Adherence to CONSORT Guidelines and Reporting of the Determinants of External Validity in Clinical Oncology Randomized Controlled Trials: A Review of Trials Published in Four Major Journals between 2013 and 2015.

Our primary objective was to determine the proportion of trials that report the number of patients assessed for eligibility before randomization. We performed the systematic retrieval and analysis of all phase II, III, and IV RCTs published between 2013 and 2015 in four high-impact-factor journals in the field of clinical oncology. Among 456 RCTs reviewed, 236 trials (51.8%) reported the number of patients assessed for eligibility. Among the 236 trials that reported the entire enrollment process, the reasons for patient exclusion could be found in 184 trials (78%). A flow diagram was presented in 452 trials (99.1%), and 98 trials (21.5%) included a discussion on generalizability. Reporting the parameters of external validity in medical oncology RCTs is challenging. Improving adherence to the 2010 CONSORT guidelines concerning the enrollment process could help clinicians and health policymakers establish to whom trial results apply.

Does the full-time presence of an intensivist lead to better outcomes in the cardiac surgical intensive care unit?

OBJECTIVE: The study objective was to compare clinical outcomes in a dedicated adult cardiac surgery intensive care unit before and after the implementation of 24-hour intensivist coverage. METHODS: Between 2008 and 2016, 16,454 consecutive adult patients were admitted to the cardiac surgery intensive care unit after cardiac surgery. During this period, postoperative patients in the cardiac surgery intensive care unit were managed by intensivists during the day (group A); in July 2010, the nighttime coverage was transferred from the hands of residents and fellows to intensivists (group B). Postoperative outcomes before and after this change using 1-to-1 propensity score matching were examined. Patients were stratified a priori into low- and high-risk (<5% and ≥5% predicted mortality) based on the European System for Cardiac Operative Risk Evaluation II. RESULTS: Matched patients in group A had significantly higher cardiac surgery intensive care unit (2.1% vs 1.4%, P = .01) and in-hospital (2.7% vs 1.8%, P = .008) mortality. This higher mortality was only observed among high-risk group A patients who had significantly higher rates of cardiac surgery intensive care unit mortality (6.8% vs 4.1%, P = .01) and in-hospital mortality (8.5% vs 5.3%, P = .01) compared with the high-risk group B. The median duration of mechanical ventilation (5.8 vs 4.3 hours, P < .0001) and the risk of prolonged ventilation greater than 48 hours (5.3% vs 4%, P = .008) were significantly higher among group A patients; this higher rate of respiratory adverse events was observed in all strata of preoperative risk. CONCLUSIONS: In this large cohort of patients admitted to a dedicated adult cardiac surgery intensive care unit, 24-hour intensivist coverage was associated with reduced mortality among patients with an expected operative mortality 5% or greater. These data suggest that preoperative risk stratification and adaptive cardiac surgery intensive care unit physician staffing may result in improved clinical outcomes and optimized hospital resource use.

4Fr in 5Fr sheathless technique with standard catheters for transradial coronary interventions: technical challenges and persisting issues.

OBJECTIVES: To evaluate the feasibility and potential benefits of performing sheathless 5Fr transradial percutaneous coronary interventions (PCI) using 4Fr diagnostic catheters as dilators. BACKGROUND: There is a direct association between artery-catheter mismatch and risk of radial artery occlusion. METHODS: We recruited 130 patients who underwent 4Fr sheathless diagnostic angiography with super torque (Cordis Corporation, USA) catheters followed by ad hoc PCI. To facilitate skin and vessel penetration, the Judkins right catheter (110 cm) was inserted inside the 5Fr guiding catheter (100 cm) as dilator. RESULTS: The mean age of patients was 63±12 years with 74% of males. Unfractionated heparin monotherapy was used in 84%, bivalirudin in 12%, and platelet glycoprotein 2b/3a inhibitors in 13%. Right radial artery was used in 99%. In three cases, no PCI was performed (FFR) and in two (1.5%) cases, a sheath was required after guiding catheter insertion due to local bleeding. In six cases (4.6%), upscale to 6Fr sheathed approach was required. No spasm occurred. Overall procedural success was achieved in 114/119 (96%) cases, including left main PCI, bifurcation PCI in 10 (8%) cases, CTO in 5 (4%) and IVUS use in 6 (5%) cases. Immediately after hemostasis completion, duplex ultrasound showed normal flow in 76%, occlusive thrombus in 13%, pseudo-aneurysmal dilatation in 11% and local hematoma surrounding puncture site in 20%. Hemoglobin dropped from 138±19 g/l to 131±16 g/l 4-6 hours after PCI. CONCLUSION: Using 4Fr diagnostic catheters as dilators, simple and complex PCI can be performed with standard 5Fr guiding catheters as sheathless techniques. However, suboptimal transition between diagnostic and guiding catheters likely creates radial artery trauma leading to frequent occlusive thrombus and hematoma surrounding the radial artery.