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.
STUDY QUESTION: Can oocyte functionality be assessed by observing changes in their intracytoplasmic lipid droplets (LDs) profiles? SUMMARY ANSWER: Lipid profile changes can reliably be detected in human oocytes; lipid changes are linked with maternal age and impaired developmental competence in a mouse model. WHAT IS KNOWN ALREADY: In all cellular components, lipid damage is the earliest manifestation of oxidative stress (OS), which leads to a cascade of negative consequences for organelles and DNA. Lipid damage is marked by the accumulation of LDs. We hypothesized that impaired oocyte functionality resulting from aging and associated OS could be assessed by changes in LDs profile, hereafter called lipid fingerprint (LF). STUDY DESIGN, SIZE, DURATION: To investigate if it is possible to detect differences in oocyte LF, we subjected human GV-stage oocytes to spectroscopic examinations. For this, a total of 48 oocytes derived from 26 young healthy women (under 33 years of age) with no history of infertility, enrolled in an oocyte donation program, were analyzed. Furthermore, 30 GV human oocytes from 12 women were analyzed by transmission electron microscopy (TEM). To evaluate the effect of oocytes' lipid profile changes on embryo development, a total of 52 C57BL/6 wild-type mice and 125 Gnpat+/- mice were also used. PARTICIPANTS/MATERIALS, SETTING, METHODS: Human oocytes were assessed by label-free cell imaging via coherent anti-Stokes Raman spectroscopy (CARS). Further confirmation of LF changes was conducted using spontaneous Raman followed by Fourier transform infrared (FTIR) spectroscopies and TEM. Additionally, to evaluate whether LF changes are associated with developmental competence, mouse oocytes and blastocysts were evaluated using TEM and the lipid dyes BODIPY and Nile Red. Mouse embryonic exosomes were evaluated using flow cytometry, FTIR and FT-Raman spectroscopies. MAIN RESULTS AND THE ROLE OF CHANCE: Here we demonstrated progressive changes in the LF of oocytes associated with the woman's age consisting of increased LDs size, area, and number. LF variations in oocytes were detectable also within individual donors. This finding makes LF assessment a promising tool to grade oocytes of the same patient, based on their quality. We next demonstrated age-associated changes in oocytes reflected by lipid peroxidation and composition changes; the accumulation of carotenoids; and alterations of structural properties of lipid bilayers. Finally, using a mouse model, we showed that LF changes in oocytes are negatively associated with the secretion of embryonic exosomes prior to implantation. Deficient exosome secretion disrupts communication between the embryo and the uterus and thus may explain recurrent implantation failures in advanced-age patients. LIMITATIONS, REASONS FOR CAUTION: Due to differences in lipid content between different species' oocytes, the developmental impact of lipid oxidation and consequent LF changes may differ across mammalian oocytes. WIDER IMPLICATIONS OF THE FINDINGS: Our findings open the possibility to develop an innovative tool for oocyte assessment and highlight likely functional connections between oocyte LDs and embryonic exosome secretion. By recognizing the role of oocyte LF in shaping the embryo's ability to implant, our original work points to future directions of research relevant to developmental biology and reproductive medicine. STUDY FUNDING/COMPETING INTEREST(S): This research was funded by National Science Centre of Poland, Grants: 2021/41/B/NZ3/03507 and 2019/35/B/NZ4/03547 (to G.E.P.); 2022/44/C/NZ4/00076 (to M.F.H.) and 2019/35/N/NZ3/03213 (to Ł.G.). M.F.H. is a National Agency for Academic Exchange (NAWA) fellow (GA ULM/2019/1/00097/U/00001). K.F. is a Diamond Grant fellow (Ministry of Education and Science GA 0175/DIA/2019/28). The open-access publication of this article was funded by the Priority Research Area BioS under the program "Excellence Initiative - Research University" at the Jagiellonian University in Krakow. The authors declare no competing interest. TRIAL REGISTRATION NUMBER: N/A.
- MeSH
- Adult MeSH
- Embryonic Development physiology MeSH
- Humans MeSH
- Lipid Droplets metabolism MeSH
- Lipid Metabolism MeSH
- Mice, Inbred C57BL * MeSH
- Mice MeSH
- Oocytes * metabolism MeSH
- Oxidative Stress MeSH
- Spectrum Analysis, Raman MeSH
- Aging metabolism MeSH
- Microscopy, Electron, Transmission MeSH
- Maternal Age MeSH
- Animals MeSH
- Check Tag
- Adult MeSH
- Humans MeSH
- Mice MeSH
- Female MeSH
- Animals MeSH
- Publication type
- Journal Article MeSH
BACKGROUND: The recovery of autonomic functions and the ability to reproduce in particular is of the highest priority to individuals with spinal cord injury (SCI). The potential of epidural spinal cord stimulation (ESCS) for promoting recovery of sensorimotor functions in the chronic phase of SCI has long been studied. In recent years, several studies have emerged confirming the positive effect of ESCS also on the cardiovascular system and neurogenic bladder and bowel. However, the potential of ESCS in restoring sexual function, especially ejaculation, has not yet been addressed. CASE REPORT: Two cases of people with chronic sensorimotor complete SCI in the 4th thoracic spinal segment are presented. Both men were also diagnosed with severe erectile dysfunction and anejaculation. Thanks to ESCS, Participant 1 successfully restored the ejaculatory reflex using PVS in his home environment. His outcome was subsequently verified under clinical conditions. During ESCS, Participant 1 was also able to achieve ejaculation by masturbation; moreover, he conceived a child naturally without the need for IVF. In Participant 2, we then demonstrated the same effect of ESCS on the restoration of the ejaculatory reflex when targeting the stimulation to the same spinal segment. CONCLUSION: This is the first report on the potential of ESCS for restoring the ability to ejaculate in individuals with complete SCI. Confirmation of these results could significantly reduce the need for assisted reproduction and improve the quality of life of men after SCI in the future.
- MeSH
- Adult MeSH
- Ejaculation * physiology MeSH
- Epidural Space MeSH
- Erectile Dysfunction etiology therapy physiopathology MeSH
- Thoracic Vertebrae MeSH
- Humans MeSH
- Spinal Cord Stimulation * methods MeSH
- Spinal Cord Injuries * complications physiopathology therapy rehabilitation MeSH
- Check Tag
- Adult MeSH
- Humans MeSH
- Male MeSH
- Publication type
- Journal Article MeSH
- Case Reports MeSH
Using ergonomic orthopaedic chairs can address spinal issues, particularly HNP, due to their flexible and elastic properties. By achieving optimal ergonomic design, various positive aspects can be achieved, such as increasing work quality productivity and reducing the cost of injuries or accidents. This research demonstrates diverse product design approaches to enhance posture health ergonomics, address specific musculoskeletal disorder issues, and consider local needs and available materials. Rattan is a tropical vine widely used in the furniture industry and predominantly found in wooded areas such as Indonesia. This research combines market research, morphology, ergonomic study, concept selection, QFD, HoQ, stiffness test, and prototype review. The QFD method was chosen in this study due to its excellence in connecting consumer desires with the product development process. Data of respondents consist of 51 % of respondents were male, 49 % were female, 88 % were aged between 18 and 34 years old, and 10 % were aged between 35 and 54 years old. The approach of 6 stages of product design as the primary framework for developing our product such as: planning, concept development (concept screening, product morphology, concept selection), system-level design, detailed design, testing, refinement and launching. Based on the calculations using the HOQ, it is identified that the primary focus in designing the rattan-based orthopaedic seating, lies in the orthopaedic design that provides maximum comfort for the spine. The comparison results indicate that the stiffness level of rattan weaving is nearly like latex, with a similarity percentage of 89 %. Data analysis using the QFD method indicates that the primary priority aspect is the orthopaedic design, followed by the selection of quality materials, cost-effectiveness, versatility, and appealing design aspects. Rattan's superior air circulation provides comfort by preventing excessive heat accumulation, excellence in strength and durability, ensuring ease of lightweight modelling, and providing more sustainable material.
- Publication type
- Journal Article MeSH
BACKGROUND: Remote measurement technology (RMT) involves the use of wearable devices and smartphone apps to measure health outcomes in everyday life. RMT with feedback in the form of data visual representations can facilitate self-management of chronic health conditions, promote health care engagement, and present opportunities for intervention. Studies to date focus broadly on multiple dimensions of service users' design preferences and RMT user experiences (eg, health variables of perceived importance and perceived quality of medical advice provided) as opposed to data visualization preferences. OBJECTIVE: This study aims to explore data visualization preferences and priorities in RMT, with individuals living with depression, those with epilepsy, and those with multiple sclerosis (MS). METHODS: A triangulated qualitative study comparing and thematically synthesizing focus group discussions with user reviews of existing self-management apps and a systematic review of RMT data visualization preferences. A total of 45 people participated in 6 focus groups across the 3 health conditions (depression, n=17; epilepsy, n=11; and MS, n=17). RESULTS: Thematic analysis validated a major theme around design preferences and recommendations and identified a further four minor themes: (1) data reporting, (2) impact of visualization, (3) moderators of visualization preferences, and (4) system-related factors and features. CONCLUSIONS: When used effectively, data visualizations are valuable, engaging components of RMT. Easy to use and intuitive data visualization design was lauded by individuals with neurological and psychiatric conditions. Apps design needs to consider the unique requirements of service users. Overall, this study offers RMT developers a comprehensive outline of the data visualization preferences of individuals living with depression, epilepsy, and MS.
- MeSH
- Depression * psychology MeSH
- Adult MeSH
- Epilepsy * psychology MeSH
- Qualitative Research * MeSH
- Middle Aged MeSH
- Humans MeSH
- Mobile Applications MeSH
- Wearable Electronic Devices MeSH
- Patient Preference psychology statistics & numerical data MeSH
- Multiple Sclerosis * psychology MeSH
- Aged MeSH
- Telemedicine MeSH
- Data Visualization MeSH
- Focus Groups * MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- MeSH
- Antioxidants analysis MeSH
- Cichorium intybus chemistry MeSH
- Phenols analysis chemistry MeSH
- Flavonoids analysis MeSH
- Hemerocallis chemistry MeSH
- Plants, Edible * chemistry MeSH
- Clinical Laboratory Techniques MeSH
- Flowers * chemistry MeSH
- Ascorbic Acid analysis MeSH
- Quercetin analysis MeSH
- Tagetes chemistry MeSH
- Viola chemistry MeSH
- Research MeSH
BACKGROUND: Micro- and nanoplastics (MNPs) are emerging pollutants of concern with ubiquitous presence in global ecosystems. MNPs pose potential implications for human health; however, the health impacts of MNP exposures are not yet understood. Recent evidence suggests that MNPs can cross the placental barrier, underlying the urgent need to understand their impact on reproductive health and development. OBJECTIVE: The Actionable eUropean ROadmap for early-life health Risk Assessment of micro- and nanoplastics (AURORA) project will investigate MNP exposures and their biological and health effects during pregnancy and early life, which are critical periods due to heightened vulnerability to environmental stressors. The AURORA project will enhance exposure assessment capabilities for measuring MNPs, MNP-associated chemicals, and plastic additives in human tissues, including placenta and blood. METHODS: In this interdisciplinary project, we will advance methods for in-depth characterization and scalable chemical analytical strategies, enabling high-resolution and large-scale toxicological, exposure assessment, and epidemiological studies. The AURORA project performs observational studies to investigate determinants and health impacts of MNPs by including 800 mother-child pairs from 2 existing birth cohorts and 110 women of reproductive age from a newly established cohort. This will be complemented by toxicological studies using a tiered-testing approach and epidemiological investigations to evaluate associations between maternal and prenatal MNP exposures and health perturbations, such as placental function, immune-inflammatory responses, oxidative stress, accelerated aging, endocrine disruption, and child growth and development. The ultimate goal of the AURORA project is to create an MNP risk assessment framework and identify the remaining knowledge gaps and priorities needed to comprehensively assess the impact of MNPs on early-life health. RESULTS: In the first 3 years of this 5-year project (2021-2026), progress was made toward all objectives. This includes completion of recruitment and data collection for new and existing cohorts, development of analytical methodological protocols, and initiation of the toxicological tiered assessments. As of September 2024, data analysis is ongoing and results are expected to be published starting in 2025. CONCLUSIONS: As plastic pollution increases globally, it is imperative to understand the impact of MNPs on human health, particularly during vulnerable developmental stages such as early life. The contributions of the AURORA project will inform future risk assessment. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/63176.
- MeSH
- Adult MeSH
- Risk Assessment MeSH
- Humans MeSH
- Maternal Exposure adverse effects MeSH
- Microplastics * adverse effects toxicity MeSH
- Nanoparticles adverse effects toxicity MeSH
- Pregnancy MeSH
- Check Tag
- Adult MeSH
- Humans MeSH
- Pregnancy MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
Pokročilá prax v ošetrovateľstve je pomerne mladou rolou. Kreovala sa v dôsledku potrieb a požiadaviek doby. V súčasnosti národné politiky deklarujú, že situácia vďaka stúpajúcej krivke výskytu neinfekčných a chronických ochorení je s momentálnym systémovým nastavením dlhodobo neudržateľná. Je potrebné posilniť ľudské zdroje obzvlášť v oblasti ošetrovateľstva v primárnej starostlivosti. Slovenské zdravotníctvo vníma sestru s pokročilou praxou od roku 2018. Hlavným cieľom príspevku odborného charakteru je priblížiť sestru - praktika v primárnej starostlivosti ako jednu z kategórií pokročilej praxe v ošetrovateľstve, ktorej prioritným odborným zameraním je komplexný manažment ošetrovateľskej starostlivosti a poskytovaných služieb. Príspevok vysvetľuje nomenklatúru a koncepciu pokročilej praxe v ošetrovateľstve, jej zaradenie v kontexte vzdelávania na základe európskeho a národného kvalifikačného rámca, stručne popisuje históriu a vývoj z dôvodu pochopenia opodstatnenosti jej potreby v súčasnej náročnej dobe, a predkladá podmienky pre jej integráciu prostredníctvom odporúčaného vzdelania a praktickej prípravy. Uplatnenie pokročilej praxe v ošetrovateľstve so zdôvodnením podporujú mnohé medzinárodné a európske organizácie, vrátane ICN a EFN. Potreba vnímania ošetrovateľstva ako odboru na pokročilej úrovni, a pochopenia roly ako takej, sú predpokladom zefektívnenia ošetrovateľskej a zdravotnej starostlivosti s významne pozitívnymi výsledkami pre pacientov/ klientov, ale aj pre samotné sestry a ich pracovnú spokojnosť.
Advanced practice nursing is a relatively modern topic. It has been shaped by the needs and demands of the times. At present, national policies declare that the situation due to the rising curve of non-communicable and chronic diseases is unsustainable in the long term with the current system set-up. There is a need to strengthen human resources, particularly in the field of nursing (specifically advanced practice nursing, according to the ICN), in order to be able to cope effectively with health promotion, prevention and disease management. The Slovak health sector has seen the advanced practice nurse since 2018. The main aim of this paper of a professional nature is to present the nurse practitioner as one of the categories of advanced practice in nursing, whose priority professional focus is the management of nursing care and services provided to patients/clients in primary health care. The paper explains the nomenclature and concept of advanced practice in nursing, its inclusion in the context of education based on the European and National Qualifications Framework, briefly describes its history and development in order to understand the rationale for its need in the current challenging times, and presents the conditions for its integration through recommended education and practical training according to the model of other countries where the role is established. A summary of the positive benefits of establishing advanced practice nursing in primary health care is the conclusion of this paper.
There are two key sources of data that contribute to biomedicine research: surveillance and questionnaires and interviews. The Centers for Disease Control and Prevention (CDC, Atlanta, GA, USA) defines surveillance as the ongoing systematic collection, analysis, and interpretation of health data, essential to the planning, implementation, and evaluation of public health practice, closely integrated with the timely dissemination to those who need to know. The three things to keep in mind about surveillance systems are that they are ongoing (collecting information only once is not a surveillance system), the data collected are used (analyzed and interpreted) and finally, surveillance data is disseminated. There are several tangible applications of surveillance as a tool. For example, surveillance data can be used to establish public health priorities, aid in determining resource allocation and assess or evaluate public health programs. Surveillance data originate from many sources; therefore, standardization of surveillance practices is an ongoing challenge.For epidemiologists specifically, surveillance data can be used to determine a baseline for the detection of epidemics or for early detection of epidemics. This is clearly the positive meaning and impact of this system collecting sensitive population data. However, expression surveillance means in effect, supervision or control. The subsequent resulting regulations are the subject of reflection in this article.
- MeSH
- COVID-19 epidemiology MeSH
- Epidemiological Monitoring * MeSH
- Medical Informatics methods MeSH
- Humans MeSH
- Paternalism MeSH
- Artificial Intelligence * MeSH
- Legal Epidemiology MeSH
- Government MeSH
- Check Tag
- Humans MeSH
- Publication type
- Review MeSH
- Geographicals
- China MeSH
Acute and chronic heart failure remains a very serious and high priority problem in contemporary cardiology. New, modern drugs are currently emerging in the treatment of heart failure while the possibilities of their further use for this diagnosis are being expanded. These findings have been summarized in the 2023 update of the European Society of Cardiology Guidelines for heart failure. This article provides a brief summary of the new developments in pharmacotherapy based on the above recommendations.
Akutní a chronické srdeční selhání stále představují velmi závažný a prioritní problém současné kardiologie. V současné době se v léčbě srdečního selhání objevují nové, moderní léky a zároveň se u této diagnózy rozšiřují možnosti jejich dalšího použití. Tyto poznatky byly shrnuty v aktualizaci guidelines pro srdeční selhání Evropské kardiologické společnosti v roce 2023. Článek přináší stručné shrnutí novinek ve farmakoterapii dle těchto doporučení.
