PURPOSE: The purpose of this narrative review is to provide a comparison of several countries with different legislation and approaches to pharmacovigilance and to point out how these impact the number of adverse drug reactions (ADRs) that are reported to national competent authorities. METHODS: Legislative and statistical data regarding ADR reporting from various national competent authorities' websites, databases, and pharmacovigilance centers were used. In combination with the WHO pharmacovigilance quantitative indicator that was applied to evaluate the effectiveness of particular national pharmacovigilance systems in our scope. RESULTS: The study compared pharmacovigilance systems in six countries, focusing on ADR reporting from 2010 onwards. All countries required MAHs to report ADRs, while healthcare professionals' obligations varied. Per-capita ADR reports increased in all countries with available data, with the United States having a significantly higher reporting rate, possibly due to FDA campaigns. Despite starting later, China's per-capita reporting rate surpassed that of the Czech Republic and Japan. The study highlighted various measures taken by countries to enhance ADR reporting systems since the inception of their programs, contributing to the overall increase in reporting rates. CONCLUSIONS: ADR reporting is a global priority, with efforts made by different countries to strengthen their pharmacovigilance systems. Some success can be seen in gradually improving per-capita ADR reporting rates. The varying reporting rates and measures taken by each country may serve as a basis for further research and exchange of best practices to improve drug safety monitoring worldwide.
- Klíčová slova
- informační a komunikační technologie,
- MeSH
- informační systémy MeSH
- internet MeSH
- on-line systémy MeSH
- předškolní dítě MeSH
- výchova dítěte MeSH
- vývoj dítěte MeSH
- Check Tag
- předškolní dítě MeSH
Introduction: Effective coping mechanisms and available support systems are essential to managing the disease and maintaining the mental health of women with breast cancer. It has been found that spirituality and religion can be an important supportive element in coping with cancer and its consequences. Aim: To analyse spiritual and religious (s/r) interventions provided by health care professionals to breast cancer patients, and their relationship to physical health, psychosocial, and spiritual outcomes. Methods: Integrative literature review of systematic literature reviews and/or meta-analysis was chosen. PubMed and Web of Science databases for the period 2013-2023 after entering the keywords "spiritual, religious, existential, positive psychology, mindfulness, interventions, breast cancer, cancer" in English were searched. Results: The review included 13 systematic reviews and/or meta-analyses (SRMA). Effect of mindfulness intervention was most frequently analysed. S/r interventions significantly associated with improvements in spiritual and existential well-being, quality of life and personal well-being, hope, optimism, cognitive functions and reductions of anxiety, depression, hopelessness, stress, and fatigue. Two SRMA found that s/r interventions were associated with improvements in cortisol levels, inflammatory cytokine activity, and lymphocyte function. Conclusion: The analysed studies showed that s/r interventions are associated with improved biological, psychosocial and spiritual outcomes, which supports the application of these interventions in clinical practice.
- MeSH
- komplementární terapie klasifikace metody MeSH
- kvalita života MeSH
- lidé MeSH
- náboženství a psychologie MeSH
- nádory prsu * psychologie terapie MeSH
- přehledová literatura jako téma MeSH
- psychoterapie metody MeSH
- spirituální terapie * klasifikace metody MeSH
- statistika jako téma MeSH
- ukládání a vyhledávání informací metody statistika a číselné údaje MeSH
- všímavost metody MeSH
- Check Tag
- lidé MeSH
- ženské pohlaví MeSH
- Publikační typ
- přehledy MeSH
Research on the external physical load on elite youth soccer players during the weekly training microcycle in competitive periods and official matches is limited. The aims of this study were twofold: a) investigate possible differences in external physical load (PL) across player positions in U17 elite youth soccer players during official matches; b) determine the weekly training to match physical load ratio (WTMLr) across player positions. The sample included 20 outfield players from an elite soccer academy (mean age 15.94 ± 0.25 years) playing in four positions: central defender (CD), full-back (FB), central midfielder (CM) and Striker (S). Data were collected during the spring in-season period for 17 official matches played in a 4-3-3 game format. Indicators of external physical load monitored were: total distance (TD); total distance in high-speed running (HSR; > 16.1 km.h-1); total distance in sprint running (SPR; > 21.6 km.h-1); and relative physical load intensity (%HSR). The WTMLr was calculated for TD, HSR, SPR and %HSR as the ratio of the average weekly sum of training PL to the average sum of PL in an official match for a given players' position. Collectively, the training intensity during a one-week microcycle (%HSR in WTMLr) achieved only 76 % of match demands. CD performed significantly lower in all measured indicators of external PL during the official match than all other positions (p < 0.05; g > 0.80) except for TD in S. S achieved significantly higher SPR during official matches compared to CD (p < 0.05; g > 0.80), CM, and FB (g > 0.80). In contrast, CD reported higher WTMLr (medium-large effect size) in HSR and SPR indicators than all other positions. CM performed significantly higher %HSR in WTMLr than S and FB (p < 0.05; g > 0.80). Results revealed insufficient training intensity relative to match demands and, at the same time, weekly training PL did not meet match demands (especially in HSR and SPR) for players across the different positions. Therefore, practitioners should select appropriate training methods (drills and games) to ensure sufficient training intensity (HSR and SR metrics) and consider using the WTMLr, which can be used to help optimise and individualise training PL for different player positions.
Lithium is the gold standard treatment for bipolar disorder (BD). However, its mechanism of action is incompletely understood, and prediction of treatment outcomes is limited. In our previous multi-omics study of the Pharmacogenomics of Bipolar Disorder (PGBD) sample combining transcriptomic and genomic data, we found that focal adhesion, the extracellular matrix (ECM), and PI3K-Akt signaling networks were associated with response to lithium. In this study, we replicated the results of our previous study using network propagation methods in a genome-wide association study of an independent sample of 2039 patients from the International Consortium on Lithium Genetics (ConLiGen) study. We identified functional enrichment in focal adhesion and PI3K-Akt pathways, but we did not find an association with the ECM pathway. Our results suggest that deficits in the neuronal growth cone and PI3K-Akt signaling, but not in ECM proteins, may influence response to lithium in BD.
- MeSH
- bipolární porucha * farmakoterapie genetika MeSH
- celogenomová asociační studie MeSH
- fokální adheze MeSH
- fosfatidylinositol-3-kinasy genetika MeSH
- lidé MeSH
- lithium * farmakologie terapeutické užití MeSH
- multiomika MeSH
- protoonkogenní proteiny c-akt genetika MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
Large-scale biorepositories and databases are essential to generate equitable, effective, and sustainable advances in cancer prevention, early detection, cancer therapy, cancer care, and surveillance. The Mutographs project has created a large genomic dataset and biorepository of over 7,800 cancer cases from 30 countries across five continents with extensive demographic, lifestyle, environmental, and clinical information. Whole-genome sequencing is being finalized for over 4,000 cases, with the primary goal of understanding the causes of cancer at eight anatomic sites. Genomic, exposure, and clinical data will be publicly available through the International Cancer Genome Consortium Accelerating Research in Genomic Oncology platform. The Mutographs sample and metadata biorepository constitutes a legacy resource for new projects and collaborations aiming to increase our current research efforts in cancer genomic epidemiology globally.
- MeSH
- banky biologického materiálu MeSH
- databáze faktografické MeSH
- genomika MeSH
- lidé MeSH
- nádory * diagnóza MeSH
- poskytování zdravotní péče MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- přehledy MeSH
The volume of nucleic acid sequence data has exploded recently, amplifying the challenge of transforming data into meaningful information. Processing data can require an increasingly complex ecosystem of customized tools, which increases difficulty in communicating analyses in an understandable way yet is of sufficient detail to enable informed decisions or repeats. This can be of particular interest to institutions and companies communicating computations in a regulatory environment. BioCompute Objects (BCOs; an instance of pipeline documentation that conforms to the IEEE 2791-2020 standard) were developed as a standardized mechanism for analysis reporting. A suite of BCOs is presented, representing interconnected elements of a computation modeled after those that might be found in a regulatory submission but are shared publicly - in this case a pipeline designed to identify viral contaminants in biological manufacturing, such as for vaccines.
OBJECTIVES: This study aims to describe the data structure and harmonisation process, explore data quality and define characteristics, treatment, and outcomes of patients across six federated antineutrophil cytoplasmic antibody-associated vasculitis (AAV) registries. METHODS: Through creation of the vasculitis-specific Findable, Accessible, Interoperable, Reusable, VASCulitis ontology, we harmonised the registries and enabled semantic interoperability. We assessed data quality across the domains of uniqueness, consistency, completeness and correctness. Aggregated data were retrieved using the semantic query language SPARQL Protocol and Resource Description Framework Query Language (SPARQL) and outcome rates were assessed through random effects meta-analysis. RESULTS: A total of 5282 cases of AAV were identified. Uniqueness and data-type consistency were 100% across all assessed variables. Completeness and correctness varied from 49%-100% to 60%-100%, respectively. There were 2754 (52.1%) cases classified as granulomatosis with polyangiitis (GPA), 1580 (29.9%) as microscopic polyangiitis and 937 (17.7%) as eosinophilic GPA. The pattern of organ involvement included: lung in 3281 (65.1%), ear-nose-throat in 2860 (56.7%) and kidney in 2534 (50.2%). Intravenous cyclophosphamide was used as remission induction therapy in 982 (50.7%), rituximab in 505 (17.7%) and pulsed intravenous glucocorticoid use was highly variable (11%-91%). Overall mortality and incidence rates of end-stage kidney disease were 28.8 (95% CI 19.7 to 42.2) and 24.8 (95% CI 19.7 to 31.1) per 1000 patient-years, respectively. CONCLUSIONS: In the largest reported AAV cohort-study, we federated patient registries using semantic web technologies and highlighted concerns about data quality. The comparison of patient characteristics, treatment and outcomes was hampered by heterogeneous recruitment settings.
- MeSH
- ANCA-asociované vaskulitidy * farmakoterapie epidemiologie komplikace MeSH
- granulomatóza s polyangiitidou * farmakoterapie epidemiologie komplikace MeSH
- lidé MeSH
- mikroskopická polyangiitida * farmakoterapie epidemiologie MeSH
- protilátky proti cytoplazmě neutrofilů MeSH
- registrace MeSH
- správnost dat MeSH
- ukládání a vyhledávání informací MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- metaanalýza MeSH
Among medical specialties, laboratory medicine is the largest producer of structured data and must play a crucial role for the efficient and safe implementation of big data and artificial intelligence in healthcare. The area of personalized therapies and precision medicine has now arrived, with huge data sets not only used for experimental and research approaches, but also in the "real world". Analysis of real world data requires development of legal, procedural and technical infrastructure. The integration of all clinical data sets for any given patient is important and necessary in order to develop a patient-centered treatment approach. Data-driven research comes with its own challenges and solutions. The Findability, Accessibility, Interoperability, and Reusability (FAIR) Guiding Principles provide guidelines to make data findable, accessible, interoperable and reusable to the research community. Federated learning, standards and ontologies are useful to improve robustness of artificial intelligence algorithms working on big data and to increase trust in these algorithms. When dealing with big data, the univariate statistical approach changes to multivariate statistical methods significantly shifting the potential of big data. Combining multiple omics gives previously unsuspected information and provides understanding of scientific questions, an approach which is also called the systems biology approach. Big data and artificial intelligence also offer opportunities for laboratories and the In Vitro Diagnostic industry to optimize the productivity of the laboratory, the quality of laboratory results and ultimately patient outcomes, through tools such as predictive maintenance and "moving average" based on the aggregate of patient results.
- MeSH
- algoritmy MeSH
- big data * MeSH
- individualizovaná medicína metody MeSH
- lidé MeSH
- poskytování zdravotní péče MeSH
- umělá inteligence * MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH