Evidence for necrotising otitis externa (NOE) diagnosis and management is limited, and outcome reporting is heterogeneous. International best practice guidelines were used to develop consensus diagnostic criteria and a core outcome set (COS).

The study was pre-registered on the Core Outcome Measures in Effectiveness Trials (COMET) database. Systematic literature review identified candidate items. Patient-centred items were identified via a qualitative study. Items and their definitions were refined by multidisciplinary stakeholders in a two-round Delphi exercise and subsequent consensus meeting.

The final COS incorporates 36 items within 12 themes: Signs and symptoms; Pain; Advanced Disease Indicators; Complications; Survival; Antibiotic regimes and side effects; Patient comorbidities; Non-antibiotic treatments; Patient compliance; Duration and cessation of treatment; Relapse and readmission; Multidisciplinary team management.

Consensus diagnostic criteria include 12 items within 6 themes: Signs and symptoms (oedema, otorrhoea, granulation); Pain (otalgia, nocturnal otalgia); Investigations (microbiology [does not have to be positive], histology [malignancy excluded], positive CT and MRI); Persistent symptoms despite local and/or systemic treatment for at least two weeks; At least one risk factor for impaired immune response; Indicators of advanced disease (not obligatory but mut be reported when present at diagnosis). Stakeholders were unanimous that there is no role for secondary, graded, or optional diagnostic items. The consensus meeting identified themes for future research.

The adoption of consensus-defined diagnostic criteria and COS facilitates standardised research reporting and robust data synthesis. Inclusion of patient and professional perspectives ensures best practice stakeholder engagement.

Necrotising otitis externa is a serious infection with minimal evidence underpinning its management. This review aims to synthesise published evidence of antimicrobial therapies and their outcomes in necrotising otitis externa.

The review was PROSPERO registered (CRD42022353244) and conducted according to Preferred Reporting Items for Systematic Review and Meta-Analyses (‘PRISMA’) guidelines. A robust search strategy filtered 28 manuscripts into the final review. Antimicrobial therapy and clinical outcome data were extracted and analysed.

Published studies are heterogeneous, with high risk of bias and low certainty. Reporting of outcomes is poor and extremely variable. First-line therapy is most commonly in-patient (95 per cent) empiric fluoroquinolone (68 per cent) delivered intravenously (82 per cent). The lack of granular data and poor outcome reporting mean it is impossible to correlate treatment strategies with clinical outcomes.

Robust, consistent outcome reporting with reference to treatments administered is mandatory, to inform clinical management and optimise future research. Optimal antimicrobial choices and treatment strategies require clarification through prospective clinical trials.