2024
Reporting of Demographics & Subgroup Analyses in Premarketing Studies of FDA Approved High-Risk Cardiovascular Devices, 2014–2022
Swanson M, Uyeki C, Yoder S, Dhruva S, Miller J, Ross J. Reporting of Demographics & Subgroup Analyses in Premarketing Studies of FDA Approved High-Risk Cardiovascular Devices, 2014–2022. Medical Devices Evidence And Research 2024, 17: 165-172. PMID: 38707869, PMCID: PMC11067925, DOI: 10.2147/mder.s457152.Peer-Reviewed Original ResearchFood and Drug AdministrationHigh-risk cardiovascular devicesSubgroup analysisPremarketing studiesUS Food and Drug AdministrationResults of subgroup analysisParticipation of older adultsStudy participantsClinical trialsSocioeconomic positionTrial populationDrug AdministrationStudy populationConduction of subgroup analysisDemographic dataOlder adultsReporting of demographicsSubgroupsPatients' socioeconomic position.PatientsTrials
2019
Prevalence and significance of race and ethnicity subgroup analyses in Cochrane intervention reviews
Liu P, Ross JS, Ioannidis JP, Dhruva SS, Vasiliou V, Wallach JD. Prevalence and significance of race and ethnicity subgroup analyses in Cochrane intervention reviews. Clinical Trials 2019, 17: 231-234. PMID: 31709809, DOI: 10.1177/1740774519887148.Peer-Reviewed Original ResearchAge-treatment subgroup analyses in Cochrane intervention reviews: a meta-epidemiological study
Liu P, Ioannidis JPA, Ross JS, Dhruva SS, Luxkaranayagam AT, Vasiliou V, Wallach JD. Age-treatment subgroup analyses in Cochrane intervention reviews: a meta-epidemiological study. BMC Medicine 2019, 17: 188. PMID: 31639007, PMCID: PMC6805640, DOI: 10.1186/s12916-019-1420-8.Peer-Reviewed Original ResearchConceptsCochrane intervention reviewsFormal interaction testingSubgroup analysisIntervention reviewsClinical practice resourcesInsufficient trial dataPotential subgroup differencesMeta-epidemiological studyIndividual subgroup analysisCochrane reviewAppropriate statistical testsClinical significanceClinical careSubgroup findingsTrial dataClinical resourcesHealthcare interventionsBiological rationaleAnalysis of ageTrialsIndividual trialsDemographic characteristicsPractice resourcesSubgroup differencesClinical translation
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