2020
Non-inferiority trials using a surrogate marker as the primary endpoint: An increasing phenotype in cardiovascular trials
Bikdeli B, Caraballo C, Welsh J, Ross JS, Kaul S, Stone GW, Krumholz HM. Non-inferiority trials using a surrogate marker as the primary endpoint: An increasing phenotype in cardiovascular trials. Clinical Trials 2020, 17: 723-728. PMID: 32838556, PMCID: PMC8088773, DOI: 10.1177/1740774520949157.Peer-Reviewed Original ResearchConceptsNon-inferiority trialPrimary endpointClinical outcome trialsNon-inferiority marginSurrogate markerNon-inferiority designCardiovascular trialsOutcome trialsClinical outcomesDefinitive clinical outcome trialsNon-inferiority criteriaStudy protocolSurrogate outcomesBACKGROUND/Median numberSurrogate endpointsPrimary analysisCardiovascular interventionsCardiovascular medicineTrialsEndpointClinical interpretationOutcomesMarkersIntervention
2018
Biomedical journal speed and efficiency: a cross-sectional pilot survey of author experiences
Wallach JD, Egilman AC, Gopal AD, Swami N, Krumholz HM, Ross JS. Biomedical journal speed and efficiency: a cross-sectional pilot survey of author experiences. Research Integrity And Peer Review 2018, 3: 1. PMID: 29451557, PMCID: PMC5803634, DOI: 10.1186/s41073-017-0045-8.Peer-Reviewed Original Research
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
2010
Use of Administrative Claims Models to Assess 30-Day Mortality Among Veterans Health Administration Hospitals
Ross JS, Maynard C, Krumholz HM, Sun H, Rumsfeld JS, Normand SL, Wang Y, Fihn SD. Use of Administrative Claims Models to Assess 30-Day Mortality Among Veterans Health Administration Hospitals. Medical Care 2010, 48: 652-658. PMID: 20548253, PMCID: PMC3020977, DOI: 10.1097/mlr.0b013e3181dbe35d.Peer-Reviewed Original ResearchConceptsStatistical modelAcute myocardial infarctionVeterans Health Administration hospitalsVHA hospitalsHeart failurePneumonia hospitalizationsC-statisticNon-federal hospitalsMedian numberModest heterogeneityAdministration HospitalAdministrative claims dataService Medicare beneficiariesYears of age
2003
What Are Hospitals Doing to Increase Beta-Blocker Use?
Bradley EH, Holmboe ES, Wang Y, Herrin J, Frederick PD, Mattera JA, Roumanis SA, Radford MJ, Krumholz HM. What Are Hospitals Doing to Increase Beta-Blocker Use? The Joint Commission Journal On Quality And Patient Safety 2003, 29: 409-415. PMID: 12953605, DOI: 10.1016/s1549-3741(03)29049-3.Peer-Reviewed Original ResearchConceptsBeta-blocker useQuality improvement interventionsMyocardial infarctionCare coordinatorsClinical pathwayImprovement interventionsAcute myocardial infarctionCross-sectional analysisQuality improvement staffQuality improvement effortsNational registryMedian numberHospitalTelephone surveyInfarctionReminder FormInterventionImprovement effortsRegistryPrevalencePathwayPhysicians