A Core Outcome Set for Inflammatory Bowel Diseases: Development and Recommendations for Implementation in Clinical Practice Through an International Multi-stakeholder Consensus Process

作者：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 Hedin, Tanja Stamm, Mette Julsgaard, Gionata Fiorino, Simona Radice, Michela Luciana Luisa Zini, Evelyn Gross, Cornelia Sander, Ingrid Arijs, V.R. Vakouftsi, Tunde Koltai, Iliàs Charlafti, Marc Ferrante · 发表于：Journal of Crohn s and Colitis · 年份：2023 · DOI：10.1093/ecco-jcc/jjad195 · 被引用次数：15 · 研究领域：Delphi Technique in Research、Inflammatory Bowel Disease、Health Systems, Economic Evaluations, Quality of Life

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 disease-specific PROs at every contact with an IBD practitioner, and the Subjective Health Experience model questionnaire, PROMIS Global Heal...