Crohn’s Anal Fistula Quality of Life Scale (CAF-QoL)
Research type
Research Study
Full title
Development of a patient-reported outcome questionnaire to measure quality of life in people with perianal fistulae related to Crohn’s disease: the Crohn’s Anal Fistula Quality of Life Scale (CAF-QoL)
IRAS ID
230549
Contact name
Samuel Adegbola
Contact email
Sponsor organisation
London North West University Healthcare NHS Trust
Duration of Study in the UK
2 years, 0 months, 27 days
Research summary
Crohn’s disease is an inflammatory condition primarily affecting the gastrointestinal tract. About a third of patients suffer from a condition called 'perianal fistula', which describes an abnormal tunnel that forms between the anus and the skin around the anus. This leaves patients with a hole next to the anus, that is usually a source of pain and discharge. Repeated flare-ups may lead to development of ‘branches’ around the fistula and other complications including collections or abscesses. These often need surgical drainage
Treatment is challenging, as most therapies (medical / surgical) rarely achieve long standing cure of perianal fistulas in Crohn’s disease. In fact, best forms of combined therapy only achieve about a third of patients in remission at 3yrs after treatment.
The elusive nature of cure for this condition, warrants alternative means of measuring outcome of treatment. At present, outcomes used are widely variable, making it difficult to measure tangible effects of treatment. Furthermore, this makes the treatment goals difficult to appreciate. There is currently no specific quality of life tool to measure patient reported outcomes in perianal Crohn’s fistulas. As such there is no objective means of determining how patients respond to treatment or indeed how their quality of life is affected by various treatment strategies targeted at healing.
We aim to provide a tool that can be used to document patient reported outcomes in Crohn's perianal fistula. To do this, we will employ qualitative research techniques, combining experience interviews from patients with the condition as well as consensus opinion from experts in the field, through 3 phases that have been previously used by members of the research team to develop a quality of life questionnaire as a means of ascertaining patient reported outcome.
REC name
London - Harrow Research Ethics Committee
REC reference
17/LO/1563
Date of REC Opinion
4 Dec 2017
REC opinion
Further Information Favourable Opinion