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. 2021 May 14;16(5):e0251395.
doi: 10.1371/journal.pone.0251395. eCollection 2021.

Acute otitis externa: Consensus definition, diagnostic criteria and core outcome set development

Matthew E Smith  1 , John C Hardman  2 , Nishchay Mehta  3 , Gareth H Jones  4 , Rishi Mandavia  5 , Caroline Anderson  6 , Maha Khan  7 , Aula Abdelaziz  8 , Bakir Al-Dulaimy  9 , Nikul Amin  10 , Rajesh Anmolsingh  9 , Bilal Anwar  11 , Manohar Bance  12 , Katherine Belfield  13 , Mahmood Bhutta  14 , Ruaridh Buchanan  15 , Deepak Chandrasekharan  5 , Michael Chu  16 , Srikanth Chundu  17 , Katherine Conroy  7 , Gemma Crundwell  12 , Mat Daniel  18 , Jessica Daniels  19 , Sujata De  20 , Sian Dobbs  16 , Jayesh Doshi  21 , Matthew Farr  22 , Tanjinah Ferdous  5 , Eleni Fragkouli  23 , Simon Freeman  11 , Samit Ghosh  24 , Emma Gosnell  25 , S Alam Hannan  3 , Elliot Heward  7 , Faisal Javed  21 , Deepa John  12 , Helen Nicholls  26 , Anand V Kasbekar  18 , Haroon Khan  7 , Hammad Khan  27 , Sadie Khwaja  7 , Bhik Kotecha  28 , Madhankumar Krishnan  20 , Nirmal Kumar  29 , Tamara Lamb  12 , Hannah Lancer  30 , Joseph G Manjaly  3 , Marcos Martinez Del Pero  31 , Fiona McClenaghan  3 , Kristijonas Milinis  20 , Nina Mistry  32 , Hassan Mohammed  33 , Elizabeth Morris  34 , Stephen Morris-Jones  5 , Jessica Padee  35 , Surojit Pal  36 , Sanjay Patel  4 , Agamemnon Pericleous  37 , Asad Qayyum  38 , Maral Rouhani  39 , Haroon Saeed  7 , Mirusanthan Santhiyapillai  12 , Kay Seymour  15 , Sunil Sharma  20 , Richard Siau  40 , Arvind Singh  36 , Emma Stapleton  7 , Kate Stephenson  41 , Gill Stynes  18 , Bharathi Subramanian  29 , Neil Summerfield  7 , Chloe Swords  42 , Aaron Trinidade  43 , Antonia Tse  7 , Emmanuel Twumasi  12 , Harmony Ubhi  36 , Samit Unadkat  3 , Ananth Vijendren  44 , Joe Wasson  45 , Glen Watson  46 , Glennis Williams  47 , Janet Wilson  33 , Alexander Yao  48 , Ahmed Youssef  40 , Simon K W Lloyd  7 , James R Tysome  1 ; INTEGRATE (The UK ENT Trainee Research Network)
Affiliations

Acute otitis externa: Consensus definition, diagnostic criteria and core outcome set development

Matthew E Smith et al. PLoS One. .

Abstract

Objective: Evidence 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 design: COS development according to Core Outcome Measures in Effectiveness Trials (COMET) methodology and parallel consensus selection of diagnostic criteria/definition.

Setting: Stakeholders from the United Kingdom.

Subjects and methods: Comprehensive 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.

Results: Candidate 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'.

Conclusion: The 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.

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Conflict of interest statement

The authors have declared that no competing interests exist.

Figures

Fig 1
Fig 1. Flow diagram showing the three-stage Delphi consensus process.
Fig 2
Fig 2. Outcomes taken from patient interviews and the literature combined and de-duplicated to form the candidate outcomes for the first round Delphi exercise.
Fig 3
Fig 3. PRISMA diagram showing search results for both extraction periods.
Fig 4
Fig 4. Core outcome set for acute otitis externa.
Fig 5
Fig 5. Consensus minimum diagnostic criteria for AOE.
See this image and copyright information in PMC

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