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The formation of the digits is a tightly regulated process. During embryogenesis, disturbance of genetic pathways in limb development could result in syndactyly; a common congenital malformation consisting of webbing in adjacent digits. Currently, there is a paucity of knowledge regarding the exact developmental mechanism leading to this condition. The best studied canonical interactions of Wingless-type-Bone Morphogenic Protein-Fibroblast Growth Factor (WNT-BMP-FGF8), plays a role in the interdigital cell death (ICD) which is thought to be repressed in human syndactyly. Animal studies have displayed other pathways such as the Notch signaling, metalloprotease and non-canonical WNT-Planar cell polarity (PCP), to also contribute to failure of ICD, although less prominence has been given. The current diagnosis is based on a clinical evaluation followed by radiography when indicated, and surgical release of digits at 6 months of age is recommended. This review discusses the interactions repressing ICD in syndactyly, and characterizes genes associated with non-syndromic and selected syndromes involving syndactyly, according to the best studied canonical WNT-BMP-FGF interactions in humans. Additionally, the controversies regarding the current syndactyly classification and the effect of non-coding elements are evaluated, which to our knowledge has not been previously highlighted. The aim of the review is to better understand the developmental process leading to this condition.

INTRODUCTION: Perianal fistulising Crohn's disease (pfCD) can be somewhat treatment refractory. Higher infliximab trough levels (TLIs) may improve fistula healing rates; however, it remains unclear whether escalating infliximab therapy to meet higher TLI targets using proactive, or routine, therapeutic drug monitoring (TDM) improves outcomes. This randomised controlled trial aimed to assess whether infliximab therapy targeting higher TLIs guided by proactive TDM improves outcomes compared with standard therapy. METHODS AND ANALYSIS: Patients with active pfCD will be randomised 1:1 to either the proactive TDM arm or standard dosing arm and followed up for 54 weeks. Patients in the proactive TDM arm will have infliximab dosing optimised to target higher TLIs. The targets will be TLI ≥ 25 µg/mL at week 2, ≥ 20 µg/mL at week 6 and ≥ 10 µg/mL during maintenance therapy. The primary objective will be fistula healing at week 32. Secondary objectives will include fistula healing, fistula closure, radiological fistula healing, patient-reported outcomes and economic costs up to 54 weeks. Patients in the standard dosing arm will receive conventional infliximab dosing not guided by TLIs (5 mg/kg at weeks 0, 2 and 6, and 5 mg/kg 8 weekly thereafter). Patients aged 18-80 years with pfCD with single or multiple externally draining complex perianal fistulas who are relatively naïve to infliximab treatment will be included. Patients with diverting ileostomies or colostomies and pregnant or breast feeding will be excluded. Fifty-eight patients per arm will be required to detect a 25% difference in the primary outcome measure, with 138 patients needed to account for an estimated 6.1% primary non-response rate and 10% dropout rate. ETHICS AND DISSEMINATION: Results will be presented in peer-reviewed journals and international conferences. Ethics approval has been granted by the South Western Sydney Local Health District Human Research Ethics Committee in Australia. TRIAL REGISTRATION N

Introduction Considerable evidence supports an association between poor impulse control (impulsivity) and violent crime. Furthermore, impulsivity and aggression has been associated with reduced levels of serotonergic activity in the brain. Selective serotonin reuptake inhibitors (SSRIs) are a class of anti depressants that aim to regulate brain serotonin concentrations. Several small studies in psychiatric populations have administered SSRIs to impulsive -aggressive individuals, resulting in reduced impulsivity, anger, aggression and depression. However, no clinical trial has been undertaken in a criminal justice population. This protocol describes the design and implementation of the first systematic study of the potential benefits of SSRIs in impulsive -violent offenders who are at high risk of reoffending. Methods and analysis A randomised, double-blinded, multicentre trial to test the clinical efficacy of an SSRI, sertraline hydrochloride, compared with placebo on recidivism and behavioural measures (including impulsivity, anger, aggression, depression and self-reported offending) over 12 months. 460 participants with histories of violence and screening positive for impulsivity are recruited at several local courts and correctional service offices in New South Wales, Australia. Ethics and dissemination Results will be submitted for publication in a peer-reviewed journal. Possible implications of the effectiveness of this pharmacological intervention include economic benefits of reducing prison costs and societal benefits of improving safety. This study has received ethical approval from the University of New South Wales, Aboriginal Health Medical Research Council, Corrective Services NSW and the NSW Justice Health and Forensic Mental Health Network. Trial registration number ACTRN12613000442707.

Purpose: To provide estimates for the prevalence of dry eye disease globally and in sub-groups defined by: diagnostic criterion, sex, geographic location and age, using a Bayesian approach. Methods: Modelling prevalence as a Beta distribution, estimates were inferred from Bayesian posterior distributions obtained by combing an uninformed prior with likelihood functions generated from all relevant studies reporting dry eye prevalence between 1997 and 2021. Results: Global prevalence of dry eye disease was estimated at 11.59% (standard deviation (SD) = 0.04). For symptomatic disease, the estimate was 9.12% (SD = 0.04), with women 9.5% (SD = 0.05) and men 6.8% (SD = 0.06); prevalence was lowest in North America, 4.6% (SD = 0.03) and highest in Africa, 47.9% (SD = 1.8). For signs, prevalence was 35.2% (SD = 0.3), with woman 34.7% (SD = 0.7) and men 37.6% (SD = 0.7); North America showed the lowest regional prevalence, 3.5%, (SD = 0.4) with Eastern Asia the highest, 42.8% (SD = 0.4). Using TFOS DEWS II diagnostic criteria resulted in a global prevalence of 29.5% (SD = 0.8), with women 28.1% (SD = 1.2) and men 24.9% (SD = 1.4). Prevalence was lowest during the fifth decade, increasing approximately linearly with age thereafter. Estimates for other categories are given in accompanying tables. Conclusion: A simple, flexible, yet powerful means of combining data from multiple sources to yield prevalence estimates across a range of circumstances is described, that is compatible with published guidelines for conducting meta-analysis. Estimates can be readily updated as new information emerges, or according to need. Understanding the specific characteristics of studies chosen for inclusion is critical to the validity of the outcome. Although dry eye disease is evidently common, affecting about one in 11 people world-wide, data are sparse for the young and all geographical locations except Eastern Asia.

To demonstrate the health and well-being benefits of facilitated arts engagement with women veterans, we draw on a key practice-based example from the Australian National Veterans Arts Museum (ANVAM), an organization with expertise in collaborative art-making with veterans. We outline ANVAM’s framework and the processes art therapists use to create facilitated art exhibitions. We discuss how veterans’ involvement with art-making has therapeutic benefits, can contribute new knowledge on health and well-being, and convey nuances of gender-specific experiences. We briefly outline the trend in evidence from academic literature on arts-health research with veterans and the sparse creative research with women veterans to highlight the potential of art-based methods in veteran health and well-being research, given growing numbers and the expanding roles of women in defence. Arts-health research using diverse methods has yielded promising results in this field. As such, interdisciplinary, co-designed, and strength-based art-based research with women veterans can add to knowledge co-creation on this topic.

Purpose: People with age-related macular degeneration (AMD) experience high rates of depression, but rarely engage in or have access to tailored mental wellbeing programmes. This qualitative study investigated the perspectives of those primarily with late AMD on mental health and mental wellbeing programmes. Methods: Twenty-eight people with late AMD in at least one eye, and one person with early AMD in both eyes, aged 56–87 years (mean age 78 years) attending a private eye clinic between December 2019 and January 2020 in Sydney, New South Wales, Australia, participated. Individual semi-structured interviews were conducted and analysed deductively using content analysis, following the individual level factors for health promotion interventions in the behaviour change wheel: Capability (Physical & Psychological), Opportunity (Physical & Social), and Motivation (Reflective & Automatic). Results: Six major themes were identified: Capability: (1) Impact of vision loss on mobility and leisure pursuits; (2) Adjustment to living with vision loss; Opportunity: (3) Program considerations for those with AMD; (4) Stigma and self-perception of vision loss and mental health; Motivation: (5) Accumulation of vision-related issues as a barrier to participation; (6) Examples of others living with vision loss. General personal factors relevant to delivery of a programme in this age group were also identified: Comorbidities; Limitations using technology; Isolation; Financial concerns and Beliefs that undesired effects of aging are inevitable. Conclusions: Complex individual, environmental and social factors influence the perspectives of people with late AMD on mental health, and potential participation in mental wellbeing programmes. These factors should be considered when developing and implementing mental wellbeing programmes to improve the emotional and functional rehabilitation outcomes for people with AMD.

Introduction Major depressive disorder (MDD) in people with advanced life-limiting illnesses can have significant impact on the quality-of-life of those affected. The management of MDD in the palliative care setting can be challenging as typical antidepressants may not work in time nor be tolerated due to coexisting organ dysfunctions, symptom burden and frailty. Parenteral ketamine was found to exhibit effective and rapid-onset antidepressant effect even against treatment-resistant depression in the psychiatric population. However, there is currently neither feasibility study nor available prospective study available to inform of the safety, tolerability and efficacy of such for MDD in the palliative setting. Methods and analysis This is an open-labelled, single arm, phase II pilot feasibility study involving adult patients with advanced life-limiting illnesses and MDD across four palliative care services in Australia. It has an individual dose-titration design (0.1-0.4 mg/kg) with weekly treatments of subcutaneous ketamine infusion over 2 hours. The primary outcome is feasibility. The secondary outcomes are related to the safety, tolerability and antidepressant efficacy of ketamine, participants' satisfaction in relation to the trial process and the reasons for not completing the study at various stages. The feasibility data will be reported using descriptive statistics. Meanwhile, side effects, tolerability and efficacy data will be analysed using change of assessment scores from baseline. Ethics and dissemination Ethics approval was acquired (South Western Sydney Local Health District: HREC/18/LPOOL/466). The results of this study will be submitted for publication in peer-reviewed journals and presented at relevant conferences. Trial registration number Australian New Zealand Clinical Trial Registry Number: ACTRN12618001586202; Pre-results.

STUDY OBJECTIVES: Oral appliance (OA) therapy usage can be objectively measured through temperature-sensing data chips embedded in the appliance. Initial reports of group data for short-term treatment usage suggest good nightly hours of usage. However, individual variability in treatment usage patterns has not been assessed. We aimed to identify OA treatment usage subtypes in the first 60 days and the earliest predictors of these usage patterns. METHODS: OSA patients were recruited for a study of OA therapy with an embedded compliance chip (DentiTrac, Braebon, Canada). Fifty-eight participants with 60 days of downloadable treatment usage data (5-minute readings) were analyzed. A hierarchical cluster analysis was used to group participants with similar usage patterns. A random forest classification model was used to identify the minimum number of days to predict usage subtype. RESULTS: Three user groups were identified and named "consistent users" (48.3%), "inconsistent users" (32.8%) and "non-users" (19.0%). The first twenty days provided optimal data to predict which treatment usage group a patient would belong to at 60-days (90% accuracy). The strongest predictors of user group were downloaded usage data; average wear time and number of days missed. CONCLUSIONS: Granular analysis of OA usage data suggests the existence of treatment user subtypes (consistent, inconsistent and non-users). Our data suggest that 60-day usage patterns can be identified in the first twenty days of treatment using downloaded treatment usage data. Understanding initial treatment usage patterns provide an opportunity for early intervention to improve long-term usage and outcomes.

Introduction The current diagnostic pathways for cognitive impairment rarely identify babies at risk before 2 years of age. Very early detection and timely targeted intervention has potential to improve outcomes for these children and support them to reach their full life potential. Early Moves aims to identify early biomarkers, including general movements (GMs), for babies at risk of cognitive impairment, allowing early intervention within critical developmental windows to enable these children to have the best possible start to life. Method and analysis Early Moves is a double-masked prospective cohort study that will recruit 3000 term and preterm babies from a secondary care setting. Early Moves will determine the diagnostic value of abnormal GMs (at writhing and fidgety age) for mild, moderate and severe cognitive delay at 2 years measured by the Bayley-4. Parents will use the Baby Moves smartphone application to video their babies' GMs. Trained GMs assessors will be masked to any risk factors and assessors of the primary outcome will be masked to the GMs result. Automated scoring of GMs will be developed through applying machine-based learning to the data and the predictive value for an abnormal GM will be investigated. Screening algorithms for identification of children at risk of cognitive impairment, using the GM assessment (GMA), and routinely collected social and environmental profile data will be developed to allow more accurate prediction of cognitive outcome at 2 years. A cost evaluation for GMA implementation in preparation for national implementation will be undertaken including exploring the relationship between cognitive status and healthcare utilisation, medical costs, health-related quality of life and caregiver burden. Ethics and dissemination Ethics approval has been granted by the Medical Research Ethics Committee of Joondalup Health Services and the Health Service Human Research Ethics Committee (1902) of Curtin University (HRE2019-0739). Tria

Introduction Cardiovascular diseases (CVDs) are the leading causes of death and disability worldwide. Reducing dietary salt consumption is a potentially cost-effective way to reduce blood pressure and the burden of CVD. To date, economic evidence has focused on sodium reduction in food industry or processed food with blood pressure as the primary outcome. This study protocol describes the planned within-trial economic evaluation of a low-sodium salt substitute intervention designed to reduce the risk of stroke in China. Methods and analyses The economic evaluation will be conducted alongside the Salt Substitute and Stroke Study: a 5-year large scale, cluster randomised controlled trial. The outcomes of interest are quality of life measured using the EuroQol-5-Dimensions and major adverse cardiovascular events. Costs will be estimated from a healthcare system perspective and will be sought from the routinely collected data available within the New Rural Cooperative Medical Scheme. Cost-effectiveness and cost-utility analyses will be conducted, resulting in the incremental cost-effectiveness ratio expressed as cost per cardiovascular event averted and cost per quality-adjusted life year gained, respectively. Ethics and dissemination The trial received ethics approval from the University of Sydney Ethics Committee (2013/888) and Peking University Institutional Review Board (IRB00001052-13069). Informed consent was obtained from each study participant. Findings of the economic evaluation will be published in a peer-reviewed journal and presented at international conferences. Trial registration number ClinicalTrials.gov Registry (NCT02092090).

Difficulties in emotional regulation are key to the development and maintenance of chronic pain. Recent evidence shows internet-delivered dialectic behaviour therapy (iDBT) skills training can reduce emotional dysregulation and pain intensity. However, further studies are needed to provide more definitive evidence regarding the efficacy of iDBT skills training in the chronic pain population. A single-case experimental design (SCED) with multiple baselines will be used to examine the efficacy of a 4-week iDBT-Pain skills training intervention (iDBT-Pain intervention) to reduce emotional dysregulation and pain intensity in individuals with chronic pain. The iDBT-Pain intervention encompasses two components: (1) iDBT-Pain skills training sessions (iDBT-Pain sessions) and (2) the iDBT-Pain skills training web application (iDBT-Pain app). Three individuals with chronic pain will be recruited and randomly allocated to different baseline phases (5, 9 or 12 days). Following the baseline phase, participants will receive six 60–90 min iDBT-Pain sessions approximately 4 or 5 days apart, delivered by a psychologist via Zoom. To reinforce learnings from the iDBT-Pain sessions, participants will have unlimited use of the iDBT-Pain app. A 7-day follow-up phase (maintenance) will follow the intervention, whereby the iDBT-Pain sessions cease but the iDBT-Pain app is accessible. Emotional regulation, as the primary outcome measure, will be assessed using the Difficulties in Emotion Regulation Scale. Pain intensity, as the secondary outcome measure, will be assessed using a visual analogue scale. Generalisation measures will assess psychological state factors (depression, anxiety and coping behaviour), alongside sleep quality, well-being and harm avoidance. SCEDs are increasingly considered effective designs for internet-delivered psychological interventions because SCED enables the investigation of interindividual variability in a heterogeneous population such as chronic pain. This t

Introduction Falls have a multifactorial aetiology, which may limit the effectiveness of the common approach of exercise as the sole intervention strategy. Multifactorial interventions could be more effective in people at high risk of falling; however, the focus of such interventions has traditionally been quite narrow. This paper describes the design of a randomised controlled trial that will evaluate the effectiveness of an eHealth programme, which addresses cumulative effects of key fall-risk factors across the triad of physical, affective and cognitive functions on falls in older people. Methods and analysis 518 older people aged 65 years and over with high fall risk, defined as having a history of falls in the past 6 months, self-reported fear of falling or being aged 80 years or over, will be recruited via local advertisements, newsletters and presentations, and randomised to an intervention or health education control group. The intervention comprises balance exercise, cognitive-motor exercise and cognitive-behavioural therapy, with their dosage based on participant's baseline balance, executive function and mood. The primary outcome is the rate of falls in the 12 months after randomisation. Secondary outcomes at 6 and 12 months comprise programme adherence, healthcare use, physical activity, balance and mobility, cognitive function, psychological well-being, quality of life, health literacy and user experience and attitudes towards the programme. Data will be analysed following intention to treat to gauge real-world effectiveness. We will further determine complier averaged causal effects to correct for varying adherence and conduct economic analyses to gain insight into cost-effectiveness and cost-utility. Ethics and dissemination Ethical approval was obtained from the University of New South Wales (UNSW) Human Research Ethics Committee in December 2017. Outcomes will be disseminated via peer-reviewed articles, conference presentations, community events and

Introduction Poverty and deprivation can harm children's future health, learning, economic productivity and societal participation. The Australian Healthier Wealthier Families project seeks to reduce the childhood inequities caused by poverty and deprivation by creating a systematic referral pathway between two free, community-based services: Universal, well-child nursing services, which provide health and development support to families with children from birth to school entry, and financial counselling. By adapting the successful Scottish 'Healthier Wealthier Children' model, the objectives of this Australian pilot are to test the (1) feasibility of systematising the referral pathway, and (2) short-term impacts on household finances, caregiver health, parenting efficacy and financial service use. Methods and analysis This pilot randomised controlled trial will run in three sites across two Australian states (Victoria and New South Wales), recruiting a total of 180 participants. Nurses identify eligible caregivers with a 6-item, study-designed screening survey for financial hardship. Caregivers who report one or more risk factors and consent are randomised. The intervention is financial counselling. The comparator is usual care plus information from a government money advice website. Feasibility will be evaluated using the number/proportion of caregivers who complete screening, consent and research measures, and access financial counselling. Though powered to assess feasibility, impacts will be measured 6 months post-enrolment with qualitative interviews and questionnaires about caregiver-reported income, loans and costs (adapted from national surveys, for example, the Household, Income and Labour Dynamics in Australia Survey); health (General Health Questionnaire 1, EuroQol five-dimensional questionnaire, Depression, Anxiety, Stress Scale short-form); efficacy (from the Longitudinal Study of Australian Children); and financial service use (study-designed) compared

Introduction Process evaluations provide insight into how interventions are delivered across varying contexts and why interventions work in some contexts and not in others. This manuscript outlines the protocol for a process evaluation embedded in a cluster randomised trial of a digital depression prevention intervention delivered to secondary school students (the Future Proofing Study). The purpose is to describe the methods that will be used to capture process evaluation data within this trial. Methods and analysis Using a hybrid type 1 design, a mixed-methods approach will be used with data collected in the intervention arm of the Future Proofing Study. Data collection methods will include semistructured interviews with school staff and study facilitators, automatically collected intervention usage data and participant questionnaires (completed by school staff, school counsellors, study facilitators and students). Information will be collected about: (1) how the intervention was implemented in schools, including fidelity; (2) school contextual factors and their association with intervention reach, uptake and acceptability; (3) how school staff, study facilitators and students responded to delivering or completing the intervention. How these factors relate to trial effectiveness outcomes will also be assessed. Overall synthesis of the data will provide school cluster-level and individual-level process outcomes. Ethics and dissemination Ethics approval was obtained from the University of New South Wales (NSW) Human Research Ethics Committee (HC180836; 21st January 2019) and the NSW Government State Education Research Applications Process (SERAP 2019201; 19th August 2019). Results will be submitted for publication in peer-reviewed journals and discussed at conferences. Our process evaluation will contextualise the trial findings with respect to how the intervention may have worked in some schools but not in others. This evaluation will inform the development of a mo

Introduction Despite being a preventable cause of death, drowning is a global public health threat. Australia records an average of 288 unintentional drowning deaths per year; an estimated annual economic burden of $1.24 billion AUD ($2017). On average, a further 712 hospitalisations occur due to non-fatal drowning annually. The Australian state of New South Wales (NSW) is the most populous and accounts for 34% of the average fatal drowning burden. This study aims to explore the demographics and outcome of patients who are admitted to hospitals for drowning in NSW and also investigates prediction of patients' outcome based on accessible data. Methods and analysis This protocol describes a retrospective, cross-sectional data linkage study across secondary data sources for any person (adult or paediatric) who was transferred by NSW Ambulance services and/or admitted to a NSW hospital for fatal or non-fatal drowning between 1/1/2010 and 31/12/2019. The NSW Admitted Patient Data Collection will provide data on admitted patients' characteristics and provided care in NSW hospitals. In order to map patients' pathways of care, data will be linked with NSW Ambulance Data Collection and the NSW Emergency Department Data Collection. Finally patient's mortality will be assessed via linkage with NSW Mortality data, which is made up of the NSW Register of Births, Deaths and Marriages and a Cause of Death Unit Record File. Regression analyses will be used to identify predicting values of independent variables with study outcomes. Ethics and dissemination This study has been approved by the NSW Population & Health Services Research Ethics Committee. Results will be disseminated through peer-reviewed publications, mass media releases and at academic conferences. The study will provide outcome data for drowning patients across NSW and study results will provide data to deliver evidence-informed recommendations for improving patient care, including updating relevant guidelines.

Objectives To examine the safety of an agonist-type treatment, lisdexamfetamine (LDX), at 250 mg/day among adults with methamphetamine (MA) dependence. Design A dose-escalating, phase-2, open-label, single-group study of oral LDX at two Australian drug treatment services. Setting The study was conducted at two Australian stimulant use disorder treatment clinics. Participants There were 16 participants: at least 18 years old, MA dependent for at least the preceding 2 years using ICD-10 criteria, reporting use of MA on at least 14 of the preceding 28 days. Interventions Daily, supervised LDX of 100-250 mg, single-blinded to dose, ascending-descending regimen over 8 weeks (100-250 mg over 4 weeks; followed by 4-week dose reduction regimen, 250-100 mg). Participants were followed through to week 12. Outcomes Primary outcomes were safety, drug tolerability and regimen completion at the end of week 4. Participants were followed to week 12. Secondary outcomes included: change in MA use; craving; withdrawal; severity of dependence; risk behaviour; change in other substance use; medication acceptability; potential for non-prescription use; adherence and neurocognitive functioning. Results Fourteen of 16 participants (87.5%) completed escalation to 250 mg/day. Two participants withdrew from the trial in the first week: one relocated away from the study site, the other self-withdrew due to a possible, known side effect of LDX (agitation). There was one serious adverse event of suicidal ideation which resolved. All other adverse events were mild or moderate in severity and known side effects of LDX. No participant was withdrawn due to adverse events. MA use decreased from a median of 21 days (IQR: 16-23) to 13 days (IQR: 11-17) over the 4-week escalation period (p=0.013). Conclusions LDX at a dose of up to 250 mg/day was safe and well tolerated by study participants, warranting larger trials as a pharmacotherapy for MA dependence. Trial registration number ACTRN12615000391572.

Background: The early detection of developmental conditions such as autism is vital to ensure children can access appropriate and timely evidence-based supports, services, and interventions. Children who have undetected developmental conditions early in life are more likely to develop later health, developmental, learning, and behavioral issues, which in turn can have a cumulative effect over the life course. Methods: The current protocol describes a multi-site, cluster randomized control trial comparing a developmental surveillance pathway for autism to usual care, using opportunistic visits to general practitioners (GPs). Units of randomization are GP clinics across two Australian states (New South Wales and Victoria), with thirty clinics within each state, each of which will aim to recruit approximately forty children aged between ~18- and 24-months, for a total of ~2,400 participants. Children will be randomized to two clusters; namely, an autism surveillance pathway (ASP) or surveillance as usual (SaU). The screening process for the ASP arm involves primary and secondary screenings for developmental concerns for autism, using both parent and GP reports and observations. Children in both arms who show signs of developmental concerns for autism will be offered a full developmental assessment by the research team at 24 months of age to determine the efficacy of developmental surveillance in successfully identifying children with autism. Trial Registration: The trial is registered with ANZCTR (ACTRN12619001200178) and reporting of the trial results will be according to recommendations in the CONSORT Statement.

Purpose: To assess the diversity of leadership bodies of member organisations of the International Council of Ophthalmology (ICO) and the World Council of Optometry (WCO) in terms of: (1) the proportion who are women in all world regions, and (2) the proportion who are ethnic minority women and men in Eurocentric high-income regions. Methods: We undertook a cross-sectional study of board members and chairs of ICO and WCO member organisations using a desk-based assessment of member organisation websites during February and March 2020. Gender and ethnicity of board members and chairs were collected using a combination of validated algorithmic software and manual assessment, based on names and photographs where available. Gender proportions were calculated across Global Burden of Disease super-regions, and gender and ethnicity proportions in the high-income regions of Australasia, North America and Western Europe. Results: Globally, approximately one in three board members were women for both ICO (34%) and WCO (35%) members, and one in three ICO (32%) and one in five WCO (22%) chairpersons were women. Women held at least 50% of posts in only three of the 26 (12%) leadership structures assessed; these were based in Latin America and the Caribbean (59% of WCO board positions held by women, and 56% of WCO chairs), and Southeast Asia, East Asia and Oceania (55% of ICO chairs). In the Eurocentric high-income regions, white men held more than half of all board (56%) and chair (58%) positions and white women held a further quarter of positions (26% of board and 27% of chair positions). Ethnic minority women held the fewest number of board (6%) and chair (7%) positions. Conclusions: Improvements in gender parity are needed in member organisations of the WCO and ICO across all world regions. In high-income regions, efforts to address inequity at the intersection of gender and ethnicity are also needed. Potential strategies to enable inclusive leadership must be centred on struc

Objective The aim of this study was to provide a comprehensive evidence on risk factors for transmission, disease severity and COVID-19 related deaths in Africa. Design A systematic review has been conducted to synthesise existing evidence on risk factors affecting COVID-19 outcomes across Africa. Data sources Data were systematically searched from MEDLINE, Scopus, MedRxiv and BioRxiv. Eligibility criteria Studies for review were included if they were published in English and reported at least one risk factor and/or one health outcome. We included all relevant literature published up until 11 August 2020. Data extraction and synthesis We performed a systematic narrative synthesis to describe the available studies for each outcome. Data were extracted using a standardised Joanna Briggs Institute data extraction form. Results Fifteen articles met the inclusion criteria of which four were exclusively on Africa and the remaining 11 papers had a global focus with some data from Africa. Higher rates of infection in Africa are associated with high population density, urbanisation, transport connectivity, high volume of tourism and international trade, and high level of economic and political openness. Limited or poor access to healthcare are also associated with higher COVID-19 infection rates. Older people and individuals with chronic conditions such as HIV, tuberculosis and anaemia experience severe forms COVID-19 leading to hospitalisation and death. Similarly, high burden of chronic obstructive pulmonary disease, high prevalence of tobacco consumption and low levels of expenditure on health and low levels of global health security score contribute to COVID-19 related deaths. Conclusions Demographic, institutional, ecological, health system and politico-economic factors influenced the spectrum of COVID-19 infection, severity and death. We recommend multidisciplinary and integrated approaches to mitigate the identified factors and strengthen effective prevention strategi

Background COVID-19 has caused a global public health crisis affecting most countries, including Ethiopia, in various ways. This study maps the vulnerability to infection, case severity and likelihood of death from COVID-19 in Ethiopia. Methods Thirty-eight potential indicators of vulnerability to COVID-19 infection, case severity and likelihood of death, identified based on a literature review and the availability of nationally representative data at a low geographic scale, were assembled from multiple sources for geospatial analysis. Geospatial analysis techniques were applied to produce maps showing the vulnerability to infection, case severity and likelihood of death in Ethiopia at a spatial resolution of 1 km×1 km. Results This study showed that vulnerability to COVID-19 infection is likely to be high across most parts of Ethiopia, particularly in the Somali, Afar, Amhara, Oromia and Tigray regions. The number of severe cases of COVID-19 infection requiring hospitalisation and intensive care unit admission is likely to be high across Amhara, most parts of Oromia and some parts of the Southern Nations, Nationalities and Peoples' Region. The risk of COVID-19-related death is high in the country's border regions, where public health preparedness for responding to COVID-19 is limited. Conclusion This study revealed geographical differences in vulnerability to infection, case severity and likelihood of death from COVID-19 in Ethiopia. The study offers maps that can guide the targeted interventions necessary to contain the spread of COVID-19 in Ethiopia.

Introduction: The human immunodeficiency virus 1 (HIV-1) pandemic is characterized by numerous distinct sub-epidemics (clusters) that continually fuel local transmission. The aims of this study were to identify active growing clusters, to understand which factors most influence the transmission dynamics, how these vary between different subtypes and how this information might contribute to effective public health responses. Methods: We used HIV-1 genomic sequence data linked to demographic factors that accounted for approximately 70% of all new HIV-1 notifications in New South Wales (NSW). We assessed differences in transmission cluster dynamics between subtype B and circulating recombinant form 01_AE (CRF01_AE). Separate phylogenetic trees were estimated using 2919 subtype B and 473 CRF01_AE sequences sampled between 2004 and 2018 in combination with global sequence data and NSW-specific clades were classified as clusters, pairs or singletons. Significant differences in demographics between subtypes were assessed with Chi-Square statistics. Results: We identified 104 subtype B and 11 CRF01_AE growing clusters containing a maximum of 29 and 11 sequences for subtype B and CRF01_AE respectively. We observed a > 2-fold increase in the number of NSW-specific CRF01_AE clades over time. Subtype B clusters were associated with individuals reporting men who have sex with men (MSM) as their transmission risk factor, being born in Australia, and being diagnosed during the early stage of infection (p < 0.01). CRF01_AE infections clusters were associated with infections among individuals diagnosed during the early stage of infection (p < 0.05) and CRF01_AE singletons were more likely to be from infections among individuals reporting heterosexual transmission (p < 0.05). We found six subtype B clusters with an above-average growth rate (>1.5 sequences / 6-months) and which consisted of a majority of infections among MSM. We also found four active growing CRF01_AE clusters contai

OBJECTIVES: To describe the experiences, priorities, and needs of patients with rheumatic disease and their parents during transition from paediatric to adult healthcare. SETTING: Face-to-face and telephone semistructured interviews were conducted from December 2018 to September 2019 recruited from five hospital centres in Australia. PARTICIPANTS: Fourteen young people and 16 parents were interviewed. Young people were included if they were English speaking, aged 14-25 years, diagnosed with an inflammatory rheumatic disease (eg, juvenile idiopathic arthritis, juvenile dermatomyositis, systemic lupus erythematosus, panniculitis, familial Mediterranean fever) before 18 years of age. Young people were not included if they were diagnosed in the adult setting. RESULTS: We identified four themes with respective subthemes: avoid repeat of past disruption (maintain disease stability, preserve adjusted personal goals, protect social inclusion); encounter a daunting adult environment (serious and sombre mood, discredited and isolated identity, fear of a rigid system); establish therapeutic alliances with adult rheumatology providers (relinquish a trusting relationship, seek person-focused care, redefine personal-professional boundaries, reassurance of alternative medical supports, transferred trust to adult doctor) and negotiate patient autonomy (confidence in formerly gained independence, alleviate burden on patients, mediate parental anxiety). CONCLUSIONS: During transition, patients want to maintain disease stability, develop a relationship with their adult provider centralised on personal goals and access support networks. Strategies to comprehensively communicate information between providers, support self-management, and negotiate individualised goals for independence during transition planning may improve satisfaction, and health and treatment outcomes.

OBJECTIVE: Describe the development and pretest of a prototype multibehavioural change app MAMA-EMPOWER. DESIGN: Mixed-methods study reporting three phases: (1) contextual enquiry included stakeholder engagement and qualitative interviews with Aboriginal women, (2) value specification included user-workshop with an Aboriginal researcher, community members and experts, (3) codesign with Aboriginal researchers and community members, followed by a pretest of the app with Aboriginal women, and feedback from qualitative interviews and the user-Mobile Application Rating Scale (U-MARS) survey tool. SETTINGS: Aboriginal women and communities in urban and regional New South Wales, Australia. PARTICIPANTS: Phase 1: interviews, 8 Aboriginal women. Phase 2: workshop, 6 Aboriginal women. Phase 3: app trial, 16 Aboriginal women. U-MARS, 5 Aboriginal women. RESULTS: Phase 1 interviews revealed three themes: current app use, desired app characteristics and implementation. Phase 2 workshop provided guidance for the user experience. Phase 3 app trial assessed all content areas. The highest ratings were for information (mean score of 3.80 out of 5, SD=0.77) and aesthetics (mean score of 3.87 with SD of 0.74), while functionality, engagement and subjective quality had lower scores. Qualitative interviews revealed the acceptability of the app, however, functionality was problematic. CONCLUSIONS: Developing a mobile phone app, particularly in an Aboriginal community setting, requires extensive consultation, negotiation and design work. Using a strong theoretical foundation of behavioural change technique's coupled with the consultative approach has added rigour to this process. Using phone apps to implement behavioural interventions in Aboriginal community settings remains a new area for investigation. In the next iteration of the app, we aim to find better ways to personalise the content to women's needs, then ensure full functionality before conducting a larger trial. We predict the pr

Introduction People of Ashkenazi Jewish (AJ) ancestry are more likely than unselected populations to have a BRCA1/2 pathogenic variant, which cause a significantly increased risk of breast, ovarian and prostate cancer. Three specific BRCA1/2 pathogenic variants, referred to as BRCA-Jewish founder mutations (B-JFM), account for >90% of BRCA1/2 pathogenic variants in people of AJ ancestry. Current practice of identifying eligible individuals for BRCA testing based on personal and/or family history has been shown to miss at least 50% of people who have one of these variants. Here we describe the protocol of the JeneScreen study-a study established to develop and evaluate two different population-based B-JFM screening programmes, offered to people of Jewish ancestry in Sydney and Melbourne, Australia. Methods and analysis To rmeasure the acceptability of population-based B-JFM screening in Australia, two screening programmes using different methodologies have been developed. The Sydney JeneScreen programme provides information and obtains informed consent by way of an online tool. The Melbourne JeneScreen programme does this by way of community sessions attended in person. Participants complete questionnaires to measure clinical and psychosocial outcomes at baseline, and for those who have testing, 2 weeks postresult. Participants who decline testing are sent a questionnaire regarding reasons for declining. Participants with a B-JFM are sent questionnaires 12-month and 24-month post-Testing. The questionnaires incorporate validated scales, which measure anxiety, decisional conflict and regret, and test-related distress and positive experiences, and other items specifically developed or adapted for the study. These measures will be assessed for each programme and the two population-based B-JFM screening methods will be compared. Ethics and dissemination Institutional Human Research Ethics Committee approval was obtained from the South Eastern Area Health Service Human Re

Objective: Wrist deformity in older people is common following treatment for a wrist fracture, particularly after non-surgical treatment. A cohort of older wrist fracture patients were surveyed by telephone regarding perceived deformity, bother with deformity and patient-reported wrist function. The objectives were to: (1) determine whether older patients with wrist fractures perceived a deformity of their wrist and if they were bothered by it; (2) test if there were associations between deformity and treatment-type and between deformity and function; (3) test for associations between bother and treatment-type and between bother and function; (4) measure the test-retest reliability of the 'bother' question. Results: Of 98 eligible patients who were invited to participate, 41 responded. Out of 41, 14 (34%) believed they had a deformity and 4 (10%) reported that they were bothered by the appearance of their wrist. Deformity was associated with non-surgical treatment (RR = 3.85, p = 0.006) but was not significantly associated with functional outcomes (p = 0.15). All those who were bothered belonged to the non-surgical treatment group. Bother was significantly associated with poorer functional outcomes (p = 0.006) and this association was clinically significant (MD = 35 points). The deformity and bother questions were found to have excellent test-retest reliability; κ = 1.00 and κ = 0.92, respectively.

Objectives To identify key predictors of general practitioner (GP) consultations for allergic rhinitis (AR) using meteorological and environmental data. Design A retrospective, time series analysis of GP consultations for AR. Setting A large GP surveillance network of GP practices in the London area. Participants The study population was all persons who presented to general practices in London that report to the Public Health England GP in-hours syndromic surveillance system during the study period (3 April 2012 to 11 August 2014). Primary measure Consultations for AR (numbers of consultations). Results During the study period there were 186 401 GP consultations for AR. High grass and nettle pollen counts (combined) were associated with the highest increases in consultations (for the category 216-270 grains/m3, relative risk (RR) 3.33, 95% CI 2.69 to 4.12) followed by high tree (oak, birch and plane combined) pollen counts (for the category 260-325 grains/m3, RR 1.69, 95% CI 1.32 to 2.15) and average daily temperatures between 15°C and 20°C (RR 1.47, 95% CI 1.20 to 1.81). Higher levels of nitrogen dioxide (NO 2) appeared to be associated with increased consultations (for the category 70-85 μg/m3, RR 1.33, 95% CI 1.03 to 1.71), but a significant effect was not found with ozone. Higher daily rainfall was associated with fewer consultations (15-20 mm/day; RR 0.812, 95% CI 0.674 to 0.980). Conclusions Changes in grass, nettle or tree pollen counts, temperatures between 15°C and 20°C, and (to a lesser extent) NO 2 concentrations were found to be associated with increased consultations for AR. Rainfall has a negative effect. In the context of climate change and continued exposures to environmental air pollution, intelligent use of these data will aid targeting public health messages and plan healthcare demand.

Objectives Conduct a head-to-head experimental test of responses to alcohol harm reduction advertisements developed by alcohol industry Social Aspects/Public Relations Organisations (SAPROs) versus those developed by public health (PH) agencies. We hypothesised that, on average, SAPRO advertisements would be less effective at generating motivation (H1) and intentions to reduce alcohol consumption (H2) but more effective at generating positive perceptions of people who drink (H3). Design Online experiment with random assignment to condition. Participants 2923 Australian adult weekly drinkers (49% high-risk drinkers) recruited from an opt-in online panel. Interventions Participants viewed 3 of 83 advertisements developed by PH agencies (n=2174) or 3 of 28 advertisements developed by SAPROs (n=749). Primary outcome measures Participants reported their motivation to reduce the amount of alcohol consumed; behave responsibly and/or not get drunk; and limit their drinking around/never supply to minors, as well as intentions to avoid drinking alcohol completely; reduce the number of drinking occasions; and reduce the amount of alcohol consumed per occasion. Participants also reported their perceptions of people who drink alcohol on six success-related items and four fun-related items. Results Compared with drinkers exposed to PH advertisements, those exposed to SAPRO advertisements reported lower motivation to reduce the amount of alcohol consumed (β=-0.091, 95% CI-0.171 to-0.010), and lower odds of intending to avoid alcohol completely (OR=0.77, 0.63 to 0.94) and to reduce the amount of alcohol consumed per occasion (OR=0.82, 0.69 to 0.97). SAPRO advertisements generated more favourable fun-related perceptions of drinkers (β=0.095, 0.013 to 0.177). Conclusions The alcohol harm reduction advertisements produced by alcohol industry SAPROs that were tested in this study were not as effective at generating motivation and intentions to reduce alcohol consumption as those develo

Disclosure of a hereditary condition in the family poses notable challenges for patients who often seek the assistance of genetic health professionals (GHPs). This study aimed to investigate GHPs' opinions about the ideal time for disclosure to offspring and their responsibility to at-risk relatives. Design Cross-sectional qualitative study. Setting Genetic familial cancer clinics related to mostly secondary and tertiary care hospitals and centres in urban, regional and rural areas across all states of Australia. Participants GHPs (N=73) including clinical geneticists, genetic counsellors, medical specialists, nurses, surgeons and mental health specialists (eg, psychiatrists, psychologists) who had worked with BRCA1 and BRCA2 families for an average of 9 years. Results Focus groups and interviews were transcribed and analysed thematically. GHPs perceived that life stage, maturity, parents' knowledge and capacity to disseminate information influenced parent-offspring disclosure. In general, GHPs recommended early informal conversations with offspring about a family illness. GHPs considered that facilitation of disclosure to relatives using counselling strategies was their responsibility, yet there were limitations to their role (eg, legal and resource constraints). Variability exists in the extent to which genetic clinics overcome challenges to disclosure. Conclusions GHPs' views on the ideal time for the disclosure of genetic risk are generally dependent on the patient's age and relative's ability to disclose information. A responsibility towards the patient and their at-risk relative was widely accepted as a role of a GHP but views vary depending on legislative and specialty differences. Greater uniformity is needed in genetic procedural guidelines and the role of each discipline (eg, geneticists, genetic counsellors, oncologists, nurses and mental health specialists) in genetic clinics to manage disclosure challenges.

Introduction The benefits and risks of low-dose hydrocortisone in patients with septic shock have been investigated in numerous randomised controlled trials and trial-level meta-analyses. Yet, the routine use of this treatment remains controversial. To overcome the limitations of previous meta-analyses inherent to the use of aggregate data, we will perform an individual patient data meta-analysis (IPDMA) on the effect of hydrocortisone with or without fludrocortisone compared with placebo or usual care on 90-day mortality and other outcomes in patients with septic shock. Methods and analysis To assess the benefits and risks of hydrocortisone, with or without fludrocortisone for adults with septic shock, we will search major electronic databases from inception to September 2020 (Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE and Latin American Caribbean Health Sciences Literature), complimented by a search for unpublished trials. The primary analysis will compare hydrocortisone with or without fludrocortisone to placebo or no treatment in adult patients with septic shock. Secondary analyses will compare hydrocortisone to placebo (or usual care), hydrocortisone plus fludrocortisone to placebo (or usual care), and hydrocortisone versus hydrocortisone plus fludrocortisone. The primary outcome will be all cause mortality at 90 days. We will conduct both one-stage IPDMA using mixed-effect models and machine learning with targeted maximum likelihood analyses. We will assess the risk of bias related to unshared data and related to the quality of individual trial. Ethics and dissemination This IPDMA will use existing data from completed randomised clinical trials and will comply with the ethical and regulatory requirements regarding data sharing for each of the component trials. The findings of this study will be submitted for publication in a peer-review journal with straightforward policy for open access.

Objective This study comprehensively estimated the excess cardiovascular disease (CVD) mortality attributable to influenza in an older (age ≥65 years) population. Design Ecological study. Setting Aggregated data from administrative systems on CVD mortality, influenza surveillance and meteorological data in Beijing, China. Main outcome measure Excess overall CVD, and separately for ischaemic heart disease (IHD), ischaemic stroke, haemorrhagic stroke mortality attributable to influenza, adjusting for influenza activity, time trend, seasonality and ambient temperature. Results CVD (risk ratio (RR) 1.02, 95% CI 1.01, 1.02), IHD (RR 1.01, 95% CI 1.01, 1.02), ischaemic stroke (RR=1.03, 95% CI 1.02, 1.04), but not haemorrhagic stroke (RR=1.00, 95% CI 0.99, 1.01) mortality, were significantly associated with every 10% increase in influenza activity. An increase in circulating A(H1N1)09pdm, A(H3N2) and B type virus were all significantly associated with CVD and ischaemic stroke mortality, but only A(H3N2) and B type virus with IHD mortality. The strongest increase in disease mortality was in the same week as the increase in influenza activity. Annual excess CVD mortality rate attributable to influenza ranged from 54 to 96 per 100 000 population. The 3%-6% CVD mortality attributable to influenza activity was related to an annual excess of 916-1640 CVD deaths in Beijing, China. Conclusions Influenza activity has moderate to strong associations with CVD, IHD and ischaemic stroke mortality in older adults in China. Promoting influenza vaccination could have major health benefit in this population. Background Influenza may trigger serious CVD events. An estimation of excess CVD mortality attributable to influenza has particular relevance in China where vaccination is low and CVD burden is high. Methods This study analysed data at the population level (age ≥65 years) using linked aggregated data from administrative systems on CVD mortality, influenza surveillance and meteorologica

Purpose: This study was carried out to determine if light emitting diodes (LEDs) represented a special case in exposing the retina to blue light, when compared with other methods of backlighting television and computer screens and with fluorescent tube lighting. Method: The spectral distribution of light from computer and television screens (cathode ray tube, plasma screen, organic LEDs, and screens backlit by cold cathode tubes and/or LEDs), domestic type spotlights (LED and fluorescent tube) and objects in the outdoor sunlit environment were measured with a telespectroradiometer. The spectral data were analysed for the proportion of blue light and luminance. The results were also presented as time to reach the occupational safety limit, without regard to the normal 10 000 s time limit by which time there is no summation of exposure. Results: The amount of blue light in a source is essentially independent of the technology of the light source, but closely related to the correlated colour temperature. Conclusions: Fluorescent lamps show essentially the same proportions of blue light and LEDs do not represent a special case, given the same correlated colour temperature. Blue-blocking lenses are no more needed with LED sources than with other screen illumination methods or with fluorescent lighting. There is no evidence base on which to recommend blue-blocking lenses for indoor applications.

Tuberculosis (TB) is the leading infectious cause of human mortality and is responsible for nearly 2 million deaths every year. It is often regarded as a 'silent killer' because it predominantly affects the poor and marginalized, and disease outbreaks occur in 'slow motion' compared to Ebola or coronavirus 2 (COVID-19). In low incidence countries, TB is predominantly an imported disease and TB control in migrants is pivotal for countries to progress towards TB elimination in accordance with the World Health Organisations (WHO's) End TB strategy. This review provides a brief overview of the different screening approaches and surveillance processes that are in place in low TB incidence countries. It also includes a detailed discussion of the ethical issues related to TB screening of migrants in these settings and the different interests that need to be balanced. Given recognition that a holistic approach that recognizes and respects basic human rights is required to end TB, the review considers the complexities that require consideration in low-incidence countries that are aiming for TB elimination.

Objectives Community-based health programmes implemented in low-income and middle-income countries impact community gender norms and roles and relationships, which in turn affect individuals' health outcomes. Programmes should measure their effects on gender norms, roles and relationships in the communities in which they operate to respond to unexpected health consequences. We conducted a gender analysis on a drowning reduction programme in rural Bangladesh to identify its impacts on gendered roles and behaviours in the community. Design A mixed-method approach was used. Quantitative programme monitoring data were analysed to assess gender differences in participation and engagement. A qualitative approach using interviews, focus group discussions and observations with purposively selected programme implementing staff and participants aimed at finding explanations for quantitative findings and additional impacts of the programme on gender in the community. The analysis was conducted using Family Health International 360's Gender Integration Framework, which identifies both internal (norms) and external (behaviours) effects. Results Fewer girls (n=5030) participated in swimming classes than boys (n=6425) due to cultural restrictions and involvement in domestic work. Women were not hired in leadership roles in the implementing organisation due to lower transportation access and their perceived ability to conduct labour-intensive activities. However, communities become more accepting of local women's mobility and employment due to their engagement as swim instructors. Women swim instructors were more satisfied with the pay and part-Time nature of the work as men were able to earn more elsewhere. Menstruation management was ignored as all supervisory staff were men. Conclusions Systematised strategies are required to ensure equal participation of girls and enable equitable prevention outcomes. Within the implementing organisation, programmatic changes will support gende

Objectives: We aimed to investigate the socioeconomic inequalities in the burden of underweight and overweight among children in South Asia. We also examined other factors that were associated with these outcomes independently of household's socioeconomic status. Design Nationally-representative surveys. Settings Demographic and Health Surveys from Bangladesh, India, Pakistan, Maldives and Nepal, which were conducted between 2009 and 2016. Participants Children aged 24 to 59 months with valid measurement for height and weight (n=146 996). Primary exposure and outcome measures Primary exposures were household's wealth index and level of education. Underweight and overweight were defined according to the WHO and International Obesity Task Force definitions, respectively. Results: Underweight prevalence was 37% in Bangladesh, 38% in India, 19% in Maldives, 29% in Nepal and 28% in Pakistan. Bangladesh, India and Nepal had similar overweight prevalence (between 2% and 4%) whereas Pakistan (7%) and Maldives (9%) had higher prevalence. Households with higher wealth index or education had lower odds of having underweight children. Adjusted ORs of underweight for richest versus poorest households were 0.4 (95% CI: 0.3 to 0.5), 0.5 (95% CI: 0.5 to 0.6), 0.5 (95% CI: 0.2 to 1.4), 0.5 (95% CI: 0.3 to 0.8) and 0.7 (95% CI: 0.5 to 1.1) for Bangladesh, India, Maldives, Nepal and Pakistan, respectively. Compared with poorest households, richest households were more likely to have overweight children in all countries except Pakistan, but such associations were not significant after adjustment for other factors. There were higher odds of having overweight children in households with higher education in Bangladesh (OR 2.1 (95% CI: 1.3 to 3.5)), India (OR 1.2 (95% CI: 1.2 to 1.3)) and Pakistan (OR 1.8 (95% CI: 1.1 to 2.9)) when compared with households with no education. Maternal nutritional status was consistently associated with children's nutritional outcomes after adjustments for s

Objectives To determine the reporting quality of published randomised controlled trial (RCT) protocols before and after the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statement (2013), and any association with author, trial or journal factors. Design Methodological study. Data sources MEDLINE, Embase and CENTRAL were electronically searched using optimised search strategies. Eligibility criteria Protocols written for an RCT of living humans, published in full text in a peer-reviewed journal and published in the English language. Main outcome Primary outcome was the overall proportion of checklist items which were adequately reported in RCT protocols published before and after the SPIRIT statement. Results 300 RCT protocols were retrieved; 150 from the period immediately before the SPIRIT statement (9 July 2012 to 28 December 2012) and 150 from a recent period after the SPIRIT statement (25 January 2019 to 20 March 2019). 47.9% (95% CI, 46.5% to 49.3%) of checklist items were adequately reported in RCT protocols before the SPIRIT statement and 56.7% (95% CI, 54.9% to 58.5%) after the SPIRIT statement. This represents an 8.8% (95% CI, 6.6% to 11.1%; p<0.0001) mean improvement in the overall proportion of checklist items adequately reported since the SPIRIT statement. While 40% of individual checklist items had a significant improvement in adequate reporting after the SPIRIT statement, 11.3% had a significant deterioration and there were no RCT protocols in which all individual checklist items were complete. The factors associated with higher reporting quality of RCT protocols in multiple regression analysis were author expertise or experience in epidemiology or statistics, multicentre trials, longer protocol word length and publicly reported journal policy of compliance with the SPIRIT statement. Conclusion The overall reporting quality of RCT protocols has significantly improved since the SPIRIT statement, although a substantial propo

Objectives Across a range of health conditions, apps are increasingly valued as tools for supporting the delivery and coordination of healthcare. Research-led cross-sectional reviews of apps are a potential resource to inform app selection in face of uncertainties around content quality, safety and privacy. However, these peer-reviewed publications only capture a snapshot of highly dynamic app stores and marketplaces. To determine the extent to which marketplace dynamics might impact the interpretation of app reviews, the current study sought to quantify the lag between the reported time of app assessment and publication of the results of these studies. Design Searches were conducted on MEDLINE, Embase and PsycINFO to identify published cross-sectional reviews of health, fitness or wellness apps. Publication timeline metadata were extracted, allowing the primary outcome measure, the delay between app store search and manuscript publication, to be calculated. A secondary measure, the time between search and manuscript submission, was also calculated where possible. Results After screening, 136 relevant cross-sectional app review studies were analysed. The median time to publication was 431 days (approximately 14 months, range: 42-1054 days). The median time to submission was 269 days (approximately 9 months, range: 5-874 days). Studies which downloaded apps typically took longer to publish (p=0.010), however the number of apps reviewed did not impact the time to publication (p=0.964). Studies which recommended specific apps were not published more rapidly (p=0.998). Conclusions Most health app reviews present data that are at least a year out-of-date at the time of publication. Given the high rate of turnover of health apps in public marketplaces, it may not be appropriate, therefore, for these reviews to be presented as a resource concerning specific products for commissioners, clinicians and the public. Alternative sources of information may be better calibrated to

Introduction Psychotherapy may reduce suicidal thoughts and behaviour, but its effectiveness is not well examined. Furthermore, conventional meta-analyses are unable to test possible effects of moderators affecting this relationship. This protocol outlines the building of a comprehensive database of the literature in this research field. In addition, we will conduct an individual patient data meta-analysis (IPD-MA) to establish the effectiveness of psychotherapy in reducing suicidality, and to examine which factors moderate the efficacy of these interventions. Methods and analysis To build a comprehensive database, randomised controlled trials examining the effect of any psychotherapy targeting any psychiatric disorder on suicidal thoughts or behaviour will be identified by running a systematic search in PubMed, Embase, PsycINFO, Web of Science, Scopus and The Cochrane Central Register of Controlled Trials from data inception to 12 August 2019. For the IPD-MA, we will focus on adult outpatients with suicidal ideation or behaviour. In addition, as a comparison group we will focus on a control group (waiting-list, care as usual or placebo). A 1-stage IPD-MA will be used to determine the effectiveness of psychotherapy on suicidal ideation, suicide attempts and/or suicide deaths, and to investigate potential patient-related and intervention-related moderators. Subgroup and sensitivity analyses will be conducted to test the robustness of the findings. Additionally, a conventional MA will be conducted to determine the differences between studies that provided IPD and those that did not. IPD-MA may determine the effectiveness of psychotherapy in reducing suicidality and provide insights into the moderating factors influencing the efficacy of psychotherapy. Answering these questions will inform mental healthcare practitioners about optimal treatments for different groups of individuals with suicidal ideation and/or behaviour and consequently help to reduce suicide risk. Eth

Objective: Despite concern regarding high rates of mental illness and suicide amongst the medical profession, the link between working hours and doctors' mental health remains unclear. This study examines the relationship between average weekly working hours and junior doctors' (JDs') mental health in Australia. Design and participants: A randomly selected sample of 42 942 Australian doctors were invited to take part in an anonymous Beyondblue National Mental Health Survey in 2013, of whom 12 252 doctors provided valid data (response rate approximately 27%). The sample of interest comprised 2706 full-time graduate medical trainees in various specialties, at either intern, prevocational or vocational training stage. Consultants and retired doctors were excluded. Outcome measures: Main outcomes of interest were caseness of common mental disorder (CMD) (assessed using a cut-off of 4 as a threshold on total General Health Questionnaire-28 score), presence of suicidal ideation (SI) (assessed with a single item) and average weekly working hours. Logistic regression modelling was used to account for the impact of age, gender, stage of training, location of work, specialty, marital status and whether JDs had trained outside Australia. Results: JDs reported working an average of 50.1 hours per week (SD=13.4). JDs who worked over 55 hours a week were more than twice as likely to report CMD (adjusted OR=2.05; 95% CI 1.62 to 2.59, p<0.001) and SI (adjusted OR=2.00; 95% CI 1.42 to 2.81, p<0.001) compared to those working 40-44 hours per week. Conclusions Our results show that around one in four JDs are currently working hours that are associated with a doubling of their risk of common mental health problems and SI. These findings suggest that management of working hours represents an important focus for workplaces to improve the mental health of medical trainees.

Introduction For individuals presenting to the emergency department (ED) for a suicide attempt, the period after discharge from hospital is marked by heightened vulnerability for further suicide attempts. Effective care following a suicidal crisis has the potential to significantly decrease this risk. The current study aims to examine the impact of the LifeSpan multilevel suicide prevention model on experiences of care following a suicidal crisis. Perspectives from healthcare consumers (individuals who have presented to the ED following a suicidal crisis), carers, and health professionals will be explored. The LifeSpan model is currently being evaluated as a high-fidelity trial in four geographically defined regions in New South Wales, Australia. Methods and analysis This study will use a mixed methods prospective cohort design. Quantitative data collection includes a structured survey, administered to healthcare consumers from LifeSpan sites and control sites. Two cohorts of healthcare consumers will be recruited 12 months apart with baseline assessment occurring within 18 months of the ED presentation, and follow-up 12 months after the initial assessment. Survey participants will be recruited online and through participating EDs, mental health organisations and aftercare services. Qualitative interview data from healthcare consumers, carers who have accompanied a loved one to the ED following a suicidal crisis and health professionals who provide care to people at risk of suicide will be collected concurrently with the recruitment of the first cohort of survey participants. Purposive and convenience sampling techniques will be used for recruitment of interview participants. The primary outcome for this study will be healthcare consumers' experiences of service provided at the ED. Analysis will be undertaken of the change over time within LifeSpan sites, as well as between LifeSpan sites and control sites, using mixed effects repeated measures models as principal m

Introduction Metformin and diets aimed at promoting healthy body weight are the first line in treating type 2 diabetes mellitus (T2DM). Clinical practice, backed by clinical trials, suggests that many individuals do not reach glycaemic targets using this approach alone. The primary aim of the Personalised Medicine in Pre-diabetes-Towards Preventing Diabetes in Individuals at Risk (PREDICT) Study is to test the efficacy of personalised diet as adjuvant to metformin in improving glycaemic control in individuals with dysglycaemia. Methods and analysis PREDICT is a two-Arm, parallel group, single-masked randomised controlled trial in adults with pre-diabetes or early-stage T2DM (with glycated haemoglobin (HbA1c) up to 8.0% (64 mmol/mol)), not treated with glucose-lowering medication. PREDICT is conducted at the Clinical Research Facility at the Garvan Institute of Medical Research (Sydney). Enrolment of participants commenced in December 2018 and expected to complete in December 2021. Participants are commenced on metformin (Extended Release, titrated to a target dose of 1500 mg/day) and randomised with equal allocation to either (1) the Personalised Nutrition Project algorithm-based diet or (2) low-fat high-dietary fibre diet, designed to provide caloric restriction (75%) in individuals with body mass index >25 kg/m 2. Treatment duration is 6 months and participants visit the Clinical Research Facility five times over approximately 7 months. The primary outcome measure is HbA1c. The secondary outcomes are (1) time of interstitial glucose <7.8 mmol/L and (2) glycaemic variability (continuous glucose monitoring), (3) body weight, (4) fat mass and (5) abdominal visceral fat volume (dual-energy X-ray absorptiometry), serum (6) low-density lipoprotein cholesterol (7) high-density lipoprotein cholesterol and (8) triglycerides concentrations, (9) blood pressure, and (10) liver fat (Fibroscan). Ethics and dissemination The study has been approved by the St Vincent's Hospital H

Objective To examine the ability of ear, nose and throat (ENT) outreach programmes to improve health outcomes among Aboriginal and Torres Strait Islander people. Methods We conducted a systematic literature search of nine databases (Medline, CINAHLS, PsycINFO, Embase, Cochrane, Scopus, Global health, Informit Rural health database and Indigenous collection) and grey literature sources for primary studies evaluating ENT outreach services for Aboriginal and Torres Strait Islander people. This review included English language studies of all types, published between 2000 and 2018, that supplied ENT outreach services to Aboriginal and Torres Strait Islander Australians and provided data to evaluate their aims. Two authors independently evaluated the eligible articles and extracted relevant information. Risk of bias was assessed using the Mixed Methods Assessment Tool. Results Of the 506 studies identified, 15 were included in this review. These 15 studies evaluated eight different programs/activities. Studies were heterogeneous in design so a meta-analysis could not be conducted. Seven studies measured health-related outcomes in middle ear or hearing status; six reported overall positive changes one reported no clinically significant improvements. Five programmes/activities and their corresponding studies involved Aboriginal and Torres Strait Islander people and organisations in delivery and evaluation, but involvement in programme or study design was unclear. Conclusion While some studies demonstrated improved outcomes, the overall ability of ENT programmes to improve health outcomes for Aboriginal and Torres Strait Islander children is unclear. The impact of ENT outreach may be limited by a lack of quality evidence, service coordination and sustainability. Community codesign and supporting and resourcing local capacity must be a component of outreach programmes and ongoing evaluation is also recommended. Improvements in these areas would likely improve health outcomes.

INTRODUCTION: Pregnancy induces significant physiological and cardiometabolic changes, and is associated with alterations in the maternal microbiota. Increasing rates of prepregnancy obesity, metabolic abnormalities and reduced physical activity, all impact negatively on the microbiota causing an imbalance between the commensal microorganisms (termed dysbiosis), which may drive complications, such as gestational diabetes or hypertensive disorders. Considerable work is needed to define the inter-relationships between the microbiome, nutrition, physical activity and pregnancy outcomes. The role of the microbiota during pregnancy remains unclear. The aim of the study is to define microbiota signatures longitudinally throughout pregnancy and the first year post birth, and to identify key clinical and environmental variables that shape the female microbiota profile during and following pregnancy. METHODS AND ANALYSIS: The Microbiome Understanding in Maternity Study (MUMS) is an Australian prospective longitudinal cohort study involving 100 mother-infant pairs. Women are enrolled in their first trimester and followed longitudinally. Assessment occurs at <13+0, 20+0-24+6 and 32+0-36+6 weeks gestation, birth and 6 weeks, 6 months and 12 months postpartum. At each assessment, self-collected oral, vaginal and faecal samples are collected with an additional postpartum skin swab and breastmilk sample. Each infant will have oral, faecal and skin swab samples collected. Measurements include anthropometrics, body composition, blood pressure, serum hormonal and metabolic parameters and vaginal pH. Dietary intake, physical activity and psychological state will be assessed using validated self-report questionnaires, and pregnancy and infant outcomes recorded. Parametric and non-parametric hypothesis tests will be used to test the association between high-risk and low-risk pregnancies and their outcomes. ETHICS AND DISSEMINATION: The study received the following approval: South Easter

Introduction The development of type 2 diabetes mellitus disproportionately affects South Asian women with prior gestational diabetes mellitus (GDM). The Lifestyle InterVention IN Gestational diabetes (LIVING) Study is a randomised controlled trial of a low-intensity lifestyle modification programme tailored to women with previous GDM, in India, Bangladesh and Sri Lanka, aimed at preventing diabetes/pre-diabetes. The aim of this process evaluation is to understand what worked, and why, during the LIVING intervention implementation, and to provide additional data that will assist in the interpretation of the LIVING Study results. The findings will also inform future scale-up efforts if the intervention is found to be effective. Methods and analysis The Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) methodological approach informed the evaluation framework. Michie's Behaviour Change Theory and Normalisation Process Theory were used to guide the design of our qualitative evaluation tools within the overall RE-AIM evaluation framework. Mixed methods including qualitative interviews, focus groups and quantitative analyses will be used to evaluate the intervention from the perspectives of the women receiving the intervention, facilitators, site investigators and project management staff. The evaluation will use evaluation datasets, administratively collected process data accessed during monitoring visits, check lists and logs, quantitative participant evaluation surveys, semistructured interviews and focus group discussions. Interview participants will be recruited using maximum variation purposive sampling. We will undertake thematic analysis of all qualitative data, conducted contemporaneously with data collection until thematic saturation has been achieved. To triangulate data, the analysis team will engage in constant iterative comparison among data from various stakeholders. Ethics and dissemination Ethics approval has been obtained from the respect

Objectives To (1) assess women's current knowledge regarding long-term cardiovascular health after hypertensive disorders of pregnancy (2) elicit women's preferred educational content and format regarding health after hypertensive disorders of pregnancy. Design and setting A custom-created online survey exploring Australian women's knowledge about long-term health after hypertensive disorders of pregnancy, distributed through consumer groups and social media. Participants 266 women with (n=174) or without (n=92) a history of hypertensive disorders of pregnancy. Primary and secondary outcome measures (1) Proportion of women identifying long-term health risks after hypertensive disorder of pregnancy using a 10-point risk knowledge score with 0-4 low', 4.1-7.0 moderate' and 7.1-10 high'. (2) Exploration of preferred content, format and distribution of educational material post hypertensive disorder of pregnancy. Results Knowledge scores about health after hypertensive disorder of pregnancy were moderate in groups with and without a history of the disorder. Knowledge was highest regarding risk of recurrent hypertensive disorders in a subsequent pregnancy, moderate' for chronic hypertension and heart attack, moderate' and low' regarding risk of heart disease and low' for diabetes and renal disease. Only 36% of all participants were aware that risks start within 10 years after the affected pregnancy. The majority of respondents with a history of hypertensive disorder of pregnancy (76%) preferred receiving information about long-term health 0-6 months post partum from a healthcare provider (80%), key organisations (60%), social media (47%) and brochures/flyers (43%). Conclusions Women's knowledge regarding health risks after hypertensive disorder of pregnancy was moderate', although with important disease-specific gaps such as increased risk of diabetes. Most women wanted to be informed about their long-term health from a healthcare provider.

INTRODUCTION: Diet is an important modifiable risk factor for many chronic diseases. Measurement of dietary intake usually relies on self-report, subject to multiple biases. There is a need to understand gender differences in the self-report of dietary intake and the implications of any differences in targeting nutrition interventions. Literature in this area is limited and it is currently unknown whether self-report dietary assessment methods are equally accurate for women and men. The aim of this systematic review is to determine whether there are differences by gender in reporting energy intake compared with a reference measure of total energy expenditure. METHODS AND ANALYSIS: A comprehensive search of published original research studies will be performed in MEDLINE, Scopus, Web of Science, EMBASE, CINAHL and Cochrane library. Original research studies will be included if they were conducted in free-living/unhospitalised adults and included a measure for both women and men of (a) self-reported energy intake and (b) total energy expenditure by doubly labelled water. One author will conduct the electronic database searches, two authors will independently screen studies, conduct a quality appraisal of the included studies using standardised tools and extract data. If further information is needed, then study authors will be contacted. If appropriate, a random-effects meta-analysis will be conducted, with inverse probability weighting, to quantify differences in the mean difference in agreement between reported energy intake and measured energy expenditure between women and men, by self-report assessment method. Subgroup analyses will be conducted by participant factors, geographical factors and study quality. ETHICS AND DISSEMINATION: All data used will be from published primary research studies or deidentified results provided at the discretion of any study authors that we contact. We will submit our findings to a peer-reviewed scientific journal and will dissemin

Objectives This study responds to calls for greater focus on nursing roles, and the need for nursing integration within the antimicrobial optimisation agenda. The objective of this study was to explore Australian hospital nurses' views on antimicrobial resistance and antimicrobial stewardship (AMS) in a hospital setting, in order to better understand the opportunities for and challenges to integration of nursing staff in antimicrobial optimisation within hospital settings. Design Qualitative one-on-one, semistructured interviews. Interview transcripts were digitally audio-recorded and transcribed verbatim. Data were subject to thematic analysis supported by the framework approach and informed by sociological methods and theory. Setting Four hospitals (three public and one private), across metropolitan, regional and remote areas, in two Australian states. Participants 86 nurses (77 females, 9 males), from a range of hospital departments, at a range of career stages. Results Findings were organised into three thematic domains: (1) the current peripheral role of nurses in AMS; (2) the importance of AMS as a collaborative effort, and current tensions around interprofessional roles and (3) how nurses can bolster antimicrobial optimisation within AMS and beyond. Conclusion Nursing staff are central to infection management within the hospital and are thus ideally located to enhance antibiotic optimisation and contribute to AMS governance. However, without increased interprofessional cooperation, education and integration in the AMS agenda, as well as addressing organisational/resource constraints in the hospital, the nursing role in stewardship will remain limited.

Introduction There is a gap between the care people with knee osteoarthritis (OA) should receive according to evidence-based guidelines and the care they do receive. This feasibility study aims to test the feasibility of developing and implementing a codesigned, physiotherapy-led, multidisciplinary, evidence-based model of care for knee OA, among community physiotherapy practices in Australia, where community practice is defined as a professional physiotherapy business that is not controlled or paid for by the government. Methods and analysis A mixed-methods quasi-experimental (pre/postintervention) study. In the preintervention phase, all consented physiotherapists working in nine metropolitan-based, community physiotherapy practices, and 26 patients with knee OA will be recruited. Patients will be recruited from all practices by the physiotherapists, using the outlined inclusion/exclusion criteria. An audit of physiotherapy treatment notes will occur using a proforma, to gain an understanding of current community physiotherapy treatment and documentation. Patient and physiotherapist interviews will be conducted to determine current practice for the management of knee OA. A codesign phase will follow, where a model of care will be developed by researchers, patients, clinical staff, members of the public and other stakeholders, based on current guidelines for conservative management of knee OA. In the postintervention phase, a further 26 patients will be recruited, and the assessment process repeated to determine whether there is a change in practice. The feasibility outcome measures are: (1) number of patients who are recorded as receiving care according to current evidence-based guidelines; (2) number of patients who have patient-reported outcomes incorporated into their assessment and management plan; and (3) acceptability of the developed model to patients and physiotherapists. The clinical outcomes will include assessment of patient-reported outcome measures (p