Using ehealth strategies in delivering dietary and other therapies in patients with irritable bowel syndrome and inflammatory bowel disease

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1 bs_bs_banner doi: /jgh REVIEW ARTICLE Using ehealth strategies in delivering dietary and other therapies in patients with irritable bowel syndrome and inflammatory bowel disease Dorit Vedel Ankersen,* Katrine Carlsen, Dorte Marker,* Pia Munkholm* and Johan Burisch* *Gastroenterology Department, North Zealand University Hospital, Frederikssund, Denmark, Pediatric Department, Hvidovre University Hospital, Hvidovre, Denmark Key words diet, inflammatory bowel disease and irritable bowel syndrome, patient compliance, telemedicine. Accepted for publication 21 December Correspondence Dorit Vedel Ankersen, Gastroenterology Department, North Zealand University Hospital., Frederikssundvej 30 DK-3600, Frederikssund, Denmark. Disclosures: DVA has received a restricted research grant from Ferring Pharmaceuticals, and congress fees from Calpro AS and Genetic Analysis AS. KC has received unrestricted research grants from MSD and Tillotts Pharma. DM has received congress fees from Calpro AS, MSD and Pharmacosmos. JB has received consulting fees from Celgene, Janssen-Cilag, Abbvie and Ferring, and lecture fees from Abbvie, Pfizer, MSD and Takeda. PM has received consultant fees from Jannsen-Cilag, Ferring International, MSD, Abbvie, Takeda, and speaker s fees from Tillotts Pharma, Nestle, Ferring and Calpro AS. All authors declare that they have no conflicts of interest with regard to this article. Abstract Health-care systems around the world are facing increasing costs. Non-adherent, chronically ill patients are one such expense incurred by health-care providers. Web-based home-monitoring of patients or ehealth has been shown to increase adherence to medical therapy, facilitate contact between patients and health-care professionals, and reduce time to remission for patients with inflammatory bowel disease (IBD). Web-based treatment is a supportive tool for the health-care provider in an out-patient clinic. ehealth web-programs, such as the Constant Care application, visualize disease activity in a traffic light system and empower patients to screen for disease activity, enabling them to respond appropriately to their symptoms. The ehealth screening procedure for monitoring both pediatric and adult IBD patients is based on a self-obtained symptom score, together with a fecal biomarker for inflammation (fecal calprotectin) that the patients can measure independently using their smart phone, providing both patient and physician with an immediate disease status that they can react to instantaneously. Likewise, web applications for IBD patients, web applications for irritable bowel syndrome (IBS) patients and also IBD patients with co-existing IBS, have proven valuable for monitoring and treating IBS symptoms with a diet low in fermentable oligo-, di-, monosaccharides and polyols (low-fodmap diet). With careful disease monitoring via the web application and increased patient adherence, ehealth might be capable of improving the natural disease course of IBD and IBS. Introduction It is not the strongest of the species that survives, Nor the most intelligent that survives.it is the one that is most adaptable to change Charles Darwin Community effectiveness of therapy involves direct costs (e.g., medication and special nutrition) and indirect costs (e.g., sick leave due to relapse or chronic fatigue). Non-adherent patients with inflammatory bowel disease (IBD) are costly to health-care providers when relapses necessitate that immunosuppressive therapy be prescribed, including expensive biological agents. 1 Web-based treatment, or ehealth, is a supportive tool for the health-care provider in an out-patient clinic with the potential to enhance the self-management of IBD patients. According to the Copenhagen definition of ehealth, 2 it empowers patients and enables them to screen for disease activity, as well as guide them to respond to alarm symptoms visualized by the three-color traffic light system: red (severe disease activity), yellow (mild to moderate disease activity), and green (remission) (Fig. 1). Mucosal healing validated by endoscopy or by fecal calprotectin 3 is the goal of IBD therapy today. Individualized therapy is important in IBD because various environmental factors influence patients disease course and their risk of relapse, including smoking, stress, NSAIDs, non-adherence to treatment, and post-infectious gastroenteritis. Using ehealth technology, the disease course of the patients is visualized and individualized treatment made possible. In this paper, we will present our concept of web-monitoring of patients as well as data from ehealth trials using the Constant Care application from our research group. The principles can similarly be applied to patients with irritable bowel syndrome (IBS) and other functional gastrointestinal disorders. 27

2 Figure 1 Total inflammatory burden score (TIBS) consisting of a cumulative sum of short chronic colitis activity index for ulcerative colitis or Harvey Bradshaw index of Crohn s disease and fecal calprotectin shown as a traffic light color. Reproduced from Burisch & Munkholm 2 with permission. Tools for telemonitoring The Constant Care application. The Constant Care application 4 9 combines disease monitoring with an algorithm that actively provides treatment advice and is able to aid patients in treatment adherence, as well as individual dosing of medication. It consists of a patient education package (elearning and educational video-clips) and a web-based disease monitoring package. With the disease monitoring package, patients are able to record their disease activity, as well as their fecal calprotectin (FC) level, the latter being measured using a smart phone application and home testing kit. 10 Based on these results, the total inflammation burden score is calculated by adding FC level scores to those from clinical activity indices and visualized according to a traffic light color system of red, yellow, or green, to illustrate inflammatory activity (Fig. 1). The Constant Care application then directs individualized treatment for the patient and reduces potential lead time from relapse to action of treatment (Fig. 2). The physician has an electronic list of all patients using the web program and their current disease status, again using the traffic light system. Based on this list, the physician or nurse can perform their daily web ward round. Symptom scores for telemonitoring. Simple clinical colitis activity index (SCCAI) is combined with FC in the web application for ulcerative colitis patients. SCCAI consists of six objective sub-questions reflecting the disease activity over the 24 h prior to completion. SCCAI can be completed rapidly, and it is a reliable and validated measure of disease activity when selfadministered. 11 The counterpart to SCCAI for Crohn s patients using the web application is the Harvey Bradshaw index. Harvey Bradshaw index is likewise validated and is a selfadministered scheme that consists of five objective sub-questions reflecting the disease activity during the 24 h prior to completion. 12 Telemonitoring of symptom severity in IBS or in IBD with co-existing IBS has been included in web applications of Constant Figure 2 Influence of ehealth monitoring of the disease course of patients with inflammatory bowel disease. (Burish J, Munkholm P. The epidemiology of inflammatory bowel disease. Scand J Gastroenterol 2015;50:942-51) 1. With permission from Taylor & Francis Ltd, 28

3 Care by the IBS-severity scores system (IBS-SSS). It is a validated and self-administered measure reflecting the symptom severity during the 10 days prior to completion, and it consists of a fiveitem visual analog scale. 13 Pediatric IBD telemonitoring differs from adult versions mainly in the use of pediatric symptom scores. Pediatric ulcerative colitis activity index 14 and the abbreviated pediatric Crohn s disease activity index 15 are validated and suitable for self-administering via telecommunications. The symptom scores are supplemented by the objective parameter of the FC score, and a pediatric telemedicine algorithm reflects the total inflammation burden score and directs how the family should act. 9 Patient-reported outcomes in telemedicine. Patient-reported outcomes capture the patient s illness experience in a structured format and may help physicians to better understand symptoms from the patient s perspective. 16 The ultimate patient-reported outcome is improvement in health-related quality of life (HRQOL). Several different instruments exist for the assessment of HRQOL in IBD and IBS. The short version of IBDQ, the s-ibdq, is used in telemedicine and consists of 10 questions covering the following four broad domains: physical health, psychological health, social relationships, and environment. 17 The pediatric IBD HRQOL questionnaire, IMPACT III, 18 is used in pediatric telemedicine. The questionnaire consists of 35 questions with a five-point Likert scale subdivided into the following domains: bowel symptoms; body image; emotional functioning; social functioning; tests/treatments; and systemic symptoms. The questionnaire mirrors the adult IBDQ. IMPACT III is validated and was developed for 8 to 17-year-old IBD patients. The IBSQ is a validated, self-administered questionnaire with highly reproducible results for assessing the perceived quality of life for persons with IBS, using a recall period of the prior month. The IBSQ consists of 34 items, each with a five-point response scale. The 34 items are based on the following eight variables: dysphoria, interference with activity, body image, health worry, food avoidance, social reactions, sex and relationships. The individual responses to the 34 items are summed in a total score. The total score of the individual responses can be transformed into a0 100 scale for ease of interpretation, with higher scores indicating better IBS-specific quality of life. 19 ehealth influencing natural disease course of IBS and IBD results from clinical trials ehealth in adults. In several ehealth trials, 4,5,7,8 we have shown that patients are satisfied when using ehealth applications and that the physicians were able to individualize medical treatment in accordance with the patient s disease activity, to obtain remission quicker than with regular care, and achieve deep remission with mucosal healing (validated by FC). In addition, ehealth homemonitoring has made contact with health-care professionals easier. Using Constant Care ehealth applications, patient education delivered by the ehealth nurse, combined with elearning, has empowered patients by enabling them to perform individualized, self-administered therapy. By using web-based telemonitoring, ehealth patients have i) improved adherence to medication, including collecting medication from the pharmacy; ii) been able to increase medication dosing at home; iii) performed homemonitoring of symptom scores and FC; iv) benefited from an enhanced HRQOL 16 ; and v) been better at listening to their medical doctor s advice. 8 Similar results have been found in IBS ehealth solutions with a diet low in fermentable oligo-, di- and monosaccharides and polyols (FODMAP). In low-fodmap dietary therapy of IBS and IBS-like IBD, reintroduction of FODMAPs is essential for avoiding reduced bacterial abundance and a skewed microbiome in the long term. 20 Careful monitoring of these patients, such as via an ehealth platform, is essential when re-introducing them to high-fodmap foods that might affect the severity of their IBS symptoms. 20 When a relapse occurs, standard care with appointment at the medical doctor s office leads to delay in the treatment advice, as compared with ehealth care. However, the home-monitoring screening-on-demand of disease activity, plus the point-of-care test for FC (CalproSmart by Calpro Inc., Norway), provides the cumulative total inflammation burden score in just 18 min. 6,10 The ehealth platform and/or the nurse advise the patients in step-up treatment of 5-ASA or planning of infliximab infusion, thereby initiating therapy far earlier than with standard care. The reduced lead time helps with lowering inflammation burden and bringing about remission in a shorter time. 2,6,8 IBS and IBD with IBS-like symptoms. Newly published English clinical guidelines for IBS recommend dietary treatment, for example, a low-fodmap diet, for treating IBS symptoms. 21 Three ehealth trials were carried out to prove the value of the low-fodmap diet. In the first trial, 19 IBS patients were monitored via During the first 6 weeks, they were monitored only via the web application following a 6-week period on the diet. Significant reductions in IBS-SSS were observed for both periods, substantiating the claim that ehealth alone has an impact on IBS severity and the low-fodmap diet as well. 4 In the second trial, 123 IBS patients were randomized to 6 weeks on a low-fodmap diet versus 6 weeks on a normal Danish diet versus Lactobacillus rhamnosus GG. 5 Significant differences were observed between the low-fodmap and normal Danish diets. In the third ehealth trial, 89 IBD patients with IBS-like symptoms were randomized to one of the two for 6 weeks. Adherence to the diet was measured by g/day of FODMAPs. There was a significant reduction in g FODMAPs per day in the low-fodmap group and non-significant reduction in the normal Danish dietary group. The proportion of responders, defined as a reduction of more than 50 points on IBS-SSS, was significantly greater in the low-fodmap group (81%) than in control group (46%). Likewise, a significantly greater reduction in IBS-SSS was also observed. Furthermore, the low-fodmap group had a significantly greater increase in their quality of life (s-ibdq). The changes in symptom score (IBS-SSS) correlated with the changes seen in quality of life (s-ibdq). Long-term evaluation of a low-fodmap diet in IBS and IBD patients. Consecutive patients with IBS or IBD with co-existing IBS, and who previously attended an outpatient clinic for low-fodmap dietary management, were invited to participate in a retrospective questionnaire analysis. The questionnaires 29

4 Figure 3 Copenhagen disease course types evaluated in long-term follow-up of 131 patients with irritable bowel syndrome (IBS) prior to, and following, treatment with a diet low in fermentable oligo-, di- and monosaccharides and polyols. 22 Copenhagen disease course types IBS: (a) Mild IBS with indolent course; (b) Mild IBS with aggressive course; (c) Chronic IBS with continuous course; (d) Chronic IBS with intermittent course. Reproduced from Maagaard et al. 22 with permission. Figure 4 Copenhagen disease course types evaluated in long-term follow-up of 49 patients with inflammatory bowel disease (IBD) with irritable bowel syndrome (IBS)-like symptoms prior to, and following, treatment with a diet low in fermentable oligo-, di- and monosaccharides and polyols. 22 Copenhagen disease course types IBS: (a) Mild IBS with indolent course; (b) Mild IBS with aggressive course; (c) Chronic IBS with continuous course; (d) Chronic IBS with intermittent course. Reproduced from Maagaard et al. 22 with permission. gathered information on recall of dietary treatment, efficacy, and adherence to the diet, Copenhagen IBS disease course, stool type, and quality of life. One hundred and eighty patients (131 IBS, 49 IBD) were included. Median follow-up time was 16 months (range 2 80). Eighty-seven percent reported either partial (54%) or full (32%) improvement, with greatest amelioration of bloating (82%) and abdominal pain (71%). Copenhagen IBS disease course and stool type improved significantly after dietary intervention (P < 0.001) (Figs 3, 4). One-third of patients adhered to the diet. 22 ehealth in children. Medical adherence is a challenge in adolescent IBD patients, and the transition from being a patient at the pediatric department to one at the adult gastroenterology department can be difficult. It requires that the young patient be empowered and able to self-manage their disease. It is hypothesized that the self-administered ehealth approach that involves young patients (aged years) monitoring their own disease supports the objectives of empowerment and adherence. The application is designed for the younger patient (10 17 years old) and is being tested in an ongoing randomized clinical study. 9 Results will be published 2017 (clinicaltrials.org ID: NCT ). Future aspects [ ]It is the one that is most adaptable to change. There is little doubt that patients are the most adaptable to change. They are eager to be involved in their treatment and monitoring 30

5 using smart phones or their regular computer and respond appropriately to their current inflammation burden. The advantages of ehealth applications and home monitoring are obvious and include offering the patient quick and easy access to medical care, nutritional advice, and providing patients with more individualized treatment. Self-management promotes patient engagement and empowerment, and represents a unique opportunity for a selected group of patients with IBD and IBS that require life-long followup and maintenance treatment. Patients with less aggressive disease courses, or in maintenance of remission, can likewise be followedup primarily using ehealth, thus reducing the burden on the healthcare system by allowing for better and more effective allocation of resources. However, we have yet to prove if ehealth monitoring can change the natural disease course of IBD and IBS. References 1 Burisch J, Munkholm P. The epidemiology of inflammatory bowel disease. Scand. J. Gastroenterol. 2015; 50: Burisch J, Munkholm P. Telemonitoring and self-care in patients with IBD. In: Cross RK, Watson AR, eds. Telemanagement of Inflammatory Bowel Disease. Springer, New York, USA, 2015; Neurath MF, Travis SPL. Mucosal healing in inflammatory bowel diseases: a systematic review. Gut 2012; 61: Pedersen N, Vegh Z, Burisch J et al. Ehealth monitoring in irritable bowel syndrome patients treated with low fermentable oligo-, di-, mono-saccharides and polyols diet. World J. Gastroenterol. 2014; 20: Pedersen N, Andersen NN, Végh Z et al. Ehealth: low FODMAP diet vs Lactobacillus rhamnosus GG in irritable bowel syndrome. World J. Gastroenterol. 2014; 20: Pedersen N, Elkjaer M, Duricova D et al. EHealth: Individualisation of infliximab treatment and disease course via a self-managed web-based solution in Crohn s disease. Aliment. Pharmacol. Ther. 2012; 36: Pedersen N, Thielsen P, Martinsen L et al. ehealth: individualization of mesalazine treatment through a self-managed web-based solution in mildto-moderate ulcerative colitis. Inflamm. Bowel Dis. 2014; 20: Elkjaer M, Shuhaibar M, Burisch J et al. E-health empowers patients with ulcerative colitis: a randomised controlled trial of the web-guided Constant-care approach. Gut 2010; 59: Carlsen K, Jakobsen C, Hansen LF et al. Self-administered telemedicine empowers paediatric and adolescent patients with inflammatory bowel disease. J. Pediatr. Gastroenterol. Nutr. 2016; 62. Confer: Vinding KK, Elsberg H, Thorkilgaard T et al. Fecal calprotectin measured by patients at home using smartphones a new clinical tool in monitoring patients with inflammatory bowel disease. Inflamm. Bowel Dis. 2016; 2: Jowett SL, Seal CJ, Phillips E et al. Defining relapse of ulcerative colitis using a symptom-based activity index. Scand. J. Gastroenterol. 2003; 38: Harvey RF, Bradshaw JM. A simple index of Crohn s-disease activity. Lancet (London, England) 1980; 1: Drossman DA, Chang L, Bellamy N et al. Severity in irritable bowel syndrome: a Rome Foundation Working Team report. Am. J. Gastroenterol. 2011; 106: quiz Turner D, Otley AR, Mack D et al. Development, validation, and evaluation of a pediatric ulcerative colitis activity index: a prospective multicenter study. Gastroenterology 2007; 133: Turner D, Griffiths AM, Walters TD et al. Mathematical weighting of the pediatric Crohn s disease activity index (PCDAI) and comparison with its other short versions. Inflamm. Bowel Dis. 2012; 18: Carlsen K, Munkholm P, Burisch J. Evaluation of quality of life in Crohn s disease and ulcerative colitis what is health-related quality of life? In: Baumgart DC, ed. Crohn s Disease and Ulcerative Colitis: From Epidemiology and Immunobiology to a Rational Diagnostic and Therapeutic Approach, 2nd edn. Boston, MA: Springer International Publishing AG, Irvine EJ, Zhou Q, Thompson AK. The short inflammatory bowel disease questionnaire: a quality of life instrument for community physicians managing inflammatory bowel disease. CCRPT investigators. Canadian Crohn s relapse prevention trial. Am. J. Gastroenterol. 1996; 91: Griffiths AM, Nicholas D, Smith C et al. Development of a quality-oflife index for pediatric inflammatory bowel disease: dealing with differences related to age and IBD type. J. Pediatr. Gastroenterol. Nutr. 1999; 28: S46 S Patrick DL, Drossman DA, Frederick IO et al. Quality of life in persons with irritable bowel syndrome: development and validation of a new measure. Dig. Dis. Sci. 1998; 43: Halmos EP, Christophersen CT, Bird AR et al. Diets that differ in their FODMAP content alter the colonic luminal microenvironment. Gut 2014; 64: Hookway C, Buckner S, Crosland P et al. Irritable bowel syndrome in adults in primary care: summary of updated NICE guidance. BMJ 2015; 350: h701 h Maagaard L, Vegh Z, Burisch J et al. Follow-up of patients with functional bowel symptoms treated with a low FODMAP diet. World J. Gastroenterol. 2016; 15: