bluuebunny/crossref_metadata_2025_split huggingface dataset:
P220 IBD-Disk: italian translation and validation in a population-based cohort
Authors: Nardone O M , Calabrese G , Allocca M , Caprioli F , D'Alessandro E , Fantini M , Onali S , Orlando A , Rispo A , Savarino E , Soriano A , Variola A , Castiglione F 
Published: January 2024

Abstract

Background
As an objective endpoint in IBD Disease-Modification Trials, measures of disability and health-related quality of life have been proposed. IBD-DISK is an easy-to-use, and self-administered analogic visual tool designed for assessing disability. However, successful dissemination of this tool will require a cultural adaptation and translation process. To date, the IBD-Disk has not been validated in Italian clinical practice. Hence, we aimed to validate the IBD-Disk in an Italian population-based cohort according to the COSMIN recommendations.

Methods
The IBD-Disk italian translation and validation study was a cross-sectional multicentre study conducted in 8 Italian IBD referral centres. After forward-backward translation into Italian, patients were consecutively recruited from February 2023 to October 2023. Patients completed the following questionnaires: IBD-Disk (at baseline, T0, and after seven days, T1) and IBD-Disability Index (IBD-DI) for disability, IBDQ-32, and SF-36 for quality of life. Validation included assessment of validity, reproducibility, internal consistency. We further investigated the correlation between IBD-Disk and IBD activity and clinical factors associated with IBD-Disk.

Results
At baseline, 513 patients (237,46.2% CD; 276,53.8% UC) completed the IBD-Disk[Table.1]. Internal consistency was excellent with a Cronbach’s α of 0.93. The intraclass correlation coefficient (ICC) was 0.94 for test-retest (T0 and T1) (p&lt; 0.001). To evaluate construct validity, the IBD-Disk was compared with the IBD-DI, revealing a significant positive correlation (r = 0.70; p &lt; 0.001). Furthermore, it exhibited a positive correlation with both IBDQ-32(r=0.82, p&lt; 0.001) and SF-36(r=0.093, p= 0.035). The overall IBD-Disk median score was 32(12-52), with 219(42.7%) reporting moderate-to-severe disability (IBD-DISK ≥ 40). The IBD-Disk score was significantly higher in patients with active CD disease based on HBI ≥ 5 compared to patients with inactive disease(p &lt; 0.001). Similarly, for UC, patients with active disease, measured with a partial Mayo score ≥2, showed a higher IBD-DISK score than those in clinical remission[Fig.1]. Additionally, moderate-to-severe disability significantly increased in female [OR =2.83; 95% CI(1,97-4,07)] and in patients with active extraintestinal manifestations [OR = 1,71; 95%CI(1,23-2,81) p=0.04].

Conclusion
This study validated the IBD-Disk in a large cohort of Italian IBD patients, demonstrating that it is a valid, reliable and responsive tool for quantifying disability. This validation enables the broad implementation of IBD-DISK across Italy, facilitating its integration into the daily clinical management of IBD patients.
P232 Common variable immunodeficiency-associated enteropathy in consecutive patients from a tertiary hospital
Authors: Miranda-Bautista J , Di Natale M , Mejía González M A , Martínez Lozano H , Balastegui Martín H , Marín-Jiménez I , Fernández Cruz E , Bañares R , Menchén L 
Published: January 2024

Abstract

Background
Common variable immunodeficiency (CVID) patients may develop intestinal inflammatory involvement in 9-20% of cases, although its diagnosis, management and prognosis are not well established.

Methods
We performed a transversal study with retrospective data collection. We reviewed all clinical records from consecutive adult CVID patients followed in Gregorio Marañón Hospital (Spain) from January 1st 1990 to January 1st 2023. A diagnosis of CVID-associated enteropathy (CVID-E) was established if patchy intestinal inflammation (Crohn-like pattern) or colonic inflammation (ulcerative colitis-like pattern) was demonstrated, or villous atrophy was observed in duodenal biopsies (celiac-like pattern) or inflammatory infiltrate was observed in colonic biopsies (microscopic colitis-like pattern). Differences between CVID-E patients and the rest of the CVID cohort were evaluated using chi-square and T student methods, when appropriate.

Results
89 patients with confirmed CVID following ESID criteria were included. Patients’ characteristics are summarised in Table 1. All patients were receiving intravenous or subcutaneous Igs and reached an Ig G trough level &gt;1000 mg/dL. CVID-E was diagnosed in 26 patients (29,2%), at a median of 6,4 years after CVID diagnosis. Surprisingly, 10 patients (38,5%) were diagnosed with CVID-E before or at the same time of CVID diagnosis. 5 patients were dead (19,2%), and the causes of death were gastric cancer (1 patient), liver complications (1), infectious complications (1), enteropathy (1) and unknown cause (1). 73,1% suffered from GI infections (Giardia lamblia, Campylobacter jejuni and Clostridioides difficile were the most frequent agents). The most frequent pattern of the disease was Crohn-like disease (Figure 1). Although exclusive celiac-like pattern was found in only 3 patients, 5 Crohn-like, 4 UC-like and 2 microscopic colitis-like pattern patients also presented duodenal atrophy. Unexpectedly, 46,2% of CVID-E patients suffered from concomitant liver involvement. Eight patients received corticosteroids, 2 azathioprine and 1 patient received infliximab and subsequent ustekinumab. One patient needed subtotal colectomy, another ileal resection and another patient received a terminal colostomy due to severe perianal disease. CVID-E patients presented statistically more frequent liver involvement, more GI infections, and a tendency towards more GI cancer.

Conclusion
CVID-E is frequent among CVID patients. These patients suffer from more GI infections, liver involvement and probably more GI cancer. Screening of levels of Igs at diagnosis of IBD and celiac disease is advisable as CVID diagnosis can occur at the same time or even after enteropathy diagnosis.
P245 Biologics Sequencing in Clinical Units (BISCUITS): Comparing outcomes in Crohn’s disease patients on second-line biologics
Authors: Bartalucci G , Taylor F , Gleave C , Dobson L , Bodger K , Dodd S , Bloom S , Passey A , Nissinen R , Wirth D , Andreas D , Lee J , Cummings J R F 
Published: January 2024

Abstract

Background
Optimal drug sequencing for patients with Crohn’s disease (CD) who fail first line therapy with TNF-α inhibitors (TNFi) remains unclear. BISCUITS uses validated real world data from the UK IBD Registry (IBDR) to compare outcomes in CD patients who failed first line therapy with TNFi and underwent either a within-class switch (WCS) to an alternative TNFi or an out-of-class switch (OCS) to a different mechanism of action.

Methods
A feasibility study of 86,000 IBDR patient records identified a potential cohort of 2,678 CD patients who switched from a TNFi to a second biologic. Patients with no other prior IBD diagnosis who switched between 26/08/2015 and 31/03/2021 were included. The primary outcome was time to treatment failure after WCS or OCS, defined as days between initiation of second line (index) biologic and cessation, analysed using unadjusted Kaplan-Meier survival curves & Cox proportional-hazards models. Secondary outcomes included corticosteroid- and surgery- free drug persistence at one year (no drug stop, no steroid treatment or IBD related surgery within 365 days of index), analysed using binary logistic regression adjusting for age at index, early or later treatment with first line TNFi, primary non-response (PNR) or secondary loss of response (SLOR) to first-line TNFi, and immunomodulation therapy at index.

Results
An initial cohort of seven UK sites contacted, consented, and validated data for 180 patients; demographics and significant differences in case mix are shown in Table 1. Preliminary unadjusted findings suggest that OCS were less likely to discontinue index treatment compared to WCS (hazard ratio (HR): 0.64, 95% Confidence Interval (CI): 0.42 – 0.96, p = 0.03). Subgroup analysis in patients who experienced PNR to their initial TNFi indicated OCS were less likely to discontinue index treatment compared to WCS (HR: 0.25, 95% CI: 0.12 – 0.51, p &lt; 0.001). Conversely, no significant difference in drug persistence was seen in the SLOR group (HR = 0.81, 95% CI: 0.49 – 1.36, p = 0.4), as shown in Figure 1. Binary logistic regression indicated OCS were more likely to show steroid-free drug survival at one year (adjusted odds ratio (aOR): 2.10, 95% CI: 1.10 -– 4.10, p = 0.026), surgery-free drug survival at one year (aOR = 3.31, 95% CI: 1.70 – 6.65, p &lt; 0.001), and steroid- & surgery- free drug survival at one year (aOR = 2.14, 95% CI: 1.13 – 4.10, p = 0.02).

Conclusion
Real world data from this study shows overall higher drug persistence rates in OCS patients and higher steroid- and surgery- free drug survival at one year. OCS was similarly associated with significantly higher rates of drug survival in patients with PNR, but no significant difference was seen in patients with SLOR.
P246 Histologic remission is an important therapeutic target in patients who achieve endoscopic remission of ulcerative colitis
Authors: Lee J , Kim S J , Lee D S 
Published: January 2024

Abstract

Background
Histologic activity has been established as a crucial prognostic determinant in individuals diagnosed with ulcerative colitis(UC), while achieving histologic remission is increasingly recognized as a significant long-term therapeutic goal. However, the available literature still lacks adequate evidence concerning the selection of an optimal histological index and its utility in predicting prognosis

Methods
This retrospective study involved the analysis of medical records and endoscopic results from patients diagnosed with UC between January 2015 and December 2022. Endoscopic remission was defined as a Mayo endoscopic sub-score of ≤1. Histological assessment utilized the Nancy index, with a score of ≤1 indicating histological remission. Among patients with UC who achieved endoscopic remission, the study assessed the maintenance of remission and the occurrence of recurrence based on histological remission

Results
A total of 114 patients with UC who achieved mucosal healing were enrolled for histological evaluation. Among them, 16.7% (19/114) experienced flare-ups, and a statistically significant inverse correlation was observed with histologic remission (see Table). Multivariate analysis further identified non-histologic remission (Nancy index &gt;2) as an independent risk factor for recurrence (Hazard ratio: 3.513, CI: 1.334-9.257, P=0.011). Particularly noteworthy was the significantly lower recurrence rate when histologic remission is achieved, especially in patients with MES 1 (see Figure)

Conclusion
Our study demonstrated a robust correlation between histologic remission assessed by the Nancy index and sustained clinical remission. The Nancy index, reflecting relatively straightforward histological activity, is considered a valuable metric that can aid in establishing treatment goals
P249 Development and validation of a novel model to predict disease behavior progression in Crohn's disease patients with intestinal stenosis
Authors: Wang Y , Chen H , Mao R 
Published: January 2024

Abstract

Background
Approximately more than half of patients with Crohn's disease (CD) develop a stenosis phenotype and are at high risk of requiring endoscopic or surgical intervention. Surgical rates vary widely among Crohn's disease patients with intestinal strictures present. The aim of this study was to stratify Crohn's disease patients with intestinal stenosis using multiple algorithms to differentiate their poor prognostic characteristics using currently available clinical indicators.

Methods
This is a single-center retrospective cohort study that retrospectively collected CD patients with intestinal stenosis admitted from October 2018 to October 2022 at the First Hospital of Sun Yat-sen University. Demographic, symptomatic, and clinical test indicators at the time of first diagnosis of intestinal stenosis at baseline in our hospital were collected. Study endpoints were penetrating phenotype, or bowel resection. Imaging or surgical data were collected from patients at every 6 months, 1 year, 2 years, and 3 years from the baseline of stenosis, thus determining whether the patients had undergone disease behavioral progression. Patients who experienced progression within 3 months were excluded. Logistics regression model, random forest model, and xgboost model were constructed based on the above information.

Results
Twenty-seven baseline variables were retrospectively collected from 288 patients for analysis (Table 1). 202 cases were in the training set and 86 cases were in the test set, in which a five-fold cross-validation was performed. According to different algorithms, we constructed logistic regression model, random forest model and xgboost model, among which the xgboost model had the best efficacy in the test set, with an AUC of 0.734 for predicting the progression of disease behaviors after 3 years of stenosis, compared to 0.687 and 0.709 for logistic regression model and random forest model, respectively (Figure 1). in terms of terms of model interpretability, the first 4 important variables for exploring xgboos, were albumin, globulin, abdominal cramps, and abdominal distension. Finally, we attempted to predict disease progression at 6 months, 1 year, and 2 years using the model with AUCs of 0.749, 0.760, and 0.784, respectively.

Conclusion
We constructed a model based on simple metrics that can accurately predict the progression of disease behaviour in patients with intestinal stenosis Crohn's disease.
P252 Male Genitourinary Dysfunction after Minimally Invasive and Open Ileoanal Pouch
Authors: Hernandez Dominguez O , Prien C , Almarzooqi R , Sanchetti H , Lavryk O , Somovilla J , Kanters A , Liska D , Gorgun E , Hull T , Steele S , Holubar S 
Published: January 2024

Abstract

Background
Restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA) is the preferred surgical treatment for IBD or FAP. As these diseases often manifest during adolescence or early adulthood, treatment effects on genitourinary function (GU), sexual function, and fertility are of paramount importance. However, the difference in male GU function and sexual function after minimally invasive IPAA (MIS-IPAA) compared to open-IPAA are unclear. We conducted an observational survey to compare long-term GU functionality in male patients’ post MIS-IPAA or open-IPAA.

Methods
All adult male patients who underwent IPAA at a single tertiary hospital between 1983 and 2023 were identified, and demographics and clinical data were obtained from our prospectively maintained pouch registry. Patients were surveyed using validated questionnaires (Table 1). The primary outcome was the composite survey scores. Patients were stratified into MIS-IPAA (laparoscopic, robotic, single-incision surgery) or open-IPAA groups based on the mode of pelvic/rectal dissection. Reoperative IPAA procedures (revisions, redo, and excisions), incomplete surveys, patients with permanent ileostomy, and status post prostatectomy were excluded.

Results
A total of 1,836 patients were surveyed, and 457 (24.9%) submitted a response. After exclusion criteria, 296 responses were analyzed: 236 (79.7%) open-IPAA and 60 (20.3%) MIS-IPAA. In both groups, most patients had ulcerative colitis (88 vs. 89%). Compared to open-IPAA, MIS-IPAA had a similar age at surgery (40.6 vs. 40.9, p=0.88), younger age at survey (48.2 vs 58.2, p&lt;0.001), and shorter interval between surgery and survey (7.7 vs. 17.4, p&lt;0.001). Male MIS-IPAA patients were able to achieve orgasm more successfully than those with open-IPAA (5 vs. 4, p=0.001). No significant difference was observed between MIS- and open-IPAA in erectile function (SHIM score 22.5 vs 21, p=0.22), IBD-specific male sexual dysfunction (IBD-MSDS, 3 vs. 2, p=0.19), lower urinary tract symptoms (LUTS) (CLLS, 4 vs. 6, p=0.16), or use of therapeutic aids for sexual activity (6 vs. 6, p=0.7). There was no difference in global quality of life (CGQoL, 0.83 vs 0.80, p=0.6). There were no differences between the patients who had difficulty conceiving a child (4 vs. 7, p=0.46) and those who experienced infertility (1 vs. 2, p=0.54). Patients experiencing infertility showed no difference in quality of life between the MIS- and open-IPAA groups (FertiQoL, 84.9 vs 85.9, p=0.64).

Conclusion
Minimally invasive IPAA had a higher preservation of orgasm ability than did open IPAA. There was no difference in erectile function, LUTS, need for therapeutic aids for sexual function, or fertility between MIS and open approach to pelvic dissection in IPAA.
P258 Correlation between patient-reported disease activity, physician’s global assessment and quality of life in Inflammatory Bowel Disease
Authors: Lopes S , Santos I , Teixeira M , Sequeira C , Teixeira C , Gamito É , Alves A L 
Published: January 2024

Abstract

Background
As a chronic disease, patients’ perspectives on their disease status and quality of life is an essential part of inflammatory bowel disease (IBD) management. Patient reported outcomes should be the standard of measure for signs and symptoms evaluation. We aimed to evaluate the correlation between patients’ self-assessment of disease activity, activity scores and the physician’s global assessment.

Methods
A unicentric cross-sectional study was conducted. The Short Inflammatory Bowel Disease Questionnaire (SIBDQ) was administered to consecutively evaluated IBD patients in the outpatient setting. Additionally, a pilot questionnaire containing items related to disease activity was also applied to both the patients and the attending physician.
Disease activity was categorized as remission, mild, moderate, or severe. Remission was defined as Harvey Bradshaw Index (HBI) ≤ 4 for Crohn's disease or Mayo Clinic Subscore (MCS) ≤ 2 for ulcerative colitis.
Correlations between patient's perspective on disease activity, attending physician’s global assessment, activity scores and patient's quality of life were assessed using Spearman’s rank correlation coefficient.

Results
A total of 105 patients were included (female: 52%; mean age: 44±15 years), of whom 68% had Crohn's disease. 71% percent of patients were receiving biological therapy (table 1).
A quarter of the patients (n=27) perceived their disease to be in remission, of whom 56% were indeed in deep remission and 19% in endoscopic remission (table 1). A statistically significant positive correlation was observed between patient self-assessment and HBI scores (mean=2.5±6.5 points, r=0.400, p=0.001) and MCS scores (mean=3.4±4.0 points, r=0.574, p&lt;0.001).
Among patients who did not consider themselves in remission, 42% rated the activity of their disease as mild, 23% as moderate, and 9% as severe. The attending physician assessed 26% with mild disease, 22% with moderate disease, and 18% with severe disease (table 1). There was a statistically significant positive correlation between patient and physician assessments (r=0.374; p&lt;0.001).
The mean score on the SIBDQ was 28±11 points (table 1), and a statistically significant positive correlation was found between patient self-assessment of disease activity and the SIBDQ (r=0.508, p&lt;0.001).

Conclusion
These observational data suggest a weak correlation between patient-reported disease activity and the physician’s global assessment. Divergent perceptions of disease activity between patients and physicians may compromise patient-engagement. Furthermore, the moderate correlation observed with overall quality of life supports the importance of alignment patients and physicians to improve the quality of care provided.
P275 Fecal calprotectin, intestinal ultrasound, and their combination for the diagnosis of Crohn’s disease
Authors: Fumery M , Dubian S , Brazier F , Buisson A , Meynier J , Yzet C 
Published: January 2024

Abstract

Background
The diagnosis of inflammatory bowel disease (IBD) is often challenging in clinical practice and performed by ileocolonoscopy, an invasive and costly procedure. We aimed to evaluate the diagnostic accuracy of fecal calprotectin (FC) and intestinal ultrasound (IUS),independently and in combination, as screening tools for adults with suspected IBD to reduce the number of unnecessary endoscopic procedures.

Methods
We conducted a retrospective monocentric study that included consecutive adult patients with (i) ileocolonoscopy for suspected IBD between January 2021 and June 2023 who had either (ii) IUS and/or (iii) a FC test within three months. Bowel wall thickness (BWT) (normal value ≤ 3mm) and the color Doppler signal (CDS) was evaluated for all segments. The presence of lymphadenopathy, loss of stratification, stricture, and fistula was also recorded.

Results
In total, 119 patients (69% females) with a median age of 32 years (IQR, 24.0-41.0) were included. The most common symptoms were abdominal pain (n=88, 75%) and chronic diarrhea (n=89, 75%). Among the 119 patients, 74 (62%) had IUS, 101 (82%) had a FC test, and 56 (47%) had both. Forty patients (34%) had a diagnosis of IBD, including 31 (26%) withCD and 9 (8%) with UC. By ROC curve analysis, the best threshold of FC to diagnose IBD was117 ug/g (Se 97%, Sp 73%, PPV 67%, NPV 98%, AUC 0.88, 95%CI [0.81; 0.94], p=0.006).Using this threshold, only 3% of patients were misclassified as non-IBD. Screening by measuring FC levels would result in a 48% reduction in the number of adults requiring endoscopy. Abnormal IUS was significantly associated with a diagnosis of IBD (OR 5.6, 95%IC[2.1; 16.2], P=0.0008). The association of a BWT &gt; 3 mm and a positive CDS was associated with a Se, Sp, PPV, and NPV of 48%, 100%, 100%, and 75%, respectively, but 52% of patients were misclassified as non-IBD. The combination of a BWT &gt; 3 mm, CDS, and FC &gt; 117 ug/ghad a Se, Sp, PPV, and NPV of 44%, 100%, 100%, and 69%, respectively. For patients with anormal IUS and FC &lt; 117 ug/g, 4% were misclassified as non-IBD.

Conclusion
The combination of FC and IUS is a useful screening strategy to identify patients who truly require endoscopy for suspected IBD. Calprotectin is a highly effective test for ruling out IBD. Conversely, relying solely on IUS lacks the discriminative power to safely rule out IBD.However, it shows a high PPV and is a potent tool for diagnosing IBD.