Background and Aims: Standardising health outcome measurements supports delivery of care and enables data-driven learning systems and secondary data use for research. As part of the Health Outcomes Observatory [H2O] initiative, and building on existing knowledge, a core outcome set [COS] for inflammatory bowel diseases [IBD] was defined through an international modified Delphi method.
Methods: Stakeholders rated 90 variables on a 9-point importance scale twice, allowing score modification based on feedback displayed per stakeholder group. Two consecutive consensus meetings were held to discuss results and formulate recommendations for measurement in clinical practice. Variables scoring 7 or higher by =80% of the participants, or based on consensus meeting agreement, were included in the final set.
Results: In total, 136 stakeholders (45 IBD patients [advocates], 74 health care professionals/researchers, 13 industry representatives, and four regulators) from 20 different countries participated. The final set includes 18 case-mix variables, three biomarkers [haemoglobin to detect anaemia, C-reactive protein and faecal calprotectin to detect inflammation] for completeness, and 28 outcomes (including 16 patient-reported
outcomes [PROs] and one patient-reported experience). The PRO-2 and IBD-Control questionnaires were recommended to collect diseasespecific PROs at every contact with an IBD practitioner, and the Subjective Health Experience model questionnaire, PROMIS Global Health and Self-Efficacy short form, to collect generic PROs annually.
Conclusions: A COS for IBD, including a recommendation for use in clinical practice, was defined. Implementation of this set will start in Vienna, Berlin, Barcelona, Leuven, and Rotterdam, empowering patients to better manage their care. Additional centres will follow worldwide.
Liselotte Fierens, Nicholas Carney, Gottfried Novacek, C. Janneke van der Woude, Britta Siegmund, Francesc Casellas, Natalia Borruel, Anouk S. Huberts, Elena Sonnenberg, Nathalie Gerold, Christian Primas, Charlotte R. H. Hedin, Tanja Stamm, Mette Julsgaard, Gionata Fiorino, Simona Radice, Michela Luciana Luisa Zini, Evelyn Gross, Cornelia Sander, Ingrid Arijs, Vasiliki-Rafaela Vakouftsi, Tunde Koltai, Health Outcomes Observatory [H2O] Patient Advisory Board for Inflammatory Bowel Diseases, Health Outcomes Observatory [H2O] Steering Committee, Iliàs Charlafti, Marc Ferrante
Disease Category: Gastroenterology
Disease Name: Inflammatory bowel disease (IBD)
Age Range: Unknown
Sex: Either
Nature of Intervention:
- Academic research representatives
- Clinical experts
- Consumers (patients)
- Pharmaceutical industry representatives
- Regulatory agency representatives
- Researchers
- COS for practice
- Consensus meeting
- Delphi process
PubMed and other specialised databases of the consensus-based standards for the selection of health measurement instruments [COSMIN] and Core Outcome Measures in Effectiveness Trials [COMET] initiatives were screened in January, 2021. Stakeholders rated 90 variables on a 9-point importance scale twice, allowing score modification based on feedback displayed per stakeholder group. Two consecutive consensus meetings were held to discuss results and formulate recommendations for measurement in clinical practice. Variables scoring 7 or higher by =80% of the participants, or based on consensus meeting agreement, were included in the final set.