bluuebunny/crossref_metadata_2025_split huggingface dataset:
P237 Cognitive debriefing of a patient-reported outcome measure for abdominal pain and loose stool frequency in Crohn’s disease
Authors: Gibble T H , Kosa K , Basnyat B , Martin S , Moses R , Dubinsky M 
Published: January 2024

Abstract

Background
Abdominal pain (AP) and loose stools are key symptoms of Crohn’s disease (CD). Patient-reported AP and loose stool frequency (SF) items comprise two of the three patient-reported items included in the Crohn’s Disease Activity Index. These AP and SF items are referred to as "the PRO" in Lilly’s clinical trials. This study aimed to elicit in-depth information on how patients understand and respond to the PRO.

Methods
Cognitive debriefing interviews were conducted in adults and adolescents (aged 15–17 years) with moderately to severely active CD. Eligible participants self-reported disease severity but had to provide proof that they were diagnosed with CD ≥6 months ago. Participants must have received biologic and/or conventional therapy for CD and must not have had surgery to treat CD. Participants provided feedback on the PRO and described what PRO response options or score changes would reflect meaningful improvement in symptoms or denote successful treatment. Interview transcripts and field notes were analysed using a standard thematic analysis approach.

Results
17 adults and 3 adolescents participated during May–July 2023. Participants had a mean age of 38 (range=17–60) years; 70% (n=14) were female; 70% (n=14) were White. Participants had been diagnosed, on average, 10 (range=0.5–29) years ago. Most participants (n=13, 65%) reported moderate CD severity. All participants interpreted the AP item as intended, found the response options clear and easy to use, and reported that it would be easy to recall their AP severity over 24 hours. Of the 13 participants reporting AP (mild: n=6, 30%; moderate: n=7, 35%), nearly all (n=11, 85%) would consider a 1-level improvement (e.g., ‘mild’ to ‘none’ on the four-level scale) as meaningful. Most participants (n=11, 55%) would consider a treatment successful if their AP was ‘mild’; while many others (n=8, 40%) would need their AP to be completely resolved (i.e., ‘none’). All participants easily understood the SF item, interpreted it as intended, and reported that it would be easy to recall how many very soft or liquid stools they had experienced in a 24-hour period. Participants generally considered a 35.5% decrease in the number of very soft or liquid stools to be a meaningful improvement. On average, participants would consider a treatment successful if they had 1.7 (range=0–5, median=1) very soft or liquid stools per day.

Conclusion
Participants understood and easily completed the PRO. These findings support the content validity of the PRO in adults and adolescents with moderately to severely active CD and provide insights on the amount of change in AP and SF that patients would consider meaningful.
P256 Relationship and sexuality in Inflammatory Bowel Disease: results from a patient questionnaire
Authors: Jäghult S , Bello F , Almer S 
Published: January 2024

Abstract

Background
Health-related quality of life has been studied for almost 30 years in patients with Inflammatory Bowel Disease (IBD). However, the knowledge concerning consequences of illness like fatigue, psychological illness, and relationship and sexuality is still sparse.
The aim of this study was to gather more information about the IBD patient´s view concerning relationship and sexuality and how patients experience the support and help from the healthcare professionals.

Methods
A questionnaire was sent digitally to all members with an IBD diagnosis in the Swedish patient association. The questionnaire contained seven questions. Four of them concerned background data (age, gender, diagnosis, IBD-surgery). The final three questions concerned relationships and sexuality and were qualitatively analyzed with content analysis.

Results
Out of 2274 patients who received the questionnaire, a total of 556 answered (24%). The median age was 55 years of age, 69% were women, 46% had ulcerative colitis, 45% Crohn´s disease, 6% microscopic colitis, and 3% had a mixed form. A total of 36% had undergone surgery due to IBD.
Question 5: "What kind of problems have you experienced regarding relationships and sexuality?" A total of 78% stated some kind of problem. The most common physical problems were pain (14%), incontinence/urgency (11%), and gas/bloating (9%). The most frequent psychological problems were fear of leakage (13%), decreased sexual drive (11%), and loss of energy (8%). Several patients described that their sexual life always needed to be carefully planned, and some described that they avoided having a partner because of difficulties to initiate relationships.
Question 6: "What kind of help and support from the healthcare do you want?" A total of 64% wished that healthcare professionals raised questions concerning relationships and sexuality as an equal natural part as the rest of health status.
Question 7: "Have you spontaneously raised questions concerning relationships and sexuality in your contacts with healthcare professionals?" A total of 84% answered no. Reasons stated were that it was felt uncomfortable, embarrassing, due to lack of time and that other concerns were prioritized. Some patients expressed that they had no contact with their healthcare center at all.

Conclusion
A total of 78% of the patients answering this questionnaire acknowledged that they experienced physical issues and fears concerning relationships and sexuality, mostly due to pain and leakage. A more active support was wanted from 64% of the patients, but only 14% had themselves raised the topic to health care professionals. More knowledge and awareness concerning relationships and sexuality are needed to ensure person-centered care for all IBD-patients.
P260 Clinical-ultrasound comparison of enthesis lesions in inflammatory bowel diseases
Authors: Gainullina G , Kirillova E , Abdulganieva D 
Published: January 2024

Abstract

Background
The objective of study was to compare the frequency of enthesis lesions in pts with inflammatory bowel diseases (IBD) according to clinical examination and ultrasound (US).

Methods
95 IBD pts were prospectively enrolled into the study: 55 pts with ulcerative colitis and 40 - with Crohn's disease. The average age of pts was 32 (26; 37) years. The average duration of the disease was 48 (12; 96) months. During clinical examination, palpation tenderness of 46 enthesis of the upper and lower extremities was assessed in each pt. According to the results of the evaluation, the number of painful entheses was calculated. US examination with power Doppler detected inflammatory (hypoechogenicity of enthesis, thickening of enthesis, presence of vascularization) and structural (erosion, enthesophyte) changes in entheses. US examination included 68 entheses of the upper and lower extremities in each pt.

Results
A total of 4370 entheses were examined clinically. Pain on palpation of entheses was noted in 49 pts (52%). The number of painful entheses was 149 (3.4%). A total of 6460 entheses were examined using US. Enthesites were found in 72 pts (76%), including vascularized enthesites in 35 pts (37%). The total number of identified enthesites was 293/6460 (4.5%), enthesites with vascularization - 62/6460 (1.0%). Structural changes in entheses were common. Erosions were determined in 76 pts (80%), the total number of enthesis erosions was 313/6460 (4.8%). Enthesophytes were detected in 37 pts (39%), the total number of enthesophytes was 91/6460 (1.4%). The number of enthesites detected by US - 72 pts (76%) significantly exceeded the number of clinically painful entheses on palpation - 49 pts (52%) (p=0.0008).

Conclusion
In pts with IBD, according to US, the frequency of detection of enthesis lesions - 72 pts (76%) was significantly higher than in clinical examination - 49 pts (52%).
P263 Clinical-Endoscopic Correlation of Postoperative Recurrence in Surgically Treated Crohn's Disease Patients
Authors: Siham B , amri F , koulali H , zazour A , ismaili Z , Kharrasse G 
Published: January 2024

Abstract

Background
The majority of patients with Crohn's disease (CD) require surgical intervention at some point in their disease course, particularly ileocolic resection. However, the average rate of clinical postoperative relapse is 30% at 3 years and 60% at 10 years. Endoscopic postoperative recurrence precedes clinical recurrence, highlighting the importance of conducting a colonoscopy 6 to 12 months postoperatively to establish the Rutgeerts score,which predicts the risk of clinical recurrence. The aim of this study is to correlate endoscopic findings with the clinical symptoms of these patients.

Methods
We retrospectively analyzed clinical symptoms and Rutgeerts scores of Crohn's disease patients who underwent ileocolic resection during the course of their disease, and followed at the Hepato-Gastroenterology Department of MOHAMMED VI university hospital in Oujda, Morocco, during the period [2018-2023]

Results
Sixty Crohn's disease patients underwent at least one surgical operation during the course of their disease, comprising 25 females and 35 males with a sex ratio (M/F: 1.4). The average age of our patients was 35 years [20-73]. The average time between diagnosis and the first surgery was 4 years. All these patients received postoperative medical treatment before colonoscopy, including azathioprine or methotrexate in 26 patients (43%) and anti-TNF in 34 cases (56%), with an average time of 8 months between surgery and the start of treatment. According to the Montreal classification, the ileocolic form dominated in 88% of cases, with a penetrating phenotype in 40% and a structuring phenotype in 60%. The operative indication was primarily obstructive syndromes in 85% of cases and collections in15%. The average time to perform colonoscopy after surgery was 10 months. During follow-up, 80% of patients were asymptomatic post-surgery, with Rutgeerts scores of I0-I1 in 11(23%) patients, I2 in 13 (27%) cases, I3 in 9 (19%) cases, and I4 in 15 (31%) cases.However, clinical recurrence, characterized by diarrhea, abdominal pain, or Koenig's syndrome, was observed in 20% of patients, with an average postoperative clinical recurrence time of 2 years. The endoscopic findings in these patients revealed Rutgeerts scores of I2 in 4 cases (33%), I3 in 3 cases (25%), and I4 in 5 cases (41%).

Conclusion
In summary, despite postoperative medical management, the risk of clinical recurrence isnotable. Early postoperative colonoscopy, assessing Rutgeerts scores, proves crucial inpredicting clinical recurrence risk. The observed clinical-endoscopic discordance emphasizes the need for a comprehensive approach to monitoring postoperative outcomes in Crohn's disease.
P266 Predictive tissue-based biomarkers in treatment of Inflammatory Bowel Disease with biologicals and small molecules: a systematic review
Authors: Mookhoek A , Sönmez D , Kovacic L , Juillerat P , Misselwitz B , Dawson H 
Published: January 2024

Abstract

Background
The treatment landscape of inflammatory bowel disease (IBD) has changed in the past decade with introduction of new drug classes. For most drugs, only 30% of patients achieve long-term remission. Clinical implementation of predictive biomarkers to support precision medicine is lacking. As the interactions of immune system and microbiome in the colonic mucosa may hold the key to the prediction problem, we performed a systematic review to assess the status of tissue-based biomarkers in the era of biological and small molecule therapies.

Methods
A literature search was performed in Medline, Embase, the Cochrane Library, Web of science and the ECCO abstract database in July 2023. Papers were considered eligible when reporting on biomarkers, extracted from biopsies obtained during colonoscopy, that had predictive value regarding therapy success of a specific non-TNFα biological or small molecule. Two authors independently assessed eligibility and extracted the data.

Results
From 10,141 screened records with 155 papers assessed for eligibility, a total of 43 studies were included. The majority was published in the last 5 years (87%). Data on the clinical history of patients and the interval between biopsy and therapy onset was often lacking, in part while 49% of studies were published as conference abstracts. Heterogeneity in therapy success assessment regarding modality (clinical, endoscopic, and/or histologic) and interval (4-58 weeks) was striking. With 28 studies, vedolizumab is the best investigated drug. Of the 16 studies reporting on gene expression, 7 used data from the GEMINI-I/LTS trials. These studies reported a range from a single predictive gene such as TREM1 and OSM to a classifier of 267 differentially expressed genes. Studies looking at the protein level (n=7) focused mostly on target engagement. In 7 studies, biomarker discovery was performed through histological evaluation, mainly looking at mucosal eosinophil counts. One study looking at the microbiome did not find differences between responders and non-responders of vedolizumab.

Conclusion
Our systematic review shows that tissue-based predictive biomarker discovery in IBD is a young and dynamic field of research. This is reflected by the heterogeneity in how and when therapy success is assessed. Moreover, the various methods to analyze gene expression data yield vastly different results when applied to the same dataset. We therefore propose guideline development to support clinical implementation of predictive biomarkers.
P300 An Expert Delphi Consensus: Early Identification of Patients at Risk of Crohn's Disease in Perianal Fistulas and Abscesses (PREFAB) and Identification and Management of Isolated Perianal Crohn's Disease (ipCD) - Part A, PREFAB
Authors: Munster L , Hanna L N , Dige A , Lundby L , Hart A L , Buskens C J , Tozer P J , van der Bilt J D W 
Published: January 2024

Abstract

Background
In ± 10% of all Crohn’s disease (CD) patients a perianal abscess (PAA) or fistula (PAF) is the manifesting symptom. The delay in diagnosis of CD, from fistula or abscess onset, is very long and associated with worse outcomes. The aim of this Delphi study was to reach consensus on a clinical decision tool to help select patients with raised suspicion of CD in PAA/PAF patients, to identify underlying CD earlier and reduce the diagnostic delay.

Methods
A panel of international experts in the field of proctology and/or Inflammatory Bowel Disease (IBD), consisting of surgeons, gastroenterologists and radiologists were invited to participate in the PREFAB part of this Delphi study. The first round was an electronic survey and the second round a virtual consensus meeting. In the first round, participants were asked to anonymously provide their opinion probing 1) the relevance and use of clinical characteristics (“Red Flags”) suggestive of underlying CD, 2) the use of faecal calprotectin (FCP) as an adjunct for screening for CD and 3) on the diagnostic work-up for IBD in PAA/PAF patients with raised clinical suspicion. In the second round, statements were paired/revised based on the feedback from the first round and presented in a final set of statements. Consensus was predefined as ≥70% agreement.

Results
A total of 30 experts participated in the first round and 25 in the second round (83.3%). Final consensus was reached for 29% of all statements in the first Delphi round and, after adjustments/merging, for all 11 statements (100%) in the second round. Ninety-seven percent of participants agreed that shortening of the delay in diagnosis by using a clinical decision tool could improve outcomes in patients with perianal disease as a first symptom. Consensus was reached on the red flags to be included in the clinical decision tool, on screening of all patients with any perianal fistula (regardless of the complexity, biological behaviour and co-existent perianal symptoms) to identify CD in an early (sub)clinical phase, on referral criteria and on the diagnostic workup and follow up of patients with raised suspicion.

Conclusion
A clinical decision tool for early identification of CD in patients with PAA/PAF as a first symptom could shorten delay in diagnosis and improve outcomes. Global consensus for this tool, including a practical and relevant algorithm for finding or excluding CD in patients with PAA/PAF as a manifesting sign, was reached within two rounds. This clinical decision tool will be validated in 2024 in a large, prospective multicenter study.
P309 Impact of EBV Status on decision making for advanced therapies in IBD Patients
Authors: Robertson H , Thut J , Turnbull J , Whitehead E , Fitzgerald A L , McBride J , Savage R , Wilkinson J , Harper P , Rice J , Pattinson A , Bautista N , Sebastian S 
Published: January 2024

Abstract

Background
The CESAME study suggested that Thiopurines confer increased risk of lymphomas in IBD patients who are naïve to Epstein - Barr virus (EBV) particularly in young males. European Crohn’s and Colitis Organisation (ECCO) guidelines recommend considering EBV screening in individuals prior to initiating immunomodulator therapy. The impact of EBV serology status on decision-making processes regarding advanced therapies in IBD patients is not studied before.

Methods
Consecutive patients initiated on advanced therapies (biologics or small molecules). EBV nuclear and vca IgG status were recorded. The first advanced therapy of the positive and negative patients were compared. Proportion of the negative patients who seroconverted and the time to seroconversion were analysed.

Results
We included 491 patients (M: F 1:14). Median age of patients who had EBV serology done prior to initiating on advanced therapies was 31.5 years (range 5-84 years) .In 41 (8.35%) patients, neither nuclear nor vca IgG antibody were detected at initial screening. The median age of EBV negative patients was 26 years (range 13-51 years).30 of the EBV negative patients were males. Azathioprine/6MP was not initiated in 37 (90.24%) of the EBV negative patients. Re-testing of EBV negative patients were done at a median interval of 28 months (range 3-90 months). 5 of these retested patients (12.2%), seroconverted and in three of this patients Azathioprine was used following seroconversion.

Conclusion
A significant minority of IBD patients are EBV negative when tested as part of pre biologic screening, including in male patients above the age of 25.
Thiopurine therapy was avoided in these patients. Only a fraction of EBV negative patient seroconverted on re-testing. The impact of EBV testing in treatment decision, as well as the attributable costs needs to be evaluated further.
P314 Serum levels of Leucin-Rich α2 Glycoprotein predicts endoscopic mucosal healing of Crohn's disease
Authors: Sonoda A , Okano S , Iwamoto S , Sako M , Fukata M 
Published: January 2024

Abstract

Background
It has been suggested that serum levels of Leucin-Rich α2 Glycoprotein (LRG) correlate with disease activity of Crohn’s disease (CD). Small bowel capsule endoscopy (SBCE) can be performed together with ileo-colonoscopy (ICS) at the same day to assess mucosal healing in patients with clinically quiescent CD. The aim of this study was to determine the usefulness and a cut off value of LRG that indicate mucosal healing in patients with CD.

Methods
Clinically quiescent CD (CDAI&lt;150) patients without perianal lesions received SBCE and ICS at the same day between July 2021 and August 2023 were included. Serum levels of CRP and LRG were measured in the time frame of median 23 days before or after the exam (IQR 14, 43). Endoscopic findings were evaluated by modified simple endoscopic score for CD (mSES-CD) composed of 3 variables (size of ulcers, proportion of ulcer surface and disease affected surface) of each 7 segments (jejunum, upper ileum, lower ileum, right colon, transvers colon, left colon and rectum). Mucosal healing was defined by the mSES-CD score of 0.

Results
Among 51 CD patients enrolled, 88.2% were male with the median age of 20 (IQR 22, 35) and the disease duration of 69 months (IQR 23, 35). History of small or large intestinal resection was found in 15 (29.4%) and 14 (27.4%) cases, respectively. The median CRP and LRG were 0.1 mg/dL (IQR 0.1, 0.4), and 12.3 μg/mL (IQR 8.8, 18.3), respectively. The median mSES-CD was 3 (0,6%), and 20 (39.2%) cases were score 0. There was a high correlation between LRG and CRP levels (p&lt;0.0001, r=0.78), and the cut of value of LRG that indicates negative CRP (&lt; 0.4 mg/dL) was 16.6 μg/mL; area under the curve (AUC) of ROC analysis 0.91, sensitivity 90.0%, specificity 84.8%. In addition, a significant correlation between LRG levels and mSES-CD was found (p&lt; 0.0001, r= 0.65), while no correlation between CRP and mSES-CD (p=0.72, r= 0.27). The cut off value of LRG that indicates mucosal healing was 10.2 μg/mL (AUC 0.915, sensitivity 89.7%, specificity 85.7%) with positive predictive value of 92.9% and negative predictive value of 80.0%.

Conclusion
LRG can be a reasonable biomarker to monitor disease status of CD especially in clinically quiescent patients with small bowel CD. LRG values less than 10.2 μg/mL indicates endoscopic mucosal healing in patients with CD.
P318 Performance of rectosigmoidoscopy and rectoscopy to assess endoscopic and histological healing in ulcerative colitis
Authors: Yzet C , Moreau C , Chatelain D , Meudjo E , Brazier F , Hautefeuille V , Robert C , Decrombecque C , Sarba R , Pichois R , Michaud A , Fumery M 
Published: January 2024

Abstract

Background
Endoscopic and histological healing are associated with improved long term outcomes in ulcerative colitis (UC). Considering all the limitations of endoscopy, we aimed to compare the performance of complete colonoscopy, rectosigmoidoscopy (RS) and rectoscopy to assess endoscopic and histological healing in UC.

Methods
Between January 2021 and January 2023, all consecutive UC patients who underwent complete colonoscopy were prospectively included. Endoscopic activity was assessed by the Mayo Endoscopic Score (MES) on the 5 colonic segment. Endoscopic healing was defined by a MES=0 on all explored segments and histological healing was defined by a NANCY score ≤ 1 (2 biopsies/segments). The correlation between colonoscopy, RS and rectoscopy in terms of endoscopic and histological mucosal was assessed using Cohen's kappa coefficient.

Results
80 patients were included. Thirty-four patients had a MES=0 on all the 5 colonic segments. The correlation between the colonoscopy and RS was almost perfect with an index к of 0.949 for Mayo 0, and к of 0.945 for Mayo 0-1. The correlation between histological healing in RS and colonoscopy was almost perfect (к=0.877, p&lt;0.001). Additionally, the correlation between rectoscopy and colonoscopy for the evaluation of endoscopic[mf1] and histological healing was almost perfect (к=0.826 (p &lt; 0.001) and к=0.8 (p &lt; 0.001), respectively).

Conclusion
RS is sufficient to assess both endoscopic healing and histological healing in UC. With a false negative rate &lt; 10%, rectoscopy is effective to assess endoscopic and histologic healing in UC.