Chronic otitis media A scoping review and evidence map for a suite of Cochrane reviews Mahmood Bhutta TWJ & Colledge Family Memorial Otology Fellow Systematic review team Dr Chris Brennan-Jones, Prof Anne Schilder, Prof Martin Burton, Dr Lee-Yee Chong, Karen Head Lead Patient Representative Courtney McMahen Clinical expert team Dr Mahmood Bhutta, Prof Shyan Vijayasekaran, Prof Peter Richmond, Prof Peter Morris, Dr Tom Snelling, Dr Nathan Tu

Background Chronic suppurative otitis media is a major global disease Disproportionately affects poor & under-resourced populations Regional prevalence of CSOM per thousand population (2005) Two Cochrane reviews completed over 10 years ago. Need to examine evidence from new trials and provide relevant guidance based on those findings. Also an opportunity to examine emerging treatments like Betadine ear washes, which are currently the subject of trials. Original plan was for 2-3 reviews of pragmatic treatments such as topical antiseptics (i.e. Betadine ear wash) – but decided this was a good opportunity to pursue the full suite of non-surgical interventions for CSOM Our searches identified one major international guideline: the current World Health Organization (WHO) guideline, published in 2004 (CSOM – burden of illness and management options). Part of the evidence base that was used to support this guideline was published as two Cochrane systematic reviews on the use of antibiotics. CD005608: Systemic antibiotics versus topical treatments for chronically discharging ears with underlying eardrum perforations; CD004618: Topical antibiotics without steroids for chronically discharging ears with underlying eardrum perforations

Treatments Primary ear care Medical care Surgical care Aural toileting Topical antiseptics Topical antibiotics +/- steroids Systemic antibiotics Tympanoplasty Surgical care Medical care Primary ear care Two Cochrane reviews completed over 10 years ago. Need to examine evidence from new trials and provide relevant guidance based on those findings. Also an opportunity to examine emerging treatments like Betadine ear washes, which are currently the subject of trials. Original plan was for 2-3 reviews of pragmatic treatments such as topical antiseptics (i.e. Betadine ear wash) – but decided this was a good opportunity to pursue the full suite of non-surgical interventions for CSOM Our searches identified one major international guideline: the current World Health Organization (WHO) guideline, published in 2004 (CSOM – burden of illness and management options). Part of the evidence base that was used to support this guideline was published as two Cochrane systematic reviews on the use of antibiotics. CD005608: Systemic antibiotics versus topical treatments for chronically discharging ears with underlying eardrum perforations; CD004618: Topical antibiotics without steroids for chronically discharging ears with underlying eardrum perforations

Aims Initial scoping exercise to identify existing gaps in evidence & to define important outcome measures for interventions for COM External stakeholder engagement Conduct a suite of high-priority Cochrane reviews on COM Incorporate findings into local, national (CRE_ICHEAR TAG) and international (WHO) clinical guidelines Two Cochrane reviews completed over 10 years ago. Need to examine evidence from new trials and provide relevant guidance based on those findings. Also an opportunity to examine emerging treatments like Betadine ear washes, which are currently the subject of trials. Original plan was for 2-3 reviews of pragmatic treatments such as topical antiseptics (i.e. Betadine ear wash) – but decided this was a good opportunity to pursue the full suite of non-surgical interventions for CSOM Our searches identified one major international guideline: the current World Health Organization (WHO) guideline, published in 2004 (CSOM – burden of illness and management options). Part of the evidence base that was used to support this guideline was published as two Cochrane systematic reviews on the use of antibiotics. CD005608: Systemic antibiotics versus topical treatments for chronically discharging ears with underlying eardrum perforations; CD004618: Topical antibiotics without steroids for chronically discharging ears with underlying eardrum perforations

Evidence base Last Cochrane review conducted in 2005 Many potential trials published since then (1859 hits) Details blinded……

Stakeholder engagement Known experts identified and asked to identify others (snowball effect) 10 Stakeholders recruited (7 Australia, 2 Asia, 1 Africa) Stakeholder opinions elicited (Jan 2017) Which treatments they use & how these are administered Prioritise (rank) review topics Confirm / refute outcome measures Confirm / refute subgroups for analysis Findings and details discussed within research team Finalised protocol

Review topics Topical antibiotics vs placebo (subgroup by antibiotic class) Systemic antibiotics vs placebo (subgroup by antibiotic class) Topical antibiotics vs systemic antibiotics Topical antibiotics vs topical antiseptic Topical antiseptic vs placebo (subgroup by chemical class) Aural toileting vs placebo Topical corticosteroid (+/- antibiotic) vs no corticosteroid Public health measures or preventative therapies Decongestants, antihistamines Surgery

Outcomes Resolution of ear discharge Health related quality of life at 2 weeks, 2-4 weeks, >4 weeks Health related quality of life questionnaires such as COMOT-12, COMOT-15, CES Hearing Pure tone average Adverse effects Pain / discomfort Ototoxicity (hearing loss, dizziness and tinnitus) Secondary fungal infection Primary outcome measures Secondary outcome measures

Analysis controversies Duration of discharge for diagnosis (6 weeks?) Include studies with chronic ear discharge and diagnosis unknown (if proportion is <20%) Exclude cholesteatoma / tympanic membrane retraction Analysis by patient (by ear analysis also) Adjunctive aural toileting ignored for topical therapies Subgroup by Young children (age < 4) High risk groups (grommets, indigenous groups, cleft palate, Down syndrome) Pure tone average is an incomplete evaluation of hearing

Completion timeline Protocols nearing completion Complete analysis by end of 2017 Publish suite of reviews in 2018

Acknowledgments Funding Participants in the stakeholder exercise CRE ICHEAR, 2016-2017 Western Australia Department of Health Colledge Family Memorial Fellowship / TWJ Fellowship Participants in the stakeholder exercise Traditional owners of this land and their elders Contacts m.bhutta@doctors.org.uk Chris.brennan-jones@telethonkids.org.au