2020
Clinical Outcomes With Beta-Blocker Use in Patients With Recent History of Myocardial Infarction
Jackevicius CA, Krumholz HM, Ross JS, Koh M, Chong A, Austin PC, Stukel TA, Azizi P, Ko DT. Clinical Outcomes With Beta-Blocker Use in Patients With Recent History of Myocardial Infarction. Canadian Journal Of Cardiology 2020, 36: 1633-1640. PMID: 32416066, DOI: 10.1016/j.cjca.2020.01.024.Peer-Reviewed Original ResearchConceptsPrior myocardial infarctionMyocardial infarctionStable patientsPopulation-based observational studyAngina 1 yearDeath/hospitalizationHistory of revascularisationBeta-blocker useMajor cardiovascular eventsHospital discharge diagnosisUse of BBsIndividual end pointsContemporary clinical trialsYears of ageCardiovascular eventsIndex dateCohort studyComposite outcomeBB useHeart failureMedian agePrimary outcomeClinical outcomesAtrial fibrillationDischarge diagnosis
2019
Rates of Physician Coprescribing of Opioids and Benzodiazepines After the Release of the Centers for Disease Control and Prevention Guidelines in 2016
Jeffery MM, Hooten WM, Jena AB, Ross JS, Shah ND, Karaca-Mandic P. Rates of Physician Coprescribing of Opioids and Benzodiazepines After the Release of the Centers for Disease Control and Prevention Guidelines in 2016. JAMA Network Open 2019, 2: e198325. PMID: 31373650, PMCID: PMC6681551, DOI: 10.1001/jamanetworkopen.2019.8325.Peer-Reviewed Original ResearchConceptsLong-term opioid useOpioid usePrevention guidelinesMA groupDisease controlCoprescription of opioidsRetrospective cohort studyUS national databaseInsurance groupsMedicare AdvantageSickle cell diseaseGuideline releasePrescription daysPrescribed opioidsBenzodiazepine prescriptionsCohort studyMedian agePharmacy claimsChronic painCell diseaseCoprescriptionMAIN OUTCOMESame clinicianClaims dataHospice care
2018
Evidence supporting FDA approval and CMS national coverage determinations for novel medical products, 2005 through 2016
Roginiel AC, Dhruva SS, Ross JS. Evidence supporting FDA approval and CMS national coverage determinations for novel medical products, 2005 through 2016. Medicine 2018, 97: e12715. PMID: 30290675, PMCID: PMC6200488, DOI: 10.1097/md.0000000000012715.Peer-Reviewed Original ResearchConceptsOriginal clinical trialsCMS national coverage determinationsNational Coverage DeterminationClinical trialsFDA approvalControl armFDA approval documentsQuality of trialsCross-sectional studySignificant differencesCoverage determinationMedian ageMedian timePivotal trialsQuantity of evidenceInclusion criteriaTrial participantsMedicare populationCMS coverageDrug AdministrationStudy sizeNovel therapeuticsMedicaid ServicesMarketing approvalTrials
2017
Adoption of immunotherapy into real-world practice: Insights from the use of checkpoint inhibitors.
O'Connor J, Seidl-Rathkopf K, You P, Nussbaum N, Torres A, Fessele K, Darius K, Adelson K, Yin E, Presley C, Chiang A, Ross J, Abernethy A, Gross C. Adoption of immunotherapy into real-world practice: Insights from the use of checkpoint inhibitors. Journal Of Clinical Oncology 2017, 35: e14583-e14583. DOI: 10.1200/jco.2017.35.15_suppl.e14583.Peer-Reviewed Original ResearchElectronic health record databaseReal-world practiceCheckpoint inhibitorsAdvanced non-small cell lung cancerFDA approvalNon-small cell lung cancerDeath-1 checkpoint inhibitorsMetastatic renal cell carcinomaAdoption of immunotherapyGeneralizability of trialsCell lung cancerRenal cell carcinomaDrug Administration approvalHealth record databaseChi-square testStudy drugOlder patientsSystemic therapyAdvanced melanomaMedian ageTherapy linesCell carcinomaLung cancerAdministration approvalClinical trials
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