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

Area of Science:

• Otolaryngology
• Infectious Diseases
• Medical Research Methodology

Background:

• Necrotising otitis externa (NOE) diagnosis and management lack standardized evidence.
• Outcome reporting in NOE studies is inconsistent, hindering data synthesis.

Purpose of the Study:

• To develop consensus diagnostic criteria for NOE.
• To establish a core outcome set (COS) for NOE research based on international best practices.

Main Methods:

• Systematic literature review and qualitative patient studies identified candidate items.
• A two-round Delphi exercise and consensus meeting with multidisciplinary stakeholders refined items and definitions.
• The study was pre-registered on the Core Outcome Measures in Effectiveness Trials (COMET) database.

Main Results:

• Consensus diagnostic criteria include 12 items across 6 themes (e.g., signs/symptoms, pain, investigations, persistent symptoms, risk factors, advanced disease indicators).
• The core outcome set (COS) comprises 36 items within 12 themes (e.g., complications, survival, treatment, relapse).
• Stakeholders agreed on essential diagnostic items, excluding secondary or optional criteria.

Conclusions:

• Standardized diagnostic criteria and COS promote consistent research reporting and data synthesis in NOE.
• Incorporating patient and professional perspectives ensures comprehensive stakeholder engagement and best practices.