2024
Derivation of an Annualized Claims-Based Major Adverse Cardiovascular Event Estimator in Type 2 Diabetes
McCoy R, Swarna K, Deng Y, Herrin J, Ross J, Kent D, Borah B, Crown W, Montori V, Umpierrez G, Galindo R, Brito J, Mickelson M, Polley E. Derivation of an Annualized Claims-Based Major Adverse Cardiovascular Event Estimator in Type 2 Diabetes. JACC Advances 2024, 3: 100852. PMID: 38939660, PMCID: PMC11198625, DOI: 10.1016/j.jacadv.2024.100852.Peer-Reviewed Original ResearchType 2 diabetesMedicare fee-for-service planClaims-based prediction modelPopulation risk stratificationRisk of Major Adverse Cardiovascular EventsMajor adverse cardiovascular eventsNon-Hispanic whitesFee-for-service plansStudy cohortClinical trials of cardiovascular diseaseCox proportional hazards modelsProportional hazards modelCare populationHealth systemPrimary preventionMedicare AdvantageParticipant identificationPayer levelPharmacy claimsDecentralized clinical trialsHazards modelCardiovascular diseaseRisk predictionMedicarePatient population
2023
Assessing the use of observational methods and real-world data to emulate ongoing randomized controlled trials
Wallach J, Deng Y, Polley E, Dhruva S, Herrin J, Quinto K, Gandotra C, Crown W, Noseworthy P, Yao X, Jeffery M, Lyon T, Ross J, McCoy R. Assessing the use of observational methods and real-world data to emulate ongoing randomized controlled trials. Clinical Trials 2023, 20: 689-698. PMID: 37589143, PMCID: PMC10843567, DOI: 10.1177/17407745231193137.Peer-Reviewed Original ResearchConceptsBaseline participant characteristicsParticipant characteristicsPrimary endpointSecondary endpointsTrial publicationsMajor adverse cardiovascular eventsPropensity score-matched participantsFirst major adverse cardiovascular eventAdverse cardiovascular eventsBaseline patient characteristicsNonfatal myocardial infarctionOptumLabs Data WarehouseElectronic health record dataRepresentative patient populationHealth record dataCardiovascular eventsClinical characteristicsPatient characteristicsPatient populationMyocardial infarctionExclusion criteriaDrug effectivenessTrialsRecord dataEndpointUS Food and Drug Administration regulatory reviewer disagreements and postmarket safety actions among new therapeutics
Eadie A, MacGregor A, Wallach J, Ross J, Herder M. US Food and Drug Administration regulatory reviewer disagreements and postmarket safety actions among new therapeutics. BMJ Evidence-Based Medicine 2023, 28: 151-156. PMID: 36944478, DOI: 10.1136/bmjebm-2022-112005.Peer-Reviewed Original ResearchConceptsNovel therapeuticsNew therapeuticsUS FoodReviewer disagreementTherapeutic approvalsFDA safety communicationCross-sectional studyBlack box warningPatient populationBox warningDrug AdministrationDrug approvalFDA reviewSafety actionsRegulatory approvalTherapeuticsFDAApprovalMarket approvalFDA reviewersReviewersInstances of disagreementReviewActionAdministrationMetrics, baseline scores, and a tool to improve sponsor performance on clinical trial diversity: retrospective cross sectional study
Varma T, Mello M, Ross J, Gross C, Miller J. Metrics, baseline scores, and a tool to improve sponsor performance on clinical trial diversity: retrospective cross sectional study. BMJ Medicine 2023, 2: e000395. PMID: 36936269, PMCID: PMC9951369, DOI: 10.1136/bmjmed-2022-000395.Peer-Reviewed Original ResearchRetrospective cross-sectional studyCross-sectional studyPivotal trialsOlder adultsSectional studyNovel oncology therapeuticsUS cancer populationUS Cancer StatisticsUS patient populationAmerican Cancer SocietyPatient populationCancer populationOncology therapeuticsCancer SocietyCancer statisticsNovel cancer therapeuticsOncology trialsBaseline scoresPatientsUS FoodDrug AdministrationTrial dataStudy participantsTrialsEthics Committee
2022
Population-Level Strategies for Nirmatrelvir/Ritonavir Prescribing—A Cost-effectiveness Analysis
Savinkina A, Paltiel A, Ross J, Gonsalves G. Population-Level Strategies for Nirmatrelvir/Ritonavir Prescribing—A Cost-effectiveness Analysis. Open Forum Infectious Diseases 2022, 9: ofac637. PMID: 36589482, PMCID: PMC9792084, DOI: 10.1093/ofid/ofac637.Peer-Reviewed Original ResearchCost-effectiveness analysisTrade-offs implicitSevere diseaseDecision analytic modelAllocation decisionsPay thresholdsPolicy strategiesUnvaccinated patientsVaccination statusHigh riskTreatment effectivenessHigh-risk individualsAllocation strategyPopulation-level strategiesWillingnessFurther priorityDrug costsSensitivity analysisCostRitonavir treatmentUnvaccinated personsVaccinated adultsPatient populationClinical trialsLower risk
2021
Unplanned hospital visits after ambulatory surgical care
Bongiovanni T, Parzynski C, Ranasinghe I, Steinman MA, Ross JS. Unplanned hospital visits after ambulatory surgical care. PLOS ONE 2021, 16: e0254039. PMID: 34283840, PMCID: PMC8291649, DOI: 10.1371/journal.pone.0254039.Peer-Reviewed Original ResearchConceptsUnplanned hospital visitsSame-day surgeryHospital visitsAmbulatory surgeryHealthcare costsDischarge care qualityHospital visit ratesNumber of comorbiditiesEmergency department visitsMajority of surgeriesAmbulatory surgical careSpecific patient populationsQuality's Healthcare CostMedicaid Services measuresPatient hospital visitsQuality of careType of procedureDepartment visitsHospital admissionPatient characteristicsOutpatient settingPatient populationProcedure typeSurgical careSurgical facilitiesIdentification of Hospitals That Care for a High Proportion of Patients With Social Risk Factors
Matty R, Heckmann R, George E, Barthel AB, Suter LG, Ross JS, Bernheim SM. Identification of Hospitals That Care for a High Proportion of Patients With Social Risk Factors. JAMA Health Forum 2021, 2: e211323. PMID: 35977204, PMCID: PMC8796989, DOI: 10.1001/jamahealthforum.2021.1323.Peer-Reviewed Original ResearchConceptsSocial risk factorsIdentification of hospitalsProportion of patientsRisk factorsCross-sectional studyHospital performance measuresPatient populationHospital Readmissions Reduction ProgramAfrican American raceProportion of hospitalsDisadvantaged patient populationsReadmissions Reduction ProgramHigher proportionSocioeconomic status scoresSame hospitalStatus scoreCrowded householdsMAIN OUTCOMEMedicaid coverageAmerican racePatientsHospitalHealthcare ResearchDisadvantaged populationsSuch hospitals
2019
Analysis of Postapproval Clinical Trials of Therapeutics Approved by the US Food and Drug Administration Without Clinical Postmarketing Requirements or Commitments
Skydel JJ, Luxkaranayagam AT, Dhruva SS, Ross JS, Wallach JD. Analysis of Postapproval Clinical Trials of Therapeutics Approved by the US Food and Drug Administration Without Clinical Postmarketing Requirements or Commitments. JAMA Network Open 2019, 2: e193410. PMID: 31074812, PMCID: PMC6512282, DOI: 10.1001/jamanetworkopen.2019.3410.Peer-Reviewed Original ResearchConceptsPostapproval clinical trialsClinical trialsPrimary completion datePostmarketing requirementsNovel therapeuticsDrug AdministrationUS FoodNew indicationsPharmaceutical companiesNew clinical studiesCross-sectional analysisClinical outcomesStudy design elementsPatient populationUnapproved indicationsEfficacy dataClinical studiesStudy completionMAIN OUTCOMEFirst approvalMost trialsTrialsFDATherapeutic approvalsTherapeutics