Journal of Medical Internet Research - International Scientific Journal for Medical Research, Information and Communication on the Internet #Preprint #PeerReviewMe: Warning: This is a unreviewed preprint. Readers are warned that the document has not been peer-reviewed by expert/patient reviewers or an academic editor, may contain misleading claims, and is likely to undergo changes before final publication, if accepted, or may have been rejected/withdrawn. Readers with interest and expertise are encouraged to sign up as peer-reviewer, if the paper is within an open peer-review period. Please cite this preprint only for review purposes or for grant applications and CVs (if you are the author). Background: Web-based systems provide safe and well-accepted management of mild to moderate inflammatory bowel disease (IBD) patients, with potential cost savings. However, the efficacy of different eHealth applications on disease outcomes is inconsistent between studies and data are lacking in complex IBD. Objective: To compare the impact on health outcomes and healthcare use of remote monitoring with a web system, TECCU (Telemonitorización de la Enfermedad de Crohn y Colitis Ulcerosa [Telemonitoring of Crohn’s Disease and Ulcerative Colitis]) in complex IBD patients vs standard care and telephone care. Methods: We performed a 3-arm randomized controlled trial (ClinicalTrials.gov identifier: NCT02943538). Adult IBD patients who initiated immunosuppressant and/or biological agents were recruited from the specialized IBD Unit of a public university hospital and then randomized to receive remote monitoring (G_TECCU), nurse-assisted telephone care (G_NT) or standard care with in-person visits (G_control). All patients attended study visits at baseline and at 12 and 24 weeks, in addition to each type of intervention. The primary outcome was the percentage of patients in remission at 24 weeks. Secondary health outcomes were quality of life, medication adherence, adverse effects, satisfaction and social activities. The number of outpatient visits and telephone calls, emergency visits, hospitalizations, IBD-related surgeries and corticosteroid courses were also collected. Results: In total, 63 patients were selected (21 in each group). During the study period, 90,5% of patients (19/21) in G_control, 95,2% of patients in G_AT (20/21) and 85,7% of patients in G_TECCU (18/21) were compliant to the intervention. After 24 weeks, the percentage of patients in remission was higher in G_TECCU (81%) compared with G_NT (66,7%) and G_control (71.4%), with a higherimprovement in disease activity in G_TECCU vs G_control both considering Harvey-Bradshaw/Mayo (OR= 0.12 [95% CI 0.003 to 2.162]; p=0.189) and Harvey-Bradshaw/Walmsley indexes (OR= 0.11 [95% CI 0.004 to 1.55]; p=0.126). Disease activity improvement was also associated to a higher reduction in fecal calprotectine values in G_TECCU vs G_control (estimated intervention effect -0.90 [95% CI -1.96 to 0.16]; p= 0.106) at the end of the study. All completer patients adhered to treatment in G_TECCU andquality of life, social activities and satisfaction improved in the 3 groups. The number of outpatient visits and telephone calls was lower in G_TECCU, with similar safety profile compared with G_NT and G_control. Conclusions: This pilot clinical trial suggests that TECCU is a safe strategy for improving health outcomes in complex IBD patients, with less frequent use of health care resources. Clinical Trial: ClinicalTrials.gov: NCT02943538; https://clinicaltrials.gov/ct2/show/NCT02943538 (Archived by WebCite at http://www.webcitation.org/6y4DQdmt8).

This review article summarizes the evidence about telemedicine applications (e.g., telemonitoring, teleconsulting, and tele-education) in the management of patients with inflammatory bowel disease (IBD), and we aim to give an overview of the acceptance and impact of these interventions on health outcomes. Based on the literature search on "inflammatory bowel disease," "Crohn's disease" and "ulcerative colitis" in combination with "e-health," "telemedicine," and "telemanagement," we selected 58 titles and abstracts published up to June 2014 and searched in PubMed, EMBASE, MEDLINE, Cochrane Database, Web of Science and Conference Proceedings. Titles and abstracts were screened for a set of inclusion criteria: e-health intervention, IBD as the main disease, and a primary study performed. Finally, 16 were included for full reading, data extraction, and critical appraisal of the evaluation. Most studies use telemonitoring (home telemanagement system or web portal) and telecare (real-time telephone and image) as telemedicine applications and assessed the feasibility and acceptance of these systems, adherence to treatment, quality of life, and patient knowledge, particularly in patients with ulcerative colitis. Furthermore, some of these studies evaluated the patients' empowerment, health care costs, and safety of telemonitoring in IBD. In conclusion, the health outcomes of telemedicine applications in IBD suggest that these could be implemented in clinical practice because they are safe and feasible applications that are well accepted by the patient and improve adherence, quality of life, and disease knowledge. Further studies with large sample sizes and complex diseases are needed to confirm these results.

Background: Although electronic health interventions are considered safe and efficient, evidence regarding the cost-effectiveness of telemonitoring in inflammatory bowel disease is lacking. Objective: We aimed to evaluate the cost-effectiveness and cost-utility of the Telemonitorización de la Enfermedad de Crohn y Colitis Ulcerosa (Telemonitoring of Crohn’s Disease and Ulcerative Colitis [TECCU]) Web platform (G_TECCU intervention group) for telemonitoring complex inflammatory bowel disease, compared with standard care (G_control) and nurse-assisted telephone care (G_NT intervention group). Methods: We analyzed cost-effectiveness from a societal perspective by comparing the 3 follow-up methods used in a previous 24-week randomized controlled trial, conducted at a tertiary university hospital in Spain. Patients with inflammatory bowel disease who initiated immunosuppressants or biologic agents, or both, to control inflammatory activity were recruited consecutively. Data on the effects on disease activity (using clinical indexes) and quality-adjusted life-years (using the EuroQol 5 dimensions questionnaire) were collected. We calculated the costs of health care, equipment, and patients’ productivity and social activity impairment. We compared the mean costs per patient, utilities, and bootstrapped differences. Results: We included 63 patients (21 patients per group). TECCU saved €1005 (US $1100) per additional patient in remission compared with G_control (95% CI €–13,518 to 3137; US $–14,798 to 3434), with a 79.96% probability of being more effective at lower costs. Compared with G_NT, TECCU saved €2250 (US $2463) per additional patient in remission (95% CI €–15,363 to 11,086; US $–16,817 to 12,135), and G_NT saved €538 (US $589) compared with G_control (95% CI €–6475 to 5303; US $–7088 to 5805). G_TECCU and G_NT showed an 84% and 67% probability, respectively, of producing a cost saving per additional quality-adjusted life-year (QALY) compared with G_control, considering those simulations that involved negative incremental QALYs as well. Conclusions: There is a high probability that the TECCU Web platform is more cost-effective than standard and telephone care in the short term. Further research considering larger cohorts and longer time horizons is required. Trial Registration: ClinicalTrials.gov NCT02943538; https://clinicaltrials.gov/ct2/show/NCT02943538 (http://www. webcitation.org/746CRRtDN)

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Background: Despite the continuous adaptation of eHealth systems for patients with inflammatory bowel disease (IBD), a significant disconnection persists between users and developers. Since non-adherence remains high, it is necessary to better understand the patients’ perspective on telemonitoring for IBD. Accordingly, this study aimed to adapt the TECCU telemonitoring app to the preferences and needs of IBD patients. Methods: A qualitative study was carried out using successive focus groups of IBD patients. Meetings were audio-recorded and a thematic analysis was employed until data saturation was achieved. The first group included patients who had used the TECCU App in a pilot clinical trial, and subsequent meetings included patients with Crohn’s disease and ulcerative colitis recruited from the Spanish Confederation of patient associations. The information collected at each meeting guided consecutive changes to the platform. Results: Data saturation was reached after three focus groups involving a total of 18 patients. Three main themes emerged: (1) platform usability, (2) the communication process, and (3) platform content. All participants indicated that TECCU is easy to use, permitting continuous and personalized feedback. According to patients´ perspectives, the platform was adapted to foster a flexible follow-up and shared decision-making using open and safe communication networks. Many participants appreciated the educational elements and, consequently, the app was connected to reliable and continuously updated webpages. Conclusions: IBD patients valued the usability and personalized monitoring offered by the TECCU App. Improvements in the messaging system and continuously updated educational content were introduced to address patients´ needs and favor their engagement.