bluuebunny/crossref_metadata_2025_split huggingface dataset:
P224 Deconstructing distress: Stakeholder engagement for evidence-based, patient-centered interventions for the management of IBD-associated psychological distress
Authors: Heisler C G , Rohatinsky N , Stewart M , Vallis M , Shepherd T , Wozney L , Cassidy C , Currie B , Phalen-Kelly K , Robar J , Targownik L , Huard T , Neil E , Jones J 
Published: January 2022

Abstract

Background
The growing prevalence of Inflammatory Bowel Disease (IBD) along with increasing complexity of providing high-quality, patient-centered care within a resource-constrained healthcare environment presents a major challenge. IBD-related psychological distress (IBD-PD) is the emotional impact of IBD and is associated with mental health disorders, increased disease severity, and premature mortality. With estimates of nearly 90% of IBD patients experiencing PD, the inability to provide high-quality, person- centered care for IBD- PD that is proportionate to clinical need is a significant care gap in the Canadian healthcare system. The aim of this project was to generate stakeholder-derived data to inform the design and development of stepped-intensity, cognitive behavioral therapy-based interventions for IBD-PD using evidence-based, patient–centered interventions and implementation strategies.

Methods
Virtual semi-structured interviews were conducted from September to October 2021. The interview guide was developed iteratively by researchers, IBD care providers, and patient research partners and guided by the COM-B Model of Behaviour and the Theoretical Domains Framework. Interview questions assessed perceptions, experiences, barriers, and facilitators to accessing IBD-PD care. Adults diagnosed with IBD were recruited from academic centers across Canada. Interviews were co-facilitated by a researcher and patient research partner, audio recorded, and transcribed. Using thematic analysis, codes were generated to identify themes using an inductive approach.

Results
As of October 2021, eleven interviews have been completed, with data collection ongoing. The mean participant age was 33.5 years (range 21–55 years) with 63.6% of respondents identified as female (7/11). The majority of participants worked full time (8/11, 72.7%) and all had completed at least high school. Diagnoses of Crohn’s Disease (7/11, 63.6%) were more common than ulcerative colitis (4/11, 36.4%) among the participants. Thematic analyses identified five major themes: 1) Lack of holistic care and acknowledgement of IBD-PD; 2) System-level and financial barriers to psychological support; 3) Lack of psychological support from providers with an understanding of IBD; 4) Preference for individualized virtual-based support; 5) Heavy reliance on informal support structures (caregivers) due to lack of access to formal psychological support.

Conclusion
As part of human-centered design, stakeholder engagement is key to understanding behavioral, social, attitudinal, and environmental barriers and facilitators for accessing IBD-PD care. Interviews are ongoing and specific intervention functions will be defined and incorporated into patient-centered implementation strategies.
P254 Crohn’s disease of the pouch: an overdiagnosed condition?
Authors: de Jong D C , Reijntjes M , Wessels E , Buskens C , Hompes R , Löwenberg M , Gecse K , D’Haens G , Bemelman W , Duijvestein M 
Published: January 2022

Abstract

Background
Approximately 10% of ulcerative colitis (UC) patients undergoing ileal pouch-anal anastomosis (IPAA) are believed to develop ‘de novo Crohn’s disease’ (CD) of the pouch (1). Clear diagnostic criteria are lacking, but the diagnosis is mostly based on the development of fistula, strictures, treatment refractory disease, pre-pouch ileitis, or typical endoscopic findings fitting with CD, such as ulcers and patchy inflammation (1, 2). However, the findings on which this diagnosis is established may be caused by (unrecognized) surgical complications such as silent anastomotic leakage. It is important to distinguish these complications from what is truly a ‘de novo CD’ as treatment strategies differ in both groups. We aimed to investigate incidence rates and reasons for diagnosing CD of the pouch.

Methods
In total, 483 consecutive UC patients who underwent a proctocolectomy and IPAA in a tertiary IBD referral centre from January 1990 until December 2017 were retrospectively reviewed. Patients with a diagnosis ‘CD of the pouch’ were identified based on medical records, and could be based on either clinical, endoscopic, imaging and/or histological findings.

Results
Median follow-up time was 20 years (IQR 10 – 24). In 46 out of 483 patients (10%), de novo CD of the pouch was diagnosed, which was mostly based on endoscopic findings (29/46, 63%). Presence of pre-pouch ileitis was the most common reason to diagnose CD of the pouch, which was present in 18/29 patients (62%), followed by ulcerations in 6/29 (21%). On MRE, 19/46 (41%) patients had a fistula or sinus, 4/46 patients (9%) had a stricture (all proximal of the pouch). Interestingly, 12/46 patients (26%) never underwent cross sectional imaging after IPAA construction.
Only ten patients (22%) showed histologic findings with a preference for CD in biopsies, revised colectomy specimen, and/or pouch excision specimen. Only two patients had granulomas, others showed signs of transmural inflammation, ulcerations or fibrosis. Other histologic findings were non-specific.

Conclusion
In our centre, 10% of patients were ‘diagnosed’ with de novo CD of the pouch. However, as confirmatory histological signs of CD were present in only 22%, chronic surgical complications as underlying cause might be of greater importance. It is advised to perform cross sectional imaging in every patient after a year after pouch construction to rule out silent leaks that might cause symptoms at a later stage mimicking Crohn’s disease, avoiding a diagnostic dilemma.
P280 Prognosis of patients with Crohns Disease in transmural remission with gastrointestinal ultrasound
Authors: Nylund K , Sævik F , von Volkmann H L , Gilja O H 
Published: January 2022

Abstract

Background
Gastrointestinal ultrasound (GIUS) can be used to measure bowel wall thickness (BWT). If the bowel wall is less than 3 mm in all bowel segments in a patient with Crohn’s disease(CD) this predicts endoscopic remission with a high degree of accuracy, but still some CD patients with disease located to the terminal ileum and colon will have a thickened bowel wall even if they are in endoscopic remission. Could BWT be an independent predictor of disease activity in CD? The aim of the study was to investigate if a normalisation of bowel wall thickness in CD patients affects risk for important negative clinical endpoints such as need for corticosteroids, failure in maintenance treatment, hospital admissions and surgery.

Methods
Patients with CD referred to the Haukeland University Hospital for ileocolonoscopy were examined with GIUS and followed for at least 12 months. The clinical endpoints examined were defined as the need for short- or long-time treatment with corticosteroids, changes in the maintenance treatment including drug switch and dose adjustments, hospital admissions and any surgical procedure that could be related to Crohn’s disease. Patients were categorized into 3 groups according to their findings on endoscopy and GIUS: The activity group (1) consisted of patients with activity on GIUS defined as any bowel wall segment ≥3mm and Simple Endoscopic score of Crohn’s disease (SES-CD) &gt;2. The group in transmural remission (2) was defined as all patients with BWT &lt;3mm independent of findings on endoscopy. The final group (3) consisted of the patients with isolated endoscopic remission defined as SES-CD ≤2 and BWT ≥3mm in one or more bowel segment.

Results
155 CD patients were included in the study. In total 61/155 patients experienced one or more negative, clinical endpoint during the one year follow up period. 9/155 received treatment with corticosteroids, 50/155 had adjustments in their medical therapy, 32/155 were admitted to the hospital at least once and 18/155 had surgery. In group 1, 44/92 experienced one or more endpoints while the corresponding numbers were 9/40 in group 2 and 8/23 in group 3. The frequency of clinical endpoints were significantly different between the different groups (p=0,020, Fischer’s exact test). Only patients in group 1 were operated.

Conclusion
The group with transmural remission had fewer patients with negative, clinical endpoints which suggests that GIUS is well suited for distinguishing between CD patients with high or low risk for negative clinical endpoints.
P282 Influence of phenotype at diagnosis and of other potential prognostic factors on the prognosis of Crohn’s Disease in Chinese population
Authors: Xiao Z , Wu L , Cao Q 
Published: January 2022

Abstract

Background
L4 Crohn’s disease (CD) is defined as any lesion location proximal to terminal ileum according to Montreal classification. L4 disease was considered to associated with poor prognosis. However, the outcome of CD patients with esophagogastroduodenal disease and small intestinal lesions remains to clarified. Our aim was to confirm whether the outcome diffs among the patients with different L4 disease.

Methods
Our study included 670 patients who confirmed CD between January 2014 and December 2020 retrospectively. As similar as Paris classification, we divide L4-disease in adult into L4a and L4b with a ligament of Treitz as a boundary. The primary outcome was defined as intestinal surgery. Clinical manifestation and outcomes were compared among L4a, L4b, and non-L4 disease.

Results
Totally 237(10.0%) patients had isolated L4 disease or L4 disease concomitant non-L4 disease. Among them, 67(10.0%) patients suffered from L4a disease and 168(25.1%) patients has a L4b disease. Patients with L4b disease were more likely to undergo intestinal surgery compared to L4a and non-L4 disease (41.7% versus 9.0% and 21.8%, respectively, both p&lt;0.0001). However, L4a wasn’t a risk factor for intestinal surgery than non-L4 disease(9% versus 21.8%, p=0.074). At diagnosis, L4b group has a higher percentage of intestinal obstruction than L4-GD and non-L4 group (39.3% versus 17.9% and 22.4%, respectively, p=0.0021 and p&lt;0.0001). Results of multivariate analysis also showed that intestinal obstruction at diagnosis, disease behavior and disease location was a independent predictors for intestinal resection, and L4b (HR 1.786; 95%CI 1.302–2.303, p=0.0032) show significant differences between non-L4 disease.

Conclusion
Within L4 disease, L4b disease was a risk factor associated a poor prognosis compared to non-L4 disease. But the same result can’t be found in L4a disease. It might indicate that we need divide L4 phenotype of Montreal classification into L4a subgroup and L4b subgroup, and treat patients with L4-intestnal disease with biological agents earlier.
P294 On the way to disease control: Fatigue as part of a novel composite endpoint in an analysis of a prospective open label observation trial
Authors: Tran F , Nikolaus S , Schrinner F , Kümpers J , Lessing A , Lintner J , Lessing M , Sievers L K , Rosenstiel P , Aden K , Franke A , Schreiber S 
Published: January 2022

Abstract

Background
Ambitious therapeutic goals in the therapy of inflammatory bowel disease need more stringent individual endpoints. Several definitions for composite endpoints are under evaluation to describe disease control. Most commonly symptomatic (PRO2) remission is combined with endoscopic response, histology and/or biomarker remission. Here we explore the addition of fatigues as a lead problem reported by patients with IBD as part of a composite endpoint.

Methods
We have conducted an interim analysis of an ongoing open label study of patients with Crohn’s disease (CD) and ulcerative colitis (UC) assigned to anti-TNF therapy, vedolizumab, ustekinumab or tofacitinib. Patients are scheduled for evaluations at start of the respective therapy and at weeks 2, 6, 14, 26 and 52. Endoscopies are conducted before therapy and at weeks 14 and 52. Clinical remission (CR) was defined as CDAI &lt; 150 and reduction of partial Mayo score (pMayo) &gt; 50% vs. baseline at week 14. All patients who are not in CR and/or no improvement in endoscopy at week 14 are assessed for a switch in the mechanism of action and observation schedules after a switch are reset to week 0. FACIT-F scores &lt;30 was defined as clinically relevant fatigue.

Results
Fatigue was present in 52% patients (39/75) at baseline. 54% (25/46) of the patients achieved CR at week 14 while 46% (21/46) did not meet CR criteria (non-responder). Fatigue at baseline was persistent at week 14 in 12% (3/25) of CR responders, in contrast to 43 % (9/21) of non-responders. 64% (21/33) of all patients reached a combined endpoint of CR and absence of fatigue. If fatigue was present at baseline (n = 25), fatigue response was observed in 52% (13/25) of the patients, while CR was only reached in 40% (10/25) and the combined endpoint of CR and fatigue response in 24% (6/25) of the patients at week 14. In contrast, 71% (15/21) of patients without fatigue at baseline reached CR at week 14. Absence of fatigue at baseline thus increased the chance of CR at week 14, with an OR of 3.75 [1.031 – 11.50] (p = 0.0422 in Fisher’s exact test).

Conclusion
Fatigue is an important complaint strongly impacting the patients’ quality of life. A composite endpoint including fatigue and clinical remission (based on pMayo and CDAI) can be reached in a significant percentage of patients treated with biological therapies. Presence of fatigue at baseline might serve as a strong marker for clinical non-response at week 14. Further evaluation and replication of this novel composite endpoint will be conducted in our ongoing trial with a particular focus on inclusion of endoscopies and long-term outcome.
P297 Treatment of patients with complex perianal Crohn’s disease with darvadstrocel: a single-institution real life experience
Authors: Borruel PhD N , Martí M , Armario D , Ibarz A , Robles V , Herrera C , Mayorga L , Pérez Z , Alonso C , Elena C , Planes M , Oller E , Espín E , Casellas F 
Published: January 2022

Abstract

Background
Complex perianal disease in patients with Crohn’s disease (CD) represents a therapeutic challenge since, despite biological treatment, half of the patients do not achieve an adequate response. Treatment with allogenic expanded adipose-derived mesenchymal stem cells (Darvadstrocel) has proven to be an innovative treatment in patients refractory to treatment with immunomodulators and anti-TNF antibodies.

Methods
To assess the efficacy of Darvadstrocel treatment in clinical practice in patients with CD and complex perianal fistula. Method: We performed a prospective descriptive study in patients with CD and complex perianal fistula (high intersphincteric, transsphincteric, extrasphincteric or suprasphincteric; presence or ≥ 2 external opening or abscesses), refractory to antiTNF treatment, treated consecutively with Darvadstrocel at our Crohn’s and Colitis Attention Unit. Each patient was treated with 120 million stem cells (half of the dose was injected along the tract walls and the other
half around the internal opening/s). Response to treatment was assessed as combined remission according to the criteria of the ADMIRE study (clinical assessment of closure of all treated external openings that drained before treatment and absence of collections&gt; 2 cm confirmed by MRI).

Results
From July 2020 to October 2021 12 patients (10M / 2H) have been treated with Darvadstrocel. All patients were in clinical remission (luminal disease) and had perianal disease refractory to anti-TNF treatment. In addition, 7/12 patients were also refractory to ustekinumab. The patients had previously been treated with a mean of 5.7 perianal surgeries (1–16), most of them curettage and seton placement or replacement. One patient had previously been treated with mesenchymal stem cells in 2014 (ADMIRE participant). All fistulas were complex, 5 with a single tract, 2 with a branched tract and 5 with a double tract; 7 were transsphincteric, 1 intersphincteric (double), 1 supraelevator, 1 suprasphincteric, and 2 extrasphincteric. 6/10 patients underwent a previous conditioning surgery (cleaning, curettage and seton placement) two weeks before cell administration. Six of the 10 patients with a follow-up of at least 6 months had combined remission (60%). Two of the three patients with a 1-year follow-up presented combined remission. Regarding safety, no relevant adverse effects have been observed: 2 patients presented abscesses in the immediate postoperative period (self-drained without subsequent recurrence).

Conclusion
In real-life clinical practice, treatment with Darvadstrocel can be an effective and safe therapy in patients with CD and complex perianal disease refractory to biological treatment.
P305 Low ALT is more Common in Patients with IBD than Healthy Controls and is Associated with Active Disease
Authors: Shafrir A , Katz L , Zinger A , Safadi R , Kaliski I 
Published: January 2022

Abstract

Background
Sarcopenia is underdiagnosed in patients with Inflammatory bowel disease (IBD). Studies have shown that low alanine transaminase (ALT) levels are associated with sarcopenia. We evaluated the association of low ALT levels with the IBD diagnosis and activity.

Methods
Data of patients from state mandatory health maintenance organization in Israel was collected. Electronic medical records within the past two years included diagnosis, medications, blood and stool tests. Based on ICD9 coding, patients diagnosed with Ulcerative Colitis (UC) or Crohn’s disease (CD) were compared to healthy control group. Patients with ICD9 diagnosis of chronic liver disease, cirrhosis, and age &lt;18 were not included. Serum ALT lower than, 15 was considered low.

Results
Our cohort consisted of, 348,454 patients, of them, 1780 patients with CD and, 916 with UC. Mean ALT was lower among patients with IBD than healthy controls (22.71 vs., 24.04, p-value&lt;0.001). In multivariate logistic regression, controlling for age, sex, BMI, and smoking status, IBD was associated with low ALT levels (OR –, 1.25, 95% CI, 1.12–1.39, p-value&lt;0.001)
Of the CD patients, 392 (27.96%) were in the low ALT group. Patients in the low ALT group were younger (38.85 vs., 42.38 p- value&lt;0.001), were less likely to be male (33.9% vs., 54.7%), had lower BMI (23.94 vs., 26.29 p – value&lt;0.001). Fecal Calprotectin and CRP was higher in the low ALT group (601.25 vs., 282.33 p-value&lt;0.001, 12.94 vs., 7.35 p value&lt;0.001 respectively) while serum albumin was lower (4.12 vs., 4.28 p-value&lt;0.001).
Among patients with UC, 204 (30.13%), had low ALT. Patients in the low ALT group were slightly younger (46.92 vs., 49.65 p-value=0.06), less likely to be male, 22.5% vs., 52% p-value&lt;0.001), had lower BMI (25 vs., 26.37 p-value=0.004). Patients with low ALT had higher CRP levels (12.92 vs., 6 p-value&lt;0.001) and non-significantly higher fecal calprotectin levels (779.52 vs., 498.18 p-value, 0.16). Serum albumin was lower in the low ALT group (4.04 vs., 4.26 p value&lt;0.001)
In multivariate linear regression models, controlling for age, gender IBD subtype, and smoking status, low ALT was associated with elevated fecal calprotectin and CRP and lower albumin levels (p-value&lt;0.001).

Conclusion
Patients with IBD have lower ALT levels than the general population. Among patients with IBD, low ALT is associated with active disease. Further studies are warranted to strengthen the association of low ALT with sarcopenia among patients with IBD.
P361 PREPARE-IBD: Physician Responses to disease Flares and Patient Adaptation in Relation to Events in Inflammatory Bowel Disease during the COVID-19 pandemic: A multicentre cohort analysis
Authors: Saifuddin A , Kent A , Mehta S , Hicks L , Gonzalez H , Segal J , Brooks M , Subramanian S , Bhala N , Conley T , Patel K , Lamb C , Walker G , Kennedy N , Sebastian S 
Published: January 2022

Abstract

Background
The COVID-19 pandemic continues to pose complex problems across Europe and the world, with rising numbers of infections and the ongoing need for drastic public health interventions. This is difficult for patients with immune-mediated disorders like Inflammatory Bowel Disease (IBD), where immunosuppressive medications may affect susceptibility to serious infection. It was particularly challenging for physicians and patients during the first wave of the pandemic, when it was unclear whether anti-inflammatory flare treatment should be adapted to reduce infection risk, whilst trying to ensure symptomatic control and avoid admission to overwhelmed hospitals. Despite the development of various IBD / COVID-19 databases, the treatment adaptations and outcomes of patients experiencing IBD flares during the COVID-19 pandemic remain undefined. We aimed to compare IBD management and outcomes between pandemic and pre-pandemic cohorts.

Methods
An observational cohort study was performed, comprising patients who contacted IBD teams for a symptom flare between March – June, 2020 in, 60 National Health Service trusts in the United Kingdom. Data were compared to a pre-pandemic cohort after propensity-matching for age and disease severity. Statistical analyses were performed using R (version, 4.1.0, Vienna, Austria).

Results
In total, 3728 patients in the pandemic (n=1864) and pre-pandemic (n=1864) cohorts were included. The principal findings were reduced systemic corticosteroid prescription during the pandemic in both Crohn’s disease (prednisolone: pandemic, 199/752, 26.5% vs, 263/708, 37.1%; p&lt;0.001) and ulcerative colitis (UC) (prednisolone: pandemic, 372/1112, 33.5% vs, 470/1156, 40.7%, p&lt;0.001), with increases in poorly bioavailable oral corticosteroids in Crohn’s (pandemic, 117/752, 15.6% vs, 48/708, 6.8%; p&lt;0.001) and UC (pandemic, 131/1112, 11.8% vs, 60/1156, 5.2%; p&lt;0.001). Ustekinumab (Crohn’s and UC) and vedolizumab (UC) treatment also significantly increased during the pandemic. Three-month steroid-free remission was similar in both Crohn’s (pandemic, 175/616, 28.4% vs, 195/608, 32.1%; p=0.17) and UC (pandemic, 312/858, 36.4% vs, 404/1006, 40.2%; p=0.095). The, 65 patients experiencing a flare and COVID-19 were more likely to have moderate-to-severely active disease at three months compared to those with a flare alone.

Conclusion
Despite several treatment adaptations during the pandemic, steroid-free outcomes were comparable to pre-pandemic levels, though patients with a flare and COVID-19 experienced worse outcomes. These findings have implications for IBD management during future waves or pandemics