bluuebunny/crossref_metadata_2025_split huggingface dataset:
P672 The escalation of therapy or intervention (ETI) calculator for ulcerative colitis: does it have the potential to help outpatient capacity meet demand?
Authors: Walsh A J , Matini L , Kantschuster R , Lepetyukh M , Simadibrata D , Collins G , Wilson J , Hussain M , Tarafdar A , Brain O , Palmer R , Ambrose T , Satsangi J , Travis S P L 
Published: January 2020

Abstract

Background
Demand for outpatient clinic appointments for ulcerative colitis (UC) often exceeds capacity, since spaces are frequently assigned to routine follow-up of patients who are well. Demand might better be managed by targeting appointments for patients in need of therapeutic decisions. The TrueColours UC (TCUC) Escalation of Therapy or Intervention (ETI) calculator is a potential enabling tool.

Methods
TCUC is a web-based programme based on email prompts linked to validated, disease-specific indices. The ETI Calculator was created after logistic regression showed that patient-reported symptoms (Simple Clinical Colitis Activity Index) and quality of life (IBD Control-8) could calculate the probability of therapy escalation or an urgent intervention during an outpatient appointment (OPA, Figure 1). From June 2018 to August 2019, all OPA for 650 patients using TCUC and under standard OPA follow-up were examined. The probability of escalation at each OPA was calculated using the most recent prior SCCAI and IBD-Control scores (within 2 weeks of appointment). Clinic letters were assessed to determine whether treatment escalation or intervention had occurred during the OPA.

Results
Of 650 patients, 236 had a total of 403 OPAs. 210/403 (52%) of these OPAs resulted in no treatment escalation; 159/403 (40%) had escalation and 34/410 (8%) had de-escalation. An ETI calculator threshold set at 5% estimated probability of treatment escalation would have correctly identified 143/159 (90%) escalation events. 16/159 (10%) escalations were not correctly predicted: 12/16 were escalations of medication (oral 5-aminosalicylic acid, n = 3), azathioprine (2), methotrexate (1), increase infliximab dose (2), adalimumab (3), tofacitinib (1). Other escalations were endoscopy requests (2), dermatology/rheumatology referrals (2). Importantly, 6/16 (38%) had taken steroids within 1 month of data collection. 143/403 (35%) of OPAs could have been deferred using a 5% ETI threshold. In contrast, increasing the ETI threshold to 25% would have allowed 274/403 (68%) OPAs to be deferred but would have resulted in missing an additional 53 escalations.

Conclusion
A model that predicts the likelihood of treatment escalation or intervention during an OPA, based on real-time data entered by patients, has the potential to improve outpatient clinic resource utilisation. The calculator may not be valid to triage patients recently on steroids.
P680 Biological treatment and potential risk of adverse postoperative outcome in patients with inflammatory bowel disease: An open-source expert panel review of the current literature and perspectives
Authors: El-Hussuna A 
Published: January 2020

Abstract

Background
There is widespread concern that treatment with biologics agents may be associated with sub-optimal postoperative outcome after surgery for inflammatory bowel diseases (IBD). We aimed to search and analyse the literature regarding the potential association of biologic treatment on adverse postoperative outcome in patients with IBD. We used the subject as a case in point for surgical research. The aim was not to conduct a new systematic review.

Methods
This is an updated narrative review written in a collaborative method by authors invited through Twitter via the following hashtags (#OpenSourceResearch and #SoMe4Surgery). The manuscript was presented as slides on Twitter to allow discussion of each section of the paper sequentially. A Google document was created which was shared across social media and comments and edits were verified by the primary author to ensure accuracy and consistency.

Results
Forty-one collaborators responded to the invitation, and a total of 106 studies were identified that investigated the potential association of pre-operative biological treatment on postoperative outcome in patients with IBD. Most of these studies were retrospective observational cohorts, 3 were prospective, 4 experimental and 3 population-based studies. These studies were previously analyzed in 10 systematic/narrative reviews and 14 meta-analyses. Type of biologic agents, dose, drug concentration, anti-drug antibodies, interval between last dose and types of surgery varied widely among the studies. Adjustment for confounders and bias control ranged from good to very poor. Only 10 studies reported postoperative outcome according to Clavien-Dindo classification.

Conclusion
Although a large number of studies investigated the potential effect of biological treatment on postoperative outcomes, many reported divergent results. There is a need for randomised controlled trials. Future studies should focus on avoiding the weakness of prior studies we identified. Seeking collaborators and sharing information via Twitter was integral to widening the contributors/authors and peer review for this paper, and was an effective method of collaboration.
P691 Corticosteroids usage in patients with inflammatory bowel disease: Results of a multi-national audit in Asia
Authors: Kim D H , Park D I , Kobayashi T , Ahuja V , Jang B I , Cao Q , Lee Y J , Ran Z 
Published: January 2020

Abstract

Background
The use of corticosteroids (CS) has been a well-established treatment for active Inflammatory bowel disease (IBD). While many investigators have reported the efficacy of CS in treating IBD, systemic CS are often associated with various side-effects. The aim of this study was to investigate the present status of CS usage in Asian patients with IBD.

Methods
Authors reviewed medical records of IBD patients who were regularly followed at multiple centres in South Korea, China, Japan, and India. Patient characteristics including diagnosis, phenotype, severity at diagnosis, and treatment history of CS usage in the prior 12 months were collected using web-based case report form. All cases of CS usage were reviewed of its suitability and were categorised as ‘non-IBD’, ‘appropriate’, and ‘avoidable’ groups.

Results
A total of 1,291 patients (434 Crohn’s disease [CD], 848 ulcerative colitis [UC], and 9 Indeterminate colitis) from 4 countries (18 physicians from 8 hospitals) were reviewed between May and September 2019. Among them, 339 patients (26.3%) received CS during the past year. There was no significant difference in the incidence of CS use between CD and UC patients. Multiple CS exposure over the recent 12 months were identified in 16 patients (4.7%). The mean duration of CS use was 96.5 days. Short-term and long-term side-effects of CS occurred in 21 (6.1%) and 4 (1.2%) patients, respectively. 285 patients (84.1%) were able to reduce the dosage of CS below the prednisolone equivalent of 10mg/day within 3 months from CS initiation without recurrence of the disease. However, 15 patients (4.4%) relapsed after stopping CS. A total of 340 CS used cases were confirmed in the 339 patients when cases with undeterminable suitability of its use were excluded and 36 events (10.6%) were classified as avoidable CS use. Patients who received ‘avoidable’ CS had longer disease duration than who received ‘appropriate’ CS (3227.5 days and 1450.5 days, respectively. p = 0.007). Both ‘avoidable’ and ‘appropriate’ group had started with similar CS dosage (37.2 and 38.8mg, respectively. p = 0.694). However, ‘avoidable’ group received CS longer than ‘appropriate’ group (125.7 and 37.7 days, respectively. p = 0.013). Multivariate analysis revealed that longer disease duration was significantly related with ‘avoidable’ CS exposure (OR=1.166; 95% CI=1.023–1.329; p = 0.022).

Conclusion
Treatment for IBD is advancing; however, a significant proportion of patients still receive CS. In particular, the longer the disease duration, ‘avoidable’ CS uses in patients tend to increase. Application of CS in patients with IBD should be delivered with much caution, as ‘avoidable’ CS use is associated with longer CS use.
P700 Effect of vitamin D in disease activity score and clinical relapse in patients with inflammatory bowel disease: A systematic review and meta-analysis
Authors: Guzman Y , Samson O , Segal J P , Limdi J K , Hayee B 
Published: January 2020

Abstract

Background
Vitamin D deficiency has been reported as highly prevalent among patients with inflammatory bowel disease (IBD) and current studies have demonstrated an association between low vitamin D status and an increased risk of clinically active disease, mucosal inflammation and clinical relapse. The aim of our study was to conduct a systematic review and meta-analysis exploring the effect of vitamin D supplementation in clinical and biochemical disease activity scores and relapse rate in patients with IBD.

Methods
We performed a search of major electronic databases (MEDLINE, EMBASE, Cochrane Library) and sources for grey literature (GreyNet international, Google Scholar, Web of Science) from inception to October 2019. Our search strategy was limited to the English and Spanish language. The results were supplemented by a manual search of the bibliographies of the shortlisted review and original study articles. Inclusion criteria: Adults (over 18 years old) with IBD (ulcerative colitis or Crohn’s disease); interventional (RCTs or non-RCTs) or observational studies; studies assessed the effect of vitamin D supplementation on disease activity scores and relapse rate. Exclusion criteria: Reviews, case reports, editorial, comment, letters; duplicates studies; insufficient data or unable to calculate outcome measures with available data. Mean difference was considered as the effect measure with 95% confidence interval (95% CI) and two sided P values. For relapse rate outcome, unadjusted OR were calculated using dichotomous data (events vs. total). Heterogeneity was assessed using χ2 test and I2 statistic. Review Manager software v.5.3 was used.

Results
A meta-analysis of five studies (n = 253) showed a lower relapse rate in vitamin D supplementation group compared with control group (OR: 0.33, 95% CI 0.18–0.61, p =  0.0004, I2: 0%) (Figure 1). Harvey Bradshaw Index improved by 1.52 points (95% CI: 0.14–2.90, p = 0.03, I2 51%) in vitamin D group compared with the score at baseline and C-reactive protein levels decreased compared with the levels at baseline (mean difference: 3.70 mg/l, 95% CI 0.10–7.29, p = 0.04, I2 0%) (Figures 2 and 3). Even though other studies reported different clinical remission tools such as SCCAI or CDAI, it was not possible to pool the results due to insufficient data to conduct a meta-analysis.

Conclusion
Our systematic review and meta-analysis provides evidence that vitamin D supplementation can improve clinical outcomes and reduce relapse rate in patients with IBD.
P708 The effect of psychotherapy on quality of life in inflammatory bowel disease patients: A systematic literature review
Authors: Paulides E , Boukema I , van der Woude C J , de Boer N K H 
Published: January 2020

Abstract

Background
Inflammatory bowel disease (IBD) is a chronic disease, both influencing patients physical and mental health and thereby interfering with quality of life (QoL). This systematic review aims to assess the effect of psychotherapy on IBD patients’ QoL.

Methods
A systematic search was conducted on 07 October 2019 using Embase, Medline (Ovid), PubMed, Cochrane, Web of Science, PsycInfo and Google Scholar, to collect all types of clinical trials with psychotherapeutic interventions that measured QoL in IBD patients aged 18 and over. Quality of evidence was assessed using GRADE criteria.

Results
Out of 2560 articles, 31 studies (32 articles) were included with a total number of 2397 patients. Of the 31 eligible studies, twelve showed a significant positive effect and four had mixed results regarding the impact of psychotherapeutic interventions on QoL. Eight studies were rated as of moderate quality, of which five showed a significant effect. All four studies focussing on patients with active disease showed a positive effect of psychotherapy. No specific preference for a type of psychotherapy, type of disease or psychological condition at baseline was found. No meta-analysis could be performed due to heterogeneity of design, implementation and statistical analyses of the studies.

Conclusion
Psychotherapeutic interventions can improve QoL in IBD patients, but there is mixed evidence. Patients with active disease seem to profit more from psychotherapy than those in remission. More high quality research is needed to provide tailored psychological therapy to adults with IBD.
P709 Is azathioprine safe as long-term treatment in paediatric patients with inflammatory bowel disease?
Authors: Martínez Ibeas M A , Bacelo Ruano I , Rodríguez Manchón S , Velasco Rodríguez-Belvís M , Viada Bris J F , Domínguez Ortega G , Muñoz Codoceo R A 
Published: January 2020

Abstract

Background
The toxicity of azathioprine (AZA) includes myelosuppression, infections, pancreatitis, photosensitivity, and hepatotoxicity. The aim of this study was to describe the adverse effects profile of azathioprine as long-term treatment in paediatric inflammatory bowel disease (IBD).

Methods
An observational, descriptive and retrospective study was performed in the paediatric IBD Unit of a tertiary care hospital from September 2008 to December 2018. It was included patients under 18 diagnosed with IBD who were treated with AZA during their follow-up. We recorded epidemiological data, thiopurine methyltransferase (TPMT) enzyme activity, AZA side effects, and the dosage the patients were receiving when these effects took place. Bone marrow suppression (BMS) was defined as leukopenia, thrombocytopenia and/or anaemia. Acute pancreatitis (AP) induced by azathioprine was considered when two of these criteria (Atlanta 2012) were met: lipase increase (&gt; 3 times normal value), congruent signs and symptoms and/or echographic findings, without other possible aetiology and with complete recovery after AZA withdrawal.

Results
We included 52 patients, being 31 men (59.6%). They were diagnosed with Crohn′s disease (CD) (73%), ulcerative colitis (UC) (21%) and IBD-unclassified (6%). The median TPMT activity was 17 U/ml (14.2–19.2). Up to 63.5% developed adverse effects by AZA with a median time from the beginning of treatment of 11.4 months (2.6–26.4) and a median dosage of 2 mg/kg/day (1.7–2.3). The most frequent side effect was BMS (52%). These patients had a median TPMT activity of 16.9 U/ml (14.2–18.9), the median duration of treatment was 14 months (3.9–27.7), and the median dosage was 2 mg/kg/d (1.8–2.5). BMS was more frequent in patients with UC (p 0.04) and longer treatment (p 0.08). No differences were found according to age, sex or TPMT activity. Up to 11.5% developed AP, the median duration of treatment until its appearance was 1.5 months (0.7–43.3) and the median dosage was 2 mg/kg/d (1.5–2.5). No differences were found related to age, sex, diagnosis or dosage. Other side effects were: 3 flu-like symptoms, 3 opportunistic infections, 2 hypertransaminasemia, and 1 patient with elevated pancreatic enzymes and hyperbilirubinemia. AZA was discontinued in 14 patients (43.8%): in 6 due to AP, in 4 due to severe lymphopenia, in 2 because of Epstein-Barr virus infection, in 1 due to flu-like symptoms and in 1 with several adverse effects.

Conclusion
More than half of the patients treated with AZA presented side effects, mainly BMS, although most of them were mild and temporary, and the withdrawal of the drug was not necessary. It seems that TPMT activity is not useful to predict BMS, but this adverse effect could be related to a longer treatment.
P710 The influence of probiotics to the efficacy of 5-ASA for the patients of ulcerative colitis
Authors: YASUDA R , Uchiyama K , Takagi T , Kubota M , Sugino S , Azuma Y , Kitae H , Torii T , Takayama S , Inoue K , Katada K , Kamada K , Ishikawa T , Konishi H , Naito Y , Itoh Y 
Published: January 2020

Abstract

Background
5-ASA is a key drug to treat the patients with mild-to-moderate ulcerative colitis (UC). Probiotics is sometimes used to UC patients for the purpose to correct dysbiosis of intestine. In theory, the efficacy of 5-ASA, especially pH-dependent release formulation of mesalazine may be weakened by the co-treatment with probiotics because of its effect leading to acidic condition in large intestine. However, the detail analysis about UC patients treating with 5-ASA and probiotics has not been elucidated. In the present study, we demonstrated the clinical course of UC patients treated by 5-ASA with probiotics to investigate the effect of probiotics to 5-ASA treatment.

Methods
The subjects were 85 UC patients who were in clinical remission and taking 5-ASA at the hospital of Kyoto Prefectural University of Medicine from January to March 2014. The clinical characteristics (age, sex, clinical activity index, disease location, and type of 5-ASA) and the rate of relapse until October 2019 were compared between probiotics group and no probiotics group. Furthermore, the rates of relapse were analysed for each specific 5-ASA between probiotics user and no probiotics user. The clinical activity index (CAI) was determined using Lichtiger index. The relapse of UC is defined by the increase of CAI, additional medication for UC, and endoscopic deterioration of colonic mucosa.

Results
Patients were included 39 cases in probiotics group and 46 cases in no probiotics group. There was no significant difference between probiotics and no probiotics group on the average age (53.1 ± 16.8 vs. 51.3 ± 14.2 years old, p = 0.59), the rate of male gender (41.0% vs. 41.3%, p =0.97), the average CAI (2.1 ± 0.64 vs. 2.0 ± 0.73, p = 0.59), disease location (extensive/left/rectum: 20/7/12 vs. 21/10/15 cases, p = 0.31), and type of 5-ASA (salazosulfapyridine/time-dependent mesalazine/pH-dependent mesalazine: 5/18/16 vs. 6/18/22 cases, p = 0.46). Besides, there was no significant difference between probiotics group and no probiotics group (51.3% vs. 52.2%, p = 0.93) about the rate of relapse. Regarding each specific 5-ASA usage, there was no significant difference on salazosulfapyridine (40.0% vs. 33.3%, p = 1), time-dependent mesalazine (44.4% vs. 50.0%, p = 1), and pH-dependent mesalazine (62.5% vs. 59.1%, p = 0.90) between probiotics user and no probiotics user.

Conclusion
In the present study, the co-treatment with probiotics did not affect the relapse with UC patients regardless the type of 5-ASA, suggesting that the usage of probiotics might not disturb the efficacy of 5-ASA for UC patients.
P716 Clinical significance of residual non-rectal inflammation in ulcerative colitis patients with clinical remission
Authors: Shin J , Seong G , Song J H , Kong S M , Kim T J , Kim E R , Hong S N , Chang D K , Kim Y H 
Published: January 2020

Abstract

Background
The advancement of therapeutic agents has made it possible to achieve endoscopic remission in inflammatory bowel disease. Consequently, the treatment goal of ulcerative colitis (UC) also has been changed to achieve endoscopic remission (ER). However, there was insufficient clinical evidence of whether a step-up treatment should be performed to achieve ER in clinical remission (CR) without ER. And there is inadequate data on the need to consider the distribution and severity of residual inflammation in UC. This retrospective study aimed to evaluate the prognostic significance (such as step-up therapy, hospitalisation, and colectomy) of the distribution and severity of residual inflammation in UC patients with CR.

Methods
A total of 134 UC patients who underwent endoscopic evaluation in CR and underwent colonoscopy more than 3 times between January 2000 and December 2018 were retrospectively reviewed. Patients were allocated by endoscopic healing state and distribution of inflammation to an ER (n = 33, 24.6%), residual non-rectal inflammation with patchy distribution (NRI) (n = 17, 12.7%) or residual rectal involvement with continuous or patchy distribution (RI) (n = 84, 62.7%). We reviewed the patient’s characteristics, endoscopic findings and ascertain poor outcome-free survival (PFS) until June 2019.

Results
In UC patient with CR, the PFS was significantly better in ER and NRI (p = 0.003). ER and NRI had similar PFS (p = 0.683). The baseline clinical characteristics of NRI and RI were not significantly different except for the pattern of residual inflammation (p &lt; 0.001). Multivariate analysis showed that NRI was a good prognostic factor of PFS for UC with CR Like ER (hazard ratio 0.53 (0.05–6.30), p = 0.615).

Conclusion
There was no statistically significant difference in the PFS between ER and NRI in the CR state of UC patients. Therefore, we propose selective escalation of treatment modality in CR patients, even if they do not reach ER.
P719 Effectiveness and safety of ustekinumab induction therapy in ulcerative colitis: A GETAID real-world cohort study
Authors: Amiot A , Vered A , Filippi J , Cadiot G , Laharie D , Melanie S , Altwegg R , Bouhnik Y , Peyrin-biroulet L , Gilletta C , Roblin X , Pineton de chambrun G , Vuitton L , Bourrier A , Nancey S , Gornet J M , Nahon S , Bouguen G , Viennot S , Benjamin P , Fumery M 
Published: January 2020

Abstract

Background
Phase III trials have demonstrated the efficacy and safety of ustekinumab in moderate-to-severe ulcerative colitis (UC), but no real-life data is currently available.

Methods
Between January and September 2019, all consecutive patients with UC treated with ustekinumab in 20 French GETAID centres were included. The primary outcome was steroid-free clinical remission (partial Mayo Clinic score ≤ 2) at weeks 12–16 without rectal bleeding subscore &gt; 1.

Results
One hundred and three patients were included with a median age and disease duration of 39.3 [interquartile range (IQR), 29.1–52.3] and 7.6 [3.6–12.9] years, respectively. Most of the patients had left sided colitis (41.8%) or pancolitis (52.4%). History of immunomodulator, anti-TNF and vedolizumab therapies was noted in 84.5%, 99.0% and 85.4% of the cases, respectively. Steroid-free clinical remission and clinical remission rates were 35.0% and 39.8% at weeks 12–16, respectively. Normalisation of rectal bleeding and stool frequency (subscore 0 for both outcomes) was noted in 19.4% of patients whereas normalisation of rectal bleeding (subscore 0) with a stool frequency subscore of 0 or 1 was noted in 39.8%. Two patients discontinued ustekinumab before the weeks 12–16 visit and were referred to surgery. Predictors of therapeutic failure at weeks 12–16 were a partial Mayo Clinic score &gt; 6 at week 0 (HR = 10.0, 95%CI [1.11––100.0], p = 0.04) and an history of previous use of anti-TNF and vedolizumab (HR = 33.3, 95%CI [2.4–100.0], p = 0.01). Improvement in endoscopic activity of UC at weeks 12–16 was observed according to Ulcerative Colitis Endoscopic Index of Severity (5.0 ± 1.2 vs. 3.8 ± 1.9, p &lt; 0.001). Adverse events occurred in 7.8% and serious adverse events in 3.9%.

Conclusion
In this first real-life cohort study of refractory UC patients treated with ustekinumab, clinical remission without corticosteroids was observed in one-third of cases at weeks 12–16. Clinical severity and previous use of anti-TNF and vedolizumab were associated with therapeutic failure.