Development and Validation of a Patient-reported Score to Screen for Mucosal Inflammation in Inflammatory Bowel Disease.

Autor: de Jong MJ; Maastricht University Medical Center+, Department Gastroenterology and Hepatology, Maastricht, The Netherlands.; Maastricht University Medical Center+, NUTRIM - School for Nutrition and Translational Research in Metabolism, Maastricht, The Netherlands., Roosen D; Maastricht University Medical Center+, Department Gastroenterology and Hepatology, Maastricht, The Netherlands., Degens JHRJ; Maastricht University Medical Center+, Department Gastroenterology and Hepatology, Maastricht, The Netherlands., van den Heuvel TRA; Maastricht University Medical Center+, Department Gastroenterology and Hepatology, Maastricht, The Netherlands.; Maastricht University Medical Center+, NUTRIM - School for Nutrition and Translational Research in Metabolism, Maastricht, The Netherlands., Romberg-Camps M; Zuyderland Medical Center, Department of Gastroenterology, Geriatrics, Internal and Intensive Care Medicine [Co-MIK], Sittard-Geleen, The Netherlands., Hameeteman W; Maastricht University Medical Center+, Department Gastroenterology and Hepatology, Maastricht, The Netherlands., Bodelier AGL; Amphia Hospital Breda, Department of Gastroenterology and Hepatology, Breda, The Netherlands., Romanko I; Clinical Research Center for Inflammatory Bowel Diseases IBD Center ISCARE, Prague, Czech Republic., Lukas M; Clinical Research Center for Inflammatory Bowel Diseases IBD Center ISCARE, Prague, Czech Republic., Winkens B; Maastricht University Medical Center, Department of Methodology and Statistics, Maastricht, The Netherlands.; Maastricht University Medical Center+, CAPHRI Care and Public Health Research Institute, Maastricht, The Netherlands., Markus T; CCUVN, Woerden, The Netherlands., Masclee AAM; Maastricht University Medical Center+, Department Gastroenterology and Hepatology, Maastricht, The Netherlands.; Maastricht University Medical Center+, NUTRIM - School for Nutrition and Translational Research in Metabolism, Maastricht, The Netherlands., van Tubergen A; Maastricht University Medical Center+, Department of Rheumatology, Maastricht, The Netherlands.; Maastricht University Medical Center+, CAPHRI Care and Public Health Research Institute, Maastricht, The Netherlands., Jonkers DMAE; Maastricht University Medical Center+, Department Gastroenterology and Hepatology, Maastricht, The Netherlands.; Maastricht University Medical Center+, NUTRIM - School for Nutrition and Translational Research in Metabolism, Maastricht, The Netherlands., Pierik MJ; Maastricht University Medical Center+, Department Gastroenterology and Hepatology, Maastricht, The Netherlands.; Maastricht University Medical Center+, NUTRIM - School for Nutrition and Translational Research in Metabolism, Maastricht, The Netherlands.
Jazyk: angličtina
Zdroj: Journal of Crohn's & colitis [J Crohns Colitis] 2019 Apr 26; Vol. 13 (5), pp. 555-563.
DOI: 10.1093/ecco-jcc/jjy196
Abstrakt: Background and Aims: Patient-reported outcome measures [PROMs] assessing inflammatory 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 fill out 13 clinical questions derived from the literature. During endoscopy, inflammation was assessed with the simplified endoscopic score for Crohn's disease [CD] and the Mayo endoscopic subscore for ulcerative colitis [UC]. Based on correlation with endoscopic inflammation, questions were reduced to a total of six for CD and five 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 sensitivity, specificity, negative predictive value [NPV], and positive predicitive value [PPV] of 96.7%, 66.7%, 94.7%, and 76.3% for CD and of 88.2%, 81.4%, 95.6%, and 60.0% for UC, respectively, compared with endoscopy.
Conclusions: The MIAH is the first PROM developed to predict endoscopic inflammation in IBD patients. A combination of this questionnaire and a CHT shows excellent diagnostic accuracy to screen for patients who need further assessment of disease activity, and can be used in daily practice, telemedicine systems, and trials.
(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.)
Databáze: MEDLINE
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