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Postoperative delirium (POD) is common. It is associated with increased morbidity and mortality. Many cases may be preventable and melatonin offers promise as a preventative agent.ObjectiveThis systematic review provides an up-to-date synthesis of the evidence on the effect of melatonin in preventing POD.DesignA systematic search of randomised controlled trials of melatonin in POD was run across multiple databases (EMBASE, MEDLINE, CINAHL, PsycINFO) and a clinical trials registry (ClinicalTrials.org) (1 January 1990 to 5 April 2022). Studies examining the effects of melatonin on POD incidence in adults are included. Risk of bias was assessed using the Cochrane risk of bias 2 tool.Outcome measuresThe primary outcome is POD incidence. Secondary outcomes are POD duration and length of hospital stay. Data synthesis was undertaken using a random-effects meta-analysis and presented using forest plots. A summary of methodology and outcome measures in included studies is also presented.ResultsEleven studies, with 1244 patients from a range of surgical specialties were included. Seven studies used melatonin, in variable doses, and four used ramelteon. Eight different diagnostic tools were used to diagnose POD. Time points for assessment also varied. Six studies were assessed as low risk of bias and five as some concern. The combined OR of developing POD in the melatonin groups versus control was 0.41 (95% CI 0.21 to 0.80, p=0.01).ConclusionThis review found that melatonin may reduce the incidence of POD in adults undergoing surgery. However, included studies displayed inconsistency in their methodology and outcome reporting. Further work to determine the optimum regime for melatonin administration, along with consensus of how best to evaluate results, would be beneficial.PROSPERO registration numberCRD42021285019.

Background Consistent outcome assessment in surgical research, from early phase studies (during introduction and refinement of new procedures) to late phase studies (to establish comparative effectiveness) needs improvement to ensure efficient and safe surgical care. This study explored the potential continuity of outcome domain assessment throughout the evaluation lifecycle of surgical interventions. Methods Core outcome sets (COS) for late phase studies of surgical interventions were identified through COMET database searches. Core outcomes/outcome domains were extracted and mapped to core domains of a COS developed specifically for evaluating surgical innovation (COHESIVE COS). Outcomes/domains were categorised as “definite match” (clear similarity), “possible match” (potential similarity) and “no match” (no similarity) COHESIVE domain based on similarity in wording or meaning. Results A total of 54 COS studies were included, yielding 573 core outcomes/domains. Most late phase core outcomes/domains ( N  = 519, 91%) showed clear or possible similarity. All late phase COS studies recommended measurement of COHESIVE domains ‘Intended benefits’ and ‘Expected and unexpected disadvantages’. Some late phase outcomes/domains also showed similarity with early phase COHESIVE domains, including ‘Problems with the device working’, ‘Patients’ experience’ and ‘Operators’/surgeons’ experience’. A minority of late phase outcomes/domains showed no similarity with COHESIVE domains ( n  = 54, 9%). Conclusion High similarity between outcome domains recommended in early and late phase evaluations of surgical interventions demonstrates continuity of outcome domain assessment throughout the surgical innovation lifecycle is possible. Harmonising outcome measurement throughout the research pathway can streamline evaluation, enhancing access to beneficial treatment and improving early detection of harms.

IntroductionPostoperative delirium (POD) is a major cause of morbidity, particularly in elderly patients. Melatonin has been suggested as a low-risk pharmacological intervention to help prevent POD. A previous systematic review found limited high-quality evidence to support the use of melatonin in the prevention of POD. Several further randomised studies have since been published. This systematic review aims to synthesise the evidence from randomised controlled trials (RCTs) examining the effect of melatonin on the prevention of POD in older adults.Methods and analysisA systematic search of RCTs of melatonin (any dose and formulation) in POD will be run across Embase, Medline, CINAHL and PsychInfo. RCTs published from January 1990 until the end of February 2022 and reporting outcomes for melatonin use to prevent POD in patients will be included. Screening of search results and data extraction from included articles will be performed by two independent reviewers. The primary outcome will be incidence of POD in older adults undergoing surgery. Secondary outcomes are delirium duration and length of hospital stay. The review will also describe the dosage, timing and administration regimes of melatonin therapy and as well as the scales and definitions used to describe POD. A registry review of ongoing trials will be also be performed. For the meta-analysis, data will be pooled using a random effects model to generate a forest plot and obtain an odds ratio (OR) for the incidence of POD. Results will be reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement.Ethics and disseminationNo ethical approval is required. This review will be disseminated via peer-reviewed manuscript and conferences. The results will be used as the basis of work to optimise this intervention for future trials in surgical populations.PROSPERO registration numberThis review is registered with PROSPERO (CRD42021285019).

PurposeDuring Cesarean Sections, distractions which interrupt task specific activities include auditory, equipment, theatre traffic, and irrelevant communication. Aims of this study were to investigate frequency and types of distractions and to assess impact on patient safety and theatre efficiency.MethodsProspective observational study in a London hospital in women undergoing elective and emergency Cesarean Sections. Distractions were recorded prospectively in primiparous women having uncomplicated elective and emergency Cesarean Sections over a 4 week period. Level of distraction is categorized as I: no noticeable impact on surgical team; II: ≥ 1 team member affected; and III: all members affected. Safety outcomes assessed included perioperative complications such as postpartum hemorrhage, organ injury, postsurgical pyrexia (first 48 h), return to theatre, readmissions, and postdelivery anemia < 7 g/dl.ResultsData from 33 elective and 23 emergency cases were collected. Mean number of level II/III distractions/case was 13.20 (± 6.93) and number of level II/III distracting events was greater during elective compared to emergency cases (mean 14.91 vs 12.00, p = 0.04). In total, 17.89% of distractions occurred during crucial part of surgery between skin incision and delivery of baby, while delays resulting from level II/III distractions accounted for 11.25% of total operating time. There were no intra- or postoperative complications observed in the cohort of cases.ConclusionsDistractions did not culminate in perioperative complications, but disrupted surgeons’ task activity, prolonging mean procedure duration by 26.8%. Recognising sources and effects of distractions will enable measures to be taken to improve theatre productivity and patient safety.

Robotic Roux-en-Y gastric bypass (RRYGB) is an innovative alternative to traditional laparoscopic approaches. Literature has been published investigating its safety/efficacy; however, the quality of reporting is uncertain. This systematic review used the Idea, Development, Exploration, Assessment and Long-term follow-up (IDEAL) framework to assess the reporting quality of available literature. A narrative summary was formulated, assessing how comprehensively governance/ethics, patient selection, demographics, surgeon expertise/training, technique description and outcomes were reported. Forty-seven studies published between 2005 and 2024 were included. There was incomplete/inconsistent reporting of governance/ethics, patient selection, surgeon expertise/training and technique description, with heterogenous outcome reporting. RRYGB reporting was poor and did not align with IDEAL guidance. Robust prospective studies reporting findings using IDEAL/other guidance are required to facilitate safe widespread adoption of RRYGB and other surgical innovations.

Robot-assisted anti-reflux surgery (RA-ARS) is increasingly being used to treat refractory gastro-oesophageal reflux disease. The IDEAL (Idea, Development, Exploration, Assessment, Long-term follow up) Collaboration’s framework aims to improve the evaluation of surgical innovation, but the extent to which the evolution of RA-ARS has followed this model is unclear. This study aims to evaluate the standard to which RA-ARS has been reported during its evolution, in relation to the IDEAL framework. A systematic review from inception to June 2020 was undertaken to identify all primary English language studies pertaining to RA-ARS. Studies of paraoesophageal or giant hernias were excluded. Data extraction was informed by IDEAL guidelines and summarised by narrative synthesis. Twenty-three studies were included: two case reports, five case series, ten cohort studies and six randomised controlled trials. The majority were single-centre studies comparing RA-ARS and laparoscopic Nissen fundoplication. Eleven (48%) studies reported patient selection criteria, with high variability between studies. Few studies reported conflicts of interest (30%), funding arrangements (26%), or surgeons’ prior robotic experience (13%). Outcome reporting was heterogeneous; 157 distinct outcomes were identified. No single outcome was reported in all studies.The under-reporting of important aspects of study design and high degree of outcome heterogeneity impedes the ability to draw meaningful conclusions from the body of evidence. There is a need for further well-designed prospective studies and randomised trials, alongside agreement about outcome selection, measurement and reporting for future RA-ARS studies.

BackgroundIn 2016, a report by Health Education England advocated using simulation based-learning and placing a greater emphasis on human factors (HF) training to improve patient safety across the NHS. 1 HF have been incorporated into several post-graduate training programmes, in particular anaesthesia, where potential risk to patient safety is high. Our innovative, simulation-based, one-day course sought to expand this training to final year medical students.Summary of workIn this pilot, we organised two training days and a total of 33 students attended. The course began with a brief introductory lecture about HF concepts. Following this, six scenarios were simulated; these scenarios were based on real experiences that illustrated different aspects of HF.Both before and after the course, the students completed a modified version of a 14-part questionnaire developed by Reedy et al.2 to evaluate learning outcomes in HF training.Summary of resultsThe response rate was 100%.With respect to questions developed by Reedy et al.2, using an ordinal Likert scale, we found that students’ greatest mean improvement in confidence (2.27) was in ‘monitoring the ‘big picture’ during a clinical scenario’ and the least improvement (1.24) was seen in ‘involving colleagues in your decision making’. With respect to our own questions, the greatest mean improvement in confidence was seen in ‘reporting a system error or critical incident’ (2.42). Pre-teaching and post-teaching feedback was analysed using a paired t-test and showed a significant improvement in human factor(s) skills (p<0.000001).Qualitative feedback revealed that students appreciated opportunities to practice dealing with problems commonly encountered in foundation training, such as dealing with challenging colleagues and system errors. Negative feedback was largely directed at only being able to participate in one scenario.Discussion and conclusionsSimulation-based learning improved the confidence of our final year medical students in criteria relating to HF. Evaluating whether increased confidence leads to behavioural change is, however, fraught with difficulty. We plan to organise this training day for the next cohort of final year medical students, and in our future study design plan to include follow-up to assess if there has been an impact on their clinical practice.RecommendationsWe believe that a major strength of our design was in having the faculty member who developed the simulation scenario - based on their own clinical experiences - also leading the ‘debrief’ for that session. This grounding in reality made the learning points, discussion and reflection authentic.ReferencesHealth Education England, The Commission on Education and Training for Patient Safety (2016). Improving Safety Through Education and Training. Available at: https://www.hee.nhs.uk/sites/default/files/documents/Improving%20safety%20through%20education%20and%20training.pdf [Accessed 21 Apr 2019]Reedy G.B., Lavelle M., Simpson T. and Anderson J.E., 2017. Development of the Human Factors Skills for Healthcare Instrument: a valid and reliable tool for assessing interprofessional learning across healthcare practice settings. BMJ Simulation and Technology Enhanced Learning, 3(4), pp.135–141.