DOP084 Development of a core outcome set for Inflammatory Bowel Disease patients with stomas
Authors: Kumar L , Hanly M , Fennessy A , O'Morain N , Martin S , Keogh A , Burns R , Kehoe A , Dames N , Kimman M , Sahnan K , Tozer P , Doherty G ,   Investigator Network for Inflammatory Bowel Disease Therapy in Ireland (INITIative)
Published: January 2025

Background

A significant number of patients with Inflammatory Bowel Disease (IBD) undergo surgery resulting in a stoma. For many, an ostomy is not curative. Patients may continue to experience disease exacerbations and require continued medical therapies. Despite this, patients with IBD and stomas are excluded from clinical trials, largely due to the heterogeneity in outcomes and the lack of validated measurement tools for this cohort. The TOAST-IBD project aimed to address this issue by developing a Core Outcome Set (COS) for IBD patients with stomas.

Methods

A long-list of candidate outcomes was generated through a systematic review and patient focus groups. Consensus was established via a two-round Delphi process using a 9-point Likert scale based on how important candidates felt it was in determining treatment success. This was followed by a final consensus meeting. Stakeholders were recruited internationally and grouped into 4 panels (patients, specialist and research nurses, colorectal surgeons, and gastroenterologists). Participants received feedback from their panel in the first round and from all participants in the second round to allow refinement of their scores.

Results

A total of 68 outcomes were extracted via a systematic review of the existing literature and an additional 11 unique outcomes were added from 4 90-minute online patient focus groups. A further 9 outcomes were proposed by the study working group, generating a total of 88 outcomes to be included in the voting process. 76 stakeholders (73.1% response rate) from 17 countries carried forward 37 outcomes through a two-round Delphi process. The final consensus meeting of 37 experts and patients agreed on a six domain COS. The COS included the maintenance of hydration and volume status, the maintenance of nutritional status, symptom-based clinical activity, objective marker-based disease activity and two quality of life (QOL) domains (IBD-related QOL and stoma-specific QOL). Adverse effects from treatment did not reach a consensus to be included in the core outcome set but was considered important to be captured where applicable.

Conclusion

An IBD Stoma COS has been produced by all key stakeholders. This COS will serve as the foundation for development of relevant measurement instruments for IBD patients with stomas so as to include this underrepresented cohort in future clinical trials.

References

1.Bernstein, C.N., et al., Hospitalisations and surgery in Crohn's disease. Gut, 2012. 61(4): p. 622-9.

2.Cosnes, J., et al., Epidemiology and natural history of inflammatory bowel diseases. Gastroenterology, 2011. 140(6): p. 1785-94.

3.Vuyyuru, S.K., et al., Patients With Crohn's Disease and Permanent Ileostomy Are Universally Excluded From Clinical Trials: A Systematic Review. Am J Gastroenterol, 2023. 118(7): p. 1285-1288.

4. Kumar, L., et al, TOAST-IBD: Treatment related Outcomes Associated with SToma in IBD: Developing core outcomes measures for intervention studies in patients with IBD who have stomas. Published July 18, 2023. http://www.initiativeibd.ie/toast-ibd-study/