2019
Association of Statewide Certificate of Need Regulations With Percutaneous Coronary Intervention Appropriateness and Outcomes
Chui PW, Parzynski CS, Ross JS, Desai NR, Gurm HS, Spertus JA, Seto AH, Ho V, Curtis JP. Association of Statewide Certificate of Need Regulations With Percutaneous Coronary Intervention Appropriateness and Outcomes. Journal Of The American Heart Association 2019, 8: e010373. PMID: 30642222, PMCID: PMC6497347, DOI: 10.1161/jaha.118.010373.Peer-Reviewed Original ResearchConceptsAcute coronary syndromePercutaneous coronary interventionPCI proceduresCON statesAppropriate use criteriaNon-CON statesCoronary syndromePCI registryCoronary interventionCON regulationsIntervention appropriatenessChi-square analysisAmerican CollegeHealthcare costsNeed regulationsPCI appropriatenessUse criteriaAbsolute differenceHealthcare servicesNew healthcare servicesAssociationPCILower proportionOutcomesACS
2018
The US Food and Drug Administration’s expedited approval programs: Evidentiary standards, regulatory trade-offs, and potential improvements
Wallach JD, Ross JS, Naci H. The US Food and Drug Administration’s expedited approval programs: Evidentiary standards, regulatory trade-offs, and potential improvements. Clinical Trials 2018, 15: 219-229. PMID: 29871509, DOI: 10.1177/1740774518770648.Commentaries, Editorials and LettersFactors Associated With Postmarketing Research for Approved Indications for Novel Medicines Approved by Both the FDA and EMA Between 2005 and 2010: A Multivariable Analysis
Zeitoun J, Ross JS, Atal I, Vivot A, Downing NS, Baron G, Ravaud P. Factors Associated With Postmarketing Research for Approved Indications for Novel Medicines Approved by Both the FDA and EMA Between 2005 and 2010: A Multivariable Analysis. Clinical Pharmacology & Therapeutics 2018, 104: 1000-1007. PMID: 29377075, DOI: 10.1002/cpt.1038.Peer-Reviewed Original Research
2017
Trends in Omalizumab Utilization for Asthma: Evidence of Suboptimal Patient Selection
Jeffery MM, Shah ND, Karaca-Mandic P, Ross JS, Rank MA. Trends in Omalizumab Utilization for Asthma: Evidence of Suboptimal Patient Selection. The Journal Of Allergy And Clinical Immunology In Practice 2017, 6: 1568-1577.e4. PMID: 28958746, DOI: 10.1016/j.jaip.2017.07.034.Peer-Reviewed Original ResearchConceptsOmalizumab initiationAsthma controlICS-LABAPatient selectionLow adherenceBetter asthma controlCohort of nonusersSuboptimal patient selectionPoor asthma controlLow adherence ratesPatient-level characteristicsLarge US databaseMedicare Advantage beneficiariesAsthma biologicsExacerbation frequencyOmalizumab useIncident useComparison cohortICS/Medication adherenceAdherence ratesPrevalent usersAdministrative claimsAsthmaUtilization trends
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
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
2009
Determinants of Cardiac Catheterization Use in Older Medicare Patients With Acute Myocardial Infarction
Ko DT, Ross JS, Wang Y, Krumholz HM. Determinants of Cardiac Catheterization Use in Older Medicare Patients With Acute Myocardial Infarction. Circulation Cardiovascular Quality And Outcomes 2009, 3: 54-62. PMID: 20123672, PMCID: PMC3024143, DOI: 10.1161/circoutcomes.109.858456.Peer-Reviewed Original ResearchMeSH KeywordsAge FactorsAgedAged, 80 and overCardiac CatheterizationChi-Square DistributionComorbidityFemaleHemorrhageHospitalizationHumansLikelihood FunctionsLogistic ModelsMaleMedicareMyocardial InfarctionPatient SelectionPractice Patterns, Physicians'Risk AssessmentRisk FactorsSeverity of Illness IndexSex FactorsTime FactorsTreatment OutcomeUnited StatesConceptsAcute myocardial infarctionCardiac catheterization useCardiac catheterizationInappropriate indicationsAMI patientsAppropriate indicationsMyocardial infarctionRisk scoreCardiology/American Heart Association class IBaseline cardiovascular riskOlder Medicare patientsHigh-risk patientsDemographic factorsMore comorbiditiesCardiovascular riskOlder patientsMale sexProcedure indicationFemale sexMedicare patientsAmerican CollegeAMI admissionsMedicare feePatientsCatheterization