Background
Patients with colorectal cancer have a high risk of iron deficiency anaemia (IDA) due to chronic tumour induced blood loss, a reduced dietary iron intake from poor nutrition or gastrointestinal malabsorption. This pilot, double blinded, randomised controlled trial (RCT) examined the effect and feasibility of using preoperative iron isomaltoside for treating iron deficiency anaemia.
Methods
Forty eligible adults with IDA were randomised to receive either intravenous iron isomaltoside (20 mg.kg-1 up to 1000 mg over 30 minutes) or usual preoperative care (control) three weeks before scheduled colorectal surgery. The primary outcomes were perioperative changes in haemoglobin and ferritin concentrations.
Results
The recruitment rate was 78% of all eligible referred patients (1.9 patients/month). The haemoglobin and ferritin concentrations were higher in the iron isomaltoside group than the control group over the perioperative period (group*time interaction P = 0.042 and P < 0.001 respectively). Mean haemoglobin change from baseline to before surgery was higher in the iron isomaltoside group (7.8, 95% CI: 3.2 to 12.3 g.l-1) than the control group (1.7, 95% CI: -1.9 to 5.3 g.l-1) [mean difference 6.1, 95% CI: 0.3 to 11.8 g.l-1; P = 0.040]. The ferritin change from baseline to before surgery between groups was large in favour of the iron isomaltoside group (mean difference 296.9, 95% CI: 200.6 to 393.2 μg.l-1; P < 0.001]. There were no differences between groups in packed red blood cell transfusions needed, surgical complications, quality of recovery and days (alive and) at home within 30 days after surgery.
Conclusion
Iron isomaltoside therapy was safe and had a minimal effect on perioperative changes in haemoglobin concentration. Given the slow recruitment and new evidence emerging during the conduct of this study, conducting a multi-centre RCT based on the current pilot trial protocol is unlikely to be feasible.
Trial registration
ClinicalTrials.gov NCT03565354.
Introduction: Traditional simulation debriefing is both time-and resource-intensive. Shifting the degree of primary learning responsibility from the faculty to the learner through self-guided learning has received greater attention as a means of reducing this resource intensity. The aim of the study was to determine if video-assisted self-debriefing, as a form of self-guided learning, would have equivalent learning outcomes compared to standard debriefing.Methods: This randomized cohort study consisting of 49 PGY-1 to -3 emergency medicine residents compared performance after video self-assessment utilizing an observer checklist versus standard debriefing for simulated emergency department procedural sedation (EDPS). The primary outcome measure was performance on the second EDPS scenario.Results: Independent-samples t-test found that both control (standard debrief) and intervention (video selfassessment) groups demonstrated significantly increased scores on Scenario 2 (standard-t(40) = 2.20, p < 0.05; video-t(45) = 3.88, p < 0.05). There was a large and significant positive correlation between faculty and resident self-evaluation (r = 0.70, p < 0.05). There was no significant difference between faculty and residents selfassessment mean scores (t(24) = 1.90, p = 0.07).
Conclusions:Residents receiving feedback on their performance via video-assisted self-debriefing improved their performance in simulated EDPS to the same degree as with standard faculty debriefing. Video-assisted selfdebriefing is a promising avenue for leveraging the benefits of simulation-based training with reduced resource requirements. P rocedural sedation is a core competency for the practice of emergency medicine comprising a specific competency milestone in the Accreditation for Graduate Medical Education Next Accreditation System. 1 Despite advances in technology such as end-tidal CO 2 monitoring, the safety profiles of commonly used From the
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