PRESTO
Research type
Research Study
Full title
PRESTO: Development of a new patient-reported outcome measure (PROM) to assess psychosocial response to stoma in people with inflammatory bowel disease (IBD).
IRAS ID
343285
Contact name
Lesley Dibley
Contact email
Sponsor organisation
University of Greenwich
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
Many people with inflammatory bowel disease (IBD) require surgery. Sometimes, this means creating a stoma, so that waste leaves the body via an opening in the abdominal wall and is collected in a bag fixed to the skin. Previous studies, including our own, show that many people struggle to adjust to life with a stoma, and that many factors potentially affect adjustment. People learn to cope quickly with the practical care of a new stoma because they have no choice; it must be managed, just as we must manage going to the toilet. But psychosocial and emotional adjustment can take many years, and in some cases, may never be achieved.
This project develops a new patient-reported outcome measure (PROM) to track adjustment to a stoma over time. We have completed the first two phases of the project with the help of community-based participants and have developed the draft PROM. For the next phases we will recruit people aged 18 years and over, with a current stoma, or due to have a stoma for IBD, from NHS gastroenterology clinics. Participants will be interviewed online whilst completing the draft PROM so that we can check it is usable (cognitive interview) and/or complete it twice – online, about two weeks apart, so that we can check that it is reliable over time (validation).
The Patient Response to Stoma (PRESTO) PROM will be used just before stoma-forming surgery to assess the likely response to the stoma. It can then be used at timepoints after surgery to re-assess; any alteration in scores will reflect the level of adjustment. Using the new PROM like this means those more likely to struggle can be identified early and offered additional support, whilst assessing over time will offer a more realistic picture of the journey to adjustment, informing clinical practice.
REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
25/YH/0095
Date of REC Opinion
25 Jun 2025
REC opinion
Further Information Favourable Opinion