Telemedicine for management of inflammatory bowel disease (myIBDcoach): a pragmatic, multicentre, randomised controlled trial.

BACKGROUND: Tight and personalised control of inflammatory bowel disease in a traditional setting is challenging because of the disease complexity, high pressure on outpatient clinics, and rising incidence. We compared the effects of self-management with a telemedicine system, which was developed for all subtypes of inflammatory bowel disease, on health-care utilisation and patient-reported quality of care versus standard care. METHODS: We did this pragmatic, randomised trial in two academic and two non-academic hospitals in the Netherlands. Outpatients aged 18-75 years with inflammatory bowel disease and without an ileoanal or ileorectal pouch anastomosis, who had internet access and Dutch proficiency, were randomly assigned (1:1) to care via a telemedicine system (myIBDcoach) that monitors and registers disease activity or standard care and followed up for 12 months. Randomisation was done with a computer-generated sequence and used the minimisation method. Participants, health-care providers, and staff who assessed outcome measures were not masked to treatment allocation. Primary outcomes were the number of outpatient visits and patient-reported quality of care (assessed by visual analogue scale score 0-10). Safety endpoints were the numbers of flares, corticosteroid courses, hospital admissions, emergency visits, and surgeries. Analyses were by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT02173002. FINDINGS: Between Sept 9, 2014, and May 18, 2015, 909 patients were randomly assigned to telemedicine (n=465) or standard care (n=444). At 12 months, the mean number of outpatient visits to the gastroenterologist or nurse was significantly lower in the telemedicine group (1·55 [SD 1·50]) than in the standard care group (2·34 [1·64]; difference -0·79 [95% CI -0·98 to -0·59]; p<0·0001), as was the mean number of hospital admissions (0·05 [0·28] vs 0·10 [0·43]; difference -0·05 [-0·10 to 0·00]; p=0·046). At 12 months, both groups reported high mean patient-reported quality of care scores (8·16 [1·37] in the telemedicine group vs 8·27 [1·28] in the standard care group; difference 0·10 [-0·13 to 0·32]; p=0·411). The mean numbers of flares, corticosteroid courses, emergency visits, and surgeries did not differ between groups. INTERPRETATION: Telemedicine was safe and reduced outpatient visits and hospital admissions compared with standard care. This self-management tool might be useful for reorganising care of inflammatory bowel disease towards personalised and value-based health care. FUNDING: Maastricht University Medical Centre and Ferring.

Risk of impaired nutritional status and flare occurrence in IBD outpatients.

BACKGROUND: Inflammatory bowel disease (IBD) patients are at risk of an impaired nutritional status. The impact thereof on the IBD relapse risk is clinically relevant, though sparsely investigated. AIM: The aim was to explore the association between an impaired nutritional status risk and the occurrence of disease flares in IBD outpatients participating in a longitudinal telemedicine study. METHODS: IBD outpatients were recruited from the myIBDcoach study cohort, with one year clinical follow-up. Through myIBDcoach, a telemedicine tool, patients reported on disease activity and risk of impaired nutritional status (i.e. Short Nutritional Assessment Questionnaire >1 and/or BMI < 18.5 kg/m2) every one to three months. Data was analysed by generalized estimating equation modelling. RESULTS: In total, 417 patients were included. During follow-up, 49 patients (11.8%) flared after initial clinical remission and 53 patients (12.7%) showed an increased risk of impaired nutritional status. The risk of impaired nutritional status was associated with flare occurrence (OR 2.61 (95% CI 1.02-6.69)). CONCLUSIONS: The risk of an impaired nutritional status was associated with subsequent flares in IBD outpatients. This emphasizes the importance of monitoring disease activity in IBD patients at risk of impaired nutritional status.

Plasma intestinal fatty acid-binding protein fails to predict endoscopic disease activity in inflammatory bowel disease patients.

BACKGROUND: Monitoring disease activity in inflammatory bowel disease (IBD) is of major importance to prevent long-term complications. Intestinal fatty acid-binding protein (I-FABP) has been identified as a marker for intestinal damage and correlates with the degree of inflammation. The aim of the present study was to evaluate whether I-FABP can predict active disease or remission in Crohn's disease (CD) and ulcerative colitis (UC) in a real-life IBD cohort. METHODS: In total, 70 patients with endoscopic disease activity available and 194 patients with disease activity on the basis of a stringent combi-score of clinical activity index, C-reactive protein, and fecal calprotectin were included. Plasma I-FABP was compared between patients with active disease and remission. In a small subgroup of CD patients, follow-up samples were analyzed. RESULTS: In CD (139.2 vs. 119.2 pg/ml; P=0.37) and UC (107.8 vs. 151.8 pg/ml; P=0.33), the median I-FABP did not differ in endoscopic active disease versus remission. In UC patients with active disease on the basis of the combi-score, the median I-FABP (106.8 vs. 172.0 pg/ml; P=0.03) was significantly lower than in patients in remission, but not in CD (145.5 vs. 157.5 pg/ml; P=0.29). Neither disease location in CD nor extent of disease in UC influenced I-FABP significantly. I-FABP was not different (P=0.78) in CD patients with a change in disease activity over time. CONCLUSION: Plasma I-FABP did not differ between endoscopic active disease and remission in both CD and UC. I-FABP was lower in active UC but not CD on the basis of the combi-score. On the basis of these findings, I-FABP has no potential as a novel noninvasive biomarker for disease activity in IBD.