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
2021
Characteristics of Clinical Studies Used for US Food and Drug Administration Supplemental Indication Approvals of Drugs and Biologics, 2017 to 2019
Dhodapkar M, Zhang AD, Puthumana J, Downing NS, Shah ND, Ross JS. Characteristics of Clinical Studies Used for US Food and Drug Administration Supplemental Indication Approvals of Drugs and Biologics, 2017 to 2019. JAMA Network Open 2021, 4: e2113224. PMID: 34110392, PMCID: PMC8193429, DOI: 10.1001/jamanetworkopen.2021.13224.Peer-Reviewed Original ResearchConceptsPrimary efficacy end pointEfficacy end pointPivotal trialsIndication approvalsActive comparatorClinical outcomesSupplemental indicationsUS FoodEnd pointOriginal approvalTherapeutic areasPivotal efficacy trialsCross-sectional studyAdditional clinical dataDrug Administration approvalNew indication approvalsStrength of evidenceAdministration approvalMonths durationClinical dataClinical studiesEfficacy trialsMedian numberCancer indicationsMAIN OUTCOMEUS Food and Drug Administration utilization of postmarketing requirements and postmarketing commitments, 2009–2018
Skydel JJ, Zhang AD, Dhruva SS, Ross JS, Wallach JD. US Food and Drug Administration utilization of postmarketing requirements and postmarketing commitments, 2009–2018. Clinical Trials 2021, 18: 488-499. PMID: 33863236, PMCID: PMC8292154, DOI: 10.1177/17407745211005044.Peer-Reviewed Original ResearchConceptsClinical studiesPostmarketing requirementsUS FoodDrug AdministrationNew therapeuticsClinical evidenceNew prospective cohort studyProspective cohort studyCross-sectional studyDrug Administration approvalCohort studyRetrospective studyUnapproved indicationsAdministration approvalClinical indicationsClinical trialsBACKGROUND/Median numberDisease populationTherapeutic safetyTherapeutic indicationsSecondary analysisNovel therapeuticsSmall molecule drugsOriginal approval
2020
Non-inferiority trials using a surrogate marker as the primary endpoint: An increasing phenotype in cardiovascular trials
Bikdeli B, Caraballo C, Welsh J, Ross JS, Kaul S, Stone GW, Krumholz HM. Non-inferiority trials using a surrogate marker as the primary endpoint: An increasing phenotype in cardiovascular trials. Clinical Trials 2020, 17: 723-728. PMID: 32838556, PMCID: PMC8088773, DOI: 10.1177/1740774520949157.Peer-Reviewed Original ResearchConceptsNon-inferiority trialPrimary endpointClinical outcome trialsNon-inferiority marginSurrogate markerNon-inferiority designCardiovascular trialsOutcome trialsClinical outcomesDefinitive clinical outcome trialsNon-inferiority criteriaStudy protocolSurrogate outcomesBACKGROUND/Median numberSurrogate endpointsPrimary analysisCardiovascular interventionsCardiovascular medicineTrialsEndpointClinical interpretationOutcomesMarkersIntervention
2019
Evolution of the American College of Cardiology and American Heart Association Cardiology Clinical Practice Guidelines: A 10‐Year Assessment
DuBose‐Briski V, Yao X, Dunlay SM, Dhruva SS, Ross JS, Shah ND, Noseworthy PA. Evolution of the American College of Cardiology and American Heart Association Cardiology Clinical Practice Guidelines: A 10‐Year Assessment. Journal Of The American Heart Association 2019, 8: e012065. PMID: 31566106, PMCID: PMC6806052, DOI: 10.1161/jaha.119.012065.Peer-Reviewed Original ResearchConceptsValvular heart diseaseClinical practice guidelinesAmerican Heart AssociationLevel of evidenceAmerican CollegeLOE BHeart failureHeart AssociationHeart diseasePractice guidelinesCardiology/American Heart Association (ACC/AHA) guideline recommendationsCardiology/American Heart Association guidelinesCardiology/American Heart AssociationMedian proportionCardiology clinical practice guidelinesAmerican Heart Association guidelinesHeart Association guidelinesClass of recommendationLOE AGuideline recommendationsResults ThirtyAssociation guidelinesMedian numberStable ischemiaLevel I
2018
Biomedical journal speed and efficiency: a cross-sectional pilot survey of author experiences
Wallach JD, Egilman AC, Gopal AD, Swami N, Krumholz HM, Ross JS. Biomedical journal speed and efficiency: a cross-sectional pilot survey of author experiences. Research Integrity And Peer Review 2018, 3: 1. PMID: 29451557, PMCID: PMC5803634, DOI: 10.1186/s41073-017-0045-8.Peer-Reviewed Original Research
2016
Population Of US Practicing Psychiatrists Declined, 2003–13, Which May Help Explain Poor Access To Mental Health Care
Bishop TF, Seirup JK, Pincus HA, Ross JS. Population Of US Practicing Psychiatrists Declined, 2003–13, Which May Help Explain Poor Access To Mental Health Care. Health Affairs 2016, 35: 1271-1277. PMID: 27385244, DOI: 10.1377/hlthaff.2015.1643.Peer-Reviewed Original ResearchConceptsPrimary care physiciansMental health careCare physiciansMental illnessSupply of psychiatristsHealth carePoor accessSevere mental illnessHospital referral regionsMental health servicesTeam-based carePrimary careMedian numberReferral regionsNonphysician providersUS populationHealth servicesMental healthStudy periodCarePsychiatristsPatientsNeurologistsIllnessPhysiciansCharacterisation 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
2015
Postmarket Modifications of High‐Risk Therapeutic Devices in Otolaryngology Cleared by the US Food and Drug Administration
Rathi VK, Ross JS, Samuel AM, Mehra S. Postmarket Modifications of High‐Risk Therapeutic Devices in Otolaryngology Cleared by the US Food and Drug Administration. Otolaryngology 2015, 153: 400-408. PMID: 26044785, DOI: 10.1177/0194599815587508.Peer-Reviewed Original ResearchConceptsClinical dataUS FoodDrug AdministrationPMA pathwayRetrospective cohort studyAdditional clinical dataPremarket approval pathwaySignificant clinical implicationsCohort studyHigh-risk medical devicesMedian numberClinical implicationsMarketing clearanceLife spanAdministrationSubstantial numberPMA applicationApproval pathwaySupplementsFDATherapeutic devicesPathway
2014
Clinical Trial Evidence Supporting FDA Approval of Novel Therapeutic Agents, 2005-2012
Downing NS, Aminawung JA, Shah ND, Krumholz HM, Ross JS. Clinical Trial Evidence Supporting FDA Approval of Novel Therapeutic Agents, 2005-2012. JAMA 2014, 311: 368-377. PMID: 24449315, PMCID: PMC4144867, DOI: 10.1001/jama.2013.282034.Peer-Reviewed Original ResearchConceptsPivotal efficacy trialsNovel therapeutic agentsClinical trial evidencePivotal trialsEfficacy trialsTherapeutic agentsEnd pointTrial evidenceMedian numberAvailable FDA documentsSingle pivotal trialTrial end pointsSurrogate end pointsNumber of patientsLength of treatmentCross-sectional analysisPrimary outcomeClinical outcomesTrial completion ratesClinical benefitPlacebo comparatorSurrogate outcomesMAIN OUTCOMEDrug AdministrationUS Food
2011
Estimating and Reporting on the Quality of Inpatient Stroke Care by Veterans Health Administration Medical Centers
Arling G, Reeves M, Ross J, Williams LS, Keyhani S, Chumbler N, Phipps MS, Roumie C, Myers LJ, Salanitro AH, Ordin DL, Myers J, Bravata DM. Estimating and Reporting on the Quality of Inpatient Stroke Care by Veterans Health Administration Medical Centers. Circulation Cardiovascular Quality And Outcomes 2011, 5: 44-51. PMID: 22147888, PMCID: PMC3261327, DOI: 10.1161/circoutcomes.111.961474.Peer-Reviewed Original ResearchConceptsVeterans Health Administration medical centersStroke care qualityEligible patientsMedical CenterInpatient stroke care qualityDeep vein thrombosis prophylaxisEvidence-based quality indicatorsCare qualityInpatient stroke carePressure ulcer risk assessmentUlcer risk assessmentStudy patientsThrombosis prophylaxisEarly ambulationIschemic strokeLipid managementRetrospective cohortDysphagia screeningStroke careMedian numberPatientsFiscal year 2007Interfacility variationQuality indicatorsQI rates
2010
Use of Administrative Claims Models to Assess 30-Day Mortality Among Veterans Health Administration Hospitals
Ross JS, Maynard C, Krumholz HM, Sun H, Rumsfeld JS, Normand SL, Wang Y, Fihn SD. Use of Administrative Claims Models to Assess 30-Day Mortality Among Veterans Health Administration Hospitals. Medical Care 2010, 48: 652-658. PMID: 20548253, PMCID: PMC3020977, DOI: 10.1097/mlr.0b013e3181dbe35d.Peer-Reviewed Original ResearchConceptsStatistical modelAcute myocardial infarctionVeterans Health Administration hospitalsVHA hospitalsHeart failurePneumonia hospitalizationsC-statisticNon-federal hospitalsMedian numberModest heterogeneityAdministration HospitalAdministrative claims dataService Medicare beneficiariesYears of age