555 Journal of Crohn's and Colitis, 2019, 555–563 doi:10.1093/ecco-jcc/jjy196 Advance Access publication November 24, 2018 Original Article Copyright © 2018 European Crohn’s and Colitis Organisation (ECCO). Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com Original Article Development and Validation of a Patient- reported Score to Screen for Mucosal Infammation in Infammatory Bowel Disease Marin J. de Jong, a,b Danielle Roosen, a Juliette H. R. J. Degens, a Tim R. A. van den Heuvel, a,b Marielle Romberg-Camps, c W. Hameeteman, a Alexander G. L. Bodelier, d Igor Romanko, e Milan Lukas, e Bjorn Winkens, f,i Tineke Markus, g Ad A. M. Masclee, a,b Astrid van Tubergen, h,i Daisy M. A. E. Jonkers, a,b Marie J. Pierik a,b a Maastricht University Medical Center+, Department Gastroenterology and Hepatology, Maastricht, The Netherlands b Maastricht University Medical Center+, NUTRIM – School for Nutrition and Translational Research in Metabolism, Maastricht, The Netherlands c Zuyderland Medical Center, Department of Gastroenterology, Geriatrics, Internal and Intensive Care Medicine [Co-MIK], Sittard-Geleen, The Netherlands d Amphia Hospital Breda, Department of Gastroenterology and Hepatology, Breda, The Netherlands e Clinical Research Center for Infammatory Bowel Diseases IBD Center ISCARE, Prague, Czech Republic f Maastricht University Medical Center, Department of Methodology and Statistics, Maastricht, The Netherlands g CCUVN, Woerden, The Netherlands h Maastricht University Medical Center+, Department of Rheumatology, Maastricht, The Netherlands i Maastricht University Medical Center+, CAPHRI Care and Public Health Research Institute, Maastricht, The Netherlands Corresponding author: M. J. Pierik, MD, PhD, Department of Gastroenterology and Hepatology, Maastricht University Medical Center +, Maastricht, The Netherlands. Tel.: +31 43 38 75 021; email: M.pierik@mumc.nl Abstract Background and Aims: Patient-reported outcome measures [PROMs] assessing infammatory bowel disease [IBD] activity are of interest for monitoring in clinical practice, telemedicine systems, or trials. Different PROMs for follow-up of disease activity are available; however, none was developed with endoscopy as gold standard. The objective of this study was to develop and validate a PROM to predict endoscopic disease activity, following the recommendations of the Food and Drug Administration. Methods: During development, 178 IBD patients undergoing a colonoscopy were asked to fll out 13 clinical questions derived from the literature. During endoscopy, infammation was assessed with the simplifed endoscopic score for Crohn’s disease [CD] and the Mayo endoscopic subscore for ulcerative colitis [UC]. Based on correlation with endoscopic infammation, questions were reduced to a total of six for CD and fve for UC. The newly developed Monitor IBD At Home questionnaire [MIAH] was validated in an independent cohort of 135 CD and 131 UC patients. Additionally, diagnostic accuracy of the MIAH combined with a calprotectin home test [CHT] was assessed. Results: The MIAH-CD includes questions on rectal bleeding, mucus, stool frequency, urgency, fatigue, and patient-reported disease activity.The MIAH-UC contains items on rectal bleeding, stool frequency, urgency, abdominal pain, and patient-reported disease activity. Both questionnaires showed to be valid, reliable, and responsive to changes. The MIAH and CHT combined had a Downloaded from https://academic.oup.com/ecco-jcc/article/13/5/555/5205616 by guest on 13 March 2022