Helen Terry

Assessing fatigue in inflammatory bowel disease: comparison of three fatigue scales.

Fatigue is commonly reported by patients with inflammatory bowel disease (IBD), both in quiescent and active disease. Few fatigue scales have been tested in IBD.

Developing a Standard Set of Patient-Centred Outcomes for Inflammatory Bowel Disease-an International, Cross-disciplinary Consensus

Background and Aims Success in delivering value-based healthcare involves measuring outcomes that matter most to patients. Our aim was to develop a minimum Standard Set of patient-centred outcome measures for inflammatory bowel disease [IBD], for use in different healthcare settings. Methods An international working group [n = 25] representing patients, patient associations, gastroenterologists, surgeons, specialist nurses, IBD registries and patient-reported outcome measure [PROM] methodologists participated in a series of teleconferences incorporating a modified Delphi process. Systematic review of existing literature, registry data, patient focus groups and open review periods were used to reach consensus on a minimum set of standard outcome measures and risk adjustment variables. Similar methodology has been used in 21 other disease areas [www.ichom.org]. Results A minimum Standard Set of outcomes was developed for patients [aged ≥16] with IBD. Outcome domains included survival and disease control [survival, disease activity/remission, colorectal cancer, anaemia], disutility of care [treatment-related complications], healthcare utilization [IBD-related admissions, emergency room visits] and patient-reported outcomes [including quality of life, nutritional status and impact of fistulae] measured at baseline and at 6 or 12 month intervals. A single PROM [IBD-Control questionnaire] was recommended in the Standard Set and minimum risk adjustment data collected at baseline and annually were included: demographics, basic clinical information and treatment factors. Conclusions A Standard Set of outcome measures for IBD has been developed based on evidence, patient input and specialist consensus. It provides an international template for meaningful, comparable and easy-to-interpret measures as a step towards achieving value-based healthcare in IBD.

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

PTH-088 Assessing fatigue in inflammatory bowel disease comparison and validation of three fatigue scales: ibd-f, mfi and maf scales

Introduction Patients with inflammatory bowel disease (IBD) report fatigue in both quiescent (41%) and active disease (86%);1however, due to its subjective nature it is difficult to assess. Many different fatigue scales exist, although most have not been tested with IBD populations. Only one scale has been developed specifically for people with IBD.2We aimed to assess validity and reliability of three fatigue assessment scales in an IBD adult population and to determine factors correlated with fatigue. Method A cross-sectional study. Participants (n = 605) were randomly selected and completed questionnaires assessing fatigue, anxiety, depression, quality of life and IBD activity. A sub-group of responders (n = 70) were sent the same mailing 6 weeks later for test-retest. The fatigue scales used were: the Inflammatory Bowel Disease Fatigue (IBD-F), the Multidimensional Fatigue Inventory (MFI) and the Multidimensional Assessment Fatigue (MAF). Internal consistency was measured by Cronbach’s alpha and test-retest reliability by the intra-class correlation coefficient (ICC). Results 465 (77%) questionnaires were completed for the test and 69% for retest. All three scales are highly correlated (p < 0.001). Test-retest suggests good agreement for all scales’ total scores with ICC values of 0.74 and 0.83 (IBD-F Section 1 and 2), 0.74 (MAF) and 0.65–0.84 (MFI). Age, gender, bowel condition, anxiety, depression and IBDQ scores were significantly associated with level of fatigue (p < 0.001) for all three fatigue scales. Older patients had lower fatigue scores, females had higher scores than males, colitis patients had significantly lower scores than Crohn’s patients, patients with a higher level of anxiety and depression had higher fatigue scores and better IDBQ was associated with lower fatigue scores. Conclusion All three tested fatigue scales were found to be valid and reliable measures of IBD fatigue. Factors such as age, gender, bowel condition, quality of life, anxiety and depression are significantly associated with fatigue and should all be taken into account in the process of care delivery to people with IBD and fatigue. Disclosure of interest W. Czuber-Dochan Grant/ Research Support from: Big Lottery Fund in collaboration with Crohn’s and Colitis UK, Speaker Bureau of: Dr Falk Pharma UK, Ferring, C. Norton Grant/ Research Support from: Big Lottery Fund in collaboration with Crohn’s and Colitis UK, Speaker Bureau of: Ferring, Shire, P. Bassett: None Declared, S. Berliner Conflict with: Trustee for Crohn’s and Colitis UK, F. Bredin Grant/Research Support from: Service development awards from Shire and ferring, M. Darvell Employee of: Crohn’s and Colitis UK, A. Forbes Grant/ Research Support from: Big Lottery Fund in collaboration with Crohn’s and Colitis UK, Speaker Bureau of: Dr Falk UK, Warner-Chilcott, NPS, M. Gay Consultant for: Crohn’s and Colitis UK, Conflict with: Trustee for Crohn’s and Colitis UK, E. Ream: None Declared, H. Terry Employee of: Crohn’s and Colitis UK References Czuber-Dochan W, Ream E, Norton C. Review article: description and management of fatigue in inflammatory bowel disease. Alimentary Pharmacology & Therapeutics. 2013;37(5):505–516 Czuber-Dochan W, Norton C, Bassett P, Berliner S, Bredin F, Darvell M, Forbes A, Gay M, Nathan I, Ream E, Terry H. Development and psychometric testing of inflammatory bowel disease fatigue (IBD-F) patient self-assessment scale. Journal of Crohn’s & Colitis. 2014;8:1398–1406

PTU-064 Inflammatory bowel disease and fatigue: the effect of physical activity and/or omega 3 supplementation

Introduction Fatigue is frequently reported by patients with Inflammatory Bowel Disease (IBD), despite disease remission. However, no previous intervention trial has studied this symptom. We tested the effects on fatigue in IBD patients from (i) individual advice to increase physical activity (PA) and/or (ii) supplementation with omega-3 fatty acids. Method Design:a randomised controlled 2 × 2 factorial study compared change-from-baseline scores in intervention and control groups. Primary outcome: change in FACIT-F (Functional Assessment of Chronic Illness Therapy – Fatigue) score; main secondary outcomes: change in fatigue survey scores including IBD-fatigue (IBD-F); PA by monitors (Actigraph, Pensacola, US); adverse effects. Eligibility: IBD remission; ≤2 portions oily fish/week; ≤ 60 min moderate-vigorous PA/week; no comorbidities causing fatigue; no depression. Interventions: exercise advice (15 min consultation) and fish oil supplement (2.97 g per day omega-3, “Take Omega 3”©, Edinburgh, UK); Controls: dietary consultation and placebo supplement. All patients received follow-up support (email, telephone). Results Over 640 IBD outpatients were screened: 74 of those eligible consented to inclusion and randomisation, 60 commenced the intervention, and 52 completed the study according to protocol. At baseline the four groups did not differ significantly (gender, age, disease location or past IBD activity, level of PA, or FACIT-F score). The only effect on fatigue from the primary outcome – significant deterioration in FACIT-F score (95% CI:-8.6-(-0.7); p = 0.02) – was with omega-3 supplement. Fatigue was however significantly reduced in the exercise groups, measured by IBD-F score (95% CI:-3.8-(-0.2); p = 0.03). There were no significant interactions between effects of exercise and fish oil on fatigue, or consistent trends in fatigue or PA levels across the various measures between the four groups. Only 1 treatment-related adverse event was reported (in exercise group), suggesting that neither exercise nor fish oil were associated with likelihood of occurrence of an adverse effect, including gastrointestinal symptoms. Conclusion The apparent worsening of fatigue with fish oil is unexplained. Exercise and fish oil, singly or in combination, were shown to be safe and generally well-tolerated in IBD patients. There was no evidence of adverse exercise-related effects on gut-related symptoms, and some evidence of improvement in fatigue. Hence, regular moderate-vigorous exercise may provide self-management options in IBD-related fatigue. Disclosure of interest A. McNelly Grant/ Research Support from: Big Lottery Fund in collaboration with Crohn’s and Colitis UK, I. Nathan Grant/ Research Support from: Big Lottery Fund in collaboration with Crohn’s and Colitis UK, Speaker Bureau of: Dr Falk Pharma UK, M. Monte: None Declared, G. Grimble: None Declared, C. Norton Grant/ Research Support from: National Lottery in collaboration with Crohn’s and Colitis UK, Speaker Bureau of: Ferring; Shire, F. Bredin: None Declared, W. Czuber-Dochan Grant/ Research Support from: Big Lottery Fund in collaboration with Crohn’s and Colitis UK, Speaker Bureau of: Dr Falk Pharma UK; Ferring, S. Berliner Consultant for: Crohn’s and Colitis UK, M. Gay Consultant for: Crohn’s and Colitis UK, M. Darvell Employee of: Crohn’s and Colitis UK, H. Terry Employee of: Crohn’s and Colitis UK, A. Forbes Grant/ Research Support from: Big Lottery Fund in collaboration with Crohn’s and Colitis UK, Speaker Bureau of: Dr Falk Pharma UK; Warner-Chilcott; NPS.

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.

PWE-054 Independent validation of the ibd-control questionnaire: results from a large-scale electronic patient experience survey (ibd2020)

Introduction The IBD-Control Questionnaire is a self-completed patient reported outcome measure developed to rapidly capture disease control from the patient perspective.1Eight of the question items generate a summary score (IBD-Control-8) ranging from 0 (worst control) to 16 (best control). We aimed to evaluate the feasibility of capturing the items electronically (rather than on paper) and to validate their measurement properties independently within the setting of a large-scale UK patient experience survey. Method The IBD2020 survey was an electronic (online) questionnaire of patient experiences of healthcare across Europe, promoted in the UK by the national charity, Crohn’s and Colitis UK. The survey included items about sociodemographics, disease type, treatments, self-reported disease activity (last 3 months), relapse status (last 12 months), disease impact and a wide range of questions about care experiences. The IBD-Control-8 questions were incorporated into the UK survey, allowing an opportunity to validate its performance. Results 818 UK patients completed the survey (Female n = 611; Under 30 years, n = 259; 30–44 yrs n = 352; 45–59 yrs 1n=42, 60 yrs plus n = 45; CD n = 483; Previous surgery n = 275; Current stoma n = 69). Self-reported disease activity in last 3 months: Remission 10.8%, Minimal 21.1%, Mildly 28.0%, Moderately 22.1%, Severely 8.7%, Missing 9.3%. 701/818 (85.7%) completed all IBD-Control-8 questions, (mean score [sd]: 7.3 [4.9]; range: 0–16). Internal consistency was strong (Cronbach’s alpha: 0.82). Construct validity of IBD-Control-8 was confirmed by: (a) moderately strong negative correlation (Spearman’s rho values) with ‘Disease Activity In Last 3 months’ (Overall -0.68; CD -0.67; UC -0.66; Post-surgery -0.65) and ‘Number of Relapses in Last 12 months’ (Overall -0.61; CD -0.59; UC -0.60; Post-surgery -0.58) and (b) Significantly higher mean [sd] scores for remission versus any level of disease activity (13.1 [3.1] versus 6.4 [4.5]; p < 0.001). Utility of IBD-Control-8 as a screening test to identify ‘quiescent’ patients (score of 13+) was confirmed (specificity: 88.2% versus self-reported ‘remission’ status; 95% versus remission or minimal activity). Conclusion The IBD-Control-8 items from the IBD-Control Questionnaire are well suited to large-scale electronic surveys, with excellent completion rates within a lengthy patient experience survey. This study provides independent confirmation of its previously reported psychometric properties in a large cohort of UK patients. Disclosure of interest None Declared. Reference Bodger, et al. Gut. 2014;63(7):1092–102

PWE-120 What Do Healthcare Professionals Know About Fatigue In Patients With Ibd And How Do They Manage It?

Introduction Fatigue is one of the top complaints in inflammatory bowel disease (IBD) with 40% of patients in remission and 86% in active condition reporting fatigue.1 However patients report that their complaints of fatigue are often not addressed in clinical consultations.2 This study aimed to gain an understanding of healthcare practitioners’ (HCPs) perception of IBD fatigue as experienced by people with IBD. Methods Descriptive phenomenology with purposive sampling was used to identify a range of professionals (gastroenterologists, IBD nurses, general practitioners, dietitians, psychologists and pharmacists). In-depth semi-structured interviews were conducted with 20 HCPs who work with people with IBD (June–Dec 2012). Colazzi’s framework was used to analyse the data.3 Results Three main themes and several sub-themes were identified. The main themes were: the phenomenon of fatigue as perceived by HCPs; the impact of fatigue on patients’ lives; and the methods used by HCPs to deal with fatigue. Fatigue was identified as an important, but difficult and often frustrating, symptom to understand. The study participants perceived fatigue as ‘a complicated and complex thing’. HCPs reported that fatigue impacts on the emotional, private and public aspects of patients’ functioning, however there were very few methods suggested on how to assess and manage the fatigue in a systematic way. Many expressed a desire for better education about fatigue and better multi-disciplinary effort to manage fatigue. Conclusion Despite fatigue being one of the symptoms most frequently reported by IBD patients, it remains poorly understood by HCPs, who find fatigue challenging and frustrating. There is a need for a systematic and structured assessment and management of this distressing symptom and HCPs should communicate with each other about care for each individual patient. There is a need for an assessment framework and for intervention strategies to be tested. It is essential for multidisciplinary team members to be involved in planning and managing coordinated care of patients reporting fatigue in IBD. References Czuber-Dochan W, Ream E, Norton C, Review article: description and management of fatigue in inflammatory bowel disease. Alim Pharma and Therap 2013;37(5):505–16 Czuber-Dochan W, et al. The experience of fatigue in people with inflammatory bowel disease: an exploratory study. JAN 2013;69(9):1987–99 Colazzi P, Psychological research as a phenomenology views it. In Valle R, King M Eds. Existential Phenomenological Alternatives for Psychology. 1978;New York: New York University Press Disclosure of Interest W. Czuber-Dochan Grant/research support from: Big Lottery Fund managed by Crohn’s and Colitis UK, C. Norton Grant/research support from: Big Lottery Fund managed by Crohn’s and Colitis UK, S. Berliner Conflict with: Trustee Crohn’s and Colitis UK, F. Bredin Grant/research support from: Big Lottery Fund managed by Crohn’s and Colitis UK, M. Darvell Employee of: Crohn’s and Colitis UK, A. Forbes Grant/research support from: Big Lottery Fund managed by Crohn’s and Colitis UK, M. Gay Conflict with: Vice-Chair and Trustee Crohn’s and Colitis UK, I. Nathan Grant/research support from: Big Lottery Fund managed by Crohn’s and Colitis UK, E. Ream: None Declared, H. Terry Employee of: Crohn’s and Colitis UK.

PWE-121 Development And Psychometric Testing Of An Inflammatory Bowel Disease Fatigue (ibd-f) Patient Self-assessment Scale

Introduction Fatigue is one of the main symptoms of inflammatory bowel disease (IBD) and is frequently reported by people in both active and quiescent disease. Different fatigue assessment scales have been used to measure fatigue, but none has been developed or tested in IBD.1 This study aimed to develop a new fatigue scale specific to the needs and experiences of people with IBD. Methods A sequential mixed methods design was used: a qualitative phase (Phase 1) to assess patients’ experience of fatigue and four mixed qualitative-quantitative phases (Phase 2–5) to refine the scale and to assess its psychometric properties. Phase 1–4 participants were purposively selected from a group of volunteers who self reported their fatigue, and participants for Phase 5 were randomly selected from the Crohn’s and Colitis UK members database. Results 567 people participated in the 5 phases. The resulting IBD-F questionnaire has 3 sections: Section 1 Fatigue Assessment; Section 2 Fatigue Impact on Daily Activities; Section 3 Additional Comments about Fatigue. Initial validation suggests that the questionnaire has good face and content validity and acceptable to excellent test-retest stability (ICC 0.74 for section 1 and 0.83 for section 2) and a high degree of internal consistency with Cronbach’s alpha value of over 0.9. Conclusion The participants in the study confirmed that fatigue in IBD is burdensome. Items generated and refined by people with IBD-fatigue reflect their experience and form the basis of this new IBD-fatigue scale, which is psychometrically robust and its reliability falls within statistically acceptable ranges. The fatigue scores obtained by the newly developed, disease specific IBD-F self-assessment scale strongly correlated with the existing fatigue scales (MFI and MAF) developed with other diseases.2,3 The scale can be used by patients and practitioners to assess severity and impact of fatigue in people with IBD. An electronic copy of IBD-F scale can be accessed through website link http://www.fatigueinibd.co.uk from July 2014. References Whitehead L, The measurement of fatigue in chronic illness: a systematic review of unidimensional and multidimensional fatigue measures. J of Pain and Symptom Manag. 2009;37(1):107–28 Smets EM, et al. The Multidimensional Fatigue Inventory (MFI) psychometric qualities of an instrument to assess fatigue. J of Psychosom Research. 1995;39:315–25 Belza B, et al. Correlates of fatigue in older adults with rheumatoid arthritis. Nur Research. 1993;42(2):93–9 Disclosure of Interest W. Czuber-Dochan Grant/research support from: Big Lottery Fund managed by Crohn’s and Colitis UK, C. Norton Grant/research support from: Big Lottery Fund managed by Crohn’s and Colitis UK, S. Berliner Conflict with: Trustee Crohn’s and Colitis UK, F. Bredin Grant/research support from: Big Lottery Fund managed by Crohn’s and Colitis UK, M. Darvell Employee of: Crohn’s and Colitis UK, A. Forbes Grant/research support from: Big Lottery Fund managed by Crohn’s and Colitis UK, M. Gay Conflict with: Vice-Chair and Trustee Crohn’s and Colitis UK, I. Nathan Grant/research support from: Big Lottery Fund managed by Crohn’s and Colitis UK, E. Ream: None Declared, H. Terry Employee of: Crohn’s and Colitis UK, P. Bassett: None Declared.