2021
Reporting of Study Participant Demographic Characteristics and Demographic Representation in Premarketing and Postmarketing Studies of Novel Cancer Therapeutics
Varma T, Wallach JD, Miller JE, Schnabel D, Skydel JJ, Zhang AD, Dinan MA, Ross JS, Gross CP. Reporting of Study Participant Demographic Characteristics and Demographic Representation in Premarketing and Postmarketing Studies of Novel Cancer Therapeutics. JAMA Network Open 2021, 4: e217063. PMID: 33877309, PMCID: PMC8058642, DOI: 10.1001/jamanetworkopen.2021.7063.Peer-Reviewed Original ResearchConceptsNovel cancer therapeuticsPostmarketing studyBlack patientsCancer therapeuticsDemographic dataOlder adultsUS cancer populationUS Cancer StatisticsCross-sectional studyRace/ethnicityParticipants' demographic characteristicsPercentage of trialsPatient sexCancer populationClinical studiesCancer statisticsMAIN OUTCOMEDrug AdministrationFDA approvalStudy participantsCancer typesDemographic characteristicsDemographic informationStudy samplePatientsDemographic Characteristics of Participants in Trials Essential to US Food and Drug Administration Vaccine Approvals, 2010–2020
Zhang AD, Puthumana J, Egilman AC, Schwartz JL, Ross JS. Demographic Characteristics of Participants in Trials Essential to US Food and Drug Administration Vaccine Approvals, 2010–2020. Journal Of General Internal Medicine 2021, 37: 700-702. PMID: 33660209, PMCID: PMC7928194, DOI: 10.1007/s11606-021-06670-3.Peer-Reviewed Original Research
2019
Age-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
2013
Diagnoses and Timing of 30-Day Readmissions After Hospitalization for Heart Failure, Acute Myocardial Infarction, or Pneumonia
Dharmarajan K, Hsieh AF, Lin Z, Bueno H, Ross JS, Horwitz LI, Barreto-Filho JA, Kim N, Bernheim SM, Suter LG, Drye EE, Krumholz HM. Diagnoses and Timing of 30-Day Readmissions After Hospitalization for Heart Failure, Acute Myocardial Infarction, or Pneumonia. JAMA 2013, 309: 355-363. PMID: 23340637, PMCID: PMC3688083, DOI: 10.1001/jama.2012.216476.Peer-Reviewed Original ResearchConceptsAcute myocardial infarctionCommon readmission diagnosesAcute MI hospitalizationReadmission diagnosesDays of hospitalizationPatient demographic characteristicsHeart failureMyocardial infarctionHF hospitalizationReadmission timingPneumonia hospitalizationsMedian timeMI hospitalizationMedicare feeIndex HF hospitalizationIndex pneumonia hospitalizationProportion of patientsDemographic characteristicsService claims dataMI cohortPneumonia cohortHF cohortCondition categoriesHospitalizationReadmission