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International audience; Differences of sex development are conditions with discrepancies between chromosomal, gonadal and phenotypic sex. In congenital hypogonadotropic hypogonadism, a lack of gonadotropin activity results primarily in the absence of pubertal development with prenatal sex development being (almost) unaffected in most patients. To expedite progress in the care of people affected by differences of sex development and congenital hypogonadotropic hypogonadism, the European Union has funded a number of scientific networks. Two Actions of the Cooperation of Science and Technology (COST) programmes - DSDnet (BM1303) and GnRH Network (BM1105) - provided the framework for ground-breaking research and allowed the development of position papers on diagnostic procedures and special laboratory analyses as well as clinical management. Both Actions developed educational programmes to increase expertise and promote interest in this area of science and medicine. In this Perspective article, we discuss the success of the COST Actions DSDnet and GnRH Network and the European Reference Network for Rare Endocrine Conditions (Endo-ERN), and provide recommendations for future research.

International audience; Hepatitis A virus (HAV) and norovirus are important agents of food-borne human viral illness, with common vehicles including bivalve molluscan shellfish, soft fruit and various vegetables. Outbreaks of viral illness due to contamination of the surfaces of foods, or food preparation surfaces by for example infected food handlers are also common. Virus analysis of food matrices can contribute towards risk management for these hazards and a two-part technical specification for determination of Hepatitis A virus and norovirus in food matrices (ISO/TS 15216:2013) was published jointly by the European Committee for Standardisation and the International Organization for Standardization in 2013.As part of the European Mandate No. M381 to validate 15 standards in the field of food microbiology, an international validation study involving 18 laboratories from 11 countries in Europe was conducted between 2012 and 2014. This study aimed to generate method characteristics including limit of detection, limit of quantification, repeatability and reproducibility for ISO 15216 – Part 1, the method for quantification, in seven food matrices.The organization and results of this study, including observations that led to improvements in the standard method are presented here. After its conclusion, the method characteristics generated were added to the revised international standard, ISO 15216-1:2017, published in March 2017.

I-MOVE/I-MOVE+ study team: Portugal - Baltazar Nunes, Ausenda Machado, Ana Paula Rodrigues, Verónica Gomez, Irina Kislaya, Mafalda Sousa Uva (Departamento de Epidemiologia, Instituto Nacional de Saúde Doutor Ricardo Jorge); Raquel Guiomar, Pedro Pechirra, Paula Cristóvão, Patrícia Conde, Inês Costa (Departamento de Doenças Infeciosas, Instituto Nacional de Saúde Doutor Ricardo Jorge). I-MOVE/I-MOVE+study team - Portugal: Baltazar Nunes, Departamento de Epidemiologia, Instituto Nacional de Saúde Dr. Ricardo Jorge; Ausenda Machado, Departamento de Epidemiologia, Instituto Nacional de Saúde Dr. Ricardo Jorge; Ana Paula Rodrigues, Departamento de Epidemiologia, Instituto Nacional de Saúde Dr. Ricardo Jorge; Verónica Gomez, Departamento de Epidemiologia, Instituto Nacional de Saúde Dr. Ricardo Jorge; Irina Kislaya, Departamento de Epidemiologia, Instituto Nacional de Saúde Dr. Ricardo Jorge; Mafalda Sousa Uva, Departamento de Epidemiologia, Instituto Nacional de Saúde Dr. Ricardo Jorge; Raquel Guiomar, Departamento de Doenças Infeciosas, Instituto Nacional de Saúde Dr. Ricardo Jorge; Pedro Pechirra, Departamento de Doenças Infeciosas, Instituto Nacional de Saúde Dr. Ricardo Jorge; Paula Cristóvão, Departamento de Doenças Infeciosas, Instituto Nacional de Saúde Dr. Ricardo Jorge; Patrícia Conde, Departamento de Doenças Infeciosas, Instituto Nacional de Saúde Dr. Ricardo; Jorge Inês Costa, Departamento de Doenças Infeciosas, Instituto Nacional de Saúde Dr. Ricardo Jorge. We measured early 2016/17 season influenza vaccine effectiveness (IVE) against influenza A(H3N2) in Europe using multicentre case control studies at primary care and hospital levels. IVE at primary care level was 44.1%, 46.9% and 23.4% among 0-14, 15-64 and ≥ 65 year-olds, and 25.7% in the influenza vaccination target group. At hospital level, IVE was 2.5%, 7.9% and 2.4% among ≥ 65, 65-79 and ≥ 80 year-olds. As in previous seasons, we observed suboptimal IVE against influenza A(H3N2). This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 634446. info:eu-repo/semantics/publishedVersion

International audience; Financing innovative medical devices is an important challenge for national health policy makers, and a crucial issue for hospitals. However, when innovative medical devices are launched on the European market there is generally little clinical evidence regarding both efficacy and safety, both because of the flaws in the European system for regulating such devices, and because they are at an early stage of development. To manage the uncertainty surrounding the reimbursement of innovation, several European countries have set up temporary funding schemes to generate evidence about the effectiveness of devices. This article explores two different French approaches to funding innovative in-hospital devices and collecting supplementary data: the coverage with evidence development (CED) scheme introduced under Article L. 165-1-1 of the French Social Security Code; and national programs for hospital-based research. We discuss pros and cons of both approaches in the light of CED policies in Germany and the UK. The CED policies for devices share common limitations. Thus, transparency of CED processes should be enhanced and decisions need to be made in a timely way. Finally, we think that closer collaboration between manufacturers, health authorities and hospitals is essential to make CED policies more operational.

Europe's €1-billion science and technology project needs to clarify its goals and establish transparent governance, say Yves Fregnac and Gilles Laurent.

Dengue is a major international public health concern and one of the most important arthropod-borne diseases [1]. Approximately 2.5 billion people—40% of the world's population, in over 100 countries—are at risk of dengue virus (DENV) infection [2]. In recent years the average annual incidence of dengue-related serious disease in many tropical counties has been rising dramatically, with the infection becoming endemic in areas where its occurrence was once sporadic [3]. The exponential increase over the last decade has been connected to societal changes, such as population growth and increasing urbanization [4]. In addition, it has been suggested that rising temperatures and global climate change may lead to the expansion of the range of major mosquito vectors into new areas, extension of the transmission season in current endemic areas, and increase in the mosquito species vectorial capacity [5]–[7]. Human migration (likely including infected hosts) and international travel are constantly introducing new vectors and pathogens into novel geographic areas [8]. For example, chikungunya virus was introduced into northeastern Italy in 2007, causing an outbreak with local transmission due to the presence of Aedes albopictus, a vector also capable of transmitting dengue virus [9]. In 2010, three authochthonous cases of dengue were reported in Europe, thereby highlighting the potential for global spread of this disease [10], [11]. The island of Madeira, where the mosquito vector Aedes aegypti is present, experienced a major dengue outbreak in the fall of 2012 [12], highlighting that the introduction of dengue to non-endemic areas is a real threat. Dengue has been neglected for many years. Major research gaps for dengue exist in the areas of epidemiology under changing climate conditions, clinical management, pathogenesis, vector control, surveillance and response, vaccines, drugs, and health policy research [13]. The European Commission (EC) launched a call under the Seventh Framework Programme with the title of “Comprehensive control of Dengue fever under changing climatic conditions” (http://ec.europa.eu/research/participants/portal/page/cooperation?callIdentifier=FP7-HEALTH-2011-single-stage). The focus of this call is summarized in Box 1. Within this framework, in 2011, the EC awarded a total of approximately €18 million to three consortia. The hosting institutions are Heidelberg University Hospital (Germany), the Institute Pasteur (Paris, France), and Umea University (Sweden). Each consortium has partners from countries with endemic and epidemic dengue. In total, the consortia comprise 38 partners from 21 countries, of which 11 are from Asia and Latin America, the current hotspots of dengue endemicity, and one from Africa (Figure 1). Figure 1 The world map of the three EU-funded dengue consortia. Box 1. European Commission Seventh Framework Programme FP7 Cooperation - Health HEALTH.2011.2.3.3-2: Comprehensive control of Dengue fever under changing climatic conditions. FP7-HEALTH-2011-single-stage Research should develop innovative tools for one or more of the following aspects: better diagnosis, surveillance, development of treatment, prevention and vaccination strategies, prevention, and/or prediction and prevention of the spread of dengue fever to previously uninfected regions (including Europe), in the context of climate change. Research may also include studies on the underlying pathogenesis with respect to viral and host factors that can predict disease severity and prepare for further development of new vaccines, antiviral compounds, and more targeted treatment schemes. Funding Scheme Specific International Cooperation Action (SICA) Collaborative Project (small- or medium-scale focused research project) target regions: Latin America and/or Asia. SICA aims to bring about the balanced participation of third countries in collaboration with European partners. Expected Impact Better tools, and the use thereof, for improved comprehensive control of dengue fever at a global level. Participation from both SICA target regions and Small and Medium Enterprises SMEs in the projects should help ensure innovation and exploitation of the results in this area/topic. The degree of such participation will be considered during the evaluation. Source: http://ec.europa.eu/research/health/infectious-diseases/emerging-epidemics/call-for-proposals_en.html The funding of such a large and complex research programme focusing on a single disease highlights the emphasis that the European Commission has put on dengue and its potential threat to Europe. In this paper, we present these three consortia and outline their scientific strategies and potential role within the international dengue research community.

International audience; Methods for analyzing and displaying EEG signals are discussed. The increasing availability and affordability of powerful computer equipment makes possible the use of ever more sophisticated signal processing techniques, which extract relevant (but not readily discernible) information from long-term EEG recordings and can easily identify important features in the EEG. Whether these techniques are actually taken up in clinical practice is heavily dependent on how well they match clinical requirements. This article concentrates on requirements set in the context of long-term recordings in the ICU that demand the ability to process short-term discrete events as well as long-term trend information. A huge range of potentially useful signal processing techniques exists. This article illustrates the value of some of these techniques for ICU signals using the EEG recordings collected during the IMPROVE project

International audience; AIM: To evaluate the impact of the new European paediatric regulatory framework on the activities of Ethics Committees operating in Europe and to assess their involvement and interest in paediatric research. METHODS: Task-force in Europe for Drug Development for the Young Network of Excellence and Relating Expectations and Needs to the Participation and Empowerment of Children in Clinical Trials project set up an inventory of Ethics Committees existing in Europe and conducted a survey on their approach to paediatric trials. RESULTS: Ethics Committees operating in 22 European Countries participated in this survey. Results showed a high lack of knowledge, understanding and awareness of the current European paediatric regulatory framework and a lack of involvement of Ethics Committees in paediatric research, especially in terms of training and education, demonstrated also by the decreasing number of Ethics Committees answering exhaustively to the whole questionnaire. The majority of participating Ethics Committees expressed interest in future initiatives related to paediatric research. CONCLUSIONS: Despite a limited knowledge and understanding of the current paediatric regulatory framework, a significant number of Ethics Committees operating in Europe show interest in initiatives related to paediatric research. Networking may be an essential tool to be used to enhance Ethics Committees role in supporting paediatric research. Any initiative should be undertaken at European level in collaboration with European Union Institutions.

International audience; The European Commission announced in 2008 that a fundamental revision of the medical device directives is being considered in order to clarify and strengthen the current legal framework. The system for testing and approving devices in Europe was established >20 years ago as a 'New Approach' to a previously little-regulated industry. It is recognized by many that the regulatory system has not kept pace with technological advances and changing patterns of medical practice. New legislation will be drafted during 2011, but medical experts have been little involved in this important process. This context makes it an opportune time for a professional association to advise from both clinical and academic perspectives about changes which should be made to improve the safety and efficacy of devices used in clinical practice and to develop more appropriate systems for their clinical evaluation and post-marketing surveillance. This report summarizes how medical devices are regulated and it reviews some serious clinical problems that have occurred with cardiovascular devices. Finally, it presents the main recommendations from a Policy Conference on the Clinical Evaluation of Cardiovascular Devices that was held at the European Heart House in January 2011.

International audience; Bevacizumab in combination with platinum-based chemotherapy is associated with increased survival outcomes compared to chemotherapy alone in patients with non-squamous metastatic non-small cell lung cancer (mNSCLC). The objective of this study was to estimate potential economic benefits from a societal perspective in patients returning to work when treated with bevacizumab-based combination therapy. These economic benefits were assessed with respect to reduced productivity losses and described in terms of per patient cost savings. The analysis was conducted for France, Germany, Italy and Spain. Clinical outcomes in terms of progression-free survival (PFS) were based on two phase III clinical trials (E4599 and AVAiL) comparing bevacizumab + chemotherapy vs. chemotherapy alone. Potential cost savings due to reduction in productivity losses were assessed in progression-free patients who return back to work (human capital approach). It was assumed that 20% of all progression-free patients with performance status 0 or 1 and below 55 years of age would return back to work after the induction therapy maintaining their prior employment status (60% part-time, 40% full-time). Savings were calculated over 1 and 1.5 year time horizons. Mean savings, per progression-free patient ranged from 12,401 euro in Spain at year 1 to 39,001 euro in France at year 1.5. Respective findings proved to be fairly sensitive to the change of employment patterns and labour costs. This analysis shows that bevacizumab-based treatment can result in substantial cost savings in progression-free patients with mNSCLC.

Despite increasing efforts and support for anti-malarial drug R&D, globally anti-malarial drug discovery and development remains largely uncoordinated and fragmented. The current window of opportunity for large scale funding of R&D into malaria is likely to narrow in the coming decade due to a contraction in available resources caused by the current economic difficulties and new priorities (e.g. climate change). It is, therefore, essential that stakeholders are given well-articulated action plans and priorities to guide judgments on where resources can be best targeted. The CRIMALDDI Consortium (a European Union funded initiative) has been set up to develop, through a process of stakeholder and expert consultations, such priorities and recommendations to address them. It is hoped that the recommendations will help to guide the priorities of the European anti-malarial research as well as the wider global discovery agenda in the coming decade.

Contains fulltext : 69096.pdf (Publisher’s version ) (Closed access) This paper reports on quality assessment of MRS in the European Union-funded multicentre project INTERPRET (International Network for Pattern Recognition of Tumours Using Magnetic Resonance; http://azizu.uab.es/INTERPRET), which has developed brain tumour classification software using in vivo proton MR spectra. The quality assessment consisted of both MR system quality assurance (SQA) and quality control (QC) of spectral data acquired from patients and healthy volunteers. The system performance of the MR spectrometers at all participating centres was checked bimonthly by a short measurement protocol using a specially designed INTERPRET phantom. In addition, a more extended SQA protocol was performed yearly and after each hardware or software upgrade. To compare the system performance for in vivo measurements, each centre acquired MR spectra from the brain of five healthy volunteers. All MR systems fulfilled generally accepted minimal system performance for brain MRS during the entire data acquisition period. The QC procedure of the MR spectra in the database comprised automatic determination of the signal-to-noise ratio (SNR) in a water-suppressed spectrum and of the line width of the water resonance (water band width, WBW) in the corresponding non-suppressed spectrum. Values of SNR > 10 and WBW < 8 Hz at 1.5 T were determined empirically as conservative threshold levels required for spectra to be of acceptable quality. These thresholds only hold for SNR and WBW values using the definitions and data processing described in this article. A final QC check consisted of visual inspection of each clinically validated water-suppressed metabolite spectrum by two, or, in the case of disagreement, three, experienced MR spectroscopists, to detect artefacts such as large baseline distortions, exceptionally broadened metabolite peaks, insufficient removal of the water line, large phase errors, and signals originating from outside the voxel. In the end, 10% of 889 spectra with completed spectroscopic judgement were discarded.

International audience

International audience; BACKGROUND: Epidemiologic evidence related to asthma control in patients from the general population is scanty. OBJECTIVES: We sought to assess asthma control in several European centers according to the Global Initiative for Asthma (GINA) guidelines and to investigate its determinants. METHODS: In the European Community Respiratory Health Survey II (1999-2002), 1241 adults with asthma were identified and classified into inhaled corticosteroid (ICS) users and non-ICS users in the last year. Control was assessed in both groups by using the GINA proposal (controlled, partly controlled, and uncontrolled asthma), and it was related to potential determinants. RESULTS: Only 15% (95% CI, 12% to 19%) of subjects who had used ICSs in the last year and 45% (95% CI, 41% to 50%) of non-ICS users had their asthma under control; individuals with uncontrolled asthma accounted for 49% (95% CI, 44% to 53%) and 18% (95% CI, 15% to 21%), respectively. Among ICS users, the prevalence of uncontrolled asthma showed great variability across Europe, ranging from 20% (95% CI, 7% to 41%; Iceland) to 67% (95% CI, 35% to 90%; Italy). Overweight status, chronic cough and phlegm, and sensitization to Cladosporium species were associated with poor control in ICS users. About 65% and 87% of ICS users with uncontrolled and partly controlled asthma, respectively, were on a medication regimen that was less than recommended by the GINA guidelines. CONCLUSION: Six of 7 European asthmatic adults using ICSs in the last year did not achieve good disease control. The large majority of subjects with poorly controlled asthma were using antiasthma drugs in a suboptimal way. A wide variability in asthma control emerged across Europe. CLINICAL IMPLICATIONS: Greater attention should be paid to asthma management and to the implementation of the GINA guidelines.