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Acute otitis externa: Consensus definition, diagnostic criteria and core outcome set development.
Matthew E Smith1, John C Hardman2, Nishchay Mehta3
1Cambridge Ear Institute, Cambridge, United Kingdom.
Plos One
|May 14, 2021
Summary
Researchers developed a consensus definition, diagnostic criteria, and core outcome set (COS) for acute otitis externa (AOE) to standardize research. Patient input highlighted the importance of quality-of-life outcomes in AOE management.
Area of Science:
- Otolaryngology
- Clinical Research Methodology
Background:
- Acute otitis externa (AOE) management lacks standardized diagnostic criteria and outcome measures.
- Existing research may not reflect patient priorities regarding AOE impact.
Purpose of the Study:
- To develop a consensus definition for AOE.
- To establish clear diagnostic criteria for AOE.
- To create a core outcome set (COS) for AOE research.
Main Methods:
- Utilized Core Outcome Measures in Effectiveness Trials (COMET) methodology.
- Conducted a literature review and online Delphi exercise with diverse stakeholders (patients, ENT doctors, GPs, nurses, etc.).
- Incorporated patient-reported outcomes emphasizing quality of life and daily activities.
Main Results:
- A consensus definition of AOE was established: 'diffuse inflammation of the ear canal skin of less than 6 weeks duration'.
- Eight diagnostic criteria reached consensus for AOE.
- A COS comprising six outcomes was finalized: pain, disease severity, quality-of-life impact, patient satisfaction, treatment outcomes, and microbiology.
Conclusions:
- A standardized definition, diagnostic criteria, and COS will enhance AOE research and facilitate meta-analyses.
- Patient engagement revealed critical outcome deficiencies in previous AOE studies, particularly concerning daily life impacts.
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