Acute otitis externa: Consensus definition, diagnostic criteria and core outcome set development.
Creators: name: Smith, Matthew E
name: Hardman, John C
name: Mehta, Nishchay
name: Jones, Gareth H
name: Mandavia, Rishi
name: Anderson, Caroline
name: Khan, Maha
name: Abdelaziz, Aula
name: Al-Dulaimy, Bakir
name: Amin, Nikul
name: Anmolsingh, Rajesh
name: Anwar, Bilal
name: Bance, Manohar
name: Belfield, Katherine
name: Bhutta, Mahmood
name: Buchanan, Ruaridh
name: Chandrasekharan, Deepak
name: Chu, Michael
name: Chundu, Srikanth
name: Conroy, Katherine
name: Crundwell, Gemma
name: Daniel, Mat
name: Daniels, Jessica
name: De, Sujata
name: Dobbs, Sian
name: Doshi, Jayesh
name: Farr, Matthew
name: Ferdous, Tanjinah
name: Fragkouli, Eleni
name: Freeman, Simon
name: Ghosh, Samit
name: Gosnell, Emma
name: Hannan, S Alam
name: Heward, Elliot
name: Javed, Faisal
name: John, Deepa
name: Nicholls, Helen
name: Kasbekar, Anand V
name: Khan, Haroon
name: Khan, Hammad
name: Khwaja, Sadie
name: Kotecha, Bhik
name: Krishnan, Madhankumar
name: Kumar, Nirmal
name: Lamb, Tamara
name: Lancer, Hannah
name: Manjaly, Joseph G
name: Martinez Del Pero, Marcos
name: McClenaghan, Fiona
name: Milinis, Kristijonas
name: Mistry, Nina
name: Mohammed, Hassan
name: Morris, Elizabeth
name: Morris-Jones, Stephen
name: Padee, Jessica
name: Pal, Surojit
name: Patel, Sanjay
name: Pericleous, Agamemnon
name: Qayyum, Asad
name: Rouhani, Maral
name: Saeed, Haroon
name: Santhiyapillai, Mirusanthan
name: Seymour, Kay
name: Sharma, Sunil
name: Siau, Richard
name: Singh, Arvind
name: Stapleton, Emma
name: Stephenson, Kate
name: Stynes, Gill
name: Subramanian, Bharathi
name: Summerfield, Neil
name: Swords, Chloe
name: Trinidade, Aaron
name: Tse, Antonia
name: Twumasi, Emmanuel
name: Ubhi, Harmony
name: Unadkat, Samit
name: Vijendren, Ananth
name: Wasson, Joe
name: Watson, Glen
name: Williams, Glennis
name: Wilson, Janet
name: Yao, Alexander
name: Youssef, Ahmed
name: Lloyd, Simon K W
name: Tysome, James R
Publisher: name: Apollo - University of Cambridge Repository
Year: 2021

description: 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.