Development of a core outcome set for IBD patients with stomas

Background and aims: A significant number of patients with inflammatory bowel disease (IBD) undergo stoma-forming surgery. For many, an ostomy is not curative, and disease exacerbations requiring ongoing therapy may be required. Despite this, IBD patients with stomas are frequently excluded from clinical trials due to the heterogeneity in outcomes and the absence of validated measurement tools. The TOAST-IBD project aimed to develop a Core Outcome Set (COS) for IBD patients with stomas undergoing interventional trials to address this issue.

Methods

Candidate outcomes were identified through a systematic literature review and patient focus groups. These were refined using a two-round online Delphi process, with scoring based on the importance of each outcome in determining treatment success. Participants were recruited internationally and grouped into four stakeholder panels: patients, specialist and research nurses, colorectal surgeons, and gastroenterologists. Feedback was provided after each round to allow score refinement. A final consensus meeting determined the COS.