2023
Adding device identifiers to claims forms—a key step to advance medical device safety
Kadakia K, Dhruva S, Ross J, Krumholz H. Adding device identifiers to claims forms—a key step to advance medical device safety. The BMJ 2023, 380: p82. PMID: 36631149, DOI: 10.1136/bmj.p82.Commentaries, Editorials and Letters
2021
Strengthening the FDA’s Enforcement of ClinicalTrials.gov Reporting Requirements
Ramachandran R, Morten CJ, Ross JS. Strengthening the FDA’s Enforcement of ClinicalTrials.gov Reporting Requirements. JAMA 2021, 326: 2131-2132. PMID: 34766971, DOI: 10.1001/jama.2021.19773.Commentaries, Editorials and LettersMeSH KeywordsActivin Receptors, Type IIAntineoplastic AgentsAxitinibCarcinoma, Renal CellClinical Trials as TopicClinical Trials, Phase II as TopicDrug IndustryHumansImmunoglobulin Fc FragmentsKidney NeoplasmsLaw EnforcementMandatory ReportingNational Institutes of Health (U.S.)Recombinant Fusion ProteinsRegistriesUnited StatesUnited States Food and Drug Administration
2020
Association Between Industry Payments to Physicians and Device Selection in ICD Implantation
Annapureddy AR, Henien S, Wang Y, Minges KE, Ross JS, Spatz ES, Desai NR, Peterson PN, Masoudi FA, Curtis JP. Association Between Industry Payments to Physicians and Device Selection in ICD Implantation. JAMA 2020, 324: 1755-1764. PMID: 33141208, PMCID: PMC7610190, DOI: 10.1001/jama.2020.17436.Peer-Reviewed Original ResearchConceptsCRT-D implantationCRT-D devicesCross-sectional studyNational Cardiovascular Data Registry ICD RegistryFirst-time ICDFirst-time implantationProportion of patientsEntire study cohortDevice selectionProportion of devicesICD implantationICD RegistryPrimary outcomeCardiac resynchronizationStudy cohortPatient groupMAIN OUTCOMEPatientsPhysiciansICDAbsolute differenceImplantationManufacturer CHigher total paymentsAssociationMandatory Registration and Results Reporting of Real-World Evidence Studies of FDA-Regulated Medical Products
Dhruva SS, Shah ND, Ross JS. Mandatory Registration and Results Reporting of Real-World Evidence Studies of FDA-Regulated Medical Products. Mayo Clinic Proceedings 2020, 95: 2609-2611. PMID: 33289654, DOI: 10.1016/j.mayocp.2020.04.013.Commentaries, Editorials and LettersCharacteristics of Ongoing Clinical Trials for Alcohol Use Disorder Registered on ClinicalTrials.gov
Wallach JD, Krystal JH, Ross JS, O’Malley S. Characteristics of Ongoing Clinical Trials for Alcohol Use Disorder Registered on ClinicalTrials.gov. JAMA Psychiatry 2020, 77: 1081-1084. PMID: 32459295, PMCID: PMC7254444, DOI: 10.1001/jamapsychiatry.2020.1167.Peer-Reviewed Original ResearchConsistency of trial reporting between ClinicalTrials.gov and corresponding publications: one decade after FDAAA
Talebi R, Redberg RF, Ross JS. Consistency of trial reporting between ClinicalTrials.gov and corresponding publications: one decade after FDAAA. Trials 2020, 21: 675. PMID: 32703252, PMCID: PMC7376878, DOI: 10.1186/s13063-020-04603-9.Peer-Reviewed Original ResearchDisagreements Within the US Food and Drug Administration Regarding Approval of Novel Therapeutic Agents, 2011-2015
MacGregor A, Zhang AD, Wallach JD, Ross JS, Herder M. Disagreements Within the US Food and Drug Administration Regarding Approval of Novel Therapeutic Agents, 2011-2015. JAMA Network Open 2020, 3: e209498. PMID: 32706379, PMCID: PMC7382003, DOI: 10.1001/jamanetworkopen.2020.9498.Peer-Reviewed Original ResearchAssociation of Use of an Intravascular Microaxial Left Ventricular Assist Device vs Intra-aortic Balloon Pump With In-Hospital Mortality and Major Bleeding Among Patients With Acute Myocardial Infarction Complicated by Cardiogenic Shock
Dhruva SS, Ross JS, Mortazavi BJ, Hurley NC, Krumholz HM, Curtis JP, Berkowitz A, Masoudi FA, Messenger JC, Parzynski CS, Ngufor C, Girotra S, Amin AP, Shah ND, Desai NR. Association of Use of an Intravascular Microaxial Left Ventricular Assist Device vs Intra-aortic Balloon Pump With In-Hospital Mortality and Major Bleeding Among Patients With Acute Myocardial Infarction Complicated by Cardiogenic Shock. JAMA 2020, 323: 734-745. PMID: 32040163, PMCID: PMC7042879, DOI: 10.1001/jama.2020.0254.Peer-Reviewed Original ResearchMeSH KeywordsAgedCause of DeathExtracorporeal Membrane OxygenationFemaleHeart ArrestHeart-Assist DevicesHemorrhageHospital MortalityHumansIntra-Aortic Balloon PumpingMaleMatched-Pair AnalysisMiddle AgedMyocardial InfarctionPercutaneous Coronary InterventionPropensity ScoreRegistriesRetrospective StudiesShock, CardiogenicST Elevation Myocardial InfarctionConceptsMicroaxial left ventricular assist deviceIntra-aortic balloon pumpLeft ventricular assist deviceAcute myocardial infarctionPercutaneous coronary interventionNational Cardiovascular Data RegistryCardiogenic shockHemodynamic supportMyocardial infarctionRegistry-based retrospective cohort studyCardiology-National Cardiovascular Data RegistryChest Pain-MI RegistryST-elevation myocardial infarctionMechanical circulatory support devicesGreater hemodynamic supportHospital major bleedingRetrospective cohort studyPropensity-matched pairsCirculatory support devicesVentricular assist deviceClinical laboratory dataHospital mortalityMajor bleedingHospital deathCohort studyAttribution of Adverse Events Following Coronary Stent Placement Identified Using Administrative Claims Data
Dhruva SS, Parzynski CS, Gamble GM, Curtis JP, Desai NR, Yeh RW, Masoudi FA, Kuntz R, Shaw RE, Marinac‐Dabic D, Sedrakyan A, Normand S, Krumholz HM, Ross JS. Attribution of Adverse Events Following Coronary Stent Placement Identified Using Administrative Claims Data. Journal Of The American Heart Association 2020, 9: e013606. PMID: 32063087, PMCID: PMC7070203, DOI: 10.1161/jaha.119.013606.Peer-Reviewed Original ResearchMeSH KeywordsAdministrative Claims, HealthcareAgedAged, 80 and overCoronary RestenosisCoronary ThrombosisDatabases, FactualDrug-Eluting StentsFemaleHumansMaleMedicareMyocardial InfarctionPercutaneous Coronary InterventionProduct Surveillance, PostmarketingRegistriesRetreatmentRisk AssessmentRisk FactorsTime FactorsTreatment OutcomeUnited StatesConceptsIndex percutaneous coronary interventionPercutaneous coronary interventionSame coronary arteryDrug-eluting stentsNCDR CathPCI RegistrySubsequent percutaneous coronary interventionAcute myocardial infarctionCoronary arteryClaims dataCathPCI RegistryAdverse eventsIndex procedureMyocardial infarctionRepeat percutaneous coronary interventionReal-world registry dataTarget vessel revascularizationCoronary stent placementAdministrative claims dataLong-term safetyLongitudinal claims dataPotential safety eventsVessel revascularizationCoronary interventionDES placementStent thrombosis
2019
Association of Statewide Certificate of Need Regulations With Percutaneous Coronary Intervention Appropriateness and Outcomes
Chui PW, Parzynski CS, Ross JS, Desai NR, Gurm HS, Spertus JA, Seto AH, Ho V, Curtis JP. Association of Statewide Certificate of Need Regulations With Percutaneous Coronary Intervention Appropriateness and Outcomes. Journal Of The American Heart Association 2019, 8: e010373. PMID: 30642222, PMCID: PMC6497347, DOI: 10.1161/jaha.118.010373.Peer-Reviewed Original ResearchConceptsAcute coronary syndromePercutaneous coronary interventionPCI proceduresCON statesAppropriate use criteriaNon-CON statesCoronary syndromePCI registryCoronary interventionCON regulationsIntervention appropriatenessChi-square analysisAmerican CollegeHealthcare costsNeed regulationsPCI appropriatenessUse criteriaAbsolute differenceHealthcare servicesNew healthcare servicesAssociationPCILower proportionOutcomesACS
2018
Registration, results reporting, and publication bias of clinical trials supporting FDA approval of neuropsychiatric drugs before and after FDAAA: a retrospective cohort study
Zou CX, Becker JE, Phillips AT, Garritano JM, Krumholz HM, Miller JE, Ross JS. Registration, results reporting, and publication bias of clinical trials supporting FDA approval of neuropsychiatric drugs before and after FDAAA: a retrospective cohort study. Trials 2018, 19: 581. PMID: 30352601, PMCID: PMC6199729, DOI: 10.1186/s13063-018-2957-0.Peer-Reviewed Original ResearchConceptsRetrospective cohort studyPublication biasNeuropsychiatric indicationsCohort studyClinical trialsRelative riskEfficacy trialsFDA approvalPositive trialsFisher's exact testRecent FDA approvalDrug Administration Amendments ActClinical trial publicationsTRIAL REGISTRATIONMAIN OUTCOMEProportion of trialsNeuropsychiatric drugsNew drug approvalsTrial publicationsExact testMedical interventionsTrialsDrug approvalNew drugsDrugsPublication and Dissemination of Results in Clinical Trials of Neurology
Sreekrishnan A, Mampre D, Ormseth C, Miyares L, Leasure A, Ross JS, Sheth KN. Publication and Dissemination of Results in Clinical Trials of Neurology. JAMA Neurology 2018, 75: 890-891. PMID: 29710083, PMCID: PMC6145765, DOI: 10.1001/jamaneurol.2018.0674.Peer-Reviewed Original ResearchQuantifying the utilization of medical devices necessary to detect postmarket safety differences: A case study of implantable cardioverter defibrillators
Bates J, Parzynski CS, Dhruva SS, Coppi A, Kuntz R, Li S, Marinac‐Dabic D, Masoudi FA, Shaw RE, Warner F, Krumholz HM, Ross JS. Quantifying the utilization of medical devices necessary to detect postmarket safety differences: A case study of implantable cardioverter defibrillators. Pharmacoepidemiology And Drug Safety 2018, 27: 848-856. PMID: 29896873, PMCID: PMC6436550, DOI: 10.1002/pds.4565.Peer-Reviewed Original ResearchConceptsAdverse event ratesSafety differencesEvent ratesMedical device utilizationICD utilizationRate ratioNational Cardiovascular Data RegistryICD modelsImplantable cardioverter defibrillatorEvent rate ratioMost patientsCardioverter defibrillatorProportion of individualsAmerican CollegeData registryRoutine surveillanceSample size estimatesAverage event rateDevice utilizationSignificance levelDifferencesPatientsRegistryDefibrillatorICDPostmarket studies required by the US Food and Drug Administration for new drugs and biologics approved between 2009 and 2012: cross sectional analysis
Wallach JD, Egilman AC, Dhruva SS, McCarthy ME, Miller JE, Woloshin S, Schwartz LM, Ross JS. Postmarket studies required by the US Food and Drug Administration for new drugs and biologics approved between 2009 and 2012: cross sectional analysis. The BMJ 2018, 361: k2031. PMID: 29794072, PMCID: PMC5967364, DOI: 10.1136/bmj.k2031.Peer-Reviewed Original ResearchConceptsProspective cohort studyCohort studyClinical trialsPostmarketing requirementsTimeliness of registrationNew drugsUS FoodDrug AdministrationFDA approvalStudy designNumber of patientsSectional analysisPostmarket studiesFirst approvalRegistrySecondary analysisTrialsBiologicsDrugsComparator typeAdministrationApprovalFDAFDA's authorityFactors Associated With Postmarketing Research for Approved Indications for Novel Medicines Approved by Both the FDA and EMA Between 2005 and 2010: A Multivariable Analysis
Zeitoun J, Ross JS, Atal I, Vivot A, Downing NS, Baron G, Ravaud P. Factors Associated With Postmarketing Research for Approved Indications for Novel Medicines Approved by Both the FDA and EMA Between 2005 and 2010: A Multivariable Analysis. Clinical Pharmacology & Therapeutics 2018, 104: 1000-1007. PMID: 29377075, DOI: 10.1002/cpt.1038.Peer-Reviewed Original Research
2017
Association of the FDA Amendment Act with trial registration, publication, and outcome reporting
Phillips AT, Desai NR, Krumholz HM, Zou CX, Miller JE, Ross JS. Association of the FDA Amendment Act with trial registration, publication, and outcome reporting. Trials 2017, 18: 333. PMID: 28720112, PMCID: PMC5516301, DOI: 10.1186/s13063-017-2068-3.Peer-Reviewed Original ResearchConceptsCardiovascular diseaseTRIAL REGISTRATIONFDA approvalNew drugsClinical trial registrationFDA Amendments ActDrug Administration Amendments ActAccessible trial registryClinical trial publicationsTrials RegistryResultsBetween 2005Efficacy trialsFDA reviewersTrial publicationsOutcome reportingMedical literatureReviewer interpretationsTrialsReporting of findingsDiseaseFDA documentsDrugsDiabetesFDAAAReviewers
2015
US Federal Government Efforts to Improve Clinical Trial Transparency with Expanded Trial Registries and Open Data Sharing
Shaw DL, Ross JS. US Federal Government Efforts to Improve Clinical Trial Transparency with Expanded Trial Registries and Open Data Sharing. The AMA Journal Of Ethic 2015, 17: 1152. PMID: 26698589, DOI: 10.1001/journalofethics.2015.17.12.pfor1-1512.Commentaries, Editorials and LettersTrial-Results Reporting and Academic Medical Centers
Zarin DA, Tse T, Ross JS. Trial-Results Reporting and Academic Medical Centers. New England Journal Of Medicine 2015, 372: 2371-2372. PMID: 25992618, DOI: 10.1056/nejmc1505965.Peer-Reviewed Original ResearchReporting of Noninferiority Trials in ClinicalTrials.gov and Corresponding Publications
Gopal AD, Desai NR, Tse T, Ross JS. Reporting of Noninferiority Trials in ClinicalTrials.gov and Corresponding Publications. JAMA 2015, 313: 1163-1165. PMID: 25781447, PMCID: PMC5897692, DOI: 10.1001/jama.2015.1697.Peer-Reviewed Original Research
2014
Predictors of clinical trial data sharing: exploratory analysis of a cross-sectional survey
Rathi VK, Strait KM, Gross CP, Hrynaszkiewicz I, Joffe S, Krumholz HM, Dzara K, Ross JS. Predictors of clinical trial data sharing: exploratory analysis of a cross-sectional survey. Trials 2014, 15: 384. PMID: 25277128, PMCID: PMC4192345, DOI: 10.1186/1745-6215-15-384.Peer-Reviewed Original ResearchMeSH KeywordsAccess to InformationAgedAttitude of Health PersonnelChi-Square DistributionClinical Trials as TopicCooperative BehaviorCross-Sectional StudiesDatabases, FactualFemaleHealth Knowledge, Attitudes, PracticeHumansInformation DisseminationInternetMaleMiddle AgedPerceptionRegistriesResearch PersonnelSurveys and QuestionnairesConceptsTrial funding sourceExact testMain outcome measuresFisher's exact testCross-sectional surveyChi-square testClinical trialsTrial characteristicsOutcome measuresGeneral medical journalsClinical trialistsWeb-based surveyTrialistsExploratory analysisBackgroundA numberStatistical significanceSignificant differencesExternal investigatorsClinical trial data sharingTrialsMedical journalsPharmaceutical companiesFunding sourcesIndustry fundingPotential respondents