Health CareConceptsProportion of participantsPrimary care institutionsHypertension awarenessPrimary care systemBlood pressureCare institutionsCardiac Events Million Persons ProjectAverage diastolic blood pressureMedical Sciences (CAMS) Innovation FundAverage systolic blood pressureCare systemMillion Persons ProjectHistory of hypertensionDiastolic blood pressurePrimary care surveySystolic blood pressureCardiovascular disease riskBlood pressure measurementsCross-sectional studyParticipant-level dataProportion of physiciansRoutine service deliveryPrimary care roleHealth Care SurveyPublic health services
2022
Comparison of Clinical Study Results Reported in medRxiv Preprints vs Peer-reviewed Journal Articles
Janda G, Khetpal V, Shi X, Ross J, Wallach J. Comparison of Clinical Study Results Reported in medRxiv Preprints vs Peer-reviewed Journal Articles. JAMA Network Open 2022, 5: e2245847. PMID: 36484989, PMCID: PMC9856222, DOI: 10.1001/jamanetworkopen.2022.45847.Peer-Reviewed Original ResearchConceptsPrimary end pointPrimary end point resultsPeer-reviewed journalsClinical studiesEnd pointClinical trialsObservational studyStudy characteristicsEnd point resultsClinical study resultsMost clinical studiesCross-sectional studyHealth-related outcomesSample sizeMAIN OUTCOMEPeer-reviewed publicationsMedRxivEffect estimatesStudy interpretationDiscordant pairsCOVID-19TrialsRetracted papers originating from paper mills: cross sectional study
Candal-Pedreira C, Ross J, Ruano-Ravina A, Egilman D, Fernández E, Pérez-Ríos M. Retracted papers originating from paper mills: cross sectional study. The BMJ 2022, 379: e071517. PMID: 36442874, PMCID: PMC9703783, DOI: 10.1136/bmj-2022-071517.Peer-Reviewed Original ResearchConsistency between trials presented at conferences, their subsequent publications and press releases
Rowhani-Farid A, Hong K, Grewal M, Reynolds J, Zhang A, Wallach J, Ross J. Consistency between trials presented at conferences, their subsequent publications and press releases. BMJ Evidence-Based Medicine 2022, 28: 95-102. PMID: 36357160, PMCID: PMC10086295, DOI: 10.1136/bmjebm-2022-111989.Peer-Reviewed Original ResearchMeSH KeywordsCross-Sectional StudiesEvidence-Based PracticeHealth Services ResearchHumansLogistic ModelsResearch DesignResearch ReportSample SizeConceptsClinical trialsConference abstractsTrial resultsEndpoint definitionsPrimary efficacy end pointEnd pointEfficacy end pointPrimary efficacy endpointClinical Trials RegistryMedical conferencesMultiple logistic regressionCross-sectional analysisSafety endpointEfficacy endpointPeer-reviewed journalsTrial abstractsTrials RegistryTrial characteristicsConsistency of reportingSample sizePrimary analysisSecondary analysisInternational medical conferencesLogistic regressionStudy designCharacterization and corroboration of safety signals identified from the US Food and Drug Administration Adverse Event Reporting System, 2008-19: cross sectional study
Dhodapkar MM, Shi X, Ramachandran R, Chen EM, Wallach JD, Ross JS. Characterization and corroboration of safety signals identified from the US Food and Drug Administration Adverse Event Reporting System, 2008-19: cross sectional study. The BMJ 2022, 379: e071752. PMID: 36198428, PMCID: PMC9533298, DOI: 10.1136/bmj-2022-071752.Peer-Reviewed Original ResearchConceptsPotential safety signalsSafety signalsSectional studyUS FoodDrug Administration Adverse Event Reporting SystemLiterature searchAdverse Event Reporting SystemSentinel InitiativeDrug Safety CommunicationsEvent Reporting SystemDrug safety signalsAdverse eventsCase seriesCase reportRegulatory actionDrug labelingSignificant associationFDA regulatory actionsComprehensive safety evaluationFAERSFDAHospital-Administered Cancer Therapy Prices for Patients With Private Health Insurance
Xiao R, Ross JS, Gross CP, Dusetzina SB, McWilliams JM, Sethi RKV, Rathi VK. Hospital-Administered Cancer Therapy Prices for Patients With Private Health Insurance. JAMA Internal Medicine 2022, 182: 603-611. PMID: 35435948, PMCID: PMC9016607, DOI: 10.1001/jamainternmed.2022.1022.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedCross-Sectional StudiesHospitalsHumansInsurance, HealthLeuprolideMedicare Part BNeoplasmsUnited StatesConceptsCancer CenterCancer therapyCross-sectional studyHospital acquisition costNational Cancer InstituteCross-sectional analysisPrimary outcomeSecondary outcomesPrivate health insuranceMAIN OUTCOMEClinical careCancer InstituteMedicare Part B spendingTherapyAcquisition costsPart B spendingHospitalCancer treatmentHealth insuranceFinancial burdenB spendingPatientsSame centerOutcomesPayersSpending by the Centers for Medicare & Medicaid Services Before and After Confirmation of Benefit for Drugs Granted US Food and Drug Administration Accelerated Approval, 2012 to 2017
Skydel JJ, Egilman AC, Wallach JD, Ramachandran R, Gupta R, Ross JS. Spending by the Centers for Medicare & Medicaid Services Before and After Confirmation of Benefit for Drugs Granted US Food and Drug Administration Accelerated Approval, 2012 to 2017. JAMA Health Forum 2022, 3: e221158. PMID: 35977252, PMCID: PMC9142876, DOI: 10.1001/jamahealthforum.2022.1158.Peer-Reviewed Original ResearchMeSH KeywordsBiomarkersCross-Sectional StudiesDrug ApprovalMedicaidMedicarePharmaceutical PreparationsUnited StatesUnited States Food and Drug AdministrationConceptsSurrogate end pointsCross-sectional studyClinical benefitConfirmation of benefitEnd pointOriginal indicationClinical outcomesUS FoodConfirmatory trialsMedicaid ServicesPrimary end pointUnproven clinical benefitsTrial end pointsClinical trial resultsTypes of drugsPostapproval trialsAccelerated approvalClinical trialsMAIN OUTCOMEDrug AdministrationMedicare Part BStandard approvalConversion statusSupplemental indicationsTrial resultsApprovals and Timing of New Formulations of Novel Drugs Approved by the US Food and Drug Administration Between 1995 and 2010 and Followed Through 2021
Gupta R, Morten CJ, Zhu AY, Ramachandran R, Shah ND, Ross JS. Approvals and Timing of New Formulations of Novel Drugs Approved by the US Food and Drug Administration Between 1995 and 2010 and Followed Through 2021. JAMA Health Forum 2022, 3: e221096. PMID: 35977259, PMCID: PMC9123500, DOI: 10.1001/jamahealthforum.2022.1096.Peer-Reviewed Original ResearchMeSH KeywordsCross-Sectional StudiesDrug ApprovalDrugs, GenericHumansPrescription DrugsTabletsUnited StatesUnited States Food and Drug AdministrationConceptsCross-sectional studyNovel drugsTherapeutic valueUS FoodDrug AdministrationWorld Health Organization Model ListGeneric approvalCapsule formMultivariable analysisAccelerated approvalClinical usefulnessMAIN OUTCOMEPrescription drugsBrand-name drugsModel ListEssential medicinesDrugsApproval statusMedicine inclusionFDANovel tabletBlockbuster statusApprovalAdministrationDrug salesAssociation Between Payments by Pharmaceutical Manufacturers and Prescribing Behavior in Rheumatology
Duarte-García A, Crowson CS, McCoy RG, Herrin J, Lam V, Putman MS, Ross JS, Matteson EL, Shah ND. Association Between Payments by Pharmaceutical Manufacturers and Prescribing Behavior in Rheumatology. Mayo Clinic Proceedings 2022, 97: 250-260. PMID: 35120693, PMCID: PMC9013005, DOI: 10.1016/j.mayocp.2021.08.026.Peer-Reviewed Original ResearchMeSH KeywordsCross-Sectional StudiesDrug CostsDrug IndustryHumansMedicare Part DPractice Patterns, Physicians'Prescription DrugsRetrospective StudiesRheumatologyUnited StatesAssessment of Hypothetical Out-of-Pocket Costs of Guideline-Recommended Medications for the Treatment of Older Adults With Multiple Chronic Conditions, 2009 and 2019
Zhou T, Liu P, Dhruva SS, Shah ND, Ramachandran R, Berg KM, Ross JS. Assessment of Hypothetical Out-of-Pocket Costs of Guideline-Recommended Medications for the Treatment of Older Adults With Multiple Chronic Conditions, 2009 and 2019. JAMA Internal Medicine 2022, 182: 185-195. PMID: 34982097, PMCID: PMC8728660, DOI: 10.1001/jamainternmed.2021.7457.Peer-Reviewed Original ResearchMeSH KeywordsAgedAtrial FibrillationChronic DiseaseCross-Sectional StudiesDiabetes Mellitus, Type 2Drug CostsHealth ExpendituresHeart FailureHumansHypercholesterolemiaHypertensionMedicare Part CMedicare Part DMultiple Chronic ConditionsOsteoarthritisOsteoporosisPrescription DrugsPulmonary Disease, Chronic ObstructiveRetrospective StudiesUnited StatesConceptsCommon chronic diseasesGuideline-recommended medicationsGuideline-recommended managementPrescription drug plansCross-sectional studyChronic conditionsChronic diseasesPocket costsOlder adultsOutpatient medicationsMedicare prescription drug plansInitial treatmentMedicare Advantage plansRetrospective cross-sectional studyMultiple chronic conditionsMedicare Part D plansPart D plansSubstantial financial burdenAtrial fibrillationMAIN OUTCOMEExclusion criteriaMedicare beneficiariesAnnual outHypothetical patientsMedications