Bringing together 20 years of Otitis Media research. (CIA Leach, Morris, Mulholland, Lehmann, Cheng, Marsh, Smith-Vaughan, Torzillo and Silburn).
Our Ear Health Research Program has applied standardised assessments of ear disease and nasopharyngeal (NP) carriage that have retained core methods since 1992. Lifestyle questionnaires have also been administered regarding social determinants (household crowding and maternal education), and modifiable risk factors such as smoking and breastfeeding. Vaccination status and antibiotic prescribing have also been collected prospectively.
While this data has the potential to answer many hypothesis regarding otitis media (OM), three key questions have been posed by the CRE.
- Vaccine efficacy
- Calculate vaccine efficacy
- Design efficient informative sentinel surveillance
- Measure the direct and indirect (herd) effects of PCV13 including serotype replacement in the NT and WA
- Monitor causal pathways to OM
- Antibiotic resistance and treatment failure
- The BIGDATA from surveillance over 20 years will be used to measure the prevalence of antimicrobial resistant and susceptible strains of each non-vaccine serotype, such as serotype 16F56 that have persisted over time, or serotypes 6C or 15B that have emerged since PCV introduction
- Meta-analysis of individual patient data from azithromycin trials19 will be used to better understand the relationship between antibiotic resistance and clinical outcome.
- Large datasets will increase statistical power and enable meta-analyses of antimicrobial therapies and OM outcomes. Public concern regarding rising prevalence of antimicrobial resistance is challenged by the incredibly high incidence of infection among Indigenous people. These data are critical to evidence based policy and recommendations to justify the best use of azithromycin in the treatment of OM high-risk children.
- To describe the social and educational disadvantage associated with very early onset of persistent OM.
We believe that early onset of OM, and particularly early TMP, predicts greater hearing loss, greater demand for ENT services, and poorer developmental and educational outcomes.
- Studies that include middle ear assessments in the first six months of life will be selected from the bigdata set for linkage with Departments of Health and Education routinely collected administrative data at individual level, such as referrals to ENT surgeons, audiologists and speech pathologists, school attendance and the National Assessment Program – Literacy and Numeracy (NAPLAN) and Australian Early Development Index (AEDI) results. We have ethical approval for original studies and will seek approval to waive individual consent for linkage with administrative health and education data at the individual level.
- This linkage of our high quality standardised OM assessment data from clinical trials (not available from routine health care) with administrative data on long term health, social and educational outcomes is an innovative, efficient way of gaining much greater knowledge of how early OM is affecting the quality of life for Indigenous children.