2023
Comparative effectiveness of second line glucose lowering drug treatments using real world data: emulation of a target trial
Deng Y, Polley E, Wallach J, Herrin J, Ross J, McCoy R. Comparative effectiveness of second line glucose lowering drug treatments using real world data: emulation of a target trial. BMJ Medicine 2023, 2: e000419. PMID: 37577025, PMCID: PMC10414064, DOI: 10.1136/bmjmed-2022-000419.Peer-Reviewed Original ResearchYear cumulative incidence rateCumulative incidence rateType 2 diabetesLiraglutide armMetabolic failureSitagliptin armGlycaemic controlInsulin glargineMedian timeIncidence rateComparative effectivenessCox proportional hazards regressionPropensity scoreTarget trialsInsulin glargine armProportional hazards regressionOptumLabs Data WarehouseTarget trial emulationStatistical analysis planMetformin monotherapyMacrovascular complicationsMicrovascular outcomesStudy drugStudy armsTrial emulation
2022
Emulating the GRADE trial using real world data: retrospective comparative effectiveness study
Deng Y, Polley EC, Wallach JD, Dhruva SS, Herrin J, Quinto K, Gandotra C, Crown W, Noseworthy P, Yao X, Lyon TD, Shah ND, Ross JS, McCoy RG. Emulating the GRADE trial using real world data: retrospective comparative effectiveness study. The BMJ 2022, 379: e070717. PMID: 36191949, PMCID: PMC9527635, DOI: 10.1136/bmj-2022-070717.Peer-Reviewed Original ResearchConceptsSecondary outcomesMetformin monotherapyTreatment groupsRetrospective comparative effectiveness studyCox proportional hazards regressionPropensity scoreIncident microvascular complicationsNationwide claims databaseProportional hazards regressionType 2 diabetesComparative effectiveness studiesMacrovascular complicationsMicrovascular complicationsProspective trialAdverse eventsGlycemic controlHospital admissionInsulin glarginePrimary outcomeMedian timeHazards regressionClaims databaseObservational studyInverse propensity scoreEligibility criteria
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 approvalTrialsAge of Data at the Time of Publication of Contemporary Clinical Trials
Welsh J, Lu Y, Dhruva SS, Bikdeli B, Desai NR, Benchetrit L, Zimmerman CO, Mu L, Ross JS, Krumholz HM. Age of Data at the Time of Publication of Contemporary Clinical Trials. JAMA Network Open 2018, 1: e181065-e181065. PMID: 30646100, PMCID: PMC6324269, DOI: 10.1001/jamanetworkopen.2018.1065.Peer-Reviewed Original ResearchConceptsClinical trialsFinal data collectionParticipant enrollmentInternal medicineMultivariable linear regression analysisFirst participant enrollmentPrimary end pointMultivariable regression analysisContemporary clinical trialsClinical trial dataJAMA Internal MedicineRegression analysisCross-sectional analysisTime of publicationMedian timeTrial characteristicsOutcome measuresMAIN OUTCOMENew England JournalClinical practiceLinear regression analysisTrial dataEnd pointTrial resultsTrialsBiomedical journal speed and efficiency: a cross-sectional pilot survey of author experiences
Wallach JD, Egilman AC, Gopal AD, Swami N, Krumholz HM, Ross JS. Biomedical journal speed and efficiency: a cross-sectional pilot survey of author experiences. Research Integrity And Peer Review 2018, 3: 1. PMID: 29451557, PMCID: PMC5803634, DOI: 10.1186/s41073-017-0045-8.Peer-Reviewed Original Research
2017
Postmarket Safety Events Among Novel Therapeutics Approved by the US Food and Drug Administration Between 2001 and 2010
Downing NS, Shah ND, Aminawung JA, Pease AM, Zeitoun JD, Krumholz HM, Ross JS. Postmarket Safety Events Among Novel Therapeutics Approved by the US Food and Drug Administration Between 2001 and 2010. JAMA 2017, 317: 1854-1863. PMID: 28492899, PMCID: PMC5815036, DOI: 10.1001/jama.2017.5150.Peer-Reviewed Original ResearchConceptsNovel therapeuticsSafety eventsAccelerated approvalTherapeutic characteristicsUS FoodDrug AdministrationFDA approvalInitial regulatory approvalClinician decision makingNew safety risksMedian followCohort studyMedian timeMultivariable analysisBoxed warningDrug classesMAIN OUTCOMEClinical practicePostmarket periodPsychiatric diseasesPriority reviewTherapeutic areasOrphan statusPsychiatric therapeuticsBiologics
2013
Hospital readmission performance and patterns of readmission: retrospective cohort study of Medicare admissions
Dharmarajan K, Hsieh AF, Lin Z, Bueno H, Ross JS, Horwitz LI, Barreto-Filho JA, Kim N, Suter LG, Bernheim SM, Drye EE, Krumholz HM. Hospital readmission performance and patterns of readmission: retrospective cohort study of Medicare admissions. The BMJ 2013, 347: f6571. PMID: 24259033, PMCID: PMC3898430, DOI: 10.1136/bmj.f6571.Peer-Reviewed Original ResearchConceptsAcute myocardial infarctionRetrospective cohort studyReadmission diagnosesReadmission ratesHeart failureMyocardial infarctionCohort studySpecific diagnosisReadmission performanceHospital readmission performancePatterns of readmissionDay readmission rateRisk-standardized readmission ratesLow performing hospitalsHospital performanceHigh performing hospitalsReadmission timingDay readmissionHospital stayIndex admissionHospital dischargeReadmission patternsHospital admissionCommon diagnosisMedian timeDiagnoses 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
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