Hospital Lluis Alcanyis

Subcutaneous (SC) infliximab biosimilar CT-P13 has shown comparable efficacy and safety to the intravenous (IV) formulation in inflammatory bowel disease (IBD). However, long-term real-world data remain limited. This study assessed the three-year effectiveness, safety, and pharmacokinetics profile of SC CT-P13 in IBD patients switched from IV infliximab. Prospective, observational, multicenter study conducted in eight hospitals (Valencian Community, Spain). Adult patients with ulcerative colitis (UC) or Crohn's disease (CD) receiving IV infliximab were switched to SC CT-P13 and followed for up to 3 years. Clinical activity, inflammatory biomarkers, adverse events, treatment persistence, and infliximab trough levels were assessed, including analyses according to immunomodulatory therapy (IM) use and dosing intensities. Seventy-four patients were included (43% UC, 57% CD). Mean SC CT-P13 trough levels increased significantly from baseline to 3 years (8.15 ± 5.93 to 15.89 ± 7.99 µg/mL, p<0.001), with consistent results across disease type, intensified dosing, and perianal CD subgroups. Inflammatory markers (CRP, calprotectin) remained stable throughout follow-up. Concomitant IM use decreased from 51% at baseline to 26.3% at study end, without changes in pharmacokinetics, clinical outcomes, or biomarkers. Treatment persistence at 3 years was 80% overall and 88% when considering only discontinuations due to loss of efficacy or adverse events. Fourteen patients (19%) experienced adverse events, predominantly mild. Switching from intravenous to subcutaneous infliximab biosimilar CT-P13 was associated with sustained treatment persistence, stable disease control, favorable pharmacokinetics, and good tolerability over 3 years. These real-world findings support SC CT-P13 as a convenient long-term maintenance option in routine clinical practice.

IntroductionDepression is a highly prevalent disease that severely impacts the life of patients. Inadequate response to at least two antidepressants despite adequacy of treatment and adherence is known as treatment-resistant depression (TRD), which entails a higher social and economic burden than non-resistant major depression. The lack of consensus on the definition of TRD and other aspects complicates management of the disease. Intranasal esketamine has a novel mechanism of action that differs from that of traditional antidepressants by improving neuroplasticity and synaptogenesis.Material and methodsA scientific committee comprising ten psychiatrists, experts in TRD in Spain, reviewed the literature (grey literature and articles or scientific communications published between January 2014 and January 2024 in PubMed) and developed statements on theoretical and conceptual aspects of TRD. Statements were developed in a first meeting following a discussion group approach, refined in a second meeting following a nominal group technique, and consensus was finally drafted in a third meeting.ResultsA series of statements and recommendations were developed. Definitions for TRD and clinical response were proposed. The impact of therapeutic inertia was highlighted, identifying its causes and consequences. The role of intranasal esketamine in the TRD therapeutic treatment landscape was reviewed, and a treatment algorithm was developed, including specifics on evaluation of response to avoid therapeutic inertia and ensure an adequate treatment.ConclusionsThis is the first consensus developed in Spain regarding theoretical aspects of TRD and the role of intranasal esketamine in TRD therapeutic approach. A definition of TRD was proposed, together with a treatment algorithm.

Los tres centros educativos públicos que conformamos la agrupación, CEIP Mendigoiti (Pamplona, Navarra), CEIP Attilio Bruschetti (Xátiva, Valencia) y CEIP Rosa dels vents (Mallorca) hemos desarrollado un proyecto común durante los cursos 2022-2023 y 2023-2024. La temática principal de nuestra agrupación se fundamenta en la implementación de metodologías activas y propuestas didácticas que potencien el éxito educativo de todo el alumnado. Promover una mejora pedagógico-didáctica pasa necesariamente por plantearnos una nueva arquitectura, un nuevo diseño de los entornos educativos, que rompa con la rigidez tradicional de espacios inmutables y se abra a la polivalencia y a la flexibilidad de los mismos. De ese deseo nace el proyecto DUALIZA-TE: Diseño de Entornos Educativos y Situaciones de Aprendizaje en clave DUA (Diseño Universal para el Aprendizaje). La posibilidad de colaborar entre tres escuelas de diferentes regiones que trabajamos en el diseño de entornos educativos, nos ha permitido reflexionar y potenciar la importancia del necesario diálogo que ha de existir entre la pedagogía y la arquitectura, entre el aprendizaje y el espacio. Además, nos ha facilitado generar acciones que nos lleven a diseñar, construir y adecuar instalaciones educativas que tengan en cuenta las necesidades de la infancia, acoger la diversidad humana y ofrecer entornos de aprendizaje seguros, no violentos, inclusivos y eficaces donde todo el alumnado aprende y progresa. Igualmente el proyecto fomenta la formación para el desarrollo profesional docente en las competencias profesionales que le son propias tales como: competencia científica, didáctica, comunicativa, digital, en innovación, investigación y mejora, trabajo en equipo, gestión y organización y en habilidades relacionales y comunicativas, a través de la observación,el intercambio de experiencias, el diseño de entornos educativos y el diseño de situaciones de aprendizaje interdisciplinares en clave DUA.

Abstract Background The Spanish Incisional Hernia Surgery Registry EVEREG began in 2012 and currently has more than 160 participating centers. The aim of this study is to evaluate the results of the main variables collected in these 10 years of registry. Methods The registered variables are analyzed in the period from its beginning in July 2012 to September 2023. The variables are divided into demographics, characteristics of the hernia, surgery and follow-up. Results In 10 years, 14894 cases have been registered. 54.4% women and 45.6% men, with an average BMI of 30.4. 20.2% with type II Diabetes Mellitus, 20-9% smokers and 33.6% with a previous abdominal wall intervention. The average diameters of the hernias are 6.9 cm transverse and 8.6 cm longitudinal. The most frequent location is M3 (56.4%), M2 (43.3%) and M4 (34.2%). 23.5% relpased and 29.5 % trocar hernias. Open approach was performed in 90.2%. Prosthesis was placed in 97.9% of cases, synthetic in 99.2% of them. The main plane of mesh placement was retromuscular in 37.9%. In the postoperative period, 12.5% of cases presented some complication, the majority classified as Clavien grades 1 and 2 (74.3%). Conclusion The data presented must be analyzed considering that they include the different techniques carried out in the long study period. The creation fo surgical registries allows us to know the real data of the surgery performed ant its analysis is very useful for the personal and general improvement of each procedure analyzed.

The rupture of the rotator cuff is a common condition in Orthopedics, with massive and irreparable tears posing a challenge for Orthopedic surgeons. There are multiple techniques described for its treatment, with one of the most recent being the implantation of a subacromial balloon. This technically simple technique has shown good biomechanical results in the literature but controversial clinical outcomes. Most of the existing literature is of low scientific evidence. Studies with higher evidence are starting to emerge, but there is still no clear definition of the role of subacromial balloons.

In June, 2021, WHO published the most complete catalogue to date of resistance-conferring mutations in Mycobacterium tuberculosis. Here, we aimed to assess the performance of genome-based antimicrobial resistance prediction using the catalogue and its potential for improving diagnostics in a real low-burden setting. In this retrospective population-based genomic study M tuberculosis isolates were collected from 25 clinical laboratories in the low-burden setting of the Valencia Region, Spain. Culture-positive tuberculosis cases reported by regional public health authorities between Jan 1, 2014, and Dec 31, 2016, were included. The drug resistance profiles of these isolates were predicted by the genomic identification, via whole-genome sequencing (WGS), of the high-confidence resistance-causing variants included in the catalogue and compared with the phenotype. We determined the minimum inhibitory concentration (MIC) of the isolates with discordant resistance profiles using the resazurin microtitre assay. WGS was performed on 785 M tuberculosis complex culture-positive isolates, and the WGS resistance prediction sensitivities were: 85·4% (95% CI 70·8-94·4) for isoniazid, 73·3% (44·9-92·2) for rifampicin, 50·0% (21·1-78·9) for ethambutol, and 57·1% (34·0-78·2) for pyrazinamide; all specificities were more than 99·6%. Sensitivity values were lower than previously reported, but the overall pan-susceptibility accuracy was 96·4%. Genotypic analysis revealed that four phenotypically susceptible isolates carried mutations (rpoB Leu430Pro and rpoB Ile491Phe for rifampicin and fabG1 Leu203Leu for isoniazid) known to give borderline resistance in standard phenotypic tests. Additionally, we identified three putative resistance-associated mutations (inhA Ser94Ala, katG Leu48Pro, and katG Gly273Arg for isoniazid) in samples with substantially higher MICs than those of susceptible isolates. Combining both genomic and phenotypic data, in accordance with the WHO diagnostic guidelines, we could detect two new multidrug-resistant cases. Additionally, we detected 11 (1·6%) of 706 isolates to be monoresistant to fluoroquinolone, which had been previously undetected. We showed that the WHO catalogue enables the detection of resistant cases missed in phenotypic testing in a low-burden region, thus allowing for better patient-tailored treatment. We also identified mutations not included in the catalogue, relevant at the local level. Evidence from this study, together with future updates of the catalogue, will probably lead in the future to the partial replacement of culture testing with WGS-based drug susceptibility testing in our setting. European Research Council and the Spanish Ministerio de Ciencia.

PurposeThe CoVID-TE model was developed with the aim of predicting venous thrombotic events (VTE) in cancer patients with Sars-Cov-2 infection. Moreover, it was capable of predicting hemorrhage and mortality 30 days following infection diagnosis. The model is pending validation.Methods/patientsMulticenter retrospective study (10 centers). Adult patients with active oncologic disease/ antineoplastic therapy with Sars-Cov-2 infection hospitalized between March 1, 2020 and March 1. 2022 were recruited. The primary endpoint was to study the association between the risk categories of the CoVID-TE model and the occurrence of thrombosis using the Chi-Square test. Secondary endpoints were to demonstrate the association between these categories and the occurrence of post-diagnostic Sars-Cov-2 bleeding/ death events. The Kaplan–Meier method was also used to compare mortality by stratification.Results263 patients were enrolled. 59.3% were men with a median age of 67 years. 73.8% had stage IV disease and lung cancer was the most prevalent tumor (24%). A total of 86.7% had an ECOG 0–2 and 77.9% were receiving active antineoplastic therapy. After a median follow-up of 6.83 months, the incidence of VTE, bleeding, and death 90 days after Sars-Cov-2 diagnosis in the low-risk group was 3.9% (95% CI 1.9–7.9), 4.5% (95% CI 2.3–8.6), and 52.5% (95% CI 45.2–59.7), respectively. For the high-risk group it was 6% (95% CI 2.6–13.2), 9.6% (95% CI 5.0–17.9), and 58.0% (95% CI 45.3–66.1). The Chi-square test for trends detected no statistically significant association between these variables (p > 0.05). Median survival in the low-risk group was 10.15 months (95% CI 3.84–16.46), while in the high-risk group it was 3.68 months (95% CI 0.0–7.79). The differences detected were not statistically significant (p = 0.375).ConclusionsThe data from our series does not validate of the CoVID-TE as a model to predict thrombosis, hemorrhage, or mortality in cancer patients with Sars-Cov-2 infection.