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Traumatic wounds are one of the most common problems leading people to the Emergency Department (ED), accounting for approximately 5,4 % of all the visits, and up to 24 % of all the medical lawsuits. In order to provide a standardized method for wound management in the ED, we have organized a workshop, involving several Italian and European experts. Later, all the discussed statements have been submitted for external validation to a multidisciplinary expert team, based on the so called Delphi method. Eight main statements have been established, each of them comprising different issues, covering the fields of wound classification, infectious risk stratification, tetanus and rabies prophylaxis, wound cleansing, pain management, and suture. Here we present the results of this work, shared by the Academy of Emergency Medicine and Care (AcEMC), and the World Society of Emergency Surgery (WSES). [ABSTRACT FROM AUTHOR]

The aim of this paper is to describe the essential points of Italian and European legislation governing the use of animals in biomedical experimentation. A close look will be taken at the principles of the 3Rs, which represent the mainstay of the legal architecture based on which a correct interpretation may be drawn of the legislative documents on animal experimentation. Furthermore, this paper will address the ways in which Directive 2010/63/EU is implemented in Italian legislation on the welfare of laboratory animals. In addition to an assessment of legal issues (such as the scope of jurisdiction of supervisory authorities tasked with issuing authorizations), it will include a discussion of cases of inadequate and insufficient implementation of the requirements laid down by Directive 2010/63/EU. Both the consistency of the interpretation of national legislation with the Directive and the direct effectiveness of the Directive in national law, in which animal testing has been and still is the subject of heated debate between supporters and opponents, will be examined. [ABSTRACT FROM AUTHOR]

To date photovoltaic energy systems have been widely installed on homes in Europe and all over the world. In Europe and in Italy investments in domestic photovoltaic power plants (PV) were boosted by generous feed-in tariffs that made these investments extremely attractive for small private investors, such as homeowners. It is commonly agreed that the greater the building energy efficiency, the greater the property market value. It is of paramount importance to determine the value that PV systems may add to home sale transactions. The aim of the paper is to investigate whether Smart Grids (SGs) innovation can increase market values due to higher production and consumption flexibility. SGs give de facto producers and consumers, the opportunity to be active in the energy market and strategically decide their optimal production/consumption pattern. In this paper, we provide a model based on the real option theory to determine the value of this flexibility and the related market value increase. We model the homeowner decision to invest in a solar home with a PV plant and connect to an SG by comparison to the decision to invest in a solar home not connected to an SG. We determine the property potential market value increase due to the opportunity to perform active energy management given by smart grids and we compare this value increase to the PV plant value per se. To capture the value of managerial flexibility we implement a real option approach. Results of simulations, performed according to zonal prices' trend and volatility in the North and South of Italy, show that in the North and in the South, being connected to an SG increases by about 5-10% the PV investment's value and this quota increases as energy savings and flexibility increase. The greater the flexibility, the greater the property market value. [ABSTRACT FROM AUTHOR]

The Eco-Management and Audit Scheme (EMAS) is a voluntary Regulation that defines the European Environmental Management System (EMS). Today the EMAS is undergoing a revision process, in order to fit the scheme to organizations and stakeholders’ requirements and increase its diffusion. Italy accounts for roughly 1,000 of the 4,000 certified European organizations and, especially during the last five years, a growing number of organizations have not renewed the certification. Thus, the aim of the survey is to investigate why many Italian organizations have dropped out of EMAS, and to identify which enabling measures would be more effective in order to encourage organizations to move back to the certification. The target of the questionnaire were the 339 Italian organizations that did not renew their EMAS registration between 2010 and 2015, and respondents were 99. In the first part of the paper, we present the general findings, while in the second one, certified Public Administrations and private-owned organizations are compared in order to delineate significant differences between the two groups. Concerning motivations for not renewing EMAS, implementation costs were the key reasons for both groups. Conversely, considering the possible enabling measures, while private-owned organizations demand long term tax benefits, Public Administrations prefer a greater consideration of EMAS in public funding. This paper systematically addresses this phenomenon through a survey, contributing to reduce the existing gap in literature and providing a useful input to decision-makers who are overseeing the EMAS revision process. [ABSTRACT FROM AUTHOR]

This paper explores the changing role of Islam in Europe, via the case of Italy. The focus is on the contemporary geographies of the changing identities and relationships in the Euro-Mediterranean region. The article intends to challenge the continuous representation of Islam in Europe between homogeneity and otherness. Indeed, the approach considers that relationships which shape places (and are shaped by places) do not stem only from media narratives, from powers and ideologies in general, but also from people's everyday inter-ethnic, inter-cultural, and emotional interactions. The latter do not occur in a vacuum, but rather in places and digital communication channels under grids of power. They are sometimes characterized by behaviours of self-caging and last but not least they always develop in light of geographical transformative power of encounters as 'situated' dynamics of people. Encounters are further shaped and have transformative potential within realms of 'moral geographies' of people and society's values and beliefs while dealing with 'difference'. The paper is based on a series of fieldwork carried out by the author over the years including expert interviews (interreligious dialogue associations, religious leaders, and researchers) and surveys/interviews with immigrants from across the Mediterranean, and on available data and literature for Italy. Main findings for policy-making can be summarized as follows: Europe is a periphery for Umma, not a central place, but in contrast to some origin countries, Islam versions as Islam as predominant not a minority religion. Conversely, the European tradition of human rights, universalism, and democracy should be re-examined and practiced not only in the abstract but in the concrete form of engaged human relations with 'empathy', while laissez faire multiculturalism, aggressive assimilation or 'culturalism' exceptions should be avoided. [ABSTRACT FROM AUTHOR]

Chikungunya virus (CHIKV) is a mosquito-borne infection that is emerging in temperate areas of Europe, following the expansion of one of its vector species, Aedes albopictus. Although CHIKV fever is a self-limiting disease, with a clinical syndrome often resolving within few days, it can also cause severe sequelae, including chronic polyarthralgia lasting up to 5 years. Additionally, CHIKV outbreaks may limit blood bank donations, adding economic burden on the health system. Public health authorities in Europe need to increase their preparedness against this emerging threat. Two large CHIKV outbreaks occurred in Italy in 2007 and 2017, with hundreds of cases and significant geographical spread. The aim of this paper is to review and compare the 2 Italian outbreaks in terms of available estimates of key epidemiological features, patient clinical presentation, virus and immunological characteristics, and public health response. Recommendations for public health and future directions for research are also discussed and highlighted. Key results: Both outbreaks started in small towns, but cases were also detected in nearby larger cities where transmission was limited to small clusters. The time spans between the first and the last symptom onsets were similar between the 2 outbreaks, and the delay from the symptom onset of the index case and the first case notified was considerable. Comparable infection and transmission rates were observed in laboratory. The basic reproductive number (R0) was estimated in the range of 1.8–6 (2007) and 1.5–2.6 (2017). Clinical characteristics were similar between outbreaks, and no acute complications were reported, though a higher frequency of ocular symptoms, myalgia, and rash was observed in 2017. Very little is known about the immune mediator profile of CHIKV-infected patients during the 2 outbreaks. Regarding public health responses, after the 2007 outbreak, the Italian Ministry of Health developed national guidelines to implement surveillance and good practices to prevent and control autochthonous transmission. However, only a few regional authorities implemented it, and the perception of outbreak risk and knowledge of clinical symptoms and transmission dynamics by general practitioners remained low. Major conclusions: Efforts should be devoted to developing suitable procedures for early detection of virus circulation in the population, possibly through the analysis of medical records in near real time. Increasing the awareness of CHIKV of general practitioners and public health officials through tailored education may be effective, especially in small coastal towns where the outbreak risk may be higher. A key element is also the shift of citizen awareness from considering Aedes mosquitoes not only as a nuisance problem but also as a public health one. We advocate the need of strengthening the surveillance and of promoting the active participation of the communities to prevent and contain future outbreaks. Author summary: In Europe, vector-borne diseases have been increasing during the last decades. CHIKV is an example of a neglected emerging disease transmitted by the alien mosquitoes Ae. albopictus that caused 2 large outbreaks in Italy in 2007 and 2017. It is important to compare the main epidemiological, clinical, virological, and immunological features, as well as the public health responses, to increase preparedness to face future outbreaks. [ABSTRACT FROM AUTHOR]

Ecoregionalization is the process by which a territory is classified in similar areas according to specific environmental and climatic factors. The climate and the environment strongly influence the presence and distribution of vectors responsible for significant human and animal diseases worldwide. In this paper, we developed a map of the eco-climatic regions of Italy adopting a data-driven spatial clustering approach using recent and detailed spatial data on climatic and environmental factors. We selected seven variables, relevant for a broad set of human and animal vector-borne diseases (VBDs): standard deviation of altitude, mean daytime land surface temperature, mean amplitude and peak timing of the annual cycle of land surface temperature, mean and amplitude of the annual cycle of greenness value, and daily mean amount of rainfall. Principal Component Analysis followed by multivariate geographic clustering using the k-medoids technique were used to group the pixels with similar characteristics into different ecoregions, and at different spatial resolutions (250 m, 1 km and 2 km). We showed that the spatial structure of ecoregions is generally maintained at different spatial resolutions and we compared the resulting ecoregion maps with two datasets related to Bluetongue vectors and West Nile Disease (WND) outbreaks in Italy. The known characteristics of Culicoides imicola habitat were well captured by 2/22 specific ecoregions (at 250 m resolution). Culicoides obsoletus/scoticus occupy all sampled ecoregions, according to its known widespread distribution across the peninsula. WND outbreak locations strongly cluster in 4/22 ecoregions, dominated by human influenced landscape, with intense cultivations and complex irrigation network. This approach could be a supportive tool in case of VBDs, defining pixel-based areas that are conducive environment for VBD spread, indicating where surveillance and prevention measures could be prioritized in Italy. Also, ecoregions suitable to specific VBDs vectors could inform entomological surveillance strategies. [ABSTRACT FROM AUTHOR]

Agriculture, one of the main economic pillars in Europe, plays a growing important role towards the environmental sustainability of the extra-urban land, in which the agricultural activities may proactively contribute to control and regulate the whole ecological conditions. Modern agriculture currently needs big quantities of agrochemicals, which are necessary for the growth and protection of crops and animals. These agrochemicals are commercially distributed to consumers in many types of containers. The most widely used packaging solutions usually employ plastic materials (e.g., containers for liquid pesticide; sacks for granular fertiliser; etc.). These materials, after the use of the agrochemical, need to be decontaminated, before being entrained in a recycling process, in the framework of a circular economy. In the present paper the main results coming from a EU-funded international project are reported, with specific reference to a pilot station that was realised in Italy with the aim to implement and test a codified system for the decontamination of these plastic containers for agrochemicals. The experimental tests were supported by relevant laboratory analysis, which have confirmed that the triple-rinsing decontamination procedure - traditionally employed by farmers for washing and decontaminating these containers - may be effective only under some well-defined conditions. Triple rinsing by farmers has indeed led to an only partial decontamination of the plastic containers, if farmers did not follow an appropriate triple-rinsing protocol, or did not triple-rinse the containers immediately after their emptying. [ABSTRACT FROM AUTHOR]

Background: The Sarcoma Policy Checklist was created by a multidisciplinary expert group to provide policymakers with priority areas to improve care for sarcoma patients.Main Body: This paper draws on this research, by looking more closely at how France, Germany, Italy, Spain, Sweden and the United Kingdom are addressing each of these priority areas. It aims to highlight key gaps in research, policy and practice, as well as ongoing initiatives that may impact the future care of sarcoma patients in different European countries. A pragmatic review of the published and web-based literature was undertaken. Telephone interviews were conducted in each country with clinical and patient experts to substantiate findings. Research findings were discussed within the expert group and developed into five core policy recommendations. The five identified priority areas were: the development of designated and accredited centres of reference; more professional training; multidisciplinary care; greater incentives for research and innovation; and more rapid access to effective treatments. Most of the countries studied have ongoing initiatives addressing many of these priorities; however, many are in early stages of development, or require additional funding and resources.Conclusion: Gaps in access to quality care are particularly concerning in many of Europe's lower-resourced countries. Equitable access to information, clinical trials, innovative treatments and quality specialist care should be available to all sarcoma patients. Achieving this across Europe will require close collaboration between all stakeholders at both the national and European level. [ABSTRACT FROM AUTHOR]

Sequential cropping in the Biogasdoneright™ (BDR™) system in Italy has recently gained attention to combine food and renewable energy production in a sustainable way, as well as for carbon sequestration. However, little is known on the potential to expand the practice in other regions of Europe. In this paper, sequential crop calendars were developed for different EU climate regions, and the EU biomethane potential of the anaerobic digestion (AD) of sequential crops was estimated for a Conservative_Scenario and a Maximum_Scenario, assuming different percentages of primary crop land dedicated to the practice and biogas yields. A total EU biomethane potential of 46 bcm/yr and 185 bcm/yr was estimated from the AD of sequential crops in the two scenarios, respectively, and the Continental region registered the highest potential compared to the other regions. The additional benefits of the combination of sequential cropping with other agricultural conservation practices and digestate use included in BDR™ systems were also discussed. In conclusion, the paper shows that with appropriate innovations in crop management, sequential cropping could be applied in different agroclimatic regions of Europe, contributing to climate and renewable energy targets. [ABSTRACT FROM AUTHOR]

Background: Accounting for patients' perspective has become increasingly important. Based on the Consumer Quality Index method (founded on Consumer Assessment of Healthcare Providers and Systems) a questionnaire was recently developed for Dutch cancer patients. As a next step, this study aimed to adapt and pilot this questionnaire for international comparison of cancer patients experience and satisfaction with care in six European countries.Method: The Consumer Quality Index was translated into the local language at the participating pilot sites using cross-translation. A minimum of 100 patients per site were surveyed through convenience sampling. Data from seven pilot sites in six countries was collected through an online and paper-based survey. Internal consistency was tested by calculating Cronbach's alpha and validity by means of cognitive interviews. Demographic factors were compared as possible influencing factors.Results: A total of 698 patients from six European countries filled the questionnaire. Cronbach's alpha was good or satisfactory in 8 out of 10 categories. Patient satisfaction significantly differed between the countries. We observed no difference in patient satisfaction for age, gender, education, and tumor type, but satisfaction was significantly higher in patients with a higher level of activation.Conclusion: This European Cancer Consumer Quality Index(ECCQI) showed promising scores on internal consistency (reliability) and a good internal validity. The ECCQI is to our knowledge the first to measure and compare experiences and satisfaction of cancer patients on an international level, it may enable healthcare providers to improve the quality of cancer care. [ABSTRACT FROM AUTHOR]

Therapeutic use of an unauthorised drug (or of an authorised drug for an unauthorised indication) for patients with a life-threating disease is permitted outside a clinical trial as an Expanded Access Programme (EAP).The regulations regarding EAPs is not the same all over the world. For example, the recommendation of the European Medicines Agency (EMA) in EU countries also includes within EAPs patients who have been treated in a clinical trial and who wish to continue the treatment. Nevertheless, the patients treated in a clinical trial could have the option of continuing treatment for an extended period in an Open-label Extension study, aimed to generate long-term data on efficacy, safety, tolerability and administration.The aims of this paper - based on the difficulties and incoherence encountered by an Italian Ethic Committee (EC) during the authorisation process of EAPs - are: understanding the origin of this misclassification by analysing differences and similarities among USA, European and Italian regulations concerning EAPs; and showing difficulties in classifying international study protocols as a consequence of the lack of harmonisation of definitions.We performed a critical review of the current USA, European and Italian regulations and we analysed some practical cases by retrieving protocols from Clinicaltrials.gov and the Italian Clinical Trials Registry (OsSC) containing in the title the keywords 'Expanded Access Programme', "'Expanded Access', 'Open-label Extension study' or 'Early Access'.We observed that the Food and Drug Administration ( FDA) definition of EAP is very clear while the EMA definition is similar to that of an Open-label Extension study. This lack of a clear definition generates misclassification and it is possible to find an EAP with an efficacy or safety endpoint; or an EAP managed as a clinical trial; or an EAP classified in Clinical Trials Registries as a phase II, III or IV clinical trial.The internationalisation of the studies requires a harmonisation on a global level of legislation and definitions to eliminate misclassification of protocols. For this reason, the authors suggest that: a) the EMA definition should be harmonised with the FDA definition of EAPs, b) European regulation, even if optional, should be adopted in a compulsory way by national regulations. Moreover, separate registries for both EAPs and clinical trials should be organised. [ABSTRACT FROM AUTHOR]

The Lung Clearance Index (LCI) is an index derived from washout recordings, able to detect early peripheral airway damage in subjects with cystic fibrosis (CF) with a greater sensitivity than spirometry. LCI is a marker of overall lung ventilation inhomogeneity; in fact, as pulmonary ventilation worsens, the number of tidal breaths and the expiratory volumes required to clear the lungs of a marker gas are increased, as documented by a greater value. In the field of CF, LCI allows indirect investigation of the small airways (< 2 mm) the site where, from a pathophysiologic point of view, the disease begins due to the defect of the CF transmembrane-conductance regulator (CFTR) protein. Infant pulmonary function changes seem to occur before clinically overt symptoms of lower respiratory illness occur. When performing the test, it is important to refer to the American Thoracic Society and European Respiratory Society consensus statements and apply a strict standardization. In Italy the first tests were carried out in 2014 for research purpose and now approximately 10 centers are collecting data and are experiencing a consistency in repeating exams. Currently in Italian centers children at pre-school age are the main target: in this population it is important to have a sensitive and feasible test, non-invasive, that can be performed at tidal volume without sedation, and requiring minimal cooperation and coordination, and that can be used longitudinally over time. Another target could be the transplanted subjects to detect early signs of lung function decline. The content of this paper captures the experience and discussions among some of the Italian centers where LCI is currently used for research and/or in clinical practice about the method and the need to have a common approach. The aim of this paper is not to describe the methodology of MBW, but to inform the pediatric community about the possible application of LCI in CF. [ABSTRACT FROM AUTHOR]

This paper presents selected highlights from the 'Engaging with society' session of EFSA's third Scientific Conference 'Science, Food and Society' (Parma, Italy, 18–21 September 2018). The social dimension for scientific advisory bodies largely concerns science communication and public engagement. The political, economic and technological transformation of contemporary societies is challenging conventional structures and approaches in these areas. The disintermediation of communication and the proliferation of misinformation, it is argued, herald the onset of the post‐truth society. A better understanding of the way individuals consume information today has led to the development of tools to guide mediators such as journalists and communication specialists in countering these trends. Public engagement can reinforce confidence in regulatory bodies and potentially contribute to the quality of the scientific process. Scientific advisory bodies in Europe have created strategies and mechanisms to engage the public that are designed to increase transparency and representativeness. To be effective, several engagement mechanisms are needed, although factors such as resource constraints, institutional culture and public/stakeholder attitudes may limit their development. In conclusion, a more vigorous role for social research is needed to place scientific risk assessment within broader socio‐economic and political contexts. Social science expertise can help to define more impactful public information strategies and to explore the potential opportunities that engaged stakeholders and citizens can make to sustain and strengthen regulatory science. [ABSTRACT FROM AUTHOR]