The 22 methodological elements which defined the community-controlled design of the ear trial may assist community groups, external research bodies and funding agencies to improve the acceptability, quality and scope of research involving Indigenous peoples. Aboriginal community-controlled organisations are well placed to lead research, which can be interventional and of a high scientific standard without compromising the values and principles of those being researched. With over 120 Aboriginal community-controlled health services (ACCHSs) across Australia, the potential exists for these services to engage in multi-centre research to realise solutions to health problems faced by Indigenous Australians.
Objectives: To compare the effectiveness of ototopical ciprofloxacin (0.3%; CIP) with framycetin (0.5%), gramicidin, dexamethasone (FGD) eardrops (5 drops twice daily for 9 days) together with povidone‐iodine (0.5%) ear cleaning as treatments for chronic suppurative otitis media (CSOM) in Aboriginal children.
Design and participants: Aboriginal community‐controlled, community‐based, multicentre, double‐blind, randomised controlled trial in eight Aboriginal Community Controlled Health Services across northern Australia, involving 147 Aboriginal children with CSOM.
Main outcome measures: Resolution of otorrhoea (clinical cure), proportion of children with healed perforated tympanic membrane (TM) and improved hearing, 10–21 days after starting treatment.
Results: 111 children aged 1–14 years (CIP, 55; FGD, 56) completed treatment. CSOM cures occurred in 64% (CIP, 76.4%; FGD, 51.8%), with a significantly higher rate in the ciprofloxacin group (P = 0.009, absolute difference of 24.6% [95% CI, 15.8%–33.4%]). TM perforation size and the level of hearing impairment did not change. Pseudomonas aeruginosa was the most common bacterial pathogen (in 47.6%), while respiratory pathogens were rare (in 5.7%).
Conclusions: Twice‐daily ear cleaning and topical ciprofloxacin is effective at community‐level in achieving cure for CSOM. Healthcare providers to Aboriginal children with CSOM should be given special access to provide ototopical ciprofloxacin as first‐line treatment.
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