A substantial proportion of inflammatory bowel disease (IBD) patients continue to experience residual gastrointestinal symptoms even when the disease is in remission. These symptoms resemble those of irritable bowel syndrome (IBS) and are often referred to as IBD with IBS-like symptoms. However, important evidence gaps remain regarding the underlying mechanisms and effective treatment strategies. In addition, the limited number of available intervention studies is characterised by considerable heterogeneity in the outcomes that are measured and reported, making comparison between studies difficult. Notably, patient perspectives have not always been adequately incorporated, despite being essential for identifying outcomes that matter most to those living with the condition. Therefore, we aim to develop an international, consensus-based COS for residual symptoms in patients with IBD in remission including IBS-like symptoms for use in clinical trials and routine care. The existing COS for IBD will serve as an initial starting point, with relevant outcomes from the established IBD COS incorporated into the initial candidate outcome list for the Delphi process.
Yu Fan Chen, Ilse van de Koppel, Marieke J. Pierik, Daniel Keszthelyi, Luisa Avedano, Roberto Saldaña, Menne Scherpenzeel, Jean-Frederic Colombel, Merel L. Kimman, Zlatan Mujagic (principal investigator)
Disease Category: Gastroenterology
Disease Name: Inflammatory bowel disease (IBD)
Age Range: 18 - 100
Sex: Either
Nature of Intervention: Any
- Clinical experts
- Consumers (patients)
- Patient/ support group representatives
- Researchers
- COS for clinical trials or clinical research
- COS for practice
- Consensus meeting
- Delphi process
- Interview
- Systematic review
The COS will be developed in accordance with the COMET Handbook.
1. Outcomes will be identified through qualitative patient interview, a systematic review, and existing IBD COS and will be categorised according to the COMET taxonomy.
2. Identified outcomes will be prioritised through an international Delphi consensus exercise of 2-3 rounds involving patients and healthcare professionals (e.g. gastroenterologists, IBD nurse specialists/physician assistants, dieticians, psychologists, psychiatrists).
3. A consensus meeting with representatives from all stakeholder groups will take place to discuss and vote on the final COS.