Cryptoglandular Anal Fistula Core Outcome Measurement Set (AFCOMS): standardised definitions and measurement...

Area of Science:

• Gastroenterology
• Surgical Research
• Patient-Reported Outcomes

Background:

• Cryptoglandular anal fistula significantly impacts patient quality of life.
• Existing Anal Fistula Core Outcome Set (AFCOS) lacks standardized outcome definitions and measurement instruments, hindering research comparability.
• A Core Outcome Measurement Set (COMS) aligned with AFCOS is needed to improve future evidence synthesis.

Purpose of the Study:

• To establish an international, consensus-driven Core Outcome Measurement Set (COMS) for cryptoglandular anal fistula research.
• To align the COMS with the existing Anal Fistula Core Outcome Set (AFCOS).
• To standardize outcome definitions and measurement instruments for improved research consistency.

Main Methods:

• A three-phase study following the COMET methodology.
• Phase 1: Scoping review of AFCOS outcome definitions and instruments. Phase 2: Evaluation of psychometric properties using COSMIN criteria. Phase 3: International two-round Delphi survey and consensus meeting with patients and healthcare professionals.
• Consensus achieved on definitions, measurement instruments (Anal Fistula Quality of Life Scale, Vaizey score, numerical rating scale), and timepoints (3 and 12 months).

Main Results:

• International consensus reached on standardized definitions for clinical and radiological fistula healing, recurrence, new fistula development, complications (Clavien-Dindo), and reinterventions.
• Selected instruments include the Anal Fistula Quality of Life Scale, Vaizey score, and a numerical rating scale for patient satisfaction.
• Standardized timepoints for outcome assessment were established at 3 and 12 months post-treatment.

Conclusions:

• The developed AFCOMS provides standardized definitions and measurement tools for cryptoglandular anal fistula research.
• Implementation of AFCOMS will enhance reporting consistency across studies.
• This standardization will facilitate robust evidence synthesis in anal fistula research.