bluuebunny/crossref_metadata_2025_split huggingface dataset:
P120 Prevalence of endoscopic improvement and endoscopic remission according to patient reported outcomes in ulcerative colitis
Authors: Dulai P , Singh S , Jairath V , Ma C , Narula N , Vande Casteele N , Peyrin-Biroulet L , Vermeire S , D’Haens G , Feagan B , Sandborn W 
Published: January 2020

Abstract

Background
We aimed to quantify the prevalence of endoscopic improvement (EI) and remission (ER) amongst ulcerative colitis patients with various permutations of patient reported outcomes (PRO) following treatment with biologic agents or tofacitinib.

Methods
Individual participant data from active intervention and placebo arms of clinical trials of infliximab, golimumab, vedolizumab, and tofacitinib were pooled to estimate the prevalence of EI (Mayo endoscopic sub-score [MES] 0 or 1) and ER (MES 0) scores with various permutations of the rectal bleeding sub-score (RBS) and stool frequency sub-score (SFS) of the Mayo score, following induction (6–8 weeks) and maintenance (30–54 weeks) therapy. Subgroup analyses were performed by year of publication and centrally read endoscopy scoring.

Results
Data from 2586 trial participants were analysed. Using locally scored endoscopy, the prevalence of EI and ER was highest among participants with a RBS 0 + SFS 0 post induction (EI: 81%, [95% CI 78–84]; ER: 29% [26–33]) and during maintenance (EI: 91% [87–93]; ER: 57% [52–62]). Prevalence estimates were lower for more recently performed trials (p &lt; 0.01). In comparison to locally scored endoscopy, when using central endoscopy scoring the prevalence of EI and ER were lower post-induction (EI 57% [50–64], p &lt; 0.001; ER 15% [11–21], p = 0.09) and during maintenance (EI 74% [67–81], p = 0.001; ER 31% [24–38], p = 0.001) for participants achieving a RBS 0 + SFS 0.

Conclusion
Approximately eight out of 10 patients with normalisation of rectal bleeding and stool frequency have improvement in endoscopic disease activity, whereas approximately only half of these patients have endoscopic remission.
P125 Histological activity as a predictor of clinical outcome in ulcerative colitis: a 1-year prospective study
Authors: Neri B , Romeo S , Ruffa A , Calabrese E , Sena G , Grasso E , Zorzi F , Palmieri G , Soldati S , Biancone L 
Published: January 2020

Abstract

Background
The role of histological activity in clinical management of ulcerative colitis (UC) is under investigation. Primary aim was, in a prospective study, to assess the role of histological activity as predictor of clinical relapse in a cohort of UC patients (patients) undergoing colonoscopy and followed-up for 1 year. Secondary aim was to assess the correlation between clinical, endoscopic and histological activity scores.

Methods
From February 2016 to February 2017 consecutive UC patients with clinical indication for colonoscopy were enrolled and clinically followed-up for 1 year. Inclusion criteria: (1) UC diagnosis; (2) Age &gt; 18, ≤ 80 years; (3) regular follow-up; (4) indication for colonoscopy. During colonoscopy ≥2 biopsies was taken from ≥1 macroscopically involved and, possibly, from ≥1 uninvolved area. The day of colonoscopy clinical activity was assessed by the Mayo partial score, endoscopic activity by the Mayo endoscopic score, histological activity by the Geboes Simplified Score (GSS). Scores blindly assessed by three investigators. Statistical analysis: data expressed as mean [range], Spearman’s correlation coefficients, Cox hazards regression model used for univariate and multivariate analyses to identify predictors of clinical relapse at 1 year (HR[95% CI]).

Results
UC cohort included 77 UC patients. Characteristics of these 77 UC patients: 43 (55.8%) males, age 51 [24–80]; UC duration 14.7 [1–48] years. UC extent included n (%): 33 (42.8%) pancolitis, 24 (31.2%) left-sided, 20 (26%) proctitis. The day of colonoscopy, UC was clinically active in 15 (19.4%), inactive in 62 (80.6%) patients. Endoscopic activity was observed in 39 (50.6%) patients, histological activity (GSS≥ 3.1) in 37(48%) patients. Moderate correlations were observed between clinical and endoscopic scores (r = 0.439;p &lt; 0.0001) clinical and histological scores (r = 0.32;p = 0.0045), endoscopic and histological scores (r = 0.653;p &lt; 0.0001). During the clinical follow-up at 1 year, UC clinical relapse occurred in 24 (31%) patients, while 53 (69%) patients maintained clinical remission. At baseline colonoscopy, 11/24 (46%) UC patients were clinically active, 15/24 (63%) showed endoscopic activity and 16/24 (67%) patients histological activity. Univariate analysis identified clinical activity (HR 4.82 [2.15–10.82]; p &lt; 0.001) and histological activity (HR 2.599 [1.11–6.08]; p &lt; 0.027) as significant predictive factors for clinical relapse at 1 year. Multivariate model confirmed histological activity as predictive marker of clinical relapse (HR 2.44 [1.04–5.75]; p &lt; 0.041).

Conclusion
Histological activity provided independent information for clinical relapse in a cohort of UC patients prospectively followed up for 1 year. Histological activity had a significant correlation with the endoscopic and clinical activity scores.
P126 The Urgency Numeric Rating Scale (NRS): a novel patient-reported outcome measure to assess bowel urgency in adult patients with ulcerative colitis
Authors: Dubinsky M C , Naegeli DrPH, MPH A , Dong Y , Lissoos T , Arora V , Irving P 
Published: January 2020

Abstract

Background
Ulcerative colitis (UC) is a chronic disease characterised by inflammation of the rectum and colon. Bowel urgency, the sudden need for a bowel movement, is one of the most bothersome and important symptoms of UC. Treatment goals in UC focus on restoration of normal bowel frequency, control of primary symptoms of bleeding and urgency, and resolution of inflammation. The Urgency Numeric Rating Scale (NRS) is a newly developed patient-reported measure to assess the severity of the urgency to have a bowel movement in adult patients with UC.

Methods
Development of the Urgency NRS was informed through semi-structured concept elicitation and cognitive debriefing interviews. The scale asks patients to report on the immediacy status of their UC symptom over the past 24 h on an 11-point horizontal NRS anchored at 0 (No urgency) and 10 (Worst possible urgency), with higher scores indicating worse urgency severity (i.e. immediacy of need to have a bowel movement). A 2-week daily diary pilot study was conducted to assess floor and ceiling effects, test–retest reliability and construct validity. Weekly average scores were calculated as mean score over each 7-day period. A bootstrapping simulation was used to assess test–retest with intraclass correlation coefficient (ICC) [≥0.70 = substantial agreement] between week 1 and week 2 scores. Content validity was assessed by Pearson and Spearman correlation with stool frequency (SF) and patient global rating of severity (PGR-S) scores using Cohen’s conventions [r ≥ 0.5 = large; 0.3 to ≤0.5 = moderate] using week 1 scores.

Results
Through qualitative interviews, 16 adult UC patients (mean age 37.9 ± 11.6 years; 50% female; 56% White) confirmed relevance, item content and comprehensiveness of the Urgency NRS. Forty-one adult UC patients (mean age 44.2 ± 14.6 years; 51% female; 56% White) completed the 2-week study. Item distributions were uniform, with no ceiling or floor effects for the Urgency NRS (Figure 1). Test–retest reliability was high (ICC = 0.877), with simulated 95% confidence intervals ranging from 0.770 to 0.947. There was a high correlation between average urgency NRS and PGR-S scores, and a moderate correlation was observed between average Urgency NRS and number of stools in the first week (Table 1).

Conclusion
Bowel urgency is an important symptom of UC, distinct from bowel frequency and rectal bleeding. The urgency NRS is a well-defined, content-valid and reliable measurement of bowel urgency that may be used to help characterise disease activity in adult patients with UC.
P130 Faecal calprotectin is a reliable tool to assess endoscopic activity in ulcerative colitis except for short-extent proctitis
Authors: Collin R , Minet-Quinard R , Blayac L , Manlay L , Pereira B , Buisson A 
Published: January 2020

Abstract

Background
Faecal calprotectin (Fcal) is now considered a reliablebiomarker of endoscopic inflammatory activity in patients with ulcerative colitis (UC). However, this biomarker remains imperfect with some false negative in some clinical situations. We aimed to search for endoscopic factors associated with faecal calprotectin level in patients with UC and to identify situations in which this tool might be less efficient.

Methods
From a database collecting consecutively all the patients with IBD with at least one Fcal dosage in our centre between June 2016 and June 2018, we included all patients who had an endoscopic evaluation within the month before or after dosing without intervention therapeutic during this interval. Fcal level was measured by immuno-chemiluminescence in all patients.

Results
One hundred and thirty-four patients were included (E1 in 12 patients (9.0%), E2 in 69 patients (51.5%) and E3 in 53 of them (39.5%)). There was a significant correlation between the UCEIS score and Fcal level (r = 0.55, p &gt; 0.001). Fcal level was significantly associated with endoscopic Mayo score with higher values in severe cases (Mayo 0: 32 [15.5–75.3], Mayo 1: 119 [48.0–634.0], Mayo 2: 773 [150.8–1965.0] and Mayo 3: 1200 [572.0–3717.5] μg/g; p &lt; 0.01 for all comparisons). Using an ROC curve, we have defined the best CF thresholds to define an endoscopic Mayo&gt; 1. The performances are presented in the Table 1.

In the same way, 100 μg/g was the best Fcal threshold to define a remission endoscopic (endoscopic Mayo score = 0): sensitivity = 79.3% [66.6%–86.3%], specificity = 88.9% [65.3%–98.6%], PPV = 97.9% [92.5%–99.7%], VPN = 40% [24.9%–56.7%]. In multivariate analysis, endoscopic factors associated with the values of CF are: the UCEIS sub-score – vascular pattern (p = 0.001), the UCEIS sub-score – ulcerations (p = 0.013) and the extent of the disease (p = 0.009). CF level in patients with endoscopic Mayo 0 or 1 is lower in the case of low proctitis (&lt;5 cm) than in the case of more extensive RCH (45.5 [19.5–90.5] vs. 214.5 [71.5–730], p &lt; 0.001). While the values of CF were significantly correlated with UCEIS score in patients with proctitis &gt;5 cm (ρ = 0.3665, p &lt; 0.001), they were not low rectal (&lt;5 cm) (ρ = 0.1571, p = 0.71).

Conclusion
CF is a reliable tool for indirect and non-invasive assessment of activity endoscopic inflammatory disease in UC. Fcal is mainly influenced by severity and extent of the lesions. Its use should be careful in case of proctitis under 5 cm, a situation in which its performances are more questionable.
P137 Is there an abuse in the histological diagnosis of Crohn’s disease? (retrospective study)
Authors: Abou Rached A , Sanyour J , Karaki J , abi abdalllah N , Ghoussoub S 
Published: January 2020

Abstract

Background
Nine histological lesions are suggestive of the presence of Crohn’s disease: Ulcerations, erosions, granulomas, abscesses, chronic inflammation, lymphoid hyperplasia, fibro-inflammatory dystrophy, atrophy, and acute inflammation. The presence of a granuloma with at least one of the other histological lesions or the presence of at least three of these histological lesions without any granuloma will be in favor of Crohn’s disease diagnosis. The objective of our study is to review the pathology reports of patients in whom Crohn’s disease diagnosis was made and to see if they meet these histological diagnosis criteria.

Methods
It is a retrospective study whose aim is to review all histopathological reports of patients diagnosed with Crohn’s disease over a period of 10 years (2007–2017) in the largest pathology centre in Beirut. Several elements were analysed: the age, the sex, localisation of the endoscopic lesions (esophagus, stomach, duodenum, ileum and colon) as well as the number and the type of histological lesions present.

Results
During this period the number of patients diagnosed with Crohn’s disease was 3336. The mean age was 39.8, women accounted for 45.7%. The most common histological lesions in the colon and stomach were chronic inflammation (73.2% and 60.7%, respectively, acute inflammation in the ileum (79.8%), in the duodenum (80.6%) and in the esophagus in 88.2%, the presence of granuloma was noted in 22.9% of cases. The presence of granuloma with one or more other lesions was noted in 22.6%, whereas the presence of more than 3 histological criteria and more were found only in 29.4% of the biopsies.

Conclusion
This study demonstrates that only 52% of the biopsy specimens had the histological criteria necessary for the diagnosis of Crohn’s disease. A correlation with endoscopy findings and the clinics is needed to confirm the diagnosis of Crohn’s disease in 48% of patients.
P144 Vitamin C deficiency in inflammatory bowel disease: the forgotten micronutrient
Authors: Dunleavy K , Ungaro R , Manning L , Novak J , Gold S , Colombel J F 
Published: January 2020

Abstract

Background
Micronutrient deficiencies are common in patients with inflammatory bowel disease (IBD). To date, the majority of the literature has focused on vitamin D, vitamin B12, and iron deficiencies. We report a case series of patients with IBD and vitamin C deficiency.

Methods
We performed a retrospective chart review of 20 patients with IBD who had vitamin C deficiency (defined as a level ≤0.2 mg/dl) treated in a single tertiary care centre from February 2018 to October 2019. Demographics as well as disease characteristics and laboratory data were collected. In addition, data from routine nutritional assessments, performed by a nutritionist, were also included.

Results
Of these 20 patients, 11 (55%) were female with a median age of 27.5 years. Fifteen (75%) had Crohn’s disease (CD) and 5 (25%) had Ulcerative colitis (UC). Ten (50%) had been diagnosed with IBD within the last 3 years, and 10 (50%) had a duration of disease &gt;5 years. Disease location was L1 ileal in 6 (30%) patients, L2 colonic in 5 (25%) and L3 ileocolonic in 9 (45%); behaviour was B1 non-stricturing, non-penetrating in 10 (50%) patients, B2 stricturing in 7 (35%) and B3 penetrating in 3 (15%). Nine (45%) patients had previous history of surgery. At the time of the study, 13 (87%, N=15) CD patients had a Harvey–Bradshaw Index &gt;5, and 3 (60%, N = 5) UC patients had a Partial Mayo Score 5–7, indicating active disease. Overall, 14 (70%) patients were on biologic therapy. Sixteen (80%) patients had symptoms consistent with clinical scurvy, including 9 (45%) arthralgia, 6 (30%) dry brittle hair with hair loss, 4 (20%) pigmented rash, 3 (15%) gingivitis, 2 (10%) easy bruising and 1 (5%) brittle nails. Six (32%) had 3 or more of these clinical manifestations. Of those who underwent a nutrition evaluation (N = 18), 10 (56%) reported avoidance of all fruits and vegetables and 3 (17%) reported a reduction of fruits and vegetables in their diet.
While all patients experienced vitamin C deficiency, some also had concomitant vitamin D, vitamin B12, iron and ferritin deficiencies (Table 1).

Conclusion
Vitamin C deficiency can occur in IBD patients and is associated with clinical symptoms of scurvy. Prospective studies are needed to evaluate prevalence of vitamin C deficiency in IBD and its ultimate impact on clinical outcomes. Meanwhile this study emphasises the need for appropriate dietary counselling in patients with IBD.
P146 Comparison of three histologic indices in ulcerative colitis: Evaluation from the Phase 2 study of upadacitinib (U-ACHIEVE)
Authors: Jairath V , Lee W J , Zhou W , Heap G , Butler J , Shields A L , Ollis S , Harpaz N 
Published: January 2020

Abstract

Background
Several histologic indices are available for evaluating mucosal inflammation activity in ulcerative colitis (UC), although there is no consensus regarding which is the most appropriate for evaluating disease activity in clinical trials.

Methods
The correlation of three histologic indices, the Geboes Score (GS, range of major grade 0 to 5), Robarts Histopathology Index (RHI, range 0 to 33), and Nancy Index (NI, range grade 0 to grade 4) were evaluated in a Phase 2b, multicenter, randomised, double-blind, placebo-controlled study of upadacitinib in patients with moderately to severely active UC. Biopsy data were collected and centrally read using GS at Baseline and week 8; scores of RHI1 and NI2 were derived based on GS. Descriptive statistics, correlational analyses, and stratified analyses were performed in the pooled study population using as observed data.

Results
Among 250 UC patients enrolled at Baseline, 224, 214, 209 patients with non-missing values of GS, RHI and NI were observed, respectively. At week 8, the GS, RHI, and NI correlated strongly to each other (r = 0.90 to 0.98), and these 3 indices correlated highly with the subgrade of lamina propria neutrophils, erosion or ulceration, neutrophils in the epithelium, and chronic inflammatory infiltrate (Table 1). The Mayo endoscopic subscore (r = 0.62) was found to have higher correlation with GS, RHI and NI, followed by physician global assessment subscore (r = 0.48 to 0.51), rectal bleeding subscore (r = 0.36 to 0.39) and stool frequency subscore (r = 0.31 to 0.33). Faecal calprotectin (r = 0.47 to 0.50) and C-reactive protein (0.36 to 0.39) and total IBDQ score (r = 0.34 to 0.38) were moderately correlated with GS, RHI, and NI. Over 50% of patients with Mayo endoscopic subscore ≤1 were observed among patients scoring GS = 0 (24/41, 59%), GS = 1 (8/15, 53%), GS = 2 (13/26, 50%), RHI≤3 (45/82, 55%), and NI = 0 (40/69, 58%) at week 8.

Conclusion
In a moderately to severely active UC population, GS, RHI and NI correlate strongly with each other. Higher correlations were found between histologic scores and endoscopic activity than symptom-related disease activity. Further studies are warranted to evaluate the relationship between histological inflammation and long-term clinical outcomes.

References
Acknowledgements and Funding statement: Design, study conduct, and financial support for the study were provided by AbbVie; Financial support for the study was provided by AbbVie. AbbVie participated in interpretation of data, review, and approval of the abstract. All authors contributed to development of the abstract and maintained control over final content.
P156 Interobserver variation of visual assessment vs. measuring ulcer size in Crohn’s disease using the RAPID9 Software in PillCam COLON2
Authors: Quah S , Gorelik A , Tsoi E , Chow E , Sivanesan S , Brown G , Anwar S , Taylor A , Macrae F 
Published: January 2020

Abstract

Background
Ulcer size is important when assessing mucosal healing in Crohn’s disease (CD) and commonly assessed with visual estimation. There is a new built-in measurement tool in the RAPID9 reader software used in colon capsule endoscopy (CCE). We aimed to assess the agreement between visually estimating ulcer size vs. using the estimation tool and the interobserver agreement for both methods independently using PillCam Colon studies in patients with Crohn’s disease.

Methods
7 experts of PillCam readers were recruited to assess CCE in this study. 7 CCE recordings were thumbnailed for the presence of ulcers. A total of 43 ulcers were consecutively selected for this study. The readers were provided with an instruction manual which specified that they were to first visually estimate the ulcer and then subsequently measure the ulcer with the size estimation tool in RAPID9 software. Two measurements were taken, A – longest distance of the ulcer end to end, and B – longest distance that is perpendicular to A. Results were analysed using Kendall’s Coefficient of Concordance (Kendall’s W).

Results
When comparing visual assessment of ulcer size vs. using the estimation tool, both measurements A and B demonstrated statistically significant agreement (p of A = 0.000, p of B = 0.000; W of A=0.90, W of B=0.82). For measurement A, our results demonstrated higher interobserver agreement when assessing ulcer size using the estimation tool (W=0.84) as compared with visually assessing ulcer size (W=0.80). This contrasts with measurement B where there was higher interobserver agreement when visually assessing ulcer size (W=0.75) as compared with using the measurement tool (W=0.73). Nevertheless, there was no statistically significant variability amongst measurement A nor B (p = 0.000) in visual assessment and measurement tool.

Conclusion
The conventional visual estimation of ulcer size in CD using CCE was just as accurate as the measurement tool. Furthermore, consistency between readers was demonstrated with the high level of interobserver agreement for the measurement tool and visual estimation. This novel finding is reassuring given the decade of capsule studies done with older software, where a measurement tool was not available. Further study should be conducted to assess and consolidate the validity of the estimation tool in assessing ulceration and mucosal healing in CD with a larger number and variety of lesions studied.
P167 Changes of diagnosis after colectomy: a single-center experience
Authors: Variola A , Di Ruscio M , Vernia F , Resimini S , Lunardi G , Geccherle A 
Published: January 2020

Abstract

Background
Total proctocolectomy (TPC) is relatively common in inflammatory bowel diseases (IBD), occurring more in ulcerative colitis (UC) as compared with Crohn’s disease (CD) (20.3% vs. 10.5% of patients). Among IBD patients undergoing colectomy, a major complication affecting the clinical outcome is the change of diagnosis. In clinical practice, approximately 5% to 20.9% of UC patients develop CD of the pouch or of the neo-small intestine. The incidence of UC diagnosis after colectomy for complicated colonic CD is less clear. Drugs and progression of the disease can dramatically change the histological findings in this patients; endoscopy after baseline can be atypical and doesn’t provide cross-sectional informations about bowel wall. Aim of the study is to assess the rate of diagnosis change after colectomy in our center.

Methods
All the IBD patients who consecutively underwent TPC with ileal pouch–anal anastomosis (IPAA) or permanent ileostomy from January 2015 to December 2018 in our IBD Unit were included in this observational, retrospective study.

Results
Thirty-one patients (22 UC; 22 Males) were included in the study. Among UC patients 14 had pancolitis and 8 a left-sided colitis. Seven were steroid-resistant, 8 were steroid-dependant, 14 experienced failure to medical treatment (one or more biologics) and 8 patients had dysplasia. Mayo endoscopic score was 3 in all patients, but 3. In 5 out of 22 UC patients (22%), diagnosis changed in colonic CD after evaluation of the surgical specime by the pathologist. Four of these patients were referred to our institution by peripheral hospitals with a severe disease, requiring urgent/emergent colectomy and was therefore performed only a proctosigmoidoscopy. Permanent ileostomy was performed in all 5 patients. Among the 8 colonic CD patients 2 were steroid-resistant, 2 were steroid-dependant, 7 failed to one or more biologics, 1 showed mucosal dysplasia and two had bowel stenosis. Two patients (20%) were diagnosed as UC after TPC and IPAA could therefore be performed.

Conclusion
The change of diagnosis leads to a different surgical outcome, resulting in a worsening in former UC patients and in an improvement in former CD patients. An accurate clinical, endoscopic and histological re-evaluation of the patients is therefore mandatory before TPC. Providing an elevated number of specimens to dedicated pathologists is advisable to avoid potential complications especially in UC patients.