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
Assessment of Hypothetical Out-of-Pocket Costs of Guideline-Recommended Medications for the Treatment of Older Adults With Multiple Chronic Conditions, 2009 and 2019
Zhou T, Liu P, Dhruva SS, Shah ND, Ramachandran R, Berg KM, Ross JS. Assessment of Hypothetical Out-of-Pocket Costs of Guideline-Recommended Medications for the Treatment of Older Adults With Multiple Chronic Conditions, 2009 and 2019. JAMA Internal Medicine 2022, 182: 185-195. PMID: 34982097, PMCID: PMC8728660, DOI: 10.1001/jamainternmed.2021.7457.Peer-Reviewed Original ResearchMeSH KeywordsAgedAtrial FibrillationChronic DiseaseCross-Sectional StudiesDiabetes Mellitus, Type 2Drug CostsHealth ExpendituresHeart FailureHumansHypercholesterolemiaHypertensionMedicare Part CMedicare Part DMultiple Chronic ConditionsOsteoarthritisOsteoporosisPrescription DrugsPulmonary Disease, Chronic ObstructiveRetrospective StudiesUnited StatesConceptsCommon chronic diseasesGuideline-recommended medicationsGuideline-recommended managementPrescription drug plansCross-sectional studyChronic conditionsChronic diseasesPocket costsOlder adultsOutpatient medicationsMedicare prescription drug plansInitial treatmentMedicare Advantage plansRetrospective cross-sectional studyMultiple chronic conditionsMedicare Part D plansPart D plansSubstantial financial burdenAtrial fibrillationMAIN OUTCOMEExclusion criteriaMedicare beneficiariesAnnual outHypothetical patientsMedications
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