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- A scoping review of the assessment reports of genetic or genomic tests reveals inconsistent consideration of key dimensions of clinical utilityPublication . Pezzullo, Angelo Maria; Gris, Angelica Valz; Scarsi, Nicolò; Tona, Diego Maria; Porcelli, Martina; Di Pumpo, Matteo; Piko, Peter; Adany, Roza; Kannan, Pragathy; Perola, Markus; Cardoso, Maria Luis; Costa, Alexandra; Vicente, Astrid M.; Reigo, Anu; Vaht, Mariliis; Metspalu, Andres; Kroese, Mark; Pastorino, Roberta; Boccia, StefaniaObjectives: Genetic and genomic tests are the cornerstone of personalized preventive approaches. Inconsistency in evaluating their clinical utility is often cited as a reason for their limited implementation in clinical practice. Previous reviews have primarily focused on theoretical frameworks used for clinical utility evaluations of genetic tests, rather than actual assessments and examined dimensions, rather than specific indicators within these dimensions. We aimed to review the dimensions and the specific indicators measured in published assessment reports of genetic or genomic tests. Study design and setting: We conducted a scoping review of assessment reports of genetic and genomic tests used for prevention, searching through PubMed, Web of Science, Scopus, the websites of 20 different organizations, Google, and Google Scholar. From the included assessments, we extracted the reported indicators of clinical utility, compiling a list of disease-specific indicators that detailed their numerator, denominator, and calculation methods. We analyzed the extracted indicators by stratifying them according to ten comprehensive dimensions of clinical utility, the assessment framework used, and the type of indicator (categorized as quantitative, qualitative, reference, or no evidence reported). From these indicators, we then distilled a list of general indicators. Results: We reviewed 3054 unique references and 12,000 results from gray literature searches, ultimately selecting 57 assessment reports. The reference frameworks used were health technology assessment (HTA) (42%), Evaluation of Genomic Applications in Practice and Prevention (EGAPP) (25%), ACCE (21%), and others (12%). We identified 951 disease-specific indicators. The dimensions most frequently evaluated (ie, had at least one indicator) were analytic validity (60%), clinical validity (79%), clinical efficacy (79%), and economic impact (58%). Only 12 assessments compared health outcomes between tested and untested groups, and fewer than 15% of the assessments addressed equity, acceptability, legitimacy, and personal value. Conclusion: Our study illustrates that, although dimensions such as equity and acceptability, are significantly emphasized in traditional evaluation frameworks, these are often not considered in the assessments. Additionally, our study has underscored a significant dearth of reported primary evidence concerning the clinical efficacy of these tests.
- Interim 2024/25 influenza vaccine effectiveness: eight European studies, September 2024 to January 2025Publication . Rose, Angela; Lucaccioni, Héloïse; Marsh, Kimberly; Kirsebom, Freja; Whitaker, Heather; Emborg, Hanne-Dorthe; Botnen, Amanda Bolt; O’Doherty, Mark G.; Pozo, Francisco; Shahul Hameed, Safraj; Andrews, Nick; Hamilton, Mark; Lauenborg Møller, Karina; Trebbien, Ramona; Marques, Diogo F.P.; European IVE groupThe 2024/25 influenza season in Europe is currently characterised by the co-circulation of influenza A(H1N1)pdm09, A(H3N2) and B/Victoria viruses, with influenza A(H1N1)pdm09 predominating. Interim vaccine effectiveness estimates from eight European studies conducted in 17 countries indicate an overall influenza A vaccine effectiveness of 32–53% in primary care settings and 33–56% in hospital settings, with some indications of lower effectiveness by subtype and higher effectiveness against influenza B (≥58% across settings). Where feasible, influenza vaccination should be encouraged and other preventive measures strengthened.
- Whole-Genome Sequencing of Extended-Spectrum β-Lactamase-Producing Klebsiella pneumoniae Isolated from Human Bloodstream InfectionsPublication . Sabença, Carolina; Rivière, Rani; Costa, Eliana; Sousa, Sara; Caniça, Manuela; Silva, Vanessa; Igrejas, Gilberto; Torres, Carmen; Poeta, PatríciaKlebsiella pneumoniae is a Gram-negative bacterium commonly associated with bloodstream infections (BSIs), which can lead to severe clinical outcomes, especially in immunocompromised individuals or patients with underlying health conditions. The increasing prevalence of K. pneumoniae that produces extended-spectrum β-lactamases (ESBL) poses a significant challenge for treatment and infection control, necessitating a swift diagnostic approach and tailored antimicrobial therapy to improve patient outcomes. A total of 32 K. pneumoniae isolates were recovered from BSIs from December 2021 to August 2022. Whole-genome sequencing (WGS) was performed on the 14 ESBL-producing isolates. All ESBL isolates carried the blaCTX-M-15 gene, together with other β-lactamase-encoding genes (blaTEM-1, blaSHV-28, blaSHV-26, or blaOXA-1). Three of the isolates also carried the blaKPC-3 gene. Resistance genes to quinolones, sulfonamides, tetracycline, aminoglycosides, and chloramphenicol were also detected. We can conclude that the presence of ESBL-producing isolates among K. pneumoniae of BSIs raises concerns, since these enzymes limit the available treatment options, and future research must include studies on alternative therapies for dealing with resistant bacterial infections and developing new approaches to disease treatment.