Inflammatory Bowel Disease Experts Research Articles

Consensus Statement on Managing Anxiety and Depression in Individuals with Inflammatory Bowel Disease.

Studies have found a higher risk of comorbid anxiety and depression among patients with inflammatory bowel disease (IBD) compared with healthy individuals. If left untreated, comorbid depression and anxiety in patients with IBD can lead to poorer health outcomes and an increased healthcare utilization. The goal of this work was to develop a consensus statement to begin to address patient and provider needs and responsibilities related to screening and treatment of depression and anxiety symptoms among patients with IBD. A literature scan was conducted to gather evidence-based background information and recommendations on the screening, diagnosis, and treatment of anxiety and depression in patients with IBD. This was followed by the engagement of a panel of IBD and mental health experts and patient advocates using a modified Delphi process to synthesize the literature and distill the information into a core set of statements to support provider actions and care delivery. Six statements were distilled from the literature and consensus process that link to the general management, screening, and treatment of anxiety and depression in patients with IBD. Mental healthcare and support for IBD patients is critical; the statements included in this article represent practical considerations for IBD healthcare professionals in addressing key issues on provider awareness, knowledge and behaviors, screening and treatment resources, and patient education.

Overview to Challenges in IBD 2024-2029.

The mission of the Crohn's & Colitis Foundation is to cure Crohn's disease and ulcerative colitis and to improve the quality of lives of patients living with these diseases-in other words, to care and cure. To achieve these missions, there is a need to identify and prioritize research gaps and approaches to address these gaps, which is the aim of Challenges in IBD 2024. The Foundation convened close to 80 experts in inflammatory bowel disease (IBD), including researchers, clinicians, patients and caregivers, funders, industry representatives, and Foundation scientific staff and organized them into 5 workgroups, one for each of the 5 Challenges topics: Preclinical Human IBD Mechanisms, Environmental Triggers, Precision Medicine, Novel Technologies, and Pragmatic Clinical Research. The findings of these groups outline a research agenda that intends to change the research paradigm in IBD by introducing 2 concepts in the course of IBD that warrant specific focus: interception (during the preclinical phase) and restoration of normal physiology after remission is achieved. We hope these reviews will stimulate innovations in our understanding and management of IBD.

Rare and severe adverse events in children with inflammatory bowel disease: analysis of data from the PIBD-SETQuality Safety Registry

Rare and severe adverse events can occur in children with inflammatory bowel disease (IBD), and the relationship with disease or drug treatment is often uncertain. We aimed to establish a method of reporting adverse events of interest in children with IBD, allowing for estimates of incidence rates with comparison between different regions, and, if possible, to compare with published data on rates of adverse events in children overall. For this analysis, we used data from the Paediatric Inflammatory Bowel Disease Network for Safety, Efficacy and Treatment and Quality improvement of care (PIBD-SETQuality) Safety Registry, which collects data on multiple rare and severe adverse events in children younger than 19 years with IBD. Overall, the registry collected data on ten prespecified rare and severe adverse events in children with IBD, as established by a panel of paediatric IBD experts, via reports from paediatric gastroenterologists at participating hospitals between Nov 1, 2016, and March 31, 2023. Reporting physicians, who could only be paediatric gastroenterologists or IBD nurses reporting on behalf of paediatric gastroenterologists, were recruited through invitations sent to both national and international IBD networks and at conferences. Once per month, participating paediatric gastroenterologists received an email with an anonymous and unique link to an online survey asking them to report whether any of ten rare and severe adverse events had occurred in a patient in their paediatric-IBD population in the previous month. Prevalent or retrospective rare and severe adverse events were excluded, as were events occurring in children with an unconfirmed diagnosis of IBD or for whom inflammatory colitis was part of a monogenic immunodeficiency disorder. Duplicates and events that did not meet the definitions and criteria were excluded. Physicians could also report other, non-categorised adverse events if they considered them rare and severe. In case of no response, up to two reminders were sent for each per-month survey. Annual denominator data surveys were sent to obtain the total number of person-years for the estimation of incidence rates, which were calculated via Poisson regression models. Responses were gathered from 220 paediatric gastroenterologists from 167 centres. 121 centres were in Europe, 23 centres were in North America, 17 centres were in Asia, and six centres were in Oceania. Combined, the total population with paediatric IBD consisted of an estimated 30 193 children with 114 528 person-years of follow-up. 451 adverse events were initially reported. After excluding and reorganising adverse events, 402 were eligible; 261 (65%) were categorised and 141 (35%) were non-categorised. The most frequently reported adverse events were venous-thromboembolic events (n=66), renal failure (n=43), opportunistic infections (n=42), and cancer (n=33). Haemophagocytic lymphohistiocytosis (n=4) and liver failure (n=3) were the least frequently reported adverse events. Incidence rates per 10 000 person-years were 5·50 (95% CI 4·25-6·97) for venous-thromboembolic events, 3·75 (2·74-4·99) for renal failure, 3·67 (2·67-4·89) for opportunistic infection, and 2·88 (2·01-3·98) for cancer. Of 66 venous-thromboembolic events, 31 (47%) involved cerebral venous sinus thrombosis at an incidence rate of 2·71 (95% CI 1·86-3·77). The PIBD-SETQuality Safety Registry enabled us to identify incidence rates of rare and severe adverse events in children with IBD. Our findings can guide physicians and enhance awareness of the incidence of adverse events in children with IBD that are considered to be rare. EU Horizon 2020 Research and Innovation Programme.

Comparative evaluation of a language model and human specialists in the application of European guidelines for the management of inflammatory bowel diseases and malignancies.

Society guidelines on colorectal dysplasia screening, surveillance, and endoscopic management in inflammatory bowel disease (IBD) are complex, and physician adherence to them is suboptimal. We aimed to evaluate the use of ChatGPT, a large language model, in generating accurate guideline-based recommendations for colorectal dysplasia screening, surveillance, and endoscopic management in IBD in line with European Crohn's and Colitis Organization (ECCO) guidelines. 30 clinical scenarios in the form of free text were prepared and presented to three separate sessions of ChatGPT and to eight gastroenterologists (four IBD specialists and four non-IBD gastroenterologists). Two additional IBD specialists subsequently assessed all responses provided by ChatGPT and the eight gastroenterologists, judging their accuracy according to ECCO guidelines. ChatGPT had a mean correct response rate of 87.8%. Among the eight gastroenterologists, the mean correct response rates were 85.8% for IBD experts and 89.2% for non-IBD experts. No statistically significant differences in accuracy were observed between ChatGPT and all gastroenterologists (P=0.95), or between ChatGPT and the IBD experts and non-IBD expert gastroenterologists, respectively (P=0.82). This study highlights the potential of language models in enhancing guideline adherence regarding colorectal dysplasia in IBD. Further investigation of additional resources and prospective evaluation in real-world settings are warranted.

Leaky gut, circulating immune complexes, arthralgia, and arthritis in IBD: coincidence or inevitability?

Most host-microbiota interactions occur within the intestinal barrier, which is essential for separating the intestinal epithelium from toxins, microorganisms, and antigens in the gut lumen. Gut inflammation allows pathogenic bacteria to enter the blood stream, forming immune complexes which may deposit on organs. Despite increased circulating immune complexes (CICs) in patients with inflammatory bowel disease (IBD) and discussions among IBD experts regarding their potential pathogenic role in extra-intestinal manifestations, this phenomenon is overlooked because definitive evidence demonstrating CIC-induced extra-intestinal manifestations in IBD animal models is lacking. However, clinical observations of elevated CICs in newly diagnosed, untreated patients with IBD have reignited research into their potential pathogenic implications. Musculoskeletal symptoms are the most prevalent extra-intestinal IBD manifestations. CICs are pivotal in various arthritis forms, including reactive, rheumatoid, and Lyme arthritis and systemic lupus erythematosus. Research indicates that intestinal barrier restoration during the pre-phase of arthritis could inhibit arthritis development. In the absence of animal models supporting extra-intestinal IBD manifestations, this paper aims to comprehensively explore the relationship between CICs and arthritis onset via a multifaceted analysis to offer a fresh perspective for further investigation and provide novel insights into the interplay between CICs and arthritis development in IBD.

P1141 Global perspectives on managing Inflammatory Bowel Disease (IBD) during pregnancy and lactation: current state and the necessity for enhancements

Abstract Background Reproduction is an essential part of life. Our aim was to obtain a global perspective on IBD management by gastroenterologists (GIs) during preconception, pregnancy, lactation and neonatal period. Methods An anonymous survey (75 questions) was developed to investigate different aspects of clinical practice concerning the management of pregnancy and breastfeeding in patients with IBD. A national representative from each European country, USA, Latin America, Australia and New Zealand was selected to distribute the survey among their GI colleagues who treat patients with IBD (irrespectively of their experience). Results A total of 856 GIs from 36 countries participated in the survey. Among the participants, 63% had over a decade of experience as GIs, and 61% identified themselves as IBD specialist (IBDologists). The most relevant survey results and sub-analyses based on expertise are presented in tables 1 and 2. In the management of pregnant patients in remission, treatment discontinuation occurred either consistently or occasionally as follows: 20% thiopurines, 37% vedolizumab, 31% ustekinumab, and 96% small molecules. Notably, 13% did not always discontinue small molecules in patients contemplating pregnancy. Safety was the main reason for discontinuing IBD therapy during pregnancy. Contrary to the recommendations in clinical practice guidelines, many GIs avoid starting oral or rectal budesonide, anti-TNF, vedolizumab or ustekinumab during a disease flare. Further, a third of GIs would start thiopurines for a flare during pregnancy. Moreover, 13% will never perform a colonoscopy in a pregnant patient to guide decision making. Half of GIs implemented a dedicated outpatient follow-up program for pregnant patients in remission, with 87% enrolling all pregnant patients in this program. Concerning breastfeeding, 14% believed that all drugs can be used while breastfeeding. Regarding offspring’s vaccination, about 20% recommend against the administration of non-live vaccines and only 50% recommended avoiding live vaccines during the first 12 months for children exposed to anti-TNF in-utero. Among those GIs who recommended delaying vaccines in such cases, only 41% recommended testing the infant for detectable anti-TNF levels if live vaccines were required. Among the surveyed GIs, only a minority had a referral obstetrician, and only 35% referred patients with active or complicated IBD, while 45% had a referral paediatrician with expertise in IBD. Conclusion The management of IBD during pregnancy, lactation, and neonatal period is notably suboptimal, even among GIs specifically dedicated to IBD. It is crucial to address this current need and implement urgent educational measures in this area.

PROFILE OF INFLAMMATORY BOWEL DISEASE NURSES IN BRAZIL.

•An identification of the profile of inflammatory bowel disease nurses in Brazil was peformed, and only four nurses worked exclusively with patients with inflammatory bowel disease. •The main areas of activity were outpatient clinics and ostomy care. •Nursing care was based on the nursing process, and the main topics approached in these appointments were treatment adherence and ostomy. •Nurses showed knowledge on immunosuppressive medications and biological therapy. Background - Nurses play a fundamental role within the inflammatory bowel disease (IBD) multidisciplinary team. Objective - To identify the profile of IBD nurses in Brazil and their work process organization and characterize the health services where they work. Methods - A questionnaire-based research was developed. The inclusion criteria were nurses with experience in IBD care, nurses with scientific research published in an indexed journal or in process, nurses with master's or doctorate degrees concluded or in progress, and educator nurses with expertise in IBD.Results - Seventy-four nurses were included, among whom 66 (89.19%) were women; their mean age was 40.63±9.98 years. Sixty-six percent work in the Southeast region, and more than half (54.05%) had a specialization course. Only four (5.41%) nurses worked exclusively with patients with IBD. The main areas of activity were outpatient clinics (39%) and ostomy care (35%). Nursing care was based on the nursing process (51.35%), and the main topics approached in nursing appointment were treatment adherence (72.97%), and ostomy (68.92%). Forty-seven (63.51%) nurses had knowledge on immunosuppressive medications and 52 (70.27%) on biological therapy. Most health services were integrated with a hospital that has clinical (72.97%) and surgical hospitalization units (67.57%), and 46 (62.16%) of them had an infusion center. Conclusion - Describing the work process of IBD nurses can supplement their organization of the IBD assistance process, as they do not follow any specific consensus. In addition, the characteristics necessary for IBD care are not found in all health services.

Inflammatory Bowel Disease in Children.

Inflammatory bowel disease is an important cause of chronic diarrhea in children, with a rising incidence, globally. The two main subtypes include Crohn's disease and ulcerative colitis. The clinical features are variable, and diagnosis requires initial first-line investigations followed by the involvement of specialist input for targeted imaging and endoscopy with biopsy, to confirm the diagnosis. Despite detailed investigation, inflammatory bowel disease may be clinically indistinguishable from chronic infections such as intestinal tuberculosis, and anti-tuberculosis treatment may be considered prior to further management considerations. The medical management of inflammatory bowel disease depends on subtype classification and severity, and may involve a step-wise approach to immunosuppressive therapies. In children, the consequences of poorly controlled disease are wide ranging, from psychosocial impacts and school non-attendance, to growth impairment and pubertal delay with subsequent impacts on bone health. In addition, an increased need for hospitalization and surgical intervention, and ultimately risk of cancer long-term. A multi-disciplinary team with expertise in inflammatory bowel disease is recommended to mitigate these risks and help to achieve the goal of sustained remission with endoscopic healing. This review focuses on updates on best clinical practice on the diagnosis and management of inflammatory bowel disease in children.

Quantitative Phase Imaging Using Digital Holographic Microscopy to Assess the Degree of Intestinal Inflammation in Patients with Ulcerative Colitis.

Ulcerative colitis (UC) is characterized by chronic inflammation of the colorectum. Histological remission has emerged as a potential future treatment goal; however, the histopathological assessment of intestinal inflammation in UC remains challenging with a multitude of available scoring systems and the need for a pathologist with expertise in inflammatory bowel disease (IBD). In previous studies, quantitative phase imaging (QPI) including digital holographic microscopy (DHM) was successfully applied as an objective method for stain-free quantification of the degree of inflammation in tissue sections. Here, we evaluated the application of DHM for the quantitative assessment of histopathological inflammation in patients with UC. In our study, endoscopically obtained colonic and rectal mucosal biopsy samples from 21 patients with UC were analyzed by capturing DHM-based QPI images that were subsequently evaluated using the subepithelial refractive index (RI). The retrieved RI data were correlated with established histological scoring systems including the Nancy index (NI) as well as with endoscopic and clinical findings. As a primary endpoint, we found a significant correlation between the DHM-based retrieved RI and the NI (R2 = 0.251, p < 0.001). Furthermore, RI values correlated with the Mayo endoscopic subscore (MES; R2 = 0.176, p < 0.001). An area under the receiver operating characteristics (ROC) curve of 0.820 confirms the subepithelial RI as a reliable parameter to distinguish biopsies with histologically active UC from biopsies without evidence of active disease as determined by conventional histopathological examination. An RI higher than 1.3488 was found to be the most sensitive and specific cut-off value to identify histologically active UC (sensitivity of 84% and specificity of 72%). In conclusion, our data demonstrate DHM to be a reliable tool for the quantitative assessment of mucosal inflammation in patients with UC.

Review article: Risk of cardiovascular events in patients with inflammatory bowel disease receiving small molecule drugs.

In the context of an ageing inflammatory bowel disease (IBD) population, cardiovascular comorbidities become particularly relevant. Novel small molecule drugs (SMDs) for the treatment of moderate-to-severe IBD have been recently approved, including Janus kinase (JAK) inhibitors and sphingosine-1-phosphate receptor (S1P) modulators. Data from rheumatoid arthritis population have raised concerns about the risk of cardiovascular events with the use of tofacitinib, which was extrapolated to other immune-mediated diseases and other JAK inhibitors. S1P receptor modulation has been associated with potential cardiovascular events, especially bradycardia and cardiac conduction abnormalities. To review the incidence of cardiovascular events with the use of SMDs in patients with IBD and to provide practical recommendations on mitigation strategies. Published literature was reviewed; recommendations were synthesised by experts in both cardiovascular diseases and IBD. Evidence from the IBD population does not indicate a higher risk of cardiovascular events with tofacitinib and other JAK inhibitors. The risk is higher in patients with intermediate to high cardiovascular risk. S1P modulators may be associated with a dose-dependent, first-dose effect, transient risk of conduction abnormalities (bradycardia and AV block). Screening and monitoring of cardiovascular risk factors should be done in all patients with IBD. Risk stratification for cardiovascular disease should be performed before starting treatment with SMDs. Available evidence of both JAK inhibitors and S1P modulators indicates a reassuring safety profile of SMDs from the cardiovascular perspective in the overall IBD population. Efforts should be made to identify patients with IBD at a higher risk of cardiovascular events.

BRAZILIAN CONSENSUS ON THE MANAGEMENT OF INFLAMMATORY BOWEL DISEASES IN PEDIATRIC PATIENTS: A CONSENSUS OF THE BRAZILIAN ORGANIZATION FOR CROHN’S DISEASE AND COLITIS (GEDIIB)

Approximately 25% of patients with inflammatory bowel disease (IBD) develop the disease during childhood or adolescence and treatment aims to control active symptoms and prevent long-term complications. The management of Crohn's disease (CD) and ulcerative colitis (UC) can be especially challenging in children and adolescents, related to particularities that may affect growth, development, and puberty. This consensus aims to provide guidance on the most effective medical and surgical management of pediatric patients with CD or UC. Experts in Pediatric IBD representing Brazilian gastroenterologists (Brazilian Organization for Crohn's Disease and Colitis [GEDIIB]) developed this consensus. A rapid review was performed to support the recommendations/statements. Medical and surgical recommendations were structured and mapped according to the disease type, disease activity, and indications and contraindications for medical and surgical treatment. After structuring the statements, the modified Delphi Panel methodology was used to conduct the voting. The process took place in three rounds: two using a personalized and anonymous online voting platform and one face-to-face. Whenever participants did not agree with a specific recommendation, an option to explain why was offered to enable free-text responses and provide the opportunity for the experts to elaborate or explain disagreement. The consensus of recommendations in each round was accepted when reached ≥80% agreement. The recommendations are presented according to the stage of treatment and severity of the disease in three domains: management and treatment (drug and surgical interventions), criteria for evaluating the effectiveness of medical treatment, and follow-up/ patient monitoring after initial treatment, follow-up/ patient monitoring after initial treatment. Surgical recommendations were grouped according to disease type and recommended surgery. The target audience for this consensus was general practitioners, gastroenterologists, and surgeons interested in the treatment and management of pediatric CD and UC. Additionally, the consensus aimed to support the decision-making of health insurance companies, regulatory agencies, and health institutional leaders and/or administrators.

Reimagining Gastroenterology Fellowship Training: The Third Year of the Future

Reimagining Gastroenterology Fellowship Training: The Third Year of the Future

P278 Endoscopic scoring system utilization for Inflammatory Bowel Disease activity assessment: a multicenter real-world evidence study from Argentina (DARE study)

Abstract Background The use of scores for the assessment of endoscopic activity in inflammatory bowel disease (IBD) patients is crucial for accurate and reproducible evaluation of mucosal healing, which is a relevant marker of prognosis. Frequency and patterns of their use in a real-life setting are not known. We aimed to describe the prevalence of adequate use of endoscopic scores in IBD patients who underwent colonoscopy in a real-life setting. Methods A multicenter observational study comprising six community hospitals in Argentina was undertaken. Patients with a diagnosis of Crohn’s disease or ulcerative colitis who underwent colonoscopy for endoscopic activity assessment between July 2018 and July 2022 were included. Colonoscopy reports of included subjects were manually reviewed to determine the proportion of colonoscopies that included an endoscopic score report. We compared the endoscopic findings to determine if there were differences in the score reported and the inflammatory activity described. Finally, we determined the proportion of colonoscopy reports that included all of the IBD colonoscopy report quality elements proposed by BRIDGe group. Endoscopist’s specialty, years of experience as well as expertise in IBD were assessed. Chi square test was used for the comparison of categorical variables; Student t test for the comparison of numerical variables. A multivariate analysis was performed using a logistic regression model. A p value of less than 0.05 was considered to be statistically significant. Results A total of 1206 patients were included for analysis (32.25% patients with Crohn’s disease). Mean age was 45.48±15.6. Endoscopic score reporting was found in only 34.45% of Crohn’s disease colonoscopies and in 52.87% of ulcerative colitis colonoscopies. Most frequently used scores were Mayo endoscopic score (90.56%) and SES-CD (56.03%). We found discrepancies between the score reported and the findings described in colonoscopies in 10.92% of cases; only 26% of reports included all recommendations proposed by BRIDGe group. On multivariate analysis, surgeons as operators [OR 0.08 (0.03-0.18)], &amp;gt;15 years of endoscopist experience [OR 0.24 (0.07-0.37)], IBD expertise [OR 2.86 (1.86-4.41)] and compliance of quality elements of reporting [OR 2.48 (1.24-3.76)] were significantly associated with endoscopic score reporting. Conclusion We identified a low prevalence of endoscopic activity score reporting in IBD patients’ colonoscopies. This finding is associated with operator-dependent characteristics. Educational interventions can be introduced to increase adequate score reporting.

P788 Endoscopic management of patients with high-risk colorectal colitis-associated neoplasia: a Delphi study

Abstract Background Current guidelines recommend endoscopic resection of visible and endoscopically resectable colorectal colitis-associated neoplasia (CAN) in patients with inflammatory bowel disease (IBD). However, patients with high risk CAN are often not amenable to conventional resections techniques and a consensus approach for the endoscopic management of these lesions is presently lacking. This Delphi study aims to reach consensus amongst experts on the endoscopic management of these lesions. Methods A three-round modified Delphi process was conducted to reach consensus amongst worldwide IBD and/or endoscopy experts (n=18) from three continents. Experts were chosen based on the extensive clinical experience with IBD and/or EMR/ESD in patients with IBD, and the authorship on multiple peer-reviewed publications on CAN, the endoscopic resection of CAN and/or EMR/ESD. Consensus was considered if ≥ 75% agreed or disagreed. Quality of evidence was assessed by the criteria of the Cochrane Collaboration group. Results Consensus was reached on all statements (n=14). Experts agreed on a definition for CAN and high-risk CAN (HR-CAN). Consensus was reached on the examination of the colon with enhanced endoscopic imaging prior to resection, the endoscopic resectability of a HR-CAN lesion and endoscopic assessment and standard report of CAN lesions. In addition, experts agreed on type of resections of HR-CAN (&amp;lt; 20mm, &amp;gt;20 mm, with or without good lifting), endoscopic success (technical success and outcomes), histologic assessment and follow-up in HR-CAN. Conclusion This is the first step in developing international consensus-based recommendations for endoscopic management of (HR-)CAN. Although the quality of available evidence was considered low, consensus was reached on several aspects of the management of (HR-)CAN. The present work and proposed standardization might benefit future studies.

Endoscopic management of patients with high-risk colorectal colitis–associated neoplasia: a Delphi study

Current guidelines recommend endoscopic resection of visible and endoscopically resectable colorectal colitis-associated neoplasia (CAN) in patients with inflammatory bowel disease (IBD). However, patients with high risk CAN are often not amenable to conventional resections techniques and a consensus approach for the endoscopic management of these lesions is presently lacking. This Delphi study aims to reach consensus amongst experts on the endoscopic management of these lesions. A three-round modified Delphi process was conducted to reach consensus amongst worldwide IBD and/or endoscopy experts (n=18) from three continents. Consensus was considered if ≥ 75% agreed or disagreed. Quality of evidence was assessed by the criteria of the Cochrane Collaboration group. Consensus was reached on all statements (n=14). Experts agreed on a definition for CAN and high-risk CAN (HR-CAN). Consensus was reached on the examination of the colon with enhanced endoscopic imaging prior to resection, the endoscopic resectability of a HR-CAN lesion and endoscopic assessment and standard report of CAN lesions. In addition, experts agreed on type of resections of HR-CAN (< 20mm, >20 mm, with or without good lifting), endoscopic success (technical success and outcomes), histologic assessment and follow-up in HR-CAN. This is the first step in developing international consensus-based recommendations for endoscopic management of (HR-)CAN. Although the quality of available evidence was considered low, consensus was reached on several aspects of the management of (HR-)CAN. The present work and proposed standardization might benefit future studies.

Multi-utility of therapeutic drug monitoring in inflammatory bowel diseases.

Inflammatory bowel disease (IBD) treatment targets have progressed over time from clinical response to clinical and endoscopic remission. Several data have shown a positive correlation between serum biologic drug concentrations and favorable therapeutic outcomes. Therapeutic drug monitoring (TDM) has evolved as an important approach for optimizing the use of immunobiologics, especially antitumor necrosis factor therapy, in patients with IBD. The use of TDM is supported by medical societies and IBD experts in different contexts; however, challenges remain due to knowledge gaps that limit the widespread use of it. The aim of this review is to assess the role of TDM in IBD, focusing on the implementation of this strategy in different scenarios and demonstrating the multi-utility aspects of this approach in clinical practice.

P108 Identifying Patient-Centered Future Research Priorities: A Report from the Patient Reported Outcomes after Pouch Surgery (PROPS) Delphi Consensus Study

Abstract Background The Patient Reported Outcomes after Pouch Surgery (PROPS) Delphi Consensus Study recently described Ileoanal Pouch Syndome – the constellation of functional outcomes that should be the focus of future research. Importantly, several additional items not related to bowel function were identified by patients as critical to their quality of life. The aim of this abstract is to highlight these additional items. Methods Three panels of expert stakeholders were chosen to correlate with the clinical scenario of the multidisciplinary team that cares for pouch patients: (A) patients, (B) colorectal surgeons, (C) gastroenterologists/other clinicians. IPAA patients were recruited by advertisements on the social media pages of a national patient advocacy groups. Clinicians were recruited by a 14 member scientific committee with the aim of selecting experts in inflammatory bowel disease and IPAAs. A starting list of items was generated by systematic literature review. Three rounds of Delphi surveys were employed to select high priority items based on an a priori threshold. Participants had the opportunity to suggest additional symptoms not included in the starting list. A final online consensus meeting with representation from all three expert panels was held to finalize a consensus statement. Results After three rounds of voting, 195 patients, 62 colorectal surgeons, and 48 gastroenterologists/other specialists completed all three rounds. In the patient group, 95% had UC and J-pouch anatomy. In the early Delphi rounds, approximately 74% of patients identified impact on sexual function/intimacy as a high priority outcomes, while 70% of patients identified impact on ability to conceive as a high priority. Similarly, 78% of patients believed that risk of pouchitis was a high priority, compared to 47% of surgeons and 66% of gastroenterologists. Furthermore, patients participating in the subsequent online focus groups and final consensus meeting felt strongly that future research on delivery of care, long term follow up, and proper consent before surgery (including accurate counseling on function and perception of being “cured”) were critical areas for future research. Conclusion PROPS was the first study to identify key functional outcomes after pouch surgery with direct input from a large panel of IPAA patients. The inclusion of patients in all stages of the consensus process allowed for a true patient-centered approach in defining the core domains that should be focused on in future studies of pouch function. In addition to the identification of key bowel function outcomes, the study highlighted additional patient-centered core outcomes that clinicians should focus future research efforts on.

A Comprehensive Literature Review and Expert Consensus Statement on Therapeutic Drug Monitoring of Biologics in Inflammatory Bowel Disease.

Therapeutic drug monitoring (TDM) of biologics is a rapidly evolving field. We aimed to provide a consensus statement regarding the clinical utility of TDM for biologics in inflammatory bowel disease (IBD). A modified Delphi method was applied to develop consensus statements. A comprehensive literature review was performed regarding TDM of biologic therapies in IBD, and 45 statements were subsequently formulated on the potential application of TDM in IBD. The statements, along with literature, were then presented to a panel of 10 gastroenterologists with expertise in IBD and TDM who anonymously rated them on a scale of 1-10 (1 = strongly disagree and 10 = strongly agree). An expert consensus development meeting was held virtually to review, discuss, refine, and reformulate statements that did not meet criteria for agreement or that were ambiguous. During the meeting, additional statements were proposed. Panelists then confidentially revoted, and statements rated ≥7 by 80% or more of the participants were accepted. During the virtual meeting, 8 statements were reworded, 7 new statements were proposed, and 19 statements were rerated. Consensus was finally reached in 48/49 statements. The panel agreed that reactive TDM should be used for all biologics for both primary nonresponse and secondary loss of response. It was recommended that treatment discontinuation should not be considered for infliximab or adalimumab until a drug concentration of at least 10-15 μg/mL was achieved. Consensus was also achieved regarding the utility of proactive TDM for anti-tumor necrosis factor therapy. It was recommended to perform proactive TDM after induction and at least once during maintenance. Consensus was achieved in most cases regarding the utility of TDM of biologics in IBD, specifically for reactive and proactive TDM of anti-tumor necrosis factors.

Multi-expert annotation of Crohn's disease images of the small bowel for automatic detection using a convolutional recurrent attention neural network.

Background and study aims Computer-aided diagnostic tools using deep neural networks are efficient for detection of lesions in endoscopy but require a huge number of images. The impact of the quality of annotation has not been tested yet. Here we describe a multi-expert annotated dataset of images extracted from capsules from Crohn’s disease patients and the impact of the quality of annotations on the accuracy of a recurrent attention neural network. Methods Images of capsule were annotated by a reader first and then reviewed by three experts in inflammatory bowel disease. Concordance analysis between experts was evaluated by Fleiss’ kappa and all the discordant images were, again, read by all the endoscopists to obtain a consensus annotation. A recurrent attention neural network developed for the study was tested before and after the consensus annotation. Available neural networks (ResNet and VGGNet) were also tested under the same conditions. Results The final dataset included 3498 images with 2124 non-pathological (60.7 %), 1360 pathological (38.9 %), and 14 (0.4 %) inconclusive. Agreement of the experts was good for distinguishing pathological and non-pathological images with a kappa of 0.79 ( P < 0.0001). The accuracy of our classifier and the available neural networks increased after the consensus annotation with a precision of 93.7 %, sensitivity of 93 %, and specificity of 95 %. Conclusions The accuracy of the neural network increased with improved annotations, suggesting that the number of images needed for the development of these systems could be diminished using a well-designed dataset.

P244 Clinician preferences in treating steroid resistant ulcerative colitis: a discrete-choice experiment (DCE) survey

Abstract 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.