1. Development and Validation of a Patient-reported Score to Screen for Mucosal Inflammation in Inflammatory Bowel Disease
- Author
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Igor Romanko, Ad A.M. Masclee, Alexander Bodelier, Marin J de Jong, Marie J. Pierik, Daisy Jonkers, Astrid van Tubergen, Tineke Markus, Juliette H R J Degens, Tim van den Heuvel, Milan Lukas, Mariëlle Romberg-Camps, Bjorn Winkens, Danielle Roosen, Wim Hameeteman, Interne Geneeskunde, RS: NUTRIM - R2 - Liver and digestive health, MUMC+: MA Med Staf Artsass Interne Geneeskunde (9), MUMC+: MA Maag Darm Lever (9), FHML Methodologie & Statistiek, RS: CAPHRI - R6 - Promoting Health & Personalised Care, MUMC+: MA Reumatologie (9), and RS: CAPHRI - R3 - Functioning, Participating and Rehabilitation
- Subjects
Male ,Abdominal pain ,SYMPTOMS ,Colonoscopy ,Inflammatory bowel disease ,Feces ,MAYO SCORE ,0302 clinical medicine ,Crohn Disease ,Surveys and Questionnaires ,Prospective Studies ,Intestinal Mucosa ,Irritable bowel syndrome ,HEALTH-STATUS ,Crohn's disease ,medicine.diagnostic_test ,Gastroenterology ,General Medicine ,Middle Aged ,Colitis ,Ulcerative colitis ,CROHNS-DISEASE ,PREVALENCE ,030220 oncology & carcinogenesis ,Female ,030211 gastroenterology & hepatology ,medicine.symptom ,Adult ,medicine.medical_specialty ,IBD ,BIOMARKERS ,03 medical and health sciences ,Internal medicine ,medicine ,Mucositis ,Humans ,Patient Reported Outcome Measures ,PROM ,mucosal inflammation ,business.industry ,ACTIVITY INDEX ,Reproducibility of Results ,OUTCOME MEASURES ,CARE ,Inflammatory Bowel Diseases ,medicine.disease ,CLINICAL REMISSION ,Colitis, Ulcerative ,Calprotectin ,business ,Leukocyte L1 Antigen Complex - Abstract
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.
- Published
- 2018
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