The development of a cryptoglandular Anal Fistula Core Outcome Set (AFCOS): an international Delphi study protocol

Area of Science:

• Colorectal surgery
• Evidence-based medicine
• Health outcomes research

Background:

• Cryptoglandular anal fistula affects approximately 1 in 5,000 people annually in Europe.
• Existing research on anal fistula interventions suffers from significant heterogeneity in outcome assessment.
• This variability hinders research quality, evidence synthesis, and clinical decision-making.

Purpose of the Study:

• To describe the protocol for developing a European Core Outcome Set for Anal Fistula (AFCOS).
• To establish a standardized set of outcomes for research and clinical practice related to anal fistulas.
• To enhance the quality and comparability of studies evaluating anal fistula treatments.

Main Methods:

• A systematic literature review will identify potential outcomes for the COS.
• Patient interviews in the UK and Netherlands will capture patient-important outcomes.
• A Delphi consensus process involving patients and clinicians will prioritize outcomes, culminating in a face-to-face meeting.

Main Results:

• This section will report the consensus reached on the Core Outcome Set for Anal Fistula.
• The study aims to achieve agreement on a prioritized list of outcomes.
• The final COS will be defined following a consensus meeting.

Conclusions:

• The development of the AFCOS protocol addresses the critical need for standardized outcome reporting in anal fistula research.
• Implementing the AFCOS is expected to improve research quality, facilitate evidence synthesis, and ultimately benefit patient care.
• This initiative represents a significant step towards more consistent and reliable research in the field of anal fistula.