Lesley Dibley

Background: Inflammatory bowel disease (IBD) adversely impacts the quality of life. Healthcare professionals target treatment at controlling gut inflammation. However, patients report troublesome symptoms of fatigue, abdominal pain and urgency or faecal incontinence in the absence of inflammation. Objectives: To address the symptoms of fatigue, pain and urgency/faecal incontinence in people living with inflammatory bowel disease. Research questions: Identifying the burden of symptoms: 1a. What proportion of people with inflammatory bowel disease have fatigue, pain or urgency/faecal incontinence and want help for them? 1b. Which symptoms could benefit from optimisation of medical treatment? Addressing symptoms: 2a. To develop and test a supported tailored online self-management programme (IBD-BOOST) for these symptoms in inflammatory bowel disease to improve the quality of life and reduce symptoms. 2b. Does better symptom control reduce healthcare and personal costs and is the intervention cost-effective? Design and methods: Qualitative interviews with patients and nurses. Questionnaire to identify the inter-relationship of symptoms and the desire for intervention. Feasibility study of a checklist and algorithm (‘Optimise’) to manage medically reversible causes of symptoms. Multicentre, two-arm, parallel-group, randomised controlled trial of the IBD-BOOST intervention with qualitative and quantitative process evaluation. Target population: 740 people with inflammatory bowel disease recruited from the questionnaire survey. Six months of access to IBD-BOOST was compared with care as usual. Setting and participants: United Kingdom inflammatory bowel disease clinics and online. Interventions: Randomised controlled trial – a 12-session online self-management IBD-BOOST intervention, developed jointly with patients. Main outcome measures: Primary outcomes for randomised controlled trial: United Kingdom Inflammatory Bowel Disease Questionnaire (inflammatory bowel disease-related quality of life) and Global Rating of Symptom Relief at 6 months. Cost-effectiveness of IBD-BOOST was assessed: incremental cost per quality-adjusted life-year 1 year following randomisation from healthcare service and societal perspectives. Results: Interviews: People with inflammatory bowel disease told us that they wanted help to self-manage their symptoms. Inflammatory bowel disease nurses wanted to be supportive but reported limited capacity to help. Survey: There were 8486 responses: 3281 men and 4883 women. In the previous week, 2550 (30%) reported fatigue; 1766 (21%) pain and 4565 (54%) reported faecal incontinence; 925 (10.9%) reported all three; 56% of all respondents ‘definitely’ wanted help for fatigue; 42% wanted help for pain; 53% wanted help for incontinence and 29% ‘definitely’ wanted help for all three symptoms. Feasibility study of the optimise checklist and algorithm: The 201/515 (39%) individuals reporting symptoms consented and 194/201 (97%) returned the symptom checklist; 157 (81%) returned a postal faecal calprotectin sample. The algorithm suggested at least one clinical test or intervention for fatigue, pain or incontinence in 67/157 (43%) participants, of whom 25 (37%) declined intervention for reasons unknown. Of those for whom clinical actions were indicated, 66% completed 3-month follow-up. Randomised controlled trial of the IBD-BOOST intervention: Participants ( N = 780) were randomised to the intervention ( n = 391) or care as usual ( n = 389). At 6 months, there were no statistically significant between-arm differences for United Kingdom Inflammatory Bowel Disease Questionnaire [mean difference = −1.67 (95% confidence interval = −4.17 to 0.83), p = 0.19] and Global Rating of Symptom Relief [mean difference = 0.44 (95% confidence interval = −0.56 to 1.43), p = 0.39]. Complier-averaged causal effects analysis demonstrated that participants who complied with the intervention reported better United Kingdom-Inflammatory Bowel Disease Questionnaire scores than ‘would-be’ compliers receiving care as usual ( p = 0.03). Subgroup analyses did not identify any statistically significant treatment effect modifiers; 57% completed four sessions or more. Serious adverse events were similar between groups. Process evaluation suggested high facilitator fidelity but low overall participant compliance with the programme. Cost-effectiveness of the IBD-BOOST intervention: Per participant cost for the development and delivery of intervention was £151.19. Allocation to inflammatory bowel disease-BOOST intervention resulted in additional 0.016 quality-adjusted life-years (95% confidence interval = 0.002 to 0.030) per participant over 12 months and cost savings of −£304.66 (−803.51; 194.18) for healthcare costs and −£39.48 (−388.09; 309.12) for out-of-pocket costs and time off work over months 3–6 and 9–12. Over the 12-month follow-up, there were cost savings of −£28,633 (95% confidence interval = −51,555 to 18,764) and −£33,568 (−64,421; 26,198) per quality-adjusted life-year gained with inflammatory bowel disease-BOOST from health services and societal perspectives, respectively. Limitations: Our samples were predominantly White and English-speaking. Conclusions: People with inflammatory bowel disease want help with their symptoms, but health professionals lack capacity. Over half of people with inflammatory bowel disease have faecal incontinence, and 1 in 10 have fatigue, pain and incontinence. Nearly a third want help for all three. Screening using a checklist and algorithm was feasible, and we identified around 40% who could benefit from optimisation of their medical treatment. Inflammatory bowel disease-BOOST had low compliance and did not improve disease-specific quality of life or Global Rating of Symptom Relief in inflammatory bowel disease patients with fatigue, pain and/or incontinence compared with care as usual, but it may help symptoms in people who comply with the programme. The economic evaluation indicated that the inflammatory bowel disease-BOOST intervention improves quality-adjusted life-years, and could be cost-effective, but economic results did not reach statistical significance. Future work: Research should explore targeting the intervention to specific subgroups within inflammatory bowel disease and improving adherence to digital interventions. Study registration: This study is registered as Optimising medical management ISRCTN15380317 and the RCT as ISRCTN71618461. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research Programme (NIHR award ref: RP-PG-0216-20001) and is published in full in Programme Grants for Applied Research ; Vol. 14, No. 19. See the NIHR Funding and Awards website for further award information.

This hermeneutic phenomenological study explored the meaning of post-operative pain for patients following day case shoulder surgery. Eighteen adults with a confirmed diagnosis of shoulder injury who were scheduled for day surgery were recruited purposively. Unstructured interviews were conducted by phone or online, audio recorded, transcribed verbatim, and analyzed using Diekelmann’s interpretative method. Four constitutive patterns were developed: (1) Suffering perpetually in pain ; (2) Overcoming pain ; (3) Living in an unfamiliar body ; and (4) Communicating and Lacking Essential Information . Pain was often unexpected, unpredictable and disruptive; the body was experienced as “unhomelike” due to temporary dysfunction of the affected limb and enforced dependence on others for daily help. Pain medication regimes and goals were not always understood, nor used as prescribed, though some participants were able to accept and withstand their temporary post-operative pain. Information from healthcare providers was perceived to be of poor quality, causing confusion during the post-operative period. The experience of shoulder pain following day surgery is complex, and one for which most participants were unprepared, suggesting a need for a nursing approach toward pre-operative preparation and post-operative rehabilitation – acknowledging patients’ relevant prior experiences, providing clear, concise information, creating pre-operative “shoulder” clubs and facilitating consistent follow-up which is not currently catered for by the current day case model.

Purpose: This parallel process evaluation examined the implementation of a randomised controlled trial (RCT) of IBD‐BOOST—a digital, interactive, facilitator‐supported self‐management intervention targeting fatigue, pain and urgency/faecal incontinence in individuals with inflammatory bowel disease (IBD). The RCT, involving 780 participants, compared IBD‐BOOST with usual care but found no significant differences in quality of life (QoL) or symptom relief at six months post‐randomisation. Methods: A concurrent mixed methods design was employed. Qualitative data were gathered through semi‐structured interviews; quantitative data were derived from the intervention platform's built‐in analytics. Qualitative data were analysed using narrative thematic and framework analysis; quantitative data were examined using descriptive statistics. Results: Interviews were conducted with participants pre‐ ( n = 30) and post‐intervention ( n = 28). At baseline, participants highlighted a need for improved education and support targeting fatigue, pain and urgency/faecal incontinence, expressing a preference for digital delivery due to its flexibility. Post‐intervention, treatment group interviewees reported high satisfaction with the intervention's content and structure, with many continuing to use the strategies learned, reporting enhanced symptom management and QoL. However, quantitative data indicated low adherence. Control group interviewees expressed disappointment with their allocation but anticipated benefits from deferred access to the intervention. Conclusions: Although the RCT found no statistically significant effect of IBD‐BOOST on primary outcomes, the process evaluation results revealed perceived benefits in symptom understanding and developing new management strategies. The intervention was well‐received, and patients reported improvements in QoL. There was strong patient support for the IBD‐BOOST intervention to be freely available to all individuals with IBD.

The co-existence of fatigue, pain and faecal incontinence in people with Inflammatory Bowel Disease (IBD) is unknown. We aimed to determine the presence of and relationship between these symptoms and patients’ desire for intervention. Adults with IBD in the UK, recruited from clinics, the national IBD-BioResource, a patient charity and social media sources, completed PROMIS validated patient-reported questionnaires to identify fatigue, pain and faecal incontinence, in addition to symptom severity and impact, disease activity, anxiety and depression questionnaires and questions about their desire for help with these symptoms. Statistical analysis used descriptive statistics to report presence of symptoms and Pearson correlation coefficients were calculated. Of 8486 responses, 54% reported faecal incontinence, 24% reported fatigue, and 21% reported pain; 10% reported all three symptoms in the past 7 days. Only 29% reported none of these symptoms. Fatigue and pain were moderately correlated (Pearson correlation coefficient 0.57); both fatigue and pain had a lower correlation with faecal incontinence (0.43 and 0.46 respectively). On a 0–10 scale for severity, participants scored fatigue highest, followed by incontinence then pain. For impact, participants scored incontinence highest, followed by fatigue then pain. 56% reported depression (27% with clinically relevant levels) and 49% reported anxiety (20% with clinically relevant levels); 23% had previously medically diagnosed mental health disorders. 56% of respondents “definitely” wanted help for fatigue; 53% for incontinence; 42% for pain; 29% “definitely” wanted help with all three symptoms. Factors associated with all three symptoms were Crohn’s disease (vs. ulcerative colitis), IBD activity, IBD Control score, anxiety, depression, and history of surgery (all p ≤ 0.0001). Fatigue, pain and incontinence are common in IBD and patients desire help for these symptoms, currently a substantial unmet need. Anxiety and depression are common, are underdiagnosed, and are independently associated with these symptoms.

Aims: Surgical treatment for inflammatory bowel disease (IBD) potentially includes stoma formation. Although positive clinical outcomes are widely reported, patients' responses to stoma surgery, including coming to terms with and adjusting to the stoma, vary widely. This scoping review charts the qualitative literature addressing the question: What is known about any personal psychosocial and quality of life factors that inform adjustment to living well with an intestinal stoma for IBD?Design: A scoping review methodology was employed.Data Sources: Searches of Scopus, Web of Science, CINAHL, Medline and PsycInfo in August 2023.Review Methods: Levac et al.'s (2010) methodology was followed. PRISMA‐ScR guidelines were adhered to.Results: Thirteen cross‐sectional studies were included, involving a total of 142 participants. Four themes were identified: (1) facilitative factors; (2) barriers to adjustment; (3) personal attributes; and (4) time and temporality. Data indicate that personal and psychological factors influence adjustment, but not how this occurs. Adjustment takes longer to achieve than is conventionally (clinically) expected.Conclusion: All available evidence is cross‐sectional. The identified gap in the evidence is the notable lack of longitudinal research to assess, monitor and understand the complex process of adjustment in people with IBD having stoma‐forming surgery. Detailed understanding of the process of adjustment would enable more targeted support for patients preparing for, and learning to live with, a stoma for IBD.Impact: This paper highlights the need to understand the multiple personal and psychosocial factors that affect adjustment to life with a stoma and identifies that adjustment takes significantly longer than the few weeks required to become competent in managing the stoma.Patient or Public Contribution: Not applicable.

PURPOSE: The aims of this study were to test a noninvasive self-management intervention supported by specialist nurses versus intervention alone in patients with inflammatory bowel disease (IBD) experiencing fecal incontinence and to conduct a qualitative evaluation of the trial. DESIGN: Multicenter, parallel-group, open-label, mixed-methods randomized controlled trial (RCT). SUBJECTS AND SETTING: The sample comprised patients from a preceding case-finding study who reported fecal incontinence and met study requirements; the RCT was delivered via IBD outpatient clinics in 6 hospitals (5 in major UK cities, 1 rural) between September 2015 and August 2017. Sixteen participants and 11 staff members were interviewed for qualitative evaluation. METHODS: Adults with IBD completed the study activities over a 3-month period following randomization. Each participant received either four 30-minute structured sessions with an IBD clinical nurse specialist and a self-management booklet or the booklet alone. Low retention numbers precluded statistical analysis; individual face-to-face or telephone interviews, recorded digitally and transcribed professionally, were conducted to evaluate the RCT. Transcripts were analyzed thematically using an inductive method. RESULTS: Sixty-seven participants (36%) of the targeted 186 participants were recruited. The groups comprised 32 participants (17% of targeted participants) allocated to the nurse + booklet intervention and 35 (18.8% of targeted participants) allocated to the booklet alone. Less than one-third (n = 21, 31.3%) completed the study. Given the low recruitment and high attrition, statistical analysis of quantitative data was considered futile. Participant interviews were conducted concerning study participation and 4 themes emerged that described experiences of patients and staff. These data provided insights into reasons for low recruitment and high attrition, as well as challenges of delivering resource-heavy studies in busy health service environments. CONCLUSIONS: Alternative approaches to trials of nurse-led interventions in hospital settings are needed as many interfering factors may prevent successful completion.

Objective: Inflammatory bowel disease clinical nurse specialists (IBD-CNSs) face increasing pressures due to rising clinical and patient demands, advanced complexity of work role, and minimal specialist management training and support. Stress and burn-out could undermine the stability of this workforce, disrupting clinical provision. We reviewed the literature on stress and burn-out to demonstrate the lack of evidence pertinent to IBD-CNSs and make the case for further research. Design: Following Levac et al’s scoping review framework, relevant databases were searched for publications reporting work-related stress and burn-out among specialist nurses. Following screening and consensus on selection of the final articles for review, all authors contributed to data charting. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses Scoping Review extension guided reporting of the review. Results: Of 194 retrieved articles, eight were eligible for review. None focused on IBD-CNSs, were qualitative, or UK-based. Three core themes were identified: Rates of Burn-out, Mitigating and Alleviating Factors, and Preventing and Resolving Burn-out. Risk of burn-out is greatest in novice and mid-career CNSs. Age and duration in role appear protective. Personal achievement is also protective and can mitigate earlier episodes of burn-out; opportunities for career progression are limited. Promoting personal well-being is beneficial. Senior managers have poor understanding of the role and provide inadequate support. Commitment to patients remains high. Conclusion: Burn-out arises in CNSs across clinical specialisms in the international literature and has a significant negative effect on the workforce. Further research is needed to address the dearth of evidence on burn-out in IBD-CNSs in the UK.