bluuebunny/crossref_metadata_2025_split huggingface dataset:
P155 Bowel preparation is valued more than colorectal cancer risk and interval by patients in colitis-associated colorectal cancer surveillance: a discrete choice experiment
Authors: Wijnands A M , te Groen M , Peters Y , Kaptein A A , Oldenburg B , Hoentjen F , Lutgens M W M D 
Published: May 2021

Abstract

Background
Patients with inflammatory bowel disease (IBD) undergo surveillance colonoscopies at fixed intervals to reduce the risk of colorectal cancer (CRC). Taking patients’ preferences for determining surveillance strategies into account could improve adherence and patient satisfaction. This study aimed to determine patient preferences and preference heterogeneity for CRC surveillance in IBD.

Methods
We conducted a web-based, multicentre, discrete choice experiment among adult IBD patients with an indication for surveillance, treated in two academic and one general teaching hospital in The Netherlands. Individuals were repeatedly asked to choose between three hypothetical surveillance scenarios and indicate if they would prefer this option in real-life. The choice tasks were based on bowel preparation (0.3-4L), CRC risk reduction (8% to 1–6%), and interval (1–10 years). Attribute importance scores, trade-offs, and willingness to participate were calculated using a multinomial logit model. Latent class analysis was used to identify subgroups with similar preferences.

Results
In total, 301 of 386 questionnaires sent out were completed and included in the study. The attributes and levels in the choice tasks significantly affected patients’ preferences. Bowel preparation was the most valued attribute (importance score 40.0%), followed by surveillance interval and CRC risk reduction (respectively 30.9% and 29.0%). Maximal CRC risk reduction, low-volume bowel preparation (0.3L laxative with 2L clear liquid) with two-yearly surveillance was the most preferred combination. Patients were willing to exchange a surveillance interval from three-yearly to annually for a CRC risk reduction of 2.9%. In latent class analysis, three subgroups were identified (figure 1). Willingness to participate in CRC surveillance was high, with only five patients (1.7%) always choosing ‘no surveillance’. Perceived high burden of bowel preparation and lower age were significantly associated with the ‘laxative avoidant’ group compared to the reference group ‘surveillance preferent’ (univariable odds ratio (OR) 2.92, 95% CI (confidence interval) 1.63–5.23 and OR 0.96, 95% CI 0.94–0.98, respectively). High level of education and age significantly differed in the ‘CRC risk avoidant’ group (univariable OR 3.77, 95% CI 2.11–6.75 and 0.94, 95% CI 0.92–0.96).

Figure 1: Attribute importance scores
Higher scores indicate more relative importance [0=not important at all; 100=most important]

Conclusion
Bowel preparation is seen as the most important factor by patients in CRC surveillance in IBD. Heterogeneity in preferences can be explained by three latent subgroups. Surveillance adherence could benefit from these findings.
P199 Analysis of clinical features of asymptomatic perianal fistulizing Crohn’s disease
Authors: Wu T , Huang L , Cao Q 
Published: May 2021

Abstract

Background
Perianal fistula represents an aggressive phenotype of Crohn’s disease (CD), and is detected in CD patients without perianal complains. Data of CD patients with asymptomatic perianal fistula is scarce. Our study targets to assess the clinical characteristics of adult CD patients with asymptomatic perianal fistulas in adults with CD.

Methods
This retrospectively study collected data from Sir Run Run Shaw Hospital. Newly diagnosed CD patients undergoing magnetic resonance imaging examinations during 2014–2019 were enrolled. The perianal fistulizing CD patients were divided into two groups: 1) symptomatic perianal fistula group, 2) asymptomatic perianal fistula group, then we analyze the features of clinical features, medication and prognosis of each group.

Results
Among 437 CD patients, 346 (79.2%) had perianal fistulas whereas 91 (20.8%) did not. In patients with perianal fistulas, 89 (25.7%) did not have perianal symptoms. Comparing to symptomatic perianal fistula group, asymptomatic perianal fistula group combined with lower perianal abscess incidence (73.9% vs. 25.8%, p &lt; 0.001). According to Park’s classification, the most common type of fistula in these two groups was intersphincteric fistula (73.2% vs. 53.2% p=0.094). Patients with asymptomatic perianal fistulas were described by the following features when compared with patients with symptomatic perianal fistulas: higher rate of female sex (38.2% vs. 17.9%, p &lt; 0.001), shorter disease duration at enrolment (0.8 vs. 1.0 years, p = 0.001), higher rate of stricturing behavior (32.6% vs. 18.7%, p &lt; 0.01), worse outcomes of laboratory examinations at diagnosis, including hemoglobin (119.0 vs. 131.0 g/dL, p &lt; 0.001), platelet (333.0 vs. 283.0 *10^9, p &lt; 0.001), ESR (20.0 vs. 14.0 mm/H, p &lt; 0.01), albumin (35.6 vs. 37.5 g/L, p = 0.001), C-reactive protein (27.3 vs. 15.7 mg/L, p = 0.001). The age at diagnosis and disease locations were not different. For asymptomatic perianal fistula patients, antibiotics (57.3%) and surgery (6.7%) were taken at diagnosis. The usage of biologics at diagnosis showed no difference (59.6% vs. 40.4% p=0.108). Regarding clinical outcomes, the cumulative probabilities for bowel surgery (p &lt; 0.05) and bowel obstruction (p &lt; 0.01) in asymptomatic perianal fistula group were higher than symptomatic perianal fistula group.

Conclusion
Asymptomatic perianal fistulas account for a certain proportion. Female sex, shorter disease duration, stricturing behavior and poor outcomes of laboratory examinations at diagnosis are associated with detection of asymptomatic perianal fistulas. We should pay more attention to CD patients with asymptomatic perianal fistulas because they may have poor prognosis or even worse as patients with symptomatic perianal fistulas.
P218 Assessment of the degree of intestinal destruction in Crohn’s disease at the time of diagnosis
Authors: Hassine A , Akkari I , Mrabet S , Ben Jazia E 
Published: May 2021

Abstract

Background
Certainly the presence of advanced intestinal lesions in Crohn’s disease (CD) is associated with a more frequent recourse to surgical resection. However, in general, the degree of intestinal destruction in patients with CD is not assessed at the time of diagnosis, and the natural history of CD may differ phenotypically from patient to patient. The aim of this study was to assess the degree of intestinal destruction in patients with CD at the time of diagnosis, using the Lemann Index (LI), and to identify the associated factors.

Methods
A retrospective study was conducted involving all patients with CD followed in our center over a period of 4 years (2016- 2020), and who were evaluated by endoscopy and MRI at baseline. The Lemann Index is a score that measures cumulative damage to digestive tissue from entero-MRI and endoscopy data. A LI score &gt; 2.0 was set as a cutoff to define advanced bowel injury. Hypothesis tests were applied to identify associations.

Results
112 patients with CD were included in this study, of which 53.6% were female. The mean age at diagnosis was 33.29 years [15–63]. Regarding the localization of CD, it was ileal, colonic, and ileocolonic in respectively 16.1%, 42.9% and 41%. The disease phenotype was inflammatory in 60.7%, stricturing in 21.42%, and penetrating in 17.85%. The initial flare was judged to be severe in 33.9%, moderate in 55.4% and mild in 10.7% of cases, with a mean CDAI of 305.21 [115–493]. 12 patients had already undergone bowel resection. As for the biological data, the mean value of C-Reactive Protein (CRP) at the time of diagnosis was 74.08 +/- 54.05 mg / l, and that of the sedimentation rate (ESR) was 62, 13 +/- 36.49 (the 1st hour). The mean LI was 3.14 (± 2.28) with 64 patients (57.1%) presenting an LI score indicating advanced bowel injury at diagnosis. In univariate analysis, the factors associated in a statistically significant way, with a more important Lemann Index were: the male sex (p = 0.037), the history of intestinal resection (p = 0.009), a severe initial flare (p = 0.049). Similarly, a strong correlation was observed with the initial CDAI score (p = 0.024, r = 0.05) and the initial value of ESR (p = 0.001, r = 0.01). In addition, the duration of symptoms, age at diagnosis, initial disease location and phenotype, presence or absence of anoperineal manifestations, and CRP value at diagnosis were not correlated to the degree of intestinal destruction according to the LI score, with respectively: p = 0.43, p = 0.12, p = 0.19, p = 0.49, p = 0.34 and p = 0.063.

Conclusion
In our series, advanced intestinal lesions are present at the time of diagnosis in a significant proportion of patients. Thus, the use of the Lemann score from the diagnosis of Crohn’s disease is necessary.
P223 Degree of Histological Activity is not Associated with Vedolizumab Therapy Outcome in Ulcerative Colitis
Authors: Doherty J , Brennan S , Dinneen K , Muldoon C , Mc Kiernan S , Dunne C , Mac Carthy F , Hartery K , Ciara R , Kevans D 
Published: May 2021

Abstract

Background
Histological inflammation is known to be associated with increased risk of disease relapse in patients with ulcerative colitis (UC). Vedolizumab (VDZ) is a gut selective anti-integrin which inhibits intestinal immune cell-trafficking. Whether the degree of histological activity at the time of VDZ therapy initiation is associated with therapy outcome is not known. We aimed to determine if there is an association between histological activity at the time of VDZ initiation and outcome of therapy.

Methods
A retrospective review was performed to identify UC patients treated with VDZ who had undergone an endoscopic assessment prior to therapy commencement. Baseline demographic data, information on therapy outcome and Mayo endoscopic sub score (MES) was collected for all patients. Endoscopic biopsies were retrieved and were scored for histological activity using the Geboes Score (GS). For Kaplan Meir analyses of primary endpoint, the cohort was dichotomised around a GS grade of 5. Primary endpoint was VDZ therapy outcome defined as persistence on VDZ therapy over time. Secondary endpoints included association between GS and MES and the association between a combined endoscopic and histological endpoint (MES = 3 & GS grade 5) and VDZ therapy outcome.

Results
33 patients were included [median age 44.3 years (range 17.2 -84.3); 36% male gender]. 24%, 43% and 33% of the cohort had proctitis, left-sided colitis and extensive colitis respectively. 67% of subjects had prior anti-TNF exposure. Median time from endoscopy to commencement of VDZ was 9 weeks. Median study follow-up was 68 weeks (range 6.1 – 228.7). 3%, 21%, 42% and 33% had MES of 0, 1, 2 and 3 respectively. GS grade was significantly associated with MES (p = 0.04) (Figure 1). GS grade was not associated with time to discontinuation of VDZ (p=0.64) (Figure 2). Combined endoscopic and histological endpoint was not associated with time to discontinuation of VDZ (p=0.43) (Figure 3). The presence of lamina propria eosinophils was not associated with time to discontinuation of VDZ (p=0.92).

Conclusion
GS grade is associated significantly with MES which has been demonstrated previously. Neither histological activity alone nor in combination endoscopic activity were associated with outcome of VDZ therapy. Assessment of histological activity does not appear to provide additional information when selecting patients for VDZ therapy.
P229 Standardization of Quantum Blue® rapid TDM assays with WHO international standards for adalimumab and infliximab
Authors: Afonso J , Ricken B , Schuster T , Guschin D , Schneider M 
Published: May 2021

Abstract

Background
Therapeutic drug monitoring of inflammatory bowel disease (IBD) patients under anti-TNF therapy is based on trough level determination of the drug. Rapid assays and multiple ELISAs are available that measure anti-TNF biologics. An international standard is required to improve comparability among different assays. Recently, WHO introduced anti-TNF standards for adalimumab (ADL) and infliximab (IFX). A WHO international reference material (IRM) based standardization is crucial for the harmonization of assays available on the market.

Methods
The aim of the study was to standardize the BÜHLMANN Quantum Blue® ADL and BÜHLMANN Quantum Blue® IFX based on the WHO IRM for ADL and IFX, respectively. A value transfer from the WHO reference material to the internal calibrator sets for both assays was based on a protocol previously described by Blirup-Jensen et al. (Clin Chem Lab Med 2001; 39(11):1110–1122) and by means of a commercially available ELISA. A method comparison of the ELISA and the rapid test was carried out before the value transfer to guarantee comparability of both assays. Additionally, the correlation of the WHO IRM with the currently used calibrator material was determined for ADL. The correlation of the WHO IFX standard (NIBSC 16/170) with the currently used calibrator material was presented recently (Keller et al. 2020, UEGW 2020). Calibration curves were generated with BÜHLMANN ADL calibrators and with calibrators made from WHO IRM for ADL (NIBSC 17/236). Serum samples, covering a concentration range from 1.0 to 35 µg/mL, were analysed with both calibration curves and compared by Bland-Altman and Passing-Bablok analysis.

Results
A preliminary value transfer study revealed an relative uncertainty of 12.3% for both drugs. A good comparison of the ADL and IFX rapid test and the ELISA is given: Passing-Bablok correlation coefficient (R) of 0.953 (ADL) and 0.942 (IFX), and a mean bias determined by Bland-Altman of 1.59 µg/mL (ADL) and -0.5 µg/mL (IFX), respectively. The sample values gained with BÜHLMANN calibrators showed an excellent correlation with values gained with the WHO international standard for ADL as calibrator. Passing-Bablok regression analysis revealed a slope of 1.3 and correlation coefficient (R) of 1.0.

Conclusion
To the best of our knowledge, the Quantum Blue® ADL and Quantum Blue® IFX, are the first commercially available quantitative lateral flow assays comprising a WHO based standardization. Additionally, it was demonstrated that the current standardizations of Quantum Blue® ADL correlates very well with the WHO international standard for ADL.
P268 Ileal Pouch-Anal Anastomosis Complications and Pouch Failure: A Systematic Review and Meta-Analysis
Authors: Heuthorst L , Wasmann K , Reijntjes M , Hompes R , Buskens C , Bemelman W 
Published: May 2021

Abstract

Background
Previous studies demonstrated wide variation in postoperative complication rates following ileal pouch-anal anastomosis (IPAA). This systematic review aims to assess the incidence of pouch failure and the correlation between IPAA-related complications and pouch failure.

Methods
A systematic review was performed by searching the MEDLINE, EMBASE, and Cochrane Library databases for studies reporting on pouch failure published from 1 January 2010 to 6 May 2020. A meta-analysis was performed using a random effects model. The relationship between pouch-related complications and pouch failure was assessed using Spearman’s correlations.

Results
Thirty studies comprising 22,978 patients were included. Included studies contained heterogenic patient populations, different procedural stages, varying definitions for IPAA-related complications, and different follow-up periods. The pooled pouch failure rate was 7.7% (95%CI5.56–10.59) and 10.3% (95%CI7.24–14.30) for studies with a median follow-up of ≥5 years and ≥10 years, respectively. Observed IPAA-related complications were anastomotic leakage (1–17%), pelvic sepsis (2–18%), fistula (1–30%), stricture (1–34%), pouchitis (11–61%) and Crohn’s disease of the pouch (0–18%). Pelvic sepsis (r=0.51, p&lt;0.05) and fistula (r=0.63, p&lt;0.01) were correlated with pouch failure. A sensitivity analysis including studies with a median follow-up of ≥5 years indicated that only fistula was significantly correlated with pouch failure (r=0.77, p&lt;0.01).

Conclusion
Long-term pouch failure was correlated with fistula, suggesting that early septic complications may result in fistula formation during long-term follow-up, leading to increased risk of pouch failure. Pouch survival may be improved through standardized assessment of anastomotic integrity for early identification and adequate management of anastomotic leaks.
P303 Local Application of Autologous Platelet-rich Plasma leads to Sustained Healing of Crohn’s Perianal Fistulae – One Year follow-up Results from a Single Center Pilot Study
Authors: Podmanicky D , Jezberova M , Lucenicova J , Bak V , Kadleckova B , Zelinkova Z 
Published: May 2021

Abstract

Background
Failure of wound repair and dysregulated inflammation in considered to play a key role in the persistence of Crohn’s perianal fistulae (pCD). Few preliminary reports suggest that autologous platelet-rich plasma (PRP) can enhance wound repair and may be effective in treating pCD. Therefore, the aim of our study was to determine the efficacy of autologous PRP in the treatment of pCD.

Methods
A prospective, uncontrolled, single center study in a referral IBD center was conducted between July 2018 and March 2021. Adult Crohn′s disease patients with pCD failing on antibiotics, immune suppression and/or biologics were eligible for the study. All patients had non-cutting setons for a minimal period of 6 weeks prior study intervention. Autologous PRP was separated by centrifugation 60 ml of peripheral blood in Harvest SmartPrep© System at the time of operation. After the seton removing, internal openings were closed by PDS 2/0 single suture and PRP was injected close to internal openings and fistula tracts. Patients were examined at outpatient clinic at week 1, month 1, 3, 6 and 12. Any suspected side-effects of the treatment were noted. Treatment effect was assessed by perianal Crohn Disease Activity Index (PCDAI assessed at baseline, month 1, 3, 6, 12) and van Assche MRI score (assessed at baseline and month 6 and 12). The primary end-point was complete healing at month 6 defined as closure of all external fistula openings and absence of abscess on MRI. The secondary end-point was sustained response at month 12.

Results
In total, 25 patients (pts) with pCD were included (mean age 36 years, range 21-61; 15 men). The majority of pts were using antiTNF biologics (9 adalimumab, 9 infliximab), 4 pts were treated by ustekinumab, one by vedolizumab, two patients were on immunomodulators monotherapy. By March 2021, 24 patients finished the 6 months and 21 patients the 12 months follow-up. The primary end-point of complete healing at month 6 was reached by 18 out of 24 pts (75%). All but one patients with complete healing had persistent complete healing at 12 months follow-up. Baseline PCDAI (median 5, range 2-15) decreased significantly as early as at month 1 (median 1, range 0-8; p&lt;0.001) and remained further stable over 12 months. Van Assche MRI score decreased significantly from median of 9 (range 3-18) at baseline to 5 (range 0-18) and 5.5 (range 0-18) at month 6 (p=0.001) and 12 (p=0.03); respectively.

Conclusion
Local application of autologous platelet-rich plasma leads to rapid healing of difficult-to-treat Crohn’s perianal fistulae in 75% of patients and this effect is sustained up to minimal period of one year.
P327 Long-term effectiveness of ustekinumab in refractory Crohn’s disease: an Italian multicenter real-life study
Authors: Scribano M L , Aratari A , Neri B , Bezzio C , Balestrieri P , Falasco G , Camastra C , Pantanella P , Monterubbianesi R , Tullio A , Saibeni S , Papi C , Biancone L , Cosintino R , Faggiani R 
Published: May 2021

Abstract

Background
Ustekinumab (UST) is increasingly used in Italy for the treatment of refractory Crohn’s disease (CD), however very few data concerning real-life experience has been reported. Therefore, the aim of this study was to assess the long-term effectiveness of UST in refractory CD patients treated in a large Italian cohort.

Methods
A retrospective study was conducted in 5 Italian tertiary centers. All adult CD patients who started UST because of anti-tumor necrosis factor (TNF) failure were included. The co-primary outcomes were steroid-free clinical remission (defined as Harvey Bradshaw Index, HBI ≤4) at weeks 26 and 52. Secondary outcomes were changes in HBI score, changes in C-reactive protein (CRP) values, normalization of CRP (≤0.5 mg/dl) at weeks 8, 26, and 52, and adverse events. Categorical variables were expressed as frequency and percentage. Unpaired t-test was used to compare variables. A p-value &lt;0.05 indicated statistical significance. Continuous variables were expressed as mean and standard deviation (SD), and median with interquartile range (IQR).

Results
Between Nov 2018 and Feb 2020,140 patients (51.4% male; median age 45.0 years, IQR 36.3-54.0; median disease duration 16.0 years, IQR 8.0-22.0) were included. The majority of patients had ileocolonic disease (L1, 38.6%; L2, 11.4%; L3, 50.0%) and an inflammatory phenotype (B1, 50.7%; B2, 31.0%; B3, 18.3%). All patients had previously been exposed to at least one anti-TNF agent, 27.1% to 2 anti-TNF agents, and 20.0% to vedolizumab . At inclusion 15.7% of patients received corticosteroids and 8.6% immunomodulators. All patients received an intravenous dose of 6 mg/kg, followed by subcutaneous administration of 90 mg every 8 (90%) or 12 weeks (10%) according to clinical judgment. The proportion of patients achieving steroid-free clinical remission was 61.0% and 64.2% at weeks 26 and 52 respectively. A significant decrease in the mean HBI was reported from baseline to week 8 (6.8 ± 3.6 vs 4.5 ± 3.1; p &lt;0.001), week 26 (3.5 ± 2.9; p &lt;0.001), and week 52 (3.1 ± 2.4; p &lt;0.001). The mean CRP values was also significantly decreased from baseline to week 8 (4.6 ± 7.3 vs 2.8 ± 7.1; p &lt;0.001), week 26 (1.7 ± 3.8; p &lt;0.001), and week 52 (1.1 ± 2.2; p&lt;0.001). At baseline 93 of 119 patients had high CRP value: a normal CRP value was observed in 34.9%, 37.8%, and 49.3% of patients at weeks 8, 26, and 52 respectively. Overall, 11 patients (7.9%) discontinued UST within 1 year: primary failure (n=2), secondary failure (n=6), adverse events (n=3: 2 allergic reactions, and 1 arthralgia).

Conclusion
To our knowledge this is one of the largest Italian cohort followed up to 1 year, and the results confirm that UST is an effective and safe treatment in refractory CD patients.