TY - JOUR
T1 - Development and Validation of a Patient-reported Score to Screen for Mucosal Inflammation in Inflammatory Bowel Disease
AU - de Jong, Marin J.
AU - Roosen, Danielle
AU - Degens, Juliette H. R. J.
AU - van den Heuvel, Tim R. A.
AU - Romberg-Camps, Marielle
AU - Hameeteman, W.
AU - Bodelier, Alexander G. L.
AU - Romanko, Igor
AU - Lukas, Milan
AU - Winkens, Bjorn
AU - Markus, Tineke
AU - Masclee, Ad A. M.
AU - van Tubergen, Astrid
AU - Jonkers, Daisy M. A. E.
AU - Pierik, Marie J.
N1 - Funding Information:
The study was approved by the Medical Research Ethics Committee of the Maastricht University Medical Center+. This approval was applicable to all participating centres. All patients gave written informed consent before participation.
Publisher Copyright:
Copyright © 2018 European Crohn's and Colitis Organisation (ECCO).
PY - 2019/5
Y1 - 2019/5
N2 - 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.
AB - 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.
KW - IBD
KW - PROM
KW - mucosal inflammation
KW - OUTCOME MEASURES
KW - CLINICAL REMISSION
KW - CROHNS-DISEASE
KW - ACTIVITY INDEX
KW - HEALTH-STATUS
KW - MAYO SCORE
KW - PREVALENCE
KW - BIOMARKERS
KW - SYMPTOMS
KW - CARE
U2 - 10.1093/ecco-jcc/jjy196
DO - 10.1093/ecco-jcc/jjy196
M3 - Article
C2 - 30476099
SN - 1873-9946
VL - 13
SP - 555
EP - 563
JO - Journal of Crohn's & Colitis
JF - Journal of Crohn's & Colitis
IS - 5
ER -