Cure8 research brief
People with IBD and stomas are often left out of clinical trials because outcome measures aren’t standardized. A consensus core outcome set helps ensure future trials measure outcomes that matter to patients and clinicians and makes it easier to include this underserved group.
Patients with IBD and stomas; clinical trialists; gastroenterologists; colorectal surgeons; specialist/research nurses; regulators and funders.
This paper reports development of a Core Outcome Set (COS) specifically for people with IBD who have stomas, intended for use in interventional clinical trials. The TOAST‑IBD project used a systematic review, patient focus groups, a two‑round international Delphi survey across four stakeholder panels, and a final consensus meeting.
From 81 candidate outcomes they reached agreement on a six‑domain COS covering hydration/volume status, nutritional status, symptom‑based clinical activity, objective marker‑based disease activity, and two quality‑of‑life domains (IBD‑related and stoma‑specific).
The COS aims to standardize which outcomes are measured and reported in trials that include patients with stomas and to support development of validated measurement tools, making it easier to include this commonly excluded group in future studies.
The study followed COMET methodological guidance and is registered with COMET and PROSPERO; the published record is an abstract‑level summary of the project methods and consensus outcome set.
This report describes a consensus process (systematic review, Delphi, consensus meeting) and the resulting agreed outcome domains; it does not present trial data. The COS supports development of validated measurement instruments before being applied widely.
Review the original publication for the complete reporting, methods, and context.
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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