Evaluation of a New Monoclonal Chemiluminescent Immunoassay Stool Antigen Test for the Diagnosis of Helicobacter pylori Infection: A Spanish Multicentre Study

The stool antigen test (SAT) represents an attractive alternative for detection of Helicobacter pylori. The aim of this study was to assess the accuracy of a new SAT, the automated LIAISON(R) Meridian H. pylori SA based on monoclonal antibodies, compared to the defined gold standard C-13-urea breath test (UBT). This prospective multicentre study (nine Spanish centres) enrolled patients >= 18 years of age with clinical indication to perform UBT for the initial diagnosis and for confirmation of bacterial eradication. Two UBT methods were used: mass spectrometry (MS) including citric acid (CA) or infrared spectrophotometry (IRS) without CA. Overall, 307 patients (145 naive, 162 with confirmation of eradication) were analysed. Using recommended cut-off values (negative SAT = 1.10) the sensitivity, specificity, positive predictive value, negative predictive value and accuracy were 67%, 97%, 86%, 92% and 91%, respectively, obtaining an area under the receiver operating characteristic (ROC) curve (AUC) of 0.85. Twenty-eight patients, including seven false positives and 21 false negatives, presented a discordant result between SAT and UBT. Among the 21 false negatives, four of six tested with MS and 11 of 15 tested with IRS presented a borderline UBT delta value. In 25 discordant samples, PCR targeting H. pylori DNA was performed to re-assess positivity and SAT accuracy was re-analysed: sensitivity, specificity, positive predictive value, negative predictive value, accuracy and AUC were 94%, 97%, 86%, 99%, 97% and 0.96, respectively. The new LIAISON(R) Meridian H. pylori SA SAT showed a good accuracy for diagnosis of H. pylori infection

Helicobacter pylori Diagnostic Tests Used in Europe : Results of over 34,000 Patients from the European Registry on Helicobacter pylori Management

Funding Information: This study was funded by Richen; however, clinical data were not accessible and the company was not involved in any stage of the Hp-EuReg study (design, data collection, statistical analysis, or manuscript writing). We want to thank Richen for their support. This project was promoted and funded by the European Helicobacter and Microbiota Study Group (EHMSG), the Spanish Association of Gastroenterology (AEG) and the Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd). The Hp-EuReg was co-funded by the European Union programme HORIZON (grant agreement number 101095359) and supported by the UK Research and Innovation (grant agreement number 10058099). The Hp-EuReg was co-funded by the European Union programme EU4Health (grant agreement number 101101252). Acknowledgments We want to especially thank Sylva-Astrik Torossian for her assistance in language editing. Natalia García Morales is the first author who is acting as the submission’s guarantor. All authors approved the final version of the manuscript.Peer reviewedPublisher PD

Role of compliance in Helicobacter pylori eradication treatment : Results of the European Registry on H. pylori management

Peer reviewe

Experience with Rifabutin-Containing Therapy in 500 Patients from the European Registry on Helicobacter pylori Management (Hp-EuReg)

International audienceBackground: First-line Helicobacter pylori (H. pylori) treatments have been relatively well evaluated; however, it remains necessary to identify the most effective rescue treatments. Our aim was to assess the effectiveness and safety of H. pylori regimens containing rifabutin.METHODS: International multicentre prospective non-interventional European Registry on H. pylori Management (Hp-EuReg). Patients treated with rifabutin were registered in AEG-REDCap e-CRF from 2013 to 2021. Modified intention-to-treat and per-protocol analyses were performed. Data were subject to quality control.Results: Overall, 500 patients included in the Hp-EuReg were treated with rifabutin (mean age 52 years, 72% female, 63% with dyspepsia, 4% with peptic ulcer). Culture was performed in 63% of cases: dual resistance (to both clarithromycin and metronidazole) was reported in 46% of the cases, and triple resistance (to clarithromycin, metronidazole, and levofloxacin) in 39%. In 87% of cases rifabutin was utilised as part of a triple therapy together with amoxicillin and a proton-pump-inhibitor, and in an additional 6% of the patients, bismuth was added to this triple regimen. Rifabutin was mainly used in second-line (32%), third-line (25%), and fourth-line (27%) regimens, achieving overall 78%, 80% and 66% effectiveness by modified intention-to-treat, respectively. Compliance with treatment was 89%. At least one adverse event was registered in 26% of the patients (most frequently nausea), and one serious adverse event (0.2%) was reported in one patient with leukope-nia and thrombocytopenia with fever requiring hospitalisation.Conclusion: Rifabutin-containing therapy represents an effective and safe strategy after one or even several failures of H. pylori eradication treatment

Optimisation et application des améliorations dans l'évaluation des compétences transversales conçues à partir de la vision multidisciplinaire d'ApreRED

The specific competences are acquired by the students and certified by passing the different subjects of the study plans. However, soft skills are not systematically worked on and are not evaluated, which means that their acquisition cannot be guaranteed. However, these skills are a fundamental basis in higher education and in the future employment of university graduates. The current methodological paradigm of Higher Education shows the importance of authentic and alternative evaluation of learning, based on relevant activities or execution tasks. AprenRED's work in recent years has focused on the field of soft skills. In this case, the objective of this study is to optimize and improve the strategies and instruments for evaluating soft skills, based on the results obtained in recent years, from our multidisciplinary perspective.Las competencias específicas son adquiridas por los estudiantes y certificadas mediante la superación de las diferentes materias de los planes de estudio. Sin embargo, las competencias transversales no se trabajan sistemáticamente y no se evalúan, lo que implica que no pueda garantizarse su adquisición. Sin embargo, dichas competencias son base fundamental en la formación superior y en la futura inserción laboral de los graduados universitarios. El actual paradigma metodológico de la Educación Superior muestra la importancia de la evaluación auténtica y alternativa de los aprendizajes, a partir de actividades o tareas de ejecución relevantes. El trabajo de AprenRED durante los últimos años se ha centrado en el campo de las competencias transversales. En este caso, el objetivo de este trabajo es optimizar y mejorar las estrategias e instrumentos de evaluación de las competencias transversales, en base a los resultados obtenidos en los últimos años, desde nuestra visión multidisciplinar.Des compétences spécifiques sont acquises par les étudiants et certifiées par la réussite des différentes matières des plans d'études. Cependant, les compétences transversales ne sont pas systématiquement travaillées et ne sont pas évaluées, ce qui ne permet pas de garantir leur acquisition. Or, ces compétences constituent une base fondamentale dans l'enseignement supérieur et dans l'emploi futur des diplômés universitaires. Le paradigme méthodologique actuel de l'enseignement supérieur montre l'importance d'une évaluation authentique et alternative des apprentissages, basée sur des activités ou des tâches d'exécution pertinentes. Le travail d'ApreRED ces dernières années s'est concentré sur le domaine des compétences transversales. Dans ce cas, l'objectif de ce travail est d'optimiser et d'améliorer les stratégies et les instruments d'évaluation des compétences transversales, sur la base des résultats obtenus ces dernières années, à partir de notre vision multidisciplinaire

Optimización y aplicación de rúbricas en la evaluación de competencias transversales, diseñadas desde la visión multidisciplinar de aprenred

Las competencias específicas son adquiridas por los estudiantes y certificadas mediante la superación de las diferentes materias de los planes de estudio. Con todo, las competencias transversales no se trabajan sistemáticamente y no se evalúan, lo que implica que no pueda garantizarse su adquisición. Sin embargo, dichas competencias son base fundamental en la formación superior y en la futura inserción laboral de los graduados universitarios. El actual paradigma metodológico de la educación superior muestra la importancia de la evaluación auténtica y alternativa de los aprendizajes, a partir de actividades o tareas de ejecución relevantes. El objetivo de este trabajo es optimizar y mejorar las rúbricas de evaluación para las competencias transversales, empleadas a través de los Formularios de Google, basándose en los resultados obtenidos en los últimos años. Las rubricas diseñadas desde nuestra visión multidisciplinar, tanto para los profesores como para los alumnos, se emplearon en 16 asignaturas diferentes, incluyendo una de máster, en 11 grados distintos, obteniendo 648 formularios por parte de los alumnos. Una de las 2 REIIT, 2022, 1,162-174 conclusiones de este trabajo es que las evaluaciones realizadas por el alumnado durante el curso 2020/21 fueron en general más positivas que las del curso 2019/20

Analysis of Clinical Phenotypes through Machine Learning of First-Line <i>H. pylori</i> Treatment in Europe during the Period 2013–2022: Data from the European Registry on <i>H. pylori</i> Management (Hp-EuReg)

The segmentation of patients into homogeneous groups could help to improve eradication therapy effectiveness. Our aim was to determine the most important treatment strategies used in Europe, to evaluate first-line treatment effectiveness according to year and country. Data collection: All first-line empirical treatments registered at AEGREDCap in the European Registry on Helicobacter pylori management (Hp-EuReg) from June 2013 to November 2022. A Boruta method determined the “most important” variables related to treatment effectiveness. Data clustering was performed through multi-correspondence analysis of the resulting six most important variables for every year in the 2013–2022 period. Based on 35,852 patients, the average overall treatment effectiveness increased from 87% in 2013 to 93% in 2022. The lowest effectiveness (80%) was obtained in 2016 in cluster #3 encompassing Slovenia, Lithuania, Latvia, and Russia, treated with 7-day triple therapy with amoxicillin–clarithromycin (92% of cases). The highest effectiveness (95%) was achieved in 2022, mostly in Spain (81%), with the bismuth–quadruple therapy, including the single-capsule (64%) and the concomitant treatment with clarithromycin–amoxicillin–metronidazole/tinidazole (34%) with 10 (69%) and 14 (32%) days. Cluster analysis allowed for the identification of patients in homogeneous treatment groups assessing the effectiveness of different first-line treatments depending on therapy scheme, adherence, country, and prescription year