2023
Therapeutic value of first versus supplemental indications of drugs in US and Europe (2011-20): retrospective cohort study
Vokinger K, Glaus C, Kesselheim A, Serra-Burriel M, Ross J, Hwang T. Therapeutic value of first versus supplemental indications of drugs in US and Europe (2011-20): retrospective cohort study. The BMJ 2023, 382: e074166. PMID: 37407074, PMCID: PMC10320829, DOI: 10.1136/bmj-2022-074166.Peer-Reviewed Original ResearchConceptsEuropean Medicines AgencyRetrospective cohort studyCohort studyTherapeutic valueSupplemental indicationsIndication approvalsHigh therapeutic valueAvailable treatmentsDrug AdministrationUS FoodMedicines AgencyFDA approvalHealth authoritiesCancer disordersSimilar findingsTherapeutic ratingFirst indicationDrugsIndicationsApprovalFDAPatientsLarge subsetProportionPhysicians
2022
Safety and Effectiveness of a Catheter With Contact Force and 6-Hole Irrigation for Ablation of Persistent Atrial Fibrillation in Routine Clinical Practice
Dhruva SS, Zhang S, Chen J, Noseworthy PA, Doshi AA, Agboola KM, Herrin J, Jiang G, Yu Y, Cafri G, Farr K, Ervin KR, Ross JS, Coplan PM, Drozda JP. Safety and Effectiveness of a Catheter With Contact Force and 6-Hole Irrigation for Ablation of Persistent Atrial Fibrillation in Routine Clinical Practice. JAMA Network Open 2022, 5: e2227134. PMID: 35976649, PMCID: PMC9386540, DOI: 10.1001/jamanetworkopen.2022.27134.Peer-Reviewed Original ResearchConceptsPersistent AF ablationRoutine clinical practiceMercy HealthAF ablationMayo ClinicSafety outcomesClinical practiceCatheter groupCohort studyCatheter ablationPersistent AFParoxysmal atrial fibrillation ablationThermocool SmartTouch catheterComposite of deathPrimary safety outcomeAtrial fibrillation ablationPersistent atrial fibrillationElectronic health record dataHealth system dataHealth record dataHealth care systemSmartTouch catheterThromboembolic eventsFibrillation ablationProcedural complications
2021
Real-world Cardiovascular Outcomes Associated With Degarelix vs Leuprolide for Prostate Cancer Treatment
Wallach JD, Deng Y, McCoy RG, Dhruva SS, Herrin J, Berkowitz A, Polley EC, Quinto K, Gandotra C, Crown W, Noseworthy P, Yao X, Shah ND, Ross JS, Lyon TD. Real-world Cardiovascular Outcomes Associated With Degarelix vs Leuprolide for Prostate Cancer Treatment. JAMA Network Open 2021, 4: e2130587. PMID: 34677594, PMCID: PMC8536955, DOI: 10.1001/jamanetworkopen.2021.30587.Peer-Reviewed Original ResearchConceptsMajor adverse cardiovascular eventsSecondary end pointsMyocardial infarctionClinical trialsCardiovascular diseaseProstate cancerCardiovascular eventsEnd pointRisk of MACELarge US administrative claims databasePropensity-matched cohort studyUS administrative claims databasePropensity score-matched patientsAdverse cardiovascular eventsPrimary end pointAdministrative claims databaseProportional hazards regressionRandomized clinical trialsAdministrative claims dataTrial eligibility criteriaMedicare Advantage beneficiariesProstate cancer treatmentReal-world evidenceElectronic health recordsCardiovascular outcomes
2019
Adoption of New Glucose-Lowering Medications in the U.S.—The Case of SGLT2 Inhibitors: Nationwide Cohort Study
McCoy R, Dykhoff HJ, Sangaralingham L, Ross JS, Karaca-Mandic P, Montori VM, Shah N. Adoption of New Glucose-Lowering Medications in the U.S.—The Case of SGLT2 Inhibitors: Nationwide Cohort Study. Diabetes Technology & Therapeutics 2019, 21: 702-712. PMID: 31418588, PMCID: PMC7207017, DOI: 10.1089/dia.2019.0213.Peer-Reviewed Original ResearchConceptsSodium-glucose cotransporter 2 inhibitorsGlucose-lowering medicationsHeart failureKidney diseaseMyocardial infarctionHigh-quality diabetes careMedicare Advantage insurancePrevalent adverse effectsRenal protective benefitsTreatment-risk paradoxNationwide cohort studyCotransporter 2 inhibitorsGlucose-lowering therapyPrior myocardial infarctionGlucose lowering medicationsChronic diabetes complicationsMultivariable logistic regressionNon-black patientsType 2 diabetesDiabetes type 1Insurance-related factorsCommercial health insuranceAppropriateness of usePrior hypoglycemiaSGLT2i initiationCommunicating, and Justifying, Nonefficacy Benefits for New Drugs Approved on the Basis of Noninferiority Trials
Ross JS, Wee CC. Communicating, and Justifying, Nonefficacy Benefits for New Drugs Approved on the Basis of Noninferiority Trials. JAMA Internal Medicine 2019, 179: 721-722. PMID: 30830205, DOI: 10.1001/jamainternmed.2018.8019.Commentaries, Editorials and LettersAssociation of Inferior Vena Cava Filter Use With Mortality Rates in Older Adults With Acute Pulmonary Embolism
Bikdeli B, Wang Y, Jimenez D, Ross JS, Monreal M, Goldhaber SZ, Krumholz HM. Association of Inferior Vena Cava Filter Use With Mortality Rates in Older Adults With Acute Pulmonary Embolism. JAMA Internal Medicine 2019, 179: 263-265. PMID: 30535318, PMCID: PMC6439651, DOI: 10.1001/jamainternmed.2018.5287.Peer-Reviewed Original Research
2018
Association of Racial and Socioeconomic Disparities With Outcomes Among Patients Hospitalized With Acute Myocardial Infarction, Heart Failure, and Pneumonia
Downing NS, Wang C, Gupta A, Wang Y, Nuti SV, Ross JS, Bernheim SM, Lin Z, Normand ST, Krumholz HM. Association of Racial and Socioeconomic Disparities With Outcomes Among Patients Hospitalized With Acute Myocardial Infarction, Heart Failure, and Pneumonia. JAMA Network Open 2018, 1: e182044. PMID: 30646146, PMCID: PMC6324513, DOI: 10.1001/jamanetworkopen.2018.2044.Peer-Reviewed Original ResearchMeSH KeywordsAgedAged, 80 and overBlack PeopleCohort StudiesFee-for-Service PlansFemaleHealth Status DisparitiesHeart FailureHospitalizationHospitalsHumansMaleMedicareMiddle AgedMyocardial InfarctionOutcome Assessment, Health CarePneumoniaRacial GroupsRetrospective StudiesSocial ClassUnited StatesWhite PeopleConceptsAcute myocardial infarctionRisk-standardized mortality ratesRisk-standardized readmission ratesReadmission ratesHeart failureMyocardial infarctionMortality rateIntraclass correlation coefficientAnalysis cohortBlack patientsHospital proportionSocioeconomic disparitiesHospital analysisRisk-standardized outcomesRisk-standardized ratesRetrospective cohort studySocioeconomic statusNeighborhood income levelHospital performanceHospital outcomesCohort studyNumber of hospitalsBroader systemic effectsPatient raceMAIN OUTCOMEDefining Multiple Chronic Conditions for Quality Measurement
Drye EE, Altaf FK, Lipska KJ, Spatz ES, Montague JA, Bao H, Parzynski CS, Ross JS, Bernheim SM, Krumholz HM, Lin Z. Defining Multiple Chronic Conditions for Quality Measurement. Medical Care 2018, 56: 193-201. PMID: 29271820, DOI: 10.1097/mlr.0000000000000853.Peer-Reviewed Original ResearchConceptsMultiple chronic conditionsChronic conditionsMedicare feeService beneficiariesMedicare Chronic Conditions WarehouseMCC cohortBroad cohortChronic Conditions WarehouseRisk-standardized ratesNational quality measuresUnplanned admissionsFinal cohortTotal admissionsAdmission riskAccountable care organizationsAdmission ratesOutcome measuresAdmissionCohortCohort conditionCare organizationsPatientsStakeholder inputNarrow cohortBeneficiaries
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 trendsPostmarket 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 therapeuticsBiologicsAssessing the potential clinical impact of reciprocal drug approval legislation on access to novel therapeutics in the USA: a cohort study
Larochelle M, Downing NS, Ross JS, David FS. Assessing the potential clinical impact of reciprocal drug approval legislation on access to novel therapeutics in the USA: a cohort study. BMJ Open 2017, 7: e014582. PMID: 28179418, PMCID: PMC5306516, DOI: 10.1136/bmjopen-2016-014582.Peer-Reviewed Original ResearchConceptsEuropean Medicines AgencyCohort studyClinical impactRare diseaseHealth CanadaNew therapeuticsLikely clinical impactPotential clinical impactUS patientsAvailable therapiesNovel mechanismDrug AdministrationMedicines AgencyNovel therapeuticsUS approvalNew drugsDrugsFDA submissionsReview outcomesTherapeuticsSafety concernsDiseaseFDAMechanistic noveltyAffected population
2016
Trends of Anti-Vascular Endothelial Growth Factor Use in Ophthalmology Among Privately Insured and Medicare Advantage Patients
Parikh R, Ross JS, Sangaralingham LR, Adelman RA, Shah ND, Barkmeier AJ. Trends of Anti-Vascular Endothelial Growth Factor Use in Ophthalmology Among Privately Insured and Medicare Advantage Patients. Ophthalmology 2016, 124: 352-358. PMID: 27890437, DOI: 10.1016/j.ophtha.2016.10.036.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAngiogenesis InhibitorsBevacizumabCohort StudiesDatabases, FactualDiabetic RetinopathyDrug UtilizationFemaleHumansInsurance, HealthIntravitreal InjectionsMacular DegenerationMaleMedicare Part CMiddle AgedOphthalmologyPrivate SectorRanibizumabReceptors, Vascular Endothelial Growth FactorRecombinant Fusion ProteinsRetinal Vein OcclusionRetrospective StudiesUnited StatesVascular Endothelial Growth Factor AYoung AdultConceptsAge-related macular degenerationDiabetic retinal diseaseAnti-VEGF injectionsIntravitreal anti-VEGF injectionsRetinal vein occlusionAdministrative claims dataRetinal diseasesOphthalmic diseasesVein occlusionClaims dataUse of bevacizumabCurrent Procedural Terminology codesPatients 18 yearsRetrospective cohort studyMedicare Advantage patientsOptumLabs Data WarehouseDrug Administration approvalProcedural Terminology codesGrowth factor useRanibizumab useBevacizumab useAvailable medicationsCohort studyMedication useCommon medicationsFrequency and Importance of Incomplete Screening Fetal Anatomic Sonography in Pregnancy
Silvestri MT, Pettker CM, Raney JH, Xu X, Ross JS. Frequency and Importance of Incomplete Screening Fetal Anatomic Sonography in Pregnancy. Journal Of Ultrasound In Medicine 2016, 35: 2665-2673. PMID: 27821652, DOI: 10.7863/ultra.16.01084.Peer-Reviewed Original ResearchConceptsRepeat sonographyUltrasound examinationAbnormal fetal anatomyRepeat screeningFetal anatomyIncomplete visualizationLarge single-center studyMean gestational ageRetrospective cohort studySingle-center studyMean maternal ageMain outcome measuresProportion of womenCohort studySingleton pregnanciesWeeks' gestationGestational ageMaternal ageRepeat imagingUltrasound centersOutcome measuresSonographyAnatomic componentsWomenPregnancy
2015
Differences in Colonoscopy Quality Among Facilities: Development of a Post-Colonoscopy Risk-Standardized Rate of Unplanned Hospital Visits
Ranasinghe I, Parzynski CS, Searfoss R, Montague J, Lin Z, Allen J, Vender R, Bhat K, Ross JS, Bernheim S, Krumholz HM, Drye EE. Differences in Colonoscopy Quality Among Facilities: Development of a Post-Colonoscopy Risk-Standardized Rate of Unplanned Hospital Visits. Gastroenterology 2015, 150: 103-113. PMID: 26404952, DOI: 10.1053/j.gastro.2015.09.009.Peer-Reviewed Original ResearchConceptsUnplanned hospital visitsDay of colonoscopyHospital visitsOutpatient facilitiesColonoscopy qualityHealthcare costsRisk-standardized ratesHospital outpatient departmentsUtilization Project dataAmbulatory surgery centersLogistic regression modelsHierarchical logistic regressionQuality improvement effortsPrior arrhythmiaAbdominal painElectrolyte imbalanceOutpatient departmentSurgery centersCommon causeHospital careOutcome measuresPsychiatric disordersColonoscopyUtilization ProjectPatient choice
2014
Evolution of Breast Cancer Screening in the Medicare Population: Clinical and Economic Implications
Killelea BK, Long JB, Chagpar AB, Ma X, Wang R, Ross JS, Gross CP. Evolution of Breast Cancer Screening in the Medicare Population: Clinical and Economic Implications. Journal Of The National Cancer Institute 2014, 106: dju159. PMID: 25031307, PMCID: PMC4155428, DOI: 10.1093/jnci/dju159.Peer-Reviewed Original ResearchConceptsEnd Results-MedicareBreast cancer stageCohort of womenEarly-stage tumorsBreast cancer screeningAdjunct imagingSignificant changesCancer screeningCancer stageIncidence rateBreast cancerAdjunct procedureOlder womenMedicare populationMedicare beneficiariesClinical practiceComputer-aided detectionPoisson regressionNational feeCohortBreast ultrasoundWomenEarlier cohortsLater cohortsMedicare spendingHigh 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
2013
The cost implications of prostate cancer screening in the Medicare population
Ma X, Wang R, Long JB, Ross JS, Soulos PR, Yu JB, Makarov DV, Gold HT, Gross CP. The cost implications of prostate cancer screening in the Medicare population. Cancer 2013, 120: 96-102. PMID: 24122801, PMCID: PMC3867600, DOI: 10.1002/cncr.28373.Peer-Reviewed Original ResearchConceptsProstate cancerScreening costsAnnual screening costsPopulation-based cohortProstate cancer screeningHospital referral region levelMale Medicare beneficiariesProstate-specific antigenCancer screeningLowest quartileHRR levelMedicare populationMedicare beneficiariesOlder menNational feeCancerService Medicare programCancer diagnosisMenQuartilePSACost implicationsAnnual expenditureMedicare programBiopsyAge-based and Sex-based Disparities in Screening Colonoscopy Use Among Medicare Beneficiaries
Gancayco J, Soulos PR, Khiani V, Cramer LD, Ross JS, Genao I, Tinetti M, Gross CP. Age-based and Sex-based Disparities in Screening Colonoscopy Use Among Medicare Beneficiaries. Journal Of Clinical Gastroenterology 2013, 47: 630-636. PMID: 23619827, DOI: 10.1097/mcg.0b013e31828345c8.Peer-Reviewed Original ResearchConceptsColonoscopy useScreening colonoscopyColonoscopy ratesLife expectancyMedicare beneficiariesOlder personsColorectal cancer incidencePatient demographic characteristicsLow screening ratesSex-based disparitiesShort life expectancySex-based differencesLonger life expectancyPatients 68Older patientsPatients 75Screening ratesCancer incidenceLarge cohortMedicare claimsColonoscopyMedicare dataPatientsPoisson regressionLife table approachEvaluation of the Mobile Acute Care of the Elderly (MACE) Service
Hung WW, Ross JS, Farber J, Siu AL. Evaluation of the Mobile Acute Care of the Elderly (MACE) Service. JAMA Internal Medicine 2013, 173: 990-996. PMID: 23608775, PMCID: PMC3691362, DOI: 10.1001/jamainternmed.2013.478.Peer-Reviewed Original ResearchConceptsUsual care groupShorter hospital stayAdverse eventsMACE groupUsual careHospital stayAcute careFunctional statusOlder adultsPatient outcomesCatheter-associated urinary tract infectionsTertiary acute care hospitalCare Transitions MeasureHospitalized older adultsUrinary tract infectionPairs of patientsAcute medical problemsGeneral medical servicesLength of stayAcute care hospitalsMount Sinai HospitalLower ratesElderly servicesAcute illnessCohort studyRegional Density of Cardiologists and Rates of Mortality for Acute Myocardial Infarction and Heart Failure
Kulkarni VT, Ross JS, Wang Y, Nallamothu BK, Spertus JA, Normand SL, Masoudi FA, Krumholz HM. Regional Density of Cardiologists and Rates of Mortality for Acute Myocardial Infarction and Heart Failure. Circulation Cardiovascular Quality And Outcomes 2013, 6: 352-359. PMID: 23680965, PMCID: PMC5323047, DOI: 10.1161/circoutcomes.113.000214.Peer-Reviewed Original ResearchMeSH KeywordsAgedAged, 80 and overCardiologyCohort StudiesFemaleHealth Services AccessibilityHealth Services Needs and DemandHealthcare DisparitiesHeart FailureHospitalizationHumansLinear ModelsLogistic ModelsMaleMedicareMyocardial InfarctionOdds RatioPhysiciansPneumoniaPrognosisResidence CharacteristicsRisk AssessmentRisk FactorsTime FactorsUnited StatesWorkforceConceptsAcute myocardial infarctionHeart failureHospital referral regionsMortality riskLowest quintileMyocardial infarctionReferral regionsMedicare administrative claims dataCharacteristics of patientsRisk of deathAdministrative claims dataHierarchical logistic regression modelsLogistic regression modelsRate of mortalityRegional densityHighest quintileNumber of cardiologistsWorse outcomesClaims dataPatientsPneumoniaCardiologistsHospitalizationAdmissionQuintile