bluuebunny/crossref_metadata_2025_split huggingface dataset:
P177 Lower vedolizumab trough levels before interval shortening are not predictive of success of the intervention
Authors: Ungar B , Malickova K , Hanžel J , Abu-Arisha M , Paul S , Rocha C , Ben-Shatach Z , Haj-Natour O , Yavzori M , Fudim E , Picard O , Eliakim R , Kopylov U , Lukas M , Drobne D , Chowers Y , Roblin X , Magro F , Ben-Horin S 
Published: January 2020

Abstract

Background
Pharmacokinetics of vedolizumab have been associated with therapy outcome, although real-life data has been contradictory. Thus, we set to examine whether vedolizumab levels before therapy intensification may be associated with clinical, inflammatory and endoscopic outcomes further on.

Methods
In this retrospective cohort study, vedolizumab drug levels were determined in vedolizumab-treated patients with insufficient therapy response from six medical centers in Israel and Europe, before they underwent dose-intensification. The success of dose-increase gauged by clinical scores, inflammatory (C-reactive protein values, calprotectin) indices and endoscopic data was assessed vis-à-vis pre-escalation drug levels.

Results
Overall, 161 IBD patients (74, 46% Crohn’s disease) were included, of whom 32 patients underwent intensification at end-of-induction (week 10) and 129 during maintenance period (weeks 14–44, median week 30). In total, 34%, 60% and 30% of the 161 patients reached clinical, inflammatory and endoscopic remission by 6 months after intensification, respectively.
Among 129 patients intensified during maintenance period, pre-intensification trough levels were not lower among those reaching clinical and inflammatory remission after dose-escalation (median vedolizumab levels 34.4 vs. 24.4 μg/ml, 30.7 vs. 30.5 μg/ml, p = 0.09, 0.25 respectively). Patients who reached mucosal healing also had higher, rather than lower, vedolizumab levels before intensification (median vedolizumab levels 31.3 vs. 17 μg/ml, p = 0.04 for patients with and without mucosal healing, respectively).
Similarly, among 32 patients intensified at week 6 by an extra-dose at week 10, those with higher, while not lower, levels before escalation had higher rates of post-escalation clinical remission (median levels 101 vs. 61.5 μg/ml, p = 0.05). A similar trend was observed in terms of mucosal healing (88.5 vs. 43 μg/ml, p = 0.09) and inflammatory remission (median levels 100 vs. 55 μg/ml p = 0.15).

Conclusion
Lower vedolizumab trough levels before interval shortening were not predictive of success of the intervention. These results argue against a pharmacokinetic basis for insufficient response to vedolizumab and question the need for dose-escalation. A higher pre-escalation drug-level was associated with better later outcomes, possibly indicating a lower inflammatory burden, and may serve to predict patients with low likelihood to respond to therapy continuation.
P179 The acceptability and utility of United Registries for Clinical Assessment and Research (UR-CARE) database to improve clinical care in a single centre setting
Authors: Fenech V A , Kamperidis N , Tyrrell T , Dyall L , Misra R , Barber S , Randall S , Arebi N 
Published: January 2020

Abstract

Background
The United Registries for Clinical Assessment and Research (UR-CARE) is a validated pan-European database developed by the European Crohn’s and Colitis Organisation (ECCO) to support clinical practice for patients with inflammatory bowel disease (IBD). ECCO has published guidelines to reduce variation in care. We examined the value of UR-CARE database to improve care in a cohort of newly-diagnosed IBD patients.

Methods
All patients with a new diagnosis of IBD within 6 months attended a New Diagnosis Clinic (NDC). Prior to registering patients, the purpose of UR-CARE database was explained. Patients who consented to have their clinical data added to the database signed a consent form. Mandatory fields and additional data that reflected quality of care were inputted. Descriptive statistics summarised the findings. The association between consent and disease activity or gender was examined using a chi-square test and for age using a two-sample t-test.

Results
Twenty-five out of 29 newly diagnosed patients consented for data inclusion in UR-CARE (13 males). Median age was 44 (range 18–77). Fourteen had ulcerative colitis (UC), 8 had Crohn’s disease (CD) and 3 had unclassified IBD. 8.3% reported extra-intestinal manifestations within 6 months of diagnosis. 17/25 patients had active disease. The patients that did not consent consisted of 2 males, 3/4 had active disease and mean age was 44.4 (SD 16.1) compared with 36.3 (SD 19.4) consenters.
Through the database we noted that not all mandatory diagnostic tests were requested at the time of hospital visit: 4/14 UC patients did not have a full colonoscopy and 3/8 CD patients lacked a small bowel imaging or capsule endoscopy. Only 4 out of 14 UC patients and 2 out of 8 CD patients were prescribed steroids within 6 months of their diagnosis. The 7 patients with missing investigations were identified and tests subsequently booked in line with guidelines. There was no association between consent and disease activity (p = 0.78), gender (p = 0.94) and age (p = 0.37).

Conclusion
In newly diagnosed IBD cohort, most patients consented to inclusion in UR-CARE database. There were no contributing factors associated with patient consent. The easily accessible visualisation of our data detected incomplete diagnostic tests and initiated actions to improve care early on in the disease course. UR-CARE offers potential to deliver high quality IBD care by aligning practice against ECCO guidelines. Attention to data-sharing legal and administrative barriers offers a promise for large scale studies and foster collaborative research networks.
P189 Use of transabdominal ultrasonography for the evaluation of Crohn’s disease activity
Authors: Yorulmaz E , Yigit B , Erturk M S , Erdem U , Yanc U , Yorulmaz H , Bilik Oyman G , Sezgin O 
Published: January 2020

Abstract

Background
Ileocolonoscopy is accepted as the gold standard method for the diagnosis of Crohn’s disease (CD). However, there are cases where it is inadequate due to being invasive, failure to allow endoscopic exploration of the small intestine, and failure to show the extraintestinal pathologies. In the present study, it is aimed to compare clinical, endoscopic scores and computerised tomography enterography (CTE) findings with transabdominal ultrasonography (TAUS) findings in order to evaluate the activity of CD.

Methods
The study included 79 patients diagnosed with CD. Crohn’s Disease Activity Index (CDAI) and Harvey Bradshaw Index (HBI) were used for the evaluation of the clinical activities of the patients. The patients with CDAI equal to 150 and more and HBI equal to 5 points and more were assessed as clinically active. Colonoscopic disease activity was assessed by The Simple Endoscopic Score for Crohn’ disease (SES-CD), SES-CD score of 3 and higher was defined as endoscopically active. In the evaluation of CTE and TAUS, the measurement of the thickness of the intestinal wall above 3 mm was accepted as pathological. Abscess, mass, fistula and ileus were evaluated as complications. Superior mesenteric artery (SMA) flow velocity was assessed by Color Doppler US. Limberg score was graded from Grades 0 to 4 for Doppler TAUS.

Results
Of the patients, 57 (72.1%) were male and 22 (27.8%) were female. Age average of the patients was 37.5 years (17–64) and the mean duration of disease was 48.6 months (0–240 months). Increase in the wall thickness in CTE and TAUS, detection of inflammation and complication in mesenteric fatty planes were found to be highly significant (p ˂ 0.0001). Wall thickness increase sensitivity level of TAUS according to CTE was 82%, specificity level was 97%, sensitivity level of the inflammation finding in mesenteric fatty planes was measured as 80%, and specificity level as 95%. A significant correlation was found between the wall thickness increase in CTE and TAUS and inflammation in mesenteric fatty planes via CDAI, HBI and SES-CD scoring (p ˂ 0.05). In addition, there was a significant relationship between the presence of lymphadenopathy in CTE in active patients according to HBI (p ˂ 0.05). According to the CDAI and SES-CD scores, Doppler flow velocity of SMA was significantly higher in the active group than the inactive group (p ˂ 0.05). CDAI, HBI and SES-CD results were found highly significant via the Limberg Scoring results (p &lt; 0.0001).

Conclusion
In the current study, it is shown that TAUS is a diagnostic tool as effective as CTE in the evaluation of CD activity. In addition, it is an important finding that the flow velocity of SMA increases as correlated with inflammation via the Doppler feature of TAUS.
P201 Evaluating access to inflammatory bowel disease care across Canada: Proceedings from the 2017 IBD Access Summit
Authors: MacDonald S , Heisler C G , Mathias H , Mirza R , Jones J 
Published: January 2020

Abstract

Background
Inflammatory bowel disease (IBD) is a chronic, immune-mediated disease, with Canada demonstrating the highest incidence and prevalence rates in the world. Patients with IBD often require lifelong treatment and, therefore, lifelong interactions with the healthcare system. Access to care can have a direct impact on patient health-related outcomes. Although acknowledged as a problem, the complexity of accessing IBD speciality care in Canada has not been reviewed. This lack of understanding presents a barrier in evaluating and implementing changes in IBD speciality care. The aim of the project was to identify key barriers and facilitators for and to develop a national working strategy to address limitations in access to IBD speciality care.

Methods
The IBD Summit was held in Toronto, Ontario in November 2017, sponsored by SPOR-CIHR catalyst funding and in partnership with Crohn’s and Colitis Canada. Perceptions and experiences of key stakeholders were gathered during two audio-recorded stakeholder dialogues held during the Summit. The audio recordings were transcribed and coded to compare and contrast between key stakeholders to determine potential differences in access to IBD care. Five final themes are highlighted in this report.

Results
A total of 21 key stakeholders attended, including paediatric and adult gastroenterologists, patients, researchers, and policymakers. Five key themes of importance relating to access to IBD care arose from The IBD Summit:(1) Integrated Models of Care, (2) IT Enhanced Care, (3) Health System Process, (4) Communication and Advocacy, and (5) Community Supports. The IBD Summit identified similar perceptions and experiences, highlighting common barriers and facilitators that transcend provincial borders. Shared perceptions included a need for common medical records and overall improved IT-enhanced care for managing IBD; improved centralised triage systems; increased comprehensive care support for patients and primary care physicians; and increased community supports for patients and providers.

Conclusion
Highlights from the IBD Summit present several clinically relevant and actionable suggestions for improved access to IBD speciality care across Canada. The suggestions provided by key stakeholders highlight the need for a system-level redesign in order to improve access to enhanced models of care. Improvements in access to IBD speciality care can only occur through partnerships between those working within the healthcare system and those within the community. Future research will involve pursuing deeper insight into the experience of patient and provider stakeholders as they navigate the healthcare system in order to access and provide care.
P207 Modelling 1-year surgery risk in Crohn’s disease: A retrospective cohort study
Authors: Yao J , Peng X , Jiang Y , Zhi M 
Published: January 2020

Abstract

Background
Accelerated therapeutic treatment should be considered in patients with progressive Crohn’s disease (CD) to prevent complications as well as surgery. Therefore, screening for risk factors and predicting the need for early surgery is of great importance in clinical practice. We aimed to establish a model to predict CD-related early surgery.

Methods
This was a retrospective study collecting data from CD patients diagnosed in our inflammatory bowel disease (IBD) centre from 1 January 2012 to 31 December 2016. All data were randomly stratified into a training set and a validation set at a ratio of 8:2. Multiple logistic regression analysis was conducted with receiver operating characteristic (ROC) curves constructed and areas under the curve (AUC) calculated. This model was further validated with a nomogram developed.

Results
A total of 1002 eligible patients were enrolled with a mean follow-up period of 53.54 ± 13.10 months. In total, 24.25% of patients received intestinal surgery within 1 year after diagnosis due to complications or disease relapse. Disease behaviour (B2: OR 6.693, p &lt; 0.001; B3: OR 14.405, p &lt; 0.001), smoking (OR 4.135, p &lt; 0.001), BMI (OR 0.873, p &lt; 0.001) and CRP (OR 1.022, p = 0.001) at diagnosis, previous perianal (OR 9.483, p &lt; 0.001) or intestinal surgery (OR 8.887, p &lt; 0.001), maximum bowel wall thickness (OR 1.965, p &lt; 0.001), use of biologics (OR 0.264, p &lt; 0.001), and exclusive enteral nutrition (OR 0.089, p &lt; 0.001) were identified as independent significant factors associated with early intestinal surgery. A prognostic model was established as follows: X1 = maximum BWT [mm]; X2 = smoking [0: no, 1: yes]; X3 = BMI at diagnosis [m/kg2]；X4 = previous perianal surgery [0: no, 1: yes]; X5 = previous intestinal surgery [0: no, 1: es]; X6 = disease type (stricturing or penetrating disease); X7 = use of biologics; X8 = use of EEN; X9 = CRP at diagnosis). ROC curve and calculated AUC (94.7%) confirmed an ideal predictive ability of this model with a sensitivity of 75.92% and specificity of 95.81%. Nomogram was developed to simplify the use of predictive model in clinical daily practice.

Conclusion
This prognostic model can effectively predict 1-year risk of CD-related intestinal surgery, which will assist in screening progressive CD patients and aid in tailoring therapeutic management.
P209 Prospective validation of faecal calprotectin as a predictor of steroid failure in patients with acute severe colitis
Authors: SAHU P , Kumar S , Jain S , Singh Mohil N , Sahni P , Pal S , Ranjan Das N , Nayak B , Sachdev V , Kumar Singh M , Kedia S , Makharia G , Ahuja V 
Published: January 2020

Abstract

Background
Optimal outcomes in acute severe colitis (ASC) are related to time-bound management based upon an early prediction of response to intravenous (IV) corticosteroids. We have demonstrated good diagnostic accuracy of day 3 faecal calprotectin (FCP) in this setting. The present study intended to validate these findings in a different cohort.

Methods
This prospective cohort study included IV steroid naïve (for this episode) patients with ASC, satisfying Truelove and Witts’ criteria, hospitalised from September 2018 to August 2019. Patients were subjected to baseline sigmoidoscopy, day 1 and day 3 faecal calprotectin, baseline hemogram and biochemistry, and day 3 CRP. All patients received IV steroids after hospitalisation, and the primary outcome measure was steroid-failure defined as colectomy and/or rescue therapy with ciclosporin or infliximab during admission.

Results
Of 47 patients with ASC, eight were excluded (four received steroids outside, 2-directly taken for surgery/infliximab therapy, 1-toxic megacolon on day 1, 1-infectious colitis), 39 were finally included [mean age−36.08 ± 12.58 years, male (30.7%)]. Fifteen patients (38.5%) failed IV steroids and required rescue therapy (10 infliximab, 2 cyclosporine, four surgery). On univariate analysis, the factors significantly different between steroid responders and steroid failure included UCEIS &gt;6 at baseline, Day 1 and Day 3 FCP, day 5 stool frequency, day 5 ESR and CRP, and oxford criteria (Figure 1). On multivariate analysis, only D3 FCP, UCEIS at baseline and Oxford criteria were significant predictors of steroid failure. Like the previous study, on ROC curve analysis, the day 3 FCP had similar diagnostic accuracy [AUC-0.86(0.75–0.98), and 1120.61 μg/g as a cut-off could predict steroid failure with 87% sensitivity and 79% specificity. Similarly, a combination of baseline UCEIS&gt;6 and day 3 FCP&gt;1120.61 μg/g had 100% specificity and positive predictive value for steroid failure.

Conclusion
FCP retained its value as an objective predictor of steroid failure in ASC.
P215 The effect of resection margin involvement of Crohn’s disease on the surgical and clinical recurrence after intestinal surgery
Authors: Seo J H , Lee J L 
Published: January 2020

Abstract

Background
Approximately 80% of patients with Crohn’s disease (CD) require major intestinal surgery during their lifetime and a quarter of patients will undergo repeat surgery within 5 years of the index surgery. For this reason, operative treatment of CD has been the bowel-sparing approach for several decades. This study evaluated the effects of the Crohn’s disease involvement of resection margin on clinical and surgical recurrence.

Methods
This retrospective study analysed 803 patient who underwent intestinal surgery for CD between January 2006 and December 2015. The CD involvement of resection margin was defined as microscopic involvement from the pathologic reports and grossly involvement from the operative records. Anastomosis recurrence was reviewed using the operative records and radiologic findings including colonoscopy, computed tomography and magnetic resonance imaging.

Results
In total, 41 patients (5.1%) had an active CD in the bowel resection margin – 31 patients (3.9%) with histologically, 10 patients (1.2%) with grossly. We had 221 (26.8%) reoperation cases, of which 87 (10.6%) patients were an anastomotic recurrence. When patients were stratified by surgical recurrence at anastomosis, the increased risk was not significant in resection margin positive grossly (odds ratio [OR], 3.65; 95% confidence interval [CI], 0.93–14.41) and in microscopic (OR, 1.26; 95% CI, 0.43–3.70) comparing with negative resection margin. Also, resection margin involvement was not related with clinical recurrence grossly (OR, 0.30; 95% confidence interval [CI], 0.07–1.26) and in microscopic (OR, 0.50; 95% CI, 0.21–1.17)

Conclusion
The current practice suggests the CD involvement of resection margin, even grossly or microscopic, do not influence surgical and clinical recurrence.
P218 Linked colour imaging predicts the risk of the clinical relapse in ulcerative colitis
Authors: Kanmura S , Komaki Y , Komaki F , Tanaka A , Sasaki F , Ido A 
Published: January 2020

Abstract

Background
Ulcerative colitis (UC) is a chronic inflammatory bowel disease with unknown aetiology. Recently, mucosal healing (MH) has emerged as an important therapeutic endpoint in UC. Linked colour imaging (LCI) is a novel endoscopic system that enhances the colour differences of the gastrointestinal mucosa. We aimed to evaluate the correlation between the endoscopic observation using LCI and the clinical relapse rate in UC patients.

Methods
We retrospectively analysed UC patients who underwent a total colonoscopy between August 2016 and May 2019 at our facility with Mayo endoscopic score (MES) of 0 or 1. We assessed the most relevant endoscopic findings, including erythema, vascular pattern, and friability using white-light imaging (WLI) and LCI observation. We analysed the correlation of clinical relapse rate, which means requiring additional treatment for UC, during the 2-year follow-up period with endoscopic assessment using WLI and LCI. We also evaluated the utility of LCI-observation method for predicting the prognosis in UC patients with clinical remission.

Results
Forty-seven patients were analysed, and clinical relapse was observed in 10 patients (21%) during the 2-year. Univariate analysis revealed a significant difference in decreased vascular pattern and friability between the clinical relapse and remission groups; multivariate analysis showed decreased vascular pattern observed on LCI as the only variable, which remained significantly associated with clinical relapse (p &lt;0.03). We defined LCI-mucosal score (MS) as LCI-MS 0, distinct vascular pattern and no friability; LCI-MS 1, either indistinct purple/magenta vascular pattern or friability; and LCI-MS 2, both indistinct purple/magenta vascular pattern or friability on LCI observation. The relapse rate in patients with LCI-MS 0 was 10% (3/30), which was significantly lower than in patients with LCI-MS 1 or 2 (36 %; 6/16).

Conclusion
LCI findings have the diagnostic implications in predicting the risk of clinical relapse in UC during the 2-year follow-up period.
P219 Disease-specific avoidance is a predictor for fatigue in inflammatory bowel disease patients
Authors: Fierens L , Van de Pavert I , Walentynowicz M , Coenen S , Geens P , Weyts E , Van Oudenhove L , Vlaeyen J , von Leupoldt A , Van Assche G , Vermeire S , Ferrante M , Van Diest I 
Published: January 2020

Abstract

Background
A substantial group of patients with inflammatory bowel disease (IBD) experience fatigue, even while in clinical remission. At present, disease-specific behaviours that maintain or worsen symptom burden including fatigue have not been explored. We developed a questionnaire evaluating IBD-specific avoidance behaviour and investigated how this relates to self-reported fatigue.

Methods
This study was a close collaboration between the psychology and gastroenterology department of our tertiary referral centre. A 72-item IBD-specific avoidance behaviour questionnaire (IBD-B) was generated based on literature review and input from clinicians and a patient focus group (n = 10). Between July 2018 and March 2019, 500 consecutive IBD patients were included at our infusion unit (wave 1) (participation rate 79%, 48% male, 66% Crohn’s disease (CD), median age 40). Patients completed the 72-item IBD-B, a demographic questionnaire, patient-reported outcome assessing disease activity (PRO2) and a Visual Analogue Scale (VAS) for fatigue. Test–retest reliability was assessed in 89 patients (54% male, 70% CD, median age of 40) who completed the IBD-B, PRO2 and VAS fatigue scale a second time after 4–12 weeks (wave 2). Clinical remission was defined as an abdominal pain score ≤1 and a liquid to very soft stool frequency ≤1.5 in CD patients and as no rectal bleeding and a stool frequency ≤1 in patients with ulcerative colitis (UC). A principal component analysis (PCA) was then used to reduce the number of items and investigate the underlying factor structure of the IBD-B. The predictive value of IBD-specific behaviours for fatigue was finally investigated both cross-sectionally and prospectively.

Results
At wave 1, 46% and 69% of CD and UC patients, respectively, were in clinical remission. PCA suggested a reduction of the 72-item to a final 25-item IBD-B and a seven-factor solution for use in clinical practice (loading factors &gt;0.5, Table 1). The final 25-item IBD-B showed good psychometric properties. The median (IQR) total IBD-B and fatigue scores were, respectively, 29 (40-20) and 52 (77-25) for patients in clinical remission compared with 38 (48-28) and 74 (87-50) for patients not in clinical remission (both p &lt; 0.01). Both cross-sectional and prospective significant correlations between IBD-B factors and fatigue were demonstrated (Table 2).

Conclusion
The IBD-B is a valuable tool to accurately measure IBD-specific avoidance behaviour in IBD patients. IBD patients without clinical remission report higher IBD-B values and show a higher correlation between avoidance behaviour and fatigue. Further research should now focus on identifying predictors for fatigue in IBD patients in clinical remission.