Gastroenterology · Medical Literature
Digital self-management programme for pain, fatigue and faecal incontinence in inflammatory bowel disease: cost-effectiveness analysis of the IBD-BOOST randomised controlled trial.
Abstract
People living with inflammatory bowel disease (IBD) frequently experience abdominal pain, fatigue and faecal incontinence that persist despite optimal medical treatment. This study aimed to assess the cost-effectiveness of IBD-BOOST, a digital, interactive, facilitator-supported self-management intervention targeting these symptoms. A cost-effectiveness analysis was conducted alongside the IBD-BOOST trial, which randomised people with IBD experiencing fatigue, pain and/or faecal incontinence to the IBD-BOOST intervention (N=391) or care as usual (N=389) over 12 months. While the IBD-BOOST intervention did not significantly improve the primary trial outcome measures (UK Inflammatory Bowel Disease Questionnaire and global rating of symptom relief), trends towards benefit were observed across study outcomes. Therefore, this analysis focuses on secondary health economic outcome measures. The cost of the intervention, including its development, facilitation and delivery, was assessed. Participants reported their health service use, out-of-pocket expenses and time off work over the previous 3 months and their health-related quality of life at baseline, 6-month and 12-month follow-up. Participants' costs (2023 UK£) and quality-adjusted life years (QALYs) over the 12 months were compared between study arms using mixed effects models. The IBD-BOOST intervention resulted in additional per participant 0.016 QALYs (95% CI 0.002 to 0.030) over the 12 months in the study and cost savings of -£304.66 (-803.51 to 194.18) for healthcare and -£39.48 (-388.09 to 309.12) for out-of-pocket costs and time off work over months 4-6 and 10-12. This resulted in cost savings of -£28 633 (95% CI -51 555 to 18 764) and -£33 568 (-64 421 to 26 198) per QALY gained with IBD-BOOST from health services and societal perspectives, respectively, and high probability of cost-effectiveness. The IBD-BOOST intervention is highly likely to be cost-effective for the self-management of pain, fatigue and faecal incontinence in people living with IBD. ISRCTN71618461.
Clinical relevance
Is the IBD-BOOST digital, facilitator-supported, cognitive behavioural self-management programme for fatigue, abdominal pain, and faecal incontinence cost-effective compared to care as usual in adults with inflammatory bowel disease over 12 months? __SNAPSHOT__ {"studyDesign":"Cost-effectiveness analysis (cost-utility analysis) conducted prospectively alongside a pragmatic, multicentre, two-arm, parallel-group randomised controlled trial","setting":"United Kingdom; multicentre; participants recruited from IBD clinics and national registries","sampleSize":"n=780 (intervention: n=391, care as usual: n=389)","population":"Adults with confirmed IBD (55% Crohn's disease, 45% ulcerative colitis or other IBD; 67% female; mean age 49 years) who rated the impact of fatigue and/or abdominal pain and/or faecal incontinence as ≥5/10, recruited via IBD clinics and a national cross-sectional survey","intervention":"IBD-BOOST: a 12-session interactive digital online self-management programme based on cognitive behavioural principles and a theoretically informed logic model, delivered over 6 months with a 30-minute facilitator telephone support call after session 1 and weekly in-platform email messages from a trained healthcare professional for the first 3 months","comparator":"Care as usual (CAU)","primaryOutcome":"The primary trial outcomes were the UK Inflammatory Bowel Disease Questionnaire (UK-IBDQ) and global rating of symptom relief (GRSR) at 6 months; these were not significantly improved by the intervention. The cost-effectiveness analysis therefore focused on secondary health economic outcomes: quality-adjusted life years (QALYs) measured by EQ-5D-5L at baseline, 6, and 12 months, and participant-reported healthcare utilisation, out-of-pocket expenses, and time off work at months 4–6 and 10–12","followUp":"12 months","fundingSource":"UK National Institute for Health Research (NIHR) Programme Grant for Applied Research (government-funded); not reported whether industry co-funding was involved"}
Key findings
The IBD-BOOST intervention did not meet its co-primary trial endpoints: there were no statistically significant between-group differences in UK-IBDQ (mean difference −1.67, 95% CI −4.13 to 0.80; p=0.19) or GRSR (mean difference 0.44, 95% CI −0.56 to 1.44; p=0.39) at 6 months. For the secondary health economic outcomes, IBD-BOOST resulted in an additional 0.016 QALYs per participant (95% CI 0.002 to 0.030) over 12 months compared to CAU. From a health services perspective, IBD-BOOST was associated with cost savings of −£304.66 per participant (95% CI −£803.51 to £194.18) over the measured cost windows; the combined cost-effectiveness estimate yielded savings of −£28,633 per QALY gained (95% CI −£51,555 to £18,764) from the health services perspective, and −£33,568 per QALY gained (95% CI −£64,421 to £26,198) from the societal perspective (inclusive of out-of-pocket costs and time off work, −£39.48 per participant, 95% CI −£388.09 to £309.12). The probability that the intervention was cost-effective exceeded 98% at willingness-to-pay thresholds of £20,000 to £30,000 per QALY from both health services and societal perspectives. In a complier-averaged causal effects (CACE) analysis, participants who adhered to the minimum 'dose' of four sessions reported significantly better UK-IBDQ scores than their counterparts in CAU (mean difference −2.39, 95% CI −4.34 to −0.45; p=0.02), suggesting that programme engagement drives benefit. Only 57% of intervention participants completed the minimum four sessions. Serious adverse events were similar between arms. NNT was not reported; NNH was not reported.
Practice implications
This study established that among IBD patients with refractory fatigue, pain, and/or faecal incontinence—symptoms frequently underaddressed in standard gastroenterological care—the IBD-BOOST digital self-management programme is likely cost-effective from both NHS and societal perspectives at conventional UK willingness-to-pay thresholds, and is associated with a small but statistically significant QALY gain over 12 months. Importantly, the programme did NOT demonstrate a statistically significant improvement in its co-primary trial endpoints (UK-IBDQ and GRSR), and the cost-effectiveness analysis is therefore based on secondary outcomes only, which substantially limits interpretive confidence. The QALY gain of 0.016 is statistically significant but its clinical magnitude is modest and its real-world patient-perceived importance is uncertain. Benefits appear concentrated in the approximately 57% of participants who engaged adequately with the programme; the ITT analysis does not demonstrate clinical efficacy on disease-specific quality of life. Findings are most applicable to adults with established IBD in clinical remission or stable disease who continue to experience these refractory symptoms, predominantly women (67%) with a mean age of 49 years in a UK NHS setting. Patients with active luminal inflammation or those unwilling or unable to engage with digital platforms were not well represented. Because only an abstract and conference-level data are available for some details, and the formal cost-effectiveness paper was published in July 2026, full methodological appraisal awaits complete peer-reviewed data access. Practice should not yet be changed on the basis of cost-effectiveness alone when clinical efficacy on primary endpoints was not demonstrated; however, clinicians may reasonably consider the programme as an adjunct for motivated patients with these refractory symptoms, pending confirmatory evidence or further engagement-stratified analyses. __LIMITATIONS__ Primary trial endpoints (UK-IBDQ and GRSR) were not met: the cost-effectiveness analysis is built entirely on secondary outcomes, reducing the certainty of conclusions.,Intervention engagement was suboptimal: only 57% of participants completed the minimum four sessions, introducing substantial heterogeneity of exposure in the ITT population.,The QALY gain of 0.016, while statistically significant, is small in absolute terms; the minimal clinically important difference for EQ-5D in IBD was not explicitly adjudicated.,Cost-effectiveness estimates have wide confidence intervals crossing zero and even negative values for cost savings, indicating substantial uncertainty around point estimates.,Self-reported healthcare utilisation and costs are subject to recall bias and likely underreporting.,The cost windows for health service use and societal costs (months 4–6 and 10–12) do not cover the full 12-month period, potentially underestimating or distorting true costs.,Generalisability is limited to a predominantly female (67%), middle-aged (mean 49 years), UK NHS population; applicability to other healthcare systems with different cost structures and willingness-to-pay thresholds is uncertain.,Government (NIHR) funding reduces industry bias risk, but the 5-year programme scale and development costs embedded in the intervention cost calculation may not reflect real-world implementation costs.,Only the abstract and conference-level summaries were available for some data points; the full peer-reviewed article warrants independent appraisal when accessible.,No blinding of participants or care providers was possible given the nature of the intervention, introducing potential performance and reporting bias. __BOTTOM_LINE_CATEGORY__ potentially_practice_informing __BOTTOM_LINE__ IBD-BOOST, a digital cognitive behavioural self-management programme, was associated with a small QALY gain and probable cost savings versus care as usual in IBD patients with refractory fatigue, pain, and faecal incontinence, with >98% probability of cost-effectiveness at standard UK thresholds. However, the programme did not meet its co-primary clinical trial endpoints, and cost-effectiveness estimates are based on secondary outcomes with wide confidence intervals; adequate engagement (≥4 sessions) was achieved by only 57% of participants. Clinicians may cautiously discuss IBD-BOOST as an option for motivated patients with these refractory symptoms, but broader practice change awaits confirmation of clinical efficacy in adequately powered, engagement-stratified analyses.