BIGDATA: A Protocol to Create and Extend a 25-Year Clinical Trial and Observational Data Asset to Address Key Knowledge Gaps in Otitis Media and Hearing Loss in Australian Aboriginal and Non-Aboriginal Children.

2022-04-14

Beissbarth, Jemima

Smith-Vaughan, Heidi

Cheng, Allen

Morris, Peter

Leach, Amanda

Menzies School of Health Research, Charles Darwin University, Darwin, NT, Australia.

Menzies School of Health Research, Charles Darwin University, Darwin, NT, Australia.

School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.

Infection Prevention and Healthcare Epidemiology Unit, Alfred Health, Melbourne, VIC, Australia.

Menzies School of Health Research, Charles Darwin University, Darwin, NT, Australia.

Royal Darwin Hospital, Darwin, NT, Australia.

Menzies School of Health Research, Charles Darwin University, Darwin, NT, Australia.

Streptococcus pneumoniae

antimicrobial resistance

indigenous

middle ear microbiology

nasopharyngeal carriage

non-typeable Haemophilus influenzae

otitis media

pneumococcal conjugate vaccines

Journal Article

Publication

INTRODUCTION: Otitis media (OM) is a common childhood illness, often resolving without intervention and acute and long-term complications are rare. However, Australian Aboriginal and Torres Strait Islander infants and children experience a high burden of OM and are at high risk of complications (tympanic membrane perforation and chronic infections). Bacterial OM is commonly associated with , non-typeable , and . BIGDATA is a data asset combining over 25 years of microbiology and OM surveillance research from the Ear Health Research Program at Menzies School of Health Research (Northern Territory, Australia), including 11 randomized controlled trials, four cohort studies, eight surveys in over 30 remote communities (including data from Western Australia), and five surveys of urban childcare centers including Aboriginal and Torres Strait Islander and non-Indigenous children. Outcome measures include clinical examinations (focusing on OM), antibiotic prescriptions, pneumococcal vaccination, modifiable risk factors such as smoking and household crowding, and nasopharyngeal and ear discharge microbiology including antimicrobial resistance testing. METHODS AND ANALYSIS: The initial series of projects are planned to address the following key knowledge gaps: (i) otitis media prevalence and severity over pre pneumococcal conjugate vaccines (PCVs) and three eras of increasing PCV valency; (ii) impact of increasing valency PCVs on nasopharyngeal carriage dynamics of pneumococcal serotypes, and antimicrobial resistance; (iii) impact of increasing valency PCVs on nasopharyngeal carriage dynamics and antimicrobial resistance of other otopathogens; and (iv) serotype specific differences between children with acute OM and OM with effusion or without OM. These data will be utilized to identify research gaps, providing evidence-based prioritization for ongoing research. ETHICS AND DISSEMINATION: Data asset creation and priority analyses were approved by the Human Research Ethics Committee of Northern Territory Department of Health and Menzies School of Health Research (EC00153, 18-3281), the Child and Adolescent Health Service Human Research Ethics Committee and Western Australian Aboriginal Health Ethics Committee. Dissemination will be through peer review publication and conference presentations.

link

Front Pediatr . 2022 Apr 14:10:804373. doi: 10.3389/fped.2022.804373. eCollection 2022.

2296-2360

2296-2360

https://pubmed.ncbi.nlm.nih.gov/35498792/?otool=iaurydwlib