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 dataEndpoint
2022
Vibration of effect in more than 16 000 pooled analyses of individual participant data from 12 randomised controlled trials comparing canagliflozin and placebo for type 2 diabetes mellitus: multiverse analysis
Gouraud H, Wallach J, Boussageon R, Ross J, Naudet F. Vibration of effect in more than 16 000 pooled analyses of individual participant data from 12 randomised controlled trials comparing canagliflozin and placebo for type 2 diabetes mellitus: multiverse analysis. BMJ Medicine 2022, 1: e000154. PMID: 36936564, PMCID: PMC9978683, DOI: 10.1136/bmjmed-2022-000154.Peer-Reviewed Original ResearchMajor adverse cardiovascular eventsType 2 diabetes mellitusIndividual participant dataAdverse cardiovascular eventsSerious adverse eventsPooled analysisCanagliflozin treatmentFirst centileCardiovascular eventsHazard ratioAdverse eventsDiabetes mellitusParticipant dataEffect estimatesFavour of placeboSerum glycated hemoglobinIndividual patient dataVibration of effectsWeek 12Glycated hemoglobinPlaceboCentileCanagliflozinPatient dataTrials
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