AFCOS
Research type
Research Study
Full title
AFCOS: The development of a cryptoglandular Anal Fistula (AF) Core Outcome Set (COS): an international Delphi study
IRAS ID
259864
Contact name
Nusrat Iqbal
Contact email
Sponsor organisation
Imperial College London
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
A perianal fistula is a tunnel connecting the inside of the anus to the skin around the buttock. It affects approximately 1 in 5000 people per year in European countries, causing distressing symptoms such as pain and discharge. We know that most fistulas are cryptoglandular, caused by infections in the mucus glands in the anal canal. Many studies have been conducted to assess the effectiveness of treatments for cryptoglandular fistulas, however the way in which they do this varies between studies. This makes it difficult to compare evidence in different studies, and highlights the need for a core outcome set (COS): an agreed minimum standardised set of outcomes that should be measured and reported in all interventional studies for a specific condition. The aim of this project is to develop a Core Outcome Set for cryptoglandular anal Fistula.
The first step will be a systematic review of the literature to identify outcomes that are in current use. We will then conduct qualitative patient interviews to understand outcome measures relevant to patients both in the UK and The Netherlands. These outcomes will then be prioritized by patients and healthcare professionals in multiple web-based Delphi rounds, followed by a face-to-face consensus meeting to decide on the definitive COS. We will involve patients and healthcare professionals across Europe to ensure the final COS is relevant to and representative of stakeholders across Europe.
REC name
West Midlands - Black Country Research Ethics Committee
REC reference
19/WM/0296
Date of REC Opinion
10 Oct 2019
REC opinion
Further Information Favourable Opinion