bluuebunny/crossref_metadata_2025_split huggingface dataset:
P0364 Establishment and validation of a central reader pool for magnetic resonance enterography (MRE) for use in Crohn’s disease clinical trials
Authors: Pillay L , Paverd H , Noor N , Hickman K , De Paepe K , Godfrey E M , Khwaja S , Upponi S , Kennedy N A , Parkes M , Raine T 
Published: January 2025

Abstract

Background
Clinical trials in Crohn’s disease (CD) currently rely on ileocolonoscopy to assess disease activity and monitor treatment response. There is growing interest in utilising non-invasive tests for this purpose. Magnetic resonance enterography (MRE) is non-invasive, more tolerable for patients, and allows assessment of all bowel layers and surrounding tissues. Validated systems for scoring CD severity on MRE enable standardised reporting and include Magnetic Resonance Index of Activity (MaRIA), a simplified version (MaRIAs) and the Lemann Index (LI). However, to be utilized in clinical trials, inter-reader reliability needs to be established. Here, we report the use of a standardised protocol to create a central reader pool for MRE scoring in CD and report its validation by application to the PROFILE1 clinical trial cohort.

Methods
Five accredited gastrointestinal radiologists blindly reported a total of 18 scans across 2 rounds of reading, with a consensus meeting between the rounds (Table 1). Each scan was scored using MaRIAs, MaRIAs-E (modified MaRIAs which includes small bowel segments), and LI. Intraclass correlation coefficient (ICC) was calculated to assess inter-reader reliability. To validate this reliability assessment in a clinical trial cohort, 71 scans from the PROFILE trial were double-read and ICC calculated.

Results
The central reader pool showed good inter-reader reliability after two rounds of training (ICC&gt;0.70, with 95%CI lower bound&gt;0.5). This high level of reliability was maintained in the trial validation (Figure 1).

Conclusion
Using this protocol we have successfully validated a central reader pool dedicated to severity scoring of CD that can be utilised in clinical trial setting. The ICC metrics in training rounds reflect good agreement between readers, suggesting that any single reader chosen from the pool would return a similar result to any other reader. The similarly high ICC calculated from the trial validation set suggests that the protocol used for establishing the central reader pool was robust, and high reliability of readers persisted during the PROFILE trial. Importantly, this methodology is transferable to other modalities where expert readers are asked to score images against validated scoring systems.

References
Nurulamin M. Noor et al., “A Biomarker-Stratified Comparison of Top-down versus Accelerated Step-up Treatment Strategies for Patients with Newly Diagnosed Crohn’s Disease (PROFILE): A Multicentre, Open-Label Randomised Controlled Trial,” The Lancet Gastroenterology & Hepatology 9, no. 5 (May 1, 2024): 415–27
P0365 The evolution of Geldof fistula class in patients with Crohn’s disease perianal fistula
Authors: Ibrahim F A E , Sebastian S 
Published: January 2025

Abstract

Background
Progressing the evaluation and management of Perianal fistulizing Crohn’s disease ( CD-pAF ) , an aggressive phenotype of CD , is one of the key unmet needs in Inflammatory Bowel Disease (IBD). There is sub-optimal understanding of the behavior of CD-pAF with some patients having rapid velocity of disease progression needing radical surgery such as proctectomy or diverting stoma. More recently, a practical patient-centric classification has been developed recently by Geldof et al has been used to classify patients underpinned by the behavior of CD-pAF(1). We aimed to evaluate the fistula class trajectory using Geldof classification in a large cohort of CD-pAF patients.

Methods
Data for 997 patients with Crohn’s disease perianal fistula (CD-pAF) included in a cohort study of patients with existing diagnosis of CD-pAF. Data was entered to predefined time points starting at the date of diagnosis of Cd-pAF and onward until entry into the cohort. We analysed the change in fistula classification using Geldof classification over 2 years.

Results
Data at entry to the cohort of 997 ( Males 52% , Females 48%) patients were included in the analysis The median age at fistula diagnosis was 31 years (23, 42). Among the 997 patients 686 had their Geldof class identified at baseline and 665 at 6-12 months. Class 2a followed by class 1 were the most frequent classes reported (Class 2a at baseline 376/686(55%) and Class 1 167/686(24%), at 6-12 months class 2a were 286/665(43%) and class 1 were 252/665(38%). At 12-24 months from fistula diagnosis 599 patients’ classes were reported, the most frequent being class 1 279/599(47%). There were minimal variations in Class 2b and class 2ci over the 3 time periods. (Class 2b [112/686(16%], [92/665(14%)]and [82/549(15%)] respectively, class 2ci [21/686(3%)], [20/665(3%)] [14/549(3%)] respectively). 15/686(2.1%) had proctectomy in the first 2 years.

Conclusion
While there are dynamic changes in fistula classification over 2 year period from fistula diagnosis there seems to be clustering among some classes. This indicates potential opportunity for identifying distinct classes which may have refractory course and tailor therapies accordingly.

References
(1)Geldof J, Iqbal N, LeBlanc JF, et al. Classifying perianal fistulising Crohn’s disease: an expert consensus to guide decision-making in daily practice and clinical trials. Lancet Gastroenterol Hepatol. 2022;7(6):576-584. doi:10.1016/S2468-1253(22)00007-3
P0369 The use of exhaled volatile organic compounds for the non-invasive assessment of endoscopic inflammation in patients with ileal pouch anal anastomosis (IPAA)
Authors: Qazi T , Cohen B , Ma J , Yang Q , Grove D , Regueiro M , Dweik R , Rieder F 
Published: January 2025

Abstract

Background
The incidence of inflammatory conditions in patients with ileal pouch-anal anastomosis (IPAA) constructed for the treatment of refractory ulcerative colitis (UC) and its complications is increasing. Objective assessment of IPAA inflammation is limited to surrogate markers in blood and stool which lack sensitivity and specificity or invasive endoscopic evaluations. Measurement of exhaled breath volatile organic compounds (VOCs) in breath shows promise for the assessment of inflammation. Our study aims to evaluate the pattern of VOCs in the exhaled breath of patients with IPAA and assess whether exhaled breath analysis can effectively distinguish patients with endoscopically active IPAA inflammation from patients without IPAA inflammation.

Methods
We conducted a cross-sectional study of patients with IPAA created for the management of UC. Exhaled breath samples were obtained from patients presenting for endoscopic pouch evaluation. Samples were analyzed using selective ion flow tube mass spectrometry (SIFT-MS) to measure constituent VOCs. Patients were dichotomized into subjects with significant endoscopic pouch inflammation, endoscopic pouch disease activity index greater than or equal to 4 (ePDAI ≥ 4) or patients with minimal pouch inflammation (ePDAI ≤ 1) . Similar analyses were performed in subjects with a ePDAI greater than or equal to 5. Principle component analysis (PCA) was conducted to reveal the most important VOCs that differentiate two cohorts. Principle component regression (PCR) was performed to assess the prediction performance of exhaled breath VOC analysis in differentiating the groups.

Results
In the final analysis, 70 subjects presenting for pouch endoscopic evaluation were included in the study. 29 subjects had an ePDAI less than or equal to 1 and 41 subjects had and ePDAI greater than or equal to 4. Demographics are provided in table 1. Key VOCs—ethane, octanoic acid, and propylcyclohexane—were found to differ significantly between the two groups. Figure 1 shows the receiver operating curve (ROC) of the PCR model for the full mass scan, showing an area under the curve (AUC) of 0.77 (0.66-0.88). A similar analysis in patients with PDAI of greater than equal to 5, demonstrated and AUC of 0.83 (0.72-0.94).

Conclusion
Exhaled breath VOC analysis effectively differentiates between patients with significant pouch inflammation and those with minimal inflammation. This non-invasive method shows promise as a reliable tool for assessing ileal pouch inflammation, with high patient acceptance. Further research is warranted to validate these findings and explore the potential of VOC analysis in clinical practice.
P0370 Transmural healing in Ulcerative Colitis patients improves long-term outcomes compared to endoscopic healing alone
Authors: Lim C T , Teichert C , Pruijt M , de Voogd F , D’Haens G , Gecse K 
Published: January 2025

Abstract

Background
Endoscopic healing (EH) is recognised as a long-term treatment goal for patients with ulcerative colitis (UC).1 We investigated whether transmural healing (TH) in UC as assessed by intestinal ultrasound (IUS) is associated with improved outcomes compared to EH alone.

Methods
We performed a retrospective study on patients with left-sided or extensive UC on stable maintenance treatment who had EH (Mayo Endoscopic Sub score [MES] ≤1) and an intestinal ultrasound (IUS) performed within six months of an endoscopy with no treatment alterations between IUS and endoscopy. Patients with ulcerative proctitis or on corticosteroids were excluded. TH was defined as bowel wall thickness (BWT) &lt; 3mm. The primary outcome was relapse-free survival in patients with and without TH. UC relapse was defined as at least two of the following: Simple Clinical Colitis Activity Index of ≥ 5 or physician’s global assessment of relapse; fecal calprotectin ≥ 250 ug/g; MES of ≥ 2 on any bowel segment; BWT of ≥ 3mm on any bowel segment (excluding the rectum).

Results
A total of 61 patients with a median follow up of 20 months were included (Table 1). The relapse risk for the first and second year was 7.5% and 20.5% for the TH group, respectively, compared to 29.4% and 64.3% for the non-TH group (p=0.004, Figure 1). The mean time to the first relapse, was 20.9 ± 11.1 months for the TH group and 12.2 ± 7.8 months for the non-TH group (p=0.042).
The risk of relapse for MES 0 at the first year was lower than MES 1 (3.7% compared to 20.8%), although this was not statistically significant (p=0.059). When stratifying for MES 1, TH showed improved relapse free survival for patients with MES 1 compare to those without TH (p=0.045, Figure 1). Moreover, there was a trend towards shorter time to relapse for patients with MES 1 without TH compared to those with TH (12.2 ± 7.8 months vs 18.4 ± 7.6 months)
In multivariate Cox regression, female gender (hazard ratio [HR], 2.63; 95% CI, 1.05-6.58; p=0.039), ≥ 2 previous advance therapies (HR, 4.06; 95% CI 1.08-15.28; p=0.038) and non-TH (HR, 3.99; 95% CI 1.31-12.20; p=0.015) were associated with a relapse whereas EH level (MES 0 vs MES 1) was not an associated factor (HR, 1.06; 95% CI 0.32-3.55; p=0.924).

Conclusion
In UC patients, transmural healing is associated with lower relapse risk compared to endoscopic healing alone. These findings implicate that intestinal ultrasound is a non-invasive, low-cost alternative to endoscopy for stratifying UC patients for risk of relapse.

References
1.Turner D, Ricciuto A, Lewis A, et al. STRIDE-II: An Update on the Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) Initiative of the International Organization for the Study of IBD (IOIBD): Determining Therapeutic Goals for Treat-to-Target strategies in IBD. Gastroenterology. 2021;160(5):1570-1583. doi:10.1053/j.gastro.2020.12.031
P0371 Building a Robust Artificial Intelligence Solution for Use in Ulcerative Colitis Clinical Trials
Authors: Byrne M , Requa J , Panés J , Bressler B , Panaccione R , Mendel R , East J E , Parsa N , Banerjee R , Kalapala R , Reddy D N , Rughwani H R , Flegg D , Moran G , Gallinger Z , Cheung V , Tan M , Ma C , Travis S P , Jairath V 
Published: January 2025

Abstract

Background
Artificial Intelligence (AI) is increasingly used to assess Ulcerative Colitis (UC) disease activity in clinical trials, with the goal of matching or exceeding expert performance in a reproducible manner. Certai has been created from previous AI work as a model that conforms to the new definitions within the Modified Mayo Endoscopic Score criteria.

Methods
Using the self-supervised DINOv2 method, Certai was pre-trained on 845 colonoscopic procedures and then refined with annotations from the proprietary Software for Intelligent Annotation (SIA) platform. This browser-based tool, with advanced playback controls and a UC scoring interface, enabled video annotation by eight global IBD specialists and central readers, and seven additional specialists in training on SIA. Labellers underwent rigorous onboarding to meet minimum thresholds for Intra-Class Correlation Coefficient (ICC) and Quadratic Weighted Kappa (QWK).
Certai’s architecture features two Vision Transformer models: a Quality Control (QC) model and a Scoring model. The QC model excludes frames with poor clarity, inadequate bowel prep, non-colonic views, chromoendoscopy, or biopsy procedures. The Scoring model uses multi-headed outputs to assess UC severity, grading vascular pattern, bleeding, ulcers/erosions, friability, and erythema.

Results
A total of 8.9 million frames from 39 videos were labelled across six categories, resulting in 2.17 million merged labels determined by majority vote. For inter-rater agreement on modified MES in the labelling process, the overall ICC among the onboarded labellers was 0.86, and the QWK was 0.88.
On a validation set of colonoscopy procedures, Certai achieved 100% agreement with human central readers on modified MES scores. The ICC among three expert labellers was 0.922 and rose to 0.942 with the addition of Certai. There was an additional increase of the ICC to 0.955 when Certai was paired with just one expert labeller. Similarly, QWK scores rose from 0.914 for two expert labellers to 0.961 with Certai and one expert labeller.

Conclusion
Certai represents an advance in UC disease activity assessment, meeting modified MES requirements. With further specialist labelling of an additional several hundred videos at the detailed frame level, a robust version of Certai will enable new quality standards in speed of central reading and consistency. Future applications may include stand-alone AI reads with human sign-off or a 2 + 1 reader model incorporating AI as one reader.
P0372 Fatigue in Swedish patients with Inflammatory bowel disease
Authors: Jäghult S , Pilhl Lesnovska K , Marsal J 
Published: January 2025

Abstract

Background
Fatigue is characterized as an overwhelming sense of tiredness, weakness, or exhaustion, which can be physical, psychological, or a combination of both. Fatigue is a common symptom and a significant concern for patients with IBD. International studies indicate that between 44% and 86% of patients with active disease, and 22% to 41% of those in remission, experience fatigue. This symptom can limit individual activities and negatively impact health-related quality of life. Despite its profound effects on patients, fatigue is often overlooked by healthcare professionals, who find it challenging to measure and manage. The aim of this study is to assess the prevalence of fatigue in Swedish IBD patients, both in active disease and in remission.

Methods
The study was conducted using a disease-specific questionnaire, the IBD-Fatigue Scale, which has been translated and validated into Swedish. The IBD-Fatigue Scale and questions concerning demographic data was distributed electronically to IBD patients in Stockholm and Linköping. The IBD Fatigue Scale consists of three sections. Section I assess frequency and severity of fatigue. Section II is rating experience and impact of fatigue, and section III is asking for patients’ comments and issues related to fatigue. This study will show the results of section I. A total of 2208 patients were asked to participate in the study.

Results
A total of 760 (34%) patients accepted to participate in the study and of 674 of those answered the questionnaire. The IBD-Fatigue Scale´s first section shows that fatigue is a burdensome symptom in IBD patients (figure 1). The scoring ranges between 0-20, where 0 means no fatigue and 20 means severe fatigue. The mean value showed 12,1 in the Swedish population. When comparing between sex, diagnosis and active vs remission, the patients who perceived most fatigue were woman and those with active disease (table 1).

Conclusion
This study shows that IBD-patients in Sweden suffer from fatigue to similar extent as in international studies. Those with highest perceived fatigue are women and those with active disease and those with continuous symptoms.No studies have examined the prevalence of fatigue among Swedish patients with IBD or its impact on their lives, and there is a pressing need to explore the extent of fatigue among this population and to understand their experiences and the effects of fatigue on their daily lives.
P0377 Development of Crohn’s Aid mobile application based on AI algorithms to make an early diagnosis of Crohns Disease in TB endemic regions
Authors: Mohta S , Kutum R , Pendyala R , Dev H , Kante B , Kumar Vuyyuru S , Kumar P , Virmani S , Kumar M , Bahl S , Makharia G , Chaudhury S , Kedia S , Sethi T , Ahuja V 
Published: January 2025

Abstract

Background
Intestinal tuberculosis (ITB) and Crohn’s disease (CD) mimic each other clinically, endoscopically, and radiologically and are difficult to differentiate. This is a major barrier to make an early diagnosis of CD in TB endemic areas. We aimed to develop a high accuracy machine learning-based model which could be easily implemented in an innovative way.

Methods
We retrospectively analyzed data from 1066 patients. After data cleaning, 796 patients (514 CD & 282 ITB) and data from 28 variables were included. A super learner approach using random forest and support vector machine was used for differentiating ITB from CD. Data was divided into 80 percent training and 20 percent testing data sets followed by 10-fold cross validation. The optimal cut-off for the diagnosis was obtained using the Youden index-measure to optimize the balance between sensitivity and specificity and the model was evaluated at multiple thresholds for clinical utility. The best performing model was incorporated into a mobile phone-based application. Prospective validation on 37 patients was carried out with similar accuracy.

Results
The random forest model achieved a sensitivity, specificity and accuracy of 0.92, 0.83, 0.86 respectively and performed better than the support vector machine model trained with linear and radial basis functions. The random forest model was found to have the best AUROC with a cutoff of 0.4, predicting the diagnosis of CD with a sensitivity of 93%, specificity of 83%, and accuracy of 86%, positive predictive value of 76%, and negative predictive value of 95%. The random forest model was used for creation of the application. The app is being made available on smartphones free of cost for use by any physician.

Conclusion
Our model differentiated between ITB and CD with high accuracy and has the potential to makean early diagnosis of CD. The free to use mobile application would make implementation of thisalgorithm much easier, allowing for widespread use in clinical practice and helping make moreinformed decisions. More data from multiple centers and different geographical locationswould aid in further improving the model performance.

Figure 1: Overall model training approach

Figure 2: Model performance and selection of appropriate cut-off
P0379 Characteristics of histologically confirmed upper gastrointestinal lesions in patients with Crohn’s disease in Korea
Authors: Na S Y , Ji J S , Choi H 
Published: January 2025

Abstract

Background
Crohn’s disease (CD) is a chronic, relapsing bowel disease that affects the entire gastrointestinal tract, from the mouth to the anus. Various lesions in the esophagus, stomach, and duodenum have been reported through upper gastrointestinal (UGI) endoscopy, and it is known that CD patients with UGI lesions have a poorer prognosis. This study aimed to investigate the characteristics of UGI lesions in CD patients in Korea.

Methods
This retrospective study enrolled CD patients diagnosed and followed up at Incheon St. Mary’s Hospital of The Catholic University of Korea from January 1991 to December 2020. We analyzed the characteristics of endoscopic findings and pathologic results of tissue biopsy of those who performed UGI endoscopy in patients with CD.

Results
Of a total of 282 CD patients, 157 underwent EGD, and endoscopic abnormalities were observed in 59 patients (37.6%) for whom biopsies were performed. The frequency of UGI lesions by age at diagnosis was 50% and 33.3% for A1 and A2+A3, respectively, showing no significant difference (p=0.06). The most common lesion was gastric bamboo-joint appearance (76.8%). In the esophagus and duodenum, ring-like appearances and longitudinal ulcers/erosions were mainly observed in 19.6% and 23.2% of patients, respectively. Gastric nodularity/cobblestoning and duodenal fistulas were each found in one patient (Fig). Biopsy results showed that focally enhanced gastritis was the most frequent finding (30.4%), followed by cryptitis or crypt abscess in the stomach (28.6%). In the esophagus and duodenum, lymphocytic esophagitis and microgranulomas were mainly observed in 10.7% and 19.6% of patients, respectively (Table). H. pylori infection was detected in only 5.4% of patients.

Conclusion
UGI lesions in CD are relatively common and are not affected by age at diagnosis. The bamboo-joint appearance was the most characteristic lesion in the UGI tract. Despite a significantly lower prevalence of H. pylori infection compared to the general population in Korea, many CD patients exhibited UGI lesions. Future studies are warranted to investigate clinical implications based on the distinctive features of UGI lesions.

References
1.So H, Ye BD, Park YS, et al. Gastric lesions in patients with Crohn’s disease in Korea: a multicenter study. Intest Res 2016;14:60-8.
2.Graca-Pakulska K, Błogowski W, Zawada I, et al. Endoscopic findings in the upper gastrointestinal tract in patients with Crohn’s disease are common, highly specific, and associated with chronic gastritis. Sci Rep 2023 13;13:703.
3.Greuter T, Piller A, Nicolas Fournier N, et al. Upper Gastrointestinal Tract Involvement in Crohn’s Disease: Frequency, Risk Factors, and Disease Course. J Crohns Colitis 2018;12:1399-1409.