Abstract
ObjectiveEvidence for the management of acute otitis externa (AOE) is limited, with unclear diagnostic criteria and variably reported outcome measures that may not reflect key stakeholder priorities. We aimed to develop 1) a definition, 2) diagnostic criteria and 3) a core outcome set (COS) for AOE.Study designCOS development according to Core Outcome Measures in Effectiveness Trials (COMET) methodology and parallel consensus selection of diagnostic criteria/definition.SettingStakeholders from the United Kingdom.Subjects and methodsComprehensive literature review identified candidate items for the COS, definition and diagnostic criteria. Nine individuals with past AOE generated further patient-centred candidate items. Candidate items were rated for importance by patient and professional (ENT doctors, general practitioners, microbiologists, nurses, audiologists) stakeholders in a three-round online Delphi exercise. Consensus items were grouped to form the COS, diagnostic criteria, and definition.ResultsCandidate COS items from patients (n = 28) and literature (n = 25) were deduplicated and amalgamated to a final candidate list (n = 46). Patients emphasised quality-of-life and the impact on daily activities/work. Via the Delphi process, stakeholders agreed on 31 candidate items. The final COS covered six outcomes: pain; disease severity; impact on quality-of-life and daily activities; patient satisfaction; treatment-related outcome; and microbiology. 14 candidate diagnostic criteria were identified, 8 reaching inclusion consensus. The final definition for AOE was ‘diffuse inflammation of the ear canal skin of less than 6 weeks duration’.ConclusionThe development and adoption of a consensus definition, diagnostic criteria and a COS will help to standardise future research in AOE, facilitating meta-analysis. Consulting former patients throughout development highlighted deficiencies in the outcomes adopted previously, in particular concerning the impact of AOE on daily life.
Highlights
Acute otitis externa (AOE) is a common inflammatory condition of the ear canal which remains poorly defined, and has no widely accepted diagnostic criteria
Acute otitis externa: Consensus definition, diagnostic criteria and core outcome set development patients throughout development highlighted deficiencies in the outcomes adopted previously, in particular concerning the impact of AOE on daily life
The validity of a Core outcome sets (COS) depends on its development, which must include working with key stakeholders to prioritise what may be a large number of candidate outcomes
Summary
Acute otitis externa (AOE) is a common inflammatory condition of the ear canal which remains poorly defined, and has no widely accepted diagnostic criteria. There is no standardisation of the outcomes assessed in AOE interventional trials. Core outcome sets (COS) are agreed standardised sets of outcomes that represent the minimum that should be measured and reported in all clinical studies of a specific condition [1]. The validity of a COS depends on its development, which must include working with key stakeholders to prioritise what may be a large number of candidate outcomes. The Core Outcome Measures in Effectiveness Trials (COMET) initiative has published guidance on COS development [1], which has been recognised internationally as best practice. The development of a validated COS improves consistency in outcome reporting [2], which facilitates evidence synthesis
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