2021
Characteristics of Randomized Clinical Trials in Surgery From 2008 to 2020
Robinson NB, Fremes S, Hameed I, Rahouma M, Weidenmann V, Demetres M, Morsi M, Soletti G, Di Franco A, Zenati MA, Raja SG, Moher D, Bakaeen F, Chikwe J, Bhatt DL, Kurlansky P, Girardi LN, Gaudino M. Characteristics of Randomized Clinical Trials in Surgery From 2008 to 2020. JAMA Network Open 2021, 4: e2114494. PMID: 34190996, PMCID: PMC8246313, DOI: 10.1001/jamanetworkopen.2021.14494.Peer-Reviewed Original ResearchConceptsMost trialsClinical eventsSurgical interventionSurgical RCTsClinical trialsSurgeon experienceMinor clinical eventsMore surgical interventionsReporting biasMajor clinical eventsRandomized clinical trialsRisk of biasMedian fragility indexMedian sample sizeLarge treatment effectsPrimary outcomeTRIAL REGISTRATIONControl armTrial characteristicsSurgical trialsHigh riskSuperiority designConcerns of biasPrimary analysisRCTs
2020
Characteristics of Contemporary Randomized Clinical Trials and Their Association With the Trial Funding Source in Invasive Cardiovascular Interventions
Gaudino M, Hameed I, Rahouma M, Khan FM, Tam DY, Biondi-Zoccai G, Demetres M, Charlson ME, Ruel M, Crea F, Falk V, Girardi LN, Fremes S, Chikwe J. Characteristics of Contemporary Randomized Clinical Trials and Their Association With the Trial Funding Source in Invasive Cardiovascular Interventions. JAMA Internal Medicine 2020, 180: 993-1001. PMID: 32478821, PMCID: PMC7265124, DOI: 10.1001/jamainternmed.2020.1670.Peer-Reviewed Original ResearchConceptsPrimary end pointInvasive cardiovascular interventionsPrimary outcomeClinical trialsEnd pointCardiovascular interventionsSignificant differencesComposite primary end pointContemporary Randomized Clinical TrialsStructural interventional cardiologyTrial funding sourceCardiac surgical proceduresRandomized clinical trialsNumber of patientsCross-sectional studyExperimental interventionReporting of trialsTreatment effectsMedian sample sizeLarge treatment effectsContemporary RCTsGuideline recommendationsEvidence-based practiceTrial sponsorshipFavorable outcome