The EU-FRB program aims to identify optimal treatment strategies based on independent robust high quality real-world data taking into account both the chronic nature of the disease and frequent comorbidities associated with retinal diseases. We will track the incidence of local (ocular) and systemic adverse events, which clinical trials have been unable to measure. Intravitreal treatments for retinal disorders are the most significant evolution in ophthalmology in the last decade. For many conditions (including diabetic retinopathy (DR) and age-related macular degeneration (AMD)), the new treatments were shown to be highly effective, resulting in unprecedented improvements in vision and quality of life. Both DR and AMD have common characteristics: 1) They are frequent and incidence increases: in 2013, there were 56 million patients affected by diabetes in Europe. DR is one of the major comorbidities of diabetes. The number of patients affected by AMD in the EU is expected to rise by almost 25% until 2050. 2) Both require long term follow-up and treament: the rate of recurrence of macular disease, and subsequent vision loss, is significant if treatment is withheld. Regular and close follow-up are necessary to achieve best visual outcomes and maintain vision. Most patients with neovascular AMD need to be treated regularly for a lifetime. Similar findings were reported in patients with DR as 50% of the patients still receive treatment after 3 years. Both AMD and DR are chronic conditions requiring lifelong treatment. 3) Patients with AMD and DR have a higher risk for co-morbidities such as cardiovascular disease, myocardial infarction, renal failure and stroke. Particularly in DR, renal failure, peripheral neuropathy, cardial and neurovascular complications are frequent. Similarly, the link between stroke, high blood pressure and AMD is well established. 4) Patients affected by either DME or AMD do greatly benefit from intravitreal antiVEGF injections, as shown in pivotal clinical studies. There is a need to assess the impact of comorbidities on outcomes, as patients with comorbidities are often excluded from clinical trials: these studies were performed in controlled environments with highly selected groups of patients to achieve high internal validity. Few real world data, mostly industry driven, are available. Systemic anti-VEGF, used as chemotherapy, had been shown to increase the risk of stroke, myocardial infarction, renal failure and hyper-blood pressure, but the impact of intra-vitreal injection is still debated. High-quality real-world outcomes data for DR and neovascular AMD treatments are urgently needed. Randomized clinical trials are inadequate to assess effects in life-long chronic diseases. EU-FRB We have formed a collaborative group with the expertise required to lead an international registry: ophthalmologists, epidemiologists, biostatistics, health economists, diabetologists, cardiologists and IT specialists. We aim to collect real-world data on retinal vascular disease, and related comorbidities at a European level. The EU-FRB project will fill a gap in our knowledge about how new and emerging treatments for retinal disorders can be used alone or in combination to produce the best outcomes for patients. This information will benefit to patients, health care professionals, and society. It will be the largest and continuously expanding international registry for ocular outcomes. By demonstrating the benefit of proposing a multi-disciplinary personalized treatment strategy based on observational data and using ICHOM specified outcomes, the EU-FRB project may support the use of similar registries in health. This project will place Europe at the forefront of international research on real-world outcomes of treatment by forming the most consistent registry to improve eye health and life of millions of patients.

In recent years, the majority of the world's Critical Infrastructures CIs evolved to become more flexible, cost efficient and able to offer better services and conditions for business opportunities. Towards this evolution, CIs and companies offering CI services had to adopt many of the recent advances of the Information and Communication Technologies (ICT) field. This adaptation however, was rather hasty and without thorough evaluation of its impact on security. The result was to leave CIs vulnerable to a who the new set of threats and attacks that impose high levels of risk to the public safety, economy and welfare of the population. In so far, the main approach to protect CIs is to handle them as comprehensive entities and offer them a complete solution for their overall infrastructures and systems (IT&OT departments). However Complete CI protection solutions exist in the form of individual products from individual companies. These products integrate only and tools/solutions designed by the same company, thus offering limited technical solutions. The main aim of CIPSEC is to create a unified security framework that orchestrates state-of-the-art heterogeneous security products to offer high levels of protection in IT (information technology) and OT (operational technology) departments of CIs. As part of this framework CIPSEC will offer a complete security ecosystem of additional services that can support the proposed technical solutions to work reliably and at professional quality. These services include vulnerability tests and recommendations, key personnel training courses, public-private partnerships (PPPs) forensics analysis, standardization and protection against cascading effects. All solutions and services will be validated in three pilots performed in three different CI environments (transportation, health, environment). CIPSEC will also develop a marketing strategy for optimal positioning of its solutions in the CI security market.

Lifestyle factors of the patient (e.g. smoking, hazardous alcohol drinking and malnutrition) are proven to be independent risk factors negatively impacting health outcome in the perioperative process. Evidence suggests that the implementation of intensive lifestyle intervention programs can significantly reduce the post-surgery complication risk and rehabilitation time . However, implementation of and compliance to such programs are today poor. In addition, possibilities to optimize the patients’ mental and physical state throughout the perioperative process are insufficient. LIVE INCITE aims to move beyond the current state of general information being provided about risks and post-surgery activities, to translating statistics and data to individual-specific information, making the individual plan “real” for the patient. We believe it is possible to leverage f i existing and new data, best practice behavioral change concepts, intuitive and easy-to-use user experience, modern communication and collaboration channels to integrate not only patients and care providers but also the patient’s family and friends, and new technology for continuous monitoring of and feedback on patient activities related to her defined plan. But, no matter which concepts and solutions the market will suggest, sustainability and scalability (related to the likely changing needs and pre-requisites of the specific procurer as well as the dissemination in and uptake from a European-wide procurer community) has to be enforced through principles related to interoperability, open architecture, and use of international standards. Through its consortia including specialized care hospitals, academia, patient organizations as well as collaboration and innovation platforms the project has the critical mass of knowledge to reach a truly innovative solution together with the supply side.

TALK© is a communication tool which aims to guide multi-professional clinical teams learning and improving quality of patient care and patient safety together. It is a simple and practical approach to multi-professional structured feedback and debriefing, to be used after unplanned learning events in clinical environments. Debriefing is the process of an individual or team formally reflecting on their performance after a particular task, a shift or a critical event (World Health Organisation 2009). TALK proposes an easy way to guide a constructive conversation between team members whenever new insights might be learnt from clinical experience. This includes cases or sessions in which things went well but also near misses and untoward events. Patient safety is far too often threatened by unidentified system flaws, poor practices, weaknesses in team communication and lack of appropriate action after critical events. The relevance of a culture of safety and communication is emphasized by WHO advocating debriefing in its Human Factors review, 2009. This RISE project will consist of three phases; firstly secondees will contribute to parallel implementation processes in specified units across the 3 participating countries and will undertake research to better understand the benefits of structured debriefing, communication and organisational culture. Secondly, using the data generated from the research study, further training materials will be developed and translated to support the wider deployment of the TALK tool. Thirdly, the TALK tool will be widely disseminated as a structured debriefing tool and implemented across and beyond all participating partners and its impact will be assessed.