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OBJECTIVES: During a precommissioning inspection of a new biocontainment centre, radiographers noted structural features of quarantine rooms that could compromise staff and patient safety and the X-ray image quality, even after significant modifications had been made to an earlier radiography protocol. The aim of this study was to explore the safety and effectiveness of the modified protocol, in the new space, and identify improvements, if required. DESIGN: A qualitative study using in situ simulation and video-reflexive methods. SETTING: A newly built biocontainment centre, prior to its commissioning in 2021, in a large, tertiary hospital in Sydney, Australia. PARTICIPANTS: Five radiographers, and a nurse and a physician from the biocontainment centre, consented to participate. All completed the study. INTERVENTIONS: Two simulated mobile X-ray examinations were conducted in the unit prior to its commissioning; simulations were videoed. Participants and other stakeholders analysed video footage, collaboratively, and sessions were audio recorded, transcribed and analysed thematically. Problems and potential solutions identified were collated and communicated to the hospital executive, for endorsement and actioning, if possible. RESULTS: Four themes were identified from the data: infection exposure risks, occupational health and exposure risks, communication and X-ray image quality. Facilitated group reviews of video footage identified several important issues, across these four areas of risk, which had not been identified previously. CONCLUSIONS: In situ simulation is used, increasingly, to evaluate and improve healthcare practices. This study confirmed the added value of video-reflexive methods, which provided experienced participants with a richer view of a familiar protocol, in a new setting. Video footage can be examined immediately, or later if required, by a broader group of stakeholders, with diverse experience or expertise. Using video reflexivity, clinicians

INTRODUCTION: Chemotherapy-induced peripheral neuropathy (CIPN) is a common dose-limiting side effect of neurotoxic chemotherapy. Acute symptoms of CIPN during treatment can lead to dose reduction and cessation. Trials using electroacupuncture (EA) to treat established CIPN postchemotherapy have shown some efficacy. The current trial aims to assess the feasibility and preliminary efficacy of using EA to treat CIPN during chemotherapy. METHODS AND ANALYSIS: The current study is a single-centre, 1:1 randomised, sham-controlled pilot study set in a tertiary cancer hospital in Sydney, Australia, and will recruit 40 adult patients with early breast cancer undergoing adjuvant or neoadjuvant paclitaxel chemotherapy. Patients who develop CIPN within the first 6 weeks of chemotherapy will receive either true EA or sham-EA once a week for 10 weeks. The coprimary endpoints are recruitment and adherence rate, successful blinding of patients and compliance with the follow-up period. Secondary endpoints are mean change of CIPN symptoms from randomisation to end of treatment, sustained change in CIPN symptoms at 8-week and 24-week follow-up postchemotherapy, proportion of subjects attaining completion of 12 weeks of chemotherapy without dose reduction or cessation, change in acupuncture expectancy response pretreatment, during treatment and posttreatment. The primary assessment tool for the secondary endpoints will be a validated patient-reported outcome measure (European Organisation for Research and Treatment of Cancer Quality of Life Chemotherapy-Induced Peripheral Neuropathy) captured weekly from randomisation to week 12 of chemotherapy. ETHICS AND DISSEMINATION: The study protocol (2021/ETH12123) has been approved by the institutional Human Research Ethics Committee at St Vincent's Hospital Sydney and Chris O'Brien Lifehouse. Informed consent will be obtained prior to starting study-related procedures. The results will be disseminated in peer-reviewed journals and at scientif

OBJECTIVE: There are no globally agreed on strategies on early detection and first response management of postpartum haemorrhage (PPH) during and after caesarean birth. Our study aimed to develop an international expert's consensus on evidence-based approaches for early detection and obstetric first response management of PPH intraoperatively and postoperatively in caesarean birth. DESIGN: Systematic review and three-stage modified Delphi expert consensus. SETTING: International. POPULATION: Panel of 22 global experts in PPH with diverse backgrounds, and gender, professional and geographic balance. OUTCOME MEASURES: Agreement or disagreement on strategies for early detection and first response management of PPH at caesarean birth. RESULTS: Experts agreed that the same PPH definition should apply to both vaginal and caesarean birth. For the intraoperative phase, the experts agreed that early detection should be accomplished via quantitative blood loss measurement, complemented by monitoring the woman's haemodynamic status; and that first response should be triggered once the woman loses at least 500 mL of blood with continued bleeding or when she exhibits clinical signs of haemodynamic instability, whichever occurs first. For the first response, experts agreed on immediate administration of uterotonics and tranexamic acid, examination to determine aetiology and rapid initiation of cause-specific responses. In the postoperative phase, the experts agreed that caesarean birth-related PPH should be detected primarily via frequently monitoring the woman's haemodynamic status and clinical signs and symptoms of internal bleeding, supplemented by cumulative blood loss assessment performed quantitatively or by visual estimation. Postoperative first response was determined to require an individualised approach. CONCLUSION: These agreed on proposed approaches could help improve the detection of PPH in the intraoperative and postoperative phases of caesarean birth and the first

INTRODUCTION: Gestational diabetes mellitus and overweight are associated with an increased likelihood of complications during birth and for the newborn baby. These complications lead to increased immediate and long-term healthcare costs as well as reduced health and well-being in women and infants. This protocol presents the health economic evaluation to investigate the cost-effectiveness of Bump2Baby and Me (B2B&Me), which is a health coaching intervention delivered via smartphone to women at risk of gestational diabetes. METHODS AND ANALYSIS: Using data from the B2B&Me randomised controlled trial, this economic evaluation compares costs and health effects between the intervention and control group as an incremental cost-effectiveness ratio. Direct healthcare costs, costs of pharmaceuticals and intervention costs will be included in the analysis, body weight and quality-adjusted life-years for the mother will serve as the effect outcomes. To investigate the long-term cost-effectiveness of the trial, a Markov model will be employed. Deterministic and probabilistic sensitivity analysis will be employed. ETHICS AND DISSEMINATION: The National Maternity Hospital Human Research and Ethics Committee was the primary approval site (EC18.2020) with approvals from University College Dublin HREC-Sciences (LS-E-20-150-OReilly), Junta de Andalucia CEIM/CEI Provincial de Granada (2087-M1-22), Monash Health HREC (RES-20-0000-892A) and National Health Service Health Research Authority and Health and Care Research Wales (HCRW) (21/WA/0022). The results from the analysis will be disseminated in scientific papers, through conference presentations and through different channels for communication within the project. TRIAL REGISTRATION NUMBER: ACTRN12620001240932.

INTRODUCTION: Postnatal depression affects up to one in six new mothers in Australia each year, with significant impacts on the woman and her family. Prevention strategies can be complicated by a woman's reluctance to seek professional help. Peer support is a promising but inadequately tested early intervention. Very few trials have reported on the efficacy of peer support in the perinatal period and no study has been undertaken in Australia. We will explore if proactive telephone-based peer (mother-to-mother) support, provided to women identified as being at high risk of postnatal depression, impacts on clinically significant depressive symptomatology at 6 months postpartum. METHODS AND ANALYSIS: This is a protocol for a single-blinded, multi-centre, randomised controlled trial conducted in Melbourne, Australia. Eligible women will be recruited from either the postnatal units of two maternity hospitals, or around 4 weeks postpartum at maternal and child health centres within two metropolitan council areas. A total of 1060 (530/group) women will be recruited and randomly allocated (1:1 ratio) to either-usual care, to receive the standard community postpartum services available to them, or the intervention group, to receive proactive telephone-based support from a peer volunteer for 6 months, in addition to standard community services. PRIMARY OUTCOME: clinically significant depressive symptomatology at 6 months postpartum as measured using the Edinburgh Postnatal Depression Scale. SECONDARY OUTCOMES: symptoms of anxiety and/or stress, health-related quality of life, loneliness, perception of partner support, self-rated parenting, child health and development, infant feeding and health service use. The cost-effectiveness of the intervention relative to standard care will also be assessed. ETHICS AND DISSEMINATION: Ethics approval has been obtained from La Trobe University, St. Vincent's Hospital, the Royal Women's Hospital, Northern Health, Victorian Department of He

INTRODUCTION: Longitudinal studies can provide timely and accurate information to evaluate and inform COVID-19 control and mitigation strategies and future pandemic preparedness. The Optimise Study is a multidisciplinary research platform established in the Australian state of Victoria in September 2020 to collect epidemiological, social, psychological and behavioural data from priority populations. It aims to understand changing public attitudes, behaviours and experiences of COVID-19 and inform epidemic modelling and support responsive government policy. METHODS AND ANALYSIS: This protocol paper describes the data collection procedures for the Optimise Study, an ongoing longitudinal cohort of ~1000 Victorian adults and their social networks. Participants are recruited using snowball sampling with a set of seeds and two waves of snowball recruitment. Seeds are purposively selected from priority groups, including recent COVID-19 cases and close contacts and people at heightened risk of infection and/or adverse outcomes of COVID-19 infection and/or public health measures. Participants complete a schedule of monthly quantitative surveys and daily diaries for up to 24 months, plus additional surveys annually for up to 48 months. Cohort participants are recruited for qualitative interviews at key time points to enable in-depth exploration of people's lived experiences. Separately, community representatives are invited to participate in community engagement groups, which review and interpret research findings to inform policy and practice recommendations. ETHICS AND DISSEMINATION: The Optimise longitudinal cohort and qualitative interviews are approved by the Alfred Hospital Human Research Ethics Committee (# 333/20). The Optimise Study CEG is approved by the La Trobe University Human Ethics Committee (# HEC20532). All participants provide informed verbal consent to enter the cohort, with additional consent provided prior to any of the sub studies. Study findings will be

OBJECTIVE: To examine the prevalence of alcohol use and its associated factors among in-school adolescents in Sierra Leone. DESIGN: Data for the study was sourced from the 2017 Sierra Leone Global School-Based Student Health Survey, a nationally representative survey conducted among in-school adolescents aged 10-19 years using a multistage sampling methodology. Percentages were used to present the prevalence of alcohol use among in-school adolescents. Multivariable binary logistic regression analysis was performed to examine the factors associated with alcohol use among in-school adolescents. The results were presented using adjusted odds ratios (aOR) with their respective 95% confidence interval (CI). SETTING: Sierra Leone. PARTICIPANTS: A weighted sample of 1730 in-school adolescents in Sierra Leone. OUTCOME MEASURE: Current alcohol use. RESULTS: The prevalence of alcohol use among in-school adolescents was 10.7% (7.3, 15.3). In-school adolescents in senior secondary schools were more likely to use alcohol compared with those in junior secondary school (aOR=2.13; 95% CI 1.37, 3.30). The odds of alcohol use was higher among in-school adolescents who were truant at school relative to those who were not (aOR=2.24; 95% CI 1.54, 3.26). Also, in-school adolescents who were bullied (aOR=1.85; 95% CI 1.24, 2.76), ever engaged in sexual intercourse (aOR=2.06; 95% CI 1.39, 3.06), and used marijuana (aOR=3.36; 95% CI 1.72, 6.53) were more likely to use alcohol compared with those who were not. However, in-school adolescents who reported that their parents understood their problems (aOR=0.52; 95% CI 0.33, 0.82) had a lower likelihood of consuming alcohol. CONCLUSION: Our study has shown that alcohol use is prevalent among in-school adolescents in Sierra Leone. Grade level, experiences of being bullied, history of sexual intercourse, truancy at school, and previous use of marijuana were the factors influencing alcohol use among in-school adolescents. The findings emphasise the

INTRODUCTION: The objective of this parallel group, randomised controlled trial is to evaluate a community health navigator (CHN) intervention provided to patients aged over 40 years and living with chronic health conditions to transition from hospital inpatient care to their homes. Unplanned hospital readmissions are costly for the health system and negatively impact patients. METHODS AND ANALYSIS: Patients are randomised post hospital discharge to the CHN intervention or usual care. A comparison of outcomes between intervention and control groups will use multivariate regression techniques that adjust for age, sex and any independent variables that are significantly different between the two groups, using multiple imputation for missing values. Time-to-event analysis will examine the relationship between seeing a CHN following discharge from the index hospitalisation and reduced rehospitalisations in the subsequent 60 days and 6 months. Secondary outcomes include medication adherence, health literacy, quality of life, experience of healthcare and health service use (including the cost of care). We will also conduct a qualitative assessment of the implementation of the navigator role from the viewpoint of stakeholders including patients, health professionals and the navigators themselves. ETHICS APPROVAL: Ethics approval was obtained from the Research Ethics and Governance Office, Sydney Local Health District, on 21 January 2022 (Protocol no. X21-0438 and 2021/ETH12171). The findings of the trial will be disseminated through peer-reviewed journals and national and international conference presentations. Data will be deposited in an institutional data repository at the end of the trial. This is subject to Ethics Committee approval, and the metadata will be made available on request. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry (ACTRN 12622000659707). ARTICLE SUMMARY: The objective of this trial is to evaluate a CHN intervention provided

OBJECTIVES: Androgen deprivation therapy (ADT), a common treatment for prostate cancer, has debilitating impacts on physical and psychological quality of life. While some interventions focus on managing the physical side effects of ADT, there is a paucity of interventions that also address psychosocial and educational needs. The objective of this systematic review was to identify psychological and educational survivorship interventions targeting health-related quality of life (HRQoL) outcomes in men on ADT. DESIGN: A systematic review of randomised controlled trials. DATA SOURCES: Web of Science, Cochrane, EBSCO Host, PubMed, SCOPUS from inception (1984) to 28 January 2023. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Psychological and/or educational survivorship interventions targeting HRQoL outcomes for men on ADT; minimum 80% of participants on ADT; used a validated HRQoL outcome measure; published in English in a peer-reviewed journal. DATA EXTRACTION AND SYNTHESIS: Data extraction using pre-specified study criteria was conducted. Heterogeneity of eligible studies precluded a meta-analysis. RESULTS: A total of 3381 publications were identified with eight meeting the criteria. Interventions were either psychological with a cognitive behavioural approach (n=4), or educational with (n=2) or without (n=2) psychoeducational components.Two studies reported a statistically significant improvement using a specific HRQoL measure. Most studies were not adequately powered and/or included small sample sizes limiting the conclusions that can be drawn on effectiveness. The most effective interventions were (i) individually based, (ii) educational with a psychoeducational component, (iii) supplemented with information packages and/or homework and (iv) included personalised needs assessments. CONCLUSION: There is a paucity of literature reporting psychological and educational survivorship interventions targeting HRQoL outcomes for men on ADT. What is urgently needed are person-c

INTRODUCTION: Androgen deprivation therapy (ADT) is commonly used to treat men with locally advanced or metastatic prostate cancer. Men receiving ADT experience numerous side effects and frequently report unmet supportive care needs. An essential part of quality cancer care is survivorship care. To date, an optimal effective approach to survivorship care for men with prostate cancer on ADT has not been described. This protocol describes a randomised trial of tele-based nurse-led survivorship that addresses this knowledge gap: (1) determine the effectiveness of a nurse-led survivorship care intervention (PCEssentials), relative to usual care, for improving health-related quality of life (HR-QoL) in men with prostate cancer undergoing ADT and (2) evaluate PCEssentials implementation strategies and outcomes, including cost-effectiveness, compared with usual care. METHODS AND ANALYSIS: This is an effectiveness-implementation hybrid (type 1) trial with participants randomised to one of two arms: (1) minimally enhanced usual care and (2) nurse-led prostate cancer survivorship essentials (PCEssentials) delivered over four tele-based sessions, with a booster session 5 months after session 1. Eligible participants are Australian men with prostate cancer commencing ADT and expected to be on ADT for a minimum of 12 months. Participants are followed up at 3, 6 and 12 months postrecruitment. Primary outcomes are HR-QoL and self-efficacy. Secondary outcomes are psychological distress, insomnia, fatigue and physical activity. A concurrent process evaluation with participants and study stakeholders will be undertaken to determine effectiveness of delivery of PCEssentials. ETHICS AND DISSEMINATION: Ethics approval was obtained from the Metro South Health HREC (HREC/2021/QMS/79429). All participants are required to provide written informed consent. Outcomes of this trial will be published in peer-reviewed journals. The findings will be presented at conferences and meetings, local hos

INTRODUCTION: Prescribing long-term opioid therapy is a nuanced clinical decision requiring careful consideration of risks versus benefits. Our goal is to understand patient, provider and context factors that impact the decision to prescribe opioids in patients with cancer. METHODS: We conducted a secondary analysis of the raw semistructured interview data gathered from 42 prescribers who participated in one of two aligned concurrent qualitative studies in the USA and Australia. We conducted a two-part analysis of the interview: first identifying all factors influencing long-term prescribing and second open coding-related content for themes. RESULTS: Factors that influence long-term opioid prescribing for cancer-related pain clustered under three key domains (patient-related, provider-related and practice-related factors) each with several themes. Domain 1: Patient factors related to provider-patient continuity, patient personality, the patient's social context and patient characteristics including racial/ethnic identity, housing and socioeconomic status. Domain 2: Provider-related factors centred around provider 'personal experience and expertise', training and time availability. Domain 3: Practice-related factors included healthcare interventions to promote safer opioid practices and accessibility of quality alternative pain therapies. CONCLUSION: Despite the differences in the contexts of the two countries, providers consider similar patient, provider and practice-related factors when long-term prescribing opioids for patients with cancer. Some of these factors may be categorised as cognitive biases that may intersect in an already disadvantaged patient and exacerbate disparities in the treatment of their pain. A more systematic understanding of these factors and how they impact the quality of care can inform appropriate interventions.

OBJECTIVES: Tailored models of home-based palliative care aimed to support death at home, should also ensure optimal symptom control. This study aimed to explore symptom occurrence and distress over time in Palliative Extended And Care at Home (PEACH) model of care recipients. DESIGN: This was a prospective cohort study. SETTING AND PARTICIPANTS: Participants were consecutive recipients of the PEACH rapid response nurse-led model of care in metropolitan Sydney (December 2013-January 2017) who were in the last weeks of life with a terminal or deteriorating phase of illness and had a preference to be cared or die at home. OUTCOME MEASURES: Deidentified data including sociodemographic and clinical characteristics, and symptom distress scores (Symptom Assessment Score) were collected at each clinical visit. Descriptive statistics and forward selection logistic regression analysis were used to explore influence of symptom distress levels on mode of separation ((1) died at home while still receiving a PEACH package, (2) admitted to a hospital or an inpatient palliative care unit or (3) discharged from the package (alive and no longer requiring PEACH)) across four symptom distress level categories. RESULTS: 1754 consecutive clients received a PEACH package (mean age 70 years, 55% male). 75.7% (n=1327) had a home death, 13.5% (n=237) were admitted and 10.8% (n=190) were still alive and residing at home when the package ceased. Mean symptom distress scores improved from baseline to final scores in the three groups (p<0.0001). The frequency of no symptom distress score (0) category was higher in the home death group. Higher scores for nausea, fatigue, insomnia and bowel problems were independent predictors of who was admitted. CONCLUSION: Tailored home-based palliative care models to meet preference to die at home, achieve this while maintaining symptom control. A focus on particular symptoms may further optimise these models of care.

INTRODUCTION: This paper will describe the research protocol for the Deadly Aboriginal and Torres Strait Islander Nursing and Midwifery Mentoring (DANMM) Project, which will determine the feasibility and acceptability of a cultural mentoring programme designed for Aboriginal and Torres Strait Islander nurses and midwives across five diverse local health districts in New South Wales, Australia. Government and health agencies highlight the importance of culturally appropriate and safe environments for Aboriginal people. Specifically, New South Wales Health prioritises workforce strategies that support Aboriginal people to enter and stay in the health workforce. However, retaining Aboriginal nurses and midwives remains challenging. The DANMM Project aligns with these local and state-wide health plans and strategies, addressing critical issues of workforce cultural safety and retention. METHODS AND ANALYSIS: A mixed-methods study design will be employed to assess feasibility, acceptability and preliminary efficacy of the DANMM Programme across five publicly funded local health districts in New South Wales, Australia. Adhering to cultural safety, a project cultural governance group will be formed. Quantitative outcome measures include the use of questionnaires (Nursing Workplace Satisfaction Questionnaire, Ganngaleh nga Yagaleh Cultural Safety assessment tool). Resource implications will be measured using the Organisational Commitment and Health Professional Program Readiness Assessment Compass. These will be triangulated with individual and group yarning circles to provide a holistic evaluation of the programme. ETHICS AND DISSEMINATION: The study has ethics approval: Aboriginal Health and Medical Research Council (#2054/23); New South Wales Health Human Research Committees (Greater Western Human Research Committee #2022/ETH01971, Murrumbidgee-site-specific approval, Sydney Local Health District-site-specific approval, Western Sydney Local Health District-site-specific

INTRODUCTION: Despite the high mortality rates in long-term care (LTC) homes, most do not have a formalised palliative programme. Hence, our research team has developed the Strengthening a Palliative Approach in Long Term Care (SPA-LTC) programme. The goal of the proposed study is to examine the implementation and effectiveness of the SPA-LTC programme. METHODS AND ANALYSIS: A cross-jurisdictional, effectiveness-implementation type II hybrid cluster randomised control trial design will be used to assess the SPA-LTC programme for 18 LTC homes (six homes within each of three provinces). Randomisation will occur at the level of the LTC home within each province, using a 1:1 ratio (three homes in the intervention and control groups). Baseline staff surveys will take place over a 3-month period at the beginning for both the intervention and control groups. The intervention group will then receive facilitated training and education for staff, and residents and their family members will participate in the SPA-LTC programme. Postintervention data collection will be conducted in a similar manner as in the baseline period for both groups. The overall target sample size will be 594 (297 per arm, 33 resident/family member participants per home, 18 homes). Data collection and analysis will involve organisational, staff, resident and family measures. The primary outcome will be a binary measure capturing any emergency department use in the last 6 months of life (resident); with secondary outcomes including location of death (resident), satisfaction and decisional conflict (family), knowledge and confidence implementing a palliative approach (staff), along with implementation outcomes (ie, feasibility, reach, fidelity and perceived sustainability of the SPA-LTC programme). The primary outcome will be analysed via multivariable logistic regression using generalised estimating equations. Intention-to-treat principles will be used in the analysis. ETHICS AND DISSEMINATION: The study

INTRODUCTION: There is evidence from previous studies that adults value paediatric health-related quality of life (HRQoL) and adult HRQoL differently. Less is known about how adolescents value paediatric HRQoL and whether their valuation and decision-making processes differ from those of adults. Discrete choice experiments (DCEs) are widely used to develop value sets for measures of HRQoL, but there is still much to understand about whether and how the methods choices in the implementation of DCE valuation tasks, such as format, presentation and perspective, affect the decision-making process of participants. This paper describes the protocol for a qualitative study that aims to explore the decision-making process of adults and adolescents when completing DCE valuation tasks. The study will also explore the impact of methodological choices in the design of DCE studies (including decisions about format and presentation) on participants' thinking process. METHODS AND ANALYSIS: An interview protocol has been developed using DCE valuation tasks. Interviews will be conducted online via Zoom with both an adolescent and adult sample. In the interview, the participant will be asked to go through some DCE valuation tasks while 'thinking aloud'. After completion of the survey, participants will then be asked some predetermined questions in relation to various aspects of the DCE tasks. Interviews will be recorded and transcribed and analysed using a thematic analysis approach. ETHICS AND DISSEMINATION: Ethics approval for this study has been received for the adult sample (UTS ETH20-9632) as well as the youth sample (UTS ETH22-6970) from the University of Technology Sydney Human Research Ethics Committee. Results from this study will inform the methods to be used in development of value sets for use in the health technology assessment of paediatric interventions and treatments. Findings from this study will also be disseminated through national/international conferences and pee

INTRODUCTION: Cardiac transplantation (CTx) is a life-saving operation that can improve the quality and length of a recipient's life. Immunosuppression medication, required to prevent rejection, can result in adverse metabolic and renal effects. Clinically significant complications include metabolic effects such as diabetes and weight gain, renal impairment, and cardiac disease such as allograft vasculopathy and myocardial fibrosis. Sodium glucose co-transporter 2 (SGLT2) inhibitors are a class of oral medication that increase urinary excretion of glucose. In patients with type 2 diabetes, SGLT2 inhibitors improve cardiovascular, metabolic and renal outcomes. Similar benefits have been shown in patients with heart failure and reduced ejection fraction irrespective of diabetes status. In patients with post-transplant diabetes mellitus, SGLT2 inhibitors improve metabolic parameters; however, their benefit and safety have not been evaluated in randomised prospective studies. This study will potentially provide a novel therapy to improve or prevent complications (diabetes, kidney failure and heart fibrosis) that occur with immunosuppressive medications. METHODS: The EMPA-HTx study is a randomised, placebo-controlled trial of the SGLT2 inhibitor empagliflozin 10 mg daily versus placebo in recent CTx recipients. One hundred participants will be randomised 1:1 and commence the study medication within 6-8 weeks of transplantation with treatment and follow-up until 12 months after transplantation. Demographic information, anthropomorphic measurements, pathology tests and cardiac magnetic resonance (CMR) scan will be recorded at baseline and follow-up. Patients will be reviewed monthly during the study until 12 months post-CTx and data will be collected for each patient at each study visit. The overall aim of the study is to assess the safety and efficacy of empagliflozin in CTx recipients. The primary outcome is glycaemic improvement measured as change in glycated haemoglobi

INTRODUCTION: Minimal trauma fractures (MTFs) often occur in older patients with osteoporosis and may be precipitated by falls risk-increasing drugs. One category of falls risk-increasing drugs of concern are those with sedative/anticholinergic properties. Collaborative medication management services such as Australia's Home Medicine Review (HMR) can reduce patients' intake of sedative/anticholinergics and improve continuity of care. This paper describes a protocol for an randomised controlled trial to determine the efficacy of an HMR service for patients who have sustained MTF. METHOD AND ANALYSIS: Eligible participants are as follows: ≥65 years of age, using ≥5 medicines including at least one falls risk-increasing drug, who have sustained an MTF and under treatment in one of eight Osteoporosis Refracture Prevention clinics in Australia. Consenting participants will be randomised to control (standard care) or intervention groups. For the intervention group, medical specialists will refer to a pharmacist for HMR focused on reducing falls risk predominately through making recommendations to reduce falls risk medicines, and adherence to antiosteoporosis medicines. Twelve months from treatment allocation, comparisons between groups will be made. The main outcome measure is participants' cumulative exposure to sedative and anticholinergics, using the Drug Burden Index. Secondary outcomes include medication adherence, emergency department visits, hospitalisations, falls and mortality. Economic evaluation will compare the intervention strategy with standard care. ETHICS AND DISSEMINATION: Approval was obtained via the New South Wales Research Ethics and Governance Information System (approval number: 2021/ETH12003) with site-specific approvals granted through Human Research Ethics Committees for each research site. Study outcomes will be published in peer-reviewed journals. It will provide robust insight into effectiveness of a pharmacist-based intervention on medicine-r

INTRODUCTION: Low back pain (LBP) is commonly treated with opioid analgesics despite evidence that these medicines provide minimal or no benefit for LBP and have an established profile of harms. International guidelines discourage or urge caution with the use of opioids for back pain; however, doctors and patients lack practical strategies to help them implement the guidelines. This trial will evaluate a multifaceted intervention to support general practitioners (GPs) and their patients with LBP implement the recommendations in the latest opioid prescribing guidelines. METHODS AND ANALYSIS: This is a cluster randomised controlled trial that will evaluate the effect of educational outreach visits to GPs promoting opioid stewardship alongside non-pharmacological interventions including heat wrap and patient education about the possible harms and benefits of opioids, on GP prescribing of opioids medicines dispensed. At least 40 general practices will be randomised in a 1:1 ratio to either the intervention or control (no outreach visits; GP provides usual care). A total of 410 patient-participants (205 in each arm) who have been prescribed an opioid for LBP will be enrolled via participating general practices. Follow-up of patient-participants will occur over a 1-year period. The primary outcome will be the cumulative dose of opioid dispensed that was prescribed by study GPs over 1 year from the enrolment visit (in morphine milligram equivalent dose). Secondary outcomes include prescription of opioid medicines, benzodiazepines, gabapentinoids, non-steroidal anti-inflammatory drugs by study GPs or any GP, health services utilisation and patient-reported outcomes such as pain, quality of life and adverse events. Analysis will be by intention to treat, with a health economics analysis also planned. ETHICS AND DISSEMINATION: The trial received ethics approval from The University of Sydney Human Research Ethics Committee (2022/511). The results will be disseminated via publi

INTRODUCTION: Meta-analytical evidence confirms a range of interventions, including mindfulness, physical activity and sleep hygiene, can reduce psychological distress in university students. However, it is unclear which intervention is most effective. Artificial intelligence (AI)-driven adaptive trials may be an efficient method to determine what works best and for whom. The primary purpose of the study is to rank the effectiveness of mindfulness, physical activity, sleep hygiene and an active control on reducing distress, using a multiarm contextual bandit-based AI-adaptive trial method. Furthermore, the study will explore which interventions have the largest effect for students with different levels of baseline distress severity. METHODS AND ANALYSIS: The Vibe Up study is a pragmatically oriented, decentralised AI-adaptive group sequential randomised controlled trial comparing the effectiveness of one of three brief, 2-week digital self-guided interventions (mindfulness, physical activity or sleep hygiene) or active control (ecological momentary assessment) in reducing self-reported psychological distress in Australian university students. The adaptive trial methodology involves up to 12 sequential mini-trials that allow for the optimisation of allocation ratios. The primary outcome is change in psychological distress (Depression, Anxiety and Stress Scale, 21-item version, DASS-21 total score) from preintervention to postintervention. Secondary outcomes include change in physical activity, sleep quality and mindfulness from preintervention to postintervention. Planned contrasts will compare the four groups (ie, the three intervention and control) using self-reported psychological distress at prespecified time points for interim analyses. The study aims to determine the best performing intervention, as well as ranking of other interventions. ETHICS AND DISSEMINATION: Ethical approval was sought and obtained from the UNSW Sydney Human Research Ethics Committee (HRE

INTRODUCTION: Improving access to effective contraception has the potential to reduce unintended pregnancy and abortion rates. Community pharmacists could play an expanded role in contraceptive counselling and referral to contraceptive prescribers particularly when women are already attending community pharmacy to obtain emergency contraceptive pills (ECPs) or to have medical abortion (MA) medicines dispensed. The ALLIANCE trial aims to compare the subsequent uptake of effective contraception (hormonal or intrauterine) in women seeking ECP or MA medicines, who receive the ALLIANCE community pharmacy-based intervention with those who do not receive the intervention. METHODS AND ANALYSIS: ALLIANCE is a stepped-wedge pragmatic cluster randomised trial in Australian community pharmacies. The ALLIANCE intervention involves community pharmacists delivering structured, patient-centred, effectiveness-based contraceptive counselling (and a referral to a contraceptive prescriber where appropriate) to women seeking either ECPs or to have MA medicines dispensed. Women participants will be recruited by participating pharmacists. A total of 37 pharmacies and 1554 participants will be recruited. Pharmacies commence in the control phase and are randomised to transition to the intervention phase at different time points (steps). The primary outcome is the self-reported use of effective contraception at 4 months; secondary outcomes include use of effective contraception and the rate of pregnancies or induced abortions at 12 months. A process and economic evaluation of the trial will also be undertaken. ETHICS AND DISSEMINATION: Ethical approval has been obtained from the Monash University Human Research Ethics Committee (#34563). An explanatory statement will be provided and written consent will be obtained from all participants (pharmacy owner, pharmacist and women) before their commencement in the trial. Dissemination will occur through a knowledge exchange workshop, peer-reviewed

OBJECTIVE: We aimed to identify all available studies describing measures or indicators used to monitor 41 intrapartum care practices described in the 2018 WHO intrapartum care recommendations, with a view to informing development of standardised measurement of implementing these recommendations. DESIGN: Systematic scoping review. METHODS: We conducted a scoping review to identify studies reporting measures of intrapartum care published between 1 January 2000 and 28 June 2021. Primary and secondary outcome measures included study characteristics (publication year, journal, country and World Bank classification) and intrapartum care measure characteristics (definition, numerator, denominator, measurement level and measurement approach). We searched MEDLINE, EMBASE, CINAHL, Cochrane Library, the Maternity and Infant Care Database, Global Index Medicus and grey literature using structured search terms related to included recommendations, focusing on respectful and supportive care, and clinical practices performed throughout labour and birth. The measures identified were classified by the WHO recommendation and their characteristics reported. RESULTS: We identified 150 studies which described 1331 intrapartum care measures. These measures corresponded to 35 of the 41 included WHO recommendations, and represented all domains of the WHO recommendations (care throughout labour and birth, first stage of labour, second stage of labour, third stage of labour). A total of 40.1% (534 of 1331 measures) of measures were related to respectful maternity care. Most studies used a questionnaire or survey measurement approach (522 of 1331 measures, 39.2%). CONCLUSION: This scoping review presents a database of existing intrapartum care measures used to monitor the quality of intrapartum care globally. There is no clear consensus on a core set of measures for evaluating the practice of the WHO's intrapartum care recommendations. This review provides a foundation to support the developm

INTRODUCTION: Sustainable approaches to support care coordination and symptom management needs of critically ill adults living with multimorbidity are needed to combat the challenges and complexity that multimorbidity presents. The study aims to test the feasibility of the Care cOORDInatioN And sympTom managEment (COORDINATE) intervention to improve health outcomes of adults living with multimorbidity. METHODS AND ANALYSIS: A multicomponent nurse-driven intervention was developed using experience-based co-design and human-centred design. Inclusion criteria include (1) age 55 years and older, (2) admitted to an intermediate care unit, (3) presence of two or more chronic health conditions and (4) signed informed consent. Data collection will occur at baseline (time of recruitment predischarge) and 6 weeks and 3 months following hospital discharge. Outcome of interest from this feasibility study is to evaluate the financial, technical and logistic feasibility of a full-scale study including data collection and protocol adherence. Additionally, Cohen's d effect sizes for the change in outcomes over time will be computed to establish power calculations required for a full-scale study. The protocol was prepared in accordance with Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist. ETHICS AND DISSEMINATION: The study has been reviewed and approved by the Institutional Review Board of Johns Hopkins Medical Institutions. Given the success of this feasibility study, the potential for the COORDINATE intervention to decrease the symptom burden and improve participant quality of life among critically ill people with multimorbidity will be tested in a full-scale study, and findings will be actively disseminated. TRIAL REGISTRATION NUMBER: NCT05985044.

INTRODUCTION: Poor patient assessment results in undetected clinical deterioration. Yet, there is no standardised assessment framework for >29 000 Australian emergency nurses. To reduce clinical variation and increase safety and quality of initial emergency nursing care, the evidence-based emergency nursing framework HIRAID (History, Identify Red flags, Assessment, Interventions, Diagnostics, communication and reassessment) was developed and piloted. This paper presents the rationale and protocol for a multicentre clinical trial of HIRAID. METHODS AND ANALYSIS: Using an effectiveness-implementation hybrid design, the study incorporates a stepped-wedge cluster randomised controlled trial of HIRAID at 31 emergency departments (EDs) in New South Wales, Victoria and Queensland. The primary outcomes are incidence of inpatient deterioration related to ED care, time to analgesia, patient satisfaction and medical satisfaction with nursing clinical handover (effectiveness). Strategies that optimise HIRAID uptake (implementation) and implementation fidelity will be determined to assess if HIRAID was implemented as intended at all sites. ETHICS AND DISSEMINATION: Ethics has been approved for NSW sites through Greater Western Human Research Ethics Committee (2020/ETH02164), and for Victoria and Queensland sites through Royal Brisbane & Woman's Hospital Human Research Ethics Committee (2021/QRBW/80026). The final phase of the study will integrate the findings in a toolkit for national rollout. A dissemination, communications (variety of platforms) and upscaling strategy will be designed and actioned with the organisations that influence state and national level health policy and emergency nurse education, including the Australian Commission for Quality and Safety in Health Care. Scaling up of findings could be achieved by embedding HIRAID into national transition to nursing programmes, 'business as usual' ED training schedules and university curricula. TRIAL REGISTRATION NUMBER

OBJECTIVE: To examine the prevalence of COVID-19 vaccination, and factors associated with vaccination intention and hesitancy in pregnant and postnatal women in Australia. DESIGN AND SETTING: A national online survey was conducted over 6 months between 31 August 2021 and 1 March 2022 and responses to vaccination status were categorised as: 'vaccinated', 'vaccine intended' and 'vaccine hesitant'. The data were weighted to reflect the proportion of women of reproductive age. Potential confounding variables were examined using multinomial logistic regression analyses, and all comparisons were made against vaccinated pregnant and postnatal women. PARTICIPANTS: 2140 women responded to the survey (838 pregnant; 1302 recently post partum). RESULTS: Amongst pregnant women, 586 (69.9%) were vaccinated, 166 (19.8%) indicated intention and 86 (10.3%) were hesitant. In postnatal women, this was 1060 (81.4%), 143 (11.0%) and 99 (7.6%), respectively. Only 52 (6.2%) of pregnant women stated never wanting a COVID-19 vaccine. Vaccine hesitancy increased over time, and for pregnant women was associated with: living in a state other than New South Wales (NSW) (Adjusted Relative Risk (ARR) 2.77, 95%CI: 1.68-4.56 for vaccine intention and ARR=3.31, 95%CI: 1.52-7.20 for vaccine hesitancy), younger age <30 years, not having a university education, income <80K AUD, gestation <28 weeks, having no pregnancy risk factors, and being less satisfied with life (ARR=2.20, 95%CI: 1.04-4.65 for vaccine intention and ARR=2.53, 95%CI: 1.02-6.25 for vaccine hesitancy) . For postnatal women: living in a state other than NSW or Victoria, income <80K AUD and having private obstetric care (ARR=2.06, 95%CI: 1.23-3.46) were significantly associated with vaccine hesitancy. CONCLUSIONS: Around 1 in 10 pregnant women and just over 1 in 13 postnatal women reported vaccine hesitancy in this Australian survey, and hesitancy was higher in the latter 3-month period. Tailored messages to younger mothers and those fro

BACKGROUND: Pain medicines are widely prescribed by general practitioners (GPs) when managing people with low back pain (LBP), but little is known about what drives decisions to prescribe these medicines. OBJECTIVES: The aim of this study was to investigate what influences GPs' decision to prescribe pain medicines for LBP. DESIGN: Qualitative study with in-depth interviews. SETTING: Australian primary care. PARTICIPANTS: We interviewed 25 GPs practising in Australia experienced in managing LBP (mean (SD) age 53.4 (9.1) years, mean (SD) years of experience: 24.6 (9.3), 36% female). GPs were provided three vignettes describing common LBP presentations (acute exacerbation of chronic LBP, subacute sciatica and chronic LBP) and were asked to think aloud how they would manage the cases described in the vignettes. DATA ANALYSIS: We summarised GP's choices of pain medicines for each vignette using content analysis and used framework analysis to investigate factors that affected GP's decision-making. RESULTS: GPs more commonly prescribed opioid analgesics. Anticonvulsants and antidepressants were also commonly prescribed depending on the presentation described in the vignette. GP participants made decisions about what pain medicines to prescribe for LBP largely based on previous experiences, including their own personal experiences of LBP, rather than guidelines. The choice of pain medicine was influenced by a range of clinical factors, more commonly the patient's pathoanatomical diagnosis. While many adhered to principles of judicious use of pain medicines, polypharmacy scenarios were also common. Concerns about drug-seeking behaviour, adverse effects, stigma around opioid analgesics and pressure from regulators also shaped their decision-making process. CONCLUSIONS: We identified several aspects of decision-making that help explain the current profile of pain medicines prescribed for LBP by GPs. Themes identified by our study could inform future implementation strategies t

OBJECTIVE: Dietary sodium intake represents a risk factor for cardiovascular disease and mortality. The study sought to analyse the sodium content of effervescent dietary supplements and drugs in Germany and the USA. DESIGN: Comparative cross-sectional study. SETTING AND METHODS: The sodium content of 39 dietary supplement effervescent tablets available in Germany was measured in May and June 2022 using optical emission spectrometry with inductively coupled argon plasma. The sodium content of 33 common pharmacy-only effervescent tablets (over-the-counter (OTC) drugs) in Germany was obtained from the summary of product characteristics. We compared the sodium content of the measured German dietary supplement effervescent tablets to that of 51 dietary supplement effervescent tablets available in the USA (data: National Institutes of Health's Dietary Supplement Label Database). RESULTS: The measured sodium content in the German dietary supplements was 283.9±122.6 mg sodium/tablet, equivalent to 14±6% of the maximum recommended daily sodium intake (MRDSI). Vitamin products had the highest (378.3±112.8 mg, 19±6% of MRDSI), and calcium products had the lowest mean sodium content (170.4±113.2 mg, 9±6% of MRDSI). Vitamin products contained significantly more sodium than magnesium (378.3 mg vs 232.7 mg; p=0.004), calcium (378.3 mg vs 170.4 mg; p=0.006) and mineral products (378.3 mg vs 191.6 mg; p=0.048). The sodium content measured in products available in Germany was higher when compared with the declared sodium content on the label of the products sold in the USA (283.9 mg vs 190.0 mg; p<0.001). The median summary of product characteristics-declared sodium content of a single dose of the German OTC drugs was 157.0 mg (IQR: 98.9-417.3 mg); pain/common cold drugs contained the most sodium (median: 452.1 mg; IQR: 351.3-474.0 mg). CONCLUSION: Effervescent tablets of nutritional supplements and OTC drugs contain high amounts of sodium, which often is not disclosed.

BACKGROUND: Pancreatic cancer is relatively rare and aggressive, with digestion and malabsorption issues often leading to significant weight loss. Recruitment of people with this malignancy into studies can be challenging, and innovative methods need to be explored to improve recruitment rates. AIM: To describe a mixed media methodology and the outcomes used to recruit patients to participate in a binational survey. METHODS: The details of the mixed media method used to identify and recruit people with pancreatic cancer are described. This method was used to investigate pancreatic enzyme replacement therapy use in people with pancreatic cancer across Australia and Aotearoa New Zealand. RESULTS: The mixed media approach was successful in reaching 334 participants from a range of ethnicities and regions. Results showed that social media platforms were notably more efficient and cost-effective than radio and newspaper but required additional expertise, including graphic design and media strategy knowledge. CONCLUSIONS: Social media is an effective and efficient method of recruiting people with pancreatic cancer to a national survey. Studies using media to recruit patients may need to include team members with a range of skills.

OBJECTIVE: We examined the association between partner alcohol consumption and the experience of intimate partner violence among women in Papua New Guinea. DESIGN: We performed a cross-sectional analyses of data extracted from the 2016-2018 Papua New Guinea Demographic and Health Survey. We included 3319 women in sexual unions. Multilevel binary logistic regression analysis was used to examine the association between partner alcohol consumption and intimate partner violence, controlling for the covariates. Results from the regression analysis were presented using the crude odds ratios (cORs) and adjusted odds ratios (aORs), with 95% confidence intervals (CIs). SETTING: Papua New Guinea. PARTICIPANTS: Women aged 15-49 years in sexual unions. OUTCOME MEASURES: Physical, emotional, and sexual violence. RESULTS: The prevalence of physical, emotional and sexual violence among women in sexual unions in Papua New Guinea were 45.9% (42.4 to 47.7), 45.1% (43.4 to 46.8) and 24.3% (22.9 to 25.8), respectively. The level of partner alcohol consumption was 57.3%. Women whose partners consumed alcohol were more likely to experience physical violence (aOR=2.86, 95% CI=2.43 to 3.37), emotional violence (aOR=2.89, 95% CI=2.44 to 3.43) and sexual violence (aOR=2.56, 95% CI=2.08 to 3.16) compared with those whose partners did not consume alcohol. CONCLUSION: This study found a relatively high prevalence of intimate partner violence among women in Papua New Guinea. Most importantly, this study found partner alcohol consumption to be significantly and positively associated with intimate partner violence. The study, therefore, recommends that interventions seeking to reduce intimate partner violence among women in Papua New Guinea should intensify behaviour change and education on reducing or eliminating partner alcohol consumption.

INTRODUCTION: Alcohol consumption is a leading cause of mortality, morbidity and adverse social sequelae in Sri Lanka. Effective community-based, culturally adapted or context-specific interventions are required to minimise these harms. We designed a mixed-methods stepped wedge cluster randomised control trial of a complex alcohol intervention. This paper describes the initial trial protocol and subsequent modifications following COVID-19. METHODS AND ANALYSIS: We aimed to recruit 20 villages (approximately n=4000) in rural Sri Lanka. The proposed intervention consisted of health screening clinics, alcohol brief intervention, participatory drama, film, and public health promotion materials to be delivered over 12 weeks.Following disruptions to the trial resulting from the Easter bombings in 2019, COVID-19 and a national financial crisis, we adapted the study in two main ways. First, the interventions were reconfigured for hybrid delivery. Second, a rolling pre-post study evaluating changes in alcohol use, mental health, social capital and financial stress as the primary outcome and implementation and ex-ante economic analysis as secondary outcomes. ETHICS AND DISSEMINATION: The original study and amendments have been reviewed and granted ethical approval by Rajarata University of Sri Lanka (ERC/2018/21-July 2018 and February 2022) and the University of Sydney (2019/006). Findings will be disseminated locally in collaboration with the community and stakeholders.The new hybrid approach may be more adaptable, scalable and generalisable than the planned intervention. The changes will allow a closer assessment of individual interventions while enabling the evaluation of this discontinuous event through a naturalistic trial design. This may assist other researchers facing similar disruptions to community-based studies. TRIAL REGISTRATION: The trial is registered with the Sri Lanka Clinical Trials Registry; https://slctr.lk/trials/slctr-2018-037.

INTRODUCTION: Women living in rural and regional Australia often experience difficulties in accessing long-acting reversible contraception (LARC) and medical abortion services. Nurse-led models of care can improve access to these services but have not been evaluated in Australian general practice. The primary aim of the ORIENT trial (ImprOving Rural and regIonal accEss to long acting reversible contraceptioN and medical abortion through nurse-led models of care, Tasksharing and telehealth) is to assess the effectiveness of a nurse-led model of care in general practice at increasing uptake of LARC and improving access to medical abortion in rural and regional areas. METHODS AND ANALYSIS: ORIENT is a stepped-wedge pragmatic cluster-randomised controlled trial. We will enrol 32 general practices (clusters) in rural or regional Australia, that have at least two general practitioners, one practice nurse and one practice manager. The nurse-led model of care (the intervention) will be codesigned with key women's health stakeholders. Clusters will be randomised to implement the model sequentially, with the comparator being usual care. Clusters will receive implementation support through clinical upskilling, educational outreach and engagement in an online community of practice. The primary outcome is the change in the rate of LARC prescribing comparing control and intervention phases; secondary outcomes include change in the rate of medical abortion prescribing and provision of related telehealth services. A within-trial economic analysis will determine the relative costs and benefits of the model on the prescribing rates of LARC and medical abortion compared with usual care. A realist evaluation will provide contextual information regarding model implementation informing considerations for scale-up. Supporting nurses to work to their full scope of practice has the potential to increase LARC and medical abortion access in rural and regional Australia. ETHICS AND DISSEMINATI

INTRODUCTION: There is a lack of standard nomenclature and a limited understanding of programmes and services delivered to people in prisons as they transition into the community to support their integration and reduce reoffending related risk factors. The aim of this paper is to outline the protocol for a modified Delphi study designed to develop expert consensus on the nomenclature and best-practice principles of programmes and services for people transitioning from prison into the community. METHODS AND ANALYSIS: An online, two-phase modified Delphi process will be conducted to develop an expert consensus on nomenclature and the best-practice principles for these programmes. In the preparatory phase, a questionnaire was developed comprising a list of potential best-practice statements identified from a systematic literature search. Subsequently, a heterogeneous sample of experts including service providers, Community and Justice Services, Not for Profits, First Nations stakeholders, those with lived experience, researchers and healthcare providers will participate in the consensus building phase (online survey rounds and online meeting) to achieve consensus on nomenclature and best-practice principles. Participants will indicate, via Likert scale, to what extent they agree with nomenclature and best-practice statements. If at least 80% of the experts agree to a term or statement (indicated via Likert scale), it will be included in a final list of nomenclature and best-practice statements. Statements will be excluded if 80% experts disagree. Nomenclature and statements not meeting positive or negative consensus will be explored in a facilitated online meeting. Approval from experts will be sought on the final list of nomenclature and best-practice statements. ETHICS AND DISSEMINATION: Ethical approval has been received from the Justice Health and Forensic Mental Health Network Human Research Ethics Committee, the Aboriginal Health and Medical Research Council Huma

INTRODUCTION: Chronic disease is a leading cause of death and disability that disproportionately burdens culturally and linguistically diverse (CALD) communities. Self-management is a cornerstone of effective chronic disease management. However, research suggests that patients from CALD communities may be less likely to engage with self-management approaches. The Natural Helper Programme aims to facilitate patient engagement with self-management approaches (ie, 'activation') by embedding cultural mentors with lived experience of chronic disease into chronic disease clinics/programmes. The Natural Helper Trial will explore the effect of cultural mentors on patient activation, health self-efficacy, coping efforts and health-related quality of life (HRQoL) while also evaluating the implementation strategy. METHODS AND ANALYSIS: A hybrid type-1 effectiveness-implementation cluster-randomised controlled trial (phase one) and a mixed-method controlled before-and-after cohort extension of the trial (phase 2). Hospital clinics in highly multicultural regions in Australia that provide healthcare for patients with chronic and/or complex conditions, will participate. A minimum of 16 chronic disease clinics (clusters) will be randomised to immediate (active arm) or delayed implementation (control arm). In phase 1, the active arm will receive a multifaceted strategy supporting them to embed cultural mentors in their services while the control arm continues with usual care. Each cluster will recruit an average of 15 patients, assessed at baseline and 6 months (n=240). In phase 2, clusters in the control arm will receive the implementation strategy and evaluate the intervention on an additional 15 patients per cluster, while sustainability in active arm clusters will be assessed qualitatively. Change in activation over 6 months, measured using the Patient Activation Measure will be the primary effectiveness outcome, while secondary effectiveness outcomes will explore changes in ch

OBJECTIVE: To explore hospital-level care for pre-eclampsia in Ethiopia, considering the perspectives of those affected and healthcare providers, in order to understand barriers and facilitators to early detection, care escalation and appropriate management. SETTING: A primary and a general hospital in southern Ethiopia. PARTICIPANTS: Women with lived experience of pre-eclampsia care in the hospital, families of women deceased due to pre-eclampsia, midwives, doctors, integrated emergency surgical officers and healthcare managers. RESULTS: This study identified numerous systemic barriers to provision of quality, person-centred care for pre-eclampsia in hospitals. Individual staff efforts to respond to maternal emergencies were undermined by a lack of consistency in availability of resources and support. The ways in which policies were applied exacerbated inequities in care. Staff improvised as a means of managing with limited material or human resources and knowledge. Social hierarchies and punitive cultures challenged adequacy of communication with women, documentation of care given and supportive environments for quality improvement. CONCLUSIONS: Quality care for pre-eclampsia requires organisational change to create a safe space for learning and improvement, alongside efforts to offer patient-centred care and ensure providers are equipped with knowledge, resources and support to adhere to evidence-based practice.

OBJECTIVES: The purpose of this study was to investigate exercise enjoyment in high-intensity multimodal training (HIMT) in current and previous HIMT participants and identify factors associated with HIMT that mediate exercise enjoyment and motivation. DESIGN AND SETTING: A 124-item web-based survey was distributed to a cross-sectional voluntary convenience sample from August to the end of September 2021. PARTICIPANTS: Global current and previous HIMT participants. RESULTS: The final sample included 469 responses (completion rate: 61.6%). Among eligible respondents (n=434), 379 were current HIMT participants, 55 were previous HIMT participants. Current participants demonstrated high enjoyment (Physical Activity Enjoyment Scale). The most frequently reported reasons for increased enjoyment and motivation to continue HIMT in current participants included (1) it keeps me fit, (2) training in a group and (3) variety in a session. The most frequently reported reasons for reduced motivation to continue HIMT among previous HIMT participants included (1) other (injury, COVID-19 restrictions, low motivation, personal preferences), (2) work commitments and (3) I started another type of sport, exercise or training. CONCLUSIONS: These findings indicate that HIMT is an enjoyable training method among current participants. The most commonly reported reasons for increased enjoyment and motivation were associated with the combined training method and the group environment. Reasons for reduced motivation to continue HIMT among previous HIMT participants may be related to commonly reported barriers to exercise and personal factors.

INTRODUCTION: Glioblastoma is the most common aggressive primary central nervous system cancer in adults characterised by uniformly poor survival. Despite maximal safe resection and postoperative radiotherapy with concurrent and adjuvant temozolomide-based chemotherapy, tumours inevitably recur. Imaging with O-(2-[18F]-fluoroethyl)-L-tyrosine (FET) positron emission tomography (PET) has the potential to impact adjuvant radiotherapy (RT) planning, distinguish between treatment-induced pseudoprogression versus tumour progression as well as prognostication. METHODS AND ANALYSIS: The FET-PET in Glioblastoma (FIG) study is a prospective, multicentre, non-randomised, phase II study across 10 Australian sites and will enrol up to 210 adults aged ≥18 years with newly diagnosed glioblastoma. FET-PET will be performed at up to three time points: (1) following initial surgery and prior to commencement of chemoradiation (FET-PET1); (2) 4 weeks following concurrent chemoradiation (FET-PET2); and (3) within 14 days of suspected clinical and/or radiological progression on MRI (performed at the time of clinical suspicion of tumour recurrence) (FET-PET3). The co-primary outcomes are: (1) to investigate how FET-PET versus standard MRI impacts RT volume delineation and (2) to determine the accuracy and management impact of FET-PET in distinguishing pseudoprogression from true tumour progression. The secondary outcomes are: (1) to investigate the relationships between FET-PET parameters (including dynamic uptake, tumour to background ratio, metabolic tumour volume) and progression-free survival and overall survival; (2) to assess the change in blood and tissue biomarkers determined by serum assay when comparing FET-PET data acquired prior to chemoradiation with other prognostic markers, looking at the relationships of FET-PET versus MRI-determined site/s of progressive disease post chemotherapy treatment with MRI and FET-PET imaging; and (3) to estimate the health economic impact of in

OBJECTIVE: To understand Australian women's knowledge, attitudes and behaviours surrounding preconception and pregnancy health and their preferences for information about these periods. DESIGN: Cross-sectional survey. SETTING: Making healthy changes can optimise preconception and pregnancy outcomes. Clinical practice guidelines inform preconception and pregnancy care in Australia. Women often have access to multiple sources of information on reproductive and pregnancy health. PARTICIPANTS: Women of reproductive age were asked to complete a web-based survey. The survey development was informed by preconception guidelines, consensus statements and the national pregnancy care guidelines. The survey was distributed through social media, local and national networks from 2017 to 2018. RESULTS: Completed surveys were received from 553 women.The majority (80.4%) had high educational attainment. Checking immunisation status and ensuring good mental health were rated as equally important actions both preconception (65%) and during pregnancy (78%). Limiting sedentary activities was not rated as an important action to take either preconception (36%), or during pregnancy (38%). Although women have good knowledge about the impact of weight on their own health outcomes (eg, gestational diabetes), there was less knowledge about adverse outcomes for babies like stillbirth and preterm birth. Women access many sources for reproductive health information, however, the most trusted source was from healthcare professionals. CONCLUSION: Most women of reproductive age in Australia have knowledge of the key health recommendations for preconception and pregnancy. However, there are gaps related to lifestyle behaviours particularly connected to weight gain and outcomes for babies. There is a strong preference to receive trusted information from healthcare providers through multiple resources.

OBJECTIVES: To evaluate how women access and engage with different models of maternity care, whether specialist models improve access and engagement for women with social risk factors, and if so, how? DESIGN: Realist evaluation. SETTING: Two UK maternity service providers. PARTICIPANTS: Women accessing maternity services in 2019 (n=1020). METHODS: Prospective observational cohort with multinomial regression analysis to compare measures of access and engagement between models and place of antenatal care. Realist informed, longitudinal interviews with women accessing specialist models of care were analysed to identify mechanisms. MAIN OUTCOME MEASURES: Measures of access and engagement, healthcare-seeking experiences. RESULTS: The number of social risk factors women were experiencing increased with deprivation score, with the most deprived more likely to receive a specialist model that provided continuity of care. Women attending hospital-based antenatal care were more likely to access maternity care late (risk ratio (RR) 2.51, 95% CI 1.33 to 4.70), less likely to have the recommended number of antenatal appointments (RR 0.61, 95% CI 0.38 to 0.99) and more likely to have over 15 appointments (RR 4.90, 95% CI 2.50 to 9.61) compared with community-based care. Women accessing standard care (RR 0.02, 95% CI 0.00 to 0.11) and black women (RR 0.02, 95% CI 0.00 to 0.11) were less likely to have appointments with a known healthcare professional compared with the specialist model. Qualitative data revealed mechanisms for improved access and engagement including self-referral, relational continuity with a small team of midwives, flexibility and situating services within deprived community settings. CONCLUSION: Inequalities in access and engagement with maternity care appears to have been mitigated by the community-based specialist model that provided continuity of care. The findings enabled the refinement of a realist programme theory to inform those developing maternity servic

PURPOSE: The POPPY II cohort is an Australian state-based cohort linking data for a population of individuals prescribed opioid medicines, constructed to allow a robust examination of the long-term patterns and outcomes of prescription opioid use. PARTICIPANTS: The cohort includes 3 569 433 adult New South Wales residents who initiated a subsidised prescription opioid medicine between 2003 and 2018, identified through pharmacy dispensing data (Australian Pharmaceutical Benefits Scheme) and linked to 10 national and state datasets and registries including rich sociodemographic and medical services data. FINDINGS TO DATE: Of the 3.57 million individuals included in the cohort, 52.7% were female and 1 in 4 people were aged ≥65 years at the time of cohort entry. Approximately 6% had evidence of cancer in the year prior to cohort entry. In the 3 months prior to cohort entry, 26.9% used a non-opioid analgesic and 20.5% used a psychotropic medicine. Overall, 1 in 5 individuals were initiated on a strong opioid (20.9%). The most commonly initiated opioid was paracetamol/codeine (61.3%), followed by oxycodone (16.3%). FUTURE PLANS: The POPPY II cohort will be updated periodically, both extending the follow-up duration of the existing cohort, and including new individuals initiating opioids. The POPPY II cohort will allow a range of aspects of opioid utilisation to be studied, including long-term trajectories of opioid use, development of a data-informed method to assess time-varying opioid exposure, and a range of outcomes including mortality, transition to opioid dependence, suicide and falls. The duration of the study period will allow examination of population-level impacts of changes to opioid monitoring and access, while the size of the cohort will also allow examination of important subpopulations such as people with cancer, musculoskeletal conditions or opioid use disorder.

INTRODUCTION: Many patients experience unrelieved neuropathic cancer-related pain. Most current analgesic therapies have psychoactive side effects, lack efficacy data for this indication and have potential medication-related harms. The local anaesthetic lidocaine (lignocaine) has the potential to help manage neuropathic cancer-related pain when administered as an extended, continuous subcutaneous infusion. Data support lidocaine as a promising, safe agent in this setting, warranting further evaluation in robust, randomised controlled trials. This protocol describes the design of a pilot study to evaluate this intervention and explains the pharmacokinetic, efficacy and adverse effects evidence informing the design. METHODS AND ANALYSIS: A mixed-methods pilot study will determine the feasibility of an international first, definitive phase III trial to evaluate the efficacy and safety of an extended continuous subcutaneous infusion of lidocaine for neuropathic cancer-related pain. This study will comprise: a phase II double-blind randomised controlled parallel-group pilot of subcutaneous infusion of lidocaine hydrochloride 10% w/v (3000 mg/30 mL) or placebo (sodium chloride 0.9%) over 72 hours for neuropathic cancer-related pain, a pharmacokinetic substudy and a qualitative substudy of patients' and carers' experiences. The pilot study will provide important safety data and help inform the methodology of a definitive trial, including testing proposed recruitment strategy, randomisation, outcome measures and patients' acceptability of the methodology, as well as providing a signal of whether this area should be further investigated. ETHICS AND DISSEMINATION: Participant safety is paramount and standardised assessments for adverse effects are built into the trial protocol. Findings will be published in a peer-reviewed journal and presented at conferences. This study will be considered suitable to progress to a phase III study if there is a completion rate where the CI in

OBJECTIVE: This study intended to examine the prevalence and correlates of depressive symptoms among inmates in Kaliti Prison Centre, Addis Ababa, Ethiopia. METHODS: A facility-based cross-sectional study was conducted among 694 randomly selected inmates in Kaliti Federal Prison in Ethiopia. The depressive symptom was examined using the Patient Health Questionnaire (PHQ-9). A binary logistic regression model was fitted to identify correlates of depressive symptoms. A p value <0.05 was considered to declare statistical significance, and an adjusted OR (AOR) with the corresponding 95% CI was computed to determine the strength of association. Data were analysed using SPSS V.20. RESULT: The prevalence of depressive symptoms among prisoners in the current study was 56.6% (95% CI 53.2 to 60.8). Poor social support (AOR: 3.33, 95% CI 2.03 to 5.458), personal history of mental illness (AOR=3.16, 95% CI 1.62 to 6.14), physical abuse (AOR=2.31, 95% CI 1.41 to 3.78) and comorbid chronic medical illness (AOR=3.47, 95% CI 2.09 to 5.74) were independent correlates of depressive symptoms. CONCLUSION: Our study shows that around one in two prisoners screened positive for depressive symptoms. There should be a regular screening of depressive symptoms for prisoners, and those screened positive should be linked to proper psychiatric service for early diagnosis and treatment.

OBJECTIVE The study examined high risk fertility behaviour and its association with under five undernutrition in sub Saharan Africa SSA DESIGN We conducted a cross sectional analysis of data from 32 sub Saharan African countries Demographic and Health Surveys A weighted sample of 110 522 mother child pairs was included in final analysis Multilevel binary logistic regression was used to examine the association between high risk fertility behaviour and undernutrition The results were presented using adjusted odds ratio aOR with their respective 95 confidence intervals CIs SETTING Thirty two countries in SSA OUTCOME MEASURE Stunting wasting and underweight RESULTS The pooled prevalence of stunting was 31 3 ranging from 15 0 in Gabon to 51 7 in Burundi Wasting was highest among children from Burkina Faso 19 1 and lowest among those from South Africa 1 6 The overall prevalence of wasting was 8 1 The prevalence of underweight was 17 0 with the highest among children in Niger 37 1 and lowest in South Africa 4 8 Mothers who gave birth at the age less than 18 years and those with short birth interval were more likely to have their children being stunted wasted and underweight The odds of stunting and wasting were high among children born to women with high parity However maternal age at birth more than 34 was associated with lower odds of childhood underweight as against those with age at birth less than 34 CONCLUSION Countries in SSA are encouraged to address the issue of maternal age at birth less than 18 high parity and shorter birth intervals in order to meet the Global Nutrition targets which aim to achieve a 40 reduction in the number of stunted children under the age of 5 and to reduce and maintain childhood wasting to less than 5 by 2025

OBJECTIVES: This review examined the factors influencing communication and engagement with ethnic and racial minority groups in Australia during the COVID-19 pandemic. It aimed to answer two main questions: (1) what communication problems people from these communities typically faced during the pandemic? and (2) what strategies and recommendations were suggested to enhance communication and engagement for ethnic and racial minorities during the current COVID-19 pandemic and any similar events in the future? DESIGN: Scoping review. DATA SOURCES: PubMed, EMBASE, Cochrane Library, PsychINFO and CINAHL. Grey literature was searched within organisations' websites and a Google search of key terms. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: We included original research, case studies, reports (including government and charity reports), systematic and scoping articles and literature reviews in English, published from January 2020 to August 2022. DATA EXTRACTION AND SYNTHESIS: Two researchers independently assessed the literature for eligibility and extracted data from the included literature. The selected papers were analysed and summarised into themes relevant to the research questions. The final review included 38 studies combining published academic papers and grey literature. RESULTS: Key themes relating to communication and engagement issues included a lack of trust in authority, a lack of access to information and ineffective communication channels and a lack of timely and culturally responsive materials. To reduce the issues, the papers spoke about the key role of community organisations to provide local support and community leaders as trusted spokespersons. Lastly, key recommendations to reduce inequity and strengthen future pandemic responses focused on the need for collaborations and consultations, increasing the number of bilingual workers and supporting community-led communication efforts. CONCLUSIONS: The insights gained from the activities and experiences do

OBJECTIVE: Skin cancer is Australia's most common and costly cancer. We examined the frequency of Australian general practice consultations for skin cancer-related conditions, by patient and general practitioner (GP) characteristics and by time period. DESIGN: Nationally representative, cross-sectional survey of general practice clinical activity. SETTING, PARTICIPANTS: Patients aged 15 years or older having a skin cancer-related condition managed by GPs in the Bettering the Evaluation And Care of Health study between April 2000 and March 2016. PRIMARY OUTCOME MEASURES: Proportions and rates per 1000 encounters. RESULTS: In this period, 15 678 GPs recorded 1 370 826 patient encounters, of which skin cancer-related conditions were managed 65 411 times (rate of 47.72 per 1000 encounters, 95% CI 46.41 to 49.02). Across the whole period, 'skin conditions' managed were solar keratosis (29.87%), keratinocyte cancer (24.85%), other skin lesion (12.93%), nevi (10.98%), skin check (10.37%), benign skin neoplasm (8.76%) and melanoma (2.42%). Over time, management rates increased for keratinocyte cancers, skin checks, skin lesions, benign skin neoplasms and melanoma; but remained stable for solar keratoses and nevi. Skin cancer-related encounter rates were higher for patients aged 65-89 years, male, living in Queensland or in regional or remote areas, with lower area-based socioeconomic status, of English-speaking background, Veteran card holders and non-healthcare card holders; and for GPs who were aged 35-44 years or male. CONCLUSION: These findings show the spectrum and burden of skin cancer-related conditions managed in general practice in Australia, which can guide GP education, policy and interventions to optimise skin cancer prevention and management.

OBJECTIVES: This study investigated the inequalities in access to maternal healthcare services in Bangladesh. DESIGN AND SETTING: This study used cross-sectional data from the nationally representative Bangladesh Demographic and Health Survey conducted in 2017-2018. The survey encompassed diverse regions and households across Bangladesh. The study used the Human Opportunity Index (HOI) and Shapley's decomposition technique to measure the inequality in access to maternal healthcare opportunities. PARTICIPANTS: This study included 20 127 women aged 15-49 years. Among them, 5012 women had live births in the preceding 3 years of the survey, forming the study sample. PRIMARY AND SECONDARY OUTCOME MEASURES: This study has no secondary outcome variable. The primary dependent variable is 'adequate maternal healthcare', a dichotomous variable. RESULTS: Household wealth status contributed the highest to inequality in accessing adequate maternal healthcare services (41.4%) such as receiving at least four antenatal care (ANC) visits (39.7%), access to proper ANC (50.7% and 44.0%) and health facility birth (43.4%). Maternal educational status contributes the second highest inequality among all factors in accessing adequate maternal healthcare (29.5%). Adequate maternal healthcare presented the lowest coverage rate and opportunity index among all (approximately 24% with HOI=17.2). CONCLUSIONS: We found that attained adequate maternal healthcare had the lowest coverage and widest dissimilarity, while wealth index, education and place of residence are the major factors that contribute to inequalities in accessibility to maternal healthcare services in Bangladesh. These findings underscore a need for pro-poor interventions to narrow the economic inequalities between the poor and rich in terms of accessibility to maternal healthcare services. The results indicate the need for the Bangladeshi government and its health department to strengthen their commitment to improving female educa

OBJECTIVE The study assessed the prevalence of physical violence against pregnant women and its associated factors in sub Saharan Africa SSA DESIGN We analysed cross sectional data of 108971 women in sexual unions from the most recent Demographic and Health Surveys of 26 countries in SSA The predictors of physical violence were examined using a multilevel binary logistic regression All the results were presented as adjusted odds ratios aORs with their corresponding 95 confidence intervals CIs SETTING Twenty six countries in SSA PARTICIPANTS 108 971 women who had ever been pregnant OUTCOME MEASURE Physical violence during pregnancy RESULTS Physical violence was identified in 6 0 of pregnant women in SSA The highest prevalence 14 0 was reported in South Africa while Burkina Faso recorded the lowest 2 1 Women who had primary aOR 1 26 95 CI 1 15 1 38 and secondary education aOR 1 15 95 CI 1 01 1 32 those who were cohabiting aOR 1 21 95 CI 1 11 1 32 those who were working aOR 1 17 95 CI 1 08 1 28 and those whose partners had primary aOR 1 15 95 CI 1 04 1 28 and secondary education aOR 1 14 95 CI 1 01 1 28 were more likely to experience physical violence during pregnancy compared with those who had no formal education those who were married those who were not working and those whose partners had no formal education respectively Moreover women whose partners consumed alcohol aOR 2 37 95 CI 2 20 2 56 those who had parity of four or more aOR 2 06 95 CI 1 57 2 72 and those who perceived intimate partner violence IPV as a culturally accepted norm aOR 1 55 95 CI 1 44 1 67 had higher odds of experiencing physical violence during pregnancy compared to those whose partners did not consume alcohol those with parity zero and those who did not perceive IPV as culturally accepted respectively On the contrary women who were aged 35 39 those who were of the richest wealth index and those in rural areas had reduced odds of experiencing physical violence during pregnancy CONCLUSION Based