The views of parents and carers on managing acute otitis media in urban Aboriginal and Torres Strait Islander children: a qualitative study.

OBJECTIVES: To explore the views of parents and carers regarding the management of acute otitis media in urban Aboriginal and Torres Strait Islander children who are at low risk of complications living in urban communities. STUDY DESIGN: Qualitative study; semi-structured interviews and short telephone survey. SETTING, PARTICIPANTS: Interviews: purposive sample of parents and carers of urban Aboriginal and Torres Strait Islander children (18 months - 16 years old) screened in Aboriginal medical services in Queensland, New South Wales, and Canberra for the WATCH study, a randomised controlled trial that compared immediate antibiotic therapy with watchful waiting for Aboriginal and Torres Strait Islander children with acute otitis media. SURVEY: parents and carers recruited for the WATCH trial who had completed week two WATCH surveys. RESULTS: We interviewed twenty-two parents and carers, including ten who had declined participation in or whose children were ineligible for the WATCH trial. Some interviewees preferred antibiotics for managing acute otitis media, others preferred watchful waiting, expressing concerns about side effects and reduced efficacy with overuse of antibiotics. Factors that influenced this preference included the severity, duration, and recurrence of infection, and knowledge about management gained during the trial and from personal and often multigenerational experience of ear disease. Participants highlighted the importance of shared decision making by parents and carers and their doctors. Parents and carers of 165 of 262 WATCH participants completed telephone surveys (63%); 81 were undecided about whether antibiotics should always be used for treating acute otitis media. Open-ended responses indicated that antibiotic use should be determined by clinical need, support for general practitioners' decisions, and the view that some general practitioners prescribed antibiotics too often. CONCLUSIONS: Parents and carers are key partners in managing acute otitis media in urban Aboriginal and Torres Strait Islander children. Our findings support shared decision making informed by the experience of parents and carers, which could also lead to reduced antibiotic use for managing acute otitis media.

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

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.

Acute otitis media symptoms and symptom scales in research with Aboriginal and Torres Strait Islander children.

BACKGROUND: Aboriginal and Torres Strait Islander children experience a high burden of otitis media. We collected data on symptoms associated with acute otitis media (AOM) in a clinical trial involving children receiving primary care at urban Aboriginal Medical Services. Two scales were employed to monitor symptoms over time: the AOM-Severity of Symptoms scale (AOM-SOS) and the AOM-Faces Scale (AOM-FS). This study took place at a mid-point of the un-blinded trial. METHODS: We examined symptoms at enrolment and day 7, and compared the scales for trends, and bivariate correlation (Spearman's rho) over 14 days. Responsiveness of the scales to clinical change was determined by Friedman's test of trend in two subgroups stratified by day 7 AOM status. We interviewed parents/carers and research officers regarding their experience of the scales and analysed data thematically. RESULTS: Data derived from 224 children (18 months to 16 years; median 3.6 years). Common symptoms associated with AOM at baseline were runny nose (40%), cough (38%) and irritability (36%). More than one third had no or minimal symptoms at baseline according to AOM-SOS (1-2/10) and AOM-FS scores (1-2/7). The scales performed similarly, and were moderately correlated, at all study points. Although scores decreased from day 0 to 14, trends and mean scores were the same whether AOM was persistent or resolved at day 7. Users preferred the simplicity of the AOM-FS but encountered challenges when interpreting it. CONCLUSION: We found minimally symptomatic AOM was common among Aboriginal and Torres Strait Islander children in urban settings. The AOM-SOS and AOM-FS functioned similarly. However, it is likely the scales measured concurrent symptoms related to upper respiratory tract infections, given they did not differentiate children with persistent or resolved AOM based on stringent diagnostic criteria. This appears to limit the research and clinical value of the scales in monitoring AOM treatment among Aboriginal and Torres Strait Islander children.

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.

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).

Psychological Factors and the Development of Chronic Whiplash-associated Disorder(s): A Systematic Review.

OBJECTIVES: To assess which psychological factors are important in the development of chronic whiplash symptoms. METHODS: Searches were conducted across PubMed, CINAHL, Scopus, and PsychINFO up until March 2017. Studies were included if they investigated psychological prognostic factors in association with recovery from a whiplash injury. Studies also had to be prospective, cohort, follow-up or observational studies, have a 6 month follow-up and published in English. Quality assessments were conducted by 2 independent reviewers. Thirty-one articles were included investigating 34 psychological factors. RESULTS: Poor expectations of recovery, posttraumatic stress symptoms and passive coping emerged as the most consistent prognostic factors of chronic neck pain and/or disability after a whiplash injury. Anxiety, travel anxiety, depression, personality, precollision distress, general psychological distress, and avoidance behavior were not associated with chronic whiplash problems.

A Systematic Review and Meta-Analysis of the Effectiveness of Psychological Interventions Delivered by Physiotherapists on Pain, Disability and Psychological Outcomes in Musculoskeletal Pain Conditions.

OBJECTIVE: This systematic review and meta-analysis examined the effectiveness of physiotherapist delivered psychological interventions combined with physiotherapy on pain, disability, and psychological outcomes for patients with musculoskeletal pain conditions. METHODS: The review was conducted in accordance with the (PRISMA) guidelines. Five databases were systematically searched for randomized controlled trials from inception to May 2016. Studies were required to compare a psychological intervention delivered by physiotherapists combined with physiotherapy to physiotherapy alone or usual care. Physiotherapists delivering the interventions must have undergone training by a psychologist or a health professional trained in the delivery of psychological interventions. RESULTS: A total of 34 articles met the eligibility criteria, of those, 30 were suitable for meta-analysis. There was low to high quality evidence that physiotherapist delivered psychological intervention combined with physiotherapy decreased pain in the short (26 studies, mean difference=-0.37; 95% confidence interval [CI], -0.65 to -0.09) and long term (22 studies, mean difference=-0.38; 95% CI, -0.67 to -0.10) and decreased disability in the short term (29 studies, standardized mean difference =-0.14; 95% CI, -0.26 to -0.01). Effect sizes were small. Low to high quality evidence demonstrated small to medium effects for some psychological outcomes at short-term and long-term follow-ups. DISCUSSION: The results indicate that psychological interventions delivered by physiotherapist show promise to improve health outcomes, particularly psychological outcomes, in musculoskeletal pain conditions.

Trauma-focused cognitive behaviour therapy and exercise for chronic whiplash: protocol of a randomised, controlled trial.

INTRODUCTION: As a consequence of a road traffic crash, persistent pain and disability following whiplash injury are common and incur substantial personal and economic costs. Up to 50% of people who experience a whiplash injury will never fully recover and up to 30% will remain moderately to severely disabled by the condition. The reason as to why symptoms persist past the acute to sub-acute stage and become chronic is unclear, but likely results from complex interactions between structural injury, physical impairments, and psychological and psychosocial factors. Psychological responses related to the traumatic event itself are becoming an increasingly recognised factor in the whiplash condition. Despite this recognition, there is limited knowledge regarding the effectiveness of psychological interventions, either delivered alone or in combination with physiotherapy, in reducing the physical and pain-related psychological factors of chronic whiplash. Pilot study results have shown positive results for the use of trauma-focused cognitive behaviour therapy to treat psychological factors, pain and disability in individuals with chronic whiplash. The results have indicated that a combined approach could not only reduce psychological symptoms, but also pain and disability. AIMS: The primary aim of this randomised, controlled trial is to investigate the effectiveness of combined trauma-focused cognitive behavioural therapy, delivered by a psychologist, and physiotherapy exercise to decrease pain and disability of individuals with chronic whiplash and post-traumatic stress disorder (PTSD). The trial also aims to investigate the effectiveness of the combined therapy in decreasing post-traumatic stress symptoms, anxiety and depression. PARTICIPANTS AND SETTING: A total of 108 participants with chronic whiplash-associated disorder (WAD) grade II of > 3 months and < 5 years duration and PTSD (diagnosed with the Clinician Administered PTSD Scale (CAPS) according to the DSM-5) will be recruited for the study. Participants will be assessed via phone screening and in person at a university research laboratory. Interventions will take place in southeast Queensland, Australia and southern Denmark. INTERVENTION: Psychological therapy will be delivered once a week over 10 weeks, with participants randomly assigned to either trauma-focused cognitive behavioural therapy or supportive therapy, both delivered by a clinical psychologist. Participants will then receive ten sessions of evidence-based physiotherapy exercise delivered over a 6-week period. OUTCOME MEASURES: The primary outcome measure is neck disability (Neck Disability Index). Secondary outcomes focus on: pain intensity; presence and severity of PTSD (CAPS V and PTSD Checklist 5); psychological distress (Depression, Anxiety Stress Scale 21); patient perceived functionality (SF-12, Tampa Scale of Kinesiophobia, and Patient-Specific Functional Scale); and pain-specific self-efficacy and catastrophising (Pain Self-Efficacy Questionnaire and Pain Catastrophizing Scale). After psychotherapy (10 weeks after randomisation) and physiotherapy (16 weeks after randomisation), as well as at the 6-month and 12-month follow-ups, a blind assessor will measure the outcomes. ANALYSIS: All analyses will be conducted on an intention-to-treat basis. The primary and secondary outcomes that are measured will be analysed using linear mixed and logistic regression models. Any effect of site (Australia or Denmark) will be evaluated by including a site-by-treatment group-by-time interaction term in the mixed models analyses. Effect modification will only be assessed for the primary outcome of the Neck Disability Index. DISCUSSION: This study will provide a definitive evaluation of the effects of adding trauma-focused cognitive behaviour therapy to physiotherapy exercise for individuals with chronic WAD and PTSD. This study is likely to influence the clinical management of whiplash injury and will have immediate clinical applicability in Australia, Denmark and the wider international community. The study will also have implications for both health and insurance policy makers in their decision-making regarding treatment options and funding.