2024
Intravascular 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 ResearchPremarket Evidence and Postmarketing Requirements for Real-Time Oncology Review Indication Approvals
Mooghali M, Mohammad A, Wallach J, Mitchell A, Ross J, Ramachandran R. Premarket Evidence and Postmarketing Requirements for Real-Time Oncology Review Indication Approvals. JAMA Network Open 2024, 7: e249233. PMID: 38691363, PMCID: PMC11063797, DOI: 10.1001/jamanetworkopen.2024.9233.Peer-Reviewed Original ResearchIntegrating 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
Pivotal Trial Demographic Representation and Clinical Development Times for Oncology Therapeutics
Wong A, Miller J, Mooghali M, Ramachandran R, Ross J, Wallach J. Pivotal Trial Demographic Representation and Clinical Development Times for Oncology Therapeutics. JAMA 2023, 330: 2392-2394. PMID: 38079163, PMCID: PMC10714278, DOI: 10.1001/jama.2023.21958.Peer-Reviewed Original ResearchFeasibility of Emulating Clinical Trials Supporting US FDA Supplemental Indication Approvals of Drugs and Biologics
Janda G, Wallach J, Dhodapkar M, Ramachandran R, Ross J. Feasibility of Emulating Clinical Trials Supporting US FDA Supplemental Indication Approvals of Drugs and Biologics. JAMA Internal Medicine 2023, 183: 1271-1273. PMID: 37782514, PMCID: PMC10546285, DOI: 10.1001/jamainternmed.2023.4073.Peer-Reviewed Original ResearchUnique Device Identifiers for Medical Devices at 10 Years
Dhruva S, Ross J, Wilson N. Unique Device Identifiers for Medical Devices at 10 Years. JAMA Internal Medicine 2023, 183: 1045-1046. PMID: 37603351, DOI: 10.1001/jamainternmed.2023.3572.Commentaries, Editorials and LettersFinancial Conflicts of Interest in Public Comments on Medicare National Coverage Determinations of Medical Devices
Lu A, Ji R, Ge A, Ross J, Ramachandran R, Redberg R, Dhruva S. Financial Conflicts of Interest in Public Comments on Medicare National Coverage Determinations of Medical Devices. JAMA 2023, 330: 1094-1096. PMID: 37589985, PMCID: PMC10436180, DOI: 10.1001/jama.2023.14414.Peer-Reviewed Original ResearchPress Releases of Drug-Related Randomized Trial Results Prior to Publication in High-Impact Journals: an Observational Study
Purohit U, Sacks C, Raissi A, Hughes E, Boctor M, Manzoor S, Hodzic-Santor B, Zhu K, Raudanskis A, Ross J, Fralick M. Press Releases of Drug-Related Randomized Trial Results Prior to Publication in High-Impact Journals: an Observational Study. Journal Of General Internal Medicine 2023, 38: 3107-3114. PMID: 37532876, PMCID: PMC10651612, DOI: 10.1007/s11606-023-08313-1.Peer-Reviewed Original ResearchApproval of Drugs With Unmet Trial End Points—In Reply
Johnston J, Ross J, Ramachandran R. Approval of Drugs With Unmet Trial End Points—In Reply. JAMA Internal Medicine 2023, 183: 889-890. PMID: 37307009, DOI: 10.1001/jamainternmed.2023.2240.Peer-Reviewed Original ResearchTherapeutic 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 subsetProportionPhysiciansAssociation of Receipt of Paycheck Protection Program Loans With Staffing Patterns Among US Nursing Homes
Travers J, McGarry B, Friedman S, Holaday L, Ross J, Lopez L, Chen K. Association of Receipt of Paycheck Protection Program Loans With Staffing Patterns Among US Nursing Homes. JAMA Network Open 2023, 6: e2326122. PMID: 37498597, PMCID: PMC10375300, DOI: 10.1001/jamanetworkopen.2023.26122.Peer-Reviewed Original ResearchConceptsUS nursing homesNursing homesPaycheck Protection ProgramPPP loansMean differenceEconomic evaluationLoan programsLoan recipientsAssociation of receiptArea Deprivation IndexHealthcare Cost Report Information SystemAgriculture Rural-Urban Continuum CodesRural-Urban Continuum CodesTotal weekly hoursEvent study approachNursing Home CompareMinimum Data SetSmall Business AdministrationPaycheck Protection Program (PPP) loansMAIN OUTCOMELPN hoursPractical nursesResident careLoan amountStudy periodAvailability of Unique Device Identifiers for Class I Medical Device Recalls From 2018 to 2022
Mooghali M, Ross J, Kadakia K, Dhruva S. Availability of Unique Device Identifiers for Class I Medical Device Recalls From 2018 to 2022. JAMA Internal Medicine 2023, 183: 735-737. PMID: 37184854, PMCID: PMC10186206, DOI: 10.1001/jamainternmed.2023.0727.Peer-Reviewed Original ResearchExtending the US Food and Drug Administration’s Postmarket Authorities
Lynch H, Sachs R, Lee S, Herder M, Ross J, Ramachandran R. Extending the US Food and Drug Administration’s Postmarket Authorities. JAMA Health Forum 2023, 4: e231313. PMID: 37294583, DOI: 10.1001/jamahealthforum.2023.1313.Commentaries, Editorials and LettersTrends 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 ResearchConceptsPostoperative 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 Review Time of Supplemental New Indication Approvals of Drugs and Biologics, 2017 to 2019
Dhodapkar M, Ross J, Ramachandran R. US Food and Drug Administration Review Time of Supplemental New Indication Approvals of Drugs and Biologics, 2017 to 2019. JAMA Network Open 2023, 6: e2318889. PMID: 37358857, PMCID: PMC10293905, DOI: 10.1001/jamanetworkopen.2023.18889.Peer-Reviewed Original ResearchLongitudinal Patterns in Testosterone Prescribing After US FDA Safety Communication in 2014
Sankar A, Everhart A, Jena A, Jeffery M, Ross J, Shah N, Karaca-Mandic P. Longitudinal Patterns in Testosterone Prescribing After US FDA Safety Communication in 2014. The Joint Commission Journal On Quality And Patient Safety 2023, 49: 458-466. PMID: 37380503, DOI: 10.1016/j.jcjq.2023.05.003.Peer-Reviewed Original ResearchConceptsCoronary artery diseaseFDA safety communicationPhysician characteristicsLabel prescribingCare physiciansTestosterone prescribingService administrative claims dataNon-primary care physiciansCertain physician characteristicsDrug Administration (FDA) safety communicationPrimary care physiciansAdministrative claims dataCase mix indexTestosterone therapyArtery diseaseTestosterone prescriptionsPrescribing levelsMean agePrescription trendsTeaching hospitalClaims dataPrescription levelsMedicare feePrescribingUS FoodTrends in Spending and Claims for P2Y12 Inhibitors by Medicare and Medicaid From 2015 to 2020
Essa M, Ross J, Dhruva S, Desai N, Yeh R, Faridi K. Trends in Spending and Claims for P2Y12 Inhibitors by Medicare and Medicaid From 2015 to 2020. Journal Of The American Heart Association 2023, 12: e028869. PMID: 37042289, PMCID: PMC10227267, DOI: 10.1161/jaha.122.028869.Peer-Reviewed Original ResearchEnsuring Public Trust in an Empowered FDA
Ross J, Berg K, Ramachandran R. Ensuring Public Trust in an Empowered FDA. New England Journal Of Medicine 2023, 388: 1249-1251. PMID: 37017494, DOI: 10.1056/nejmp2300438.Peer-Reviewed Original ResearchUS Food and Drug Administration Approval of Drugs Not Meeting Pivotal Trial Primary End Points, 2018-2021
Johnston J, Ross J, Ramachandran R. US Food and Drug Administration Approval of Drugs Not Meeting Pivotal Trial Primary End Points, 2018-2021. JAMA Internal Medicine 2023, 183: 376-380. PMID: 36780148, PMCID: PMC9926353, DOI: 10.1001/jamainternmed.2022.6444.Peer-Reviewed Original ResearchMeSH KeywordsDrug ApprovalHumansPharmaceutical PreparationsResearch DesignUnited StatesUnited States Food and Drug AdministrationUS 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 ResearchConceptsNovel therapeuticsNew therapeuticsUS FoodReviewer disagreementTherapeutic approvalsFDA safety communicationCross-sectional studyBlack box warningPatient populationBox warningDrug AdministrationDrug approvalFDA reviewSafety actionsRegulatory approvalTherapeuticsFDAApprovalMarket approvalFDA reviewersReviewersInstances of disagreementReviewActionAdministration