Open-access clinical trial registries: the Italian scenario

BACKGROUND: Citizens, patients and their representatives are increasingly insisting on working with health professionals to organize and discuss research protocols. The International Committee of Medical Journal Editors recommended setting up a public clinical trial registry where anyone can find key information about a trial. Around the world, governments have, in fact, now begun to legislate mandatory disclosure of all clinical trials. The aims of the present survey were to assess the availability of clinical trial registries for Italian citizens and to examine the transparency of the data items reported. METHODS: The availability of open-access clinical trial registries was surveyed on a sample of 182 websites, including research institutes and centers of excellence (IRCCS-teaching hospitals), hospitals and associations. For each registry we downloaded a sample of two trials to assess the correspondence of the data items reported. Results from the Italian and international registries were compared. RESULTS: Fifteen percent of the sample had an open-access registry of clinical trials. Comparison of the data items available, in terms of completeness and transparency, from institutional and international registries indicated wide variability. CONCLUSIONS: Italian citizens, patients and their associations have scant access to local registries of clinical trials, and international registries are generally more informative. On the European level, advocacy and lobby actions are needed among citizens and patients to boost the diffusion of open-access clinical trial registries without language barriers, thereby facilitating participation, access to information, and the coordination of clinical research

METROPOLITAN AGRICULTURE, SOCIO-DEMOGRAPHIC DYNAMICS AND THE FOOD-CITY RELATIONSHIP IN SOUTHERN EUROPE

Peri-urban agriculture is a pivotal issue in the debate on sustainable management of land in metropolitan regions worldwide. Multiple socioeconomic and environmental solutions introduced by new models of peri-urban agriculture are playing an important role in planning and management of fringe land. The recent development of peri-urban agriculture in Southern European cities was supposed to reflect latent, crisis-driven processes of 'coming back to land': new land has been extensively cultivated, and new relations have been created between farmers, communities and territories within peri-urban areas. This study describes some relevant experiences of peri-urban farming in 6 metropolitan regions (Lisbon, Barcelona, Marseille, Rome, Athens, Istanbul) representative of different socioeconomic contexts in Southern Europe, outlining strengths and weaknesses in the use of fringe land for cropping, and evidencing relevant implications for urban sustainability

Public and patient involvement: a survey on knowledge, experience and opinions among researchers within a precision oncology European project

Participatory research; Patient engagement; Precision oncologyInvestigación participativa; Compromiso del paciente; Oncología de precisiónRecerca participativa; Compromís del pacient; Oncologia de precisióBackground Patient and Public Involvement (PPI) is slowly but steadily being implemented in all phases of clinical research. As part of the European project “Building Data Rich Clinical Trials” a survey was launched to investigate the knowledge, experiences and opinions on this topic of clinicians and researchers from seven European clinical and non-clinical centers (Cancer Core Europe). Methods An invitation to take part in a cross-sectional web survey was sent to 199 clinicians and researchers working in the field of precision oncology. The questionnaire was developed ad hoc because no existing questionnaires met the purpose of this study. The analysis takes account of whether respondents had experience on PPI or not. Results On a total of 101 respondents, this survey reveals that 76.2% of them knew about PPI before answering the questionnaire, 54.5% had experience in the previous five years and 86.1% were interested in a training course on this topic. PPI knowledge grew together with career seniority (peak of 86.5% for established career professionals), while the group most interested in a course was the early-career professionals (100.0%). Finally, the majority of respondents stated they had no training or education on PPI (67.3% of experienced and 82.6% of not-experienced respondents). Conclusions This survey shows that most cancer researchers knew the term PPI, even if only a little more than half of them had any relative experience. Opinions on PPI benefits, negative effects, barriers and requirements differed between the groups of PPI experienced and not-experienced respondents, showing that experience itself can influence respondents’ opinions. Most of respondents reported they would prefer a training course based on practical rather than theoretical tools.This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 965397

Presenting evidence-based health information for people with multiple sclerosis : the IN-DEEP project protocol

Background - Increasingly, evidence-based health information, in particular evidence from systematic reviews, is being made available to lay audiences, in addition to health professionals. Research efforts have focused on different formats for the lay presentation of health information. However, there is a paucity of data on how patients integrate evidence-based health information with other factors such as their preferences for information and experiences with information-seeking. The aim of this project is to explore how people with multiple sclerosis (MS) integrate health information with their needs, experiences, preferences and values and how these factors can be incorporated into an online resource of evidence-based health information provision for people with MS and their families.Methods - This project is an Australian-Italian collaboration between researchers, MS societies and people with MS. Using a four-stage mixed methods design, a model will be developed for presenting evidence-based health information on the Internet for people with MS and their families. This evidence-based health information will draw upon systematic reviews of MS interventions from The Cochrane Library. Each stage of the project will build on the last. After conducting focus groups with people with MS and their family members (Stage 1), we will develop a model for summarising and presenting Cochrane MS reviews that is integrated with supporting information to aid understanding and decision making. This will be reviewed and finalised with people with MS, family members, health professionals and MS Society staff (Stage 2), before being uploaded to the Internet and evaluated (Stages 3 and 4).Discussion - This project aims to produce accessible and meaningful evidence-based health information about MS for use in the varied decision making and management situations people encounter in everyday life. It is expected that the findings will be relevant to broader efforts to provide evidence-based health information for patients and the general public. The international collaboration also permits exploration of cultural differences that could inform international practice.<br /

Women's perception of the benefits of mammography screening: population-based survey in four countries

Background Screening programmes are often actively promoted to achieve high coverage, which may result in unrealistic expectations. We examined women's understanding of the likely benefits of mammography screening. Methods Telephone survey of random samples of the female population aged ≥15 years in the US, UK, Italy, and Switzerland using three closed questions on the expected benefits of mammography screening. Results A total of 5964 women were contacted and 4140 women (69%) participated. Misconceptions were widespread: a majority of women believed that screening prevents or reduces the risk of contracting breast cancer (68%), that screening at least halves breast cancer mortality (62%), and that 10 years of regular screening will prevent 10 or more breast cancer deaths per 1000 women (75%). In multivariate analysis higher number of correct answers was positively associated with higher educational status (odds ratio [OR] = 1.44, 95% CI: 1.25, 1.66) and negatively with having had a mammography in the last 2 years (OR = 0.86, 95% CI: 0.73, 1.01). Compared with US women (reference group) and Swiss women (OR = 0.98, 95% CI: 0.82, 1.18) respondents in Italy (OR = 0.61, 95% CI: 0.50, 0.74) and the UK (OR = 0.73, 95% CI: 0.60, 0.88) gave fewer correct answers. Conclusion In the US and three European countries a high proportion of women overestimated the benefits that can be expected from screening mammography. This finding raises doubts on informed consent procedures within breast cancer screening programme

Chemical bond analysis for the entire periodic table: Energy Decomposition and Natural Orbitals for Chemical Valence in the Four-Component Relativistic Framework

Chemical bonding is a ubiquitous concept in chemistry and it provides a common basis for experimental and theoretical chemists to explain and predict the structure, stability and reactivity of chemical species. Among others, the Energy Decomposition Analysis (EDA, also known as the Extended Transition State method) in combination with Natural Orbitals for Chemical Valence (EDA-NOCV) is a very powerful tool for the analysis of the chemical bonds based on a charge and energy decomposition scheme within a common theoretical framework. While the approach has been applied in a variety of chemical contexts, the current implementations of the EDA-NOCV scheme include relativistic effects only at scalar level, so simply neglecting the spin-orbit coupling effects and de facto limiting its applicability. In this work, we extend the EDA-NOCV method to the relativistic four-component Dirac-Kohn-Sham theory that variationally accounts for spin-orbit coupling. Its correctness and numerical stability have been demonstrated in the case of simple molecular systems, where the relativistic effects play a negligible role, by comparison with the implementation available in the ADF modelling suite (using the non-relativistic Hamiltonian and the scalar ZORA approximation). As an illustrative example we analyse the metal-ethylene coordination bond in the group 6-element series (CO)$_5$TM-C$_2$H$_4$, with TM =Cr, Mo, W, Sg, where relativistic effects are likely to play an increasingly important role as one moves down the group. The method provides a clear measure (also in combination with the CD analysis) of the donation and back-donation components in coordination bonds, even when relativistic effects, including spin-orbit coupling, are crucial for understanding the chemical bond involving heavy and superheavy atoms.Comment: 49 pages, 2 figure