Development of a core outcome set for IBD patients with stomas
Lakshman Kumar, Micheal Hanly, Anne Fennessy, Neil O’Morain, Sean Martin, Aine Keogh, Richéal Burns, Amber Kehoe, Nicola Dames, Merel Kimman, Kapil Sahnan, Phil Tozer, Glen Doherty, , Colm O’Morain, Aoibhlinn O’Toole, Eoin Slattery, Orlaith Kelly, Cara Dunne, Catherine Rowan, Jayne Doherty, Roisin Stack, Karl Hazel, Piotr Eder, Mark Samaan, Christian Sellinger, Michael Kelly, John Burke, Audrius Dulskas, Jasper Stijns, Eleni Andriopoulou, Mary Hamzawi, Carolann Coe, Joanna Rea, Catherine Walsh, Marie Grimes, Susan Moore, Wladzia Czuber-Dochan, Kathleen Cafferky, Caron Allan, David MacDougald, Dag Stockstad, Martina O’GradyAbstract
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.
Results
A total of 81 outcomes were identified and categorized into five themes. In total, 76 stakeholders (73.1% response rate) from 17 countries participated in the Delphi process, carrying 37 outcomes forward. At the final consensus meeting, 37 experts and patients agreed on a six-domain COS: maintenance of hydration and volume status, maintenance of nutritional status, symptom-based clinical activity, objective marker-based disease activity, and two quality-of-life domains (IBD-related and stoma-specific).
Conclusion
An IBD Stoma COS has been produced by all key stakeholders. This COS will standardize outcome reporting and support creation of validated measurement instruments, facilitating the inclusion of this underserved group in future clinical trials.
Registration
This study has been registered with the COMET Initiative as study 2855 (https://www.comet-initiative.org/Studies/Details/2855) and followed its recommended methodological procedures. The systematic review has been registered with the PROSPERO database (PROSPERO-ID: CRD42023442388).