bluuebunny/crossref_metadata_2025_split huggingface dataset:
P219 Impact of COVID-19 pandemic in patients with a first consultation for suspected inflammatory bowel disease
Authors: Ramos Lopez L , Hernández A , Carrillo-Palau M , Hernández-Camba A , Alonso-Abreu I , Reygosa C , Vela M , Rodríguez G E , González-Mendez Y , Tardillo C , Arranz L , Benítez-Zafra F , Hernández-Guerra M 
Published: January 2022

Abstract

Background
During the COVID-19 pandemic, outpatient activity and the performance of complementary tests have been limited in order to optimize health care resources in patients with SARS-CoV2 infection according to the incidence of cases in each time period. The aim of this study was to determine the impact of the measures implemented by the COVID-19 pandemic on the diagnosis, initiation of treatment, and follow-up of patients referred for suspected inflammatory bowel disease (IBD) at different times during the pandemic.

Methods
Retrospective multicenter study comparing three cohorts of patients who were referred for evaluation in IBD consultation during three time periods: pre-pandemic “pre-COVID19” (pC), from March to May 2019; during health alert “alert-COVID19” (aC), from March to May 2020; and during a recent post-pandemic alert period “post-COVID19 alert” (p-aC), from January 2021 to March 2021. All patients referred with suspected IBD (“first time” consultation) were included. Epidemiological and clinical variables were recorded from the onset of digestive symptoms and up to a follow-up of 6 months after consultation.

Results
A total of 114 first-time consultations were recorded: 47 in pC (age 45.3, SD 2.6 years; 63.83% female), 24 in aC (age 48.3, SD 3.3; male 54.2%) and 43 in p-aC (age 44.5, SD 2.4; male 53.4%). Significant differences were determined in terms of the reason for consultation between the periods (recent diagnosis of IBD: 25.5% pC vs 41.7% cD vs 53.5% a-pC; p= 0.03 and suspicion of IBD: 74.5% pC vs 58.3% aC vs 46.5% in p-aC; p = 0.03). The diagnosis of IBD was confirmed in 44.6% of patients in the pC period, 66.6% in aC and 67.4% in p-aC, (p=0.06). There were no significant differences between the three periods in terms of time from suspicion of the disease to evaluation at the first visit and time to completion of complementary tests. However, there were significant differences in the time between diagnosis and initiation of treatment among the pC group (mean 1.7, SD 1.05 months), in contrast to 4.36 months (SD 2.03) in aC and 3.82 months (SD 1.3) in p-aC (p= 0.05). There were also no differences in the management (treatment and request for complementary tests) of the sucessive consultation, except for the number of hospital admissions in the six months following the first consultation (5 cases in pC vs. no admissions in aC and p-aC,p=0.03).

Conclusion
During the COVID19 pandemic,the ability to diagnose patients with IBD has been maintained with no delays in the performance of complementary tests at participating centers. However, a delay in the initiation of treatment that could negatively impact the health of IBD patients is currently being maintained.
P222 Raman Spectroscopy in the diagnosis of pIBD: experimental study
Authors: Viola I , Costa S , Pellegrino S , Acri G , Romano C 
Published: January 2022

Abstract

Background
Diagnostic delay is a major issue among the paediatric Inflammatory Bowel Disease (pIBD) population because of the association with higher risk of complications and growth failure. At present, non-invasive serological and faecal biomarkers lack sufficient sensibility and/or sensitivity to be used as a diagnostic tool in clinical practice and none can discriminate between Crohn’s Disease (CD) and Ulcerative Colitis (UC). In this setting, new non-invasive diagnostic tools with better diagnostic performance are needed.Raman Spectroscopy (RS) is a spectroscopic technique that relies on the inelastic scattering process of monochromatic light. Through the analysis of spectra molecular changes can be identified.The overall objective of this study was to explore RS performance as a non-invasive diagnostic test in IBD diagnosis.

Methods
RS was applied to the analysis of stool protein extracts in pIBD patients and a control group. Being directly in contact with the intestine stool can provide information on the bacterial and inflammatory background and represents an excellent sample material to study. At our Paediatric Gastroenterology Unit 55 patients (age 0–18) were enrolled, 32 cases (20 MC, 2 Very Early Onset-IBD, 9 CU, 2014 Porto criteria), 23 controls (functional constipation, irritable bowel syndrome, Rome IV criteria). Protein extract from faecal samples (obtained by the same kit test used to evaluate faecal calprotectin) were analysed with a DXR- Smart Raman Spectrometer (thermos Fisher Scientific, Waltham, MA, USA) with a 785 nm diode laser. After obtaining a spectrum the analysis focused on the band in the wavenumber range of about 1550–1750 cm-1 which defines the amide-I vibration modes, deconvolution of this band was performed. Ratio of the area of the sub-bands, parameter R, was calculated. Receiver Operating Characteristic (ROC) Curve and Youden Index (J) were used for statistical analysis.

Results
As represented by the ROC curve R showed a great diagnostic accuracy in differentiating between cases and controls, AUC 0,9389 (0,87-1,00) figure 1. A cut-off value of 1,2 distinguished cases from controls with sensibility 0,9 (0,78-0,95), specificity 1 (0,85-1), figure 2.

In the group of cases R distinguished CD from UC, AUC 0,83 (0,65-1) figure 3. A cut of value of 1,4 distinguished CD from UC with sensibility 1 (0,69-1), specificity 0,83 (0,58-0,96) figure 4.

Conclusion
This is the first application of RS as a non-invasive diagnostic tool on stool samples. Preliminary data show that RS may recognize IBD from non-IBD features, and, what is completely new, it can discriminate the two main forms of IBD, CD and UC. Future prospective studies including patients with suspected IBD will help defining the diagnostic performance.
P225 David against Goliath: direct comparison of hand-held bowel sonography and magnetic resonance enterography for diagnosis of Crohn’s disease
Authors: Rispo A , Mainenti P P , Testa A , de Sire R , Imperatore N , Nardone O M , Ricciolino S , Patturelli M , Olmo O , Calabrese G , Castiglione F 
Published: January 2022

Abstract

Background
The diagnosis of small bowel Crohn’s disease (CD) is mainly performed by ileo-colonoscopy (IC), while the assessment of its extension can be achieved non-invasively by using magnetic resonance enterography (MRE) and bowel sonography (BS) in view of a very concordant agreement about diagnostic accuracy. More recently, hand-held sonography has been used effectively in cardiological and orthopaedical diagnostic settings, while data about its use for CD diagnosis are still scarce. The aim of this pilot study was to evaluate the diagnostic accuracy of hand-held BS (HHBS) in comparison with MRE for the diagnosis of CD.

Methods
From September 2019 to June 2021, we prospectively studied 85 consecutive subjects who attended our third level IBD Unit for suspected CD. All patients underwent IC (as gold standard for CD diagnosis), HHBS (VScan, dual probe, 5–7.5 MHz; General Elelectric®) and MRE in a random order and blind way. MRE was assumed as reference standard for defining the extension of small bowel CD. Bivariate correlation about CD extension between MRE and HHBS was calculated by Spearman’s coefficient (r). To test the consistency between MRE and HHBS for CD location and complications (strictures, abscesses, fistulas) the Cohen’s k measure was applied. A p value of 0.05 was considered significant.

Results
The diagnosis of small bowel CD was made in 48 out of 85 subjects (56%), whereas the remaining 37 subjects received a different diagnosis. Sensitivity, specificity, positive and negative predictive values for CD diagnosis were 87% (95%CI 74–95%), 91% (95%CI 78–98%), 91% (95%CI 78–96%), 88% (95%CI 77–93%) for HHBS (TP 42, TN 34, FP 3, FN 6) and 92% (95%CI 80–97%), 95% (95%CI 81–99%), 94% (95%CI 81–98%), 91% (95%CI 85–97%) for MRE (TP 44, TN 35, FP 2, FN 4), without significant differences (p=N.S.). On the other hand, MRE was superior to HHBS in defining CD extension (r=0.67; p&lt;0.01) and location (k = 0.81; p&lt;0.01). Also, MRE showed a better diagnostic performance than HHBS for detecting strictures (k=0.75; p&lt;0.01), abscesses (k=0.68; p&lt;0.01) and fistulas (k=0.65; p&lt;0.01).

Conclusion
HHBS and MRE are two accurate and non-invasive procedures for the diagnosis of CD, even if MRE appears to be more sensitive in defining the extension, location and intestinal complications. HHBS could be used as effective ambulatory (or out-of-office) screening tool for selecting the patients to submit to MRE examination because of high probability of CD diagnosis.
P231 Emergency Colectomy for IBD Is Not Associated with Increased Risk of Postoperative Infection, Reoperation or Readmission
Authors: Connelly T , Clancy C , Cheong J Y , Jia X , Kessler H , Valente M , Holubar MD- MS S 
Published: January 2022

Abstract

Background
The current literature suggests that IBD patients have worse outcomes after emergency surgery when compared to elective surgery. We hypothesized that this association will be lost after matching cohorts of emergency and elective patients. We aimed to confirm the current emergency IBD surgery literature in a large cohort of unmatched IBD patients. We then aimed to determine if postoperative outcomes are worse in matched patients undergoing elective vs emergency colectomy.

Methods
We utilized the NSQIP PUF IBD Cohort 2005–2019 to assess 30-day outcomes in adult IBD patients undergoing emergency vs elective colectomy. Our primary outcome was any complication. Our secondary endpoints were readmission, reoperation, and mortality. Univariable and multivariable logistic regression models were used to examine the association between emergency surgery and complications in the unmatched cohort. Propensity-score matching was performed to match emergency patients to non-emergency patients on a 1:1 basis. A logistic regression model was used to assign a propensity score to each patient using emergency surgery as the outcome. All preoperative and perioperative characteristics were included in the model except those with &gt; 20% missing data. The probability of emergency surgery based on these factors was used as the propensity score. A greedy matching algorithm was used to find the best controls matches for each case. A Love plot was used to show the covariate balance. Conditional logistic regression were used to evaluate the association between outcomes and emergency surgery on the matched sample.

Results
A total of 16,790 patients (15,849 elective, 941 emergency) were included in the unmatched cohort analysis. 30-day outcomes in 21 categories including length of stay, surgical site infection, sepsis, death and cardiovascular, renal and thrombotic complications were worse in the emergency cohort (Table 1). After matching, 632 sets were constructed. The majority of adverse outcomes demonstrated in the unmatched cohort lost significance. Only unplanned intubation (OR 2.6, p=.006), &gt;48 hours on a ventilator (OR 2.8, p&lt;.001), septic shock (OR 3.6, p&lt;.001) and any complication (OR 1.3, p=.03) retained significance (Table 2).

Conclusion
In concordance with the current literature, we demonstrated increased rates of postoperative infection, cardiovascular and renal complications, reoperation and length of stay in unmatched groups of IBD patients undergoing emergency vs elective surgery. However, the majority of these complications were not significantly different after propensity matching. This suggests that emergency surgery is not associated with poorer outcomes in terms of length of stay, mortality and most morbidities as previously thought.
P236 Interobserver reliability of the Nancy index for ulcerative colitis: An assessment of the practicability and ease of use in a single-centre real-world setting
Authors: Le H D , Pflaum T , Sari S , Bretschneider F , Nikolaus S , Lassen A , Schreiber S , Aden K , Roecken C 
Published: January 2022

Abstract

Background
Histological disease severity assessment in ulcerative colitis has become a mainstay in clinical endpoints definition (“histologic remission”) in clinical trials of ulcerative colitis (UC). Among the several scores that were developed for the microscopical assessment of disease activity, the Nancy index (NI) stands out for the least amount of work load due to the lowest number of scoring items. To which extent histologic assessment using NI is affected by interobserver reliability in the real word setting, is poorly understood. We therefore performed a single-center retrospective analysis of NI assessment in patients with ulcerative colitis.

Methods
We retrospectively evaluated in two independent cohorts with a total of n=1085 of biopsy samples (sigmoid, rectum) taken from 547 clinically diagnosed UC patients, who underwent colonoscopy between 2007 and 2020. Cohort #1 consisted of 637 biopsies from 312 patients, Cohort #2 consisted of 448 biopsies from 235 patients. The NI of these samples were assessed by two blinded pathologists with a different amount of pathological experience. After each cohort a consensus conference was held where samples that were rated with different NI grades were re-assessed, and a consensual score was given by both observers. We evaluated interobserver reliability and differences in the amount of the several grades of the NI rated by the observers.

Results
The interobserver-agreement of the NI was very-good after the assessment of the 1085 samples (κ = 0,687 [95%-CI: 0,653-0,720]). An improvement of the interobserver-agreement was found with growing numbers of samples evaluated by both observers (1st cohort: κ = 0,659 [95%-CI: 0,615-0,704]; 2nd cohort: κ = 0,726 [95%-CI: 0,675-0,776]). The biggest number of differences were in NI grade 1 (observer 1: n=128; observer 2: n=236). The smallest number of differences were in NI grades 0 (observer 1: n=504; observer 2: n=479) and 3 (observer 1: n=71; observer 2: n=66). After a consensual score was given the largest part of grades were NI grade 0 (n=504) followed by NI grade 2 (n=309). The least number of samples were given NI grade 3 (n=62). Average time for scoring was less than 2 minutes.

Conclusion
The NI represents an easy-to-use index with very high interobserver reliability to assess the histological disease activity of UC patients in a real-world setting. Though further improvements of the NI regarding stricter classifications of the several grades need to be done to improve the practicability of the index. While NI grades 0 and 3 having a very high level of agreement between the observers, NI grade 1 has a lower agreement-level. This highlights the clinical need to specify histological characteristic leading to NI grade 1.
P241
Authors: Cifù A , Marino M , Sablich R , Carletti M , Blasone N , Milloch S , Curcio F , Fabris M 
Published: January 2022

Abstract

Background
In recent decades, biological drugs targeting anti-tumour necrosis factor-α (TNF-α) have represented the cornerstone in the treatment of inflammatory bowel diseases. Currently, anti- TNF-α represents a breakthrough in patient care. However, 20–50% of patients experience primary or secondary loss of response. This may be due to pharmacodynamic and/or pharmacokinetic issues, resulting in subtherapeutic drug concentrations, frequently related to the development of anti-drug antibodies (ADA).
In this context, therapeutic drug monitoring (TDM) is essential to patients’ management in order to pinpoint the basis of reduced efficacy. Indeed, a fast and reliable assessments of TDM is mandatory to allow rapid intervention, to avoid toxicity and improve treatment efficacy.
In this study we assess the analytical performance of a novel fully automated chemiluminescent assay in measuring biological drugs levels and ADA serum concentration and to compare its performances to the current diagnostic method (ELISA).

Methods
Serum levels of biological drugs (Infliximab and Adalimumab) and their respective ADA were measured in twenty infliximab (IFX)-treated IBD patients and twenty adalimumab (ADL)-treated IBD patients using both the Promonitor® ELISA kits (Grifols) and the i-TRACKER chemiluminescent (CLIA) kits (Theradiag

Results
The CLIA method is a random-access platform that allows the continuous loading of samples, while the ELISA is a time-consuming manual method to be planned in advance to reduce expenses. Actually, in our laboratory is performed only twice a month. A very good correlation was observed both for Infliximab (Spearman r=0.9695, 95%CI = 0,92-0,99, p&lt;0.0001) and Adalimumab serum levels (Spearman r=0.9476, 95%CI = 0,86-0,98, p&lt;0.0001). Among the patients with undetectable IFX serum levels, 6/8 (75%) resulted ADA positive by ELISA versus 8/8 (100%) by CLIA. Moreover, CLIA disclosed very high ADA concentration in 3 samples compared to borderline results by ELISA. Regarding ADL, all the 9 patients with undetectable serum levels presented similar ADA concentration as tested with ELISA or CLIA.

Conclusion
In conclusion, the i-TRACKER CLIA Infliximab and Adalimumab assays showed a very good correlation for serum-based drugs level quantification as compared to the related ELISA methods. Furthermore, a good agreement was observed for ADA analysis, with a higher sensitivity against anti-IFX antibodies by CLIA compared to ELISA. Our data clearly highlighted that a fully automated assay for TDM would certainly reduce costs and significantly improve the management of IBD patients in terms of a shorter turn-around time.
P257 The clinical decision support tool has low performance in predicting outcome to ustekinumab in Crohn’s disease
Authors: Alsoud D , Sabino J , Ferrante M , Verstockt B , Vermeire S 
Published: January 2022

Abstract

Background
Several biologicals and small molecules have been added to the therapeutic arsenal of inflammatory bowel disease, which generated a wide interest in precision medicine. In this context, both clinical features and laboratory tests have shown some correlation with therapy outcome. Recently, an online clinical decision support tool1 (CDST) was built, using clinical and biochemical variables (e.g. disease location, prior anti-TNF exposure), to help physicians predict the outcome of various biological treatments in Crohn’s disease (CD). We sought to evaluate the predictive performance of this tool in patients with CD initiating ustekinumab (UST).

Methods
Baseline data were collected from consecutive CD patients who started UST IV induction followed by eight weekly UST 90 mg SC maintenance from December 2015 through March 2021 at our referral center. The probability of achieving clinical remission (low, intermediate, or high) was determined using the online CDST using patients’ data. Also, differences in rates of primary non-response and ustekinumab persistence were compared between CDST classifications. Primary non-response was defined as failing to attain endoscopic response (≥50% decrease in SES-CD) nor clinical response (a drop in the physician global assessment score or patients reported outcome), both assessed at month 6 after UST initiation. Finally, we studied the relation between the individual components used to construct the CDST and the three classifications in a univariate analysis.

Results
A total of 291 CD patients started UST, of whom 237 had objectively-assessed (CRP, fCal, symptoms or endoscopy) baseline disease activity. Using the CDST, the proportion of patients with “low”, “intermediate” or “high” probability to attain clinical remission were 11.8 % (n=28), 55.7 % (n=132) and 32.5 % (n=77), respectively. The CDST could not discriminate patients with primary non-response (p value = 0.18; Figure 1), nor identify trends in drug persistence (p value = 0.44; Figure 2). In the univariate analysis, 3 out of 9 components (active fistulizing disease, disease location and concomitant immunomodulatory use) were not significantly contributing to the CDST classification (Table 1).

Conclusion
The recently developed clinical decision support tool showed low performance in predicting short-term (primary clinical and endoscopic response) and long-term (drug persistence) real-life outcomes in CD patients starting UST. These findings underscore the necessity of incorporating molecular variables, in addition to clinical ones, to construct reliable and reproducible tools to predict therapeutic outcomes.
1. https://via.juxlyapps.com/pathway/archemedx/ibd-cdst/index.html#/disease-selection
P264 Prevalence and predictors of stoma formation and restoration of intestinal continuity in patients with Crohn’s disease in a tertiary referral hospital: A retrospective explorative study
Authors: Primas C , Waldhör T , Kozbial K , Dawoud C , Riss S , Reinisch W , Niapri M , Kutschera M , Kazemi-Shirazi L , Reinisch S , Dabsch S , Pedarnig N , Angermann H , Novacek G 
Published: January 2022

Abstract

Background
Crohn’s disease (CD) is associated with a high risk of intestinal complications such as stricture, fistula and abscess formation, as well as perianal disease, frequently requiring surgical procedures and intestinal stoma formation. The aim of the present study was to evaluate the prevalence as well as predictors for surgical stoma formation in CD patients.

Methods
This is a retrospective single tertiary center cohort study of 1157 patients with CD with a median follow-up of 15 years whose characteristics (Table 1) are recorded via a validated data software (IBDIS, Inflammatory Bowel Disease Information System). The primary objective was the assessment of risk factors for intestinal stoma formation during follow-up. The probability of stoma-free survival was calculated for the entire patient population and for subgroups defined by their time of diagnosis (-1999, 2000–2009, 2010-), location and behavior of disease, presence of perianal disease (ever), gender, and smoking habits by means of Kaplan-Meier estimates.

Results
135 (11.7%) patients with intestinal stomas [78 (57.8%) ileostomies and 57 (42.2%) colostomies] were registered. The probability of stoma-free survival after 5, 10, and 20 years was 95.9%, 91.8%, and 85.5%, respectively. Stoma formation surgery was elective in 51 (37.8%) cases, emergency in 49 (36.3%) and unknown in the others (25.9%). The most common indications were perianal disease [(n=34; 25.2%), internal fistula/abscess [n=25 (18.5%)], postoperative complications [n=21 (15.6%)], stricture [n=11 (8.1%)], and refractory to treatment [n=10 (7.4%)]. The probability of stoma-free survival was significantly lower in patients with perianal disease (p&lt;0.0001) (Figure 1), colon involvement (p&lt;0.0001) (Figure 2), and penetrating disease behavior (p&lt;0.0001) (Figure 3). Time of diagnosis, gender, and smoking habit were not significantly associated with stoma-free survival. In 73 (54.1%) patients a restorative surgery for intestinal continuity was performed.

Conclusion
We found a high prevalence of intestinal stoma formation in CD patients of a tertiary center. Patients with perianal disease, penetrating behavior and colonic location, have a lower probability of stoma-free survival.