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A Core Outcome Set for Inflammatory Bowel Diseases: Development and Recommendations for Implementation in Clinical
Liselotte Fierens1, Nicholas Carney2, Gottfried Novacek3
1Department of Chronic Diseases and Metabolism, KU Leuven, Leuven, Belgium.
Journal of Crohn'S & Colitis
|November 29, 2023
Summary
A core outcome set for inflammatory bowel diseases (IBD) was established using a modified Delphi method. This standardized measurement approach aims to improve care and facilitate research in IBD management.
Area of Science:
- Gastroenterology and Clinical Research
- Health Outcomes Measurement
- Patient-Reported Outcomes
Background:
- Standardizing health outcome measurements is crucial for enhancing care delivery and enabling data-driven learning systems.
- The Health Outcomes Observatory (H2O) initiative aims to build robust data systems for research and secondary data use.
- Existing knowledge was leveraged to define a core outcome set (COS) for inflammatory bowel diseases (IBD).
Purpose of the Study:
- To define a consensus-based core outcome set (COS) for inflammatory bowel diseases (IBD) through an international modified Delphi method.
- To establish standardized measurements for inflammatory bowel diseases (IBD) to support clinical practice and research.
- To recommend specific measurement tools for collecting patient-reported outcomes (PROs) in IBD care.
Main Methods:
- An international modified Delphi method involved 136 stakeholders, including patients, healthcare professionals, and regulators from 20 countries.
- Stakeholders rated 90 variables twice on a 9-point importance scale, with feedback influencing subsequent ratings.
- Consensus meetings were held to discuss results, and variables meeting specific consensus criteria (≥80% agreement or meeting agreement) were included.
Main Results:
- A final core outcome set (COS) for IBD was defined, comprising 18 case-mix variables, 3 biomarkers (hemoglobin, C-reactive protein, fecal calprotectin), and 28 outcomes.
- The set includes 16 patient-reported outcomes (PROs) and one patient-reported experience measure.
- Specific questionnaires (PRO-2, IBD-Control, PROMIS Global Health, etc.) were recommended for collecting disease-specific and generic PROs.
Conclusions:
- A core outcome set (COS) for inflammatory bowel diseases (IBD) has been defined with recommendations for clinical practice implementation.
- Initial implementation sites include Vienna, Berlin, Barcelona, Leuven, and Rotterdam, with global expansion planned.
- The COS aims to empower patients in managing their IBD care and improve overall disease management.
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