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Criterios de interpretación del Real decreto 3/2023 en relación con la calidad del agua de consumo utilizada en la industria alimentaria
Get PDFAigua; Qualitat; Indústria alimentàriaAgua; Calidad; Industria alimentariaWater; Quality; Food industryL’objectiu d’aquest document és donar una visió harmonitzada de l’aplicació de la normativa, concretament del capítol VI del Reial decret 3/2023 sobre la qualitat de l’aigua a l’empresa alimentària, atès que es poden fer diferents interpretacions. Aquest document pretén resoldre dubtes i establir criteris, tant tècnics com sanitaris, per a poder aplicar la normativa de manera uniforme, tant per part dels operadors econòmics com pels Serveis d’inspecció.El objetivo de este documento es ofrecer una visión armonizada de la aplicación de la normativa, concretamente del capítulo VI del Real Decreto 3/2023 sobre la calidad del agua en la empresa alimentaria, dado que pueden existir diferentes interpretaciones. Este documento pretende resolver dudas y establecer criterios, tanto técnicos como sanitarios, para poder aplicar la normativa de manera uniforme, tanto por parte de los operadores económicos como por parte de los Servicios de inspección.The aim of this document is to provide a harmonised view of the implementation of the regulations, specifically Chapter VI of Royal Decree 3/2023 concerning water quality in food businesses, given that different interpretations may arise. This document seeks to clarify doubts and establish both technical and health-related criteria in order to ensure uniform application of the regulations by both economic operators and inspection services
Expanding screening through the use of liquid biopsy for early cancer detection
Get PDFScreening; Liquid biopsy; CancerCribratge; Biòpsia líquida; CàncerCribado; Biopsia líquida; CáncerScreening programs have helped reduce cancer-specific mortality by detecting cancer at earlier stages. Developing increasingly sensitive, organ-specific liquid biopsy assays to evaluate tumor-derived analytes could pave the way for non-invasive early cancer diagnosis in population screening programs
Evidence-based guidelines for the pharmacological treatment of migraine, summary version
Get PDFAcute treatment; Migraine treatment; Preventive treatmentTractament agut; Tractament de la migranya; Tractament preventiuTratamiento agudo; Tratamiento de la migraña; Tratamiento preventivoWe here present evidence-based guidelines for the pharmacological treatment of migraine. These guidelines, created by the Italian Society for the Study of Headache and the International Headache Society, aim to offer clear, actionable recommendations to healthcare professionals. They incorporate evidence-based recommendations from randomized controlled trials and expert-based opinions. The guidelines follow the GRADE approach for assessing the quality of evidence. The guideline development involved a systematic review of literature across multiple databases, adherence to Cochrane review methods, and a structured framework for data extraction and interpretation. Although the guidelines provide a robust foundation for migraine treatment, they also highlight gaps in current research, such as the paucity of head-to-head drug comparisons and the need for long-term outcome studies. These guidelines serve as a resource to standardize migraine treatment and promote high-quality care across different healthcare settings
Atezolizumab Plus Chemotherapy With or Without Bevacizumab in Advanced Biliary Tract Cancer: Clinical and Biomarker Data From the Randomized Phase II IMbrave151 Trial
Get PDFChemotherapy; Advanced biliary tract cancer; BiomarkerQuimioteràpia; Càncer de les vies biliars BiomarcadorsQuimioterapia; Cáncer de las vías biliares: BiomarcadoresPurpose
Biliary tract cancers (BTCs) harbor an immunosuppressed tumor microenvironment and respond poorly to PD-1/PD-L1 inhibitors. Bevacizumab (anti–vascular endothelial growth factor) plus chemotherapy can promote anticancer immunity, augmenting response to PD-L1 inhibition.
Patients and Methods
This randomized, double-blind, proof-of-concept phase II study enrolled patients (n = 162) with previously untreated advanced BTC (IMbrave151; ClinicalTrials.gov identifier: NCT04677504). Patients were randomly assigned 1:1 to receive cycles of atezolizumab (1,200 mg) plus bevacizumab (15 mg/kg) or atezolizumab plus placebo once every 3 weeks until disease progression or unacceptable toxicity. All patients received cisplatin (25 mg/m2) plus gemcitabine (1,000 mg/m2; cisplatin plus gemcitabine [CisGem]) on days 1 and 8 once every 3 weeks for up to eight cycles. Stratification of patients was by disease status, geographic region, and primary tumor location. The primary end point was progression-free survival (PFS). No formal hypothesis testing was performed. Exploratory correlative biomarker analysis was undertaken using transcriptome analysis (n = 95) and mutation profiling (n = 102) on baseline tumor samples.
Results
Between February and September 2021, 162 patients were enrolled. Median PFS was 8.3 months in the bevacizumab arm and 7.9 months in the placebo arm (stratified hazard ratio [HR], 0.67 [95% CI, 0.46 to 0.95]). Median overall survival (OS) was 14.9 and 14.6 months in the bevacizumab and placebo arms, respectively (stratified HR, 0.97 [95% CI, 0.64 to 1.47]). The incidence of grade 3 or 4 adverse events was 74% in both arms. High VEGFA gene expression was associated with improved PFS (HR, 0.44 [95% CI, 0.23 to 0.83]) in the bevacizumab arm versus placebo.
Conclusion
In unselected patients with advanced BTC, adding bevacizumab to atezolizumab plus CisGem modestly improves PFS but not OS. High VEGFA gene expression may represent a predictive biomarker of benefit from atezolizumab/bevacizumab, warranting further investigation.This study was sponsored by F. Hoffmann-La Roche Ltd/Genentech, Inc
Complement Activation Profiles Predict Clinical Outcomes in Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease
Get PDFComplement activation; Clinical outcomes; Myelin oligodendrocyte glycoproteinPerfiles de activación; Resultados clínicos; Glucoproteína de oligodendrocito de mielinaActivació del complement; Resultats clínics; Glicoproteïna d'oligodendròcits de mielinaBackground and Objectives
The role of the complement system in myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD) is not completely understood, and studies exploring its potential utility for diagnosis and prognosis are lacking. We aimed to investigate the value of complement factors (CFs) as diagnostic and prognostic biomarkers in patients with MOGAD.
Methods
Multicentric retrospective cohort study including patients with MOGAD, multiple sclerosis (MS) and aquaporin-4 seropositive neuromyelitis optica spectrum disorder (AQP4-NMOSD) with available paired serum and CSF samples. A panel of CFs were measured by multiplex ELISA, and the levels were compared between the 3 conditions. Univariable and multivariable analyses were performed to evaluate the association between levels of CFs and relapse and disability outcomes in MOGAD patients.
Results
Ninety-four patients (MOGAD, n = 60; MS, n = 18; AQP4-NMOSD, n = 16) were included. Mean (SD) age at sampling was 39.4 (16.7), 40.7 (7.0), and 43.3 (21.0), respectively. Female were predominant, especially in AQP4-NMOSD (88%). Combination of the serum levels of C3a, C4a, and C3a/C3 ratio showed excellent potential to discriminate MOGAD from patients with MS (area under the curve [AUC] [95% CI] 0.95 [0.90–0.99]) and from AQP4-NMOSD (AUC 0.88 [0.76–1.00]). In patients with MOGAD, CSF levels of CFs of the classical/lectin pathway influenced relapse-related outcomes, and lower C4 levels were associated with higher number of relapses during follow-up (incidence rate ratio [95% CI] 0.88 [0.78–0.99]; p = 0.04 in multivariable analysis), and a high C4a/C4 ratio was associated with increased risk of second relapse during the first year (hazard ratio [95% CI] 3.68 [1.26–10.78]; p = 0.02 in multivariable analysis). Time to second relapse was shorter in patients with MOGAD with a high CSF C4a/C4 ratio (log-rank p = 0.01). CSF levels of the membrane attack complex SC5b9 influenced disability-related outcomes, and baseline CSF SC5b9 levels were higher in patients who reached the final Expanded Disability Status Scale (EDSS) ≥ 3.0 (p = 0.002), and elevated SC5b9 levels were associated with increased risk of reaching EDSS ≥ 3.0 (odds ratio [95% CI] 1.79 [1.16–3.67]; p = 0.04 in multivariable analyses).
Discussion
Our results suggest that serum and CSF levels of CFs have diagnostic and prognostic value respectively in patients with MOGAD. These findings support the use of complement inhibitors as a therapeutic approach in these patients.The study was funded thanks to a legacy from Mrs. Adela Arbó. J.V.-A. received grant from Instituto de Salud Carlos III, Spain; FI21/00282
Epidemiologia i perfil de resistència antibiòtica de salmonel·la no tifòdica i salmonel·la tífica: Catalunya, 2022-2023
Get PDFResistència antibiòtica; Salmonel·la no tifòdica; Salmonel·la tíficaResistencia antibiótica; Salmonela no tifódica; Salmonela tíficaAntibiotic resistance; Non-typhoid Salmonella; Typhoid SalmonellaAquest informe té com a objectiu analitzar les característiques epidemiològiques dels casos confirmats de salmonel·la no tifòdica i salmonel·la tífica i analitzar la sensibilitat antimicrobiana dels casos declarats a l’SNMC durant els anys 2022-2023.This report aims to analyze the epidemiological characteristics of confirmed cases of non-typhoid salmonella and typhoid salmonella and to analyze the antimicrobial sensitivity of cases declared to the SNMC during the years 2022-2023
A cross-sectional multicentre study of multishell diffusion MRI in multiple sclerosis
Get PDFDiffusion weighted imaging; MRI; Multiple sclerosisImatges ponderades per difusió; Ressonància magnètica; Esclerosi múltipleImágenes ponderadas por difusión; Resonancia magnética; Esclerosis múltipleBackground and objectives
White matter (WM) microstructural properties from advanced multishell diffusion MRI (dMRI) have been linked to clinical disability in multiple sclerosis (MS). This multicentre study used multishell dMRI to compute WM metrics and test for differences between people with MS (pwMS) and healthy controls (HCs).
Methods
We included multishell dMRI data from 251 pwMS or clinically isolated syndrome (CIS) (mean age 40.7 years, 72.4 % women, 88.8 % relapsing remitting MS) at six MAGNIMS centres and 543 HCs. Eleven scalar metric maps were estimated from multishell dMRI sequences, based on diffusion tensor imaging (DTI) and restriction spectrum imaging (RSI). The maps were analysed using tract-based spatial statistics (TBSS). The diffusion output was submitted to paired sampled t-tests to test for case-control differences and linear regression models to test for associations with Expanded Disability Status Scale (EDSS) scores, while accounting for confounders. In a sub-sample from Oslo, we tested for correlations between EDSS and dMRI metrics within WM lesions.
Results
Significant group differences were found in nine out of eleven dMRI metrics. Linear regression models revealed significant correlations between EDSS and fractional anisotropy (FA) fast (β=-4.54, p = 0.01) and apparent diffusion coefficient (ADC) fast (β=10.92, p = 8.7 × 10−3).
Conclusions
Diffusion MRI based on clinically feasible multishell sequences uncovers WM group differences between pwMS and HCs, but only a selection of the advanced multishell parameters were sensitive to disability, and no statistically significant correlations with disability remained after Bonferroni correction.This work was supported by the South Eastern Regional Health Authority of Norway (project number 2017114; HFH), by the German Research Council (Deutsche Forschungsgemeinschaft – DFG; RC-TR-128;SG)
Evaluación de la seguridad clínica y de la eficacia y efectividad comparativa de los injertos cutáneos autólogos de tipo injerto en sello en pacientes con heridas de difícil cicatrización
Get PDFEmpelts de pell autòlegs; Cicatrització de feridesInjertos de piel autólogos; Cicatrización de heridasAutologous skin grafts; Wound healingL’objectiu general d’aquest informe d’avaluació de tecnologies sanitàries és avaluar l’evidència disponible sobre la seguretat clínica, així com l’eficàcia i l’efectivitat comparativa dels empelts cutanis autòlegs tipus empelt en segell en pacients adults amb ferides de difícil cicatrització.El objetivo general de este informe de evaluación de tecnologías sanitarias es evaluar la evidencia disponible sobre la seguridad clínica, así como la eficacia y la efectividad comparativa de los injertos cutáneos autólogos tipo injerto en sello en pacientes adultos con heridas de difícil cicatrización.The general objective of this health technology assessment report is to evaluate the available evidence on the clinical safety, as well as the efficacy and comparative effectiveness, of autologous skin grafts of the stamp graft type in adult patients with hard-to-heal wounds
Efficacy and safety of bintrafusp alfa evaluated in a phase II single-arm clinical trial in previously treated advanced pleural mesothelioma
Get PDFImmunotherapy; Mesothelioma; TGF-β blockadeImmunoteràpia; Mesotelioma; Bloqueig de TGF-βInmunoterapia; Mesotelioma; Bloqueo de TGF-βObjectives
We aimed to evaluate the efficacy (progression-free survival [PFS]) of bintrafusp alfa in patients with pleural mesothelioma (PM) who had progressed to platinum-based chemotherapy and had not previously received immunotherapy. We also assessed overall survival [OS], objective response rate [ORR], and safety and tolerability.
Materials and Methods
This open-label, non-randomised, multicentre, phase II, single-arm clinical trial was carried out by the Spanish Lung Cancer Group between October 2021 and March 2023 in 15 Spanish hospitals. We included patients ≥ 18 years old, with an ECOG PS of 0 or 1, with a histologically confirmed unresectable or metastatic PM, and with a life expectancy of at least three months.
Results
46 patients were included in the analysis. Most patients were men (78.3 %), the mean age was 70.0 years (SD, 9.5), and most presented epithelioid PM (84.8 %). The median PFS was 1.9 months (95 % CI, 1.7–3.2 months), the median duration of bintrafusp alfa response was 3.8 months, and the ORR was 6.5 % (95 % CI, 2.1–18.8 %). The median OS was 11.9 months (95 % CI, 5.8–15.7 months). Grade 3 or higher adverse events were observed in 34.8 % of patients and no grade 5 adverse event was reported.
Conclusion
Bintrafusp alfa did not reach the expected efficacy in patients with advanced PM. We did not identify new safety signals with bintrafusp alfa, and no case of bleeding was reported. Our study suggested that bintrafusp alfa has limited efficacy in PM, as reported in other solid tumours.This study was sponsored by the Spanish Lung Cancer Foundation (Fundación GECP) and financially supported by Merck (CrossRef Funder ID: https://10.13039/100009945)
Validation of the Barcelona Magnetic Resonance Imaging Predictive Model for Significant Prostate Cancer Detection in Men Undergoing Mapping per 0.5 Mm-Core Targeted Biopsies of Suspicious Lesions and Perilesional Areas
Get PDFDetection; Prostate biopsy; Prostate cancerDetecció; Biòpsia de pròstata; Càncer de pròstataDetección; Biopsia de próstata; Cáncer de próstataBackground/Objectives: Validation of predictive models (PMs) is crucial to be implemented in new populations or when advances in diagnostic approaches occurred. The aim of this study is to validate the BCN-MRI PM for sPCa when a highly effective prostate biopsy protocol is used. Methods: A prospective cohort of 457 men suspected of having PCa, for whom MRI results were reported with the Prostate Imaging-Reporting and Data System (PI-RADS) v 2.1, underwent a per 0.5 mm-core mapping targeted biopsy of suspicious lesions and perilesional areas, followed by a 12-core-systematic biopsy. These procedures took place between 1 February 2022, and 29 February 2024, at a reference center for prostate biopsy. The individual likelihood of sPCa was assessed through the BCN-MRI risk calculator. Results: The overall sPCa detection rate was 58.3%. The calibration curve of the BCN-MRI PM showed an appropriate accuracy between expected and observed probabilities with a discrimination ability for sPCa yielding an area under the curve (AUC) of 0.862 (95% CI 0.828–0.896) comparable to the AUC of 0.858 (95% CI 0.833–0.883) observed in the development cohort. The application of the BCN-MRI PM provided a net benefit over performing biopsies on all men, avoiding 24.9% of prostate biopsies at 95% sensitivity for sPCa, compared to the 23.7% reduction observed in the development cohort. Conclusions: We conclude that the BCN-MRI PM is ready to be implemented when this biopsy protocol is employed.This research was supported by the Instituto de Salut Carlos III (SP) and the European Union (PI20/01666)