2023
Characterization of US Food and Drug Administration Class I Recalls from 2018 to 2022 for Moderate- and High-Risk Medical Devices: A Cross-Sectional Study
Mooghali M, Ross J, Kadakia K, Dhruva S. Characterization of US Food and Drug Administration Class I Recalls from 2018 to 2022 for Moderate- and High-Risk Medical Devices: A Cross-Sectional Study. Medical Devices Evidence And Research 2023, 16: 111-122. PMID: 37229515, PMCID: PMC10204764, DOI: 10.2147/mder.s412802.Peer-Reviewed Original ResearchCross-sectional studyClass I medical deviceClass IHigh-risk medical devicesSerious adverse eventsSafety concernsAdverse eventsMedian numberUS FoodRecalled deviceTherapeutic useDevice recallsHigh-risk devicesDevice useSerious safety concernsMedical device recallsMultiple recallsLife-sustaining devicesDevice assessment
2022
Characterization 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 evaluationFAERSFDAEmulating the GRADE trial using real world data: retrospective comparative effectiveness study
Deng Y, Polley EC, Wallach JD, Dhruva SS, Herrin J, Quinto K, Gandotra C, Crown W, Noseworthy P, Yao X, Lyon TD, Shah ND, Ross JS, McCoy RG. Emulating the GRADE trial using real world data: retrospective comparative effectiveness study. The BMJ 2022, 379: e070717. PMID: 36191949, PMCID: PMC9527635, DOI: 10.1136/bmj-2022-070717.Peer-Reviewed Original ResearchConceptsSecondary outcomesMetformin monotherapyTreatment groupsRetrospective comparative effectiveness studyCox proportional hazards regressionPropensity scoreIncident microvascular complicationsNationwide claims databaseProportional hazards regressionType 2 diabetesComparative effectiveness studiesMacrovascular complicationsMicrovascular complicationsProspective trialAdverse eventsGlycemic controlHospital admissionInsulin glarginePrimary outcomeMedian timeHazards regressionClaims databaseObservational studyInverse propensity scoreEligibility criteriaVibration of effect in more than 16 000 pooled analyses of individual participant data from 12 randomised controlled trials comparing canagliflozin and placebo for type 2 diabetes mellitus: multiverse analysis
Gouraud H, Wallach J, Boussageon R, Ross J, Naudet F. Vibration of effect in more than 16 000 pooled analyses of individual participant data from 12 randomised controlled trials comparing canagliflozin and placebo for type 2 diabetes mellitus: multiverse analysis. BMJ Medicine 2022, 1: e000154. PMID: 36936564, PMCID: PMC9978683, DOI: 10.1136/bmjmed-2022-000154.Peer-Reviewed Original ResearchMajor adverse cardiovascular eventsType 2 diabetes mellitusIndividual participant dataAdverse cardiovascular eventsSerious adverse eventsPooled analysisCanagliflozin treatmentFirst centileCardiovascular eventsHazard ratioAdverse eventsDiabetes mellitusParticipant dataEffect estimatesFavour of placeboSerum glycated hemoglobinIndividual patient dataVibration of effectsWeek 12Glycated hemoglobinPlaceboCentileCanagliflozinPatient dataTrials
2020
Attribution 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 thrombosisUpdating insights into rosiglitazone and cardiovascular risk through shared data: individual patient and summary level meta-analyses
Wallach JD, Wang K, Zhang AD, Cheng D, Grossetta Nardini HK, Lin H, Bracken MB, Desai M, Krumholz HM, Ross JS. Updating insights into rosiglitazone and cardiovascular risk through shared data: individual patient and summary level meta-analyses. The BMJ 2020, 368: l7078. PMID: 32024657, PMCID: PMC7190063, DOI: 10.1136/bmj.l7078.Peer-Reviewed Original ResearchConceptsIndividual patient-level dataCardiovascular related deathsCardiovascular riskMyocardial infarctionRelated deathsSummary-level dataHeart failureOdds ratioSystematic reviewIncreased cardiovascular riskMore myocardial infarctionsHeart failure eventsCochrane Central RegistryAcute myocardial infarctionMyocardial infarction eventsPatient-level dataRandom-effects modelWeb of ScienceAnalysis of trialsEligible trialsComposite outcomeAdverse eventsContinuity correctionControlled TrialsRosiglitazone treatment
2019
Adverse Effects of Pharmacologic Treatments of Major Depression in Older Adults
Sobieraj DM, Martinez BK, Hernandez AV, Coleman CI, Ross JS, Berg KM, Steffens DC, Baker WL. Adverse Effects of Pharmacologic Treatments of Major Depression in Older Adults. Journal Of The American Geriatrics Society 2019, 67: 1571-1581. PMID: 31140587, DOI: 10.1111/jgs.15966.Peer-Reviewed Original ResearchConceptsSerotonin-norepinephrine reuptake inhibitorsSelective serotonin reuptake inhibitorsMajor depressive disorderOverall adverse eventsAdverse eventsYears of ageStudy withdrawalAcute phaseReuptake inhibitorsObservational studyAdverse effectsChoice of antidepressantSerious adverse eventsAcute treatment phaseNorepinephrine reuptake inhibitorsSerotonin reuptake inhibitorsSpecific adverse eventsComparative long-term studiesNonpharmacologic therapiesContinuation treatmentPatients 65Pharmacologic treatmentQTc prolongationMore fallsOutpatient setting
2018
Patterns and predictors of off-label prescription of psychiatric drugs
Vijay A, Becker JE, Ross JS. Patterns and predictors of off-label prescription of psychiatric drugs. PLOS ONE 2018, 13: e0198363. PMID: 30024873, PMCID: PMC6053129, DOI: 10.1371/journal.pone.0198363.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntipsychotic AgentsBipolar DisorderCitalopramCross-Sectional StudiesDrug PrescriptionsFemaleHumansInappropriate PrescribingInsurance, Major MedicalMaleMiddle AgedOffice VisitsOff-Label UseOutpatientsPractice Patterns, Physicians'Retrospective StudiesSleep Initiation and Maintenance DisordersTrazodoneUnited StatesConceptsNational Ambulatory Medical Care SurveyLabel prescribingChronic care managementPsychiatric drugsOutpatient visitsLabel prescriptionsCare managementAmbulatory Medical Care SurveyCommon off-label usesAdult outpatient visitsMore chronic conditionsMain outcome measuresOff-label useCross-sectional studyOff-label usesTypes of cliniciansManic-depressive psychosisStrong scientific evidenceVisit diagnosesAdverse eventsOffice visitsCare SurveyLabel usePsychiatric medicationsChronic conditions
2017
Comparison of two independent systematic reviews of trials of recombinant human bone morphogenetic protein-2 (rhBMP-2): the Yale Open Data Access Medtronic Project
Low J, Ross JS, Ritchie JD, Gross CP, Lehman R, Lin H, Fu R, Stewart LA, Krumholz HM. Comparison of two independent systematic reviews of trials of recombinant human bone morphogenetic protein-2 (rhBMP-2): the Yale Open Data Access Medtronic Project. Systematic Reviews 2017, 6: 28. PMID: 28196521, PMCID: PMC5310069, DOI: 10.1186/s13643-017-0422-x.Peer-Reviewed Original ResearchConceptsParticipant-level dataSystematic reviewSummary estimatesRecombinant human bone morphogenetic protein-2Inclusion criteriaCenter BIndividual participant-level dataMeta-analysis inclusion criteriaHuman bone morphogenetic protein-2Trial inclusion criteriaMulti-site clinical trialMain outcome measuresMost clinical outcomesStatistical methodsConcurrent systematic reviewIndependent systematic reviewsProtein 2Bone morphogenetic protein-2Summary efficacyMorphogenetic protein-2Adverse eventsClinical outcomesSurgical approachTrial inclusionClinical trials
2016
Characterisation of trials where marketing purposes have been influential in study design: a descriptive study
Barbour V, Burch D, Godlee F, Heneghan C, Lehman R, Perera R, Ross JS, Schroter S. Characterisation of trials where marketing purposes have been influential in study design: a descriptive study. Trials 2016, 17: 31. PMID: 26792624, PMCID: PMC4720997, DOI: 10.1186/s13063-015-1107-1.Peer-Reviewed Original ResearchConceptsMedian numberDrug trialsGeneral medical journalsComposite primary outcome measureStudy designTerms of blindingPrimary outcome measureTrials of drugsHigh-impact general medical journalsKey trial characteristicsIndustry-funded trialsMedical journalsAdverse eventsCategories of trialsTrial characteristicsOutcome measuresStudy populationSafety outcomesBlinded researcherStudy characteristicsDescriptive studyTrial documentationTrialsSignificant differencesMarketing trials
2013
Evaluation of the Mobile Acute Care of the Elderly (MACE) Service
Hung WW, Ross JS, Farber J, Siu AL. Evaluation of the Mobile Acute Care of the Elderly (MACE) Service. JAMA Internal Medicine 2013, 173: 990-996. PMID: 23608775, PMCID: PMC3691362, DOI: 10.1001/jamainternmed.2013.478.Peer-Reviewed Original ResearchConceptsUsual care groupShorter hospital stayAdverse eventsMACE groupUsual careHospital stayAcute careFunctional statusOlder adultsPatient outcomesCatheter-associated urinary tract infectionsTertiary acute care hospitalCare Transitions MeasureHospitalized older adultsUrinary tract infectionPairs of patientsAcute medical problemsGeneral medical servicesLength of stayAcute care hospitalsMount Sinai HospitalLower ratesElderly servicesAcute illnessCohort study
2011
Audit and feedback: An intervention to improve discharge summary completion
Dinescu A, Fernandez H, Ross JS, Karani R. Audit and feedback: An intervention to improve discharge summary completion. Journal Of Hospital Medicine 2011, 6: 28-32. PMID: 21241038, PMCID: PMC3102562, DOI: 10.1002/jhm.831.Peer-Reviewed Original ResearchConceptsDischarge summariesDuration of hospitalizationPost-intervention studyDischarge summary completionFirst-year fellowsImportant clinical informationGeriatric medicine fellowsAdverse eventsDischarge planningOutpatient settingClinical informationYear fellowsGeriatric careIntervention studiesSame checklistFeedback sessionsPerformance scoresPhase 2Feedback interventionPhase 1InterventionIndividual performance scoresAuditChecklistRehospitalization
2009
Pooled Analysis of Rofecoxib Placebo-Controlled Clinical Trial Data: Lessons for Postmarket Pharmaceutical Safety Surveillance
Ross JS, Madigan D, Hill KP, Egilman DS, Wang Y, Krumholz HM. Pooled Analysis of Rofecoxib Placebo-Controlled Clinical Trial Data: Lessons for Postmarket Pharmaceutical Safety Surveillance. JAMA Internal Medicine 2009, 169: 1976-1985. PMID: 19933959, PMCID: PMC2830805, DOI: 10.1001/archinternmed.2009.394.Peer-Reviewed Original ResearchMeSH KeywordsAdverse Drug Reaction Reporting SystemsCardiovascular SystemCyclooxygenase 2 InhibitorsDrug IndustryHumansIncidenceLactonesMyocardial InfarctionRandomized Controlled Trials as TopicRisk AssessmentSafety-Based Drug WithdrawalsSulfonesTime FactorsUnited StatesUnited States Food and Drug AdministrationConceptsPlacebo-controlled trialVoluntary market withdrawalAdverse eventsCardiovascular riskThromboembolic adverse eventsMain outcome measurementsClinical trial dataRofecoxib groupOutcome measurementsTrial dataPlaceboTrial durationSafety surveillanceTrialsMarket withdrawalDeathRiskP-valueSurveillance effortsSubjectsWithdrawalRofecoxibYearsIncidenceDose