Core outcome set for inflammatory bowel disease (IBD)
A standard set of health outcomes and measurements for inflammatory bowel disease (IBD) has been developed to improve patient care and support research. It includes key variables that should be measured in clinical practice, such as symptoms, quality of life, and lab tests, with specific tools recommended for patients to report their experiences.
At a glance
Use when
When designing IBD care pathways, clinical audits, or research studies involving IBD patients. When standardising outcome measurement across centres.
Avoid when
When local context makes recommended instruments or biomarkers unavailable or inappropriate.
Inputs
Patient-reported data, clinical variables, laboratory biomarkers (haemoglobin, CRP, faecal calprotectin)
Outputs
Standardised set of 28 outcomes including patient-reported and clinical measures, with recommendations for measurement instruments and frequency
How it works
The Core Outcome Set (COS) for IBD was developed through an international multi-stakeholder consensus process using a modified Delphi method. It includes 18 case-mix variables, 3 biomarkers (haemoglobin, C-reactive protein, faecal calprotectin), and 28 outcomes (16 patient-reported outcomes and 1 patient-reported experience). Consensus was reached when ≥80% of participants rated a variable 7–9 on a 9-point scale or through agreement in consensus meetings. Recommended instruments include PRO-2, IBD-Control, Subjective Health Experience model, PROMIS Global Health, and Self-Efficacy short form for regular or annual use in clinical practice.
- Project
- H2O
- Funding
- IMI
- Project status
- Ongoing
- HTA domains
- Clinical Effectiveness, Patient and Social Aspects
- Technology
- Non-specific
- Assumptions
- Consistent use of validated instruments across settings enables comparable data collection. Patient input is essential for meaningful outcome measurement. Routine collection supports learning health systems.
- Strengths
- Developed with broad international multi-stakeholder involvement including patients, clinicians, researchers, industry, and regulators. Combines disease-specific and generic patient-reported outcomes. Includes clear implementation recommendations.
- Limitations
- May require adaptation for use in different healthcare systems. Implementation depends on infrastructure for regular data collection. Not all outcomes may be feasible in every clinical setting.
- Geographic & clinical scope
- Inflammatory bowel disease (IBD)
- Also known as
- IBD Core Outcome Set, H2O IBD COS
Questions this answers
- › What outcomes should be measured for all IBD patients in routine care?
- › How can patient experiences be systematically captured in IBD care?
- › Which questionnaires are recommended for tracking IBD symptoms and quality of life?
- › What biomarkers are included in the standard set for IBD monitoring?
- › How was the IBD core outcome set developed and validated?
- › Where is this core outcome set being implemented first?
Related methods
Similar by meaning
Beta record. Generated from the primary source via AI extraction and independent audit, pending final human review.