Development and validation of a patient-reported score to screen for mucosal inflammation in inflammatory bowel disease.

Development and validation of a patient-reported score to screen for mucosal inflammation in inflammatory bowel disease.

J Crohns Colitis. 2018 Nov 24;:

Authors: de Jong MJ, Roosen D, Degens JHRJ, van den Heuvel TRA, Romberg M, Hameeteman W, Bodelier AGL, Romanko I, Lukas M, Winkens B, Markus T, Masclee AAM, van Tubergen A, Jonkers DMAE, Pierik MJ

Abstract
BACKGROUND & 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 golden 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 6 for CD and 5 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, NPV and PPV of 96.7%, 66.7%, 94.7%, and 76.3% for CD and of 88.2%, 81.4%, 95.6%, 60.0% for UC, compared to endoscopy.
CONCLUSION: 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.

PMID: 30476099 [PubMed - as supplied by publisher]