Development and feasibility of a telemonitoring tool with full integration in the electronic medical record: a proof of concept study for patients with inflammatory bowel disease in remission on biological therapy.

Objectives: Telemonitoring can be implemented to enhance disease monitoring and ultimately reduce the number of outpatient visits and associated costs. We developed an in house IBD mobile app and established a proof of concept study to demonstrate the effectiveness and accuracy of the telemonitoring tool for monitoring of disease activity.Methods: An IBD mobile app was designed through close collaboration between the Information Technology and Gastroenterology department of University Hospitals of Leuven. The study was proposed to all patients in remission under stable biological therapy visiting the outpatient clinic. During one-year follow-up, patients completed weekly and monthly questionnaires on their mobile device or on a website. Entered data were directly sent to the electronic medical record. Predefined red flags or alerts, generated by the answers to the questionnaires, were monitored daily.Results: The pilot study in 45 patients demonstrated accurate monitoring of disease activity with fast intervention during flares. During the 12-months follow-up period, an alert for disease activity was generated for 9 different patients out of 1296 completions of the questionnaire. Symptoms resolved spontaneously in 8 patients. One patient reported consecutive PRO-2 increase, endoscopy confirmed an IBD flare and therapy was switched. For the remaining 36 included patients, no alerts indicating disease activity increase were reported. Median compliance to all weekly and monthly questionnaires during 1 year was 52% (IQR: 24-91).Conclusions: We developed the mynexuzhealth IBD app with full integration in the electronic medical record. The app enabled continuous remote monitoring and showed accurate detection of flares.

Short Health Scale: a valid and reliable measure of quality of life in Dutch speaking patients with inflammatory bowel disease.

Objectives: Patient reported outcomes are widely used in today's clinical practice. The Short Health Scale has been proven to be an easy-to-use and reliable measure to evaluate quality of life in patients with inflammatory bowel disease. We aimed to validate this Short Health Scale in Dutch speaking patients. Methods: A total of 157 Crohn's disease and ulcerative colitis patients (46% male, median age 39 years) completed the Short Health Scale on a tablet during the outpatient clinic. Validity was assessed by correlating both individual and total Short Health Scale scores with short Inflammatory Bowel Disease Questionnaire dimensions and clinical disease activity. Test-retest reliability was assessed in eight patients in stable remission who completed the Short Health Scale a second time after 4-8 weeks. Results: All Short Health Scale items correlated with corresponding short Inflammatory Bowel Disease Questionnaire dimensions (correlation coefficients ranging from -0.403 to -0.833, all p < .01). Short Health Scale scores increased stepwise with increasing clinical disease activity (all p < .001). The results of the Short Health Scale questionnaire remained stable on repeated measurements in patients in remission (rs between 0.699 and 0.994, all p < .01 except for well-being). Conclusions: The Short health Scale is a rapid and valid instrument for measuring quality of life in Dutch speaking patients with Inflammatory Bowel Disease. Its simplicity and usability make it a good candidate for routine care and suitable for home-monitoring of patients.

Fecal calprotectin is a surrogate marker for endoscopic lesions in inflammatory bowel disease.

BACKGROUND: Fecal calprotectin is a marker of inflammation in inflammatory bowel disease (IBD). Since mucosal healing has become a goal of treatment in IBD we examined how reliably calprotectin levels reflect mucosal disease activity. METHODS: In all, 126 IBD patients and 32 irritable bowel syndrome (IBS) patients needing colonoscopy delivered a sample of feces prior to the start of bowel cleansing. Besides collection of symptom scores and blood tests, experienced endoscopists recorded the Simple Endoscopic Score for Crohn's Disease (SES-CD) and the Crohn's Disease Endoscopic Index of Severity (CDEIS) in Crohn's disease (CD) patients and the Mayo endoscopic score in ulcerative colitis (UC) patients. Stool samples were shipped for central calprotectin PhiCal Assay (enzyme-linked immunosorbent assay [ELISA]). Correlation analysis was done with Pearson statistics. RESULTS: The median (interquartile range [IQR]) fecal calprotectin levels were 175 (44-938) µg/g in CD, 465 (61-1128) µg/g in UC, and 54 (16-139) µg/g in IBS. Correlations were significant with endoscopic disease scores in both CD and in UC. Using ROC statistics, a cutoff value of 250 µg/g indicated the presence of large ulcers with a sensitivity of 60.4% and a specificity of 79.5% (positive predictive value [PPV] 78.4%, negative predictive value [NPV] 62.0%) in CD. Levels ≤ 250 µg/g predicted endoscopic remission (CDEIS ≤ 3) with 94.1% sensitivity and 62.2% specificity (PPV 48.5%, NPV 96.6%). In UC, a fecal calprotectin >250 µg/g gave a sensitivity of 71.0% and a specificity of 100.0% (PPV 100.0%, NPV 47.1%) for active mucosal disease activity (Mayo >0). Calprotectin levels significantly correlated with symptom scores in UC (r = 0.561, P < 0.001), but not in CD. CONCLUSIONS: Fecal calprotectin levels correlate significantly with endoscopic disease activity in IBD. The test appears useful in clinical practice for assessment of endoscopic activity and remission.