What is the role of out of programme clinical fellowships in the era of Shape of Training? A single-centre cohort study.

BACKGROUND: The updated Shape of Training curriculum has shortened the duration of specialty training. We present the potential role of out of programme clinical fellowships. METHOD: An electronic online survey was sent to all current fellows to understand their experiences, training opportunities and motivations.Data were collected on fellows' endoscopic experiences and publications using PubMed for all previous doctors who have completed the Sheffield Fellowship Programme. RESULTS: Since 2004, 39 doctors have completed the Sheffield Fellowship.Endoscopic experience: current fellows completed a median average of 350 (IQR 150-500) gastroscopies and 150 (IQR 106-251) colonoscopies per year. Fellows with special interests completed either 428 hepato-pancreato-biliary procedures or 70 endoscopic mucosal resections per year.Medline publications: Median average 9 publications(IQR 4-17). They have also received multiple national or international awards and 91% achieved a doctoral degree.The seven current fellows in the new Shape of Training era (57% male, 29% Caucasian, aged 31-40 years) report high levels of enjoyment due to their research projects, supervisory teams and social aspects. The most cited reasons for undertaking the fellowship were to develop a subspecialty interest, take time off the on-call rota and develop endoscopic skills. The most reported drawback was a reduced income.All current fellows feel that the fellowship has enhanced their clinical confidence and prepared them to become consultants. CONCLUSION: Out of programme clinical fellowships offer the opportunity to develop the required training competencies, subspecialty expertise and research skills in a supportive environment.

Inequalities in Healthcare Access, Experience and Outcomes in Adults With Inflammatory Bowel Disease: A Scoping Review.

BACKGROUND: Inflammatory bowel diseases (IBDs) are incurable diseases that require lifelong access to health services. Accumulating evidence of inequalities in health care access, experience, and outcomes for individuals with IBD is apparent. This review aimed to describe the inequalities in healthcare access, experiences, and outcomes of care for adults with IBD, to identify research gaps, and to identify future research priorities in this area. METHODS: A scoping review was conducted to retrieve quantitative, qualitative, and mixed methods evidence from 3 databases (EMBASE, Medline, and CINAHL) published between January 1, 2000, and September 27, 2023. RESULTS: Fifty-one studies met the criteria for inclusion. The majority (42 of 51) focused on IBD health outcomes, followed by healthcare access (24 of 51). Significantly fewer investigated patient experiences of IBD healthcare (8 of 51). Most available studies reported on race/ethnic disparities of healthcare (33 of 51), followed by inequalities driven by socioeconomic differences (12 of 51), rurality (7 of 51), gender and sex (3 of 51), age (2 of 51), culture (2 of 51), literacy (1 of 51), and sexuality (1 of 51). Inflammatory bowel disease patients from Black, Asian, and Hispanic ethnic groups had significantly poorer health outcomes. A lack of research was found in the sexual and gender minority community (1 of 51). No research was found to investigate inequalities in IBD patients with learning disabilities or autism. CONCLUSIONS: Further research, particularly utilizing qualitative methods, is needed to understand health experiences of underserved patient populations with IBD. Cultural humility in IBD care is required to better serve individuals with IBD of Black and Asian race/ethnicity. The lack of research amongst sexual and gender minority groups with IBD, and with learning disabilities, poses a risk of creating inequalities within inequalities.

Inequalities in inflammatory bowel disease healthcare access, experiences, and outcomes exist. However, it is unclear what populations and social determinants of health have been investigated in this area. This review synthesizes empirical evidence across a range of inequalities in IBD healthcare.

Patient and public involvement in the development of health services: Engagement of underserved populations in a quality improvement programme for inflammatory bowel disease using a community-based participatory approach.

INTRODUCTION: Involving people with lived experience is fundamental to healthcare development and delivery. This is especially true for inflammatory bowel disease (IBD) services, where holistic and personalised models of care are becoming increasingly important. There is, however, a significant lack of representation of underserved and diverse groups in IBD research, and there are significant barriers to healthcare access and utilisation among minority groups in IBD. IBD centres need to be aware of these experiences to address barriers via service changes, improve interactions with local communities and promote meaningful engagement for improved health outcomes. METHODS: A pragmatic community-based approach was taken to engage with leaders and members of underserved groups across 11 workshops representing Roma, Afro-Caribbean, people of African descent and the wider black, Asian and minority ethnic (BAME) communities, Muslim women, refugee community members, deprived areas of South Yorkshire, LGBTQ+ and deaf populations. Thematic analysis of field notes identified patterns of attention across the community groups and where improvements to services were most frequently suggested. RESULTS: Findings demonstrated several barriers experienced to healthcare access and utilisation, including language accessibility, staff attitudes and awareness, mental health and stigma, continuity of support, and practical factors such as ease of service use and safe spaces. These barriers acted as a lever to co-producing service changes that are responsive to the health and social care needs of these groups. CONCLUSIONS: Engaging with people from a range of communities is imperative for ensuring that service improvements in IBD are accessible and representative of individual needs and values. PATIENT OR PUBLIC CONTRIBUTION: Local community leaders and members of community groups actively participated in the co-design and development of improvements to the IBD service for a local hospital. Their contributions further informed a pilot process for quality improvement programmes in IBD centres.

Quality improvement exercises in Inflammatory Bowel Disease (IBD) services: A scoping review.

OBJECTIVE: Quality Improvement initiatives aim to improve care in Inflammatory Bowel Disease (IBD). These address a range of aspects of care including adherence to published guidelines. The objectives of this review were to document the scope and quality of published quality improvement initiatives in IBD, highlight successful interventions and the outcomes achieved. DESIGN/METHOD: We searched MEDLINE, EMBASE, CINAHL and Web of Science. Two reviewers independently screened and extracted data. We included peer reviewed articles or conference proceedings reporting initiatives intended to improve the quality of IBD care, with both baseline and prospectively collected follow-up data. Initiatives were categorised based on problems, interventions and outcomes. We used the Quality Improvement Minimum Quality Criteria Set instrument to appraise articles. We mapped the focus of the articles to the six domains of the IBD standards. RESULTS: 100 studies were identified (35 full text; 65 conference abstracts). Many focused on vaccination, medication, screening, or meeting multiple quality measures. Common interventions included provider education, the development of new service protocols, or enhancements to the electronic medical records. Studies principally focused on areas covered by the IBD standards 'ongoing care' and 'the IBD service', with less focus on standards 'pre-diagnosis', 'newly diagnosed', 'flare management', 'surgery' or 'inpatient care'. CONCLUSION: Good quality evidence exists on approaches to improve the quality of a narrow range of IBD service functions, but there are many topic areas with little or no published quality improvement initiatives. We highlight successful quality improvement interventions and offer recommendations to improve reporting of future studies.

Safety and efficacy of autologous haematopoietic stem-cell transplantation with low-dose cyclophosphamide mobilisation and reduced intensity conditioning versus standard of care in refractory Crohn's disease (ASTIClite): an open-label, multicentre, randomised controlled trial.

BACKGROUND: A previous controlled trial of autologous haematopoietic stem-cell transplantation (HSCT) in patients with refractory Crohn's disease did not meet its primary endpoint and reported high toxicity. We aimed to assess the safety and efficacy of HSCT with an immune-ablative regimen of reduced intensity versus standard of care in this patient population. METHODS: This open-label, multicentre, randomised controlled trial was conducted in nine National Health Service hospital trusts across the UK. Adults (aged 18-60 years) with active Crohn's disease on endoscopy (Simplified Endoscopic Score for Crohn's Disease [SES-CD] ulcer sub-score of ≥2) refractory to two or more classes of biological therapy, with no perianal or intra-abdominal sepsis or clinically significant comorbidity, were recruited. Participants were centrally randomly assigned (2:1) to either HSCT with a reduced dose of cyclophosphamide (intervention group) or standard care (control group). Randomisation was stratified by trial site by use of random permuted blocks of size 3 and 6. Patients in the intervention group underwent stem-cell mobilisation (cyclophosphamide 1 g/m2 with granulocyte colony-stimulating factor (G-CSF) 5 µg/kg) and stem-cell harvest (minimum 2·0 × 106 CD34+ cells per kg), before conditioning (fludarabine 125 mg/m2, cyclophosphamide 120 mg/kg, and rabbit anti-thymocyte globulin [thymoglobulin] 7·5 mg/kg in total) and subsequent stem-cell reinfusion supported by G-CSF. Patients in the control group continued any available conventional, biological, or nutritional therapy. The primary outcome was absence of endoscopic ulceration (SES-CD ulcer sub-score of 0) without surgery or death at week 48, analysed in the intention-to-treat population by central reading. This trial is registered with the ISRCTN registry, 17160440. FINDINGS: Between Oct 18, 2018, and Nov 8, 2019, 49 patients were screened for eligibility, of whom 23 (47%) were randomly assigned: 13 (57%) to the intervention group and ten (43%) to the control group. In the intervention group, ten (77%) participants underwent HSCT and nine (69%) reached 48-week follow-up; in the control group, nine (90%) reached 48-week follow-up. The trial was halted in response to nine reported suspected unexpected serious adverse reactions in six (46%) patients in the intervention group, including renal failure due to proven thrombotic microangiopathy in three participants and one death due to pulmonary veno-occlusive disease. At week 48, absence of endoscopic ulceration without surgery or death was reported in three (43%) of seven participants in the intervention group and in none of six participants in the control group with available data. Serious adverse events were more frequent in the intervention group (38 in 13 [100%] patients) than in the control group (16 in four [40%] patients). A second patient in the intervention group died after week 48 of respiratory and renal failure. INTERPRETATION: Although HSCT with an immune-ablative regimen of reduced intensity decreased endoscopic disease activity, significant adverse events deem this regimen unsuitable for future clinical use in patients with refractory Crohn's disease. FUNDING: Efficacy and Mechanism Evaluation Programme, a Medical Research Council and National Institute for Health Research partnership.

Discontinuation of Anti-Tumour Necrosis Factor Therapy in Patients with Perianal Fistulizing Crohn's Disease: Individual Participant Data Meta-Analysis of 309 Patients from 12 Studies.

BACKGROUND: The risk of relapse after anti-tumour necrosis factor [TNF] therapy discontinuation in Crohn's disease patients with perianal fistulas [pCD] is unclear. We aimed to assess this risk. METHODS: A systematic literature search was conducted to identify cohort studies on the incidence of relapse following anti-TNF discontinuation in pCD patients. Individual participant data were requested from the original study cohorts. Inclusion criteria were age ≥16 years, pCD as a (co)indication for start of anti-TNF therapy, more than three doses, and remission of luminal and pCD at anti-TNF discontinuation. The primary outcome was the cumulative incidence of CD relapse using Kaplan-Meier estimates. Secondary outcomes included response to re-treatment and risk factors associated with relapse as assessed by Cox regression analysis. RESULTS: In total, 309 patients from 12 studies in ten countries were included. The median duration of anti-TNF treatment was 14 months [interquartile range 5.8-32.5]. Most patients were treated for pCD without active luminal disease [89%], received first-line anti-TNF therapy [87%], and continued immunomodulatory therapy following anti-TNF discontinuation [78%]. The overall cumulative incidence of relapse was 36% (95% confidence interval [CI] 25-48%) and 42% [95% CI 32-53%] at 1 and 2 years after anti-TNF discontinuation, respectively. Risk factors for relapse included smoking (hazard ratio [HR] 1.5 [1.0, 2.1]) and history of proctitis (HR 1.7 [1.1, 2.5]). The overall re-treatment response rate was 82%. CONCLUSIONS: This individual participant data meta-analysis, on predominantly patients with pCD without active luminal disease and first-line anti-TNF therapy, shows that over half of patients remain in remission 2 years after anti-TNF discontinuation. Therefore, anti-TNF discontinuation may be considered in this subgroup.

Exploring Predictive Biomarkers of Relapse in Ulcerative Colitis: A Proteomics Approach.

INTRODUCTION AND AIMS: Risk stratification of subjects with a history of inflammatory bowel disease (IBD) into those likely to relapse and those who will remain quiescent continues to be a significant challenge. The aim of this study was to investigate whether certain proteomic signature profiles or biomarkers during remission are associated with future disease relapse in patients with ulcerative colitis (UC). METHODS: Endoscopic rectal samples from patients with UC in clinical, endoscopic, and histological remission at index endoscopy were collected, as well as samplers from normal control individuals. The patients were stratified to early relapsers (ERs) if they developed clinical signs of UC flare within 6 months of index endoscopy or nonrelapsers (NRs) if there was no relapse after 36 months of follow-up. The pooled rectal samples from ERs, NRs, and control individuals were subjected to nano-liquid chromatography and tandem mass spectrometry as per standard iTRAQ (isobaric tags for relative and absolute quantitation) workflow methodology. Selected proteomics-yielded candidates were subjected to orthogonal validation via immunoblotting, in a biomarker discovery exercise. RESULTS: Sixty-one patients were included, of whom 8 had clinical relapse within 6 months from the index endoscopy, and 43 patients had no clinical symptoms of relapse within the 36-month follow-up period. Ten patients who had clinical signs of relapse between 6 and 36 months were excluded. Seventeen control individuals were also included. Soluble proteomics analyses between ERs, NRs, and control individuals revealed a series of upregulated and downregulated proteins. Following orthogonal validation, upregulated TRX (P = .001) and IGHA1 (P = .001) were observed in ERs relative to NRs. CONCLUSIONS: Several novel candidate tissue biomarkers have been identified in this study, which could discriminate patients with UC at risk of early relapse from those in long-term sustained remission. Our findings may pave the way for pre-emptive UC disease monitoring and therapeutic decision making.

This study aimed to investigate if certain proteins (biomarkers) could predict whether patients with Ulcerative Colitis (UC) would have a disease relapse. Rectal samples were collected from UC patients who were in remission and from healthy individuals. The patients were categorised into two groups: those who had a flare-up within 6 months (early relapsers) and those who did not have a relapse after 36 months (non-relapsers). Using proteomics methodology, it was found that certain proteins were more common in the early relapsers compared to the non-relapsers and healthy individuals. Two proteins, TRX and IGHA1, were significantly higher in the early relapsers. These proteins could potentially be used as markers to identify UC patients who are at risk of having an early relapse. This could help monitoring UC patients more effectively and making better treatment decisions.

Development of an inflammatory bowel disease (IBD) Patient-Reported Experience Measure (PREM): A patient-led consensus work and 'think aloud' study for a quality improvement programme.

BACKGROUND: Patient-Reported Experience Measures (PREMs) are key in improving healthcare quality, but no PREM exists for inflammatory bowel disease (IBD). This study aimed to co-produce a PREM with IBD service users for IBD service evaluation and quality improvement programme. METHODS: A pool of 75 items was drawn from published survey instruments covering interactions with services and aspects of living with IBD. In Stage 1, during two workshops, eight expert service users reduced candidate items through a ranked-choice voting exercise and suggested further items. During Stage 2, 18 previously uninvolved people with IBD assessed the face and content validity of the candidate items in 'Think Aloud' interviews. During two final workshops (Stage 3), the expert service users removed, modified and added items based on the interview findings to produce a final version of the PREM. RESULTS: Stage 1 generated a draft working PREM mapped to the following four domains: Patient-Centred Care; Quality; Accessibility; Communication and Involvement. The PREM included a set of nine items created by the expert group which shifted the emphasis from 'self-management' to 'living with IBD'. Stage 2 interviews showed that comprehension of the PREM was very good, although there were concerns about the wording, IBD-relevance and ambiguity of some items. During the final two workshops in Stage 3, the expert service users removed 7 items, modified 15 items and added seven new ones based on the interview findings, resulting in a 38-item PREM. CONCLUSIONS: This study demonstrates how extensive service user involvement can inform PREM development. PATIENT OR PUBLIC CONTRIBUTION: Patients were involved as active members of the research team and as research participants to co-produce and validate a PREM for IBD services. In Stage 1, eight expert service users ('the expert group') reduced candidate items for the PREM through a voting exercise and suggested new items. During Stage 2, 18 previously uninvolved people with IBD (the 'think aloud' participants) assessed the validity of the candidate items in 'Think Aloud' interviews as research participants. In Stage 3, the expert group removed, changed and added items based on the interview findings to produce a final version of the 38-item PREM. This study shows how service user involvement can meaningfully inform PREM development.

Patient preferences and current practice for adults with steroid-resistant ulcerative colitis: POPSTER mixed-methods study.

BACKGROUND: Corticosteroids are a mainstay of the treatment of moderately severe relapses of ulcerative colitis, yet almost 50% of patients do not respond fully to these and risk prolonged steroid use and side effects. There is a lack of clarity about the definitions of steroid resistance, the optimum choice of treatment, and patient and health-care professional treatment preferences. OBJECTIVES: The overall aim of this research was to understand how steroid-resistant ulcerative colitis is managed in adult secondary care and how current practice compares with patient and health-care professional preferences. DESIGN: A mixed-methods study, including an online survey, qualitative interviews and discrete choice experiments. SETTING: NHS inflammatory bowel disease services in the UK. PARTICIPANTS: Adults with ulcerative colitis and health-care professionals treating inflammatory bowel disease. RESULTS: We carried out a survey of health-care professionals (n = 168), qualitative interviews with health-care professionals (n = 20) and patients (n = 33), discrete choice experiments with health-care professionals (n = 116) and patients (n = 115), and a multistakeholder workshop (n = 9). The interviews with and survey of health-care professionals showed that most health-care professionals define steroid resistance as an incomplete response to 40 mg per day of prednisolone after 2 weeks. The survey also found that anti-tumour necrosis factor drugs (particularly infliximab) are the most frequently offered drugs across most steroid-resistant (and steroid-dependent) patient scenarios, but they are less frequently offered to thiopurine-naive patients. Patient interviews identified several factors influencing their treatment choices, including effectiveness of treatment, recommendations from health-care professionals, route of administration and side effects. Over time, depending on the severity and duration of symptoms and, crucially, as medical treatment options become exhausted, patients are willing to try alternative treatments and, eventually, to undergo surgery. The discrete choice experiments found that the probability of remission and of side effects strongly influences the treatment choices of both patients and health-care professionals. Patients are less likely to choose a treatment that takes longer to improve symptoms. Health-care professionals are willing to make difficult compromises by tolerating greater safety risks in exchange for therapeutic benefits. The treatments ranked most positively by patients were infliximab and tofacitinib (each preferred by 38% of patients), and the predicted probability of uptake by health-care professionals was greatest for infliximab (62%). LIMITATIONS: The survey and the discrete choice experiments with patients and health-care professionals are limited by their relatively small sample sizes. The qualitative studies are subject to selection bias. The timing of the different substudies, both before and during the COVID-19 pandemic, is a potential limitation. CONCLUSIONS: We have identified factors influencing treatment decisions for steroid-resistant ulcerative colitis and the characteristics to consider when choosing treatments to evaluate in future randomised controlled trials. The findings may be used to improve discussions between patients and health-care professionals when they review treatment options for steroid-resistant ulcerative colitis. FUTURE WORK: This research highlights the need for consensus work to establish an agreed definition of steroid resistance in ulcerative colitis and a greater understanding of the optimal use of tofacitinib and surgery for this patient group. A randomised controlled trial comparing infliximab with tofacitinib is also recommended. FUNDING: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 41. See the NIHR Journals Library website for further project information.

Steroids are one of the main treatments for ulcerative colitis; however, steroids work well for only about 50% of people who take them. There are many other treatments that can be given when steroids do not work, but evidence is limited about how these treatments are best used. To carry out better research about the best treatment options and to improve clinical practice in the future, this study aimed to find out how adults with steroid-resistant ulcerative colitis are managed in hospital and why patients and health-care professionals prefer different treatments. The study combined various methods of research, including an online survey of health-care professionals (n = 168), interviews with health-care professionals (n = 20) and patients (n = 33), a survey of health-care professionals (n = 116) and patients (n = 115) to ask them about treatment preferences, and a multistakeholder workshop (n = 9). The interviews with and survey of health-care professionals found that most health-care professionals define steroid resistance as an incomplete response to 40 mg per day of prednisolone after 2 weeks. The survey also found that the most frequently offered drugs are anti-tumour necrosis factor drugs (particularly infliximab). Patient interviews found that several factors influenced treatment choices, including effectiveness of treament, guidance from health-care professionals, route of administration and side effects. Patients were willing to try alternative treatments and surgery over time. The survey found that a higher level of remission and a lower chance of side effects strongly influenced treatment choices. Patients are less likely to choose a treatment that takes longer to improve symptoms. Health-care professionals are willing to make difficult compromises by tolerating greater safety risks in exchange for therapeutic benefits. Infliximab and tofacitinib were ranked most positively by patients, and the predicted uptake by health-care professionals was greatest for infliximab. The results of this study help improve understanding of why people choose certain treatments, improve decision-making in partnership and inform the design of future research.

The development of a minimum dataset for MRI reporting of anorectal fistula: a multi-disciplinary, expert consensus process.

There are a range of sphincter-preserving procedures available to treat anorectal fistula, some of which can be precluded, or rendered more optimal by specific features of fistula anatomy. Magnetic resonance imaging (MRI) is the gold standard modality for assessing anorectal fistula. To maximise clinical utility, the MRI report should accurately describe these clinically relevant features. We aimed to develop a minimum dataset for reporting MRI of anorectal fistula, in order to improve the assessment and management of these patients. A longlist of 70 potential items for the minimum dataset was generated through systematic review of the literature. This longlist was presented to radiologists, surgeons and gastroenterologists in an online survey to understand the features that shape current clinical practice. The longlist and survey results were then presented to an expert consensus panel to generate the final minimum dataset through discussion and anonymous voting. The final minimum dataset details the general characteristics, features of the internal and external openings, path of the fistula through the sphincters and any associated extensions and collections that should be described in all MRI reports for anal fistula. Additional surgical and perianal Crohn's disease subsets were developed to indicate the features that aid decision-making for these patients, in addition to a minimum dataset for the clinical request. This study represents a multi-disciplinary approach to developing a minimum dataset for MRI reporting of anal fistula, highlighting the most important features to report that can assist in clinical decision-making. KEY POINTS: • This paper recommends the minimum features that should be included in all MRI reports for the assessment of anal fistula, including Parks classification, number of tracts, features of the internal and external opening, path of the tract through the sphincters, the presence and features of extensions and collections. • Additional features that aid decision-making for surgery or in the presence of Crohn's disease have been identified. • The items that should be included when requesting an MRI are specified.

Patient preferences for treatment in steroid resistant ulcerative colitis - a discrete-choice experiment.

BACKGROUND AND AIM: Understanding treatment preferences in those patients who are not responding to corticosteroids for ulcerative colitis is important in informing treatment choices. This study aimed to assess the relative importance of treatment characteristics to patients by conducting a discrete-choice experiment. METHODS: Patients completed the questionnaire online. All data were collected between September and December 2020. Participants were shown 13 discrete-choice experiment tasks - a series of side-by-side comparisons of competing, hypothetical treatment characteristics and asked to select a preferred treatment. Survey responses were analysed using descriptive statistics and regression analyses. RESULTS: 115 patients completed the study. Patient preferences were strongest for treatments with a lower chance of side effects, this attribute had the most influence on the choice of treatment patients preferred. The second most important attribute was an improvement in maintaining remission. Conversely, route and frequency of administration were least important on the choice of treatment patients preferred. Respondents were willing to make trade offs and accept treatment benefits to compensate them for receiving a treatment with a less desirable attribute level. Participants were willing to accept a larger benefit of 45% improvement in maintenance of remission to accept a treatment with a higher probability of side effects. The benefit required was smaller with a 10% improvement in remission required to accept a treatment with a lower probability of side effects. CONCLUSION: Quantifying preferences helps to identify and prioritise treatment characteristics that are important to patients. The results highlight the importance of careful discussion of side effects, including the magnitude of risk, using visualisation tools during a patient consultation to support decisions.

The effect of infliximab dose escalation in inflammatory bowel disease patients with antibodies to infliximab.

BACKGROUND: Infliximab dose escalation (DE) can be used in inflammatory bowel disease patient; however, the long-term benefit remains unclear, especially in those with antibodies to infliximab (ATI). The aim was to assess the effect of DE in patients with ATI on drug level, clinical response and ATI status. METHODS: All patients undergoing infliximab DE (a reduction in dose interval between infusions <8 weeks ± an increase in dose up to 10 mg/kg) at a referral centre between April 2016 and August 2019 were included. RESULTS: Ninety-two patients were DE: 51 were men, 50 had CD and 63 were receiving immunosuppression. A total of 87 people received DE for a median of 44 weeks (range 4-176). Five stopped infliximab after 1 dose of DE: 2 for loss of response and 3 for infusion reaction. In patients with ATI ≤10 vs. >10 AU/mL, DE significantly increased drug levels: median infliximab levels of 1.4 and 0.9 at baseline, respectively, to 3.2 and 3.5 at week 24. After DE, 21/35 ATI-positive patients had a fall in ATI ≤10 AU/mL. At week 24 following DE 62/92 patients were in clinical remission. Duration of clinical remission was shorter in those with ATI >10 AU/mL (median 24 weeks, range 0-88) than in those with transient/ATI ≤10 AU/mL (median 36 weeks, range 0-126, P = 0.06). CONCLUSIONS: A strategy of DE for selected patients receiving infliximab is associated with an increase in drug levels and reduced ATI positivity. This is associated with clinical remission in approximately 70% of patients at 6 months.

The LUCID study: living with ulcerative colitis; identifying the socioeconomic burden in Europe.

BACKGROUND: Ulcerative colitis (UC) is an inflammatory bowel disease with increasing prevalence worldwide. Current treatment strategies place considerable economic and humanistic burdens on patients. The aim of this study was to determine the socioeconomic burden of UC in adult patients in European countries in a real-world setting. METHODS: In this retrospective, cross-sectional and observational pan-European study, patients with moderate or severe UC were assigned to ARM 1 and patients who had moderate or severe UC but achieved mild or remission status 12 months before index date (or clinical consultation date), were assigned to ARM 2. Clinical and medical resource use data were collected via electronic case report forms, and data on non-medical and indirect costs, and health-related quality of life (HRQoL) were collected via patient and public involvement and engagement (PPIE) questionnaires. Per-patient annual total costs per ARM and per country were calculated using the collated resource use in the last 12 months (between the start of the documentation period and patient consultation or index date) and country specific unit costs. Quality of life was described by arm and by country. RESULTS: In the physician-reported eCRF population (n = 2966), the mean annual direct medical cost was €4065 in ARM 1 (n = 1835) and €2935 in ARM 2 (n = 1131). In the PPIE population (ARM 1, n = 1001; ARM 2, n = 647), mean annual direct cost was €4526 in ARM 1 and €3057 in ARM 2, mean annual direct non-medical cost was €1162 in ARM 1 and €1002 in ARM 2, mean annual indirect cost was €3098 in ARM 1 and €2309 ARM 2, and mean annual total cost was in €8787 in ARM 1 and €6368 in ARM 2. HRQoL scores showed moderate to high burden of UC in both groups. CONCLUSIONS: The cost and HRQoL burden were high in patients in both ARM 1 and ARM 2 indicating unmet needs in the UC active population.

Quantitative Magnetic Resonance Imaging in Perianal Crohn's Disease at 1.5 and 3.0 T: A Feasibility Study.

Perianal Crohn's Disease (pCD) is a common manifestation of Crohn's Disease. Absence of reliable disease measures makes disease monitoring unreliable. Qualitative MRI has been increasingly used for diagnosing and monitoring pCD and has shown potential for assessing response to treatment. Quantitative MRI sequences, such as diffusion-weighted imaging (DWI), dynamic contrast enhancement (DCE) and magnetisation transfer (MT), along with T2 relaxometry, offer opportunities to improve diagnostic capability. Quantitative MRI sequences (DWI, DCE, MT and T2) were used in a cohort of 25 pCD patients before and 12 weeks after biological therapy at two different field strengths (1.5 and 3 T). Disease activity was measured with the Perianal Crohn's Disease Activity index (PDAI) and serum C-reactive protein (CRP). Diseased tissue areas on MRI were defined by a radiologist. A baseline model to predict outcome at 12 weeks was developed. No differences were seen in the quantitative MR measured in the diseased tissue regions from baseline to 12 weeks; however, PDAI and CRP decreased. Baseline PDAI, CRP, T2 relaxometry and surgical history were found to have a moderate ability to predict response after 12 weeks of biological treatment. Validation in larger cohorts with MRI and clinical measures are needed in order to further develop the model.

Monitoring established Crohn's disease with pan-intestinal video capsule endoscopy in Europe: clinician consultation using the nominal group technique.

OBJECTIVE: Monitoring established Crohn's disease (CD) through a "treat-to-target" strategy aims to reduce and prevent long-term bowel damage and disability. Despite the availability of different monitoring techniques, there is a current lack of integrated evidence to guide optimal monitoring in terms of appropriate tools and timing. Pan-intestinal video capsule endoscopy (PCE) enables non-invasive and direct visualization of the entire intestinal tract with proven safety and efficacy. This study aims to generate insights on the value of PCE for monitoring established CD from the physician's perspective. METHODS: The Nominal Group Technique (NGT) was used to create discussion around pre-defined research questions aimed at identifying target patient populations for PCE, benefits of PCE in terms of improving disease management, comparative benefits of PCE over standard of care, research priorities to ratify the use of PCE, and hurdles to PCE utilization. A NGT panel was held in Brussels, Belgium in October 2018 with 9 gastroenterology experts. Data were collected from multiple rankings of statements to the research questions and analyzed descriptively. RESULTS: Consensus indicated that PCE is differentiated from other diagnostic tools, allowing for non-invasive and direct visualization of the luminal intestinal tract in one single procedure. Participants agreed that PCE is beneficial for mapping and grading established CD in all patients, enabling individual and tailored treatment decision-making. Time required to read PCE results was identified as the main utilization hurdle by participants. Well-designed studies are needed to confirm improved outcomes amongst patients with CD managed through a PCE-guided approach. CONCLUSIONS: This study, using the NGT, generated expert opinion on the value of PCE for monitoring established CD in terms of target patient populations and benefits compared to other diagnostic modalities. Participants perceived PCE to facilitate a "treat-to-target" strategy for CD management. Further research is needed to support this value perception.

Food-related quality of life is impaired in inflammatory bowel disease and associated with reduced intake of key nutrients.

BACKGROUND: Inflammatory bowel disease (IBD) may impact the extent to which food, eating, and drinking bring satisfaction and enjoyment to peoples' lives, and this may impact dietary intake. The prevalence of an impaired food-related quality of life (FR-QoL), its associated factors, and its impact on diet have not been explored. OBJECTIVES: To measure the prevalence and nature of the burden of impaired FR-QoL in people with IBD, the factors associated with these, and their associations with nutrient intake. METHODS: We recruited 1576 outpatients with IBD (≥16 years old) in person from 7 IBD centers across the United Kingdom. Patients completed validated questionnaires to measure their FR-QoL, quality of life (QoL), distress, fatigue, anxiety, and depression. Dietary intake was recorded using the European Prospective Investigation into Cancer FFQ. A health professional recorded disease activity, Montreal classification, blood results, BMI, and malnutrition risk. FR-QoL was regressed onto explanatory variables using univariable and multivariable analyses. RESULTS: Data from 1221 patients were available (77.4% response; Crohn's disease, 65%; ulcerative colitis, 35%). The FR-QoL mean (± SD) score was 80.8 ± 26.9, with wide ranges (minimum, 29; maximum, 145). Following multivariable regression, the strongest associations with FR-QoL were the number of recent disease flares (5 flares ß = -12.7; P < 0.001), the IBD-specific QoL (ß = 0.33; P < 0.001), and IBD-related distress (ß = -0.26; P < 0.001). Patients with poorer FR-QoL had lower intakes of fiber (nonstarch polysaccharide; Q1 to Q5 difference = 2.1 g/d; 95% CI: 0.4-3.8; P = 0.048), calcium (192.6 mg/d; 95% CI: 112.5-272.6; P < 0.001), phosphorus (167 mg/d; 95% CI: 58-276; P = 0.041), and magnesium (34.4 mg/d; 95% CI: 9.3-59.4; P = 0.041). CONCLUSIONS: Impaired FR-QoL is prevalent in IBD and is associated with recurrent disease flares, a reduced IBD-specific QoL, and greater IBD-related distress. A poorer FR-QoL was associated with lower intakes of key nutrients of importance to IBD, including those relating to gut health and bone mineralization.

Predicting the development of psychological morbidity in inflammatory bowel disease: a systematic review.

BACKGROUND: Psychological morbidity in inflammatory bowel disease is common with significant impact on quality of life and health outcomes, but factors which predict the development of psychological morbidity are unclear. AIM: To undertake a systematic literature review of the predictors of psychological morbidity in patients with inflammatory bowel disease. METHODS: Electronic searches for English-language articles were performed with keywords relating to psychological morbidity according to the Diagnostic and Statistical Manual of Mental Disorders IV and subsequent criteria, and inflammatory bowel disease; in MEDLINE, PsychInfo, Web of Science and EMBASE for studies published from January 1997 to 25 January 2019. RESULTS: Of 660 studies identified, seven met the inclusion criteria. All measured depression, with three also measuring anxiety. Follow-up duration was variable (median of 18 months range 6-96 months). Risk factors identified for development of psychological morbidity included physical factors: aggressive disease (HR 5.77, 95% CI 1.89 to 17.7) and greater comorbidity burden (OR 4.31, 95% CI 2.83 to 6.57) and psychological risk factors: degree of gratitude (r=-0.43, p<0.01) and parenting stress (R-change=0.03, F(1,58)=35.6, p<0.05). Age-specific risk was identified with young people (13-17 years) at increased risk. CONCLUSIONS: Identifiable risks for the development of psychological morbidity in inflammatory bowel disease include physical and psychological factors. Further research is required from large prospective studies to enable early interventions in those at risk and reduce the impact of psychological morbidity.

Systematic Review of Factors Affecting Transition Readiness Skills in Patients with Inflammatory Bowel Disease.

BACKGROUND AND AIMS: The incidence of inflammatory bowel disease [IBD] diagnosed before adulthood is increasing worldwide. Transition from paediatric to adult health care requires certain skills. The aim of this study was to identify factors affecting these skills. METHODS: This review was registered on the PROSPERO database [CRD42019152272]. Inclusion criteria were: 1] studies of factors affecting transition readiness skills in patients with IBD; 2] written in English; 3] published since 1999. MEDLINE, CINAHL, and PsychINFO databases were searched between 1999 and 2019. Quality was assessed using the Joanna Briggs Institute critical appraisal tools. RESULTS: Searches identified 822 papers. Sixteen papers were included. Age was positively associated with skills including disease knowledge and performing self-management behaviours [14 studies]. Improvement often occurs at 18; however, skill deficiency may still remain. Increased self-efficacy [confidence] was associated with greater disease knowledge and performing self-management behaviours [three studies]. Self-efficacy was positively correlated with transition duration [two studies] and health-related quality of life [r = 0.57, p <0.001] [one study], negatively correlated with depression [r = -0.57, p <0.001] and anxiety [r = -0.23, p = 0.03] [one study], and was associated with higher education level [two studies] and a family history of IBD [one study]. Females had higher self-management scores [three studies], and greater health care satisfaction was significantly associated with higher knowledge [one study]. Greater transition communication improved knowledge, self-management, and overall transition readiness [two studies]. CONCLUSIONS: Potentially modifiable factors have been identified that could be supported in the transitioning IBD population, to improve transition readiness. Identification of those with non-modifiable characteristics associated with poor readiness may aid targeted support.

Survey to define informational needs of patients undergoing surgery for Crohn's anal fistula.

AIM: There are many surgical treatments used in Crohn's anal fistula, although none is perfect. Decisions about surgery in this condition may be preference sensitive. The aim of this study was to identify what information patients would like in order to make treatment decisions and to explore experiences of making decisions in this setting. METHOD: A survey was designed based upon qualitative interviews and input from patients and clinicians. It included a long list of informational items to be ranked on a scale of importance, a control preference scale, the decision regret scale, and items exploring preferred information formats. This was distributed through 10 English hospitals to patients with recent surgical treatment for Crohn's anal fistula. Results were analysed using principal component analysis, to identify key informational needs, and other appropriate descriptive statistics. RESULTS: In total 92 questionnaires were returned (response rate 41.8%); 48 (52.5%) respondents were women and 54 (58.7%) had undergone seton insertion. Principal component analysis identified three information needs: wound and aftercare, effect on perianal symptoms, severity of surgery. Decision-making preferences showed a desire to participate in decision-making. Median decision regret score was 25/100 (i.e., low). The preferred format for sharing information to support decision-making was from the surgeon, 80/92 (87.0%), and from a booklet, 58/92 (63.0%). CONCLUSION: Key informational needs in this condition are wound and after care, effect on perianal symptoms, and severity of surgery. Patients would like this information to help engage in shared decision-making.