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 interpretationOutcomesMarkersInterventionRelevance of Cardiac Surgery Outcome Reporting 3 Years Later in a New York and California Statewide Analysis
Mori M, Shahian DM, Suter LG, Geirsson A, Lin Z, Krumholz HM. Relevance of Cardiac Surgery Outcome Reporting 3 Years Later in a New York and California Statewide Analysis. JAMA Surgery 2020, 155: 442-444. PMID: 32129801, PMCID: PMC7057169, DOI: 10.1001/jamasurg.2019.6367.Peer-Reviewed Original ResearchMeSH KeywordsCaliforniaCoronary Artery BypassHumansNew YorkResearch ReportTime FactorsTreatment Outcome
2013
Time to Publication Among Completed Clinical Trials
Ross JS, Mocanu M, Lampropulos JF, Tse T, Krumholz HM. Time to Publication Among Completed Clinical Trials. JAMA Internal Medicine 2013, 173: 825-828. PMID: 23460252, PMCID: PMC3691813, DOI: 10.1001/jamainternmed.2013.136.Peer-Reviewed Original Research2013 ACCF/AHA Key Data Elements and Definitions for Measuring the Clinical Management and Outcomes of Patients With Acute Coronary Syndromes and Coronary Artery Disease
Cannon CP, Brindis RG, Chaitman BR, Cohen DJ, Cross JT, Drozda JP, Fesmire FM, Fintel DJ, Fonarow GC, Fox KA, Gray DT, Harrington RA, Hicks KA, Hollander JE, Krumholz H, Labarthe DR, Long JB, Mascette AM, Meyer C, Peterson ED, Radford MJ, Roe MT, Richmann JB, Selker HP, Shahian DM, Shaw RE, Sprenger S, Swor R, Underberg JA, Van de Werf F, Weiner BH, Weintraub WS. 2013 ACCF/AHA Key Data Elements and Definitions for Measuring the Clinical Management and Outcomes of Patients With Acute Coronary Syndromes and Coronary Artery Disease. Circulation 2013, 127: 1052-1089. PMID: 23357718, DOI: 10.1161/cir.0b013e3182831a11.Peer-Reviewed Original Research