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Lookup NU author(s): Hassan Mohammed, Emerita Professor Janet WilsonORCiD, Dr Alexander Yao
This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).
© 2021 Smith et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.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.
Author(s): Smith ME, Hardman JC, Mehta N, Jones GH, Mandavia R, Anderson C, Khan M, Abdelaziz A, Al-Dulaimy B, Amin N, Anmolsingh R, Anwar B, Bance M, Belfield K, Bhutta M, Buchanan R, Chandrasekharan D, Chu M, Chundu S, Conroy K, Crundwell G, Daniel M, Daniels J, De S, Dobbs S, Doshi J, Farr M, Ferdous T, Fragkouli E, Freeman S, Ghosh S, Gosnell E, Alam Hannan S, Heward E, Javed F, John D, Nicholls H, Kasbekar AV, Khan H, Khan H, Khwaja S, Kotecha B, Krishnan M, Kumar N, Lamb T, Lancer H, Manjaly JG, Del Pero MM, McClenaghan F, Milinis K, Mistry N, Mohammed H, Morris E, Morris-Jones S, Padee J, Pal S, Patel S, Pericleous A, Qayyum A, Rouhani M, Saeed H, Santhiyapillai M, Seymour K, Sharma S, Siau R, Singh A, Stapleton E, Stephenson K, Stynes G, Subramanian B, Summerfield N, Swords C, Trinidade A, Tse A, Twumasi E, Ubhi H, Unadkat S, Vijendren A, Wasson J, Watson G, Williams G, Wilson J, Yao A, Youssef A, Lloyd SKW, Tysome JR, Chittick G, Wong J, Kay T, Sheldrake J, Saunders R, Edmiston R, Bondin D, Jaafar M, Mallick S, Majithia A, Jayaram S, Cumberworth V, Raja M, Alla A, Bird B, Leopard K, Jacobsen N, Hale A, Prasad A, Jones H, Butterworth O, Lapa T, Adab K, Asim S, Ologunde R, Khattak A, Chaudhry M, Sherazi Z, Anderson G, Lal P, Bayston R
Publication type: Article
Publication status: Published
Journal: PLoS ONE
Year: 2021
Volume: 16
Issue: 5
Online publication date: 14/05/2021
Acceptance date: 25/04/2021
Date deposited: 08/06/2021
ISSN (electronic): 1932-6203
Publisher: Public Library of Science
URL: https://doi.org/10.1371/journal.pone.0251395
DOI: 10.1371/journal.pone.0251395
PubMed id: 33989313
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