2023
Exploring unique device identifier implementation and use for real-world evidence: a mixed-methods study with NESTcc health system network collaborators
Dhruva S, Ridgeway J, Ross J, Drozda J, Wilson N. Exploring unique device identifier implementation and use for real-world evidence: a mixed-methods study with NESTcc health system network collaborators. BMJ Surgery Interventions & Health Technologies 2023, 5: e000167. PMID: 36704544, PMCID: PMC9872505, DOI: 10.1136/bmjsit-2022-000167.Peer-Reviewed Original ResearchHealth systemReal-world evidence generationDevice identificationPrior conceptual modelInformation technologyHealth system characteristicsWorkflow changesNetworkReal-world evidenceImplementationResearch NetworkClinical benefitSupply chainMedical devicesSystem characteristicsTechnologyRWE studiesEffectiveness studiesCurrent stateConceptual modelBrief surveyMixed-method studySustainment (EPIS) frameworkInterview topicsMedical device safety
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
Feasibility of Using Real-World Data to Replicate Clinical Trial Evidence
Bartlett VL, Dhruva SS, Shah ND, Ryan P, Ross JS. Feasibility of Using Real-World Data to Replicate Clinical Trial Evidence. JAMA Network Open 2019, 2: e1912869. PMID: 31596493, PMCID: PMC6802419, DOI: 10.1001/jamanetworkopen.2019.12869.Peer-Reviewed Original ResearchConceptsPrimary end pointClinical trialsReal-world evidenceEnd pointElectronic health recordsEHR dataExclusion criteriaClinical trial evidenceRandomized clinical trialsHigh-impact general medical journalsReal-world populationInsurance claimsTraditional clinical trialsCross-sectional analysisSame clinical questionPercentage of trialsPrimary outcomeClinical outcomesClinical evidenceTrial evidenceTrial populationTrial inclusionObservational studyAdministrative claimsMAIN OUTCOME
2018
Real-World Evidence: Promise and Peril For Medical Product Evaluation.
Dhruva SS, Ross JS, Desai NR. Real-World Evidence: Promise and Peril For Medical Product Evaluation. P & T : A Peer-reviewed Journal For Formulary Management 2018, 43: 464-472. PMID: 30100687, PMCID: PMC6065494.Commentaries, Editorials and Letters