bluuebunny/crossref_metadata_2025 huggingface dataset:
P643 Generalizability of Crohn’s disease randomized controlled trials compared to clinical practice
Authors: Chhibba T , Frolkis A , Ma C
Published: January 2022

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 (>=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 (>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

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

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<0.001) and 2 years prior to diagnosis (6.2% and 5.3%,p<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<0.001) and for depression at 10 years (3.7% vs 4.5%, p<0.001) and 2 years (8.1% vs 9.6%, p<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<0.001], depression [11.3 vs 7.5 per 1000 patient years,HR 1.34 (1.28–1.39),p<0.001], insomnia [9.6 vs 6.0 per 1000 patient years,HR 1.54(1.5–1.6),p<0.001] and DSH [1.6 vs 1.2 per 1000 patient years,HR 1.20(1.07–1.35),p<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<0.001),age quintile <27.4 years (HR 4.48(3.95–5.93),p<0.001) compared to >61.3 years,anxiety (HR 1.57(1.35–1.82),p<0.001),depression (HR 5.97(5.33–6.69),p<0.001),insomnia (HR 2.32(2.02–2.66),p<0.001), and severe mental illness (HR 5.74(4.56–7.22),p<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

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

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.
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

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<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>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

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

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<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

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

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<.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

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

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

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

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.
Treatment of myasthenia gravis with the method of tonifying spleen and replenishing qi in traditional Chinese medicine
Authors: Jiang Li , Xu Peng , Zhang Dongmei , Lu Jing , Chang Tianying , Zhang Yinbin , Wang Jian
Published: January 2022

Background:

Myasthenia gravis (MG) is an autoimmune disease that is associated with the production of autoantibodies. The symptoms of MG are mainly mediated by pathogenic antibodies directed against nicotinic acetylcholine receptors, resulting in a decrease in the number of acetylcholine receptors molecules on the postsynaptic membrane of the neuromuscular junction endplate, leading to clinical symptoms of muscle fatigue and weakness. At present, traditional Chinese medicine (TCM) treatment of MG has a better effect by tonifying spleen and replenishing qi. The purpose of this study was to systematically evaluate the efficacy and safety of TCM therapy for tonifying spleen and replenishing qi in the treatment of myasthenia gravis.

Methods:

We searched the following databases from their establishment until December 2021: PubMed, Cochrane Library, EMBASE, Web of Science, Springer, CNKI, Wanfang, China Biomedical Database, China Science and Technology Journal Database, Chinese Knowledge Infrastructure, China Clinical Trial Registry, and Baidu Scholars. The literature search language was limited to Chinese and English, and publication time and status were not limited. Randomized controlled trials (RCTs) were included. Two researchers independently searched and screened the articles, assessed their quality, and used the RevMan 5.4.1 software to perform a meta-analysis of the included literature.

Results:

This study compared the main outcome indicators: efficacy rate, recurrence rate, quality of life, and quantitative myasthenia gravis (QMG). Secondary outcome indicators were the clinical absolute score, TCM syndrome score, serum acetylcholine receptor antibody level, and electromyogram low-frequency repetitive nerve stimulation.

Conclusion:

This study aimed to evaluate whether the TCM method of tonifying spleen and replenishing qi is effective in the treatment of MG and to provide evidence-based data.

Ethics and dissemination:

The protocol of the systematic review did not require ethical approval because it did not involve human subjects. This article will be published in peer-reviewed journals and will be presented at conferences.
Characteristics and survival outcomes of primary splenic cancers
Authors: Lei Yanna , Huang Qian , Li Xiaoying , Zheng Xiufeng , Liu Ming
Published: January 2022

Primary splenic cancers represent a small number of cancer cases and studies on its clinicopathological features and outcomes are limited. Splenic lymphomas and primary splenic angiosarcoma (PSA) are the 2 most common histological types of splenic cancers. This population-based study aimed to investigate the clinical characteristics and survival outcomes of patients with splenic lymphomas or PSA.

Patients diagnosed with splenic lymphomas or PSA between 2000 and 2015 were identified from the Surveillance Epidemiology and End Results database of the National Cancer Institutes. Overall survival (OS) and cancer-specific survival (CSS) rates were calculated using the Kaplan–Meier method. A Cox proportional hazard models were used to identify independent predictors of cancer-specific mortality.

A total of 700 patients with splenic lymphoma and 48 patients with PSA were included in this study. The median age of patients with splenic lymphoma was 65 years and 57 years for patients with PSA. For patients with splenic lymphoma, the most prevalent histological subtypes were splenic marginal zone lymphoma and diffuse large B-cell lymphoma. A total of 52.6% of the cases had stage IV disease based on the Ann Arbor staging system. Five-year OS and CSS were 76.9% and 83.4%, respectively. Multivariate analysis revealed that independent predictors of splenic lymphoma CSS included race, stage, chemotherapy, and histological subtype. However, a much shorter OS time was seen in the PSA cohort which had a 5-year OS of 11.8%, a median OS of 10.0 months and the 5-year CSS of 12.4%. Chemotherapy was correlated with better outcomes in patients with PSA. However, the survival benefits of surgery for splenic cancer were not statistically significant in our study.

The current study is the largest cohort of primary splenic cancer presented in literature based on the Surveillance Epidemiology and End Results database and our large series describe the characteristics and survival outcomes of such rare diseases which may provide reliable information for further studies and clinicians.
High expression of HOXB7 is an unfavorable prognostic factor for solid malignancies
Authors: Zhou Ting , Feng Zonghao , Yang Fan , Zhu Weipeng , Cao Jiashun , Hou Xianming , Zhao Yue , Chen Donghong
Published: January 2022

Background:

HOXB7 is abnormally expressed in a variety of tumors, but its prognostic value remains unclear due to sample size limitation and outcome inconsistency in previous studies. This meta-analysis was performed to explore the effect of HOXB7 expression on prognoses and clinicopathological factors in range of the whole solid tumors.

Methods:

PubMed, EMBASE, and Web of Science databases were searched to identify included studies. Hazard ratios (HR) with its 95% confidence interval (CI) and clinicopathological factors were extracted. Subgroup analyses were performed according to histopathological type, tumor occurrence systems, and HOXB7 detection methods.

Results:

A total of 3430 solid tumors patients from 20 studies (21 cohorts) were included in the meta-analysis. The results showed that high HOXB7 expression was significantly associated with worse survival (overall survival: HR = 1.98, 95%CI: 1.74–2.26, P < .001 and disease-free survival: HR = 1.59, 95%CI: 1.21–2.09, P = .001), more advanced tumor-node-metastasis (TNM) stage (odds ratio [OR] = 2.14, 95%CI: 1.68–2.73, P < .001), positive lymph node metastasis (OR = 2.16, 95%CI: 1.74–2.70, P < .001), more distant metastasis (OR = 1.63, 95%CI: 1.01–2.63, P = .048), poorer differentiation (OR = 1.48, 95%CI: 1.14–1.91, P = .003), and higher Ki-67 expression (OR = 2.53, 95%CI: 1.68–3.84, P < .001). Subgroup analysis showed that survival of patients with HOXB7 high expression was worse in either squamous cell carcinomas or non-squamous cell carcinomas, digestive tumors or non-digestive tumors, and protein level or mRNA level.

Conclusion:

High HOXB7 expression might be a valuable biomarker of poor prognosis for solid tumors. HOXB7 promotes tumor proliferation and metastasis, and is associated with poorer differentiation, more advanced stage, even the chemotherapy resistance, suggesting that HOXB7 is a potential therapeutic target for solid tumors.
Application of fecal microbial transplantation in hepatic encephalopathy after transjugular intrahepatic portosystemic shunt
Authors: Li Jun , Wang Dan , Sun Jingping
Published: January 2022

Rationale:

Transjugular intrahepatic portosystemic shunt (TIPS) is mainly used to treat acute and chronic esophageal, gastric, and intestinal variceal bleeding and refractory ascites caused by portal hypertension. The most common complication of TIPS is the development of hepatic encephalopathy (HE). Fecal microbiota transplantation (FMT) is an emerging method for treating diseases by altering the intestinal flora. We present 2 cases of FMT that ameliorated liver function and HE after TIPS.

Patient concerns:

In this report, 2 patients with liver cirrhosis secondary to hepatitis B had recurrent Grade 2-3 HE after TIPS.

Diagnosis:

Two patients were diagnosed as having HE.

Interventions:

The 2 patients separately received 3 times of FMT.

Outcomes:

The liver function of both patients improved, the clinical symptoms were relieved, and the number of HE attacks decreased significantly after FMT.

Lessons:

FMT may be another effective way to treat HE, and is worthy of further research.
Severe vaginal bleeding due to vaginal metastasis from renal cell carcinoma with inferior vena cava tumor thrombus
Authors: Geng Zhihai , Zhang Qinghua , Jia Peng , Miao Jia , Lin Qian
Published: January 2022

Rationale:

Renal cell carcinoma (RCC) is the most common type of kidney cancer and is the second most common urologic neoplasm. Vaginal metastasis from RCC is extremely rare clinically.

Patient concerns:

A 56-year-old woman presented with intermittent vaginal bleeding that had persisted for 1 month. Enhanced computed tomography examination suggested a vaginal mass (3 × 2 × 2 cm), right kidney tumor (15 × 12 × 10 cm), and an inferior vena cava tumor thrombus. During gynecologic examination, the mass was necrotic and caused uncontrollable vaginal bleeding.

Diagnoses:

Based on clinical and imaging examinations and the pathology, she was diagnosed as vaginal metastasis from RCC.

Interventions:

The patient received percutaneous transcatheter arterial embolization to stop uncontrollable vaginal bleeding, and then treated with targeted therapy.

Outcomes:

Vaginal bleeding disappeared after interventional embotherapy. However, disease progressed, and the patient died 9 months later.

Lessons:

In cases of vaginal bleeding, the possibility of metastatic renal cell carcinoma should be considered. Percutaneous transcatheter arterial embolization is an effective and novel treatment for uncontrollable vaginal bleeding caused by vaginal metastasis of RCC.
Effects of neuroplasticity in people with knee osteoarthritis
Authors: Iuamoto Leandro Ryuchi , Ito Fábio Luis Kenji , Tomé Thales Augusto , Hsing Wu Tu , Meyer Alberto , Imamura Marta , Battistella Linamara Rizzo
Published: January 2022

Background:

Knee osteoarthritis (OA) is associated with chronic inflammation in somatic structures, which alters sensory afferents and leads to plastic changes in the nervous system.

Methods:

A systematic literature review was carried out, without language restrictions, period, or status of publication. The database used were Medline, EMBASE, Cochrane Library and clinicaltrials.gov. Extra bibliographic references were extracted through the discussion with specialists, and through scientific researches in conference papers.

Results:

The electronic search found 938 articles. When excluding duplicates and applying the inclusion/exclusion criteria, 5 studies were considered: 2 using EEG and 3 using TMS. Significant reduction of EEG activity in the cingulate medium cortex, reduction of conditioned pain modulation (CPM) in studies with EEG, as well as the occurrence of an association between pain and motor response threshold/intracortical pain facilitation in studies with TMS were observed.

Conclusions:

The study contributes to a better understanding of the neurophysiological changes seen in the cingulate medium cortex, decrease in CPM and motor response threshold/intracortical pain facilitation. Advances in neuroplasticity studies may aid in the screening for early diagnosis of knee OA in the future. However, more studies are necessary.