In this study, 255 patients between 15 and 70 years were recruited after being accepted for patient education at Haukeland University Hospital in Norway between 2017 and 2019. Random patients on the waiting list to the onsite multidisciplinary 2-day group-based education program, IBS-school, were contacted by phone by a study nurse and offered to attend the novel multidisciplinary digital 5-module eHealth program, from here on referred to as the “eHealth program.” Patients attending the IBS-school were recruited on site when attending the 2-day group-based education program. Patients received oral and written information before giving written consent and sent it to the hospital by post. Furthermore, 123 patients that attended the IBS-school were used for comparison (N=255, 1:1). Here, patients were recruited by a study nurse on site. They received an oral and written information about the study before signing consent (Figure 1). Inclusion criteria included (1) being referred to receiving patient education on IBS by a gastroenterologist or general practitioner after the diagnosis of IBS had been determined (International Classification of Primary Care, Second Editon [ICPC-2] code D93; International Statistical Classification of Diseases, Tenth Revision [ICD-10] code K58), (2) being between 18 and 70 years, and (3) understanding written and oral Norwegian. There were no specific exclusion criteria.

Eligible patients gave informed written consent and participants were given the option to withdraw from the study at any time point without a specific reason. The data were deidentified and stored on a secure hospital server, and analysis was performed on anonymous data. None of the participants were compensated. The study was approved by the Regional Ethical Committee of Western Norway (REC-2016/1098).

Statistical analyses were performed using SPSS Statistics (version 26, IBM) for Microsoft Windows. Baseline patient characteristics and questionnaires were first presented according to intervention—eHealth group and IBS-school. At 3 months after intervention, patients were categorized as responders or nonresponders. For comparison between groups, unpaired t test were performed for parametric data and Mann-Whitney U for nonparametric data. For comparisons before and after interventions, paired t tests were performed for parametric data and Wilcoxon signed rank test for nonparametric data. A P value <.05 was considered statistically significant. The intervention responder or nonresponder analysis to the eHealth program or IBS-school was carried out performing a paired t test on data from patients who filled out the 3-month questionnaires (n=71 and n=50, respectively). A χ² test of independence was used to assess differences between intervention response.

A flowchart of participating patients is illustrated in Figure 2. Of the 132 eligible patients who gave written consent to participate in the eHealth program group of the study, 7 did not fill out the minimum requirement including the electronic case report form and the IBS-SSS questionnaire. Of the 125 patients who completed the program, 54 patients did not respond to the IBS-SSS questionnaire at 3 months. Hence, the follow-up data from patients attending the eHealth program reduced to n=71 at 3 months. Of the 123 eligible patients who gave written consent to participate in the IBS-school group of the study, 5 did not fill out the minimum requirement including the electronic case report form and the IBS-SSS questionnaire. Thus, of the 118 patients who completed the program, 69 patients did not respond to the IBS-SSS questionnaire at 3 months. Hence, the follow-up data from patients attending the eHealth program reduced to n=49 at 3 months.

Participants were predominantly female (190/235, 81%) with a mean age of 38.3 (SD 12.4) years (Characteristics are summarized in Table 1). An unpaired t test showed that there was no difference in age between groups. A Mann-Whitney U test was performed to evaluate whether sex differed between groups, reveling no significant difference between patients attending the eHealth program and patients attending the IBS-school (Table S1 in Multimedia Appendix 1, U=6407.0, z=−1.394, P=.16). Furthermore, participants at the IBS-school and eHealth program displayed similar baseline characteristics upon enrollment, including moderate to severe IBS symptom severity.

There was no significant difference between most relevant features at baseline, except for anxiety and depression, as shown in Table 1. Here, patients attending the eHealth program scored an average of 11 (SD 5.2) which corresponds to mild to moderate anxiety, while patients attending the IBS-school scored 9.4 (SD 5.1), corresponding to a mild level of anxiety (2-tailed t₂₃₂=2.37, P=.02). Thus, both patient groups displayed an anxiety score typical of a clinical case of anxiety (HADS-anxiety ≥8 is considered a clinical case [20]), and patients attending the eHealth program presented a significantly higher baseline score than patients attending the IBS-school. Furthermore, patients attending the eHealth program reported significantly higher depression scores than patients attending the IBS-school (mean 7, SD 4.1 vs mean 5.9, SD 4, respectively; t₂₃₂=2.01, P=.045). However, both groups displayed an average depression score corresponding to nonclinical severity of depression (HADS-depression ≤8 is considered noncase [20]) which gives the difference little relevance on group level.

A paired t test revealed that patients attending the eHealth program reported a significant reduction in IBS symptom severity at 3 months, shown in Figure 3 (mean 279.3, SD 80 vs mean 242.7, SD 79.3; t₇₀=4.91, P<.001). Comparably, patients attending the IBS-school did not report a significant reduction in symptom severity (mean 248.6, SD 86.6 vs mean 235.4, SD 98.9; t₄₉=0.85, P=.40). Refer to Table S2 of Multimedia Appendix 1 for data. However, none of the groups achieved a clinically meaningful improvement of ≥50 points on IBS-SSS at 3 months. Patients in the eHealth program-group reported a 37-point reduction, whereas patients attending IBS-school reported a 13-point reduction in IBS-SSS total score (Table S2 of Multimedia Appendix 1). Thus, for further analysis we categorized participants as a “responder” or “non-responder” to the intervention, where the sample response threshold for responders was set as ≥50-point decrease in total IBS-SSS score, a threshold that has been demonstrated to correlate with improvements in clinical symptoms [2].

Patient satisfaction was investigated in both groups 3 months after enrollment (CSQ-8). Patients who attended the IBS-school reported a mean score of 24.2 (SD 3.7), compared with patients attending the eHealth program with a mean score of 23.5 (SD 4.0), which are both equivalent to “good” health care offers [22]. An unpaired t test revealed no significant difference between group scores (t₁₁₅=−1.032, P=.31; Table 4).

In this study, we have shown that the novel digital multidisciplinary eHealth program has a significant reducing effect on IBS symptom severity and is useful as a tool in disease self-management. In total, 41% (29/71) of participants reported significant and clinically relevant symptom relief. Furthermore, we show that the eHealth program is safe, as patients not responding to the intervention reported unchanged symptoms and quality of life at 3 months. In addition, eHealth intervention–responding patients reported significant benefits on multiple domains of IBS-related quality of life such as body image, food avoidance, health worry, interference with activity, relations, and social relations. Levels of anxiety were significantly reduced, and levels of dysphoria were improved.

Comparably, 36% (18/50) of participants reported a clinically significant effect to the onsite multidisciplinary 2-day group-based education program, the so-called “IBS-school.” Thus, our results indicate that the digital multidisciplinary eHealth program may be equally effective to the IBS-school, which is often a standard treatment offer to newly diagnosed patients. Furthermore, patients responding to the IBS-school intervention did not report any significant improvements in quality of life or in anxiety, but a small not clinically meaningful decrease in depression scores. The number of IBS-school responders were too low for more in-depth statistical analysis on the domains of quality of life.

A χ² test of independence showed no difference between intervention outcome in the 2 groups; hence the eHealth program did not have a better intervention response than the IBS-school on the measures of symptom severity. However, the eHealth program had a significant effect on other aspects of IBS symptomatology, including anxiety and quality of life, whereas IBS-school did not.

Patients rated both the eHealth program and the IBS-school as good health care offers on measures of patient satisfaction of health care quality, scoring them 23.5 and 24.2 out of a maximum of 32 points, respectively.

We believe these results indicate that a digital eHealth approach, designed to provide patients with evidence-based information and practical skills, is preferable to an onsite multidisciplinary 2-day group-based education program covering the same topics.

Initially at baseline in both groups, the greatest impairment in quality of life was observed for the subscale of food avoidance followed by body image, inactivity, and dysphoria. This order of impairment is similar to findings by Drossmann et al [21] in an international study from 2009 (n=1966). However, our findings show lower scores on all subscales except dysphoria and health worries, which are in the same magnitude. In comparison with a newer study on quality of life by Kopczyńska et al [23] (n=87), our baseline results show much lower scores on both overall and all subscales of quality of life. A recent Vietnamese study showed that patient education, lifestyle, and dietary intervention, administered by clinical pharmacists, improved IBS related quality of life compared with standard medical therapy over 8 weeks [10]. These study patients also showed a much higher baseline and postintervention quality of life-scores compared with our study. We speculate that our study participants represent a group with more severe IBS because they are referred to a tertiary health care institution that due to capacity issues has to prioritize those patients who need it the most. However, the low baseline scores on food avoidance in our study indicate that both our interventions with a key focus on diet was the right call. This core problem was targeted because food is a known important trigger of IBS-symptoms [24]. On the domain of food avoidance, we observed an improvement in eHealth program-responders, compared with baseline (Tables 2 and 3). No such improvement was observed in patients attending the IBS-school. We speculate that this is due to the differences in comprehensiveness and durability. The eHealth program is designed to engage the patient interactively to learn how to make appropriate changes in diet. It offers a thorough guidance with videos and instructions on how to follow the low FODMAP diet, including the exclusion and reintroduction of foods. In addition, the patient has the option of digital question and answer sessions with a clinical dietitian throughout the program. The IBS-school is also designed for patients to learn how to self-help, but the program is much shorter with its 2 days of physical attendance. In the light of these results, we deduce that the eHealth program is not inferior to the established IBS-school as a health care offer. In fact, we show that an eHealth intervention program can provide the patient with self-help tools that can lead to reduced gastrointestinal symptoms and enhance quality of life for patients with IBS. This aligns with a recent randomized controlled study by Tayama et al [13] (n=40) showing that a multidisciplinary eHealth self-management program leads to an increased intake of FODMAP-groups and subsequently a more extensive diet. Severe food avoidance and dietary restriction is previously reported in 13% (829/955) of IBS-patients and this subgroup of IBS-patients reported more severe IBS-symptoms, reduced quality of life, and reduced intake of nutrients [24]. Thus, providing patients with evidence-based information, practical tools, and support by a clinical dietitian is important in clinical care of patients with IBS.

eHealth programs in the form of apps, internet-guided programs, or telehealth has recently accelerated as useful tools in clinical medicine. In an American study on satisfaction during COVID-19, most patients with IBS reported high satisfaction rates and ease of use with telehealth [25]. Here the authors reported on multiple benefits including the patient having to take less time off from work and improved access to the care team. Their most commonly reported challenges with telehealth included feeling impersonal and being unable to address all of their issues or concerns. A majority felt that telehealth was as good as or better than face-to-face visits and would use telehealth for future care. Only approximately 10% (130/1311) of the patients remained dissatisfied. In 2020, a Polish study showed that an educational program combined with elements of behavioral therapy, individualized for patients with IBS, is an important part of therapy [26]. In addition, as a part of a dietetic-led gastroenterology service in primary care, feasibility, acceptability, and cost-efficiency of using webinars to deliver first-line patient education for patients with IBS, has been shown to be successful [27]. A meta-analysis of chronic gastrointestinal illness interventions (19 studies conducted in 8 countries, n=3193) showed that eHealth gastrointestinal interventions improved patients’ quality of life, psychological distress, medication adherence, and illness-related knowledge [28]. The meta-analysis also showed that eHealth gastrointestinal interventions significantly reduced the number of patient visits to the hospital. Taken together with our results, these findings support eHealth interventions holding decent promise in improving outcomes for patients with IBS.

Comparably on patient satisfaction, a randomized controlled trial by Lackner et al [29] showed that patients who received 4 gastroenterologist-led patient education sessions over 2 weeks reported 26.6 in patient satisfaction. Here, 43.5% (63/145) of patients reported improvement in addition to a higher satisfaction score than in our study. However, both these and our results reflect that subjective symptom relief may not be required for the patient to experience the treatment as useful. This is also highlighted by our patients attending the IBS-school who did not experience significant enhancement in quality of life nor reduction in symptom severity, but still reported a higher satisfaction than patients who objectively benefited more from the eHealth program.

All 255 recruited patients completed the programs. However, there was a very high percentage that did not submit the 3-month questionnaires. In total, 41% (54/132) percent of patients attending the eHealth program, and 54% (67/123) of the patients who attended the IBS-school did not submit the 3-month follow-up questionnaires on IBS symptoms severity (Figure 1). Unfortunately, this occurred despite multiple efforts and reminders (phone calls, emails, and SMS text messages) from the research team encouraging the participants to respond. First, this high percentage of missing data are significant and may have affected the results of the study even though the rates appear similar across the groups. However, high dropout rates are a common issue in eHealth studies and known as “the law of attrition” [30]. This warrants the need for a larger study where an intention-to-treat analysis can be carried out without diminishing the power of the study. Second, eHealth literacy is defined by Norman and Skinner [31] as “the ability to seek, find, understand, and appraise health information from electronic sources and apply the knowledge gained to addressing or solving a health problem”. The individual patient’s level of health literacy was not mapped during the study and variations in these abilities may have affected our results. Third, the patient population represents all subtypes of IBS and there are no analyses focusing on the differences in response between patients with predominant diarrhea, constipation, or a mix of the 2. Comorbidities or other additional diagnoses are common in IBS [32] but have not been excluded in this study and may have affected the results. Fourth, the use of drugs during the study period have not been reported. Hence, many drugs have side effects such as nausea, vomiting, diarrhea, constipation, flatulence, which are symptoms that the patient may confused with IBS symptoms. Fifth, a high placebo effect, which can be up to 40%, is a known challenge in clinical studies on IBS [20]. Although this study has not been designed with a control group, the placebo effect may have affected our results in either group and have not been adjusted for. However, we may speculate that the phenomenon has affected patients in both groups equally and importantly, the placebo effect may recede after 12 weeks, which was our end point [33]. Sixth, as both programs are broad and cover a variety of information, advice, and treatment including the low FODMAP diet and principles of CBT, another limitation of this study is the unknown specifics patients were responding to in either program. Indeed, there are no measures on cognition verifying the direct effects of the principles of CBT or exposure therapy. This needs to be further investigated in a prospective study, and we acknowledge that an in-depth explanation for our observed benefits after attending the eHealth program remain to be clarified. Thus, these aspects are objectives in our currently ongoing randomized controlled trial [34]. In the light of limited primary and secondary health care resources, it will be useful to develop prediction tools to identify which patients may achieve improvement in both symptom severity and domains of quality of life. For these stratification analyses to be clinically meaningful, the number of participants need to be higher than reported in this study and performed in and randomized controlled trial.

We conclude that the digital multidisciplinary eHealth program has a significant effect on IBS symptom severity in a portion of patients, and is useful as a tool in disease self-management. In addition, it does not result in worse symptom scores than an onsite multidisciplinary 2-day group-based education program after 3 months. We believe these results indicate that a digital eHealth approach, that include benefits such as 3 months unlimited access to quality assured information and treatment with documented effect, is preferable to an onsite multidisciplinary 2-day group-based education program covering the same topics.