2018
Availability of Investigational Medicines Through the US Food and Drug Administration’s Expanded Access and Compassionate Use Programs
Puthumana J, Miller JE, Kim J, Ross JS. Availability of Investigational Medicines Through the US Food and Drug Administration’s Expanded Access and Compassionate Use Programs. JAMA Network Open 2018, 1: e180283-e180283. PMID: 30646072, PMCID: PMC6324420, DOI: 10.1001/jamanetworkopen.2018.0283.Peer-Reviewed Original ResearchConceptsCompassionate use programInvestigational medicinesFDA approvalNew drug application submissionAccess programExpanded AccessUS FoodAvailable FDA documentsLife-threatening conditionCross-sectional studyEvidence of safetyProtection of patientsUse programClinical trialsMAIN OUTCOMEDrug AdministrationInfectious diseasesDrug accessClinical development periodsFDA documentsApplication submissionPatientsDiseaseApprovalMonths
2017
Factors Associated with Refugee Acute Healthcare Utilization in Southern Connecticut
Semere W, Agrawal P, Yun K, Di Bartolo I, Annamalai A, Ross JS. Factors Associated with Refugee Acute Healthcare Utilization in Southern Connecticut. Journal Of Immigrant And Minority Health 2017, 20: 327-333. PMID: 28382427, DOI: 10.1007/s10903-017-0574-8.Peer-Reviewed Original ResearchConceptsAcute care useAcute care visitsCare useMonths of arrivalCare visitsMedical evaluationDay of arrivalAcute healthcare utilizationRetrospective cohort studyAcute care utilizationCohort studyCare utilizationHealthcare utilizationMale sexHospital visitsEmergency roomPrior historyHealth characteristicsLower likelihoodSouthern ConnecticutGreater likelihoodVisitsTimely evaluationAdult refugeesMonths
2016
Publication and reporting of clinical trial results: cross sectional analysis across academic medical centers
Chen R, Desai NR, Ross JS, Zhang W, Chau KH, Wayda B, Murugiah K, Lu DY, Mittal A, Krumholz HM. Publication and reporting of clinical trial results: cross sectional analysis across academic medical centers. The BMJ 2016, 352: i637. PMID: 26888209, PMCID: PMC4768882, DOI: 10.1136/bmj.i637.Peer-Reviewed Original ResearchConceptsAcademic medical centerInterventional clinical trialsClinical trialsMedical CenterStudy completionPrimary completion dateClinical trial resultsReporting of resultsSectional analysisInterventional trialsProportion of trialsTrial resultsTrialsMonthsPhase IIManual reviewLead investigatorUnited StatesProportionRate of publicationReportingCompletionPatientsCenter
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 documentsMonthsPostmarket
2014
Descriptions and Interpretations of the ACCORD-Lipid Trial in the News and Biomedical Literature: A Cross-Sectional Analysis
Downing NS, Cheng T, Krumholz HM, Shah ND, Ross JS. Descriptions and Interpretations of the ACCORD-Lipid Trial in the News and Biomedical Literature: A Cross-Sectional Analysis. JAMA Internal Medicine 2014, 174: 1176-1182. PMID: 24796406, PMCID: PMC4124903, DOI: 10.1001/jamainternmed.2014.1371.Peer-Reviewed Original ResearchConceptsACCORD lipid trialACCORD-LipidFibrate useTrial interpretationImproved cardiovascular outcomesCross-sectional studyCross-sectional analysisStatin therapyCardiovascular outcomesCardiovascular riskDiabetes (ACCORD) trialDiabetes mellitusConflicts of interestTrialsPatientsFenofibrateAuthor conflictsLipid componentsMellitusTherapyPhysiciansMonthsUsual Source of Care and Outcomes Following Acute Myocardial Infarction
Spatz ES, Sheth SD, Gosch KL, Desai MM, Spertus JA, Krumholz HM, Ross JS. Usual Source of Care and Outcomes Following Acute Myocardial Infarction. Journal Of General Internal Medicine 2014, 29: 862-869. PMID: 24553957, PMCID: PMC4026492, DOI: 10.1007/s11606-014-2794-0.Peer-Reviewed Original ResearchConceptsAcute myocardial infarctionUsual sourceMyocardial infarctionMortality rateBaseline risk factorsAcute clinical eventsMain outcome measuresAMI severityAMI patientsMultivariable analysisKey ResultsAmongClinical eventsSocio-demographic characteristicsRisk factorsOutcome measuresReadmissionHigh mortalityPatientsMortalityCareMonthsInfarctionAdultsOutcomesAssociation
2012
Publication of NIH funded trials registered in ClinicalTrials.gov: cross sectional analysis
Ross JS, Tse T, Zarin DA, Xu H, Zhou L, Krumholz HM. Publication of NIH funded trials registered in ClinicalTrials.gov: cross sectional analysis. The BMJ 2012, 344: d7292. PMID: 22214755, PMCID: PMC3623605, DOI: 10.1136/bmj.d7292.Peer-Reviewed Original Research
2011
Use of Fibrates in the United States and Canada
Jackevicius CA, Tu JV, Ross JS, Ko DT, Carreon D, Krumholz HM. Use of Fibrates in the United States and Canada. JAMA 2011, 305: 1217-1224. PMID: 21427374, PMCID: PMC3332101, DOI: 10.1001/jama.2011.353.Peer-Reviewed Original ResearchMeSH KeywordsCanadaCardiovascular DiseasesCohort StudiesCosts and Cost AnalysisDiabetes Mellitus, Type 2Drug CostsDrugs, GenericFenofibrateFibric AcidsHealth ExpendituresHumansHydroxymethylglutaryl-CoA Reductase InhibitorsHypolipidemic AgentsMedical AuditPractice Patterns, Physicians'PrescriptionsUnited StatesConceptsUse of fibratesRole of fibratesObservational cohort studyIMS Health dataFenofibrate useCardiovascular riskCohort studyDiabetes (ACCORD) trialClinical benefitFibratesMonthsPrescriptionUnited StatesPatientsNegative resultsFenofibrateHealth dataCurrent useGeneric formulationPopulationStatinsTherapyTrials