INFLATE : a protocol for a randomised controlled trial comparing nasal balloon autoinflation to no nasal balloon autoinflation for otitis media with effusion in Aboriginal and Torres Strait Islander children

Background: Otitis media with effusion (OME) is common and occurs at disproportionately higher rates among Indigenous children. Left untreated, OME can negatively affect language, development, learning, and health and wellbeing throughout the life-course. Currently, OME care includes observation for 3 months followed by consideration of surgical ventilation tube insertion. The use of a non-invasive, low-cost nasal balloon autoinflation device has been found beneficial in other populations but has not been investigated among Aboriginal and Torres Strait Islander children. Methods/design: This multi-centre, open-label, randomised controlled trial will determine the effectiveness of nasal balloon autoinflation compared to no nasal balloon autoinflation, for the treatment of OME among Aboriginal and Torres Strait Islander children in Australia. Children aged 3–16 years with unilateral or bilateral OME are being recruited from Aboriginal Health Services and the community. The primary outcome is the proportion of children showing tympanometric improvement of OME at 1 month. Improvement is defined as a change from bilateral type B tympanograms to at least one type A or C1 tympanogram, or from unilateral type B tympanogram to type A or C1 tympanogram in the index ear, without deterioration (type A or C1 to type C2, C3, or B tympanogram) in the contralateral ear. A sample size of 340 children (170 in each group) at 1 month will detect an absolute difference of 15% between groups with 80% power at 5% significance. Anticipating a 15% loss to follow-up, 400 children will be randomised. The primary analysis will be by intention to treat. Secondary outcomes include tympanometric changes at 3 and 6 months, hearing at 3 months, ear health-related quality of life (OMQ-14), and cost-effectiveness. A process evaluation including perspectives of parents or carers, health care providers, and researchers on trial implementation will also be undertaken. Discussion: INFLATE will answer the important clinical question of whether nasal balloon autoinflation is an effective and acceptable treatment for Aboriginal and Torres Strait Islander children with OME. INFLATE will help fill the evidence gap for safe, low-cost, accessible OME therapies. Trial registration: Australia New Zealand Clinical Trials Registry ACTRN12617001652369. Registered on 22 December 2017. The Australia New Zealand Clinical Trials Registry is a primary registry of the WHO ICTRP network and includes all items from the WHO Trial Registration data set. Retrospective registration.</p

Mixed-methods evaluation of screening for hearing loss using the hearScreen™ mobile health application in Aboriginal and Torres Strait Islander children presenting to an urban primary healthcare service

Recommendations for hearing screening for Aboriginal and Torres Strait Islander children aged 4 years have a limited evidence base. Using the hearScreen™ (HearX, Camden, DE, USA) mobile health application as part of a mixed-methods study, the aim of this study was to assess the proportion of 4-year-old Aboriginal and Torres Strait Islander children with hearing difficulties, as well as the feasibility and acceptability of the test itself. Of the 145 4-year-old Aboriginal and Torres Strait Islander children who were regular patients of the service during the recruitment period, 50 were recruited to the present study. Of these 50 children, 42 (84%) passed the hearing screening test, 4 (8%) did not and 4 (8%) were unable to complete the test. Nine caregivers were interviewed. Themes included the priority given to children's health by caregivers, positivity and trust in the test, preference for having the test conducted in primary care and the importance of an Aboriginal and Torres Strait Islander person providing the screening test. These findings lend support to hearing screening for school-age children in primary care provided by an Aboriginal and Torres Strait Islander healthcare worker using the hearScreen™ test

The socioemotional challenges and consequences for caregivers of Aboriginal and Torres Strait Islander children with otitis media: A qualitative study

Abstract Introduction Living with ear disease can have extensive impacts on physical, emotional and social well‐being. This study explored otitis media (OM) and its management from the perspective of caregivers of Aboriginal and Torres Strait Islander children. Methods Semi‐structured interviews were conducted from 2015 to 2020 with caregivers of Aboriginal and Torres Strait Islander children with OM. Thematic analysis of transcripts was undertaken using a constructivist grounded theory approach through the leadership and the cultural lens of an Aboriginal community‐based researcher. Results Caregivers described OM as having profound impacts on their child's physical, developmental, and emotional well‐being, with long waits for specialist treatment contributing to extra strain on families. Children's well‐being suffered when OM was mistaken for poor behaviour and children were punished, with caregivers subsequently experiencing strong feelings of guilt. Concerns were conveyed about the social implications of having a sick child. The variable nature of OM symptoms meant that caregivers had to monitor closely for sequelae and advocate for appropriate treatment. Success in navigating the diagnosis and treatment of OM can be strongly impacted by the relationship between caregivers and health professionals and the perceived access to respectful, collaborative and informative healthcare. Conclusion OM may have substantial social and emotional consequences for children and their caregivers. A holistic understanding of the way in which OM impacts multiple facets of health and well‐being, as well as recognition of challenges in accessing proper care and treatment, will aid families managing OM and its sequelae. Patient or Public Contribution Governing boards, managers, staff and community members from five Australian Aboriginal Medical Services were involved in the approval, management and conduct of this study and the wider clinical trials. The caregivers of Aboriginal and Torres Strait Islander patients at these services informed the interview study and guided its purpose

Randomised clinical trial research within Aboriginal and Torres Strait Islander primary health services : A qualitative study

Objective To better understand how to undertake valuable, ethical and sustainable randomised controlled clinical trial (RCT) research within Aboriginal and Torres Strait Islander primary health services. Design In a qualitative approach, we utilised data collected between 2013 and 2020 during the planning and implementation of two RCTs. The data comprised agreed records of research meetings, and semistructured interviews with clinical trial stakeholders. The stakeholders were parents/carers of child participants, and site-based research officers, healthcare providers and community advisory groups. Our thematic analysis was informed by constructivist grounded theory. Setting The RCTs investigated the management of otitis media in Aboriginal and Torres Strait Islander children, with the first RCT commencing recruitment in 2014 and the second in 2017. They took place in Aboriginal Medical Services (AMSs), large primary health services for Aboriginal and Torres Strait Islander people, based in urban and regional communities across two Australian states and one territory. Results We analysed data from 56 meetings and 67 interviews, generating themes on making research valuable and undertaking ethical and sustainable RCTs. Aboriginal and Torres Strait Islander leadership, and support of AMSs in their service delivery function were critical. The broad benefits of the trials were considered important to sustainability, including workforce development, enhanced ear healthcare and multidirectional research capacity building. Participants emphasised the long-term responsibility of research teams to deliver benefits to AMSs and communities regardless of RCT outcomes, and to focus on relationships, reciprocity and creating positive experiences of research. Conclusion We identify principles and strategies to assist in undertaking ethical and sustainable RCTs within Aboriginal and Torres Strait Islander primary health services. Maintaining relationships with AMSs and focusing on mutual workforce development and capacity building creates opportunities for long-term benefits so that health research and RCTs work for Aboriginal and Torres Strait Islander peoples, services, communities and researchers. Trial registration number ACTRN12613001068752 (Pre-results); ACTRN12617001652369 (Pre-results). </p