bluuebunny/crossref_metadata_2025_split huggingface dataset:
P668 Real world use and adverse events of SARs-CoV-2 vaccination in Greek patients with Inflammatory Bowel Disease
Authors: Orfanoudaki E , Zacharopoulou E , Kitsou V , Karmiris K , Theodoropoulou A , Mantzaris G J , Tzouvala M , Michopoulos S , Zampeli E , Michalopoulos G , Karatzas P , Viazis N , Liatsos C , Bamias G , Koutroubakis I E 
Published: January 2022

Abstract

Background
Since inflammatory bowel disease (IBD) patients were excluded from vaccine authorization studies, limited knowledge exists regarding perceptions for and unfavorable effects of COVID-19 vaccination in this group. The aim of this study was to investigate the real world use and adverse events (AE) of vaccines against COVID-19 in IBD patients.

Methods
Fully vaccinated IBD patients followed in Greek centers were invited to participate in an anonymous online self reporting survey that included information regarding their demographics, clinical characteristics, treatment, vaccination perceptions and potential AEs. Patients were vaccinated with either messenger-RNA or viral vector vaccines that are currently EMA approved. AEs were stated as any kind of new symptom or sign onset, including localized (at the injection site) or systematic ones (fatigue, headache, allergic reactions, fever, lymphadenopathy, myalgias/arthralgias and gastrointestinal disorders).

Results
A total of 1007 IBD patients [male 50.5%, median age (IQR) 44 (35–55) years, Crohn’s disease 64.3%, history of COVID-19 infection 2.6%] who completed the survey after they have fulfilled their vaccination program were included. Detailed demographics and clinical characteristics of the study population are presented in Table 1.
More than half of the patients (51%) stated that they show confidence in vaccination whereas the rest although reluctant/hesitant admitted the protection it offers. The median (IQR) time between 2nd vaccine dose and questionnaire completion was 15 (5–43) days. There were no serious AEs leading to emergency room visit or hospitalization. Total AEs were reported by 81% after dose 1 (D1) and 76% after dose 2 (D2), reduced to 44% and 51% when excluding isolated injection site reactions respectively. Systemic AEs were more common after D2 (P&lt;0.0001). Very few patients reported new onset abdominal symptoms [abdominal pain 4% (D1), 6% (D2) and diarrhea 5% (D1), 7% (D2)].
In the multiple regression analysis AE occurrence was positively associated with young age and female gender after both doses, whereas inactive disease was negatively associated with AE only in D1 (p=0.044). No association with the use of medications including advanced therapy was found (p&gt;0.05), except from corticosteroids after D2 (p=0.003) but it was a small (32/1007 patients) heterogenous (monotherapy, double or triple immunosupression) sample to draw conclusions.

Conclusion
The presence of SARs-CoV-2 vaccination AEs in Greek patients with IBD is similar to the reported in other populations. Young age and female gender but not IBD related medications are associated with the development of AEs after both doses.
P669 Validation of prior infliximab exposure and total colectomy outcome in patients with ulcerative colitis in Sweden
Authors: Huang Z , Hill D , Bengtsson C , Wang M , Hakkarainen K M , Hellström P M 
Published: January 2022

Abstract

Background
Clinical procedures and treatments may be recorded in Swedish national registers with different quality levels. The study objective was to assess the prevalence of any prior exposure to infliximab (IFX) treatment and validate register data of prior IFX exposure and first occurrence of total colectomy (TC) in ulcerative colitis (UC) patients using electronic medical records (EMR) as the reference.

Methods
Prior IFX exposure (from Swedish Prescribed Drug Register (SPDR) and National Patient Register (NPR)) and first occurrence of TC (from NPR) were validated against EMR data from 6 hospitals in 3 Swedish counties (Stockholm, Uppsala and Dalarna). UC patients (UC cohort) were identified from EMR between 19 Sep 2013 and 31 Dec 2018, from which 3 drug initiation sub-cohorts were formed: 1. Golimumab (GLM) as recorded in SPDR; 2. Adalimumab (ADA) as recorded in SPDR; 3. GLM, IFX, ADA or thiopurines as recorded in SPDR or IFX recorded in EMR or NPR (Super cohort).
For prior IFX exposure, the look-back period was any time before cohort entry (at drug initiation) for as long as historical data were available. For the outcome of TC, the follow-up period was from cohort entry until 31 Dec 2018. EMR data were linked to SPDR/NPR data using unique person identification numbers. Validity was assessed based on 4 parameters: sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV). In addition, prevalence of prior IFX exposure was assessed.

Results
Mean age of UC cohort was 47.5 years and males comprised 51.6%. Using EMR data alone; and combined data sources (EMR and SPDR/NPR), prevalence of prior IFX exposure was higher in the GLM cohort (33.0%; 38.6%) vs. ADA cohort (26.7%; 31.4%), respectively.
For validation of prior IFX exposure in SPDR/NPR, sensitivity was low in both GLM (3.4%) and ADA (5.9%) cohorts, as was PPV (GLM: 16.7%; ADA: 25.0%). The specificity (GLM: 91.5%; ADA: 93.6%) and NPV (GLM: 65.9%; ADA: 73.2%) were relatively high.
Most validation parameters for TC were very high in UC and Super cohorts (UC: sensitivity 100.0%, specificity 99.6%, NPV 100.0%; Super cohort: sensitivity 100.0%, specificity 98.8%, NPV 100.0%), with slightly lower PPV (UC: 80.6 %; Super cohort: 75.6 %).

Conclusion
Prevalence of prior IFX exposure was higher in UC patients initiating GLM vs. initiating ADA therapies. As expected, SPDR/NPR had an incomplete capture of prior IFX exposure, since IFX was intravenously administered in hospitals and not registered in SPDR/NPR. EMRs were most valid data sources for hospital administrated drugs. In contrast, all validation parameters for TC were high, indicating that the TC outcome identified from the NPR was highly valid.
P675 Associations between Inflammatory Bowel Disease, social isolation, and mortality: evidence from UK Biobank cohort study
Authors: Chen J , Geng J , Wang J , Fu T , Sun Y , Chen H , Chen X , Wang X , Hesketh T 
Published: January 2022

Abstract

Background
Social well-being of patients with inflammatory bowel disease (IBD) is garnering increased attention; however, the impact of social isolation remains poorly understood. We investigated whether patients with IBD are at a higher risk of social isolation, and whether any such isolation is associated with increased mortality.

Methods
We investigated 489,731 participants from UK Biobank (including 5,671 with IBD); the mean follow-up was 11.63 years. Diagnoses of IBD and its subtypes of Crohn’s disease (CD) and ulcerative colitis (UC) were confirmed with the combination of self-reporting, primary care, and hospital admission data. Social isolation was measured by the frequency of meeting family/friends, leisure and social activity, and communal/solitary living. Mortality was ascertained through data linkage with national death registries. Logistic regression was used to calculate the association between social isolation and IBD. The association between social isolation and mortality was investigated using multivariable Cox regression models.

Results
In the fully adjusted model, CD (odd ratio [OR]=1.24, 95% CI: 1.07, 1.42, P=0.003) was cross-sectionally associated with social isolation, whereas UC was not (OR=0.99, 95% CI: 0.89, 1.11, P=0.875). Social isolation was prospectively associated with an elevated risk of incident mortality among patients with CD (HR=2.09, 95% CI: 1.51, 2.89, P&lt;0.001), but not among those with UC (HR=1.28, 95% CI: 0.94, 1.76, P=0.121). Data from subgroup and sensitivity analyses were consistent with those from the primary analysis.

Conclusion
Patients with CD are more likely to be socially isolated. Socially-isolated patients with CD increases the risk of premature death.
P704 Bifidobacterium longum species protect murine colitis through different activation repertoires of immune cells
Authors: Kim J H , Seul P I , Mijeong S , YooJin S , Kibeom K , Hyun Woo M , Tae Il K , Won Ho K , Seung Won K , Jae Hee C 
Published: January 2022

Abstract

Background
Inflammatory bowel disease (IBD) is a chronic disease that causes an inappropriate immune response due to genetic and environmental factors. The scientific interest in mechanisms of probiotics are world-widely growing. Bifidobacterium plays an essential role in the maturation of the immune system, and the prevention of colitis and tumor. However, only limited reports on bifidobacterium isolated to prevent colitis and their exact mechanisms of action remain poorly understood. This study identifies the different anticolitic effects between B. breve strain and Bifidobacterium longum (B. longum) strain, the most abundant probiotic strains in lactating babies. We explore the different activation repertoire of the immune cell according to Bifidobacterium species and the mechanisms in these processes.

Methods
We administrated B. breve and B. longum ATCC by oral gavage 1×109 CFU to RAG1 KO mice. Colitis was induced with 2.5% DSS for 7 days. To assess the direct role of B. longum on ILCs, ILCs from B. breve- and B. longum-treated wild-type mice were transferred to RAG1 KO mice. We observed daily weight loss, stool consistency, and rectal bleeding of mice and transformed to the disease activity index (DAI) scores. Macrophages and T-cell subsets in splenocytes, lamina propria cells were analyzed by flow cytometry. Gene expression and cytokine profiles were determined using qRT-PCR. We performed whole-genome sequencing of reactive oxygen species (ROS)-resistant B. longum species using DNA full-sequencing analysis.

Results
The two functional strains of B. breve and B. longum ameliorate gut immunopathology during colitis in RAG1 knockout mice. However, B. longum but not B. breve, drastically restored body weight loss, DAI, and colon length compared to B. breve-treated group. We found that the anticolitic effect of B. longum is specialized by modulation of ILCs. Newly identified B. longum strain from the feces of healthy adults has ROS resistance even though it is anaerobic bacteria. The new B. longum strain exhibits ANI values of 94.92% with respect to B. longum ATCC 15697. The new B. longum strain has a strong colonization ability and improves DSS-induced colitis in the wild-type mice than other strains. Our data revealed genus-specific effects of bifidobacteria on colonization in the colon, and ILCs, thus discriminating a differential degree of modulation of immune cells.

Conclusion
We explore the different activation repertoire of the immune cell according to Bifidobacterium species and the mechanisms in these processes. These findings suggest that B. longum can be used as a potent immunomodulatory of ILCs, which has significant implications for IBD treatment.
N05 Patient involvement in Inflammatory Bowel Disease therapy and disease-related parameters - Is there an association?
Authors: Haj Natour O , Magnezi R , Ben Horin S , Lipkin M , Ungar B , Galper A , Sina S , Kopylov U 
Published: January 2022

Abstract

Background
Recent studies have demonstrated the importance of involving patients afflicted by a chronic disease in their own medical therapy with respect to disease control, compliance and general quality of life. Patient activation refers to patients’ independence in daily activities, involvement in the therapeutic process and having the knowledge, skills, and confidence to manage their health and health care. This study examined the association between the degree of activation of patients with inflammatory bowel disease (IBD) and its effect on health indices

Methods
This prospective longitudinal study included patients with Crohn’s Disease (CD) or ulcerative colitis (UC) treated at Sheba Medical Center, Israel. The patients answered questionnaires weekly during a period of 8 months using an application installed on their personal mobile phone. The questionnaires addressed clinical and emotional disease parameters, patient’s sense of disease-control (IBD-control), quality of life (short IBD quality of life questionnaire (S-IBDQ) and patient activation measure (PAM), a 4-level model of health behavior. The lowest level indicates that the patient may not believe his/her role in self-care management is important; the second level indicates that the patient lacks confidence or knowledge to take an active role; the third level indicates that the patient is beginning to be active; and the at highest level, patients actively attempt (even with difficulty) to maintain health management behaviors over time. Demographic and medical information, as well as clinical data were retrieved from the medical records.

Results
Among 356 IBD patients, 208 (58%) answered all questionnaire items and were included in the study 159 (76%) had CD, and 49 (24%) UC, 116 (56%) women and 92 (44%) men). Median scores of the questionnaires were as follows: PAM -63, IQR- 52.9–70.8; SIBDQ- median 44, interquartile ratio (IQR) 40–75; IBD-control 62.4, IQR- 45.7–82. 2 IBD-control mental health component- 47, IQR- 41.1–53.3). PAM was significantly correlated with questionnaires associated with overall well-being, emotional status and quality of life (SIBDQ -r=0.34 p=0.0001, IBD-control -r=0.24, p=0.004 and PROMIS-mental health component r=0.48, p&lt;.0001). There was no significant correlation between PAM and inflammatory markers (C-reactive protein- r=0.09, fecal calprotectin - r=0.12).

Conclusion
Intensive weekly mobile-App based monitoring program was feasible and adhered to by most patients. PAM scores correlated significantly with their sense of disease-control and mental health scores. Hence, IBD patients’ involvement in medical therapy increases their self-management, sense of disease-control and emotional well-being.
N14 Who can do it, if not me? - Identification of biopsychosocial predictors for the quality of life, satisfaction with life, and acceptance of the gastrointestinal disease
Authors: Rudnik A , Piotrowicz G , Piotrowicz A , Bidzan M , Rydzewska G 
Published: January 2022

Abstract

Background
Both IBS and inflammatory bowel diseases (including ulcerative colitis, UC, and Crohn’s disease, CD) are disorders that impact patients’ physical and mental health. Psychological factors play a special role in their course as well as in coping with symptoms and the treatment process. Hence, there is a huge need for a holistic approach to patients, based on their psychological resources.

Methods
In total 104 patients (N = 104), 58 women and 46 men suffering from IBS (35), UC (33), or CD (36) participated in the study. The average age equaled 32.56 years (SD = 11.04) and the average duration of the disease was 8.5 years (SD = 6.9). The structured questionnaires such as the Quality of Life SF-36v2 Questionnaire - the Polish version, the Satisfaction with Life Scale SWLS (Diener, Emmons, Larson, Griffin, Polish adapt. by Juczynski), the Acceptance of Illness Scale AIS (Felton, Revenson, Hinrichsen, Polish adapt. by Juczynski), the Generalised Self Efficacy Scale GSES (Schwarzer, Jerusalem, Juczynski), and the author’s own survey were used for data collection.

Results
Hierarchical regression analyses were performed to investigate whether psychological factors play a predictive role for the physical and mental components of quality of life and the sense of life satisfaction. Regression analysis showed that the independent variables in step 1 accounted for 0.3% of the variance of the sense of life satisfaction (F2.101 = 0.175, p = 0.840). The independent variables added in step 2 further explained 18.5% of the variance (F6.95 = 3.608, p = 0.003). The independent variables added in step 3 further explained 8.3% of the variance (F4.91 = 2.607, p = 0.041). Independent variables accounted for a total of 27.2% of the variance of the sense of satisfaction with life (F12.91 = 2.831, p = 0.002). The significant independent variables in step 3 were generalized self-efficacy and disease acceptance, indicating that patients convinced of their own effectiveness and accepting their disease achieved higher scores in terms of the sense of satisfaction with life.

Conclusion
Two predictors were identified as a result of the study. It has been shown that the acceptance of illness is a predictor of patients’ sense of life satisfaction as well as the physical and mental component of quality of life. The second predictor for the sense of satisfaction with life is generalized self-efficacy, which is also a predictor for the acceptance of the illness. The results of the study allow for the creation of individually tailored therapeutic programs to improve patients’ quality of life.
N15 Feedback from adolescents and parents on the transition process to an Irish Adult IBD service
Authors: Hamzawi M , Brannick S , Hickey Y , Jones F , Brett Kilmurray O , Sheridan J , Cullen G 
Published: January 2022

Abstract

Background
A nurse-led service improvement project has implemented a structured MDT model of transition for adolescents transitioning their IBD care to adult service in a tertiary hospital over a two-year period. Guidelines recommend obtaining service user and carer/parent perspectives on the process and identifying when additional emotional and psychological support is required. This had not been completed to date by the service.

Methods
Adolescents (13) and their parents/carer (7) who have been attending the service for 1 year were invited to complete a service-designed, patient experience questionnaire to determine how well they have adapted to adult services. Items from The Brief Illness Perception Questionnaire (B-IPQ) were used to measure how participants understand and are impacted by their IBD. Negative illness perceptions are associated with anxiety, depression and poor quality of life.

Results
Of the 13 responses from adolescents 85% felt ready to leave children’s services at time of transfer compared to 71% of the parents. 87% of parents had concerns re transfer compared to 31% of adolescents.92% of the adolescents felt they had a chance to talk about their concerns and would also be happy to individually contact the IBD nurses with questions. Only 23% would like the IBD nurses to contact parents directly for information/medical updates. A common theme in the open-ended questions for both the adolescents and parents was the change in responsibility with the questions being directly asked to the adolescent and they are now the point of contact for the service. The most common topics for more information were fatigue, stress, diet, and getting this from a website or individually were the preferred methods. When attending clinic appointments adolescents always want to see a doctor but would like the opportunity to meet with the IBD nurse, dietitian and psychologist when required and 85% would consider using an online self-booking system if available. 50%of the adolescents reported their IBD affected them emotionally and were concerned about their illness.

Conclusion
Parents had greater concerns than their children regarding transition. Since moving to the adults services the adolescents attending can express their concerns and will independently contact the service. The service needs to consider providing more information about the topics requested and support in infusion services. The introduction to the IBD service of the patient information booklet, dedicated adolescent clinics, pre attendance MDT introduction meetings helped create a positive experience for the adolescents and parents. The MDT model of transition may help facilitate an individualised intervention pathway to address concerns and improve outcomes for this group.
Association between MTHFR C677T and A1298C gene polymorphisms and maternal risk for Down syndrome
Authors: Ginani Carla Talita Azevedo , Luz Jefferson Romáryo Duarte da , Silva Saulo Victor e , Coppedè Fabio , Almeida Maria das Graças 
Published: January 2022

Abstract

Background:
Down syndrome (DS) is one of the most common chromosomal abnormalities among live-born babies and one of the best-known intellectual disability disorders in humans. Errors leading to trisomy 21 are primarily arising from defects in chromosomal segregation during maternal meiosis (about 88% of cases), and the focus of many investigations has been to identify maternal risk factors favoring chromosome 21 malsegregation during oogenesis. Maternal polymorphisms of genes required for folate metabolism are the most investigated risk factors for the birth of children with DS. Through this review, we sought to investigate the association of the polymorphisms “C677T” and “A1298C” of the MTHFR gene with maternal risk for DS.

Methods:
We will use the databases PubMed, Embase, Scopus and Web of Science to search for case-control studies published from 1999 up to September 2021 without language restriction. Results will be presented as relative risks and 95% confidence intervals for dichotomous outcomes and mean differences, or standardized mean differences along with 95% confidence intervals, for continuous outcomes. The all data synthesis will be analyzed on the Review Manager 5.2 version software.

Results:
This study will be able to clarify all the doubts we seek and that it will be able to provide accurate data that will be able to describe how these polymorphisms can act to increase the predisposition for the birth of children with DS in different populations and under different dietary conditions.

Conclusions:
This study will clarify the relationship between C677T and A1298C polymorphisms MTHFR gene with increased the maternal risk for Down syndrome.

Registration:
This systematic review and meta-analysis protocol has been registered on the Prospective Registry of International Systematic Review and Meta-analyses: CRD42021269338.
LigaSure hemorrhoidectomy versus the procedure for prolapse and hemorrhoids
Authors: Zhang Leichang , Xie Yufang , Huang Derong , Ma Xiaofei , Wang Wanchun , Xiao Huirong , Zhong Wu 
Published: January 2022

Abstract

Background:
LigaSure hemorrhoidectomy and the procedure for prolapse and hemorrhoids (PPH) are both relatively new treatments for managing symptomatic hemorrhoids. This review aimed to evaluate and compare their short-term outcomes.

Methods:
We searched MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials and the China National Knowledge Infrastructure database for randomized controlled trials comparing the LigaSure procedure and PPH published in any language from 1998 to October 2013.

Results:
A total of 5 studies involving 397 participants were included in this review. Pooled analysis showed that the LigaSure procedure was associated with significantly lower recurrence rate [relative risk (RR) = 0.21, 95% confidence interval (CI): 0.06 to 0.72, P = .01] and significantly shorter operating time [mean difference (MD) = −6.39, 95% CI: −7.68 to −5.10, P < .001]. The analysis showed no significant difference in postoperative pain between the two techniques (MD = 0.55, 95% CI: −0.15 to 1.25, P = .12] or in time off work or away from normal activity [standard MD = 0.13, 95% CI: −1.80 to 2.06, P = .9]. The two techniques did not show significant differences in postoperative complications or other patient-related outcomes (P > .05).

Conclusions:
Our review indicates that both LigaSure hemorrhoidectomy and PPH are safe alternatives for the management of hemorrhoids. Available evidence suggests that the LigaSure technique is associated with shorter operating time and lower hemorrhoid recurrence rate, but these conclusions should be further confirmed in large, multicenter randomized controlled trials with long-term follow-up.