Diagnostic criteria and core outcome set development for necrotising otitis externa: the COSNOE Delphi consensus study
Year: 2024
Type: article
Abstract: OBJECTIVE: Evidence for necrotising otitis externa (NOE) diagnosis and management is limited, and outcome reporting is heterogeneous. International best practice guidelines were used to develop consensus diagnostic criteria and a core outcome set (COS). METHODS: The study was pre-registered on the Core Outcome Measures in Effectiveness Trials (COMET) database. Systematic literature review identified candidate items. Patient-centred items were identified via a qualitative study. Items and their definitions were refined by multidisciplinary stakeholders in a two-round Delphi exercise and subsequent consensus meeting. RESULTS: The final COS incorporates 36 items within 12 themes: Signs and symptoms; Pain; Advanced Disease Indicators; Complications; Survival; Antibiotic regimes and side effects; Patient comorbidities; Non-antibiotic treatments; Patient compliance; Duration and cessation of treatment; Relapse and readmission; Multidisciplinary team management.Consensus diagnostic criteria include 12 items within 6 themes: Signs and symptoms (oedema, otorrhoea, granulation); Pain (otalgia, nocturnal otalgia); Investigations (microbiology [does not have to be positive], histology [malignancy excluded], positive CT and MRI); Persistent symptoms despite local and/or systemic treatment for at least two weeks; At least one risk factor for impaired immune response; Indicators of advanced disease (not obligatory but mut be reported when present at diagnosis). Stakeholders were unanimous that there is no role for secondary, graded, or optional diagnostic items. The consensus meeting identified themes for future research. CONCLUSION: The adoption of consensus-defined diagnostic criteria and COS facilitates standardised research reporting and robust data synthesis. Inclusion of patient and professional perspectives ensures best practice stakeholder engagement.
Authors: Sirat Lodhi, Kirsty Dodgson, Michael Dykes, Veena Vishwanath, Rohit Bazaz, Sachin Mathur, Glen Watson, Katherine Cartwright, Amy Pearson, Deborah Wearmouth, Richard List, Phillip Yates, Joanna Dixon, Arullendran Puveendran, Margarita Wilson, Katherine Watson, Milo Cullinan, Youssef Mentias, Ruth Capper, Linda Jewes, Sebastian Wallis, David Hamilton, Brook Adams, Mamoona Khalid-Raja, Barzo Faris, Maha Khan, Stefan Linton, Rohma Abrar, Eloise Owen, Vasiliki Bisbinas, Ali Ijaz, Kimberley Lau, Sara Timms, Jack Bruce, Emma Stapleton
Institutions: Manchester Royal Infirmary, Manchester University NHS Foundation Trust, Wythenshawe Hospital, Royal Preston Hospital, Sheffield Teaching Hospitals NHS Foundation Trust, University of Hull, Newcastle upon Tyne Hospitals NHS Foundation Trust, Sunderland Royal Hospital, Doncaster Royal Infirmary, York Hospital, Stepping Hill Hospital, St John's Hospital, University of Manchester, University of Sheffield
Language: English
Subfield: Infectious Diseases
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $3,450
OpenAlex ID: W4395009652