Remote monitoring of IBD

Rationale: Crohn’s disease (CD) and ulcerative colitis (UC) are chronic inflammatory bowel diseases (IBD) with a heterogeneous disease course. Recurrent mucosal inflammation or chronic subclinical inflammation results in damage to the bowel and complications like stenosis, fistula and colorectal cancer. Therefore, tight control of mucosal inflammation is important to prevent complications. With the early onset in life and the lack of curative treatment, a lifetime of monitoring is needed. Endoscopy is the golden standard to detect mucosal inflammation. This is however an invasive procedure and not suitable for frequent monitoring. The ideal monitoring test is non-invasive, simple to conduct, and detects (imminent) disease activity, so treatment can be timely optimized. The test should be suitable for remote monitoring and should measure doctor’s perspective on disase activity, but also take into account the patient’s perspective. Several non-invasive patient questionnaires to monitor disease activity have been developed, such as the Monitor IBD At Home (MIAH) score, mobile Health Index (mHI), the Manitoba IBD Index and IBD-control questionnaire. Diagnostic accuracy of symptom-based monitoring is insufficient. The Maastricht University Medical Center+ recently implemented QuantOn Cal (QOC) tests for patients to determine fecal calprotectin at home. It is yet unknown which patient questionnaire, combined with the QOC test, has the best diagnostic test accuracy for mucosal inflammation.

Objective: The main objective of this study is to determine the best remote monitoring tool for mucosal inflammation in adults patients with inflammatory bowel disease, relative to the golden standard endoscopy.

Study design: This is a cross-sectional cohort study. IBD patients are asked to fill out questions regarding disease activity (MIAH, mHI, Manitoba, IBD-control), perform one QOC test and collect one stool sample for routine laboratory calprotectin measurement, before the start of the bowel preparation for the ileocolonoscopy. During this ileocolonoscopy, endoscopic disease activity according to the SES-CD or MES will be determined.

Study population: Adult patients with an established diagnosis of Crohn’s disease or ulcerative colitis, scheduled for an ileocolonoscopy as part of routine care, are eligible.
Main study parameters/endpoints: The main study parameter is the diagnostic test accuracy of various patient reported scores (MIAH, mHI, Manitoba, IBD-control) in combination with the QOC test in detecting mucosal inflammation, using ileocolonoscopy as the golden standard.

We hypothesize that the MIAH combined with the QOC and the mHI combined with the QOC will have the best diagnostic accuracy, and have comparable overall se/sp.
We hypothesize that the diagnostic accuracy of the Manitoba and IBD control is less, since these scores are focused more on patient’s than on doctor’s perspective of disease activity, and consequently less on mucosal inflammation.

baseline, 1 week