Azmina Verjee

What are the top 10 research questions in the treatment of inflammatory bowel disease? A Priority Setting Partnership with the James Lind Alliance

Background and Aims: Many uncertainties remain regarding optimal therapies and strategies for the treatment of inflammatory bowel disease. Setting research priorities addressing therapies requires a partnership between health care professionals, patients and organisations supporting patients. We aimed to use the structure of the James Lind Alliance Priority Setting Partnership, which has been used in other disease areas, to identify and prioritise unanswered questions about treatments for inflammatory bowel disease. Methods: The James Lind Priority Setting Partnership uses methods agreed and adopted in other disease areas to work with patients and clinicians: to identify uncertainties about treatments; to agree by consensus a prioritised list of uncertainties for research; then to translate these uncertainties into research questions which are amenable to hypothesis testing; and finally to take results to research commissioning bodies to be considered for funding. Results: A total of 1636 uncertainties were collected in the initial survey from 531 respondents, which included 22% health care professionals and 78% patients and carers. Using the rigorously applied processes of the priority setting partnership, this list was distilled down to the top 10 research priorities for inflammatory bowel disease. The top priorities were: identifying treatment strategies to optimise efficacy, safety and cost-effectiveness; and stratifying patients with regard to their disease course and treatment response. Diet and symptom control [pain, incontinence and fatigue] were also topics which were prioritised. Conclusions: A partnership involving multidisciplinary clinicians, patients and organisations supporting patients has identified the top 10 research priorities in the treatment of patients with inflammatory bowel disease.

Developing a core outcome set for fistulising perianal Crohn’s disease

Objective Lack of standardised outcomes hampers effective analysis and comparison of data when comparing treatments in fistulising perianal Crohn’s disease (pCD). Development of a standardised set of outcomes would resolve these issues. This study provides the definitive core outcome set (COS) for fistulising pCD. Design Candidate outcomes were generated through a systematic review and patient interviews. Consensus was established via a three-round Delphi process using a 9-point Likert scale based on how important they felt it was in determining treatment success culminating in a final consensus meeting. Stakeholders were recruited nationally and grouped into three panels (surgeons and radiologists, gastroenterologists and IBD specialist nurses, and patients). Participants received feedback from their panel (in the second round) and all participants (in the third round) to allow refinement of their scores. Results A total of 295 outcomes were identified from systematic reviews and interviews that were categorised into 92 domains. 187 stakeholders (response rate 78.5%) prioritised 49 outcomes through a three-round Delphi study. The final consensus meeting of 41 experts and patients generated agreement on an eight domain COS. The COS comprised three patient-reported outcome domains (quality of life, incontinence and a combined score of patient priorities) and five clinician-reported outcome domains (perianal disease activity, development of new perianal abscess/sepsis, new/recurrent fistula, unplanned surgery and faecal diversion). Conclusion A fistulising pCD COS has been produced by all key stakeholders. Application of the COS will reduce heterogeneity in outcome reporting, thereby facilitating more meaningful comparisons between treatments, data synthesis and ultimately benefit patient care.

Faecal incontinence intervention study (FINS): self-management booklet information with or without nurse support to improve continence in people with inflammatory bowel disease: study protocol for a randomized controlled trial

BackgroundInflammatory bowel disease, comprising Crohn’s disease and ulcerative colitis, is a life-long currently incurable illness. It causes bouts of acute intestinal inflammation, in an unpredictable relapsing-remitting course, with bloody diarrhoea and extreme urgency to access a toilet. Faecal incontinence is a devastating social and hygiene problem, impacting heavily on quality of life and ability to work and socialise. Faecal incontinence affects 2–10 % of adults in the general population. People with inflammatory bowel disease have a high risk of incontinence with up to 74 % affected. No previous study has explored conservative interventions for these patients.MethodsThis randomised controlled trial will recruit 186 participants to answer the research question: does implementation of the UK nationally recommended guidance approach to stepwise management of faecal incontinence improve bowel control and quality of life in people with inflammatory bowel disease? We have worked with people with inflammatory bowel disease to translate this guidance into a condition-specific information booklet on managing incontinence. We will randomise participants to receive the booklet, or the booklet plus up to four 30-minute sessions with an inflammatory bowel disease specialist nurse. To be eligible, patients must be in disease remission and report incontinence. The primary outcome measure at 6 months after randomisation is the St Mark’s incontinence score. Other outcomes include quality of life, MY-MOP (generic tool: participants set two goals for intervention, grading goals at baseline and then re-scoring after intervention) and EQ-5D-5 L to enable calculation of quality-adjusted life years. Analysis will be on an intention-to-treat basis. Qualitative interviews will explore participant and health professionals’ views on the interventions.DiscussionFew high-quality studies of conservative interventions in inflammatory bowel disease, and none for faecal incontinence, have been conducted. We have collaborated with patients to design this study. Blinding to this behavioural intervention is not possible, but our self-report outcome measures with a degree of objectivity. There is genuine equipoise between the booklet only and booklet plus nurse arms, and the study will determine if additional support from a nurse is a crucial element in implementing advice.Trial registrationclinitrials.gov.uk: NCT02355834 (Date of registration: 12 December 2014).Protocol version: 4.0. 08.04.15

P446 Patient and public involvement in a clinical trial for perianal Crohn’s fistula

the two groups. Patients with active fistulas had significantly more work impairment (median 0.20 vs. 0.10, p = 0.010). Furthermore, patients with active fistulas held more negative views concerning the effects of their illness on daily functioning (adjusted β = 0.78; CI(95%) = 0.28 to 1.27 (95% CI), p = 0.003). No differences were found in coping strategies between the two groups. Conclusions: Patients with active perianal fistulas have a lower physical health, experience more work impairment and perceived more illness consequences compared with CD patients without perianal fistulas, which is important for the gastroenterologist to consider when treating these patients. Reference 1. van Erp SJ et al. Classifying back pain and peripheral joint complaints in inflammatory bowel disease patients: a prospective longitudinal follow-up study. J Crohns Colitis, 2016;10:166–175.

PTU-004 Asking about bowel control problems in IBD: results of face-to-face screening versus self-reporting

Introduction Patients with IBD have difficulty revealing concerns about bowel control problems to clinicians,1 who do not actively ask about this symptom2 despite clinical guidelines recommending active-case finding in high-risk populations.3 With no available evidence to advise clinicians on how to ask, we aimed to determine the results of face-to-face or self-reported screening to identify faecal incontinence (FI) in IBD patients. We also asked about patients’ desire for interventions to improve continence. FI was defined in this study as: ‘ever having accidental passing of stool, faeces, poo into your underclothes, that you are either unaware of at the time, or unable to control’. Methods This cross-sectional survey used a study-specific questionnaire to screen participants at either face-to-face interview (by clinician/researcher) or anonymously (participant self-completed). Eligibility criteria: 18 to 80 years of age, confirmed diagnosis of IBD, no current fistula, no stoma, any level of disease activity. Disease activity was measured using the Harvey Bradshaw Index or the Simple Clinical Colitis Activity Index. Results Of 1336 participants, 48% were male; mean age 43 years (range 18–80); 55% had Crohn’s Disease (CD), 41% ulcerative colitis (UC), 4% IBD unclassified. FI (occurring ever) was reported by 63% of 772 screened face-to-face and 56% of 564 self-report participants (p=0.012). A total of 38.7% of all respondents expressed interest in an intervention for FI. Patients with CD were more likely to report FI than those with UC (p≤0.05). FI was reported by 49% of participants in remission, and by 59%, 83% and 93% of participants with mild, moderate and severe relapse of IBD respectively (p≤0.001). Conclusions Bowel control problems are very common in patients with IBD (including in remission) and these symptoms can be identified by face-to-face interview and postal screening. Interest in interventions for FI is expressed by 38.7 of patients with IBD. References . Dibley L, Norton C. Experience of fecal incontinence in people with inflammatory bowel disease: self-reported experiences among a community sample. Inflammatory Bowel Diseases2013;19(7):1450–62. . Dibley L, Norton C. Help-seeking for fecal incontinence among people with inflammatory bowel disease. JWOCN 2013;40(6):631–638. . National Institute for Health and Clinical Excellence. Management of faecal incontinence in adults. London: NICE;2007. Report No.: CG 49.

What are the dietary treatment research priorities for inflammatory bowel disease?: A short report based on a Priority Setting Partnership with the James Lind Alliance

BACKGROUND Treatment of inflammatory bowel disease (IBD) involves a multidisciplinary approach comprising medical management and sometimes surgery. Although diet is central to IBD management, the optimal diet for patients with IBD is uncertain. A UK collaborative partnership within the James Lind Alliance was set up between patients, clinicians and other stakeholders to develop research priorities in IBD. The aim of this short report is to provide a comprehensive summary of the research priority findings relating to diet in the treatment of IBD. METHODS The James Lind Alliance Priority Setting Partnership process was used to develop research priorities in IBD. In brief, patients, clinicians and other stakeholders were invited to provide up to five treatment uncertainties in IBD. These uncertainties were collated, revised and ranked, leading to a final top 10 research questions in IBD. RESULTS A total of 1671 uncertainties from 531 participants were collected and refined to exclude duplicates leaving 1253 uncertainties. Of these, 348 were categorised as diet-related and grouped according to topic. There were 206 uncertainties related to how diet can be used to treat IBD or alleviate symptoms. Seventy-two percent of diet-related questions came from patients. One broadly diet-related and two diet-specific treatment uncertainties were included in the top 10 research priorities for IBD. CONCLUSIONS Dietary treatment options in the management of IBD are important research priorities. Almost three-quarters of diet related questions came from patients, who were particularly interested in how diet can impact disease activity and symptom control.