bluuebunny/crossref_metadata_2025_split huggingface dataset:
P621 Secure Electronic Document Signing Uptake in Biologic Prescribing for Immune Mediate Diseases
Authors: Sharma S , Jones J , Stewart M 
Published: January 2022

Abstract

Background
The COVID-19 pandemic drastically impacted workflows in gastroenterology practice. Physicians managing immune-mediated diseases (IMDs) must complete special authorization (SA) and prescription renewal (Rx) forms for patients on biologic therapy. This adds significant administrative burden potentially leading to delays in therapy initiation and care continuity. Historically, document completion has largely been paper-based, with forms faxed between patient support programs (PSPs) and physician offices. The use of secure electronic document signing (SEDS) platforms during the pandemic has allowed physicians to receive and complete documents digitally. The aim of the project was to evaluate the impact of SEDS-based biologic documentation on clinical practice in order to 1) Determine if the use of SEDS platforms increased timeliness of document returns compared to traditional workflows 2) Assess whether SEDS usage is acceptable and sustainable and 3) Assess MD satisfaction with SEDS platforms.

Methods
This was a retrospective audit of SEDS and paper-based biologic document workflows from a single PSP (Abbvie Care). Outcomes of interest were the number of documents completed monthly using SEDS, new monthly users, and the number of active monthly users between April 1, 2020-March 31, 2021. Time (days) to SEDS completion (vs. paper process) was determined by reviewing timepoint data for SA and Rx documents from May 2019-January 2020 (‘pre- SEDS’) and for SEDS documents from May 2020-January 2021(‘SEDS’). The return time (RT) was defined as the time between date sent to a physician’s office by the PSP to the date returned to the PSP. Documents in the pre-SEDS cohort with a RT exceeding 30 days were excluded.

Results
In total, 5573 SA and Rx documents were completed by 383 physicians using the SEDS platform from April 2020-March 2021. A mean of 14.6 (sd 21.8) documents were signed per physician. The number of monthly electronic documents processed increased from 104 in April 2020 to 800 in March 2021. Active monthly users increased from 24 in April 2020 to 213 in March 2021 (31 new users monthly). A total of 19,387 paper documents were processed during the ‘pre-SEDS’ period and 3,317 electronic documents processed in the ‘SEDS’ period. The mean RT in the ‘pre-SEDS’ period was 8.03 days (sd 8.2) and the ‘SEDS’ period was 1.11 days (sd 2.6).

Conclusion
This data demonstrates acceptability, appropriateness, and improved processing efficiency of an SEDS platform improving timeliness of patient care. Next steps in this research include surveying physicians to understand the work-flow impact of SEDS, functionality, long-term sustainability, satisfaction and impacts on disease related outcomes.
P626 Anti-TNF monotherapy is associated with an adverse clinical outcome in female Inflammatory Bowel Disease patients who stop Anti-TNF treatment during the third trimester of pregnancy
Authors: Lastiri E , Herrera-De Guise C , Casellas F , Mayorga L , Robles V , Cespedes E , Perez Z , Oller E , Borruel-Sainz N 
Published: January 2022

Abstract

Background
Anti-TNF drugs are safe during pregnancy in inflammatory bowel disease (IBD), but they cross the placenta most actively in the third trimester, and some guidelines still recommend stopping them during this period. There few data that examines the impact of anti-TNF discontinuation on the clinical course of IBD, so we aimed to explore the clinical outcomes of IBD pregnant patients who stopped anti-TNF at the third trimester.

Methods
We performed a retrospective, longitudinal study on female IBD patients receiving anti-TNF agents at our IBD clinic. We included IBD pregnant patients who discontinued the anti-TNF in the third trimester of pregnancy, and we matched these cases in a 1:1 ratio with non-pregnant female IBD patients by age, type of IBD, type of anti-TNF, duration of treatment, location, and behavior of IBD. Demographic and clinical variables were collected from 18 months before anti-TNF discontinuation and 12 months after discontinuation, and when available endoscopic indices (SES CD and UC). We determined whether subjects presented any adverse clinical outcome during the follow-up defined as development of disease flare, corticosteroid use, hospital admission, need for surgery, biologic dose escalation, or switch.

Results
We included 34 pregnant patients and 34 controls. Patients who stopped anti-TNF more frequently presented an adverse clinical outcome during the follow-up year when compared to the control group (47.1% vs. 23.5% p = 0.04) and flare activity (35, 3 vs. 11.8%, p = 0.02). We found no differences in escalation or biologic switch, hospital admission, or surgery between the subjects. We also found an association between the development of an adverse clinical outcome and anti-TNF monotherapy (p=0.009) and a higher SESCD in the previous year (p=0.017). In the multivariate analysis, anti-TNF monotherapy was the only independent factor for developing an adverse clinical outcome up to 1 year after anti-TNF discontinuation (OR: 3.47, CI 95%: 1.16–10.4, p=0.026).

Conclusion
In our cohort of female IBD patients on anti-TNF, monotherapy was independently associated with an adverse clinical outcome in the following year after anti-TNF discontinuation.
P640 Incidence, prevalence, disease phenotype and maximal therapeutic step in Crohn’s disease patients in Western Hungary – a population-based study between 2007–2018, data from the Veszprem county cohort
Authors: Lakatos L , Gonczi L , Golovics P , Pandur T , David G , Erdelyi Z , Szita I , Lakatos P L 
Published: January 2022

Abstract

Background
The number of epidemiological population-based studies are still limited from Eastern Europe. The present study is a continuation of the Veszprem IBD population based cohort with a follow-up of the incidence and disease course of IBD since 1977. Our aim was to analyze the incidence and disease phenotype at diagnosis, and the maximal therapeutic step distributions during follow-up in a prospective population-based database from Veszprem Province, including incident Crohn’s disease (CD) patients diagnosed between January 1, 2007 and December 31, 2018.

Methods
Data of 421 incident CD patients were analyzed (male/female: 237/184; median age at diagnosis: 29 years(y) [IQR: 21–42]). Both in-hospital and outpatient records were collected and comprehensively reviewed at diagnosis and during clinical follow-up. The source of age- and gender-specific demographic data was derived from the national population census in 2011.

Results
Adjusted mean incidence rate was 9.94(CI95%: 9.0–10.9)/105 person-years in this 12 year period[males:11.5(CI95%:10.2–13.2)/105; females:8.4(CI95%:7.3–9.7)/105]. Prevalence rate was 191.18(CI95%:177.0–205.7)/105 persons in 2011 and 236.78(CI95%:220.8–252.8) in 2015. For detailed annual incidence rates and age-specific mean incidence rates see Figure1 and 2. Peak onset age in CD was 20–29 years of age. Diagnostic delay from symptom onset was ≥1year in 26.6%, and ≥3 years in 10% of the patients. Disease location was ileal(L1) in 29.7%, colonic(L2) in 24.5%, and ileo-colonic(L3) in 45.8% at diagnosis. Upper gastrointestinal manifestation or perianal disease were present in 7.6% and 13.5%. Disease behavior at diagnosis was luminal(B1) in 62.5%, stenosing(B2) in 17.6%, penetrating(B3) in 16.4%, and B2+B3 in 3.6%. Patients with ileocolonic disease were younger (29.2y,SD:14.6) at diagnosis compared to patients with ileal(35.7y,SD:15.5;p&lt;0.001) or colonic disease(37.7y;SD:18.1;p&lt;0.001). Extraintestinal manifestations were as follows: hepatic5.0%(PSC 1.9%), arthritis13.8%, ocular1.7%, cutan4.3%. Active smokers at diagnosis were 35.4%. Distribution of maximal therapeutic steps during the course of follow-up (8.53y,SD: 3.3) were 5-ASA in 15.7%, systemic corticosteroids in 14.3%, immunosuppressive therapy in 42.5%; anti-TNF biologic therapy in 23.3% and other biologic therapy in 2.9%.

Conclusion
The incidence of CD in this 12 year period was high, comparable to high-incidence areas in Western European countries, and comparable to previous data from the Veszprem cohort, while prevalence rates continue to rise.(Lakatos 2011, IBD). Ileocolonic location and penetrating disease behavior were somewhat higher compared to previous population-based data from Western Europe.(Burisch 2018, JCC).
P643 Generalizability of Crohn’s disease randomized controlled trials compared to clinical practice
Authors: Chhibba T , Frolkis A , Ma C 
Published: January 2022

Abstract

Background
There are no curative medical therapies for Crohn’s disease (CD). However, multiple novel treatment options are currently being evaluated in randomized controlled trials (RCTs). Historically, CD populations enrolled in RCTs have not reflected the heterogeneity of patients observed in clinical practice due to strict inclusion/exclusion criteria and protocolized trial procedures do not reflect day-to-day care. These factors have raised concerns that results from pivotal RCTs required for drug approval are poorly generalizable.
The aim of this study is to assess the generalizability of CD RCTs. We evaluated the proportion of CD patients initiating ustekinumab or vedolizumab in clinical care who would have been eligible for enrolment in the corresponding phase 3 registrational induction trial, and the factors impacting trial eligibility.

Methods
This is a retrospective cohort study using data from two ambulatory IBD clinics in Calgary, AB. Our study population included consecutive adult (&gt;=18 years) patients with a confirmed diagnosis of CD, newly initiated on ustekinumab or vedolizumab between January 1, 2018 and January 1, 2020. We then applied the inclusion/exclusion criteria from the phase 3 GEMINI II/III and UNITI I/II induction trials to determine the proportion of patients who would have been trial-eligible. We then tabulated the indications for trial exclusion to determine the characteristics of patients who would not have been reflected in the trial population.

Results
A total of 50 patients were included. The results are outlined in Table 1. The median age was 42.5 years. Most patients had non-stricturing non-penetrating disease (44%, 22/50) and ileocolonic disease distribution (48%, 24/50). A total of 66% (33/50) would have been eligible for inclusion in GEMINI II/III and (30/50) 60% would be eligible for inclusion in UNITI I/II. The most common reasons for trial exclusion included extensive surgery (total colectomy/subtotal colectomy) with short bowel or ileostomy (n=12) and surgery within 6 months of enrolment (n=3), multiple previous resections (n=2). Four patients were excluded based on intra-abdominal abscess. A total of 13 patients (26%) were temporarily ineligible due to recent biologic switch and would have required an 8-week washout prior to trial enrolment. Only two patients were excluded based on age (&gt;80 years).

Conclusion
Although most patients on ustekinumab or vedolizumab would have been eligible for the respective pivotal trials, patients who have complications of disease, extensive surgery, or altered anatomy are not reflected in current RCTs.
P644 Impact of Postoperative Treatment with Immunomodulators and Anti-TNFα agents on long-term Reoperation Rate in ileocaecal Crohn’s Disease
Authors: Aratari A , Scribano M L , Baccolini V , Pugliese D , De Biasio F , Verna S , Morretta C , Armuzzi A , Festa S , Papi C 
Published: January 2022

Abstract

Background
Several observations suggest that immunomodulators (IMMs) and anti-TNFα agents can affect long-term clinical course of Crohn’s disease (CD). However, no convincing surgery-sparing direct effect of these medications has been demonstrated in large population-based studies. Failure to optimize these treatments, particularly a limited use in early disease course, may explain the underperformance of these strategies in the clinical practice setting. Early introduction of IMMs/anti-TNFα in CD after surgery, either as prevention of recurrence or as treatment of early endoscopic recurrence, has become a common clinical practice and may represent a surrogate model of early treatment.
The aim of the present study was to evaluate the impact of IMMs/anti-TNFα on the long-term post-operative course after ileocaecal resection in CD patients.

Methods
All adult CD patients who underwent their first ileocaecal resection at three major referral Centers in Rome were retrospectively reviewed.
Demographic and clinical characteristics were recorded: gender, age at the time of surgery, CD behaviour (penetrating or non-penetrating), previous treatment with IMMs/anti-TNFα, and time to prescription of IMMs/anti-TNFα after surgery.
The primary endpoint was the need for second resection.
Statistical analysis. The Kaplan–Meier survival method was used to estimate the cumulative probability of first prescription of IMMs/anti-TNFα after surgery and to estimate the post-operative course free from reoperation. Cox proportional hazards regression model was used to assess the association of clinical variables with time to reoperation.

Results
surgery: cohort 1 (1980–1998; n.198); cohort 2 (1999–2009; n.218); cohort 3 (2010–2020; n.241). The mean follow-up after surgery was 83 + 41 months. The cumulative probability of receiving IMMs/anti-TNFα after surgery was significantly different between the three cohorts but the probability of a postoperative course free from reoperation was not (figure). In the multivariate analysis, treatment with IMMs/anti-TNFα prior to the first resection (HR 9.15; 95%CI 2.77–30.21) and post-operative therapy with IMMs/anti-TNFα (HR: 0.24; 95%CI 0.07–0.74) were associated to the risk of reoperation. However, these associations had a time-varying effect and become not significant after 5 and 2 years after surgery respectively. Overall, 283 patients received IMMs/anti-TNFα at any time after surgery. Comparing early treatment (within 1, 2 or 3 years after surgery) with late treatment, no difference was observed in the cumulative risk of reoperation within 10 years

Conclusion
The increasing use of IMMs/anti-TNFα agents in the post-operative setting may have little impact on the long-term reoperation rate.
P652 The burden of mental illness, including deliberate self-harm, before and after a diagnosis of IBD, a UK population study
Authors: Umar D N , Harvey P , King D , Chandan J , Adderley N , Nirantharakumar K , Trudgill N 
Published: January 2022

Abstract

Background
The burden of mental illness among IBD patients is recognised to be greater than among their healthy peers. Due to the bi-directional influence of the gut-brain axis,mental health may be linked to IBD outcomes and vice versa.
The aim of this study was to use population level data to describe the incidence of anxiety, depression, insomnia, severe mental illness and deliberate self-harm in patients with IBD.

Methods
A retrospective cohort study was conducted using The Health improvement Network (THIN) database to estimate the incidence rates of anxiety, depression, insomnia, severe mental illness and deliberate self harm in patients with IBD between 1995 to 2021 and matched controls with no pre-existing mental health illness.The prevalence of pre-existing depression, anxiety and insomnia prior to IBD diagnosis was assessed for IBD patients and matched controls.The association between deliberate self harm and incident mental health diagnoses following IBD diagnosis were estimated using Cox regression analysis.

Results
We identified 59,613 incident cases of IBD,34,615 (58.1%) had UC and 25,000 (41.9%) had Crohn’s disease. The median age was;41.5 (IQR 29.6–57.5) years,with an equal proportion of males and females with IBD (49.2% vs 50.8%).
Patients with a diagnosis of IBD had an increased prevalence of anxiety 10 years (3.0% vs 2.5%,p&lt;0.001) and 2 years prior to diagnosis (6.2% and 5.3%,p&lt;0.001). A similar pattern was seen for insomnia at 10 years (1.0% vs 0.9%, p=0.028) and 2 years (3.4% vs 3.0%, p&lt;0.001) and for depression at 10 years (3.7% vs 4.5%, p&lt;0.001) and 2 years (8.1% vs 9.6%, p&lt;0.001).
The incidence of mental illness was higher in IBD patients than controls for; anxiety [6.1 vs 5.3 per 1000 patient years,HR 1.14(1.09–1.20),p&lt;0.001], depression [11.3 vs 7.5 per 1000 patient years,HR 1.34 (1.28–1.39),p&lt;0.001], insomnia [9.6 vs 6.0 per 1000 patient years,HR 1.54(1.5–1.6),p&lt;0.001] and DSH [1.6 vs 1.2 per 1000 patient years,HR 1.20(1.07–1.35),p&lt;0.001].
Associations of deliberate self harm in this patient groups included: IBD (HR 1.20(1.07–1.35),p=0.002),female gender (HR 1.06(1.35–1.60),p&lt;0.001),age quintile &lt;27.4 years (HR 4.48(3.95–5.93),p&lt;0.001) compared to &gt;61.3 years,anxiety (HR 1.57(1.35–1.82),p&lt;0.001),depression (HR 5.97(5.33–6.69),p&lt;0.001),insomnia (HR 2.32(2.02–2.66),p&lt;0.001), and severe mental illness (HR 5.74(4.56–7.22),p&lt;0.001).

Conclusion
There is an additional burden of mental illness in patients who are later diagnosed with IBD. Following diagnosis,the incidence of depression, anxiety, insomnia and deliberate self harm is higher in individuals with IBD than controls.Patients who develop mental illness in the setting of IBD are at particularly high risk of deliberate self-harm.
P661 Pre-diagnostic vitamin D levels in Inflammatory Bowel Disease
Authors: Widbom L , Fahlander S , Stefansson K , Karling P , Hultdin J 
Published: January 2022

Abstract

Background
Vitamin D has been implicated in the pathogenesis of inflammatory bowel disease (IBD), suggested by a geographical north-south gradient in risk for IBD. IBD patients have also been shown to have lower 25(OH) vitamin D (25(OH)D3) compared to healthy subjects. In contrast, prospective studies on pre-diagnostic samples, including one with late-onset IBD (n=241), have not found any differences. The aim of our study was to study 25(OH)D3 levels in subjects later developing IBD, including late-onset cases.

Methods
In this nested case-control study, 171 individuals who later developed IBD and 337 controls (matched for age, sex, and time and place for inclusion) were included. The study population was included from the Northern Sweden Health and Disease Study (NSHDS), and the Northern Sweden Maternity Cohort (RUB). Both with the catchment area being above latitude 63°N (based in Umeå, Sweden). 25(OH)D3 concentrations were analysed with LC-MS/MS on plasma collected at least one year before IBD diagnosis and compared between cases and controls using conditional logistic regression.

Results
Results are shown in tables 1–3. Baseline characteristics are presented separately for NSHDS (Table 1) and RUB (Table 2). For NSHDS and RUB cases, median ages were 50.1 and 25.3 years respectively, and median 25(OH)D3 levels 52.9 and 52.3 nmol/L respectively. There were no differences compared to matched controls. Conditional logistic regression (Table 3) for vitamin D levels and risk for developing IBD were made for NSHDS and RUB separately and combined. It was also made separately for Ulcerative Colitis and Crohn’s disease. No differences were shown for the whole group, nor for any of the subgroups.

Conclusion
In pre-diagnostic samples, 25(OH)D3 did not differ between those who later developed IBD and controls. In subgroup analysis separately for RUB (including younger, female individuals) and NSHDS (including late-onset IBD), no differences were seen in either subgroup. This study supports previous findings indicating that vitamin D is not associated with the risk of developing IBD, including late-onset IBD, and that there is no evidence for early malabsorption of vitamin D.
P667 Unmet needs in the management of Inflammatory Bowel Diseases in Egypt
Authors: Khorshid M , Abdel-Gawad M , AbdAllah M , Tag-Adeen M , Afify S , El Deeb R , Elshaarawy O , Elbasiony M , Bassuny A N , El-Raey F , Fathy H , ElShabacy O , Cordie A , Abdelmoaty A , Elbahr O , Ali-Eldin Z , Alboraie M 
Published: January 2022

Abstract

Background
Despite the progress in the management of inflammatory bowel diseases (IBD), there are still notable unmet needs in middle- and low-income countries. Defining those unmet needs will help improve patients’ care and quality of life. In this survey, our objective was aimed at exploring the current practice of physicians managing IBD patients in Egypt and the unmet needs in diagnosis, treatment, and medical education.

Methods
A web-based survey was designed. It was sent to clinicians via emails and followed up to track response rate. The survey was composed of six domains collecting demographic data, modalities used to diagnose patients with IBD, barriers, and challenges in managing IBD patients, availability of different diagnostic modalities and complementary specialties and policies to improve IBD care in Egypt, and finally the physicians’ needs and challenges in IBD training.

Results
Two hundred and eighty-eight physicians completed the survey. The mean age (±SD) was 36.22(±7.40) years and 69.44% were males. Endoscopic findings and histopathological examination were the most commonly used methods for IBD diagnosis (84.72% and 82.29% respectively). The most common challenges to IBD diagnosis in Egypt were the low availability of IBD multidisciplinary teams and non-informative histopathological reports (55.55% and 50.34% respectively). Expensive medications and poor adherence to therapy were the most important patients’ factors leading to poor IBD management (78.47% and 72.22% respectively). Physicians strongly preferred clinical rounds and case presentations rather than lectures and web-based learning (61.2 % versus 51.5% and 47.1% respectively). Most participants agreed that developing guidelines for IBD management, increasing IBD research, establishing patient access programs, and increasing IBD awareness among patients were the most important activities needed to Improve IBD care.

Conclusion
Lack of multidisciplinary/ complimentary teams, expensive medications, and poor adherence to therapy can lead to poor IBD management in Egypt. Developing guidelines for IBD management, increasing IBD research are urgently needed to Improve IBD patients’ care.