Evaluation of a workplace suicide prevention program in the Australian manufacturing industry: protocol for a cluster-randomised trial of MATES in manufacturing.

Males are at higher risk of death by suicide than females in Australia, and among men, blue-collar males are at higher risk compared to other working males. In response, MATES in Construction developed a workplace suicide prevention program for the construction sector in 2007 that has been widely implemented in Australia. In the current project, this program is being adapted and trialled in the manufacturing sector. The common aims of MATES programs are to improve suicide prevention literacy, help-seeking intentions, and helping behaviours. The program will be evaluated using a cluster randomised-controlled trial design with waitlist controls across up to 12 manufacturing worksites in Australia. We hypothesise that after 8 months of the MATES in Manufacturing program, there will be significantly greater improvements in help-seeking intentions (primary outcome) compared to waitlist controls. The project is led by Deakin University in collaboration with the University of Melbourne, and in partnership with MATES in Construction and a joint labour-management Steering Group.Trial registration: The trial was registered retrospectively with the Australian New Zealand Clinical Trials Registry on 25 January 2022 (ACTRN12622000122752).Protocol version: 2.0, November 2022.

You Care Eye Care: A quality improvement project to prevent eye complications in the intensive care unit

Introduction: 42% of patients in the intensive care unit (ICU) will suffer ocular damage during their stay.1 Multiple mechanisms that usually protect the eye are inhibited, whilst interventions such as positive airway pressure and muscle relaxants further expose the eye to harm.2 This became increasingly evident during the COVID-19 pandemic, where non-invasive ventilation and proning of patients exposed patients to risk of injury.3 Redeployment of Ophthalmologists to ICU during the first wave of the COVID-19 pandemic highlighted the need for a robust and sustainable intervention to reduce the frequency of eye complications in our unit. Objectives: Our objective was to reduce harm to eyes in all patients within the Royal Infirmary of Edinburgh (RIE) to zero ICU within nine months. Methods: Our QI project involved initial staff and patient data collection regarding current eye care practices. A fish-bone diagram facilitated group discussions with ICU clinical teams regarding prior eye care practices. A pareto chart identified categories to focus on, with a driver diagram identifying change ideas. Our primary intervention was the design and introduction of a bespoke eye care guideline. Specific outcomes, processes, and balancing measures were set out, and multiple PDSA cycles helped to prompt interventions to ensure consistent and standardised care was delivered. Run charts were regularly reviewed and a variety of interventions were introduced throughout the data collection period as tests of change. These included: 1. posters highlighting guideline enrolment 2. formal teaching at handovers and on the unit 3. educational emails to staff members 4. prompts on daily reviews to highlight eye care assessments. Between 28 Sept 2020 -28 June 21, twenty patients in RIE ICU were randomly selected by the data collection team weekly. Patient outcome -eyes were examined and noted if they had developed any ocular complications during their stay. Patients who had evidence of ocular damage on admission were excluded unless they developed further complications. A single episode was not counted twice. Process outcomes -Eye care guideline adherence was recorded, and non-compliance was rectified following data collection. The data was recorded on run charts, accessible via MS teams, allowing all project team members to review the data remotely. Results: During our data collection period, the introduction of our guideline and educational interventions reduced the median number of patients who suffered eye complications in ICU by 50% within nine months (Figure 1). Chemosis and evidence of dry eyes were the most common complications. Since initiation of the guideline, our educational interventions have maintained median guideline compliance at 80%. Conclusion: This is a comprehensive, patient-centred, QI project, utilizing a systematic methodology to introduce a new guideline within ICU. This project has resulted in a sustained improvement of eye care standards, and reduction of eye complications within RIE ICU. This project was ongoing during the second wave of the COVID-19 pandemic, where constant rotation of medical staff, unfamiliar with ICU, required education to ensure guideline compliance was achieved. Our eye care guideline is now part of a multicentre project to standardise care across NHS healthboards.

Respiratory Safety of Lemborexant in Adult and Elderly Subjects with Moderate to Severe Obstructive Sleep Apnea: A Randomized, Double-blind, Placebo-controlled, Crossover study

Introduction: A safety risk of some commonly prescribed sleep-promoting drugs, including benzodiazepines and nonbenzodiazepine receptor agonists, is central respiratory depression. Subjects with coexisting respiratory disease such as obstructive sleep apnea (OSA), and/or the elderly, are particularly at risk. Lemborexant (LEM) is a dual orexin receptor antagonist (DORA) approved in multiple countries for the treatment of adults with insomnia. In study 102 (E2006-A001-102;NCT03471871), no differences between LEM 10 mg (LEM10) and placebo (PBO) were found on peripheral oxygen saturation (SpO2) and the apnea-hypopnea index (AHI) in adult and elderly subjects with mild OSA following a single dose and multiple doses. Study 113 (E2006-A001-113;NCT04647383) is the first to investigate the effect of LEM on respiratory safety in adults and elderly subjects with moderate to severe OSA. Materials and Methods: This was a multicenter, multiple-dose, randomized, double-blind, PBO-controlled, 2-period crossover study in adult (age ≥45 to <65y) and elderly (age ≥65 to ≤90y) subjects with moderate (15≤AHI<30) to severe (AHI≥30) OSA. Subjects were randomized to two 8-night treatment periods (separated by a washout ≥14d) with either LEM10 or PBO. In-lab polysomnography and transmissive pulse oximetry were performed at screening, on Day 1 (after a single dose) and Day 8 of study drug during both treatment periods. Treatment-emergent adverse events (TEAEs) were recorded throughout the study. Results: Forty-eight subjects were screened;33 (68.8%) were randomized;of these n=13 had moderate OSA and n=20 had severe OSA. Mean age was 60.6y;22/33 subjects (66.7%) were age ≥45 to <65y and 11/33 (33.3%) were ≥65 to ≤90y. During total sleep time, mean baseline SpO2 was 93.5% and mean AHI for moderate OSA and severe OSA groups together (n=33) was 44.2. No significant difference was found in AHI (least squares mean [LSM]) after a single dose or multiple doses of LEM10 versus PBO in subjects with moderate (single: LEM10, 31.49;PBO, 32.41, P=0.818;multiple: LEM10, 34.66;PBO, 37.16, P=0.442) or severe (single: LEM10, 48.22;PBO, 52.69, P=0.172;multiple: LEM10, 51.48;PBO, 51.15, P=0.902) OSA. LEM10 versus PBO was also not significantly different for SpO2 (LSM with moderate [single: LEM10, 93.68;PBO, 93.86, P=0.696;multiple: LEM10, 93.74;PBO, 93.86%, P=0.784] or severe [single: LEM10, 92.57;PBO, 92.65, P=0.841;multiple: LEM10, 92.63;PBO, 93.02, P=0.283] OSA). Furthermore, no significant difference was found in percentage of total sleep time during which SpO2 was below the thresholds of <90%, <85%, <80% for LEM10 vs PBO following a single dose (P=0.694, P=0.134, P=0.195, respectively) or multiple doses (P=0.481, P=0.711, P=0.699, respectively) in subjects with moderate or severe OSA. TEAEs were higher with LEM10 (18.2%) versus PBO (9.1%). One subject did not complete treatment due to an adverse event unrelated to LEM10 (COVID-19). Overall, LEM was well tolerated, and most TEAEs were mild. Conclusion: As objectively measured by AHI and SpO2 during TST, LEM, a DORA, demonstrated respiratory safety with single and multiple dosing in subjects with moderate and severe OSA, and was well tolerated. Acknowledgements: Supported by Eisai, Inc.

Norwich COVID-19 testing initiative pilot: evaluating the feasibility of asymptomatic testing on a university campus.

BACKGROUND: There is a high prevalence of COVID-19 in university-age students, who are returning to campuses. There is little evidence regarding the feasibility of universal, asymptomatic testing to help control outbreaks in this population. This study aimed to pilot mass COVID-19 testing on a university research park, to assess the feasibility and acceptability of scaling up testing to all staff and students. METHODS: This was a cross-sectional feasibility study on a university research park in the East of England. All staff and students (5625) were eligible to participate. All participants were offered four PCR swabs, which they self-administered over two weeks. Outcome measures included uptake, drop-out rate, positivity rates, participant acceptability measures, laboratory processing measures, data collection and management measures. RESULTS: 798 (76%) of 1053 who registered provided at least one swab; 687 (86%) provided all four; 792 (99%) of 798 who submitted at least one swab had all negative results and 6 participants had one inconclusive result. There were no positive results. 458 (57%) of 798 participants responded to a post-testing survey, demonstrating a mean acceptability score of 4.51/5, with five being the most positive. CONCLUSIONS: Repeated self-testing for COVID-19 using PCR is feasible and acceptable to a university population.