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. 2024 Oct 15;18(10):1583-1595.
doi: 10.1093/ecco-jcc/jjad195.

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

Liselotte Fierens  1 , Nicholas Carney  2 , Gottfried Novacek  3 , C Janneke van der Woude  4 , Britta Siegmund  5 , Francesc Casellas  6 , Natalia Borruel  6 , Anouk S Huberts  7 , Elena Sonnenberg  5 , Nathalie Gerold  3 , Christian Primas  3 , Charlotte R H Hedin  8   9 , Tanja Stamm  10   11 , Mette Julsgaard  12   13 , Gionata Fiorino  14   15 , Simona Radice  14 , Michela Luciana Luisa Zini  16 , Evelyn Gross  17 , Cornelia Sander  18 , Ingrid Arijs  19 , Vasiliki-Rafaela Vakouftsi  20 , Tunde Koltai  21 , Health Outcomes Observatory H O Patient Advisory Board For Inflammatory Bowel Diseases, Health Outcomes Observatory H O Steering Committee, Iliàs Charlafti  2 , Marc Ferrante  1   22
Affiliations

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

Liselotte Fierens et al. J Crohns Colitis. .

Abstract

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 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.

Keywords: Quality of life; socioeconomical and psychological end points.

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Conflict of interest statement

NC and IC are employees and shareholders of F. Hoffmann-La Roche. GN received lecture fees/consultant fees/advisory board member fees from AbbVie, Merck Sharp & Dohme, Takeda, Janssen-Cilag, Pfizer, Gilead, Galapagos, Ferring, Vifor, AstroPharma, Falk, Bristol Myers Squibb, Arena Pharmaceuticals, and Amgen. CJvdW has served on advisory boards for Abbvie, Takeda, Pfizer, Galapagos, and Celltrion; she is supported by research funding from ZonMW, Tramedico, Falk Benelux, and Pfizer. BS served as a consultant for AbbVie, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Galapagos, Gilead, Janssen, Lilly, Pfizer, PredictImmune, and Takeda; and received speaker’s fees from AbbVie, BMS, CED Service GmbH, Falk, Galapagos, Ferring, Janssen, Pfizer, and Takeda [served as representative of the Charité]. FC received research support from AbbVie, Ferring, MSD, Shire, Takeda, and Zambon; speaker fees from AbbVie, Chiesi, Ferring, Gebro, MSD, Shire, Takeda, and Zambon. NB received research support from AbbVie, Janssen, Takeda, Adacyte, Actial; speaker’s fees from AbbVie, Adacyte, Janssen-Cilag, MSD, Pfizer, and Takeda; and consultancy fees from Janssen-Cilag and Abbvie. ES has received speaker’s fees from Biogen, Takeda, BMS, AbbVie, and Janssen; and consultancy fees from Janssen. CH received speaker’s fees from Takeda, Ferring, AbbVie, and Janssen; and consultancy fees from Pfizer; she has acted as local principal investigator for clinical trials for Janssen and GlaxoSmithKline; she is PI on projects at the Karolinska Institutet partly funded by investigator-initiated grants from Takeda and Tillotts. TS reports grants and personal fees from AbbVie, Roche, Sanofi, Takeda, and Novartis. MJ has served as a consultant for Ferring and Takeda Pharma; and received speaker’s fee from MSD, Ferring, and Takeda Pharma; she is the PI on projects at Aarhus University Hospital partly funded by investigator-initiated grants from Takeda Pharma. GF served as a consultant for AbbVie, Takeda, Janssen, Pfizer, Galapagos, Sandoz, Amgen, and Ferring. EG received consultant fees/advisory board member fees from AbbVie, Boehringer Ingelheim RCV, Celgene, Coloplast, Dr. Falk, Eli Lilly, Ferring, Galapagos Biopharma, Gilead, Janssen-Cilag, Merck, Merck Sharp & Dohme, Pfizer, Stada, and Takeda. MF reports research support from AbbVie, Amgen, Biogen, EG, Janssen, Pfizer, Takeda, and Viatris; speaker’s fees from AbbVie, Amgen, Biogen, Boehringer Ingelheim, Falk, Ferring, Janssen-Cilag, Lamepro, MSD, Pfizer, Sandoz, Takeda, Truvion health care and Viatris; and consultancy fees from AbbVie, AgomAb Therapeutics, Boehringer Ingelheim, Celgene, Celltrion, Eli Lilly, Janssen-Cilag, Medtronic, MSD, Pfizer, Regeneron, Samsung Bioepis, Sandoz, Takeda, and Thermo Fisher. None of these activities have any relation to the present study.

Figures

Figure 1.
Figure 1.
Flowchart of the process used to develop the core outcome set.
Figure 2.
Figure 2.
Results of the literature review to prepare the preliminary list of items. COMET: Core Outcome Measure in Effectiveness Trials; COS: core outcome set; COSMIN: consensus-based standards for the selection of health measurement instruments; IBD: inflammatory bowel disease; PRO: patient-reported outcome.
Figure 3.
Figure 3.
Recommended instruments and measurement frequencies to collect the patient-reported outcomes included in the final core outcome set. The number of questions is indicated in brackets; questions in grey are only recommended if applicable, namely only for IBD patients who are currently prescribed IBD medication, IBD patients with perianal disease, and IBD patients with an ostomy. CD: Crohn's disease; IBD: inflammatory bowel diseases; SHE: Subjective Health Experience; UC: ulcerative colitis.
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