None listed
Conditions
Brief summary
Complications of ear disease, including hearing impairment and chronically infected ears, particularly chronic suppurative otitis media, can affect education, social circumstances and quality of life. Aboriginal and Torres Strait Islander children are known to have higher rates of otitis media than other children and to be more likely to develop complications. However, almost all of the research into prevalence, risk factors and treatment has been done in remote settings, despite the majority of Aboriginal and Torres Strait Islander peoples living in urban areas. In developed countries, immediate antibiotic treatment confers only a modestly decreased duration of pain and fever. Given the public health risks of antibiotic resistance, a “watchful waiting” approach to treatment is recommended for children at low risk of complications of AOM. Similarly, a recent change in national guidelines for treatment of AOM in Aboriginal and Torres Strait Islander children has recommended a shift from giving immediate antibiotic therapy for all such children, to using a “watchful waiting” approach in urban children presumed to be at low risk of complications. We will work with five Aboriginal Community Controlled Health Services and one Indigenous health service. With these services we will recruit approximately 500 children in order to provide randomised controlled trial (RCT) evidence to determine if watchful waiting is at least as effective as immediate antibiotic treatment for urban Aboriginal and Torres Strait Islander children with AOM. In addition, we will examine the cost effectiveness of the two treatment approaches from health services, societal and individual patient perspectives. We will also undertake qualitative research including process evaluation to document the implementation of the trial in each site, and the views and attitudes of the health care providers and study participants to the study and to the conduct of an RCT in Aboriginal and Torres Strait Islander communities. This is the first trial of antibiotics versus watchful waiting in urban Aboriginal and/or Torres Strait Islander children who present to a primary health care service with AOM. This research addresses two NHMRC priorities: Aboriginal health; and hearing. Our investigator team includes two Aboriginal researchers and staff from three Aboriginal health services who have contributed to this proposal from its early stages. Our research team is well placed to ensure translation of the research findings into policy and practice.
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
1. Aboriginal and/or Torres Strait Islander child (as defined by the health service they are attending) 2. Aged 18 months to 16 years (inclusive) 3. First enrolment into the study 4. Current acute otitis media without perforation diagnosed by a medical practitioner due to fluid in the middle ear on tympanometry (Type B tympanogram) and at least one of the following: bulging of the eardrum on otoscopy, ear pain
Exclusion criteria
The child has been on any antibiotic in the previous 4 days At high risk of chronic suppurative otitis media (CSOM), as defined by residing in geographic area known to have prevalence of CSOM >4% A grommet in situ, or current or past history of tympanic membrane perforation A condition which increases the risk of complications (e.g., immunosuppression, genetic or chromosomal abnormality, cleft palate or mid-face abnormalities such as seen in Down Syndrome) Systemic features necessitating antibiotic treatment (e.g., septicaemia, meningitis, pneumonia, or urinary tract infection)