2024
Class I Recalls of Cardiovascular Devices Between 2013 and 2022 : A Cross-Sectional Analysis.
See C, Mooghali M, Dhruva S, Ross J, Krumholz H, Kadakia K. Class I Recalls of Cardiovascular Devices Between 2013 and 2022 : A Cross-Sectional Analysis. Annals Of Internal Medicine 2024, 177: 1499-1508. PMID: 39284187, DOI: 10.7326/annals-24-00724.Peer-Reviewed Original ResearchCross-sectional studyCross-sectional analysisAdverse health consequencesPatient safetyClinical testingClass IHealth consequencesClinical evidenceFDA summariesPostapproval studiesDecision summariesFood and Drug AdministrationU.S. Food and Drug AdministrationEnd-point selectionPremarket approvalMultiple class IClinical studiesPostmarketing surveillanceSummaryDrug AdministrationMedical device recall databaseRecallPatientsFDAPostmarketing
2021
Sex Differences in Symptom Phenotypes Among Older Patients with Acute Myocardial Infarction
Brush JE, Hajduk AM, Greene EJ, Dreyer RP, Krumholz HM, Chaudhry SI. Sex Differences in Symptom Phenotypes Among Older Patients with Acute Myocardial Infarction. The American Journal Of Medicine 2021, 135: 342-349. PMID: 34715061, PMCID: PMC8901454, DOI: 10.1016/j.amjmed.2021.09.022.Peer-Reviewed Original ResearchConceptsAcute myocardial infarctionMyocardial infarctionSymptom combinationsOlder patientsAcute myocardial infarction subgroupsAcute myocardial infarction admissionsMyocardial infarction subgroupsPatients 75 yearsMyocardial infarction admissionsSILVER-AMI StudySymptom phenotypeClinical studiesIndividual patientsMore symptomsPatientsInfarctionDiagnostic possibilitiesSymptomsWomenPerson interviewsMenCommon phenotypeSex differencesCliniciansPhenotypeAssessment of Concordance and Discordance Among Clinical Studies Posted as Preprints and Subsequently Published in High-Impact Journals
Shi X, Ross JS, Amancharla N, Niforatos JD, Krumholz HM, Wallach JD. Assessment of Concordance and Discordance Among Clinical Studies Posted as Preprints and Subsequently Published in High-Impact Journals. JAMA Network Open 2021, 4: e212110. PMID: 33734411, PMCID: PMC7974637, DOI: 10.1001/jamanetworkopen.2021.2110.Peer-Reviewed Original Research
2020
Rates and Predictors of Patient Underreporting of Hospitalizations During Follow-Up After Acute Myocardial Infarction
Caraballo C, Khera R, Jones PG, Decker C, Schulz W, Spertus JA, Krumholz HM. Rates and Predictors of Patient Underreporting of Hospitalizations During Follow-Up After Acute Myocardial Infarction. Circulation Cardiovascular Quality And Outcomes 2020, 13: e006231. PMID: 32552061, PMCID: PMC9465954, DOI: 10.1161/circoutcomes.119.006231.Peer-Reviewed Original ResearchConceptsAcute myocardial infarctionMyocardial infarctionHospitalization eventsMedical recordsLongitudinal multicenter cohort studyMulticenter cohort studyMedical record abstractionDifferent patient characteristicsHealth care eventsPatients' underreportingTRIUMPH registryAccuracy of reportingCohort studyPatient characteristicsRecord abstractionProspective studyClinical studiesClinical investigationHospitalizationPatientsCare eventsInfarctionEvent ratesParticipantsPredictors
2017
Postapproval studies of drugs initially approved by the FDA on the basis of limited evidence: systematic review
Pease AM, Krumholz HM, Downing NS, Aminawung JA, Shah ND, Ross JS. Postapproval studies of drugs initially approved by the FDA on the basis of limited evidence: systematic review. The BMJ 2017, 357: j1680. PMID: 28468750, PMCID: PMC5421452, DOI: 10.1136/bmj.j1680.Peer-Reviewed Original ResearchConceptsSingle pivotal trialPivotal trialsPostapproval studiesSurrogate markerPrimary endpointNovel drugsClinical outcomesClinical studiesLimited evidenceSystematic reviewDouble-blind studyMedian total numberClinical evidenceSuperior efficacyBlind studyDrug AdministrationOriginal FDATrial approvalDiseaseTrialsDrugsFDAEndpointEfficacyMarkers
2016
Participation of the elderly, women, and minorities in pivotal trials supporting 2011–2013 U.S. Food and Drug Administration approvals
Downing NS, Shah ND, Neiman JH, Aminawung JA, Krumholz HM, Ross JS. Participation of the elderly, women, and minorities in pivotal trials supporting 2011–2013 U.S. Food and Drug Administration approvals. Trials 2016, 17: 199. PMID: 27079511, PMCID: PMC4832528, DOI: 10.1186/s13063-016-1322-4.Peer-Reviewed Original ResearchMeSH KeywordsAdultAge FactorsAgedClinical Trials as TopicCross-Sectional StudiesDatabases, FactualDrug ApprovalEthnicityFemaleHealth Status DisparitiesHealthcare DisparitiesHumansMaleMiddle AgedMinority GroupsPatient SelectionSex FactorsTime FactorsUnited StatesUnited States Food and Drug AdministrationConceptsSubgroup efficacy analysesPivotal trialsEfficacy analysisNovel therapeuticsSubgroup analysisTrial participantsU.S. FoodMean proportionAvailable FDA documentsCross-sectional studyDrug Administration approvalBasis of approvalYears of ageTrial patientsElderly patientsMedian ageBlack patientsAsian patientsAdministration approvalClinical studiesFDA reviewersPatientsHispanic participantsTrialsDemographic characteristics
2015
Characteristics of Clinical Studies Conducted Over the Total Product Life Cycle of High-Risk Therapeutic Medical Devices Receiving FDA Premarket Approval in 2010 and 2011
Rathi VK, Krumholz HM, Masoudi FA, Ross JS. Characteristics of Clinical Studies Conducted Over the Total Product Life Cycle of High-Risk Therapeutic Medical Devices Receiving FDA Premarket Approval in 2010 and 2011. JAMA 2015, 314: 604-612. PMID: 26262798, DOI: 10.1001/jama.2015.8761.Peer-Reviewed Original ResearchConceptsPrimary effectiveness end pointEffectiveness end pointPostmarket studiesClinical studiesClinical evidencePMA pathwayPremarket studiesEnd pointAvailable FDA documentsInitial marketing approvalPremarket approval pathwayTherapeutic devicesMedian durationMedian enrollmentHigh-risk medical devicesMAIN OUTCOMEPatientsDrug AdministrationUS FoodFDA approvalMarketing approvalLonger durationFDA documentsMonthsPostmarketPost-market clinical research conducted by medical device manufacturers: a cross-sectional survey
Ross JS, Blount KL, Ritchie JD, Hodshon B, Krumholz HM. Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey. Medical Devices Evidence And Research 2015, Volume 8: 241-249. PMID: 26060416, PMCID: PMC4454210, DOI: 10.2147/mder.s82964.Peer-Reviewed Original Research
2014
High Incarceration Rates Among Black Men Enrolled In Clinical Studies May Compromise Ability To Identify Disparities
Wang EA, Aminawung JA, Wildeman C, Ross JS, Krumholz HM. High Incarceration Rates Among Black Men Enrolled In Clinical Studies May Compromise Ability To Identify Disparities. Health Affairs 2014, 33: 848-855. PMID: 24799583, PMCID: PMC4065793, DOI: 10.1377/hlthaff.2013.1325.Peer-Reviewed Original ResearchConceptsClinical studiesHealth outcomesBlack menProspective clinical studyObservational clinical researchBlood InstituteNational HeartClinical researchWhite womenRacial disparitiesWhite menMinimal riskMenBlack womenHigh rateJail inmatesMinority populationsWomenOutcomesEffects of incarcerationImpact of incarcerationHigh incarceration ratesIncarcerationLungFollow