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Introduction Both hearing loss and dementia are associated with ageing, and it is thought that many individuals living with dementia also live with hearing loss. Despite the large comorbidity between these two disorders, there remains a clear lack of established guidelines in audiological services for assessing and managing patients living with dementia. This scoping review aims to examine whether specialist clinical pathways exist in audiology services for people living with coexisting hearing loss and dementia and to describe the specific components and features of these pathways. This review will provide up-to-date information on clinical practice, identifying any gaps in care and in the literature to inform future research hypotheses and best practice guidelines.Methods and analysis The methods are reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews. The following electronic databases will be searched: CINAHL, EMBASE, MEDLINE, PsycINFO, PubMed, Scopus and Web of Science. The eligibility criteria are defined according to the domains of the SPIDER (Sample, Phenomenon of Interest, Design, Evaluation and Research type) search strategy tool. Primary research studies and select grey literature sources (eg, practice guidelines) will be eligible if published within the last 15 years. Studies eligible for inclusion must contain adults living with suspected or confirmed dementia, their carers, or clinicians within audiology services. Initial searches were performed on 31 January 2024 and will be updated before completion and submission of the review. Article quality will be appraised using an established tool: the Mixed Methods Appraisal Tool. The results will be synthesised and reported in line with reflexive thematic analysis guidelines.Ethics and dissemination No ethical issues are foreseen as the review will collect secondary data only. Findings will be reported by peer-reviewed publication and by national and international academic conferences.

Introduction Major depressive disorder (MDD) causes significant disease burden and functional impairment during adolescence and young adulthood. While most young people recover from their first episode, around two-thirds will experience one or more relapses, which can become more severe and treatment-resistant with each episode. To address relapse in MDD, we developed a moderated online social therapy platform (titled Rebound) that integrates: (i) peer-to-peer social networking; (ii) tailored third-wave therapeutic content targeting mindfulness, self-compassion and rumination; and (iii) three types of human support (clinicians, peer workers, career consultants), informed by self-determination theory. The aim of this trial is to determine whether, in addition to treatment as usual (TAU), Rebound, an 18-month complex digital intervention, is superior to 18 months of enhanced TAU in preventing relapse and managing depressive symptoms.Methods and analysis This study is a rater-masked randomised controlled trial. The treatment conditions include Rebound plus TAU or enhanced TAU alone. We aim to recruit 255 young people with at least one episode of MDD, aged 14–27 years. The study includes monthly assessment points over 18 months. The study includes a 48-month recruitment period and an 18-month treatment phase. The primary outcome is depressive relapse at 18 months, as measured by the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), Research Version (SCID-5-RV). Secondary outcomes include the severity of depressive symptoms, time to relapse, time to remission, remission status, severity of anxiety symptoms, study and employment outcomes and cost-effectiveness. We will also examine four therapeutic mechanisms (mindfulness, self-compassion skills, social support and reduced rumination) to understand the ‘how and why’ of the intervention effects.Ethics and dissemination Melbourne Health Human Research Ethics Committee (HREC/42967/MH-2018) provided ethics approval for this study. Findings will be made available through scientific journals and forums and to the public via social media and the Orygen website.Trial registration number ANZCTR, ACTRN12619001412123.

Introduction Complex trauma can have serious impacts on the health and well-being of Aboriginal and Torres Strait Islander families. The perinatal period represents a ‘critical window’ for recovery and transforming cycles of trauma into cycles of healing. The Healing the Past by Nurturing the Future (HPNF) project aims to implement and evaluate a programme of strategies to improve support for Aboriginal and Torres Strait islander families experiencing complex trauma.Method The HPNF programme was codesigned over 4 years to improve awareness, support, recognition and assessment of trauma. Components include (1) a trauma-aware, healing-informed training and resource package for service providers; (2) trauma-awareness resources for parents; (3) organisational readiness assessment; (4) a database for parents and service providers to identify accessible and appropriate additional support and (5) piloting safe recognition and assessment processes. The programme will be implemented in a large rural health service in Victoria, Australia, over 12 months. Evaluation using a mixed-methods approach will assess feasibility, acceptability, cost, effectiveness and sustainability. This will include service user and provider interviews; service usage and cost auditing; and an administrative linked data study of parent and infant outcomes.Analysis Qualitative data will be analysed using reflexive thematic analysis. Quantitative and service usage outcomes will be described as counts and proportions. Evaluation of health outcomes will use interrupted time series analyses. Triangulation of data will be conducted and mapped to the Consolidated Framework for Implementation Research and Reach, Effectiveness, Adoption, Implementation and Maintenance frameworks to understand factors influencing feasibility, acceptability, effectiveness, cost and sustainability.Ethics and dissemination Approval granted from St Vincent’s Melbourne Ethics Committee (approval no. 239/22). Data will be disseminated according to the strategy outlined in the codesign study protocol, in-line with the National Health and Medical Research Council Aboriginal and Torres Strait Islander Research Excellence criteria.

Introduction Communicating complex information about haemodialysis (HD) and ensuring it is well understood remains a challenge for clinicians. Informed consent is a high-impact checkpoint in augmenting patients’ decision awareness and engagement prior to HD. The aims of this study are to (1) develop a digital information interface to better equip patients in the decision-making process to undergo HD; (2) evaluate the effectiveness of the co-designed digital information interface to improve patient outcomes; and (3) evaluate an implementation strategy.Methods and analysis First, a co-design process involving consumers and clinicians to develop audio-visual content for an innovative digital platform. Next a two-armed, open-label, multicentre, randomised controlled trial will compare the digital interface to the current informed consent practice among adult HD patients (n=244). Participants will be randomly assigned to either the intervention or control group. Intervention group: Participants will be coached to an online platform that delivers a simple-to-understand animation and knowledge test questions prior to signing an electronic consent form. Control group: Participants will be consented conventionally by a clinician and sign a paper consent form. Primary outcome is decision regret, with secondary outcomes including patient-reported experience, comprehension, anxiety, satisfaction, adherence to renal care, dialysis withdrawal, consent time and qualitative feedback. Implementation of eConsent for HD will be evaluated concurrently using the Consolidation Framework for Implementation Research (CFIR) methodology. Analysis: For the randomised controlled trial, data will be analysed using intention-to-treat statistical methods. Descriptive statistics and CFIR-based analyses will inform implementation evaluation.Ethics and dissemination Human Research Ethics approval has been secured (Metro North Health Human Research Ethics Committee B, HREC/2022/MNHB/86890), and Dissemination will occur through partnerships with stakeholder and consumer groups, scientific meetings, publications and social media releases.Trial registration number Australian and New Zealand Clinical Trials Registry (ACTRN12622001354774).

Introduction Listening and communication difficulties can limit people’s participation in activity and adversely affect their quality of life. Hearing, as well as listening and communication difficulties, can be measured either by using behavioural tests or self-report measures, and the outcomes are not always closely linked. The association between behaviourally measured and self-reported hearing is strong, whereas the association between behavioural and self-reported measures of listening and communication difficulties is much weaker, suggesting they assess different aspects of listening. While behavioural measures of listening and communication difficulties have been associated with poorer cognitive performance including executive functions, the same association has not always been shown for self-report measures. The objective of this systematic review and meta-analysis is to understand the relationship between executive function and self-reported listening and communication difficulties in adults with hearing loss, and where possible, potential covariates of age and pure-tone audiometric thresholds.Methods and analysis Studies will be eligible for inclusion if they report data from both a self-report measure of listening difficulties and a behavioural measure of executive function. Eight databases are to be searched: MEDLINE (via Ovid SP), EMBASE (via Ovid SP), PsycINFO (via Ovid SP), ASSIA (via ProQuest), Cumulative Index to Nursing and Allied Health Literature or CINAHL (via EBSCO Host), Scopus, PubMed and Web of Science (Science and Social Science Citation Index). The JBI critical appraisal tool will be used to assess risk of bias for included studies. Results will be synthesised primarily using a meta-analysis, and where sufficient quantitative data are not available, a narrative synthesis will be carried out to describe key results.Ethics and dissemination No ethical issues are foreseen. Data will be disseminated via academic publication and conference presentations. Findings may also be published in scientific newsletters and magazines.PROSPERO registration number CRD42022293546.

Introduction The increasing prevalence of developmental disorders in early childhood poses a significant global health burden. Early detection of developmental problems is vital to ensure timely access to early intervention, and universal developmental surveillance is recommended best practice for identifying issues. Despite this, there is currently considerable variation in developmental surveillance and screening between Australian states and territories and low rates of developmental screening uptake by parents. This study aims to evaluate an innovative web-based developmental surveillance programme and a sustainable approach to referral and care pathways, linking primary care general practice (GP) services that fall under federal policy responsibility and state government-funded child health services.Methods and analysis The proposed study describes a longitudinal cluster randomised controlled trial (c-RCT) comparing a ‘Watch Me Grow Integrated’ (WMG-I) approach for developmental screening, to Surveillance as Usual (SaU) in GPs. Forty practices will be recruited across New South Wales and Queensland, and randomly allocated into either the (1) WMG-I or (2) SaU group. A cohort of 2000 children will be recruited during their 18-month vaccination visit or opportunistic visit to GP. At the end of the c-RCT, a qualitative study using focus groups/interviews will evaluate parent and practitioner views of the WMG-I programme and inform national and state policy recommendations.Ethics and dissemination The South Western Sydney Local Health District (2020/ETH01625), UNSW Sydney (2020/ETH01625) and University of Queensland (2021/HE000667) Human Research Ethics Committees independently reviewed and approved this study. Findings will be reported to the funding bodies, study institutes and partners; families and peer-reviewed conferences/publications.Trial registration number ANZCTR12621000680864.

Introduction Hearing aids are the gold standard treatment to help manage hearing loss. However, not everyone who needs them has them, and of those who do, a significant proportion of people do not use them at all, or use them infrequently. Despite literature reviews listing key barriers and enablers to the uptake and use of hearing aids, there is little evidence to describe how this varies by population and context. This review will describe what factors are important to whom in what context when considering the provision of hearing aids for hearing loss in adults.Methods and analysis The aims of this review are as follows: (1) To iteratively review and synthesise evidence surrounding the provision of hearing aids for hearing loss in adults. (2) To generate a theory-driven understanding of factors that are important, for whom, and in what context. (3) To develop a programme theory describing contexts that can support the provision of hearing aids to result in improved outcomes for adults with hearing loss. A scoping literature search will aid the development of programme theories, to explain how the intervention is expect to work, for whom, in what circumstances and in which contexts. We will locate evidence in the following databases: CINAHL, Cochrane Library, EMBASE, MEDLINE, PsycINFO, PubMED, Web of Science with no date restrictions. A realist analytic approach will be used to refute and refine these initial programme theories. Throughout the review, relevant key stakeholders (eg, patients and clinicians) will be consulted to test and refine the programme theories.Ethics and dissemination This study was approved by the University of Nottingham Faculty of Medicine and Health Sciences Research Ethics Committee: (FMHS 95-0820) and the London Brent NHS Research Ethics Committee (Ref: 21/PR/0259). The review will be reported according to the RAMESES guidelines and published in a peer-reviewed journal.PROSPERO registration number CRD42021282049.

Introduction Bariatric surgery is an effective method of controlling glycaemia in patients with type 2 diabetes mellitus (T2DM) and obesity. Long-term studies suggest that although glycaemic control remains good, only 20%–40% of patients will maintain remission according to the American Diabetes Association criteria.Purpose This trial aims to examine the safety and efficacy of combining Roux-en-Y gastric bypass or sleeve gastrectomy with goal-directed medical therapy to improve long-term glycaemic control of T2DM.Methods and analysis This prospective, open-label multicentre randomised controlled trial (RCT) will recruit 150 patients with obesity and T2DM from tertiary care obesity centres. Patients will be randomised 1:1 to receive either bariatric surgery and standard medical care or bariatric surgery and intensive goal-directed medical therapy, titrated to specific targets for glycated haemoglobin (HbA1c), blood pressure (BP) and low-density lipoproteins (LDL) cholesterol. The primary endpoints are the proportion of patients in each arm with an HbA1c

Objective Develop a comprehensive socially inclusive measure to assess child resilience factors.Design A socioecological model of resilience, community-based participatory research methods and two rounds of psychometric testing created the Child Resilience Questionnaire (parent/caregiver report, child report, school report). The parent/caregiver report (CRQ-P/C) is the focus of this paper.Setting Australia.Participants Culturally and socially diverse parents/caregivers of children aged 5–12 years completed the CRQ-P/C in the pilot (n=489) and validation study (n=1114). Recruitment via a large tertiary hospital’s outpatient clinics, Aboriginal and refugee background communities (Aboriginal and bicultural researchers networks) and nested follow-up of mothers in a pregnancy cohort and a cohort of Aboriginal families.Analysis Exploratory and confirmatory factor analyses conducted to assess the structure and construct validity of CRQ-P/C subscales. Cronbach’s alpha used to assess internal consistency of subscales. Criterion validity assessed with the Strengths and Difficulties Questionnaire (SDQ) parent report.Results Conceptually developed CRQ comprised 169 items in 19 subscales across five socioecological domains (self, family, friends, school and community). Two rounds of psychometric revision and community consultations created a CRQ-P/C with 43 items in 11 scales: self (positive self, positive future, managing emotions), family (connectedness, guidance, basic needs), school (teacher support, engagement, friends) and culture (connectedness, language). Excellent scale reliability (α=0.7–0.9), except basic needs scale (α=0.61) (where a highly endorsed item was retained for conceptual integrity). Criterion validity was supported: scales had low to moderate negative correlations with SDQ total difficulty score (Rs= -0.2/–0.5. p

Introduction Making health-related decisions can be difficult due to the amount and complexity of information available. Audio-visual information may improve memory for health information but whether audio-visual information can enhance health-related decisions has not been explored using quantitative methods. The objective of this systematic review is to understand how effective audio-visual information is for informing health-related decision-making compared with audio-only or visual-only information.Methods and analysis Randomised controlled trials (RCTs) will be included if they include audio-visual and either audio-only or visual-only information provision and decision-making in a health setting. Studies will be excluded if they are not reported in English. Twelve databases will be searched including: Ovid MEDLINE, PubMed and PsychINFO. The Cochrane Risk of Bias tool (V.7) will be used to assess risk of bias in included RCTs. Results will be synthesised primarily using a meta-analysis; where quantitative data are not reported, a narrative synthesis will be used.Ethics and dissemination No ethical issues are foreseen. Data will be disseminated via academic publication and conference presentations. Findings may also be published in scientific newsletters and magazines. This review is funded by the Economic and Social Research Council.PROSPERO registration number CRD42021255725.

Introduction Research highlights the importance of early intervention for children with autism spectrum disorder with better outcomes associated with earlier access to early intensive intervention (EII) programmes. However, there is significant variability in response to EII despite children receiving the same programmes.Methods and analysis A prospective, multisite cohort study using a pre–post design assesses the predictors of early intervention outcomes for children who receive EII through six early intervention services (Autism Specific Early Learning and Care Centres, ASELCCs) across Australia. Child and family characteristics at entry to and exit from ASELCCs are ascertained using measures of autism symptoms (Autism Diagnostic Observation Schedule-2; Social Communication Questionnaire); cognitive, language and developmental skills (Mullen Scale of Early Learning); adaptive function (Vineland Adaptive Behaviour Scale—second Edition); behaviours (Child Behaviour Checklist—1.5 to 5 years; Restricted Repetitive Behaviour Scale); parental stress (Parent Stress Index-4 Short Form); quality of life (Quality of Life in Autism Scale) and a semistructured family history questionnaire for sociodemographic, family and psychosocial characteristics. Characteristics at entry are used as predictors of outcome at exit following EII approximately 12 months later. The change in score from baseline to exit will be the primary outcome of interest. The mediating role of family and psychosocial factors will also be considered.Ethics approval University of New South Wales Human Research Ethics Committee (HC14267).Dissemination of results Findings will be published in peer-reviewed journals and presented at conferences. A report summarising data and the interpretation of data will be published.

Introduction There are no well-established biomedical treatments for the core symptoms of autism spectrum disorder (ASD). A small number of studies suggest that repetitive transcranial magnetic stimulation (rTMS), a non-invasive brain stimulation technique, may improve clinical and cognitive outcomes in ASD. We describe here the protocol for a funded multicentre randomised controlled clinical trial to investigate whether a course of rTMS to the right temporoparietal junction (rTPJ), which has demonstrated abnormal brain activation in ASD, can improve social communication in adolescents and young adults with ASD.Methods and analysis This study will evaluate the safety and efficacy of a 4-week course of intermittent theta burst stimulation (iTBS, a variant of rTMS) in ASD. Participants meeting criteria for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition ASD (n=150, aged 14–40 years) will receive 20 sessions of either active iTBS (600 pulses) or sham iTBS (in which a sham coil mimics the sensation of iTBS, but no active stimulation is delivered) to the rTPJ. Participants will undergo a range of clinical, cognitive, epi/genetic, and neurophysiological assessments before and at multiple time points up to 6 months after iTBS. Safety will be assessed via a structured questionnaire and adverse event reporting. The study will be conducted from November 2020 to October 2024.Ethics and dissemination The study was approved by the Human Research Ethics Committee of Monash Health (Melbourne, Australia) under Australia’s National Mutual Acceptance scheme. The trial will be conducted according to Good Clinical Practice, and findings will be written up for scholarly publication.Trial registration number Australian New Zealand Clinical Trials Registry (ACTRN12620000890932).

Introduction Hearing loss is a chronic condition affecting 12 million individuals in the UK. People with hearing loss regularly experience difficulties interacting in everyday conversations. These difficulties in communication can result in a person with hearing loss withdrawing from social situations and becoming isolated. While hearing loss research has largely deployed quantitative methods to investigate various aspects of the condition, qualitative research is becoming more widespread. Grounded theory is a specific qualitative methodology that has been used to establish novel theories on the experiences of living with hearing loss.Method and analysis The aim of this systematic review is to establish how grounded theory has been applied to investigate the psychosocial aspects of hearing loss. Methods are reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols 2015 checklist. Studies included in this review will have applied grounded theory as an overarching methodology or have grounded theory embedded among other methodologies. Studies included will have adult participants (≥18 years) who are either people with an acquired hearing loss, their family and friends (communication partners), or healthcare practitioners including audiologists, general practitioners, ear, nose and throat specialists and hearing therapists. The quality of application of grounded theory in each study will be assessed using the Guideline for Reporting and Evaluating Grounded Theory Research Studies.Ethics and dissemination As only secondary data will be used in this systematic review, ethical approval is not required. No other ethical issues are foreseen. This review is registered with the International Prospective Register of Systematic Reviews (http://www.crd.york.ac.uk/PROSPERO). Findings will be disseminated via peer-reviewed publications and at relevant academic conferences. Findings may also be published in relevant professional and third sector newsletters and magazines as appropriate. Data will inform future research and guideline development.PROSPERO registration number CRD42019134197.

Objective To determine research priorities in hyperacusis that key stakeholders agree are the most important.Design/setting A priority setting partnership using two international surveys, and a UK prioritisation workshop, adhering to the six-staged methodology outlined by the James Lind Alliance.Participants People with lived experience of hyperacusis, parents/carers, family and friends, educational professionals and healthcare professionals who support and/or treat adults and children who experience hyperacusis, including but not limited to surgeons, audiologists, psychologists and hearing therapists.Methods The priority setting partnership was conducted from August 2017 to July 2018. An international identification survey asked respondents to submit any questions/uncertainties about hyperacusis. Uncertainties were categorised, refined and rephrased into representative indicative questions using thematic analysis techniques. These questions were verified as ‘unanswered’ through searches of current evidence. A second international survey asked respondents to vote for their top 10 priority questions. A shortlist of questions that represented votes from all stakeholder groups was prioritised into a top 10 at the final prioritisation workshop (UK).Results In the identification survey, 312 respondents submitted 2730 uncertainties. Of those uncertainties, 593 were removed as out of scope, and the remaining were refined into 85 indicative questions. None of the indicative questions had already been answered in research. The second survey collected votes from 327 respondents, which resulted in a shortlist of 28 representative questions for the final workshop. Consensus was reached on the top 10 priorities for future research, including identifying causes and underlying mechanisms, effective management and training for healthcare professionals.Conclusions These priorities were identified and shaped by people with lived experience, parents/carers and healthcare professionals, and as such are an essential resource for directing future research in hyperacusis. Researchers and funders should focus on addressing these priorities.

IntroductionChild maltreatment and other traumatic events can have serious long-term physical, social and emotional effects, including a cluster of distress symptoms recognised as ‘complex trauma’. Aboriginal and Torres Strait Islander (Aboriginal) people are also affected by legacies of historical trauma and loss. Trauma responses may be triggered during the transition to parenting in the perinatal period. Conversely, becoming a parent offers a unique life-course opportunity for healing and prevention of intergenerational transmission of trauma. This paper outlines a conceptual framework and protocol for an Aboriginal-led, community-based participatory action research (action research) project which aims to co-design safe, acceptable and feasible perinatal awareness, recognition, assessment and support strategies for Aboriginal parents experiencing complex trauma.Methods and analysisThis formative research project is being conducted in three Australian jurisdictions (Northern Territory, South Australia and Victoria) with key stakeholders from all national jurisdictions. Four action research cycles incorporate mixed methods research activities including evidence reviews, parent and service provider discussion groups, development and psychometric evaluation of a recognition and assessment process and drafting proposals for pilot, implementation and evaluation. Reflection and planning stages of four action research cycles will be undertaken in four key stakeholder workshops aligned with the first four Intervention Mapping steps to prepare programme plans.Ethics and disseminationEthics and dissemination protocols are consistent with the National Health and Medical Research Council Indigenous Research Excellence criteria of engagement, benefit, transferability and capacity-building. A conceptual framework has been developed to promote the application of core values of safety, trustworthiness, empowerment, collaboration, culture, holism, compassion and reciprocity. These include related principles and accompanying reflective questions to guide research decisions.