2021
Use of Mechanical Circulatory Support Devices Among Patients With Acute Myocardial Infarction Complicated by Cardiogenic Shock
Dhruva SS, Ross JS, Mortazavi BJ, Hurley NC, Krumholz HM, Curtis JP, Berkowitz AP, Masoudi FA, Messenger JC, Parzynski CS, Ngufor CG, Girotra S, Amin AP, Shah ND, Desai NR. Use of Mechanical Circulatory Support Devices Among Patients With Acute Myocardial Infarction Complicated by Cardiogenic Shock. JAMA Network Open 2021, 4: e2037748. PMID: 33616664, PMCID: PMC7900859, DOI: 10.1001/jamanetworkopen.2020.37748.Peer-Reviewed Original ResearchMeSH KeywordsAgedAssisted CirculationCross-Sectional StudiesExtracorporeal Membrane OxygenationFemaleHeart ArrestHeart-Assist DevicesHospitals, High-VolumeHospitals, Low-VolumeHospitals, TeachingHumansIntra-Aortic Balloon PumpingMaleMiddle AgedMyocardial InfarctionPercutaneous Coronary InterventionRisk FactorsShock, CardiogenicConceptsMicroaxial left ventricular assist deviceIntra-aortic balloon pumpLeft ventricular assist devicePercutaneous coronary interventionAcute myocardial infarctionMechanical circulatory support devicesCardiogenic shockHospital-level variationSignificant hospital-level variationCirculatory support devicesMCS devicesUse of IABPDevice useMedian proportionAcute Myocardial Infarction ComplicatedCardiology-National Cardiovascular Data RegistryChest Pain-MI RegistryLimited clinical trial evidenceNational Cardiovascular Data RegistryMyocardial Infarction ComplicatedFirst medical contactSupport devicesClinical trial evidenceExtracorporeal membrane oxygenationCoronary artery stenosis
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
2017
The FDA Unapproved Drugs Initiative: An Observational Study of the Consequences for Drug Prices and Shortages in the United States.
Gupta R, Dhruva SS, Fox ER, Ross JS. The FDA Unapproved Drugs Initiative: An Observational Study of the Consequences for Drug Prices and Shortages in the United States. Journal Of Managed Care & Specialty Pharmacy 2017, 23: 1066-1076. PMID: 28944731, PMCID: PMC10397719, DOI: 10.18553/jmcp.2017.23.10.1066.Peer-Reviewed Original ResearchConceptsUnapproved Drugs InitiativeClinical evidenceAverage wholesale priceFDA approvalPrescription drugsNew clinical trial evidenceMedian shortage durationClinical trial evidenceNew clinical evidenceDrug shortagesNumber of drugsEvidence of safetyUtah Drug Information ServiceHealth-System Pharmacists
2014
Clinical Trial Evidence Supporting FDA Approval of Novel Therapeutic Agents, 2005-2012
Downing NS, Aminawung JA, Shah ND, Krumholz HM, Ross JS. Clinical Trial Evidence Supporting FDA Approval of Novel Therapeutic Agents, 2005-2012. JAMA 2014, 311: 368-377. PMID: 24449315, PMCID: PMC4144867, DOI: 10.1001/jama.2013.282034.Peer-Reviewed Original ResearchConceptsPivotal efficacy trialsNovel therapeutic agentsClinical trial evidencePivotal trialsEfficacy trialsTherapeutic agentsEnd pointTrial evidenceMedian numberAvailable FDA documentsSingle pivotal trialTrial end pointsSurrogate end pointsNumber of patientsLength of treatmentCross-sectional analysisPrimary outcomeClinical outcomesTrial completion ratesClinical benefitPlacebo comparatorSurrogate outcomesMAIN OUTCOMEDrug AdministrationUS Food