Publications by authors named "Xavier Calvet"

187 Publications

Inflammatory bowel disease integral care units: Evaluation of a nationwide quality certification programme. The GETECCU experience.

United European Gastroenterol J 2021 Jun 5. Epub 2021 Jun 5.

Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain.

Background: One of the most valued targets in inflammatory bowel disease (IBD) is for physicians to provide and patients to receive a high-level quality of care. This study aimed to evaluate the implementation of a nationwide quality certification programme for IBD units.

Methods: Identification of quality indicators (QI) for IBD Unit certification was based on Delphi methodology that selected 53 QI, which were subjected to a normalisation process. Selected QI were then used in the certification process. Coordinated by GETECCU, this process began with a consulting round and an audit drill followed by a formal audit carried out by an independent certifying agency. This audit involved the scrutiny of the selected QI in medical records. If 80%-90% compliance was achieved, the IBD unit audited received the qualification of "advanced", and if it exceeded 90% the rating was "excellence". Afterwards, an anonymous survey was conducted among certified units to assess satisfaction with the programme for IBD units.

Results: As of January 2021, 66 IBD units adhere to the nationwide certification programme. Among the 53 units already audited by January 2021, 31 achieved the certification of excellence, 20 the advanced certification, and two did not obtain the certification. The main survey results indicated high satisfaction with an average score of 8.5 out of 10.

Conclusion: Certification of inflammatory bowel disease units by GETECCU is the largest nationwide certification programme for IBD units reported. More than 90% of IBD units adhered to the programme achieved the certification.
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http://dx.doi.org/10.1002/ueg2.12105DOI Listing
June 2021

Effectiveness and safety of ustekinumab in ulcerative colitis: Real-world evidence from the ENEIDA registry.

J Crohns Colitis 2021 Apr 16. Epub 2021 Apr 16.

Hospital General San Jorge, Huesca, Spain.

Background: The development program (UNIFI) has shown promising results of ustekinumab in ulcerative colitis (UC) treatment that should be confirmed in clinical practice.

Aims: To evaluate the durability, effectiveness and safety of ustekinumab in UC in real-life.

Methods: Patients included in the prospectively maintained ENEIDA registry who received at least one intravenous dose of ustekinumab due to active UC [Partial Mayo Score (PMS) >2] were included. Clinical activity and effectiveness were defined based on PMS. Short-term response was assessed at week 16.

Results: A total of 95 patients were included. At week 16, 53% of patients had response (including 35% of patients in remission). In the multivariate analysis, elevated serum C-reactive protein was the only variable significantly associated with lower likelihood of achieving remission. Remission was achieved in 39% and 33% of patients at weeks 24 and 52, respectively. Thirty-six percent of patients discontinued the treatment with ustekinumab during a median follow-up of 31 weeks. The probability of maintaining ustekinumab treatment was 87% at week 16, 63% at week 56, and 59% at week 72; primary failure was the main reason for ustekinumab discontinuation. No variable was associated with risk of discontinuation. Three patients reported adverse events; one of them had a fatal severe SARS-CoV-2 infection.

Conclusions: Ustekinumab is effective both in the short and the long-term in real-life, even in a highly refractory cohort. Higher inflammatory burden at baseline correlated with lower probability of achieving remission. Safety was consistent with the known profile of ustekinumab.
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http://dx.doi.org/10.1093/ecco-jcc/jjab070DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8083263PMC
April 2021

Whole-Genome Sequencing and Comparative Genomics of Three Strains Isolated from the Stomach of a Patient with Adenocarcinoma.

Pathogens 2021 Mar 12;10(3). Epub 2021 Mar 12.

Secció de Microbiologia, Departament de Biologia, Sanitat i Medi Ambient, Facultat de Farmàcia i Ciències de l'Alimentació, Universitat de Barcelona, Av. Joan XXIII 27-31, 08028 Barcelona, Catalonia, Spain.

is a common pathogen associated with several severe digestive diseases. Although multiple virulence factors have been described, it is still unclear the role of virulence factors on pathogenesis and disease progression. Whole genome sequencing could help to find genetic markers of virulence strains. In this work, we analyzed three complete genomes from isolates obtained at the same point in time from a stomach of a patient with adenocarcinoma, using multiple available bioinformatics tools. The genome analysis of the strains B508A-S1, B508A-T2A and B508A-T4 revealed that they were , and negative. The differences among the three genomes were mainly related to outer membrane proteins, methylases, restriction modification systems and flagellar biosynthesis proteins. The strain B508A-T2A was the only one presenting the genotype , and had the most distinct genome as it exhibited fewer shared genes, higher number of unique genes, and more polymorphisms were found in this genome. With all the accumulated information, no significant differences were found among the isolates regarding virulence and origin of the isolates. Nevertheless, some B508A-T2A genome characteristics could be linked to the pathogenicity of .
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http://dx.doi.org/10.3390/pathogens10030331DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7998635PMC
March 2021

Effectiveness and safety of methotrexate monotherapy in patients with Crohn's disease refractory to anti-TNF-α: results from the ENEIDA registry.

Aliment Pharmacol Ther 2021 05 14;53(9):1021-1029. Epub 2021 Mar 14.

Madrid, Spain.

Background: Methotrexate can be used to maintain remission in Crohn's disease patients who are intolerant to thiopurines. Data on its use as monotherapy in other scenarios are limited.

Aim: To assess the effectiveness of methotrexate monotherapy in Crohn's disease patients after previous failure to anti-tumour necrosis factor (anti-TNFα) drugs.

Methods: A retrospective, observational multicentre study of data from the Spanish ENEIDA registry. Participants were patients with active Crohn's disease and previous failure to anti-TNFα started on methotrexate monotherapy. Short-term effectiveness was assessed at 12-16 weeks based on Harvey-Bradshaw index (HBI): clinical remission as HBI ≤ 3 points and clinical response as HBI drop of ≥ 3 points over baseline. Long-term effectiveness was defined as steroid-free methotrexate persistence from 12 to 16 weeks until maximum follow up. Adverse events were recorded.

Results: Data were compiled for 110 patients treated with methotrexate after a failed response to one (39%) or two (55.6%) anti-TNFα agents. Short-term clinical response and remission rates were 60% and 30.9% respectively. Of 74 patients who continued after week 16, long-term effectiveness was achieved in 82% and 74% at 12 and 24 months respectively. In the multivariate analysis, non-remission at short term (vs remission) was associated with long-term failure (HR 2.58, 95%CI 1.95-3.68, P = 0.028). Adverse events (evaluated in 100 patients) were recorded in 44%, and in 30.4% of these patients, they led to methotrexate discontinuation.

Conclusions: The benefits observed suggest methotrexate monotherapy could be a valid option in Crohn's disease patients with previous failure to anti-TNFα.
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http://dx.doi.org/10.1111/apt.16315DOI Listing
May 2021

Patient-Evaluated Quality of Care is Related to Better Inflammatory Bowel Disease Outcomes: The IQCARO II Project.

Patient 2021 Mar 12. Epub 2021 Mar 12.

Medical Department MSD, Madrid, Spain.

Background: Measuring quality of care (QoC) from a patient's perspective is becoming increasingly important in inflammatory bowel disease.

Objective: The objective of this study was to determine whether patients' evaluations of QoC correlate with better inflammatory bowel disease outcomes.

Methods: A survey including patients' characteristics, a decalogue of QoC indicators, and self-reported disease outcomes was completed by Spanish patients with inflammatory bowel disease. A QoC index (QoCI) was constructed with the sum of the "yes" answers in the decalogue. We evaluated the correlation of QoCI with outcomes. A sub-analysis comparing patients with high QoCI vs those with low QoCI was performed (QoCI = 10 or ≤ 7).

Results: Seven hundred and eighty-eight questionnaires were analyzed. Mean age of participants was 43.4 years (63% women). Mean QoCI was 8.1 (± 2.4). The QoCI correlated significantly with activity of the disease, number of flares, emergency/unscheduled visits, and disease control. Patients scoring in the first QoCI quartile reported a decreased rate of moderate/severe disease (34.8% vs 55.3%, p < 0.001), fewer numbers of flares (p < 0.001), and fewer emergency/unscheduled visits (p < 0.001) compared with those in the lower QoCI quartile. The high QoC group also reported better disease control.

Conclusions: Patient-evaluated QoC correlates with better outcomes. Evaluation of QoC by patients may be useful to detect inadequate care and improve inflammatory bowel disease outcomes.
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http://dx.doi.org/10.1007/s40271-021-00500-8DOI Listing
March 2021

Risk of infection associated with Janus Kinase (JAK) inhibitors and biological therapies in inflammatory intestinal disease and rheumatoid arthritis. Prevention strategies.

Gastroenterol Hepatol 2021 Feb 25. Epub 2021 Feb 25.

Servicio de Reumatología, Hospital Universitario Parc Taulí, Departamento de Medicina, Universidad Autónoma de Barcelona, Sabadell, Barcelona, España.

Patients with certain immune-mediated inflammatory diseases, such as rheumatoid arthritis (RA) and inflammatory bowel disease (IBD), have an increased risk of severe infectious diseases than the general population, which are mainly associated with the immunosuppressive treatments that they receive. These treatments act on the immune system through different mechanisms, causing different degrees of immunosuppression and a variable risk depending on whether the pathogen is a virus, bacteria or fungus. This article reviews the most relevant literature on the subject, which was selected and discussed by a panel of experts. The aim of this article is to review the risk of infections in patients with IBD and RA, and the potential preventive measures.
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http://dx.doi.org/10.1016/j.gastrohep.2021.01.007DOI Listing
February 2021

Quality in diagnostic upper gastrointestinal endoscopy for the detection and surveillance of gastric cancer precursor lesions: Position paper of AEG, SEED and SEAP.

Gastroenterol Hepatol 2021 Jun-Jul;44(6):448-464. Epub 2021 Feb 17.

Servicio de Anatomía Patológica, Hospital Universitario Príncipe de Asturias, Departamento de Medicina y Especialidades Médicas, Universidad de Alcalá de Henares, Alcalá de Henares, Madrid, España.

This position paper, sponsored by the Asociación Española de Gastroenterología [Spanish Association of Gastroenterology], the Sociedad Española de Endoscopia Digestiva [Spanish Gastrointestinal Endoscopy Society] and the Sociedad Española de Anatomía Patológica [Spanish Anatomical Pathology Society], aims to establish recommendations for performing an high quality upper gastrointestinal endoscopy for the screening of gastric cancer precursor lesions (GCPL) in low-incidence populations, such as the Spanish population. To establish the quality of the evidence and the levels of recommendation, we used the methodology based on the GRADE system (Grading of Recommendations Assessment, Development and Evaluation). We obtained a consensus among experts using a Delphi method. The document evaluates different measures to improve the quality of upper gastrointestinal endoscopy in this setting and makes recommendations on how to evaluate and treat the identified lesions. We recommend that upper gastrointestinal endoscopy for surveillance of GCPL should be performed by endoscopists with adequate training, administering oral premedication and use of sedation. To improve the identification of GCPL, we recommend the use of high definition endoscopes and conventional or digital chromoendoscopy and, for biopsies, NBI should be used to target the most suspicious areas of intestinal metaplasia. Regarding the evaluation of visible lesions, the risk of submucosal invasion should be evaluated with magnifying endoscopes and endoscopic ultrasound should be reserved for those with suspected deep invasion. In lesions amenable to endoscopic resection, submucosal endoscopic dissection is considered the technique of choice.
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http://dx.doi.org/10.1016/j.gastrohep.2021.01.002DOI Listing
February 2021

Gastroenterologists' attitudes on the detection and management of gastric premalignant conditions: results of a nationwide survey in Spain.

Eur J Cancer Prev 2020 Dec 23;Publish Ahead of Print. Epub 2020 Dec 23.

Endoscopy Unit, Hospital General of Granollers, University of Barcelona, Barcelona Endoscopy Unit, Hospital General of Granollers, Granollers Endoscopy Unit, Hospital García Orcoyen, Estella Gastroenterology Department, Hospital General Universitario, Alicante Gastroenterology Department, Hospital Costa del Sol, Marbella Endoscopy Unit, ICMDiM, Hospital Clínic of Barcelona, University of Barcelona, Barcelona Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Barcelona Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIPAPS), Barcelona Gastroenterology Department, Hospital Universitario Miguel Servet, Zaragoza Gastroenterology Department, Hospital Parc Taulí, Universitat Autónoma of Barcelona, CIBEREHD, Sabadell, Spain.

Introduction: Gastric premalignant conditions (GPC) surveillance has been proposed to improve the prognosis of gastric cancer (GC), but the early GC detection rate remaining low, and missing GC during an esophago-gastro-duodenoscopy is still a problem. We aimed to explore the gastroenterologists' attitudes on the detection and management of GPC.

Methods: A cross-sectional study was designed based on a survey among gastroenterologists from Asociación Española de Gastroenterología.

Results: The participation rate was 12% (146/1243). Eighty-one percent worked at secondary or tertiary-care hospitals with the capability to perform mucosectomy (80%), but with a lesser availability of endoscopic submucosal dissection (35%). Most respondents had high-definition endoscopes (88%), and virtual chromoendoscopy (86%), but during performing an upper endoscopy, 34% never or rarely use chromoendoscopy, and 73% apply a biopsy protocol often/very often when atrophy or intestinal metaplasia (IM) is suspected. Half of the respondents self-reported their ability to recognize atrophy or IM ≤7 (on a scale from 0 to 10), whereas ≤6 for dysplasia or early GC. Helicobacter pylori infection is eradicated and verified by ≥90%. Endoscopic surveillance of atrophy/IM is performed by 62%. An immediate endoscopy for dysplasia is not always performed. For low-grade dysplasia, 97.6% consider endoscopic management, but for high-grade dysplasia, 23% regard gastric surgery.

Conclusion: There is a wide variability in the detection and management of GPC among Spanish gastroenterologists, and compliance with guidelines and biopsy protocols could be improved. Performance of high-quality gastroscopies including use of virtual chromoendoscopy, that might allow an improvement in the GPC detection, needs also to be generalized.
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http://dx.doi.org/10.1097/CEJ.0000000000000648DOI Listing
December 2020

Gastric cancer screening in low incidence populations: Position statement of AEG, SEED and SEAP.

Gastroenterol Hepatol 2021 Jan 24;44(1):67-86. Epub 2020 Oct 24.

Servei d'Aparell Digestiu, Hospital Universitari Parc Taulí; Departament de Medicina, Universitat Autònoma de Barcelona; CIBERehd, Instituto de Salud Carlos III, Sabadell, Barcelona, España.

This positioning document, sponsored by the Asociación Española de Gastroenterología, the Sociedad Española de Endoscopia Digestiva and the Sociedad Española de Anatomía Patológica, aims to establish recommendations for the screening of gastric cancer (GC) in low incidence populations, such as the Spanish. To establish the quality of the evidence and the levels of recommendation, we used the methodology based on the GRADE system (Grading of Recommendations Assessment, Development and Evaluation). We obtained a consensus among experts using a Delphi method. The document evaluates screening in the general population, individuals with relatives with GC and subjects with GC precursor lesions (GCPL). The goal of the interventions should be to reduce GC related mortality. We recommend the use of the OLGIM classification and determine the intestinal metaplasia (IM) subtype in the evaluation of GCPL. We do not recommend to establish endoscopic mass screening for GC or Helicobacter pylori. However, the document strongly recommends to treat H.pylori if the infection is detected, and the investigation and treatment in individuals with a family history of GC or with GCPL. Instead, we recommend against the use of serological tests to detect GCPL. Endoscopic screening is suggested only in individuals that meet familial GC criteria. As for individuals with GCPL, endoscopic surveillance is only suggested in extensive IM associated with additional risk factors (incomplete IM and/or a family history of GC), after resection of dysplastic lesions or in patients with dysplasia without visible lesion after a high quality gastroscopy with chromoendoscopy.
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http://dx.doi.org/10.1016/j.gastrohep.2020.08.004DOI Listing
January 2021

Fendrix vs Engerix-B for Primo-Vaccination Against Hepatitis B Infection in Patients With Inflammatory Bowel Disease: A Randomized Clinical Trial.

Am J Gastroenterol 2020 11;115(11):1802-1811

Gastroenterology Unit, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-IP), Universidad Autónoma de Madrid, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Madrid, Spain.

Introduction: To compare Engerix-B and Fendrix hepatitis B virus for primo vaccination in inflammatory bowel disease (IBD).

Methods: Patients with IBD were randomized 1:1 to receive Engerix-B double dose or Fendrix single dose at months 0, 1, 2, and 6. Anti-HBs titers were measured 2 months after the third and fourth doses. Response to vaccination was defined as anti-HBs ≥100 UI/L. Anti-HBs titers were measured 2 months after the third and fourth doses and again at 6 and 12 months after the fourth dose.

Results: A total of 173 patients were randomized (54% received Engerix-B and 46% Fendrix). Overall, 45% of patients responded (anti-HBs ≥100 IU/L) after 3 doses and 71% after the fourth dose. The response rate after the fourth dose was 75% with Fendrix vs 68% with Engerix-B (P = 0.3). Older age and treatment with steroids, immunomodulators, or anti-tumor necrosis factor were associated with a lower probability of response. However, the type of vaccine was not associated with the response. Anti-HBs titer negativization occurred in 13% of patients after 6 months and 20% after 12 months. Anti-HBs ≥100 IU/L after vaccination was the only factor associated with maintaining anti-HBs titers during follow-up.

Discussion: We could not demonstrate a higher response rate of Fendrix (single dose) over Engerix-B (double dose). A 4-dose schedule is more effective than a 3-dose regimen. Older age and treatment with immunomodulators or anti-tumor necrosis factors impaired the success. A high proportion of IBD patients with protective anti-HBs titers after vaccination loose them over time. The risk of losing protective anti-HBs titers is increased in patients achieving anti-HBs <100 IU/L after the vaccination.
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http://dx.doi.org/10.14309/ajg.0000000000000926DOI Listing
November 2020

Comparable quality of bowel preparation with single-day versus three-day low-residue diet: Randomized controlled trial.

Dig Endosc 2020 Oct 5. Epub 2020 Oct 5.

Gastroenterology Department, Institut d'Investigació i Innovació Parc Taulí I3PT, Parc Taulí Hospital Universitari, Barcelona, Spain.

Background And Aims: There is controversy about the length of low-residue diet (LRD) for colonoscopy preparation. The aim of the study was to compare one-day vs. three-day LRD associated to standard laxative treatment for achieving an adequate colonoscopy preparation in average risk subjects with positive fecal immunochemical test undergoing screening colonoscopy.

Methods: A non-inferiority, randomized, controlled, parallel-group clinical trial was performed in the setting of average risk colorectal cancer screening program. Participants were randomized to receive 1-day vs. 3-day LRD in addition to standard polyethilenglicol treatment. Adequacy of preparation was evaluated using the Boston Bowel Preparation Scale (BBPS). Primary outcome was achieving a BBPS ≥ 2 in all colon segments. Analysis was performed for a non-inferiority margin of 5%, a 95% statistical power and one-sided 0.05 significance level.

Results: A total of 855 patients were randomized. Adequate bowel preparation was similar between groups: 97.9% of patients in the 1-day LRD group vs 96.9% in the 3-day LRD group achieved the primary outcome (P-value for non-inferiority < 0.001). The percentage of patients with BBPS scores ≥ 8 was superior in the 1-day LRD group (254 vs 221 in the 3-day LRD group, P = 0.032). The 1-day regimen was better tolerated than the 3-day diet. 47.7% (vs 28.7%, P < 0.05) of patients rated the 1-day LRD as very easy to follow.

Conclusion: The 1-day LRD is non-inferior to 3-day LRD for achieving an adequate colon cleansing before average risk screening colonoscopy and it is better tolerated.
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http://dx.doi.org/10.1111/den.13860DOI Listing
October 2020

Analysis of the Association between Fatigue and the Plasma Lipidomic Profile of Inflammatory Bowel Disease Patients.

J Proteome Res 2021 01 6;20(1):381-392. Epub 2020 Oct 6.

Digestive Diseases Service, Hospital Universitari Parc Taulí, Institut d'Investigació i Innovació Parc Taulí I3PT, Universitat Autònoma de Barcelona, Sabadell, 08208 Spain.

Inflammatory bowel disease (IBD) is a chronic, relapsing noninfectious inflammatory condition of the intestinal tract with two main phenotypes, ulcerative colitis (UC) and Crohn's disease (CD), and globally increasing incidence and prevalence. Nearly 80% of the IBD patients with active disease and 50% of those with inactive disease suffer fatigue with significant impairment of their quality of life. Fatigue has been associated with multiple factors in IBD patients but, in most cases, no direct cause can be identified, and risk factors in clinically quiescent IBD are contradictory. Furthermore, as the assessment of fatigue is subjective, there is an unmet clinical need for fatigue biomarkers. In this explorative study, we analyzed the plasma lipidomic profiles of 47 quiescent UC and CD patients (23 fatigued, 24 nonfatigued) using ultraperformance liquid chromatography-time-of-flight mass spectrometry (UPLC-TOFMS). The results showed changes in lipids associated with fatigue and IBD. Significantly decreased levels of phosphatidylcholines, plasmanyls, sphingomyelins, lysophosphatidylcholines, phosphatidylethanolamines, phosphatidylinositols, phosphatidylserines, and eicosanoids were observed in patients with fatigue. Network and metabolic pathway analysis indicated a dysregulation of the arachidonic acid and glycerophospholipid metabolisms and the sphingolipid pathway. The protein-metabolite interaction network showed interactions between functionally related metabolites and proteins, displaying 40 disease-associated hidden proteins including ABDH4, GLTP, and LCAT.
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http://dx.doi.org/10.1021/acs.jproteome.0c00462DOI Listing
January 2021

Time Trends of Crohn's Disease in Catalonia from 2011 to 2017. Increasing Use of Biologics Correlates with a Reduced Need for Surgery.

J Clin Med 2020 Sep 8;9(9). Epub 2020 Sep 8.

Servei Aparell Digestiu, Hospital Universitari Parc Taulí, 08208 Sabadell, Spain.

Background And Aims: Data from clinical trials suggest that biological drugs may improve the outcomes in Crohn's disease (CD) by reducing the need for surgery or hospitalization. The aim of this study is to evaluate the time-trends of the use of biological drugs and other treatments for CD, and its relationship with outcomes in Catalonia.

Materials And Methods: All patients with CD included in the Catalan Health Surveillance System (containing data on a population of more than 7.5 million) from 2011 to 2017 were identified. The exposures to different treatments for inflammatory bowel disease were retrieved from electronic invoicing records.

Results: Between 2011 and 2017, the use of salicylates, corticosteroids and immunosuppressive treatment fell from 28.8% to 17.1%, 15.8% to 13.7%, and 32.9% to 29.6%, respectively ( < 0.001). Biological treatment use rose from 15.0% to 18.7% ( < 0.001). Ostomy rates per 1000 patients/year fell from 13.2 in 2011 to 9.8 in 2017 ( = 0.003), and surgical resection rates from 24.1 to 18.0 ( < 0.001). The rate of CD-related hospitalizations per 1000 patients/year also fell, from 92.7 to 72.2 ( < 0.001).

Conclusions: Biological drug use rose from 15.0% to 18.7% between 2011 and 2017. During this period, we observed an improvement in the outcomes of CD patients.
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http://dx.doi.org/10.3390/jcm9092896DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7563515PMC
September 2020

Cross-sectional study of human coding- and non-coding RNAs in progressive stages of Helicobacter pylori infection.

Sci Data 2020 09 8;7(1):296. Epub 2020 Sep 8.

Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Instituto de Salud Carlos III, Madrid, Spain.

Helicobacter pylori infects 4.4 billion individuals worldwide and is considered the most important etiologic agent for peptic ulcers and gastric cancer. Individual response to H. pylori infection is complex and depends on complex interactions between host and environmental factors. The pathway towards gastric cancer is a sequence of events known as Correa's model of gastric carcinogenesis, a stepwise inflammatory process from normal mucosa to chronic-active gastritis, atrophy, metaplasia and gastric adenocarcinoma. This study examines gastric clinical specimens representing different steps of the Correa pathway with the aim of identifying the expression profiles of coding- and non-coding RNAs that may have a role in Correa's model of gastric carcinogenesis. We screened for differentially expressed genes in gastric biopsies by employing RNAseq, microarrays and qRT-PCR. Here we provide a detailed description of the experiments, methods and results generated. The datasets may help other scientists and clinicians to find new clues to the pathogenesis of H. pylori and the mechanisms of progression of the infection to more severe gastric diseases. Data is available via ArrayExpress.
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http://dx.doi.org/10.1038/s41597-020-00636-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7479617PMC
September 2020

Real-world long-term effectiveness of ustekinumab in Crohn's disease: results from the ENEIDA registry.

Aliment Pharmacol Ther 2020 09 8;52(6):1017-1030. Epub 2020 Aug 8.

Valencia, Spain.

Background: Data on the long-term administration of ustekinumab in recommended doses are limited.

Aim: To assess the real-world, long-term effectiveness of ustekinumab in refractory Crohn's disease (CD).

Methods: Multi-centre study of CD patients starting ustekinumab at the recommended dose, followed for 1 year. Values for the Harvey-Bradshaw Index (HBI), endoscopic activity, C-reactive protein (CRP), and faecal calprotectin (FC) were recorded at baseline and at weeks 26 and 52. Demographic and clinical data, previous treatments, adverse events (AEs) and hospitalisations were documented. Potential predictors of remission were examined.

Results: A total of 407 patients were analysed. The initial maintenance dose of 90 mg SC was administered every 12, 8 and 4 weeks in 56 (14%), 347 (85%) and 4 (1%) patients, respectively. After 52 weeks, treatment was discontinued in 112 patients (27.5%). At baseline, 295 (72%) had an HBI >4 points. Of these, 169 (57%) and 190 (64%) achieved clinical remission at weeks 26 and 52, respectively. FC levels returned to normal in 44% and 54% of patients at weeks 26 and 52, and CRP returned to normal in 36% and 37% of patients at weeks 26 and 52, respectively. AEs were recorded in 60 patients. The use of fewer previous anti-TNFα agents and ileal localisation were associated with clinical remission, and endoscopic severity was associated with poor response. No factors correlated with endoscopic remission.

Conclusion: After 52 weeks, ustekinumab demonstrated effectiveness in inducing clinical and endoscopic remission in patients with refractory CD.
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http://dx.doi.org/10.1111/apt.15958DOI Listing
September 2020

High Effectiveness of a 14-Day Concomitant Therapy for Treatment in Primary Care. An Observational Multicenter Study.

J Clin Med 2020 Jul 28;9(8). Epub 2020 Jul 28.

Departamento de Medicina, Universitat Internacional de Catalunya, 08195 Sant Cugat, Barcelona, Spain.

Background: The current cure rates with triple therapy combining a proton-pump inhibitor, amoxicillin and clarithromycin are unacceptably low.

Aims: To evaluate the efficacy of a 14-day concomitant therapy as an empirical first-line treatment for curing () infection in primary care.

Methods: Patients from six primary care centers in Catalonia -Spain- were included consecutively. status pre and post treatment was assessed according to local clinical practice protocol. A 14-day concomitant therapy (amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg plus omeprazole 20 mg, all drugs administered twice daily) was prescribed. Adherence to therapy and adverse events were assessed by personal interview.

Results: 112 patients were enrolled. Mean age was 46.7 ± 16.1 years. Main indication for treatment was non-investigated dyspepsia (83%). eradication was achieved in 100 of the 112 patients. Eradication rates were 89.3% (95% CI: 81.7-94.1) by intention-to-treat (ITT) analysis and 91.7% (95% CI; 84.6-95.9) per protocol (PP). No major side effects were reported; 104 (92.8%) patients complete the treatment. Forty-seven patients (42%) complained of mild side effects (metallic taste, nausea). Low adherence to treatment ( = 0.004) and significant adverse events ( = 0.004) were the variables associated with treatment failure.

Conclusions: In primary care, a 14-day concomitant therapy is highly effective and well tolerated.
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http://dx.doi.org/10.3390/jcm9082410DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7464342PMC
July 2020

Extraintestinal Manifestations in Patients with Inflammatory Bowel Disease: Study Based on the ENEIDA Registry.

Dig Dis Sci 2021 Jun 15;66(6):2014-2023. Epub 2020 Jul 15.

Department of Gastroenterology of Hospital de Sant Joan Despí Moisès Broggi, Barcelona, Spain.

Background: Patients with inflammatory bowel disease (IBD) may present extraintestinal manifestations (EIMs) that affect the joints, skin, eyes, and hepatobiliary area, among others.

Aims: Our aim was to analyse the prevalence and characteristics of EIMs in patients with IBD and to identify the possible risk factors associated with the development of EIMs in the largest series published to date.

Methods: Observational, cross-sectional study including patients from the Spanish ENEIDA registry promoted by GETECCU. We retrospectively identified all cases of EIMs in the ENEIDA registry until January 2018.

Results: The study included 31,077 patients, 5779 of whom had at least one EIM (global prevalence 19%; 95% CI 18.2-19.0). Among the different types of EIMs, rheumatic manifestations had a prevalence of 13% (95% CI 12.9-13.7; 63% of EIMs), with a prevalence of 5% (95% CI 4.7-5.2) for mucocutaneous manifestations, 2.1% (95% CI 1.9-2.2) for ocular manifestations, and 0.7% (95% CI 0.6-0.8) for hepatobiliary manifestations. The multivariable analysis showed that the type of IBD (Crohn's disease, p < 0.001), gender (female, p < 0.001), the need for an immunomodulator (p < 0.001) or biologic drugs (p < 0.001), a previous family history of IBD (p < 0.001), and an extensive location of IBD (p < 0.001) were risk factors for the presence of EIMs.

Conclusions: One-fifth of patients with IBD may have associated EIMs, with rheumatic manifestations as the most frequent (> 60% of EIMs). Female patients with severe Crohn's disease represent the group with the highest risk of developing EIMs. These patients should therefore be specially monitored and referred to the corresponding specialist when suggestive symptoms appear.
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http://dx.doi.org/10.1007/s10620-020-06424-xDOI Listing
June 2021

Bismuth quadruple regimen with tetracycline or doxycycline versus three-in-one single capsule as third-line rescue therapy for Helicobacter pylori infection: Spanish data of the European Helicobacter pylori Registry (Hp-EuReg).

Helicobacter 2020 Oct 13;25(5):e12722. Epub 2020 Jul 13.

Gastroenterology Unit, Hospital Universitario de Burgos, Spain.

Background: Different bismuth quadruple therapies containing proton-pump inhibitors, bismuth salts, metronidazole, and a tetracycline have been recommended as third-line Helicobacter pylori eradication treatment after failure with clarithromycin and levofloxacin.

Aim: To evaluate the efficacy and safety of third-line treatments with bismuth, metronidazole, and either tetracycline or doxycycline.

Methods: Sub-study with Spanish data of the "European Registry on H pylori Management" (Hp-EuReg), international multicenter prospective non-interventional Registry of the routine clinical practice of gastroenterologists. After previous failure with clarithromycin- and levofloxacin-containing therapies, patients receiving a third-line regimen with 10/14-day bismuth salts, metronidazole, and either tetracycline (BQT-Tet) or doxycycline (BQT-Dox), or single capsule (BQT-three-in-one) were included. Data were registered at AEG-REDCap database. Univariate and multivariate analyses were performed.

Results: Four-hundred and fifty-four patients have been treated so far: 85 with BQT-Tet, 94 with BQT-Dox, and 275 with BQT-three-in-one. Average age was 53 years, 68% were women. Overall modified intention-to-treat and per-protocol eradication rates were 81% (BQT-Dox: 65%, BQT-Tet: 76%, BQT-three-in-one: 88%) and 82% (BQT-Dox: 66%, BQT-Tet: 77%, BQT-three-in-one: 88%), respectively. By logistic regression, higher eradication rates were associated with compliance (OR = 2.96; 95% CI = 1.01-8.84) and no prior metronidazole use (OR = 1.96; 95% CI = 1.15-3.33); BQT-three-in-one was superior to BQT-Dox (OR = 4.46; 95% CI = 2.51-8.27), and BQT-Tet was marginally superior to BQT-Dox (OR = 1.67; 95% CI = 0.85-3.29).

Conclusion: Third-line H pylori eradication with bismuth quadruple treatment (after failure with clarithromycin and levofloxacin) offers acceptable efficacy and safety. Highest efficacy was found in compliant patients and those taking 10-day BQT-three-in-one or 14-day BQT-Tet. Doxycycline seems to be less effective and therefore should not be recommended.
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http://dx.doi.org/10.1111/hel.12722DOI Listing
October 2020

Droplet Digital PCR Detects Low-Density Infection in a Significant Proportion of Helicobacter Pylori-Negative Gastric Biopsies of Dyspeptic Patients.

Clin Transl Gastroenterol 2020 06;11(6):e00184

Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Instituto de Salud Carlos III, Madrid, Spain.

Introduction: Helicobacter pylori-infected individuals may present low-density infection, undetectable by conventional tests such as histology, rapid urease test, or urea breath test. Droplet digital polymerase chain reaction (ddPCR) is more sensitive than other polymerase chain reaction methods. We aimed to evaluate the ability of ddPCR to detect H. pylori infection in patients diagnosed as negative by conventional tests.

Methods: Dyspeptic patients (n = 236) were tested for H. pylori by histology, urea breath test, and rapid urease test. Patients were classified as having 3 positive (n = 25, control group), 2 positive (n = 12), one positive (n = 41), or zero positive (n = 158) diagnostic tests. DNA was extracted from gastric biopsies. Triplicate ddPCR testing for each of the 16S rDNA, ureA, and vacA(s) genes was performed using a QX200 ddPCR system (Bio-Rad). A gene was considered positive when detected by at least 2 of 3 repeated ddPCRs. H. pylori positivity was defined as having 2 or more positive genes.

Results: All the biopsies of the control patients were positive for all 3 16S rDNA, ureA, and vacA(s) genes. H. pylori infection was detected in 57 (36%), 22 (54%), and 9 (75%) patients with zero, 1, and 2 positive diagnostic tests, respectively. The density of infection was 5, 121, 599, and 3,133 copies of H. pylori genome equivalents for patients with zero, 1, and 2 of 3 positive test results and for the control group, respectively.

Discussion: ddPCR detected low-density "occult" H. pylori infection in a significant proportion (36%) of patients diagnosed as negative by conventional methods. The number of conventional positive tests was related to the density of infection.
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http://dx.doi.org/10.14309/ctg.0000000000000184DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7339194PMC
June 2020

Changes in the requirement for early surgery in inflammatory bowel disease in the era of biological agents.

J Gastroenterol Hepatol 2020 Dec 10;35(12):2080-2087. Epub 2020 May 10.

Hospital Universitari Germans Trias i Pujol (Badalona, Catalonia), Barcelona, Spain.

Background And Aim: Biological therapies may be changing the natural history of inflammatory bowel diseases (IBDs), reducing the need for surgical intervention. We aimed to assess whether the availability of anti-TNF agents impacts the need for early surgery in Crohn's disease (CD) and ulcerative colitis (UC).

Methods: Retrospective, cohort study of patients diagnosed within a 6-year period before and after the licensing of anti-TNFs (1990-1995 and 2007-2012 for CD; 1995-2000 and 2007-2012 for UC) were identified in the ENEIDA Registry. Surgery-free survival curves were compared between cohorts.

Results: A total of 7370 CD patients (2022 in Cohort 1 and 5348 in Cohort 2) and 8069 UC patients (2938 in Cohort 1 and 5131 in Cohort 2) were included. Immunosuppressants were used significantly earlier and more frequently in both CD and UC post-biological cohorts. The cumulative probability of surgery was lower in CD following anti-TNF approval (16% and 11%, 22% and 16%, and 29% and 19%, at 1, 3, and 5 years, respectively P < 0.0001), although not in UC (3% and 2%, 4% and 4%, and 6% and 5% at 1, 3, and 5 years, respectively; P = 0.2). Ileal involvement, older age at diagnosis and active smoking in CD, and extensive disease in UC, were independent risk factors for surgery, whereas high-volume IBD centers (in both CD and UC) and immunosuppressant use (in CD) were protective factors.

Conclusions: Anti-TNF availability was associated with a reduction in early surgery for CD (driven mainly by earlier and more widespread immunosuppressant use) but not in UC.
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http://dx.doi.org/10.1111/jgh.15084DOI Listing
December 2020

Switching to a Second Thiopurine in Adult and Elderly Patients With Inflammatory Bowel Disease: A Nationwide Study From the ENEIDA Registry.

J Crohns Colitis 2020 Sep;14(9):1290-1298

Hospital Universitari Germans Trias i Pujol, Badalona, Spain.

Background And Aims: Although commonly used in inflammatory bowel disease [IBD], thiopurines frequently cause intolerance, and switching to a second thiopurine has only been reported in some small series. Ours aims in this study were to evaluate the safety of switching to a second thiopurine in a large cohort, and to assess the impact of age on tolerance.

Methods: Adult IBD patients from the ENEIDA registry, who were switched to a second thiopurine due to adverse events [excluding malignancies and infections], were identified. At the beginning of thiopurine treatment, patients were divided by age into two groups: 18-50 and over 60 years of age. The rate and concordance of adverse events between the first and second thiopurines, treatment intolerance, and persistence with the second thiopurine were evaluated.

Results: A total of 1278 patients [13% over 60 years of age] were switched to a second thiopurine. At 12 months, the cumulative probability of switch intolerance was 43%, and persistence with treatment was 49%. Independent risk factors of switch intolerance were age over 60 years (odds ratio [OR] 1.49; 95% confidence interval [CI] 1.07-2.07; p = 0.017) , previous gastrointestinal toxicity [OR 1.4; 95% CI 1.11-1.78; p = 0.005], previous acute pancreatitis [OR 6.78; 95% CI 2.55-18.05; p <0.001], and exposure to the first thiopurine <6 months [OR 1.59; 95% CI 1.14-2.23; p = 0.007].

Conclusions: In a large series in clinical practice, switching to a second thiopurine proved to be a valid strategy. Tight monitoring of elderly IBD patients switching to a second thiopurine because of adverse events is recommended.
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http://dx.doi.org/10.1093/ecco-jcc/jjaa055DOI Listing
September 2020

Detection of Microevolution and Multiple Infection from Gastric Biopsies by Housekeeping Gene Amplicon Sequencing.

Pathogens 2020 Feb 5;9(2). Epub 2020 Feb 5.

Secció de Microbiologia, Departament de Biologia, Sanitat i Medi Ambient, Facultat de Farmàcia i Ciències de l'Alimentació, Universitat de Barcelona, Av. Joan XXIII 27-31, 08028 Barcelona, Catalonia, Spain.

Despite the great efforts devoted to research on , the prevalence of single-strain infection or mixed infection and its implications in the mode of transmission of this bacterium are still controversial. In this study, we explored the usefulness of housekeeping gene amplicon sequencing in the detection of microevolution and multiple infections. DNA was extracted from five gastric biopsies from four patients infected with distinct histopathological diagnoses. PCR amplification of six -specific housekeeping genes was then assessed on each sample. Optimal results were obtained for the and genes, which were selected for amplicon sequencing. A total of 11,833 and 403 amplicon sequences were obtained, 2042 and 112 of which were unique sequences, respectively. All and sequences were clustered at 97% to 9 and 13 operational taxonomic units (OTUs), respectively. For each sample from a different patient, a single OTU comprised the majority of sequences in both genes, but more than one OTU was detected in all samples. These results suggest that multiple infections with a predominant strain together with other minority strains are the main way by which colonizes the human stomach.
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http://dx.doi.org/10.3390/pathogens9020097DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7168683PMC
February 2020

Endoscopist's Judgment Is as Useful as Risk Scores for Predicting Outcome in Peptic Ulcer Bleeding: A Multicenter Study.

J Clin Med 2020 Feb 3;9(2). Epub 2020 Feb 3.

Hospital de Sabadell, Corporació Sanitària Universitària Parc Taulí, 08208 Sabadell, Spain.

Guidelines recommend using prognostic scales for risk stratification in patients with non-variceal upper gastrointestinal bleeding. It remains unclear whether risk scores offer greater accuracy than clinical evaluation. Compare the diagnostic accuracy of the endoscopist's judgment against different risk-scoring systems (Rockall, Glasgow-Blatchford, Baylor and the Cedars-Sinai scores) for predicting outcomes in peptic ulcer bleeding (PUB). Between February 2006 and April 2010 we prospectively recruited 401 patients with peptic ulcer bleeding; 225 received endoscopic treatment. The endoscopist recorded his/her subjective assessment ("endoscopist judgment") of the risk of rebleeding and death immediately after endoscopy for each patient. Independent evaluators calculated the different scores. Area under the receiver-operating-characteristics (ROC) curve, sensitivity, specificity, positive and negative predictive values were calculated for rebleeding and mortality. : The areas under ROC curve of the endoscopist's clinical judgment for rebleeding (0.67-0.75) and mortality (0.84-0.9) were similar or even superior to the different risk scores in both the whole group and in patients receiving endoscopic therapy. The accuracy of the currently available risk scores for predicting rebleeding and mortality in PUB patients was moderate and not superior to the endoscopist's judgment. More precise prognostic scales are needed.
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http://dx.doi.org/10.3390/jcm9020408DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7073534PMC
February 2020

Prospective, study comparing the accuracy of two different stool antigen tests (Premier Platinum HpSA and novel ImmunoCard STAT! rapid test) for the diagnosis of Helicobacter pylori infection.

Gastroenterol Hepatol 2020 Mar 4;43(3):117-125. Epub 2019 Dec 4.

Gastroenterology Unit, La Princesa University Hospital, Instituto de Investigación Sanitaria Princesa (IIS-IP), Universidad Autónoma de Madrid, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain. Electronic address:

Background: At present only monoclonal EIA (enzyme-immunoassay) stool antigen-tests have obtained optimal accuracy in the diagnosis of Helicobacter pylori. Our aim was to evaluate the accuracy of two stool antigen-tests, the validated Premier Platinum HpSA PLUS (EIA test) and the newly available ImmunoCard STAT! HpSA HD (rapid test) for the initial diagnosis and the confirmation of eradication of H. pylori infection.

Patients And Methods: Patients with indication of H. pylori diagnosis, or confirmation after treatment were included. Data were coded to protect personal data and ensure blindness between tests. Accuracy was considered as coincident diagnosis with the gold standard (C-urea breath test, UBT). The EIA was used as a bench standard. All stool tests were performed in duplicate.

Results: 264 patients completed the protocol (100 naïve, 164 post-eradication). Average age was 52 years, 61% women, 11% ulcer. Positive diagnoses by UBT were 41% for naïve and 17% for post-eradication. Overall ImmunoCard and EIA accuracies were respectively 91% (95%C.I.=88-94%) and 89% (86-93%), sensitivities 72% (67-78%) and 72% (67-78%), and specificities 98% (96-100%), and 95% (92-97%). Concordance between ImmunoCard and EIA was 95% (93-98%).

Discussion: Our results indicate that the newly available ImmunoCard rapid stool antigen-test achieves 90% accuracy, with high specificity but suboptimal sensitivity. The ImmunoCard attained equivalent accuracies as the EIA bench standard, with 95% concordance.
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http://dx.doi.org/10.1016/j.gastrohep.2019.09.009DOI Listing
March 2020

Heterogeneity of clinical management of low-grade gastric lymphoma of mucosa-associated lymphoid tissue. An audit of 198 patients in Spain.

Gastroenterol Hepatol 2020 Feb 29;43(2):79-86. Epub 2019 Nov 29.

Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain; Digestive Diseases Department, Corporación Sanitaria Parc Taulí, Sabadell, Spain; Departament de Medicina, Facultat de Medicina, Universitat Autònoma de Barcelona, Spain. Electronic address:

Introduction: Cure of Helicobacter pylori infection in patients with gastric lymphoma of mucosa-associated lymphoid tissue (MALT) leads to long-term clinical remission in the initial stages. As it is a rare disease, its management in clinical practice remains largely unknown and heterogeneity of care remains a concern. The aim was to audit the management and evolution of a large series of low-grade gastric MALT lymphomas from thirteen Spanish hospitals.

Materials And Methods: Multicentre retrospective study including data on the diagnosis and follow-up of patients with gastric low-grade MALT lymphoma from January 1998 to December 2013. Clinical, biological and pathological data were analyzed and survival curves were drawn.

Results: One-hundred and ninety-eight patients were included. Helicobacter pylori was present in 132 (69%) patients and 103 (82%) in tumors confined to the stomach (stage EI) and was eradicated in 92% of patients. Chemotherapy was given in 90 (45%) patients and 43 (33%) with stage EI. Marked heterogeneity in the use of diagnostic methods and chemotherapy was observed. Five-year overall survival was 86% (89% in EI). Survival was similar in EI patients receiving aggressive treatment and in those receiving only antibiotics (p=0.577).

Discussion: Gastric MALT lymphoma has an excellent prognosis. We observed, however, a marked heterogeneity in the use of diagnostic methods or chemotherapy in early-stage patients.
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http://dx.doi.org/10.1016/j.gastrohep.2019.08.012DOI Listing
February 2020

Management of Nonvariceal Upper Gastrointestinal Bleeding: Guideline Recommendations From the International Consensus Group.

Ann Intern Med 2019 12 22;171(11):805-822. Epub 2019 Oct 22.

Dijon-Bourgogne University Hospital, Dijon, France (R.L., M.B.).

Description: This update of the 2010 International Consensus Recommendations on the Management of Patients With Nonvariceal Upper Gastrointestinal Bleeding (UGIB) refines previous important statements and presents new clinically relevant recommendations.

Methods: An international multidisciplinary group of experts developed the recommendations. Data sources included evidence summarized in previous recommendations, as well as systematic reviews and trials identified from a series of literature searches of several electronic bibliographic databases from inception to April 2018. Using an iterative process, group members formulated key questions. Two methodologists prepared evidence profiles and assessed quality (certainty) of evidence relevant to the key questions according to the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach. Group members reviewed the evidence profiles and, using a consensus process, voted on recommendations and determined the strength of recommendations as strong or conditional.

Recommendations: Preendoscopic management: The group suggests using a Glasgow Blatchford score of 1 or less to identify patients at very low risk for rebleeding, who may not require hospitalization. In patients without cardiovascular disease, the suggested hemoglobin threshold for blood transfusion is less than 80 g/L, with a higher threshold for those with cardiovascular disease. Endoscopic management: The group suggests that patients with acute UGIB undergo endoscopy within 24 hours of presentation. Thermocoagulation and sclerosant injection are recommended, and clips are suggested, for endoscopic therapy in patients with high-risk stigmata. Use of TC-325 (hemostatic powder) was suggested as temporizing therapy, but not as sole treatment, in patients with actively bleeding ulcers. Pharmacologic management: The group recommends that patients with bleeding ulcers with high-risk stigmata who have had successful endoscopic therapy receive high-dose proton-pump inhibitor (PPI) therapy (intravenous loading dose followed by continuous infusion) for 3 days. For these high-risk patients, continued oral PPI therapy is suggested twice daily through 14 days, then once daily for a total duration that depends on the nature of the bleeding lesion. Secondary prophylaxis: The group suggests PPI therapy for patients with previous ulcer bleeding who require antiplatelet or anticoagulant therapy for cardiovascular prophylaxis.
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http://dx.doi.org/10.7326/M19-1795DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7233308PMC
December 2019

Improving Quality of Care in Inflammatory Bowel Disease Through Patients' Eyes: IQCARO Project.

Inflamm Bowel Dis 2020 04;26(5):782-791

Crohn-Colitis Care Unit, Hospital Universitari Valld`Hebron, Barcelona, Spain.

Background: Quality improvement is a major topic in inflammatory bowel disease (IBD) care, and measuring quality of care (QoC) is necessary for QoC improvement. Most QoC projects or consensus statements are designed from the health care professional point of view. Having QoC indicators designed for and fully evaluable by patients may provide a key tool for external evaluation of QoC improvement measures. The aim of the IQCARO project was to identify indicators to measure QoC from the IBD patient's point of view.

Methods: An extensive review of the literature to identify indicators of QoC was performed; first the identified indicators were reviewed by a steering committee including patients, nurses, IBD specialists, and methodologists. Then 2 focus groups of IBD patients analyzed the QoC indicators to determine whether they could be understood and evaluated by patients. The final QoC indicators were selected by a group of IBD patients using a Delphi consensus methodology.

Results: An initial list of 54 QoC indicators was selected by the steering committee. The QoC indicators were evaluated by 16 patients who participated in 2 focus groups. They identified 21 indicators that fulfilled the understandability and evaluability requirements. The 10 most relevant QoC indicators were selected by 26 patients with IBD using a Delphi consensus. The selected items covered important aspects of QoC, including professionalism, patients' autonomy, information, accessibility, and continuity of care.

Conclusions: The present Delphi consensus identified QoC indicators that are useful for developing and measuring improvement strategies in the management of IBD.
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http://dx.doi.org/10.1093/ibd/izz126DOI Listing
April 2020

TEO-Transanal Intersphincteric Intramesorectal and Laparoscopic Approach in Proctosigmoidectomy for Benign Disease.

Surg Laparosc Endosc Percutan Tech 2019 Oct;29(5):e76-e78

Coloproctology Unit, General and Digestive Surgery Service.

Purpose: Completion proctectomy is the traditional approach in the rectal stump remaining after subtotal colectomy for benign disease. It is associated with high morbidity and urinary and sexual dysfunction. To reduce this risk, a minimally invasive approach is presented, intersphincteric intramesorectal proctosigmoidectomy by transanal endoscopic operation and laparoscopy.

Patients And Methods: Patients who had undergone total or subtotal colectomy for benign disease, those with a rectosigmoid stump who had rejected intestinal reconstruction and with refractory symptoms or risk of degeneration were selected. The technique proposed and the morbidity outcomes are described.

Results: Three patients underwent this minimally invasive approach, operative time was 130 to 150 minutes. The median postoperative hospital stay was 6.6 days. Genitourinary and sexual tests performed in the male patient showed no dysfunction.

Conclusions: This minimally invasive technique, with intersphincteric resection and dissection close to the rectal wall, theoretically reduces morbidity and the damage to the autonomic pelvic nerves.
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http://dx.doi.org/10.1097/SLE.0000000000000690DOI Listing
October 2019

Effectiveness and Safety of the Sequential Use of a Second and Third Anti-TNF Agent in Patients With Inflammatory Bowel Disease: Results From the Eneida Registry.

Inflamm Bowel Dis 2020 03;26(4):606-616

Gastroenterology Department at Hospital Clínico Universitario de Salamanca, Salamanca.

Background: The effectiveness of the switch to another anti-tumor necrosis factor (anti-TNF) agent is not known. The aim of this study was to analyze the effectiveness and safety of treatment with a second and third anti-TNF drug after intolerance to or failure of a previous anti-TNF agent in inflammatory bowel disease (IBD) patients.

Methods: We included patients diagnosed with IBD from the ENEIDA registry who received another anti-TNF after intolerance to or failure of a prior anti-TNF agent.

Results: A total of 1122 patients were included. In the short term, remission was achieved in 55% of the patients with the second anti-TNF. The incidence of loss of response was 19% per patient-year with the second anti-TNF. Combination therapy (hazard ratio [HR], 2.4; 95% confidence interval [CI], 1.8-3; P < 0.0001) and ulcerative colitis vs Crohn's disease (HR, 1.6; 95% CI, 1.1-2.1; P = 0.005) were associated with a higher probability of loss of response. Fifteen percent of the patients had adverse events, and 10% had to discontinue the second anti-TNF. Of the 71 patients who received a third anti-TNF, 55% achieved remission. The incidence of loss of response was 22% per patient-year with a third anti-TNF. Adverse events occurred in 7 patients (11%), but only 1 stopped the drug.

Conclusions: Approximately half of the patients who received a second anti-TNF achieved remission; nevertheless, a significant proportion of them subsequently lost response. Combination therapy and type of IBD were associated with loss of response. Remission was achieved in almost 50% of patients who received a third anti-TNF; nevertheless, a significant proportion of them subsequently lost response.
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http://dx.doi.org/10.1093/ibd/izz192DOI Listing
March 2020