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Objectives: To adapt and apply a model for evaluating the functional benefits and cost efficiency of specialist inpatient rehabilitation to the Australian context, comparing functional outcomes and savings in the cost of ongoing care after acquired brain injury., Design: An observational cohort analysis of prospectively collected clinical data from admission to discharge, with follow-up to 3 years., Setting: A newly established state-wide inpatient postacute rehabilitation unit in Victoria, Australia for patients with moderate to severe acquired brain injury., Participants: This study included consecutive patients admitted to the programme during its first 2 years' operation (January 2016 to December 2017). Inclusion criteria consisted of complete outcome measures recorded on admission and discharge, total n=196, mean age 44.6 years (range 17-78), males:females 72:28%, aetiology:trauma n=124 (63%), stroke n=42 (21%), diffuse n=18 (9%) and other-mixed n=12 (7%)., Interventions: Specialist inpatient multidisciplinary rehabilitation., Outcome Measures: Dependency and care costs: Northwick Park Dependency Scale/Care Needs Assessment (NPCNA); Functional independence: UK Functional Assessment Measure. Cost efficiency: (a) Time is taken to offset rehabilitation costs by savings in NPCNA-estimated costs of ongoing care and (b) net projected lifetime savings., Results: Median length of stay 75 (IQR: 33.5-169.5) days, mean episode costs were $A147 044 (95% CI $A126 436, $A167 652). There was a significant reduction in dependency between admission and discharge on all measures (Holm-Bonferroni corrected p<0.001) which was sustained at follow-up in those traced at 1-3 years. Savings were greatest in the highest-dependency group. Estimated mean overall reduction in 'weekly care costs' was $A7206, offsetting the cost of rehabilitation within 5.53 months (95% CI 2.27, 8.78). Mean projected net lifetime savings were $A13.4 million (95% CI $A11.4, $A15.4) per patient., Conclusions: This study provides proof of principle for use of the NPCNA cost-efficiency model outside the UK and yields further evidence that rehabilitation for patients with complex disabilities represents value for money. For every dollar spent on inpatient rehabilitation in this cohort, an estimated $A91 was saved in ongoing care costs., Competing Interests: Competing interests: There are no significant competing interests. All authors have completed the BMJ Declaration of Competing Interests form available on request from the corresponding author. Outcome measurement is a specific research interest of our centres. LT-S is Director of UKROC and was the lead developer of the NPDS, NPCNA and the UK FIM+FAM, but neither she nor her employing institution has any financial interest in the tools which are disseminated free of charge. NAL and JM are employed by the organisation where the research was undertaken. None of the authors has any personal financial interests in the work undertaken or the findings reported., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group.)

Introduction: Infants born very preterm (VPT, <32 weeks' gestation) are at increased risk for neurodevelopmental impairments including motor, cognitive and behavioural delay. Parents of infants born VPT also have poorer mental health outcomes compared with parents of infants born at term.We have developed an intervention programme called TEDI-Prem (Telehealth for Early Developmental Intervention in babies born very preterm) based on previous research. TEDI-Prem aims to improve neurodevelopmental outcomes and parental well-being in children born VPT. Here we present the protocol outlining a multicentre, pragmatic, parallel-group, randomised controlled trial to determine the efficacy of TEDI-Prem plus usual care, compared with usual care alone., Methods and Analysis: We will recruit 466 VPT infants from the neonatal units of five hospitals in Victoria, Australia. Participants will be randomised, stratified by site of recruitment and multiple births, to TEDI-Prem plus usual care or usual care alone. The TEDI-Prem intervention programme involves 13 sessions across three phases. Phase 1 commences in the neonatal unit with four face-to-face sessions with parent/s and a physiotherapist/occupational therapist. Once discharged from the hospital, sessions across phases 2 and 3 (six and three sessions, respectively) continue via telehealth until infants are 12 months' corrected age (CA).The primary outcome is the Bayley Scales of Infant and Toddler Development-fourth edition (Bayley-4) Motor Composite Score at 12 months' CA. Secondary outcomes address other neurodevelopmental domains (Bayley-4 cognitive and language composite score; Infant Toddler Social Emotional Assessment), parental mental health (Depression Anxiety and Stress Scale 21), parent-child interaction (Emotional Availability Scale) and programme cost-effectiveness which encompasses parent quality of life (Short-Form Six-Dimension Quality of Life) and child quality of life (EuroQol Toddler and Infant Populations measure) at 12 and 24 months' CA.Mean differences between groups will be examined using linear regression for continuous outcomes and logistic regression for binary outcomes. All models will be fitted via generalised estimating equations to account for multiple births and adjusted for the hospital sites., Ethics and Dissemination: This trial has Royal Children's Hospital Human Research and Ethics Committee approval (HREC/67604/RCHM-2020) with specific site approval for all participating sites. Findings will be disseminated through peer-reviewed publications, conference presentations, digital and print media and to participants., Trial Egistration Number: This trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12621000364875)., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: The study aimed to investigate the impact of COVID-19 on the cascade of HIV care for people living with HIV (PLHIV) in Ethiopia., Design: A retrospective longitudinal study., Setting: The study was conducted in North Showa Zone, Ethiopia, from pre-COVID-19 (January 2018-December 2019) and during COVID-19 (January 2020-December 2021)., Participants: We identified 61901 records from 3925 PLHIV, of which 23 848 were recorded during the pandemic., Main Outcome Measure: We investigated indicators from four stages of the HIV care cascade, including HIV screening and diagnosis, HIV care, HIV treatment and HIV disease progression, according to a WHO framework. The indicator changes were assessed with incidence rate ratios (IRRs)., Results: For HIV screening and diagnosis, the monthly number of HIV tests experienced a 46% decline from 2520 to 1361 since the pandemic (IRR 0.553; 95% CI 0.546 to 0.561). For HIV care, the monthly number of consultations was reduced by 49.6% (from 1582 to 798) since the pandemic (IRR 0.591; 95% CI 0.581 to 0.601). Similarly, the monthly number of viral load tests was reduced by 42.8% (IRR 0.614; 95% CI 0.581 to 0.650). For HIV treatment, the number of antiretroviral therapy (ART) initiations was reduced by 27.8% and the number of ART adherence by 52.5% since the pandemic. For HIV disease progression, the monthly number of PLHIV achieving viral suppression was reduced by 61.6%, while HIV-related deaths doubled during the pandemic., Conclusion: The study highlights pandemic-induced disruptions in the cascade of care for PLHIV. Targeted interventions are necessary to protect PLHIV in public health emergencies., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Introduction: Many types of prostate cancer present minimal risk to a man's lifespan or well-being, but existing terminology makes it difficult for men to distinguish these from high-risk prostate cancers. This study aims to explore whether using an alternative label for low-risk prostate cancer influences management choice and anxiety levels among Australian men and their partners., Methods and Analysis: We will run two separate studies for Australian men and Australian women with a male partner. Both studies are between-subjects factorial (3×2) randomised online hypothetical experiments. Following consent, eligible participants will be randomised 1:1:1 to three labels: 'low-risk prostate cancer, Gleason Group 1', 'low-risk prostate neoplasm' or 'low-risk prostate lesion'. Participants will then undergo a second randomisation step with 1:1 allocation to the provision of detailed information on the benefits and harms of different management choices versus the provision of less detailed information about management choices. The required sample sizes are 1290 men and 1410 women. The primary outcome is the participant choice of their preferred management strategy: no immediate treatment (prostate-specific antigen (PSA)-based monitoring or active surveillance using PSA, MRI, biopsy with delayed treatment for disease progression) versus immediate treatment (prostatectomy or radiation therapy). Secondary outcomes include preferred management choice (from the four options listed above), diagnosis anxiety, management choice anxiety and management choice at a later time point (for participants who initially choose a monitoring strategy)., Ethics and Dissemination: Ethics approval has been received from The University of Sydney Human Research Ethics Committee (2023/572). The results of the study will be published in a peer-reviewed medical journal and a plain language summary of the findings will be shared on the Wiser Healthcare publications page http://www.wiserhealthcare.org.au/category/publications/ TRIAL REGISTRATION NUMBERS: Australian New Zealand Clinical Trials Registry (ID 386701 and 386889)., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Introduction: Critically ill patients are at risk of suboptimal beta-lactam antibiotic (beta-lactam) exposure due to the impact of altered physiology on pharmacokinetics. Suboptimal concentrations can lead to treatment failure or toxicity. Therapeutic drug monitoring (TDM) involves adjusting doses based on measured plasma concentrations and individualising dosing to improve the likelihood of improving exposure. Despite its potential benefits, its adoption has been slow, and data on implementation, dose adaptation and safety are sparse. The aim of this trial is to assess the feasibility and fidelity of implementing beta-lactam TDM-guided dosing in the intensive care unit setting., Methods and Analysis: A beta-lactam antibiotic Dose AdaPtation feasibility randomised controlled Trial using Therapeutic Drug Monitoring (ADAPT-TDM) is a single-centre, unblinded, feasibility randomised controlled trial aiming to enroll up to 60 critically ill adult participants (≥18 years). TDM and dose adjustment will be performed daily in the intervention group; the standard of care group will undergo plasma sampling, but no dose adjustment. The main outcomes include: (1) feasibility of recruitment, defined as the number of participants who are recruited from a pool of eligible participants, and (2) fidelity of TDM, defined as the degree to which TDM as a test is delivered as intended, from accurate sample collection, sample processing to result availability. Secondary outcomes include target attainment, uptake of TDM-guided dosing and incidence of neurotoxicity, hepatotoxicity and nephrotoxicity., Ethics and Dissemination: This study has been approved by the Alfred Hospital human research ethics committee, Office of Ethics and Research Governance (reference: Project No. 565/22; date of approval: 22/11/2022). Prospective consent will be obtained and the study will be conducted in accordance with the Declaration of Helsinki. The finalised manuscript, including aggregate data, will be submitted for publication in a peer reviewed journal. ADAPT-TDM will determine whether beta-lactam TDM-guided dose adaptation is reproducible and feasible and provide important information required to implement this intervention in a phase III trial., Trial Registration Number: Australian New Zealand Clinical Trials Registry, ACTRN12623000032651., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: This study aims to validate the Seizure-Related Impact Assessment Scale (SERIAS). This novel patient-reported outcome measure (PROM) compares the 'trade-off' between seizures and treatment-related adverse effects, and measures epilepsy disability qualitatively and quantitively. It fills an important gap in PROMs for epilepsy clinical trials and practice., Methods and Analysis: Adults with epileptologist-confirmed epilepsy from two Australian Epilepsy Centres are being recruited. People with functional seizures, or who are unable to self-complete English-language validated instruments are excluded. Participants providing informed consent are invited to complete questionnaires at baseline, 3 and 6 months later. SERIAS includes five questions that ask about the number of days per month that seizures or treatment-related adverse effects partially or fully impact work/home/school and family/social/non-work activities, as well as a visual analogue scale regarding epilepsy-related disability. SERIAS is completed alongside seven internationally validated instruments measuring treatment-related adverse effects, mood disorders and quality of life. Target recruitment is n=100, ensuring>50 people complete all questionnaires at all timepoints. Comprehensive psychometric analysis will be performed. Convergent validity will be investigated using bivariate correlations with relevant measures. Reliability will be investigated using Cronbach's alpha, McDonald's omega and test-retest correlation coefficients. SERIAS will be a novel PROM for epilepsy clinical trials and practice., Ethics and Dissemination: Multisite ethics approval was granted by the Alfred Health Ethics Committee (HREC 17/23). Results of this study will be disseminated through publication in peer-reviewed journals and presentations at scientific conferences., Trial Registration Number: ACTRN12623000599673., Competing Interests: Competing interests: EF reports salary support from LivaNova USA for the SERIAS validation study. EF reports grants from Brain Foundation Australia, Royal Australasian College of Physicians Fellows Research Establishment Fellowship, Monash University Early Career Postdoctoral Fellowship, Monash Partners STAR Clinician Fellowship, Sylvia and Charles Viertel Charitable Foundation Clinical Investigator Award, outside the submitted work. AC reports salary support from LivaNova USA for the SERIAS validation study. CE reports no disclosures relating to this study. J-PN reports no disclosures relating to this study. GR reports no disclosures relating to this study. TW-B reports no disclosures relating to this study. TJOB reports NHMRC Programme Grant (#APP1091593), grants from UCB Pharma, grants from Eisai Pharma, grants and personal fees from Zynerba Pharmaceuticals, grants from Biogen, outside the submitted work. PK reports no disclosures relating to this study. His institution has received research grants from Eisai, LivaNova and UCB Pharma outside the submitted work; and he has received consultancy/speaker fees from Angelini, Eisai, LivaNova, SK Life and UCB Pharma outside the submitted work. CM reports salary support from LivaNova USA for the SERIAS validation study. He has also received conference travel support and/or speaker fees from Merck, Novartis and Biogen. He has received research support from the National Health and Medical Research Council, Multiple Sclerosis Research Australia, The University of Melbourne, The Royal Melbourne Hospital Neuroscience Foundation, and Dementia Australia. JAF consults for LivaNova, and is President of the Epilepsy Study Consortium that owns the copyright to SERIAS., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: Researchers face numerous challenges when recruiting participants for health and social care research. This study reports on the challenges faced recruiting older adults for Being Your Best , a co-designed holistic intervention to manage and reduce frailty, and highlights lessons learnt amidst the COVID-19 pandemic., Design: A qualitative study design was used. Referrer interviews were conducted to explore the recruitment challenges faced by the frontline workers. An audit of the research participant (aged ≥65) database was also undertaken to evaluate the reasons for refusal to participate and withdrawal from the study., Setting: Hospital emergency departments (EDs) and a home care provider in Melbourne, Australia., Participants: Frontline workers and older adults., Results: From May 2022 to June 2023, 71 referrals were received. Of those referrals, only 13 (18.3%) agreed to participate. Three participants withdrew immediately after baseline data collection, and the remaining 10 continued to participate in the programme. Reasons for older adult non-participation were (1) health issues (25.3%), (2) ineligibility (18.3%), (3) lack of interest (15.5%), (4) perceptions of being 'too old' (11.2%) and (5) perceptions of being too busy (5.6%). Of those participating, five were female and five were male. Eleven referrer interviews were conducted to explore challenges with recruitment, and three themes were generated after thematic analysis: (1) challenges arising from the COVID-19 pandemic, (2) characteristics of the programme and (3) health of older adults., Conclusion: Despite using multiple strategies, recruitment was much lower than anticipated. The ED staff were at capacity associated with pandemic-related activities. While EDs are important sources of participants for research, they were not suitable recruitment sites at the time of this study, due to COVID-19-related challenges. Programme screening characteristics and researchers' inability to develop rapport with potential participants also contributed to low recruitment numbers., Trial Registration Number: ACTRN12620000533998; Pre-results., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Extrapleural pneumonectomy (EPP) and extended pleurectomy/decortication (ePD) are surgical cytoreductive techniques aimed at achieving macroscopic resection in malignant pleural tumours such as pleural mesothelioma, non-mesothelioma pleural malignancies such as thymoma and sarcoma, and rarely for pleural tuberculosis, in a more limited fashion. Despite extensive studies on both surgical techniques and consequences, a significant knowledge gap remains regarding how best to approach the perioperative anaesthesia challenges for EPP and ePD.It is unknown if the risk stratification processes for such surgeries are standardised or what types of functional and dynamic cardiac and pulmonary tests are employed preoperatively to assist in the perioperative risk stratification. Further, it is unknown whether the types of anaesthesia and analgesia techniques employed, and the types of haemodynamic monitoring tools used, impact on outcomes. It is also unknown whether individualised haemodynamic protocols are used to guide the rational use of fluids, vasoactive drugs and inotropes.Finally, there is a dearth of evidence regarding how best to monitor these patients postoperatively or what the most effective enhanced recovery protocols are to best mitigate postoperative complications and accelerate hospital discharge. To increase our knowledge of the perioperative and anaesthetic treatment for patients undergoing EPP/ePD, this scoping review attempts to synthesise the literature and identify these knowledge gaps., Methods and Analysis: This scoping review will be conducted in accordance with the Preferred Reporting Items for Systematic Review and Meta-Analysis Extension for Scoping Review Protocols methodology. Electronic databases, OVID Medline, EMBASE and the Cochrane Library, will be systematically searched for relevant literature corresponding to EPP or ePD and perioperative or anaesthetic management. Data will be analysed and summarised descriptively and organised according to the three perioperative stages: preoperative, intraoperative and postoperative factors in clinical care., Ethics and Dissemination: Ethics approval was not required. The findings will be disseminated through professional networks, conference presentations and publications in scientific journals., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: We aimed to assess the healthcare costs and impact on the economy at large arising from emergency medical services (EMS) treated non-traumatic shock., Design: We conducted a population-based cohort study, where EMS-treated patients were individually linked to hospital-wide and state-wide administrative datasets. Direct healthcare costs (Australian dollars, AUD) were estimated for each element of care using a casemix funding method. The impact on productivity was assessed using a Markov state-transition model with a 3-year horizon., Setting: Patients older than 18 years of age with shock not related to trauma who received care by EMS (1 January 2015-30 June 2019) in Victoria, Australia were included in the analysis., Primary and Secondary Outcome Measures: The primary outcome assessed was the total healthcare expenditure. Secondary outcomes included healthcare expenditure stratified by shock aetiology, years of life lived (YLL), productivity-adjusted life-years (PALYs) and productivity losses., Results: A total of 21 334 patients (mean age 65.9 (±19.1) years, and 9641 (45.2%) females were treated by EMS with non-traumatic shock with an average healthcare-related cost of $A11 031 per episode of care and total cost of $A280 million. Annual costs remained stable throughout the study period, but average costs per episode of care increased (P trend =0.05). Among patients who survived to hospital, the average cost per episode of care was stratified by aetiology with cardiogenic shock costing $A24 382, $A21 254 for septic shock, $A19 915 for hypovolaemic shock and $A28 057 for obstructive shock. Modelling demonstrated that over a 3-year horizon the cohort lost 24 355 YLLs and 5059 PALYs. Lost human capital due to premature mortality led to productivity-related losses of $A374 million. When extrapolated to the entire Australian population, productivity losses approached $A1.5 billion ($A326 million annually)., Conclusion: The direct healthcare costs and indirect loss of productivity among patients with non-traumatic shock are high. Targeted public health measures that seek to reduce the incidence of shock and improve systems of care are needed to reduce the financial burden of this syndrome., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Gonorrhoea, the sexually transmissible infection caused by Neisseria gonorrhoeae , has a substantial impact on sexual and reproductive health globally with an estimated 82 million new infections each year worldwide. N. gonorrhoeae antimicrobial resistance continues to escalate, and disease control is largely reliant on effective therapy as there is no proven effective gonococcal vaccine available. However, there is increasing evidence from observational cohort studies that the serogroup B meningococcal vaccine four-component meningitis B vaccine (4CMenB) (Bexsero), licensed to prevent invasive disease caused by Neisseria meningitidis , may provide cross-protection against the closely related bacterium N. gonorrhoeae . This study will evaluate the efficacy of 4CMenB against N. gonorrhoeae infection in men (cis and trans), transwomen and non-binary people who have sex with men (hereafter referred to as GBM+)., Methods and Analysis: This is a double-blind, randomised placebo-controlled trial in GBM+, either HIV-negative on pre-exposure prophylaxis against HIV or living with HIV (CD4 count >350 cells/mm 3 ), who have had a diagnosis of gonorrhoea or infectious syphilis in the last 18 months (a key characteristic associated with a high risk of N. gonorrhoeae infection). Participants are randomised 1:1 to receive two doses of 4CMenB or placebo 3 months apart. Participants have 3-monthly visits over 24 months, which include testing for N. gonorrhoeae and other sexually transmissible infections, collection of demographics, sexual behaviour risks and antibiotic use, and collection of research samples for analysis of N. gonorrhoeae -specific systemic and mucosal immune responses. The primary outcome is the incidence of the first episode of N. gonorrhoeae infection, as determined by nucleic acid amplification tests, post month 4. Additional outcomes consider the incidence of symptomatic or asymptomatic N. gonorrhoeae infection at different anatomical sites (ie, urogenital, anorectum or oropharynx), incidence by N. gonorrhoeae genotype and antimicrobial resistance phenotype, and level and functional activity of N. gonorrhoeae -specific antibodies., Ethics and Dissemination: Ethical approval was obtained from the St Vincent's Hospital Human Research Ethics Committee, St Vincent's Hospital Sydney, NSW, Australia (ref: 2020/ETH01084). Results will be disseminated in peer-reviewed journals and via presentation at national and international conferences., Trial Registration Number: NCT04415424., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Introduction: Hip fractures result in substantial health impacts for patients and costs to health systems. Many patients require prolonged hospital stays and up to 60% do not regain their prefracture level of mobility within 1 year. Physical rehabilitation plays a key role in regaining physical function and independence; however, there are no recommendations regarding the optimal intensity. This study aims to compare the clinical efficacy and cost-effectiveness of early intensive in-hospital physiotherapy compared with usual care in patients who have had surgery following a hip fracture., Methods and Analysis: This two-arm randomised, controlled, assessor-blinded trial will recruit 620 participants who have had surgery following a hip fracture from eight hospitals. Participants will be randomised 1:1 to receive usual care (physiotherapy according to usual practice at the site) or intensive physiotherapy in the hospital over the first 7 days following surgery (two additional sessions per day, one delivered by a physiotherapist and the other by an allied health assistant). The primary outcome is the total hospital length of stay, measured from the date of hospital admission to the date of hospital discharge, including both acute and subacute hospital days. Secondary outcomes are functional mobility, health-related quality of life, concerns about falling, discharge destination, proportion of patients remaining in hospital at 30 days, return to preadmission mobility and residence at 120 days and adverse events. Twelve months of follow-up will capture data on healthcare utilisation. A cost-effectiveness evaluation will be undertaken, and a process evaluation will document barriers and facilitators to implementation., Ethics and Dissemination: The Alfred Hospital Ethics Committee has approved this protocol. The trial findings will be published in peer-reviewed journals, submitted for presentation at conferences and disseminated to patients and carers., Trial Registration Number: ACTRN12622001442796., Competing Interests: Competing interests: LK, ER, IAH, INA, RP, JMN, ATB and AEH declare grant funding from the Commonwealth of Australia Medical Research Future Fund paid to their institution for the conduct of the trial., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Patient mental state deterioration impacts patient outcomes, staff and increases costs for healthcare organisations. Mental state is broadly defined to include not only mental health but a broad range of cognitive, emotional and psychological well-being factors. Mental state deterioration is inconsistently identified and managed within acute and tertiary medical settings. This protocol aims to synthesise the evidence to test and refine initial programme theories that outline the functioning of a rapid response system., Methods and Analysis: This synthesis will be guided by Pawson's key steps in realist reviews. We will clarify the scope of synthesis through an initial literature search, focusing on understanding the functioning of rapid response system in managing patients presenting with mental state deterioration in acute hospital settings. Initial programme theories will be refined by developing a search strategy to comprehensively search electronic databases for relevant English language peer-reviewed studies. Additionally, we will search the grey literature for sources to supplement theory testing. An abstraction form will be developed to record the characteristics of literature sources. We will use spreadsheets to code and report contextual factors, underlying mechanisms, and outcome configurations., Ethics and Dissemination: As this study is a realist synthesis protocol, ethics approval is not required. Synthesis findings will be published in a peer-reviewed journal and presented at scientific conferences., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Epilepsy is one of the most common neurological conditions worldwide. Despite many antiseizure medications (ASMs) being available, up to one-third of patients do not achieve seizure control. Preclinical studies have shown treatment with sodium selenate to have a disease-modifying effect in a rat model of chronic temporal lobe epilepsy (TLE)., Aim: This randomised placebo-controlled trial aims to evaluate the antiseizure and disease-modifying effects of sodium selenate in people with drug-resistant TLE., Methods: This will be a randomised placebo-controlled trial of sodium selenate. One hundred and twenty-four adults with drug-resistant TLE and ≥4 countable seizures/month will be recruited. Outcomes of interest will be measured at baseline, week 26 and week 52 and include an 8-week seizure diary, 24-hour electroencephalogram and cognitive, neuropsychiatric and quality of life measures. Participants will then be randomised to receive a sustained release formulation of sodium selenate (initially 10 mg three times a day, increasing to 15 mg three times a day at week 4 if tolerated) or a matching placebo for 26 weeks., Outcomes: The primary outcome will be a consumer codesigned epilepsy-Desirability of Outcome Rank (DOOR), combining change in seizure frequency, adverse events, quality of life and ASM burden measures into a single outcome measure, compared between treatment arms over the whole 52-week period. Secondary outcomes will compare baseline measures to week 26 (antiseizure) and week 52 (disease modification). Exploratory measures will include biomarkers of treatment response., Ethics and Dissemination: The study has been approved by the lead site, Alfred Hospital Ethics Committee (594/20). Each participant will provide written informed consent prior to any trial procedures. The results of the study will be presented at national and international conferences, published in peer-reviewed journals and disseminated through consumer organisations., Conclusion: This study will be the first disease-modification randomised controlled trial in patients with drug-resistant TLE., Trial Registration Number: ANZCTR; ACTRN12623000446662., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Three-dimensional (3D) total body photography may improve early detection of melanoma and facilitate surveillance, leading to better prognosis and lower healthcare costs. The Australian Centre of Excellence in Melanoma Imaging and Diagnosis (ACEMID) cohort study will assess long-term outcomes from delivery of a precision strategy of monitoring skin lesions using skin surface imaging technology embedded into health services across Australia., Methods and Analysis: A prospective cohort study will enrol 15 000 participants aged 18 years and above, across 15 Australian sites. Participants will attend study visits according to their melanoma risk category: very high risk, high risk or low/average risk, every 6, 12 and 24 months, respectively, over 3 years. Participants will undergo 3D total body photography and dermoscopy imaging at study visits. A baseline questionnaire will be administered to collect sociodemographic, phenotypic, quality of life and sun behaviour data. A follow-up questionnaire will be administered every 12 months to obtain changes in sun behaviour and quality of life. A saliva sample will be collected at the baseline visit from a subsample., Ethics and Dissemination: The ACEMID cohort study was approved by the Metro South Health Human Research Ethics Committee (approval number: HREC/2019/QMS/57206) and the University of Queensland Human Research Ethics Committee (approval number: 2019003077). The findings will be reported through peer-reviewed and lay publications and presentations at conferences., Trial Registration Number: ACTRN12619001706167., Competing Interests: Competing interests: HPS is a shareholder of MoleMap NZ and E-derm-Consult and undertakes regular teledermatological reporting for both companies. HPS is a Medical Consultant for Canfield Scientific, Blaze Bioscience and a Medical Advisor for First Derm. VM has received speakers fees from Novartis, Bristol Myers Squibb, Merck, Janssen and conference sponsorship from L’Oreal. PF-P has consulted for Leo, Amgen, Abbvie, UCB, Sanofi, Janssen, Novartis, BMS, MSD, Pfizer and Lilly. PF-P has received speakers fees from Janssen, Leo, Amgen, Sanofi, Lilly, Abbvie, UCB, Novartis, Merck and Pfizer., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: The world is undergoing a demographic transition to an older population. Preventive healthcare has reduced the burden of chronic illness at younger ages but there is limited evidence that these advances can improve health at older ages. Statins are one class of drug with the potential to prevent or delay the onset of several causes of incapacity in older age, particularly major cardiovascular disease (CVD). This paper presents the protocol for the STAtins in Reducing Events in the Elderly (STAREE) trial, a randomised double-blind placebo-controlled trial examining the effects of statins in community dwelling older people without CVD, diabetes or dementia., Methods and Analysis: We will conduct a double-blind, randomised placebo-controlled trial among people aged 70 years and over, recruited through Australian general practice and with no history of clinical CVD, diabetes or dementia. Participants will be randomly assigned to oral atorvastatin (40 mg daily) or matching placebo (1:1 ratio). The co-primary endpoints are disability-free survival defined as survival-free of dementia and persistent physical disability, and major cardiovascular events (cardiovascular death or non-fatal myocardial infarction or stroke). Secondary endpoints are all-cause death, dementia and other cognitive decline, persistent physical disability, fatal and non-fatal myocardial infarction, fatal and non-fatal stroke, heart failure, atrial fibrillation, fatal and non-fatal cancer, all-cause hospitalisation, need for permanent residential care and quality of life. Comparisons between assigned treatment arms will be on an intention-to-treat basis with each of the co-primary endpoints analysed separately in time-to-first-event analyses using Cox proportional hazards regression models., Ethics and Dissemination: STAREE will address uncertainties about the preventive effects of statins on a range of clinical outcomes important to older people. Institutional ethics approval has been obtained. All research outputs will be disseminated to general practitioner co-investigators and participants, published in peer-reviewed journals and presented at national and international conferences., Trial Registration Number: NCT02099123., Competing Interests: Competing interests: SZ has received NHMRC and Australian Heart Foundation research funding as the principal investigator of the STAREE trial; and payment to the institution (Monash University) from Amgen Australia, AstraZeneca, Boehringer-Ingelheim, Eli Lilly Australia, Merck Sharp & Dohme Australia, Novo Nordisk, Sanofi and Servier for consultancy work outside the submitted work. IH has received research funding from NHMRC and Royal Australasian College of Physicians and honoraria for lectures or advisory board participation from Boehringer Ingelheim, Vifor and Eli Lilly. JJM is supported by an NHMRC Leadership Fellowship (IG1173690). MN has served on a Novartis advisory board on lipid management in 2020. CMR is supported through an NHMRC Principal Research Fellowship (APP 1136372). SJN has received research support from AstraZeneca, New Amsterdam Pharma, Amgen, Anthera, Eli Lilly, Esperion, Novartis, Cerenis, The Medicines Company, Resverlogix, InfraReDx, Roche, Sanofi-Regeneron and LipoScience and is a consultant for AstraZeneca, Amarin, Akcea, Eli Lilly, Anthera, Omthera, Merck, Takeda, Resverlogix, Sanofi-Regeneron, CSL Behring, Esperion, Boehringer Ingelheim and Vaxxinity. TT-JC has received honoraria for lectures from Roche. AW has been a clinical trial investigator for Akcea, Amgen, Regeneron and Silence Therapeutics. He has served as a guideline chair and done consultancy work for the National Institute of Health and Care Excellence in the UK. AT has received research support or honoraria for lectures, advisory board or data monitoring committee participation from Amgen, The Medicines Group, Merck, Novartis and Pfizer. SAW has received payment to attend an advisory meeting on dementia for Roche., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.)

Introduction: Despite the availability of effective, subsidised hepatitis B treatment, linkage to care and treatment rates remain very low globally. In Australia, specially trained primary care physicians (general practitioner, GPs) can prescribe hepatitis B treatment, however, most hepatitis B care occurs in specialist clinics. Increasing hepatitis B management by GPs in primary care clinics is essential to achieve national hepatitis B linkage to care and treatment targets by 2030.This pilot study determines the feasibility, acceptability and effectiveness of Simply B, a novel GP hepatitis B e-support package designed to increase hepatitis B management by GPs in primary care clinics., Methods and Analysis: This study will be conducted in three parts:Part A: A prospective open-label pilot intervention study, comparing the proportion of people with hepatitis B who are managed by their GP in primary care clinics before, 12 months and 24 months after implementation of the Simply B electronic hepatitis B support package.Part B: A nested qualitative health services feasibility study using semistructured interviews and thematic analysisPart C: Cost-effectiveness analysis., Ethics and Dissemination: This study has received ethics approval by St Vincent's Hospital. Data management and analysis will be centralised through the Department of Gastroenterology, St Vincent's Hospital., Trial Registration Number: NCT05614466., Competing Interests: Competing interests: JH has received investigator-initiated research funding (Gilead Australia Fellowship 2017, 2019) and speaker fees (2017) from Gilead Sciences, and speaker fees and investigator-initiated research funding from Eisai (2020, 2021)., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Registry randomised clinical trials (RRCTs) have the potential to provide pragmatic answers to important clinical questions. RRCTs can be embedded into large population-based registries or smaller single site registries to provide timely answers at a reduced cost compared with traditional randomised controlled trials. RRCTs can take a number of forms in addition to the traditional individual-level randomised trial, including parallel group trials, platform or adaptive trials, cluster randomised trials and cluster randomised stepped-wedge trials. From an implementation perspective, initially it is advantageous to embed RRCT into well-established registries as these have typically already overcome any issues with end point validation and adjudication. With advances in data linkage and data quality, RRCTs can play an important role in answering clinical questions in a pragmatic, cost-effective way., Competing Interests: Competing interests: CMR is funded through an NHMRC Principal Research Fellowship (GHT1136372). CH is funded by a National Heart Foundation Fellowship and an NHMRC Investigator Grant. JR is funded by an Australian Government Research Training Programme (RTP) Scholarship and a Monash University Graduate Excellence Scholarship., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Patient-reported antibiotic allergy labels (AALs) are common. These labels have been demonstrated to have a negative impact on use of appropriate antibiotics and patient-related health outcomes. These patients are more likely to receive suboptimal antibiotics, have increased rates of surgical site infections and are more likely to be colonised with multidrug-resistant organisms. Increasing recognition that antibiotic allergy forms a key part of good antimicrobial stewardship has led to calls for greater access to antibiotic allergy assessment.PREPARE is a pilot randomised controlled trial of beta-lactam allergy assessment and point of care delabelling in perioperative patients utilising a validated antibiotic allergy assessment tool that has been repurposed into a smartphone application. The aim of the study is to assess the feasibility and safety of this approach in the perioperative outpatient setting., Methods and Analysis: Adult participants requiring elective surgery and are likely to require prophylactic intravenous antibiotics will be recruited. During the intervention phase, participants will be randomised to the intervention or control arm, with control patients receiving usual standard of care. Those randomised to intervention undertake a risk assessment via the smartphone application, with those deemed low risk proceeding to direct oral provocation with either a penicillin or cephalosporin. Study outcomes will be evaluated in the postintervention phase, 30 and 90 days after surgery.Feasibility of intervention delivery and recruitment will be reported as proportions with respective 95% CIs. Participants who experience an antibiotic adverse event will be reported by group with respective 95% CIs and compared using modified Poisson regression model with robust SE estimation., Ethics and Dissemination: This protocol has received approval from the Austin Health human research and ethics committee, Heidelberg, Victoria, Australia (HREC/17/Austin/575). Results will be disseminated via publication in peer-reviewed journals as well as presentation at international conferences., Trial Registration Number: ACTRN12620001295932., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Stroke survivors usually experience long-lasting functional, emotional and social consequences that might contribute to sedentary behaviour and participation restrictions, which are important targets to address during rehabilitation. However, the trajectory and inter-relationship between these factors are unknown., Methods and Analysis: Part&Sed is a research project based on an observational study design with 6 and 12 months of follow-ups in stroke survivors. In addition, a qualitative analysis of the impact of the stroke on the stroke survivor, validation of the Satisfaction with Daily Occupation-Occupational Balance assessment tool and analysis of the reliability of the Fitbit Inspire 2 activity tracker wristband will be carried out. Participants will be chronic stroke survivors with independent walking capacity. Sociodemographic and clinical data, physical activity, ambulation, sleep, quality of life, anxiety and depression, community participation, and occupational satisfaction and balance, as well as data provided by the activity tracker wristband, will be collected. In addition, if the participant has a primary caregiver, the caregiver will also be monitored. A minimum of 130 participants will be recruited to conduct a random-effects multiple regression model. Mixed models for repeated measures will assess the variation over time of the different variables associated with participation and sedentary behaviour. Psychometric properties (eg, internal consistency, construct validity, test-retest reliability) of the Satisfaction with Daily Occupation-Occupational Balance will be determined. Additionally, intraclass correlation coefficients and minimum detectable change will be calculated to assess intrasubject reliability of physical activity and sleep parameters recorded by the Fitbit Inspire 2. The qualitative analysis process will be carried out using the analysis proposed by Giorgi., Ethics and Dissemination: The study received ethical approval from the Spanish Regional Ethics Committee 'Comité de Ética de la Investigación de la Comunidad de Aragón' (PI21/333). The results will be made available via peer-reviewed publications, international conferences and official channels., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: The sexually transmitted infection chlamydia can cause significant complications, particularly among people with female reproductive organs. Optimal management includes timely and appropriate treatment, notifying and treating sexual partners, timely retesting for reinfection and detecting complications including pelvic inflammatory disease (PID). In Australia, mainstream primary care (general practice) is where most chlamydia infections are diagnosed, making it a key setting for optimising chlamydia management. High reinfection and low retesting rates suggest partner notification and retesting are not uniformly provided. The Management of Chlamydia Cases in Australia (MoCCA) study seeks to address gaps in chlamydia management in Australian general practice through implementing interventions shown to improve chlamydia management in specialist services. MoCCA will focus on improving retesting, partner management (including patient-delivered partner therapy) and PID diagnosis., Methods and Analysis: MoCCA is a non-randomised implementation and feasibility trial aiming to determine how best to implement interventions to support general practice in delivering best practice chlamydia management. Our method is guided by the Consolidated Framework for Implementation Research and the Normalisation Process Theory. MoCCA interventions include a website, flow charts, fact sheets, mailed specimen kits and autofills to streamline chlamydia consultation documentation. We aim to recruit 20 general practices across three Australian states (Victoria, New South Wales, Queensland) through which we will implement the interventions over 12-18 months. Mixed methods involving qualitative and quantitative data collection and analyses (observation, interviews, surveys) from staff and patients will be undertaken to explore our intervention implementation, acceptability and uptake. Deidentified general practice and laboratory data will be used to measure pre-post chlamydia testing, retesting, reinfection and PID rates, and to estimate MoCCA intervention costs. Our findings will guide scale-up plans for Australian general practice., Ethics and Dissemination: Ethics approval was obtained from The University of Melbourne Human Research Ethics Committee (Ethics ID: 22665). Findings will be disseminated via conference presentations, peer-reviewed publications and study reports., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Neisseria gonorrhoeae infections are common and incidence increasing. Oropharyngeal infections are associated with greater treatment failure compared with other sites and drive transmission to anogenital sites through saliva. Gonococcal resistance is increasing and new treatments are scarce, therefore, clinicians must optimise currently available and emerging treatments in order to have efficacious therapeutic options. This requires pharmacokinetic data from the oral cavity/oropharynx, however, availability of such information is currently limited., Methods and Analysis: Healthy male volunteers (participants) recruited into the study will receive single doses of either ceftriaxone 1 g, cefixime 400 mg or ceftriaxone 500 mg plus 2 g azithromycin. Participants will provide samples at 6-8 time points (treatment regimen dependent) from four oral sites, two oral fluids, one anorectal swab and blood. Participants will complete online questionnaires about their medical history, sexual practices and any side effects experienced up to days 5-7. Saliva/oral mucosal pH and oral microbiome analysis will be undertaken. Bioanalysis will be conducted by liquid chromatography-mass spectrometry. Drug concentrations over time will be used to develop mathematical models for optimisation of drug dosing regimens and to estimate pharmacodynamic targets of efficacy., Ethics and Dissemination: This study was approved by Royal Melbourne Hospital Human Research Ethics Committee (60370/MH-2021). The study results will be submitted for publication in peer-reviewed journals and reported at conferences. Summary results will be sent to participants requesting them. All data relevant to the study will be included in the article or uploaded as supplementary information., Trial Registration Number: ACTRN12621000339853., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Community integration and social participation remain a challenge for many individuals following acquired brain injury (ABI) and the transition from hospital to home is a complex journey. It is important to conceptualise this transition from the perspective of people with ABI, to inform future research with the overall aim of improving the experience of community re-engagement and maintaining important relationships within social networks., Methods and Analysis: The methodology outlined by Arksey and O'Malley and the Preferred Reporting Items for Systematic Reviews and Meta-Analysis: extension for Scoping Reviews will be used to guide the review. A comprehensive electronic database search will be conducted in MEDLINE, CINAHL, Scopus, Embase and PsychINFO. The search will aim to locate only published, qualitative or mixed methods studies and will be limited to citations published in English, from January 2014 to the date of final search completion. Quality assessment using the Critical Appraisal Skills Programme will be completed and reported.Data extraction will include participant and study characteristics.Finally, qualitative data from each citation, including participant quotes, will be extracted and thematic analysis will be completed to support conceptualisation of community participation from those who have experienced the transition to the community following discharge from hospital. Three individuals with lived experiences of ABI will be engaged as paid consultants to review and comment on the findings of the review., Ethics and Dissemination: It is intended that the findings from this review will be made available to relevant stakeholders through peer-reviewed publications and conference presentations. This scoping review does not require an ethics application., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Australia has the highest incidence of melanoma in the world with variable care provided by a diverse range of clinicians. Clinical quality registries aim to identify these variations in care and provide anonymised, benchmarked feedback to clinicians and institutions to improve patient outcomes. The Australian Melanoma Clinical Outcomes Registry (MelCOR) aims to collect population-wide, clinical-level data for the early management of cutaneous melanoma and provide anonymised feedback to healthcare providers., Methods and Analysis: A modified Delphi process will be undertaken to identify key clinical quality indicators for inclusion in the MelCOR pilot. MelCOR will prospectively collect data relevant to these quality indicators, initially for all people over the age of 18 years living in Victoria and Queensland with a melanoma diagnosis confirmed by histopathology, via a two-stage recruitment and consent process. In stage 1, existing State-based cancer registries contact the treating clinician and provide an opportunity for them to opt themselves or their patients out of direct contact with MelCOR. After stage 1, re-identifiable clinical data are provided to the MelCOR under a waiver of consent. In stage 2, the State-based cancer registry will approach the patient directly and invite them to opt in to MelCOR and share identifiable data. If a patient elects to opt in, MelCOR will be able to contact patients directly to collect patient-reported outcome measures. Aggregated data will be used to provide benchmarked, comparative feedback to participating institutions/clinicians., Ethics and Dissemination: Following the successful collection of pilot data, the feasibility of an Australia-wide roll out will be evaluated. Key quality indicator data will be the core of the MelCOR dataset, with additional data points added later. Annual reports will be issued, first to the relevant stakeholders followed by the public. MelCOR is approved by the Alfred Ethics Committee (58280/127/20)., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Severe cutaneous adverse reactions (SCAR) are a group of T cell-mediated hypersensitivities associated with significant morbidity, mortality and hospital costs. Clinical phenotypes include Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalised exanthematous pustulosis (AGEP). In this Australasian, multicentre, prospective registry, we plan to examine the clinical presentation, drug causality, genomic predictors, potential diagnostic approaches, treatments and long-term outcomes of SCAR in Australia and New Zealand., Methods and Analysis: Adult and adolescent patients with SCAR including SJS, TEN, DRESS, AGEP and another T cell-mediated hypersensitivity, generalised bullous fixed drug eruption, will be prospectively recruited. A waiver of consent has been granted for some sites to retrospectively include cases which result in early mortality. DNA will be collected for all prospective cases. Blood, blister fluid and skin biopsy sampling is optional and subject to patient consent and site capacity. To develop culprit drug identification and prevention, genomic testing will be performed to confirm human leukocyte antigen (HLA) type and ex vivo testing will be performed via interferon-γ release enzyme linked immunospot assay using collected peripheral blood mononuclear cells. The long-term outcomes of SCAR will be investigated with a 12-month quality of life survey and examination of prescribing and mortality data., Ethics and Dissemination: This study was reviewed and approved by the Austin Health Human Research Ethics Committee (HREC/50791/Austin-19). Results will be published in peer-reviewed journals and presented at relevant conferences., Trial Registration Number: Australian New Zealand Clinical Trials Registry (ACTRN12619000241134)., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Vitreoretinal lymphoma is a rare ocular cancer with high morbidity and mortality despite treatment. Diagnosis by cytopathology is often delayed, and various molecular and image-based investigations have been developed. Diverse treatments are used, but there is a limited medical evidence to differentiate their effectiveness. We designed an international registry that would collect diagnostic, treatment and outcomes data, to establish new evidence for the management of this cancer., Methods and Analysis: The International Vitreoretinal B-Cell Lymphoma Registry will accrue data retrospectively for individuals aged 18 years or older, diagnosed with new or recurrent vitreoretinal B-cell lymphoma on or after 1 January 2020. A steering committee of subspecialised ophthalmologists identified 20 key clinical data items that describe patient demographics, tissue involvements, diagnostic testing, ocular and systemic treatments and treatment complications, and visual acuity and survival outcomes. Customised software was designed to permit collection of these data across a single baseline and multiple follow-up forms. The platform collects data without identifiers and at 3 month reporting intervals. Outcomes of the project will include: (1) descriptions of clinical presentations, and diagnostic and therapeutic preferences; (2) associations between clinical presentations, and diagnostics and treatments, and between diagnostics and treatments (assessed by ORs with 95% CIs); and (3) estimations of rates of vision loss, and progression-free and overall survival (assessed by Kaplan-Meier estimates)., Ethics and Dissemination: The registry has received Australia-wide approval by a national human research ethics committee. Sites located outside Australia are required to seek local human research ethics review. Results generated through the registry will be disseminated primarily by peer-reviewed publications that are expected to inform clinical practice, as well as educational materials., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: Patient-reported outcomes (PROs) are increasingly used to measure the patient's perspective of their outcomes following healthcare interventions. The aim of this study was to determine the preferred formats for reporting service-level PROs data to clinicians, researchers and managers to support greater utility of these data to improve healthcare and patient outcomes., Setting: Healthcare professionals receiving PRO data feedback at the health service level., Participants: An interdisciplinary Project Working Group comprised of clinicians participated in three workshops to codesign reporting templates of summarised PRO data (modified Rankin Scale, EuroQol Five Dimension Descriptive System, EuroQol Visual Analogue Scale and Hospital Anxiety and Depression Scale) using a modified Delphi process. An electronic survey was then distributed to short list the preferred templates among a broad sample of clinical end users. A final workshop was undertaken with the Project Working Group to review results and reach consensus on the final templates., Primary and Secondary Outcome Measures: The recommendation of preferred PRO summary data feedback templates and guiding principles for reporting aggregate PRO data to clinicians was the primary outcome. A secondary outcome was the identification of perceived barriers and enablers to the use of PRO data in hospitals. For each outcome measure, quantitative and qualitative data were summarised., Results: 31 Working Group members (19 stroke, 2 psychology, 1 pharmacy, 9 researchers) participated in the workshops, where 25/55 templates were shortlisted for wider assessment. The survey was completed by 114 end users. Strongest preferences were identified for bar charts (37/82 votes, 45%) and stacked bar charts (37/91 votes, 41%). At the final workshop, recommendations to enhance communication of PROs data for comparing health service performance were made including tailoring feedback to professional roles and use of case-mix adjustment to ensure fair comparisons., Conclusions: Our research provides guidance on PROs reporting for optimising data interpretation and comparing hospital performance., Competing Interests: Competing interests: DAC: is the Data Custodian for the AuSCR. All other authors report no potential conflicts of interest with respect to the research, authorship and/or publication of this article. National and Victorian clinical networks were also drawn upon to contribute to this research., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Mobile stroke units (MSUs) equipped with a CT scanner are increasingly being used to assess and treat stroke patients' prehospital with thrombolysis and transfer them to the most appropriate hospital for ongoing stroke care and thrombectomy when indicated. The effect of MSUs in both reducing the time to reperfusion treatment and improving patient outcomes is now established. There is now an opportunity to improve the efficacy of treatment provided by the MSU. Tenecteplase is a potent plasminogen activator, which may have benefits over the standard of care stroke lytic alteplase. Specifically, in the MSU environment tenecteplase presents practical benefits since it is given as a single bolus and does not require an infusion over an hour like alteplase., Objective: In this trial, we seek to investigate if tenecteplase, given to patients with acute ischaemic stroke as diagnosed on the MSU, improves the rate of early reperfusion., Methods and Analysis: TASTE-A is a prospective, randomised, open-label, blinded endpoint (PROBE) phase II trial of patients who had an ischaemic stroke assessed in an MSU within 4.5 hours of symptom onset. The primary endpoint is early reperfusion measured by the post-lysis volume of the CT perfusion lesion performed immediately after hospital arrival., Ethics and Dissemination: The study was approved by the Royal Melbourne Hospital Human Ethics committee. The findings will be published in peer-reviewed journals, presented at academic conferences and disseminated among consumer and healthcare professional audiences., Trial Registration Number: NCT04071613., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: There is compelling evidence that either centre-based or home-based pulmonary rehabilitation improves clinical outcomes in chronic obstructive pulmonary disease (COPD). There are known health service and personal barriers which prevent potentially eligible patients from accessing the benefits of pulmonary rehabilitation. The aim of this hybrid effectiveness-implementation trial is to examine the effects of offering patients a choice of pulmonary rehabilitation locations (home or centre) compared with offering only the traditional centre-based model., Method and Analysis: This is a two-arm cluster randomised, controlled, assessor-blinded trial of 14 centre-based pulmonary rehabilitation services allocated to intervention (offering choice of home-based or centre-based pulmonary rehabilitation) or control (continuing to offer centre-based pulmonary rehabilitation only), stratified by centre-based programme setting (hospital vs non-hospital). 490 participants with COPD will be recruited. Centre-based pulmonary rehabilitation will be delivered according to best practice guidelines including supervised exercise training for 8 weeks. At intervention sites, the home-based pulmonary rehabilitation will be delivered according to an established 8-week model, comprising of one home visit, unsupervised exercise training and telephone calls that build motivation for exercise participation and facilitate self-management. The primary outcome is all-cause, unplanned hospitalisations in the 12 months following rehabilitation. Secondary outcomes include programme completion rates and measurements of 6-minute walk distance, chronic respiratory questionnaire, EQ-5D-5L, dyspnoea-12, physical activity and sedentary time at the end of rehabilitation and 12 months following rehabilitation.Direct healthcare costs, indirect costs and changes in EQ-5D-5L will be used to evaluate cost-effectiveness. A process evaluation will be undertaken to understand how the choice model is implemented and explore sustainability beyond the clinical trial., Ethics and Dissemination: Alfred Hospital Ethics Committee has approved this protocol. The trial findings will be published in peer-reviewed journals, submitted for presentation at conferences and disseminated to patients across Australia with support from national lung charities and societies., Trial Registration Number: NCT04217330., Competing Interests: Competing interests: AEH, AM, CFM, GH, NAL, NC and PO declare grant funding from the Commonwealth of Australia Medical Research Future Fund paid to their institution for the conduct of the trial. CFM declares non-financial board roles as Chair COPD National Programme, Lung Foundation Australia and Medical Director Institute for Breathing and Sleep. No other competing interests are declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.)

Introduction: Status migrainosus is a disabling complication of migraine, which frequently results in hospitalisation. For patients who fail to respond to simple analgesia, triptans and intravenous prochlorperazine or chlorpromazine, there are limited treatment options, and a paucity of high-quality evidence to guide clinical practice. Eptinezumab, an intravenous monoclonal antibody specific for the calcitonin gene-related peptide ligand which achieves maximal plasma concentration immediately following administration and may improve migraines from day one. Intravenous lignocaine is an anaesthetic medication used in treatment of status migrainosus, often requiring prolonged admissions and with potential cardiac adverse events. The aim of this study is to assess the efficacy and safety of eptinezumab in the treatment of status migrainosus in comparison to intravenous lidocaine., Methods and Analysis: Status migrainosus inpatient treatment with eptinezumab is a randomised, controlled, single-centre clinical trial conducted in a parallel design with an active comparator conducted in Melbourne, Australia. This study randomises forty patients (1:1) to receive either eptinezumab or an infusion of intravenous lignocaine for up to 5 days. It will assess the effect of eptinezumab compared with intravenous lignocaine in aborting status migrainosus, with the primary outcome of time from infusion until resolution of pain. It will explore several secondary measures including change in health resource utilisation, effect on patient reported outcomes of migraine disability and the safety and tolerability of each medication., Ethics and Dissemination: This study has been reviewed and approved by the Human Research Ethics Committee of Alfred Health, local reference number 443/21, and all participants will provide informed consent for participation in the trial and dissemination of results., Trial Registration Number: The trial registration number is ACTRN12621001616864. The results of this study will be disseminated through peer-reviewed journals, conference presentations and social media., Competing Interests: Competing interests: JCR has received compensation from the Pharmaceutical Society of Australia, sponsored by Viatris for educational material. ZC is supported by an Early Career Fellowship from the National Health and Medical Research Council (NHMRC) of Australia (GNT1156444). He/his institution has received consultancy fees and/or research grants from Arvelle Therapeutics and UCB Pharma for works outside the submitted work. EJH has served on advisory boards for Sanofi-Genzyme, Novartis, Teva, Eli Lilly, Allergan, Lundbeck, been involved in clinical trials sponsored by Novartis, Teva, Xalud, Daewong and Novotech, and has received payment for educational presentations from Allergan, Teva, Eli Lilly and Novartis., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: Patients with ST-elevation myocardial infarction (STEMI) that occur while already in hospital ('in-hospital STEMI') face high mortality. However, data about this patient population are scarce. We sought to investigate differences in reperfusion and outcomes of in-hospital versus out-of-hospital STEMI., Design, Setting and Participants: Consecutive patients with STEMI all treated with percutaneous coronary intervention (PCI) across 30 centres were prospectively recruited into the Victorian Cardiac Outcomes Registry (2013-2018)., Primary and Secondary Outcomes: Patients with in-hospital STEMI were compared with patients with out-of-hospital STEMI with a primary endpoint of 30-day major adverse cardiovascular events (MACE). Secondary endpoints included ischaemic times, all-cause mortality and major bleeding., Results: Of 7493 patients with PCI-treated STEMI, 494 (6.6%) occurred in-hospital. Patients with in-hospital STEMI were older (67.1 vs 62.4 years, p<0.001), more often women (32% vs 19.9%, p<0.001), with more comorbidities. Patients with in-hospital STEMI had higher 30-day MACE (20.4% vs 9.8%, p<0.001), mortality (12.1% vs 6.9%, p<0.001) and major bleeding (4.9% vs 2.3%, p<0.001), than patients with out-of-hospital STEMI. According to guideline criteria, patients with in-hospital STEMI achieved symptom-to-device times of ≤70 min and ≤90 min in 29% and 47%, respectively. Patients with out-of-hospital STEMI achieved door-to-device times of ≤90 min in 71%. Occurrence of STEMI while in hospital independently predicted higher MACE (adjusted OR 1.77, 95% CI 1.33 to 2.36, p<0.001) and 12-month mortality (adjusted OR 1.49, 95% CI 1.08 to 2.07, p<0.001)., Conclusions: Patients with in-hospital STEMI experience delays to reperfusion with significantly higher MACE and mortality, compared with patients with out-of-hospital STEMI, after adjustment for confounders. Focused strategies are needed to improve recognition and outcomes in this high-risk and understudied population., Competing Interests: Competing interests: JS is supported by a Monash University scholarship. RD receives teaching and travel grants from Abbott, Medtronic and Boehringer. He serves on the advisory board of Astra Zeneca. SJD is proctor for Medtronic and his work is supported by a grant (1111170) from the National Health and Medical Research Council of Australia. SZ has obtained research funding from Abbott Vascular, Biotronik Australia and Medtronic Australia and speaking honoraria from AstraZeneca. All other authors have no conflicts of interest., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: In radiotherapy, tumour tracking leads the radiation beam to accurately target the tumour while it moves in a complex and unpredictable way due to respiration. Several tumour tracking techniques require the implantation of fiducial markers around the tumour, a procedure that involves unnecessary risks and costs. Markerless tumour tracking (MTT) negates the need for implanted markers, potentially enabling accurate and optimal radiotherapy in a non-invasive way., Methods and Analysis: We will perform a phase I interventional trial called MA rkerless image G uidance using I ntrafraction K ilovoltage x-ray imaging (MAGIK) to investigate the technical feasibility of the MTT technology developed at the University of Sydney (sponsor). 30 participants will undergo the current standard of care lung stereotactic ablative radiation therapy, with the exception that kilovoltage X-ray images will be acquired continuously during treatment delivery to enable MTT. If MTT indicates that the mean lung tumour position has shifted >3 mm, a warning message will be displayed to indicate the need for a treatment intervention. The radiation therapist will then pause the treatment, shift the treatment couch to account for the shift in tumour position and resume the treatment. Participants will be implanted with fiducial markers, which act as the ground truth for evaluating the accuracy of MTT. MTT is considered feasible if the tracking accuracy is <3 mm in each dimension for >80% of the treatment time., Ethics and Dissemination: The MAGIK trial has received ethical approval from The Alfred Human Research Ethics Committee and has been registered with ClinicalTrials.gov with the Identifier: NCT04086082. Estimated time of first recruitment is early 2022. The study recruitment and data analysis phases will be performed concurrently. Treatment for all 30 participants is expected to be completed within 2 years and participant follow-up within a total duration of 7 years. Findings will be disseminated through peer-reviewed publications and conference presentations., Trial Registration Number: NCT04086082; Pre-result., Competing Interests: Competing interests: C-CS and PK are inventors on patent application PCT/AU2016/000086 that is related to markerless tumour tracking. This patent and associated intellectual property were assigned by the University of Sydney to ASTO CT., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Convolutional neural networks (CNNs) can diagnose skin cancers with impressive accuracy in experimental settings, however, their performance in the real-world clinical setting, including comparison to teledermatology services, has not been validated in prospective clinical studies., Methods and Analysis: Participants will be recruited from dermatology clinics at the Alfred Hospital and Skin Health Institute, Melbourne. Skin lesions will be imaged using a proprietary dermoscopic camera. The artificial intelligence (AI) algorithm, a CNN developed by MoleMap Ltd and Monash eResearch, classifies lesions as benign, malignant or uncertain. This is a preintervention/postintervention study. In the preintervention period, treating doctors are blinded to AI lesion assessment. In the postintervention period, treating doctors review the AI lesion assessment in real time, and have the opportunity to then change their diagnosis and management. Any skin lesions of concern and at least two benign lesions will be selected for imaging. Each participant's lesions will be examined by a registrar, the treating consultant dermatologist and later by a teledermatologist. At the conclusion of the preintervention period, the safety of the AI algorithm will be evaluated in a primary analysis by measuring its sensitivity, specificity and agreement with histopathology where available, or the treating consultant dermatologists' classification. At trial completion, AI classifications will be compared with those of the teledermatologist, registrar, treating dermatologist and histopathology. The impact of the AI algorithm on diagnostic and management decisions will be evaluated by: (1) comparing the initial management decision of the registrar with their AI-assisted decision and (2) comparing the benign to malignant ratio (for lesions biopsied) between the preintervention and postintervention periods., Ethics and Dissemination: Human Research Ethics Committee (HREC) approval received from the Alfred Hospital Ethics Committee on 14 February 2019 (HREC/48865/Alfred-2018). Findings from this study will be disseminated through peer-reviewed publications, non-peer reviewed media and conferences., Trial Registration Number: NCT04040114., Competing Interests: Competing interests: VM is supported by an NHMRC Early Career Fellowship. VM reports personal fees from Novartis, personal fees from Bristol-Myers-Squibb, personal fees from Merck, outside the submitted work. MH reports personal fees from MoleMap Ltd, during the conduct of the study; and is a shareholder in MoleMap Ltd. AB reports personal fees from MoleMap Ltd, during the conduct of the study; personal fees from Molemap Ltd, outside the submitted work; and is a shareholder in Molemap Ltd. AS reports personal fees from MoleMap Ltd, during the conduct of the study; personal fees from Molemap Ltd, outside the submitted work. ZG reports personal fees from MoleMap Ltd. NW and SM are former employees of the Cancer Collaborative Trials Group contracted to implement the SMARTI Study—Melanoma and Skin Cancer Trials (MASC Trials) Ltd. CF is supported by a Monash University Research Training Program Scholarship. RW, NA, WC and MW have nothing to disclose. The study is sponsored by Monash University and endorsed by MASC Trials Ltd., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: Artificial intelligence (AI) algorithms have been developed to detect imaging features on chest X-ray (CXR) with a comprehensive AI model capable of detecting 124 CXR findings being recently developed. The aim of this study was to evaluate the real-world usefulness of the model as a diagnostic assistance device for radiologists., Design: This prospective real-world multicentre study involved a group of radiologists using the model in their daily reporting workflow to report consecutive CXRs and recording their feedback on level of agreement with the model findings and whether this significantly affected their reporting., Setting: The study took place at radiology clinics and hospitals within a large radiology network in Australia between November and December 2020., Participants: Eleven consultant diagnostic radiologists of varying levels of experience participated in this study., Primary and Secondary Outcome Measures: Proportion of CXR cases where use of the AI model led to significant material changes to the radiologist report, to patient management, or to imaging recommendations. Additionally, level of agreement between radiologists and the model findings, and radiologist attitudes towards the model were assessed., Results: Of 2972 cases reviewed with the model, 92 cases (3.1%) had significant report changes, 43 cases (1.4%) had changed patient management and 29 cases (1.0%) had further imaging recommendations. In terms of agreement with the model, 2569 cases showed complete agreement (86.5%). 390 (13%) cases had one or more findings rejected by the radiologist. There were 16 findings across 13 cases (0.5%) deemed to be missed by the model. Nine out of 10 radiologists felt their accuracy was improved with the model and were more positive towards AI poststudy., Conclusions: Use of an AI model in a real-world reporting environment significantly improved radiologist reporting and showed good agreement with radiologists, highlighting the potential for AI diagnostic support to improve clinical practice., Competing Interests: Competing interests: CMJ is a radiologist employed by the radiology practice and a clinical consultant for Annalise-AI. LD, LO-R and NE are independent of Annalise-AI and have no interests to declare. MRM, JS, CT, AJ and QDB are employed by or seconded to Annalise-AI. Study conception, study design, ethics approval and data security were conducted independent of Annalise-AI., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Progressive supranuclear palsy (PSP) is a neurodegenerative disorder for which there are currently no disease-modifying therapies. The neuropathology of PSP is associated with the accumulation of hyperphosphorylated tau in the brain. We have previously shown that protein phosphatase 2 activity in the brain is upregulated by sodium selenate, which enhances dephosphorylation. Therefore, the objective of this study is to evaluate the efficacy and safety of sodium selenate as a disease-modifying therapy for PSP., Methods and Analysis: This will be a multi-site, phase 2b, double-blind, placebo-controlled trial of sodium selenate. 70 patients will be recruited at six Australian academic hospitals and research institutes. Following the confirmation of eligibility at screening, participants will be randomised (1:1) to receive 52 weeks of active treatment (sodium selenate; 15 mg three times a day) or matching placebo. Regular safety and efficacy visits will be completed throughout the study period. The primary study outcome is change in an MRI volume composite (frontal lobe+midbrain-3rd ventricle) over the treatment period. Analysis will be with a general linear model (GLM) with the MRI composite at 52 weeks as the dependent variable, treatment group as an independent variable and baseline MRI composite as a covariate. Secondary outcomes are change in PSP rating scale, clinical global impression of change (clinician) and change in midbrain mean diffusivity. These outcomes will also be analysed with a GLM as above, with the corresponding baseline measure entered as a covariate. Secondary safety and tolerability outcomes are frequency of serious adverse events, frequency of down-titration occurrences and frequency of study discontinuation. Additional, as yet unplanned, exploratory outcomes will include analyses of other imaging, cognitive and biospecimen measures., Ethics and Dissemination: The study was approved by the Alfred Health Ethics Committee (594/20). Each participant or their legally authorised representative and their study partner will provide written informed consent at trial commencement. The results of the study will be presented at national and international conferences and published in peer-reviewed journals., Trial Registration Number: Australian New Zealand Clinical Trials Registry (ACTRN12620001254987)., Competing Interests: Competing interests: All authors report a grant from the NHMRC to support this study. The authors report the following disclosures outside of this study: LV reports personal fees from Biogen Australia, and research funding from Biogen, Eisai and LMI. AHE reports honoraria for presentations from Merck, Allergan, Ipsen, Teva, UCB, Abbott, AbbVie, STADA, participation in scientific advisory board meetings with Allergan, AbbVie, Ipsen and STADA and shares in GKC and CSL. DD reports consultancy fees from Biogen, Novartis. KLB, CMalpas, CMarotta, IHH, SK, JF, MC, SJGL, ST, JDOS, TK, LC, ML, CMH and DV report no disclosures., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: To evaluate the ability of a commercially available comprehensive chest radiography deep convolutional neural network (DCNN) to detect simple and tension pneumothorax, as stratified by the following subgroups: the presence of an intercostal drain; rib, clavicular, scapular or humeral fractures or rib resections; subcutaneous emphysema and erect versus non-erect positioning. The hypothesis was that performance would not differ significantly in each of these subgroups when compared with the overall test dataset., Design: A retrospective case-control study was undertaken., Setting: Community radiology clinics and hospitals in Australia and the USA., Participants: A test dataset of 2557 chest radiography studies was ground-truthed by three subspecialty thoracic radiologists for the presence of simple or tension pneumothorax as well as each subgroup other than positioning. Radiograph positioning was derived from radiographer annotations on the images., Outcome Measures: DCNN performance for detecting simple and tension pneumothorax was evaluated over the entire test set, as well as within each subgroup, using the area under the receiver operating characteristic curve (AUC). A difference in AUC of more than 0.05 was considered clinically significant., Results: When compared with the overall test set, performance of the DCNN for detecting simple and tension pneumothorax was statistically non-inferior in all subgroups. The DCNN had an AUC of 0.981 (0.976-0.986) for detecting simple pneumothorax and 0.997 (0.995-0.999) for detecting tension pneumothorax., Conclusions: Hidden stratification has significant implications for potential failures of deep learning when applied in clinical practice. This study demonstrated that a comprehensively trained DCNN can be resilient to hidden stratification in several clinically meaningful subgroups in detecting pneumothorax., Competing Interests: Competing interests: All authors have reviewed and approved this manuscript. Authors JS, CT, QDB, MRM, XH, HA, JL, PB and CMJ are employees of, or are seconded to, Annalise.ai. NE and LO-R have no interests to declare., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: To present Australia-wide data on paediatric COVID-19 and multisystem inflammatory syndromes to inform health service provision and vaccination prioritisation., Design: Prospective, multicentre cohort study., Setting: Eight tertiary paediatric hospitals across six Australian states and territories in an established research surveillance network-Paediatric Active Enhanced Disease (PAEDS)., Participants: All children aged <19 years with SARS-CoV-2 infection including COVID-19, Paediatric Inflammatory Multisystem Syndrome Temporally Associated with SARS-CoV-2 (PIMS-TS) and Kawasaki-like disease TS infection (KD-TS) treated at a PAEDS site from 24 March 2020 to 31 December 2020., Intervention: Laboratory-confirmed SARS-CoV-2 infection., Main Outcome: Incidence of severe disease among children with COVID-19, PIMS-TS and KD-TS. We also compared KD epidemiology before and during the COVID-19 pandemic., Results: Among 386 children with SARS-CoV-2 infection, 381 (98.7%) had COVID-19 (median 6.3 years (IQR 2.1-12.8),53.3% male) and 5 (1.3%) had multisystem inflammatory syndromes (PIMS-TS, n=4; KD-TS, n=1) (median 7.9 years (IQR 7.8-9.8)). Most children with COVID-19 (n=278; 73%) were Australian-born from jurisdictions with highest community transmission. Comorbidities were present in 72 (18.9%); cardiac and respiratory comorbidities were most common (n=32/72;44%). 37 (9.7%) children with COVID-19 were hospitalised, and two (0.5%) required intensive care. Postinfective inflammatory syndromes (PIMS-TS/KD-TS) were uncommon (n=5; 1.3%), all were hospitalised and three (3/5; 60%) required intensive care management. All children recovered and there were no deaths. KD incidence remained stable during the pandemic compared with prepandemic., Conclusions: Most children with COVID-19 had mild disease. Severe disease was less frequent than reported in high prevalence settings. Preventative strategies, such as vaccination, including children and adolescents, could reduce both the acute and postinfective manifestations of the disease., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Post-traumatic epilepsy (PTE) is a recognised complication of traumatic brain injury (TBI), and is associated with higher rates of mortality and morbidity when compared with patients with TBI who do not develop PTE. The majority of the literature on PTE has focused on adult populations, and consequently there is a paucity of information regarding paediatric cohorts. Additionally, there is considerable heterogeneity surrounding the reported incidence of PTE following childhood TBI in the current literature. The primary aim of our study is to summarise reported PTE incidences in paediatric populations to derive an accurate estimate of the global incidence of PTE following childhood TBI. Our secondary aim is to explore risk factors that increase the likelihood of developing PTE., Methods and Analysis: A systematic literature search of Embase (1947-2021), PubMed (1996-2021) and Web of Science (1900-2021) will be conducted. Publications in English that report the incidence of PTE in populations under 18 years of age will be included. Publications that evaluate fewer than 10 patients, report an alternative cause of epilepsy, or in which a paediatric cohort is not discernable, will be excluded. Independent investigators will identify the relevant publications, and discrepancies will be adjudicated by a third independent investigator. Data extracted will include incidence of PTE, time intervals between TBI and PTE, seizure characteristics, injury characteristics, patient demographics and clinical data. Data extraction will be performed by two independent investigators and cross-checked by a third investigator. A descriptive analysis of PTE incidence will be conducted and a weighted mean will be calculated. If sufficient data are available, stratified meta-analysis of subgroups will also be conducted., Ethics and Dissemination: Ethics approval was not required for this study. We intend to publish our findings in a high-quality peer-reviewed journal on completion., Prospero Registration Number: CRD42021245802., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: The incidence of Neisseria gonorrhoeae and its antimicrobial resistance is increasing in many countries. Antibacterial mouthwash may reduce gonorrhoea transmission without using antibiotics. We modelled the effect that antiseptic mouthwash may have on the incidence of gonorrhoea., Design: We developed a mathematical model of the transmission of gonorrhoea between each anatomical site (oropharynx, urethra and anorectum) in men who have sex with men (MSM). We constructed four scenarios: (1) mouthwash had no effect; (2) mouthwash increased the susceptibility of the oropharynx; (3) mouthwash reduced the transmissibility from the oropharynx; (4) the combined effect of mouthwash from scenarios 2 and 3., Setting: We used data at three anatomical sites from 4873 MSM attending Melbourne Sexual Health Centre in 2018 and 2019 to calibrate our models and data from the USA, Netherlands and Thailand for sensitivity analyses., Participants: Published available data on MSM with multisite infections of gonorrhoea., Primary and Secondary Outcome Measures: Incidence of gonorrhoea., Results: The overall incidence of gonorrhoea was 44 (95% CI 37 to 50)/100 person-years (PY) in scenario 1. Under scenario 2 (20%-80% mouthwash coverage), the total incidence increased (47-60/100 PY) and at all three anatomical sites by between 7.4% (5.9%-60.8%) and 136.6% (108.1%-177.5%). Under scenario 3, with the same coverage, the total incidence decreased (20-39/100 PY) and at all anatomical sites by between 11.6% (10.2%-13.5%) and 99.8% (99.2%-100%). Under scenario 4, changes in the incidence depended on the efficacy of mouthwash on the susceptibility or transmissibility. The effect on the total incidence varied (22-55/100 PY), and at all anatomical sites, there were increases of nearly 130% and large declines of almost 100%., Conclusions: The effect of mouthwash on gonorrhoea incidence is largely predictable depending on whether it increases susceptibility to or reduces the transmissibility of gonorrhoea., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: After first stroke, the transition from rehabilitation to home can be confronting and fraught with challenges. Although stroke clinical practice guidelines recommend predischarge occupational therapy home visits to ensure safe discharge and provision of appropriate equipment, there is currently limited evidence to support this recommendation., Methods and Analysis: The HOME Rehab trial is a national, multicentre, phase III randomised controlled trial with concealed allocation, blinded assessment and intention-to-treat analysis being conducted in Australia. The trial aim is to determine the effect and potential cost-effectiveness of an enhanced occupational therapy discharge planning intervention that involves pre and postdischarge home visits, goal setting and occupational therapy in the home (the HOME programme) in comparison to an in-hospital predischarge planning intervention. Stroke survivors aged ≥45 years, admitted to a rehabilitation ward, expected to return to a community (private) dwelling after discharge, with no significant prestroke disability will be randomly allocated 1:1 to receive a standardised discharge planning intervention and the HOME programme or the standardised discharge planning intervention alone. The primary outcome is participation measured using the Nottingham Extended Activities of Daily Living. Secondary outcome areas include hospital readmission, disability, performance of instrumental activities of daily living, health-related quality of life, quality of care transition and carer burden. Resources used/costs will be collected for the cost-effectiveness analysis and hospital readmission. Recruitment commenced in 2019. Allowing for potential attrition, 360 participants will be recruited to detect a clinically important treatment difference with 80% power at a two-tailed significance level of 0.05., Ethics and Dissemination: This study is approved by the Alfred Health Human Research Ethics Committee and site-specific ethics approval has been obtained at all participating sites. Results of the main trial and the secondary endpoint of cost-effectiveness will be submitted for publication in peer-reviewed journals Trial registration number ACTRN12618001360202., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Community-dwelling people recovering from hip fracture have the physical capacity to walk in their community but lack the confidence to do so. The primary aim of this trial is to determine whether motivational interviewing increases time spent walking at 12 months in community-dwelling people after hip fracture compared with an attention placebo control group. Secondary aims are to evaluate cost effectiveness, patient and health service outcomes and to complete a process evaluation., Methods and Analysis: An assessor-blinded parallel group randomised controlled design with embedded health economic evaluation and process evaluation will compare the effects of n=270 participants randomly allocated to an experimental group (motivational interviewing) or a control group (dietary advice). For inclusion, participants are aged ≥65 years, living at home independently within 6 months of discharge from hospital after hip fracture and able to walk independently and communicate with conversational English. Key exclusion criteria are severe depression or anxiety, impaired intellectual functioning and being medically unstable to walk. Participants allocated to the experimental group will receive 10 (8 weekly and 2 booster) telephone-based sessions of motivational interviewing to increase walking over 16 weeks. Participants allocated to the control group will receive an equivalent dose of telephone-based dietary advice. The primary outcome is daily time spent walking over 7 days assessed at weeks 0, 9, 26 and 52. Secondary outcomes include measures of psychological-related function, mobility-related function, community participation, health-related quality of life and falls. Health service utilisation and associated costs will be assessed. Process evaluation will assess the fidelity of the motivational interviewing intervention and explore contextual factors through semistructured interviews., Ethics and Dissemination: Ethical approval obtained from Eastern Health (E19-002), Peninsula Health (50261/EH-2019), Alfred Health (617/20) and La Trobe University (E19/002/50261). The findings will be disseminated in peer-reviewed journals, conference presentations and public seminars., Trial Registration Number: ACTRN12619000936123., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: To explore the perspectives of hospital staff regarding the provision of smoking cessation care., Study Design: A qualitative description study using focus group discussions., Study Setting: Data were collected across metropolitan regional and rural hospitals in Victoria, Australia, between November and December 2019., Participants: Clinical and non-clinical hospital staff., Results: Five focus groups were conducted across four hospitals. Staff (n=38) across metropolitan regional and rural hospitals shared similar views with regards to barriers and facilitators of smoking cessation care. Four themes were present: (1) Clinical Setting wherein views about opportunity and capacity to embed smoking cessation care, relevant policies and procedures and guidelines were discussed; (2) Knowledge consisted of the need for training on the provision of pharmacotherapy and behavioural interventions, and awareness of resources; (3) Consistency represented the need for a consistently applied approach to smoking cessation care by all staff and included issues of staff smoking; and (4) Appropriateness consisted of questions around how smoking cessation care can be safely delivered in the context of challenging patient groups and different settings., Conclusions: Staff across metropolitan regional and rural hospitals experience similar views and identified shared barriers in implementing smoking cessation care. Responding to staff concerns and providing support to address smoking with patients will help to foster a consistent approach to cessation care. Clear practice guidelines for multidisciplinary clinical roles need to underpin staff training in communication skills, include priorities around smoking cessation care, and provide the authorising environment in which clinical staff actively provide smoking cessation care., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: The burden of injury in the Kingdom of Saudi Arabia (KSA) has increased in recent years, but the country has lacked a consistent methodology for collecting injury data. A trauma registry has been established at a large public hospital in Riyadh from which these data are now available., Objectives: We aimed to provide an overview of trauma epidemiology by reviewing the first calendar year of data collection for the registry. Risk-adjusted analyses were performed to benchmark outcomes with a large Australian major trauma service in Melbourne. The findings are the first to report the trauma profile from a centre in the KSA and compare outcomes with an international level I trauma centre., Methods: This was an observational study using records with injury dates in 2018 from the registries at both hospitals. Demographics, processes and outcomes were extracted, as were baseline characteristics. Risk-adjusted endpoints were inpatient mortality and length of stay. Binary logistic regression was used to measure the association between site and inpatient mortality., Results: A total of 2436 and 4069 records were registered on the Riyadh and Melbourne databases, respectively. There were proportionally more men in the Saudi cohort than the Australian cohort (86% to 69%). The Saudi cohort was younger, the median age being 36 years compared with 50 years, with 51% of injuries caused by road traffic incidents. The risk-adjusted length of stay was 4.4 days less at the Melbourne hospital (95% CI 3.95 days to 4.86 days, p<0.001). The odds of in-hospital death were also less (OR 0.25; 95% CI 0.15 to 0.43, p<0.001)., Conclusions: This is the first hospital-based study of trauma in the kingdom that benchmarks with an individual international centre. There are limitations to interpreting the comparisons, however the findings have established a baseline for measuring continuous improvement in outcomes for KSA trauma services., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Neurocritical care is a rapidly developing subspecialty within intensive care medicine which aims to improve outcomes of critically ill neurological patients. This has inspired the formation of specialised intensive care units or services to provide dedicated care of brain-injured patients, as well as new training pathways for physicians. However, expansion has been variable worldwide and it is yet to be determined if there are clear benefits in regard to patient outcomes. We are planning a systematic review with meta-analysis to assess whether the introduction of neurocritical care units or services, or neurointensivists have favourable effects on survival., Methods and Analysis: We will include all observational and interventional studies comparing specialised neurocritical care units or services with general or non-specialised units in the care of acutely brain-injured adults. The primary outcome will be all-cause mortality at the longest follow-up, and secondary outcomes will be intensive care unit and hospital length of stay, and functional outcomes. All relevant studies will be identified through database searches. All study selection and data extraction will be conducted by two independent reviewers. We will conduct a random-effects meta-analysis to synthesise evidence for all outcomes. In addition, we will perform a subgroup analysis by disease process. We will assess confidence in the cumulative evidence using the Grading of Recommendations, Assessment, Development and Evaluations framework., Ethics and Dissemination: This systematic review and meta-analysis does not require ethical approval. We will publish findings from this systematic review in a peer-reviewed scientific journal and present these at conferences. It will be included in the primary author's higher degree research thesis., Prospero Registration Number: CRD42020177190., Competing Interests: Competing interests: AU has received in-kind support from Integra LifeSciences (trial consumables) for work unrelated to the manuscript., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: The population is ageing, with increasing health and supportive care needs. For older people, complex chronic health conditions and frailty can lead to a cascade of repeated hospitalisations and further decline. Existing solutions are fragmented and not person centred. The proposed Being Your Best programme integrates care across hospital and community settings to address symptoms of frailty., Methods and Analysis: A multicentre pragmatic mixed methods study aiming to recruit 80 community-dwelling patients aged ≥65 years recently discharged from hospital. Being Your Best is a codesigned 6-month programme that provides referral and linkage with existing services comprising four modules to prevent or mitigate symptoms of physical, nutritional, cognitive and social frailty. Feasibility will be assessed in terms of recruitment, acceptability of the intervention to participants and level of retention in the programme. Changes in frailty (Modified Reported Edmonton Frail Scale), cognition (Mini-Mental State Examination), functional ability (Barthel and Lawton), loneliness (University of California Los Angeles Loneliness Scale-3 items) and nutrition (Malnutrition Screening Tool) will also be measured at 6 and 12 months., Ethics and Dissemination: The study has received approval from Monash Health Human Research Ethics Committee (RES-19-0000904L). Results will be disseminated through peer-reviewed journals, conference and seminar presentations., Trial Registration Number: ACTRN12620000533998; Pre-results., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: Somatosensory loss is common after stroke with one-in-two individuals affected. Although clinical practice guidelines recommend providing somatosensory rehabilitation, this impairment often remains unassessed and untreated. To address the gap between guideline recommendations and clinical practice, this study sought to understand the factors influencing delivery of evidence-based upper limb sensory rehabilitation after stroke., Design: Qualitative study involving focus groups and interviews. Data analysis used an inductive approach (thematic analysis) and deductive analysis using implementation theory (the Theoretical Domains Framework and Normalisation Process Theory)., Setting: Eight healthcare organisations in metropolitan and regional areas of Victoria and New South Wales, Australia., Participants: Eighty-seven rehabilitation therapists (79% occupational therapists and 21% physiotherapists) were purposively sampled and participated in a knowledge translation study with staggered recruitment from 2014 to 2018., Results: Three types of factors influenced therapists' delivery of upper limb somatosensory rehabilitation: individual ('The uncertain, unskilled therapist'), patient ('Patient understanding and priorities ' ) and organisational ('System pressures and resources ' ). Deductive analysis using implementation theory identified key determinants of practice change, such as opportunities to consolidate new skills, the anticipated benefits of upskilling as a therapy team and the work anticipated by therapists to incorporate a new somatosensory rehabilitation approach., Conclusions: Occupational therapists and physiotherapists hold valuable insights towards practice change in somatosensory rehabilitation from the 'frontline'. Therapists experience barriers to change including a lack of knowledge and skills, lack of resources and organisational pressures. Facilitators for change were identified, including social support and therapists' perceived legitimacy in using new somatosensory rehabilitation approaches. Results will inform the design of a tailored implementation strategy to increase the use of evidence-based somatosensory rehabilitation in Australia., Trial Registration Number: Australian New Zealand Clinical Trials Registry (ACTRN12615000933550)., Competing Interests: Competing interests: LMC is the lead author of the SENSe approach to sensory rehabilitation, the focus of knowledge translation in the SENSe Implement project. A SENSe training package (manual and DVD) has been developed and is available for purchase from a Not for Profit organisation. SENSe assessment and training equipment are also available for purchase. LMC has no personal financial interest in the sale of these resources. There is no patent, or intended application for a patent, associated with these resources. LMC has conducted workshops on the SENSe approach and been invited to give lectures and conference presentations on the approach., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: To explore facilitators and barriers to using experience-based co-design (EBCD) and accelerated EBCD (AEBCD) in the development and implementation of interventions to increase activity opportunities for inpatient stroke survivors., Design: Mixed-methods process evaluation underpinned by normalisation process theory (NPT)., Setting: Four post-acute rehabilitation stroke units in England., Participants: Stroke survivors, family members, stroke unit staff, hospital managers, support staff and volunteers. Data informing our NPT analysis comprised: ethnographic observations, n=366 hours; semistructured interviews with 76 staff, 53 stroke survivors and 27 family members pre-EBCD/AEBCD implementation or post-EBCD/AEBCD implementation; and observation of 43 co-design meetings involving 23 stroke survivors, 21 family carers and 54 staff., Results: Former patients and families valued participation in EBCD/AEBCD perceiving they were equal partners in co-design. Staff engaged with EBCD/AEBCD, reporting it as a valuable improvement approach leading to increased activity opportunities. The structured EBCD/AEBCD approach was influential in enabling coherence and cognitive participation and legitimated staff involvement in the change process. Researcher facilitation of EBCD/AEBCD supported cognitive participation, collective action and reflexive monitoring; these were important in implementing and sustaining co-design activities. Observations and interviews post-EBCD/AEBCD cycles confirmed creation and use of new social spaces and increased activity opportunities in all units. EBCD/AEBCD facilitated engagement with wider hospital resources and local communities, further enhancing activity opportunities. However, outside of structured group activity, many individual staff-patient interactions remained task focused., Conclusions: EBCD/AEBCD facilitated the development and implementation of environmental changes and revisions to work routines which supported increased activity opportunities in stroke units providing post-acute and rehabilitation care. Former stroke patients and carers contributed to improvements. NPT's generative mechanisms were instrumental in analysis and interpretation of facilitators and barriers at the individual, group and organisational level, and can help inform future implementations of similar approaches., Competing Interests: Competing interests: GR teaches on the EBCD training courses run by ‘The Point of Care Foundation’ in London. GR is one of the originators of EBCD. The remaining authors declare no other competing interests., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.)

Objective: This study aimed to determine the frequency of mouthwash use and its association to oral sex practice in heterosexuals., Design: A cross-sectional study., Setting: Data obtained from a sexual health clinic in Victoria, Australia, between March 2019 and April 2019., Participants: Heterosexual men and women attending the sexual health clinic answered a survey using computer-assisted self-interview., Primary and Secondary Outcome Measures: Univariable and multivariable logistic regression were performed to examine the association between frequent mouthwash use (ie, daily or weekly mouthwash use) and oral sex practices (including tongue kissing, fellatio, cunnilingus and insertive rimming)., Results: There were 681 heterosexuals included in the analysis: 315 (46.3%) men and 366 (53.7%) women. Of participants, 302 (44.3%) used mouthwash frequently, 173 (25.4%) used mouthwash infrequently and 206 (30.2%) never used mouthwash. There was no significant difference in the proportion of frequent mouthwash users between men and women (46.4% of men vs 42.6% of women; p=0.329). The proportion of frequent mouthwash users increased with increasing age groups (39.3% in ≤24 years, 45.2% in 25-34 years and 52.8% in ≥35 years or older; p trend =0.039) with those aged ≥35 years having a 1.80 times (95% CI: 1.12 to 2.89) higher odds of being a frequent mouthwash user than those aged ≤24 years. There were no significant associations between frequent mouthwash users had sexually transmitted infection (STI) risk after adjusting for age and country of birth., Conclusion: Older heterosexuals are more likely to use mouthwash. Given the high proportion and associations of mouthwash use in heterosexuals, future investigations related to oral STIs in this group should include mouthwash use., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Emerging evidence indicates that rehabilitation can improve ataxia, mobility and independence in everyday activities in individuals with hereditary cerebellar ataxia. However, with the rarity of the genetic ataxias and known recruitment challenges in rehabilitation trials, most studies have been underpowered, non-randomised or non-controlled. This study will be the first, appropriately powered randomised controlled trial to examine the efficacy of an outpatient and home-based rehabilitation programme on improving motor function for individuals with hereditary cerebellar ataxia., Methods and Analysis: This randomised, single-blind, parallel group trial will compare a 30-week rehabilitation programme to standard care in individuals with hereditary cerebellar ataxia. Eighty individuals with a hereditary cerebellar ataxia, aged 15 years and above, will be recruited. The rehabilitation programme will include 6 weeks of outpatient land and aquatic physiotherapy followed immediately by a 24- week home exercise programme supported with fortnightly physiotherapy sessions. Participants in the standard care group will be asked to continue their usual physical activity. The primary outcome will be the motor domain of the Functional Independence Measure. Secondary outcomes will measure the motor impairment related to ataxia, balance, quality of life and cost-effectiveness. Outcomes will be administered at baseline, 7 weeks, 18 weeks and 30 weeks by a physiotherapist blinded to group allocation. A repeated measures mixed-effects linear regression model will be used to analyse the effect of the treatment group for each of the dependent continuous variables. The primary efficacy analysis will follow the intention-to-treat principle., Ethics and Dissemination: The study has been approved by the Monash Health Human Research Ethics Committee (HREC/18/MonH/418) and the Human Research Ethics Committee of the Northern Territory Department of Health and Menzies School of Health Research (2019/3503). Results will be published in peer-reviewed journals, presented at national and/or international conferences and disseminated to Australian ataxia support groups., Trial Registration Number: ACTRN12618000908235., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Interstitial lung diseases are characterised by scarring of lung tissue that leads to reduced transfer of oxygen into the blood, decreased exercise capacity and premature death. Ambulatory oxygen therapy may be used to treat exertional oxyhaemoglobin desaturation, but there is little evidence to support its efficacy and there is wide variation in clinical practice. This study aims to compare the clinical efficacy and cost-effectiveness of ambulatory oxygen versus ambulatory air in people with fibrotic interstitial lung disease and exertional desaturation., Methods and Analysis: A randomised, controlled trial with blinding of participants, clinicians and researchers will be conducted at trial sites in Australia and Sweden. Eligible participants will be randomised 1:1 into two groups. Intervention participants will receive ambulatory oxygen therapy using a portable oxygen concentrator (POC) during daily activities and control participants will use an identical POC modified to deliver air. Outcomes will be assessed at baseline, 3 months and 6 months. The primary outcome is change in physical activity measured by number of steps per day using a physical activity monitor (StepWatch). Secondary outcomes are functional capacity (6-minute walk distance), health-related quality of life (St George Respiratory Questionnaire, EQ-5D-5L and King's Brief Interstitial Lung Disease Questionnaire), breathlessness (Dyspnoea-12), fatigue (Fatigue Severity Scale), anxiety and depression (Hospital Anxiety and Depression Scale), physical activity level (GENEActive), oxygen saturation in daily life, POC usage, and plasma markers of skeletal muscle metabolism, systematic inflammation and oxidative stress. A cost-effectiveness evaluation will also be undertaken., Ethics and Dissemination: Ethical approval has been granted in Australia by Alfred Hospital Human Research Ethics Committee (HREC/18/Alfred/42) with governance approval at all Australian sites, and in Sweden (Lund Dnr: 2019-02963). The results will be published in peer-reviewed scientific journals, presented at conferences and disseminated to consumers in publications for lay audiences., Trial Registration Number: ClinicalTrials.gov Registry (NCT03737409)., Competing Interests: Competing interests: All authors report non-financial support from BOC Australia in the delivery of the trial devices. AEH, YHK, LT, NSLG and CFM report non-financial support from Air Liquide Healthcare, outside the submitted work. YHK reports grants and personal fees from Boehringer Ingelheim, and personal fees from Roche, outside the submitted work. MS received research grants from Boehringer Ingelheim and Roche, outside the submitted work., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: In the 2010s, there has been an increase in sexually transmitted infections (STI) in men who have sex with men (MSM) in Australia, and since 2015 also in urban heterosexuals. Men who have sex with both men and women (MSMW) have characteristics that may differ from both men who have sex with men only (MSMO) and heterosexual men. We aimed to compare the sexual practices and the trends in HIV/STI positivity between MSMO and MSMW., Design: Repeated cross-sectional study., Setting: A sexual health centre in Melbourne, Australia., Participants: MSM aged 18 years and above who attended the Melbourne Sexual Health Centre for the first time between 2011 and 2018. This includes 12 795 MSMO and 1979 MSMW., Primary Outcome Measures: Demographic characterics, sexual practices and HIV/STI positivity., Results: Compared with MSMW, MSMO were more likely to practice anal sex and to have condomless receptive anal sex with casual male partners, and less likely to have a current regular relationship. Over the 8-year period, there was an increase in condomless receptive anal sex with casual male partners for both groups (MSMO: from 46.2% to 63.3%, p trend <0.001; MSMW: from 41.3% to 57.9%, p trend =0.011). Syphilis positivity increased in MSMO (from 5.5% to 7.9%, p trend =0.012) and MSMW (from 0.9% to 6.4%, p trend =0.004) and HIV remained stable. Gonorrhoea increased among MSMO from 2011 to 2014 (from 6.7% to 9.6%, p trend =0.002), and remained stable from 2015 to 2018. MSMO had higher odds of testing positive for gonorrhoea (adjusted OR (aOR) 1.36, 95% CI 1.13 to 1.64), chlamydia (aOR 1.39, 95% CI 1.16 to 1.67), syphilis (aOR 1.74, 95% CI 1.37 to 2.22) and HIV (aOR 4.60, 95% CI 2.43 to 8.70) than MSMW., Conclusions: MSMW have overall lower condomless sex and lower HIV/STI positivity. In the last years, changes in sexual practices in MSM have affected both MSMW and MSMO leading to an increased STI risk., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)