Development of a Core Outcome Set for Real-World Data in Inflammatory Bowel Disease: A European Crohn's and Colitis Organisation (ECCO) Position Paper

Jurij Hanzel, Peter Bossuyt, Valerie Pittet, Mark Samaan, Monika Tripathi, Wladyslawa Czuber-Dochan, Johan Burisch, Salvatore Leone, Roberto Saldaña, Filip Baert, Uri Kopylov, Susanna Jäghult, Michel Adamina, Naila Arebi, Krisztina Gecse

Research output: Contribution to journalArticlepeer-review

5 Citations (Scopus)


The utility of real-world data is dependent on the quality and homogeneity of reporting. We aimed to develop a core outcome set for real-world studies in adult patients with inflammatory bowel disease (IBD). Candidate outcomes and outcome measures were identified and categorised in a systematic review. An international panel including patients, dietitians, epidemiologists, gastroenterologists, nurses, pathologists, radiologists and surgeons participated in a modified Delphi consensus process. A consensus meeting was held to ratify the final core outcome set. A total of 26 panellists from 13 countries participated in the consensus process. A total of 271 items (130 outcomes, 141 outcome measures) in nine study domains were included in the first-round survey. Panellists agreed that real-world studies on disease activity should report clinical, endoscopic and biomarker disease activity. A disease-specific clinical index (Harvey-Bradshaw Index, Partial Mayo Score, Simple Clinical Colitis Activity Index) should be used, rather than physician global assessment. In ulcerative colitis (UC), either the UC Endoscopic Index of Severity or the Mayo Endoscopic Score can be used, but there was no consensus on an endoscopic index for Crohn's disease, nor was there consensus on the use of the presence of ulcers. There was consensus on using faecal calprotectin and C-reactive protein. There was no consensus on the use of histology in real-world studies. A core outcome set for real-world studies in IBD has been developed based on international multidisciplinary consensus. Its adoption will facilitate synthesis in the generation of real-world evidence. [Abstract copyright: © The Author(s) 2022. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation. All rights reserved. For permissions, please email: [email protected].]
Original languageEnglish
Article numberjjac136
JournalJournal Of Crohns & Colitis
Early online date3 Oct 2022
Publication statusE-pub ahead of print - 3 Oct 2022


  • real-world study
  • Crohn’s disease
  • ulcerative colitis


Dive into the research topics of 'Development of a Core Outcome Set for Real-World Data in Inflammatory Bowel Disease: A European Crohn's and Colitis Organisation (ECCO) Position Paper'. Together they form a unique fingerprint.

Cite this