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Background: Active inflammatory bowel disease (IBD) and IBD surgery can have a negative impact on ability to conceive a pregnancy many patients with stomas are concerned about pregnancy. Aim: This study aimed to describe IBD-related, stoma-related, obstetric and neonatal outcomes in pregnancies of women who had stomas formed for IBD prior to the reported pregnancies. Methods: A multicentre retrospective audit used routine records from 15 UK hospitals on women with IBD and pregnancy after stoma formation since 2014. Results: In one miscarriage, one stillbirth and 80 live births, delivery occurred in 58 cases by caesarean section (CS), of which 44 were elective and 14 emergency. The 73% CS rate compares to a national rate of 29.1%. There was a high rate of serious stoma complications at 24%, although most were managed conservatively. Conclusions: Guidance and patient information should be updated to facilitate early conversations with obstetric teams and counsel women about increased risk of planned CS after IBD surgery with a stoma.

Background Abdominal wall hernia repair is one of the most commonly performed surgical procedures worldwide, yet despite this, there remains a lack of high-quality evidence to support best management. The aim of the study was to use a modified Delphi process to determine future research priorities in this field. Methods Stakeholders were invited by email, using British Hernia Society membership details or Twitter, to submit individual research questions via an online survey. In addition, questions obtained from a patient focus group (PFG) were collated to form Phase I. Two rounds of prioritization by stakeholders (phases II and III) were then completed to determine a final list of research questions. All questions were analyzed on an anonymized basis. Results A total of 266 questions, 19 from the PFG, were submitted by 113 stakeholders in Phase I. Of these, 64 questions were taken forward for prioritization in Phase II, which was completed by 107 stakeholders. Following Phase II analysis, 97 stakeholders prioritized 36 questions in Phase III. This resulted in a final list of 14 research questions, 3 of which were from the PFG. Stakeholders included patients and healthcare professionals (consultant surgeons, trainee surgeons and other multidisciplinary members) from over 27 countries during the 3 phases. Conclusion The study has identified 14 key research priorities pertaining to abdominal wall hernia surgery. Uniquely, these priorities have been determined from participation by both healthcare professionals and patients. These priorities should now be addressed by well-designed, high-quality international collaborative research.

Background Primary and incisional ventral hernia trials collect unstandardized inconsistent data, limiting data interpretation and comparison. This study aimed to create two minimum data sets for primary and incisional ventral hernia interventional trials to standardize data collection and improve trial comparison. To support these data sets, standardized patient-reported outcome measures and trial methodology criteria were created. Methods To construct these data sets, nominal group technique methodology was employed, involving 15 internationally recognized abdominal wall surgeons and two patient representatives. Initially a maximum data set was created from previous systematic and panellist reviews. Thereafter, three stages of voting took place: stage 1, selection of the number of variables for data set inclusion; stage 2, selection of variables to be included; and stage 3, selection of variable definitions and detection methods. A steering committee interpreted and analysed the data. Results The maximum data set contained 245 variables. The three stages of voting commenced in October 2019 and had been completed by July 2020. The final primary ventral hernia data set included 32 variables, the incisional ventral hernia data set included 40 variables, the patient-reported outcome measures tool contained 25 questions, and 40 methodological criteria were chosen. The best known variable definitions were selected for accurate variable description. CT was selected as the optimal preoperative descriptor of hernia morphology. Standardized follow-up at 30 days, 1 year, and 5 years was selected. Conclusion These minimum data sets, patient-reported outcome measures, and methodological criteria have allowed creation of a manual for investigators aiming to undertake primary ventral hernia or incisional ventral hernia interventional trials. Adopting these data sets will improve trial methods and comparisons.

There is a paucity of data on pregnancies in women with stomas due to inflammatory bowel disease (IBD). The aim of this study was to assess stoma, IBD, obstetric and neonatal outcomes in pregnant patients with IBD and a stoma.Multicentre retrospective audit in 15 UK hospitals. Pregnancy, stoma and neonatal outcomes were elicited from routinely collected hospital records.Data on 82 pregnancies from 77 patients (mean age 31.4 years, 60.9% Crohn's disease, 35.4% ulcerative colitis, 3.6% IBD-U) were included. Stoma types included ileostomy in 72 (88%) and colostomy in 10 (12%) women. There was one reported miscarriage, one still birth and 80 live births. Delivery occurred in 58 cases by caesarean section (CS), of which 44 were performed electively and 14 as emergency CS. The overall CS rate was 73%. Premature delivery before week 37 occurred in 19% and birth weight2,500 g in 17%. Significant stoma related complications occurred during 20 (24%) pregnancies and included stoma prolapse in nine cases (2 required surgery), parastomal hernias in three cases (2 required surgery) and small bowel obstructions in seven cases (3 required surgery).Pregnancy for women who previously had stoma formation for IBD is associated with higher rates of caesarean section and stoma complications. Future prospective studies should capture data, including patient reported outcomes, to gather a full picture on the impact of pregnancy after stoma surgery for IBD.

Background and aim\ud \ud 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.\ud \ud \ud \ud Methods\ud \ud 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.\ud \ud \ud \ud Results\ud \ud 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.\ud \ud \ud \ud Conclusion\ud \ud 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.

Aim Abdominal wall hernia repair is one of the most commonly performed surgical procedures worldwide, yet there remains a lack of high quality evidence to support best management. The aim of the study was to use a modified Delphi process to determine future research priorities in this field. Material and Methods Stakeholders were invited by email, using British Hernia Society membership details or Twitter, to submit individual research questions via an online survey. In addition, questions obtained from a patient focus group (PFG) were collated to form Phase I. Two rounds of prioritisation by stakeholders (phase II and III) were then completed to determine a final list of questions. All questions were analysed on an anonymised basis. Results A total of 266 questions, 19 from the PFG, were submitted by 113 stakeholders in Phase I. Of these, 64 questions were taken forward for prioritisation in Phase II, which was completed by 107 stakeholders. Following Phase II analysis, 97 stakeholders prioritised 36 questions in Phase III. This resulted in a final list of 14 research questions, 3 of which were from the PFG. Stakeholders included patients and healthcare professionals (consultant surgeons, trainee surgeons and other multidisciplinary members) from over 27 countries during the 3 phases. Conclusions Fourteen key research priorities pertaining to abdominal wall hernia surgery were identified. Many topics focused on pain, mesh and what the optimal outcome measures following hernia surgery should be. Uniquely, these priorities have been determined from participation by both healthcare professionals and patients. These priorities should now be addressed by well-designed, high-quality international collaborative research.

Introduction\ud Gastrointestinal recovery describes the restoration of normal bowel function in patients with bowel disease. This may be prolonged in two common clinical settings: postoperative ileus and small bowel obstruction. Improving gastrointestinal recovery is a research priority but researchers are limited by variation in outcome reporting across clinical studies. This protocol describes the development of core outcome sets for gastrointestinal recovery in the contexts of postoperative ileus and small bowel obstruction.\ud \ud Method\ud An international Steering Group consisting of patient and clinician representatives has been established. As overlap between clinical contexts is anticipated, both outcome sets will be co‐developed and may be combined to form a common output with disease‐specific domains. The development process will comprise three phases, including definition of outcomes relevant to postoperative ileus and small bowel obstruction from systematic literature reviews and nominal‐group stakeholder discussions; online‐facilitated Delphi surveys via international networks; and a consensus meeting to ratify the final output. A nested study will explore if the development of overlapping outcome sets can be rationalized.\ud \ud Dissemination and implementation\ud The final output will be registered with the Core Outcome Measures in Effectiveness Trials initiative. A multi‐faceted, quality improvement campaign for the reporting of gastrointestinal recovery in clinical studies will be launched, targeting international professional and patient groups, charitable organizations and editorial committees. Success will be explored via an updated systematic review of outcomes 5 years after registration of the core outcome set.

IntroductionPrehabilitation in colorectal surgery is evolving and may minimise postoperative morbidity and mortality. With many different healthcare professionals contributing to the prehabilitation literature, there is significant variation in reported primary endpoints that restricts comparison. In addition, there has been limited work on patient-related outcome measures suggesting that patients with colorectal cancer needs and issues are being overlooked. The Defining Standards in Colorectal Optimisation Study aims to achieve international consensus from all stakeholders on key standards to provide a framework for reporting future prehabilitation research.Methods and analysisA systematic review will identify key standards reported in trials of prehabilitation in colorectal surgery. Standards that are important to patients will be identified by a patient and public involvement (PPI) event. The longlist of standards generated from the systematic review and PPI event will be used to develop a three-round online Delphi process. This will engage all stakeholders (healthcare professionals and patients) both nationally and internationally. The results of the Delphi will be followed by a face-to-face interactive consensus meeting that will define the final standards for prehabilitation for elective colorectal surgery.Ethics and disseminationThe University of Glasgow College of Medical, Veterinary and Life Sciences Ethics Committee has approved this protocol, which is registered as a study (200190120) with the Core Outcome Measures in Effectiveness Trials Initiative. Publication of the standards developed by all stakeholders will increase the potential for comparative research that advances understanding of the clinical application of prehabilitation.PROSPERO registration numberCRD42019120381.

Introduction Patient involvement in research is essential, not only to give patients a voice regarding how research should be carried out, but also to ensure that studies are investigating clinical outcomes that matter to them and that trial interventions are acceptable. Methods Our multidisciplinary organising committee included IBD-focussed gastroenterologists and surgeons as well as two IBD patients and members of the research team at the UK’s IBD patient charity (Crohn’s & Colitis UK, CCUK). Supported by grants from the BSG, BDRF, NIHR and CCUK, we ran two IBD Patient Research Days (IBDPRDs) to involve large, nationwide cohorts of patients in a broad range of research areas. The first took place in London in May 2018 and the second in Manchester in September 2019. Patient engagement, information and registration was carried out through CCUK’s nationwide network of members. Between the two events, 20 research groups were invited to present their studies to the audience and include specific areas for which they required patient involvement. Sessions were facilitated by members of the organising committee and digital capacity included online steaming of sessions, digital voting on research questions and feedback. Results Approximately 80 IBD patients registered for each of the IBDPRDs and purposive sampling helped to ensure a range of demographics and IBD phenotype. Presented studies included national and international trials at various phases, such as SPARE, STOP-COLITIS, ASTIClite, IBD BioResource and IBD-BOOST. Researchers asked for patient involvement on: Relevance of research topics and shaping of research questions Feedback on study design Comments on ethical aspects Issues regarding recruitment and retention Identification of future research priorities In addition to participation of patients at the events, we also engaged patients virtually, with the live streamed IBD BioResource session being watched almost 500 times and almost 900 responses being received for the accompanying patient involvement questions. IBDPRD2019 feedback demonstrated an overall patient rating of 8.7/10 and researcher rating of 9.4/10. Conclusion Patient involvement can have a powerful and positive influence on the design, conduct and delivery of IBD research. It should ideally include a large number of patients, who represent a broad range of lived IBD experiences. We plan an IBDPRD2020 and would encourage other groups to carry out similar events.

Introduction Corticosteroids are a mainstay in the treatment of moderately severe relapses of ulcerative colitis (UC), yet almost 50% of patients do not respond fully, with the risk of prolonged steroid use and side-effects. There is insufficient evidence to inform optimum treatment choice for steroid resistant disease. The aim of this study was to provide details of current practice in the management of steroid resistant UC. Methods A cross-sectional survey of Inflammatory Bowel Disease (IBD) healthcare professionals (HCPs) in the UK was conducted online using the Qualtrics platform. HCPs were invited to participate in the survey through professional networks: British Society of Gastroenterology IBD section, Royal College of Nursing IBD Nurses Network, and social media. Clinical scenarios representing patients with moderately severe UC with continuing symptoms (steroid resistant (SR)) and with relapse after steroid dose reduction (steroid dependent (SD)) were included – both thiopurine treated (TP+) and naive (TP-). Data were analysed descriptively with chi-squared tests on outcomes of interest using R software. Results 387 HCPs visited the survey; 47% (168 HCPs) consented (68% medical; 30% nurses; median 7.5 years since appointment) across all UK regions. Definitions of steroid resistance varied: 68% indicating an incomplete response to prednisolone 40 mg/day after 2 weeks and after 4 weeks in a further 58%. Only 13% felt that SR and SD disease should be treated identically. Anti-TNF drugs would be most frequently offered in each scenario (SR: TP+ 95%; TP- 87%; SD: TP+ 88%; TP- 74%) with infliximab most frequently suggested; apart from SD TP- patients flaring at prednisolone 5 mg/day. Admission for IV steroids was offered more often for SR disease (32%) than for SD (12%). In SD scenarios, thiopurine treatment would be instigated in TP- patients flaring at 25 mg prednisolone or 5 mg/day in 49% and in 70% respectively. Anti-TNF treatment would be offered more frequently if patients are TP+ in both SR (TP+ 81%; TP- 62% p=0.004) or SD patients and particularly for those relapsing at 5 mg/day (Relapse at 25 mg/day: TP+ 78% TP- 49%, p Conclusions There are important variations in practice in the UK in how to define, treat and use endoscopy in steroid resistant UC. Such variations need to be understood as part of initiatives to change practice - particularly to avoid excess steroid use - and in trial design.

Aim Around one-third of patients with Crohn's disease are affected by Crohn's fistula-in-ano (pCD). It typically follows a chronic course and patients undergo long-term medical and surgical therapy. We set out to describe current surgical practice in the management of pCD in the UK. Methods A survey of surgical management of pCD was designed by an expert group of colorectal surgeons and gastroenterologists. This assessed acute, elective, multidisciplinary and definitive surgical management. A pilot of the questionnaire was undertaken at the Digestive Disease Federation 2015 meeting. The survey was refined and distributed nationally through the trainee collaborative networks. Results National rollout obtained responses from 133 surgeons of 179 approached (response rate 74.3%). At first operation, 32% surgeons would always consider drainage of sepsis and 31.1% would place a draining seton. At first elective operation, 66.6% would routinely insert of draining seton, and 84.4% would avoid cutting seton. The IBD multidisciplinary team was available to 87.6% respondents, although only 25.1% routinely discussed pCD patients. Anti-TNF-α therapy was routinely considered by 64.2%, although 44.2% left medical management to gastroenterology. Common definitive procedures were removal of seton only (70.7%), fistulotomy (57.1%), advancement flap (38.9%), fistula plug (36.4%) and ligation of intersphincteric track (LIFT) procedure (31.8%). Indications for diverting stoma or proctectomy were intractable sepsis, incontinence, and poor quality of life. Discussion This survey has demonstrated areas of common practice, but has also highlighted divergent practice including choices of definitive surgery and multimodal management. Practical guidelines are required to support colorectal surgeons in the UK. This article is protected by copyright. All rights reserved.

Background The optimum treatment for steroid resistant ulcerative colitis (SRUC) is not clear and a range of options can be considered. The aim of this study was to quantify the relative importance of different treatment characteristics to clinicians and understand their preferences for benefit-risk trade-offs. Methods A discrete choice experiment (DCE) was conducted in the UK via online survey of clinicians with expertise in inflammatory bowel disease. This involved 12 tasks where respondents selected a preferred treatment option when presented with two competing, hypothetical treatment profiles for a SRUC scenario. Profiles described five treatment characteristics focusing on clinical outcomes and safety, identified from qualitative interviews with clinicians and evidence from systematic reviews. DCE responses were analysed using conditional logistic regressions. Regression coefficients were used to calculate benefit-risk trade-offs, to find the rate at which clinicians are willing to trade levels of risks in exchange for the preferred levels of clinical outcomes. Regression coefficients were also used to predict uptake rates for selected drugs currently prescribed to patients with SRUC. Results 116 clinicians completed the survey (age 46y; female 42%; consultant 60%; nurse 26%; mean experience 11y). Figure 1 shows the treatment characteristics that make respondents more likely (positive coefficient) or less likely (negative coefficient) to choose a treatment. One unit increase in both lymphoma risk and serious infection risk were strongly considered when clinicians were choosing a treatment compared to one unit increase in the symptom improvement characteristics. Clinicians would accept a higher lymphoma risk of 5 per 10,000 patient years for a 10% improvement in remission rate compared to 4 and 2 cases per 10,000 patient years for 10% better rates of clinical response and mucosal healing respectively. Clinicians at secondary hospitals accepted a lymphoma risk of 4 cases per 10,000 patient years for a 10% improvement in remission vs 7 per 10,000 patient years at tertiary centres. Similar trade-off results were found for serious infection risks. Predicted uptake comparing preferred characteristics to existing treatments was infliximab (62%), tofacitinib (18%), vedolizumab (15%) and adalimumab (5%). Conclusion Clinicians are willing to make difficult trade-offs and tolerate elevated safety risks in exchange for therapeutic benefits. Risk tolerance was highest if the treatment improved long term remission rate, lowest for mucosal healing and higher in clinicians at tertiary centres. The results help to better understand treatment decisions and identify outcomes that might be considered in choosing agents to evaluate in clinical trials.

Introduction 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. Methods Candidate outcomes were generated through a systematic review and patient interviews. Consensus was established via a three-round Delphi process using a nine-point Likert scale based upon 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, 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.

This study examines two aspects of teaching with a project-based learning (PBL) model in higher education settings: faculty definitions of PBL and faculty PBL practices, as evidenced by their self-described successes and challenges in implementation. Faculty participants took “a leap of faith” in their teaching practices to redefine what it means to teach and learn using PBL as an instructional methodology. The findings provide insight into how faculty conceptualization of PBL drives implementation; how the PBL approach challenges college-level teachers; and how instructors’ perceptions of their own role in the PBL process impacts how they implement PBL.

Radiation pressure due to sunlight anisotropically reflected from the oceans apparently cannot explain the fluctuations in the anomalous along-track deceleration of the LAGEOS satellite. It fails by about a factor of 2 to account for the major peaks in the acceleration. This result is based on an extreme model: a cloudless earth whose northern hemisphere consists of continent, and whose southern hemisphere consists of ocean. The continent is assumed to reflect sunlight according to Lambert's law, while the ocean reflects anisotropically according to a simple analytical law which mimics Nimbus 7 observations. The inclusion of clouds into the model would reduce the acceleration to perhaps an order of magnitude below those observed. Some other explanation for the fluctuations, which have magnitude about 2 x 10 to the -12th m/sec sq, must be sought.