Perioperative changes in haemoglobin and ferritin concentrations from preoperative intravenous iron isomaltoside for iron deficiency anaemia in patients with colorectal cancer: A pilot randomised controlled trial.

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.

Effect of a patient education video and prehabilitation on the quality of preoperative person-centred coordinated care experience: protocol for a randomised controlled trial.

INTRODUCTION: Multimodal prehabilitation, an emerging field within the Perioperative Medicine specialty, requires close multidisciplinary team coordination. The goal is to optimise the patient's health status in the 4-8 weeks before elective surgery to withstand surgical stress. Most patients are unfamiliar with the concept of prehabilitation but are interested in participating in such a programme after explanation. The objective of this randomised controlled trial is to evaluate the effect of prehabilitation (patient education video and multimodal prehabilitation) on the preoperative patient-centred coordinated care experience. METHOD AND ANALYSIS: One hundred patients undergoing major elective surgery (cardiac, colorectal, hepatobiliary-pancreatic and urology) will be recruited into a two-group, parallel, superiority, single-blinded randomised controlled trial. Patients will be randomised to receive either preoperative patient education comprising of a video and prehabilitation programme with standard care (intervention) or standard care (control). The primary outcome measure will be the quality of preoperative patient care experience using the 11-item Chinese version of the Person-Centred Coordinated Care Experience Questionnaire (P3CEQ) before surgery. Secondary outcomes will include the change in Hospital Anxiety and Depression Scale (HADS) score from trial enrolment to before surgery, Quality of Recovery Score (QoR-15) on third day after surgery and Days Alive and At Home within 30 days after surgery (DAH30). Intention-to-treat and per-protocol analyses will be performed. ETHICS AND DISSEMINATION: The Joint CUHK-NTEC Clinical Research Ethics Committee approved the study protocol (CREC Ref. No. 2021.518-T). The findings will be presented at scientific meetings, in peer-reviewed journals and to study participants. TRIAL REGISTRATION NUMBER: ChiCTR2100053637.

Rapid cycle system improvement for COVID-19 readiness: integrating deliberate practice, psychological safety and vicarious learning.

Introduction: In the face of a rapidly advancing pandemic with uncertain pathophysiology, pop-up healthcare units, ad hoc teams and unpredictable personal protective equipment supply, it is difficult for healthcare institutions and front-line teams to invent and test robust and safe clinical care pathways for patients and clinicians. Conventional simulation-based education was not designed for the time-pressured and emergent needs of readiness in a pandemic. We used 'rapid cycle system improvement' to create a psychologically safe learning oasis in the midst of a pandemic. This oasis provided a context to build staff technical and teamwork capacity and improve clinical workflows simultaneously. Methods: At the Department of Anaesthesia and Intensive Care in Prince of Wales Hospital, a tertiary institution, in situ simulations were carried out in the operating theatres and intensive care unit (ICU). The translational simulation design leveraged principles of psychological safety, rapid cycle deliberate practice, direct and vicarious learning to ready over 200 staff with 51 sessions and achieve iterative system improvement all within 7 days. Staff evaluations and system improvements were documented postsimulation. Results/Findings: Staff in both operating theatres and ICU were significantly more comfortable and confident in managing patients with COVID-19 postsimulation. Teamwork, communication and collective ability to manage infectious cases were enhanced. Key system issues were also identified and improved. Discussion: To develop readiness in the rapidly progressing COVID-19 pandemic, we demonstrated that 'rapid cycle system improvement' can efficiently help achieve three intertwined goals: (1) ready staff for new clinical processes, (2) build team competence and confidence and (3) improve workflows and procedures.