[Care assistants at the international level: a narrative review]. / Gli operatori di supporto a livello internazionale: una revisione narrativa.

. Care assistants at the international level: a narrative review. INTRODUCTION: At the international level, the role of care assistants, their competencies and scope of their professional practice has been debated for many years. Periodically updating the state of the art regarding the different training pathways, expected competencies, and responsibilities of care assistants at the international level is crucial for monitoring the evolution of these professional profiles. OBJECTIVE: To map the available classifications of care assistants at the international level, by describing (a) where these figures receive training, with which pathways, and for which competencies, and (b) where they can work and with what level of professional autonomy/interdependence with respect to other healthcare professions. METHOD: A narrative review of the literature was conducted by examining documents produced by the World Health Organization and the European Union; and that of three reference countries, the United Kingdom, Canada, and the United States of America. RESULTS: Fourteen documents were selected. Numerous care assistant profiles are described in available classifications, totaling 32 different profiles; these individuals may receive training in upper secondary school or colleges to perform a range of competencies. They may be supervised in their practice not only by nurses. In some countries, compulsory registration is required. DISCUSSION: The results show an important heterogeneity in care assistant figures internationally.

Predicting the responses of European grassland communities to climate and land cover change.

European grasslands are among the most species-rich ecosystems on small spatial scales. However, human-induced activities like land use and climate change pose significant threats to this diversity. To explore how climate and land cover change will affect biodiversity and community composition in grassland ecosystems, we conducted joint species distribution models (SDMs) on the extensive vegetation-plot database sPlotOpen to project distributions of 1178 grassland species across Europe under current conditions and three future scenarios. We further compared model accuracy and computational efficiency between joint SDMs (JSDMs) and stacked SDMs, especially for rare species. Our results show that: (i) grassland communities in the mountain ranges are expected to suffer high rates of species loss, while those in western, northern and eastern Europe will experience substantial turnover; (ii) scaling anomalies were observed in the predicted species richness, reflecting regional differences in the dominant drivers of assembly processes; (iii) JSDMs did not outperform stacked SDMs in predictive power but demonstrated superior efficiency in model fitting and predicting; and (iv) incorporating co-occurrence datasets improved the model performance in predicting the distribution of rare species. This article is part of the theme issue 'Ecological novelty and planetary stewardship: biodiversity dynamics in a transforming biosphere'.

Public health relevance of medicines developed under paediatric legislation in Europe and the USA: a systematic mapping study.

BACKGROUND: Legislation in the European Union (EU) and the USA promoting the development of paediatric medicines has contributed to new treatments for children. This study explores how such legislation responds to paediatric health needs in different country settings and globally, and whether it should be considered for wider implementation. METHODS: We searched EU and US regulatory databases for medicines with approved indications resulting from completed paediatric development between 2007 and 2018. Of 195 medicines identified, 187 could be systematically mapped to the burden of the target disease for six study countries (Australia, Brazil, Canada, Kenya, Russia, South Africa) and globally, using disability-adjusted life years (DALYs). All medicines were also screened for inclusion on the WHO Model List of Essential Medicines (EML) and the EML for children under 13 years (EMLc). RESULTS: The studied medicines were disproportionately focused on non-communicable diseases, which represented 68% of medicines and 21% of global paediatric DALYs. On the other hand, we found 28% of medicines for communicable, maternal, neonatal and nutritional disorders, representing 73% of global paediatric DALYs. Neonatal disorders and malaria were mapped with two medicines, tuberculosis and neglected tropical diseases with none. The gap between medicines and paediatric DALYs was greater in countries with lower income. Still, 34% of medicines are included in the EMLc and 48% in the EML. CONCLUSIONS: Paediatric policies in the EU and the USA are only partially responsive to paediatric health needs. To be considered for wider implementation, paediatric incentives and obligations should be more targeted towards paediatric health needs. International harmonisation of legislation and alignment with global research priorities could further strengthen its impact on child health and support ongoing efforts to improve access to medicines. Furthermore, efforts should be made to ensure global access to authorised paediatric medicines.

Mental health and work: a European perspective.

Among the many social determinants of health and mental health, employment and work are getting momentum in the European political agenda. On 30-31 January 2024, a 'High-level Conference on Mental Health and Work' was held in Brussels on the initiative of the rotating Belgian Presidency of the European Union. It addressed the issue developing two different perspectives: (1) preventing the onset of poor mental health conditions or of physical and mental disorders linked to working conditions (primary prevention); (2) create an inclusive labour market that welcomes and supports all disadvantaged categories who are at high risk of exclusion (secondary and tertiary prevention). In the latter perspective, the Authors were involved in a session focused on 'returning to work' for people with mental disorders and other psychosocial disadvantages, with particular reference to Individual Placement and Support as a priority intervention already implemented in various European nations. The themes of the Brussels Conference will be further developed during the next European Union legislature, with the aim of approving in 4-5 years a binding directive for member states on Mental Health and Work, as it is considered a crucial issue for economic growth, social cohesion and overall stability of the European way of life.

Inconsistencies in the EU regulatory risk assessment of PFAS call for readjustment.

Recognition of per- and polyfluoroalkyl substances (PFAS) as widespread environmental pollutants and a consequent risk to human health, has recently made the European Union (EU) adopt several regulatory measures for their management. The coherence of these measures is challenged by the diversity and the ubiquitous occurrence of PFAS, which also complicates the EU's endeavor to advance justified, harmonized, and transparent approaches in the regulatory assessment of chemical risks. Our study critically reviews the European approach for the risk assessment of PFAS, by applying a comparative analysis of the current and pending regulatory thresholds issued for these chemicals in water bodies, drinking water, and certain foodstuffs. Our study shows that the level of health protection embedded in the studied thresholds may differ by three orders of magnitude, even in similar exposure settings. This is likely to confuse the common understanding of the toxicity and health risks of PFAS and undermine reasonable decision-making and the equal treatment of different stakeholders. We also indicate that currently, no consensus exists on the appropriate level of required health protection regarding PFAS and that the recently adopted tolerable intake value in the EU is too cautious. Based on our analysis, we propose some simple solutions on how the studied regulations and their implicit PFAS thresholds or their application could be improved. We further conclude that instead of setting EU-wide PFAS thresholds for all the environmental compartments, providing the member states with the flexibility to consider case-specific factors, such as regional background concentrations or food consumption rates, in their national regulatory procedures would likely result in more sustainable management of environmental PFAS without compromising the scientific foundation of risk assessment, the legitimacy of the EU policy framework and public health.

Coordination of COVID-19 platform trials in Europe.

To ensure optimal coordination of the EU-funded COVID-19 platform trials, a double coordination mechanism was established. It included the Trial Coordination Board (TCB) to promote the dialogue between investigators and relevant public health stakeholders and the Joint Access Advisory Mechanism (JAAM) to streamline access of new intervention arms to the platform trials. Both the TCB and the JAAM emerged as efficient instruments to promote cooperation and optimise the use of resources within EU-funded adaptive platform trials. In addition, an adaptive platform trial toolbox was developed to collect information and literature on challenges and solutions identified to date. The recently funded 'Coordination MEchanism for Cohorts and Trials' (CoMeCT) project will endeavour to make this model sustainable, with a further expansion to other emerging infectious diseases, as part of the governance of the current and future platform trials for pandemic preparedness. This example could serve as a model for platform trial coordination in other disease areas.

Health care expenses impact on the disability-adjusted life years in non-communicable diseases in the European Union.

Background: Non-communicable diseases are a global health problem. The metric Disability-Adjusted Life Years was developed to measure its impact on health systems. This metric makes it possible to understand a disease's burden, towards defining healthcare policies. This research analysed the effect of healthcare expenditures in the evolution of disability-adjusted life years for non-communicable diseases in the European Union between 2000 and 2019. Methods: Data were collected for all 27 European Union countries from Global Burden of Disease 2019, Global Health Expenditure, and EUROSTAT databases. Econometric panel data models were used to assess the impact of healthcare expenses on the disability-adjusted life years. Only models with a coefficient of determination equal to or higher than 10% were analysed. Results: There was a decrease in the non-communicable diseases with the highest disability-adjusted life years: cardiovascular diseases (-2,952 years/105 inhabitants) and neoplasms (-618 years/105 inhabitants). Health expenditure significantly decreased disability-adjusted life years for all analysed diseases (p < 0.01) unless for musculoskeletal disorders. Private health expenditure did not show a significant effect on neurological and musculoskeletal disorders (p > 0.05) whereas public health expenditure did not significantly influence skin and subcutaneous diseases (p > 0.05). Conclusion: Health expenditure have proved to be effective in the reduction of several diseases. However, some categories such as musculoskeletal and mental disorders must be a priority for health policies in the future since, despite their low mortality, they can present high morbidity and disability.

The role of the (in)accessibility of social media data for infodemic management: a public health perspective on the situation in the European Union in March 2024.

Public health institutions rely on the access to social media data to better understand the dynamics and impact of infodemics - an overabundance of information during a disease outbreak, potentially including mis-and disinformation. The scope of the COVID-19 infodemic has led to growing concern in the public health community. The spread of harmful information or information voids may negatively impact public health. In this context, social media are of particular relevance as an integral part of our society, where much information is consumed. In this perspective paper, we discuss the current state of (in)accessibility of social media data of the main platforms in the European Union. The European Union's relatively new Digital Services Act introduces the obligation for platforms to provide data access to a wide range of researchers, likely including researchers at public health institutions without formal academic affiliation. We examined eight platforms (Facebook, Instagram, LinkedIn, Pinterest, Snapchat, TikTok, X, YouTube) affected by the new legislation in regard to data accessibility. We found that all platforms apart from TikTok offer data access through the Digital Services Act. Potentially, this presents a fundamentally new situation for research, as before the Digital Services Act, few platforms granted data access or only to very selective groups of researchers. The access regime under the Digital Services Act is, however, still evolving. Specifics such as the application procedure for researcher access are still being worked out and results can be expected in spring 2024. The impact of the Digital Services Act on research will therefore only become fully apparent in the future.

Science Shops as key intermediary structures to respond to the current health research agenda bias: Evidence from the InSPIRES project.

INTRODUCTION: To increase the likelihood of research responding to societal needs, intermediary structures such as Science Shops are being created. Science Shops respond to research needs identified and prioritized through participatory processes involving civil society. However, these are not mainstream structures, and most research needs addressed by the scientific community are not defined by a diversity of stakeholders (including citizens) but are mostly prioritized by researchers and funders. Literature shows this often leads to bias between the research topics investigated and the research needs of other relevant stakeholders. This study analyses how 14 Science Shops contribute to decreasing bias in health research agenda setting. METHODOLOGY: We compare the research priorities identified through participatory processes by the Science Shops, which participated in the European Union-funded project InSPIRES (2017-2021), to the available research addressed in the literature (identified in Web of Science), which we use as a proxy for current research priorities. RESULTS: Science Shop projects contributed to decreasing the existing bias in health research agenda setting: (1) between drug and nondrug treatments and (2) between clinical trials of treatments for illnesses affecting high-income versus middle- and low-income countries, which leads to a lack of local strategies for high disease burdens in nonhigh-income regions. CONCLUSION: This study provides the first evidence of Science Shops' effectiveness in addressing current biases in health research agenda setting. We conclude they could play a key role in shaping local, national and international research policies.

European Technical Democracy? How Consumer Associations Did-or Did Not-Shape the 1980s Automotive Environmental Standards.

Did the 1980s automotive standards reflect the European Economic Community's move toward a "technical democracy" or a broader democratic deficit? In the early 1980s, Europe's automotive sector faced multiple challenges: the European Commission's desire to harmonize technical standards and achieve greater European integration, intense competition between manufacturers, and environmental issues like acid rain. Debates on reducing air pollution focused on unleaded petrol and catalytic converters. Two associations representing civil society in Brussels responded to the increase in environmental concerns with a 1982 joint campaign. Despite a rich historiography on pollutant emission standards, highlighting the strategies of governments and companies, no study has dealt with the role nongovernmental organizations played. Based on public and private archives, particularly those of the European Bureau of Consumers' Unions, this article argues the new regulations did not result from the EU's consultation with civil society organizations like consumer groups but rather with the automotive industry.

Navigating the Science System: Research Integrity and Academic Survival Strategies.

Research Integrity (RI) is high on the agenda of both institutions and science policy. The European Union as well as national ministries of science have launched ambitious initiatives to combat misconduct and breaches of research integrity. Often, such initiatives entail attempts to regulate scientific behavior through guidelines that institutions and academic communities can use to more easily identify and deal with cases of misconduct. Rather than framing misconduct as a result of an information deficit, we instead conceptualize Questionable Research Practices (QRPs) as attempts by researchers to reconcile epistemic and social forms of uncertainty in knowledge production. Drawing on previous literature, we define epistemic uncertainty as the inherent intellectual unpredictability of scientific inquiry, while social uncertainty arises from the human-made conditions for scientific work. Our core argument-developed on the basis of 30 focus group interviews with researchers across different fields and European countries-is that breaches of research integrity can be understood as attempts to loosen overly tight coupling between the two forms of uncertainty. Our analytical approach is not meant to relativize or excuse misconduct, but rather to offer a more fine-grained perspective on what exactly it is that researchers want to accomplish by engaging in it. Based on the analysis, we conclude by proposing some concrete ways in which institutions and academic communities could try to reconcile epistemic and social uncertainties on a more collective level, thereby reducing incentives for researchers to engage in misconduct.

Effectiveness of XBB.1.5 Monovalent COVID-19 Vaccines During a Period of XBB.1.5 Dominance in EU/EEA Countries, October to November 2023: A VEBIS-EHR Network Study.

Using a common protocol across seven countries in the European Union/European Economic Area, we estimated XBB.1.5 monovalent vaccine effectiveness (VE) against COVID-19 hospitalisation and death in booster-eligible ≥ 65-year-olds, during October-November 2023. We linked electronic records to construct retrospective cohorts and used Cox models to estimate adjusted hazard ratios and derive VE. VE for COVID-19 hospitalisation and death was, respectively, 67% (95%CI: 58-74) and 67% (95%CI: 42-81) in 65- to 79-year-olds and 66% (95%CI: 57-73) and 72% (95%CI: 51-85) in ≥ 80-year-olds. Results indicate that periodic vaccination of individuals ≥ 65 years has an ongoing benefit and support current vaccination strategies in the EU/EEA.

Assessing social protection influence on health status in the European Union.

Introduction: Health status and access to healthcare services are crucial factors that directly impact the well-being of individuals and societies. In the European Union (EU), social protection measures are significant in supporting citizens' health and providing access to healthcare resources. Methods: This study investigates the relationship between social protection and health status in EU countries. We collected data from Eurostat on the EU member states' health status, healthcare expenditure, and social protection expenditure. The paper used structural equation modeling (SEM) and cluster analysis to analyze the complex interplay among these variables. Results: Findings revealed a strong positive correlation between EU countries' social protection expenditure and healthcare status. Higher social protection spending was associated with improved access to healthcare services and facilities. Moreover, the analysis showed that countries with higher social protection expenditure tended to exhibit better overall health status indicators among their populations. Discussion: The results suggest that adequate social protection expenditure positively influences health status in the European Union. By investing in robust social protection programs, governments can enhance citizens' access to healthcare services and resources, ultimately leading to improved health outcomes. These findings underscore the importance of prioritizing social protection policies to address health disparities and promote public health in the EU.

Magnetic Molecularly Imprinted Polymers for Selective Extraction of Aflatoxins from Feeds.

Magnetic molecularly imprinted polymers (MMIPs) have fused molecular imprinting technology with magnetic separation technology, emerging as an innovative material capable of recognizing specific molecules and efficiently separating target substances. Their application to the extraction and purification of mycotoxins has great potential, due to the toxicity and economic impact of these contaminants. In this work, MMIP has been proposed as a sample treatment for the determination of main four aflatoxins (B1, B2, G1 and G2) in pig feed. The MMIP was formed through the integration of magnetic material (Fe3O4) with commercial molecularly imprinted polymers, avoiding the synthesis step and, therefore, simplifying the process. The analyses were carried out by high-performance liquid chromatography with fluorescence detection and the method was validated and limits of quantification (LOQs) between 0.09 and 0.47 ng/g were obtained, below the allowed or recommended levels by the European Union. Repeatability and intermediate precision showed relative standard deviations lower than 10% in all cases and trueness ranged from 92 to 111%. Finally, the proposed method was applied to 31 real pig feed samples, detecting aflatoxins with concentrations between 0.2 and 3.2 ng/g.

How to develop new systemic treatments in ultra-rare cancers with high unmet needs? The case of alveolar soft-part sarcoma.

Developing new drugs or generating evidence for existing drugs in new indications for ultra-rare cancers is complex and carries a high-risk of failure. This gets even harder in ultra-rare tumours, which have an annual incidence of 1 per 1,000,000 population or less. Here, we illustrate the problem of adequate evidence generation in ultra-rare tumours, using Alveolar Soft-Part Sarcomas (ASPS) - an ultra-rare sarcoma newly diagnosed in approximately 60 persons a year in the European Union - as an exemplar case showing challenges in development despite being potentially relevant for classes of agents. We discuss some possible approaches for addressing such challenges, especially focussing on constructive collaboration between academic groups, patients and advocates, drug manufacturers, and regulators to optimise drug development in ultra-rare cancers. This article, written by various European stakeholders, proposes a way forward to ultimately get better options for patients with ultra-rare cancers.

From the creation of the European research area in 2000 to a Mission on cancer in Europe in 2021-lessons learned and implications.

In the year 2000, cancer research in Europe had the potential to make a difference as it had several unique strengths, such as a strong foundation in biomedical science, good patient registries, infrastructures that spanned from biological repositories to bioinformatic hubs as well as thriving Comprehensive Cancer Centers (CCCs) and basic/preclinical cancer research institutions of high international standing. Research, however, was fragmented and lacked coordination. As a result, Europe could not harness its potential for translating basic research discoveries into a clinical setting for the patients' benefit. What was needed was a paradigm shift in cancer research that addressed the translational research continuum. Along these lines, in 2000, European Union (EU) Commissioner Philippe Busquin established the European Research Area (ERA) and in 2002 the European Cancer Research Area (ECRA), and their political approval was a powerful catalyst for the increased involvement of scientists in science policy in the EU. In this report, we briefly describe the actions embraced by the cancer community and cancer organizations in response to Busquin's proposals that led to the creation of the EU Mission on Cancer (MoC) in Horizon 2020 in 2021.