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. 2024 Sep;138(9):913-920.
doi: 10.1017/S0022215124000513. Epub 2024 Apr 22.

Diagnostic criteria and core outcome set development for necrotising otitis externa: the COSNOE Delphi consensus study

Sirat Lodhi  1 , Kirsty Dodgson  2 , Michael Dykes  3 , Veena Vishwanath  3 , Rohit Bazaz  4 , Sachin Mathur  5 , Glen Watson  6 , Katherine Cartwright  7 , Amy Pearson  8 , Deborah Wearmouth  9 , Richard List  10 , Phillip Yates  11 , Joanna Dixon  12 , Arullendran Puveendran  13 , Margarita Wilson  13 , Katherine Watson  14 , Milo Cullinan  14 , Youssef Mentias  15 , Ruth Capper  16 , Linda Jewes  17 , Sebastian Wallis  18 , David Hamilton  19 , Brook Adams  20 , Mamoona Khalid-Raja  21 , Barzo Faris  22 , Maha Khan  1 , Stefan Linton  23 , Rohma Abrar  16 , Eloise Owen  24 , Vasiliki Bisbinas  1 , Ali Ijaz  25 , Kimberley Lau  6 , Sara Timms  26 , Jack Bruce  24 , Emma Stapleton  1
Affiliations

Diagnostic criteria and core outcome set development for necrotising otitis externa: the COSNOE Delphi consensus study

Sirat Lodhi et al. J Laryngol Otol. 2024 Sep.

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.

Keywords: Otitis externa; diabetes mellitus; immunosuppression therapy; osteomyelitis.

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Conflict of interest statement

None declared

Figures

Figure 1.
Figure 1.
Flowchart of the three-stage process undertaken to complete the Delphi consensus study.
Figure 2.
Figure 2.
Preferred Reporting Items for Systematic Reviews and Meta-Analysis flowchart of the systematic literature review process.
Figure 3.
Figure 3.
Stakeholder participation in the consensus process.
See this image and copyright information in PMC

References

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