- IMI Predict
- Jean Monnet Programme
- Managed Outcomes
The mission of ACCRA is to enable the development of advanced ICT Robotics based solutions for extending active and healthy ageing in daily life by defining, developing and demonstrating an agile co-creation development process. To this end, a four-step methodology (need study, cocreation, experimentation, sustainability analysis) will be defined and applied in three applications (support for walking, housework, conversation rehabilitation) and assessed in France, Italy, Netherlands and Japan. The three applications will be based on a FIWARE platform integrating a number of enablers including features of universAAL and supporting two robotics solutions, Astro (Robot) and Buddy (Robot companion).
The MAST impact assessment framework will be used integrating the following dimensions: user perceptions, user outcomes, ELSI, economic aspects, technical aspects, organisational aspects. ACCRA is a joint European-Japanese initiative including a multidisciplinary team of 6 European partners and 3 Japanese partners. The project has a three-year duration. It is structured to allow for balanced contribution and efficient synergistic collaboration between Europe and Japan.
The Innovative Medicines Initiative (IMI) is Europe's largest public-private initiative aiming to speed the development of better and safer medicines for patients. IMI supports this aim through collaborative research projects and building networks of industrial and academic experts in order to boost European pharmaceutical innovation.
In the IMI 2 Joint Undertaking, IMI has defined in its Strategic Research Agenda health priorities to ensure the needs of patients are adequately addressed and, where appropriate, patient involvement is encouraged (IMI 5th call for proposal, IMI2/INT/2015-01343, p.3). Beyond the IMI agenda, there is increasing recognition of the importance of incorporating patient needs and perspectives into decision making and to provide more avenues for patient engagement. Patients have expressed interest in seeing the decision-making processes of the European Medicines Agency (EMA)/Committee for Medicinal Products for Human Use (CHMP) take patient considerations into even greater account, e.g., in appropriate design of pre- and post-approval studies and risk management plans. For benefit-risk assessments in particular, decisions should take into consideration not only patient preferences but also endpoints and outcomes that patients regard as relevant, preferred treatment options, impact of the disease, and willingness to accept trade-offs between favourable and unfavourable effects.
While stakeholders are in agreement regarding the high value of patient input, an appropriate structured approach, including a set of systematic methodologies and recommendations for their use, is needed for inclusion and engagement of patient perspectives during the development, approval, and post-approval phases. This approach should accommodate the requirements of both Regulatory Authorities and other stakeholders, such as health technology assessment (HTA) bodies and reimbursement agencies.
Patient engagement is considered by all stakeholders as important; however, it is acknowledged that complex questions remain in relation to the methods to elicitate patient preferences and how to integrate findings into decision making.
Optogenerapy proposes a new interferon-ß (IFN-ß) drug delivery system to revolutionize Multiple Sclerosis treatment.
The aim is to develop and validate a new bio-electronic cell based implant device to be implanted subcutaneously providing controlled drug release during at least 6 months. The cell confinement within a chamber sealed by a porous membrane allows the device to be easily implanted or removed. At the same time, this membrane acts to prevent immune rejection and offers long-term safety in drug release while overcoming the adverse effects of current cellular therapies. Wireless powered optogenetics – light controlling the cellular response of genetically engineered cells – is used to control the production of IFN-ß.
Replacing standard intravenous IFN-ß delivery by subcutaneous delivery prevents short and long term side effects and efficiency-losses related to drug peaks and discontinuation, while saving non-adherence costs.
It is a low-cost system enabling large scale manufacturing and reduction of time to market up to 30% compared to other cell therapies, combining:
- Polymeric biomaterials with strong optical, biocompatibility and barrier requirements, to build the cell chamber and to encapsulate the optoelectronics.
- Optoelectronics miniaturization, autonomy and optical performance.
- Optimal cellular engineering design, enhanced by computer modelling, for stability and performance of the synthetic optogenetic gene pathway over long-term implantation.
- Micro moulding enabling optoelectronics and membrane embedding for safety and minimal invasiveness.
The innovation potential is so huge that a proof-of-concept was listed by Scientist Magazine as one of the 2014’s big advances in science.
In our top-class consortium, industrial pull meets technological push, ensuring that the preclinically validated prototype obtained at the end responds to market demands.
BOSTON SCIENTIFIC, worldwide leader in neuromodulation active implants, has clear exploitation plans and high market penetration potential. 4 research intensive SMEs: TWO, GENEXPLAIN, NEOS and ULTRASION bring specific competences while increasing their own competitiveness.
Improving quality of care has been given too little attention in health economic research in the past although it is the central goal of health care systems in Europe. The proposed ETN on “Improving Quality of Care in Europe (IQCE)” aims to address this gap and has the following aims:
- Create new evidence and improve existing health economic research in the field of quality of care. Research gaps are addressed by empirical, theoretical and experimental approaches with a focus on innovative econometric methods using novel access to databases.
- Establish a close link of the topical PhD projects to health policy and practice ensuring high relevance and practical applicability of results. Implementation of project results can potentially enhance performance of European health care systems.
- Train PhD fellows to be experts in the field of quality of care and obtain excellent profiles for different career paths in health economic research or practice.
- Contribute to better coordination of currently fragmented health economic research in Europe. This will improve the competitive position of European health economic research.
- Serve as a model for joint doctorate programmes in health economics in Europe.
This will drive the development of PhD programmes in health economics in Europe, which currently are scarce. To address these aims, the research programme consists of research clusters: (a) effectiveness & safety, (b) efficiency, (c) access & equitability, and (d) acceptability. Clusters also define secondments and joint research activities of one cluster. Across clusters, scientific training courses, soft-skill-courses and research-in-progress workshops will provide new skills and ensure interaction and exchange between PhD fellows. The strong participation of the non-academic sector in courses, workshops, acting as hosts, providing research data, or acting as practice mentors for PhD fellows will ensure transfer of research into practice.
Over 50 million people in Europe have more than one chronic disease. This number will increase dramatically in the near future. This will increase health care spending to a staggering 20% of GDP. Multi-morbidity becomes the number one threat to population health and economic sustainability of health care systems. New models of care for multi-morbid patients are urgently needed. Given the diversity of Europe’s health and social care systems there is no single model that fits them all.
SELFIE aims to improve patient-centred care for patients with multi-morbidity by proposing evidence-based, economically sustainable integrated chronic care (ICC) models that stimulate cooperation across health and social care sectors and are supported by appropriate financing/payment schemes. SELFIE specifically focuses on multi-morbidity, on generating empirical evidence of the impact of ICC and on financing/payment schemes. It is methodologically innovative by applying Multi-Criteria Decision Analysis.
SELFIE develops 5 end-results that are adjustable to different care systems in Europe, including CEE:
- A taxonomy of most promising ICC models for patients with multi-morbidity; this taxonomy includes a “toolkit” of interventions that policy makers can use to build an ICC model that best fits into their own health and social care system
- A detailed list of options for different financing/payment schemes to support the implementation of ICC for multimorbidity
- A technical document on price-setting of ICC models for patients with multi-morbidity
- A performance assessment tool to monitor goal achievement; this tool includes new indicators that specifically address the quality of care for patients with multi-morbidity
- Strategies for implementation and change management Patients, informal and professional caregivers, payers and policy makers are involved right from the beginning to ensure that SELFIE addresses the right questions and pave the pathway for implementation.
Atherosclerosis and its consequences remain the main cause of mortality in industrialized and developing nations. Despite major advances in treatment, a large number of victims die or are disabled either because the first manifestation is sudden death or an acute cardiovascular event, or because of lack of treatment efficacy, that can be partly caused by the inadequacy of the treatment. In order to reduce the risk of an acute event, unstable atherosclerosis has to be detected at an early stage of its development. However, the imaging tools that are currently available to detect the spread of atherosclerosis and to predict the associated risk are mainly based on morphological plaque and arterial wall criteria such as calcium scoring1 or Intima-Media Thickness (IMT)2. However morphological features only represent the changes in the arterial wall, while it is inflammation that causes plaque evolution. So, obtaining direct, whole body, information on plaque inflammation, including coronary arteries, using target-specific contrast agents would strongly improve the prediction of acute CV events and thus lead to a better stratification of patients' risk as well as a better fine-tuning of (preventive) treatment. Furthermore, when an acute event (MI or stroke) has occurred, microcirculation impairment and secondary inflammation processes play an important role in the final lesion size and thus in patient outcome3. Having a fast imaging method with contrast agent specific to inflammation and damages to the micro-circulation process would allow us to better adapt the therapy to the individual patients but also to better assess the efficacy of new therapies such as cyclosporine in acute MI.
COMPARE: COllaborative Management Platform for detection and Analyses of (Re-)emerging and foodborne outbreaks in Europe
COMPARE aims to harness the rapid advances in molecular technology to improve identification and mitigation of emerging infectious diseases and foodborne outbreaks. To this purpose COMPARE will establish a “One serves all” analytical framework and data exchange platform that will allow real time analysis and interpretation of sequence-based pathogen data in combination with associated data (e.g. clinical, epidemiological data) in an integrated inter-sectorial, interdisciplinary, international, “one health” approach.
The framework will link research, clinical and public health organisations active in human health, animal health, and food safety in Europe and beyond, to develop (i) integrated risk assessment and risk based collection of samples and data, (ii) harmonised workflows for generating comparable sequence and associated data, (iii) state-of-the-art analytical workflows and tools for generating actionable information for support of patient diagnosis, treatment, outbreak detection and -investigation and (iv) risk communication tools.
The analytical workflows will be linked to a flexible, scalable and open-source data- and information platform supporting rapid sharing, interrogation and analysis of sequence-based pathogen data in combination with other associated data. The system will be linked to existing and future complementary systems, networks and databases such as those used by ECDC, NCBI and EFSA. The functionalities of the system will be tested and fine tuned through underpinning research studies on priority pathogens covering healthcare-associated infections, food-borne disease, and (zoonotic) (re-) emerging diseases with epidemic or pandemic potential. Throughout the project, extensive consultations with future users, studies into the barriers to open data sharing, dissemination and training activities and studies on the cost-effectiveness of the system will support future sustainable user uptake.
Stem cell regenerative therapies hold great promise for patients suffering from a variety of disorders that are associated with tissue or organ injury. Regeneration relies on tissue or organ-specific stem and progenitor cells, but can also aim at promoting the endogenous repair capacity of the body. Mesenchymal stromal cells (MSC) are undergoing clinical testing in a variety of clinical conditions aiming at repair through direct or indirect mechanisms. Their ability to form bone or cartilage is used to directly repair these tissues. In other conditions their regenerative effects are based on endogenous repair through their anti-inflammatory properties. The latter mechanism is important in the treatment of acute Graft-versus-Host Disease (GvHD). We have been involved in the clinical development from the beginning and we have shown the therapeutic potential. However, no results of controlled randomized phase 3 studies have been published to date, thereby hampering safety and efficacy assessment.
Within our consortium we have developed an academic infrastructure for the harmonized production of MSC. In the RETHRIM proposal this will be combined with our clinical expertise to conduct the first Europe-wide placebo controlled randomized phase III trial using MSC regenerative therapy for the treatment of steroid-resistant visceral GvHD. Central to the RETHRIM project is the clinical trial for which 150 patients will be recruited. All MSC products will be extensively analysed using molecular and functional markers, in order to develop a potency signature for the product and for the prediction of response. We also intend to collect data from additional quality of life, health technology assessment and ethical studies. We will apply for an Orphan Drug Designation in Europe and this may serve as a stepping-stone for the further commercialization of the MSC product, once a positive outcome has been obtained.
AEGLE (Ancient Greek: Αἴγλη): An analytics framework for integrated and personalized healthcare services in Europe
The data generated in the health domain is coming from heterogeneous, multi-modal, multi-lingual, dynamic and fast evolving medical technologies. Today we are found in a big health landscape characterized by large volume, versatility and velocity (3Vs) which has led to the evolution of the informatics in the big biodata domain. AEGLE project will build an innovative ICT solution addressing the whole data value chain for health based on: cloud computing enabling dynamic resource allocation, HPC infrastructures for computational acceleration and advanced visualization techniques. AEGLE will:
- Realize a multiparametric platform using algorithms for analysing big biodata including features such as volume properties, communication metrics and bottlenecks, estimation of related computational resources needed, handling data versatility and managing velocity;
- Address the systemic health big bio-data in terms of the 3V multidimensional space, using analytics based on PCA techniques;
- Demonstrate AEGLE’s efficiency through the provision of aggregated services covering the 3V space of big bio-data. Specifically it will be evaluated in: a)big biostreams where the decision speed is critical and needs non-linear and multiparametric estimators for clinical decision support within limited time, b)big-data from non-malignant diseases where the need for NGS and molecular data analytics requires the combination of cloud located resources, coupled with local demands for data and visualization, and finally c)big-data from chronic diseases including EHRs and medication, with needs for quantified estimates of important clinical parameters, semantics’ extraction and regulatory issues for integrated care;
- Bring together all related stakeholders, leading to integration with existing open databases, increasing the speed of AEGLE adaptation;
- Build a business ecosystem for the wider exploitation and targeting on cross-border production of custom multi-lingual solutions based on AEGLE.
The Community Based Health Insurance (CBHI) project is aimed at evaluating an innovative health insurance system in India that is based on solidarity. ESHPM further broadened its research-horizon to the African continent by establishing partnerships with the International Institute of Social Studies (ISS), the Africa Study Center, the Ethiopian Economics Association and Addis Ababa University. Jointly, these partners and ESHPM work on an NWO-funded project on the evaluation of CBHI in Ethiopia. Furthermore, ESHPM works closely together with the Amsterdam Institute for International Development in evaluating insurance schemes in Kenia. The knowledge acquired through all these projects is highly valuable to support policy makers. They are facing the challenges of addressing major public health issues in the context of ever increasing financial and human resource constraints.
The Health Equity and Financial Protection in Asia (HEFPA) project focuses on the effects of large-scale health care reforms in six Asian countries. The evaluation of the so-called New Cooperative Medical Scheme, which was introduced in rural China, is the central issue in the HEFPA project. This insurance system aims to insure farmers against the catastrophic consequences of illness and hopes to provide better access to medical care. Within this project, researchers from ESHPM, Shandong University and Oxford University are working together to design experiments that will allow successful evaluation of both demand and supply side interventions that are aimed at improving the programme’s impact on the access to medical care and financial protection.
The Jean Monnet programme aim at promoting excellence in teaching and research in the field of European Union studies worldwide. These Actions also aim at fostering the dialogue between the academic world and policy-makers, in particular with the aim of enhancing governance of EU policies. Key activities include teaching, research, conferences, and publications in the field of EU studies.
Payment mechanisms represent one of the fundamental building blocks of any health system, introducing powerful incentives for actors in the system and fierce technical design complexities. Inpatient case payments mainly referred to as Diagnose Related Groups (DRGs), are nowadays used as a payment mechanism with ambitious aims: they seek to reimburse providers fairly for the work they undertake, but intend to encourage efficient delivery and to discourage the provision of unnecessary services and thereby target to overcome some of the drawbacks of more traditional hospital reimbursement. A case payment system that fulfils these hopes requires carefully balanced incentives as well as a methodologically sound system. Especially, DRGs need to accurately reflect the resources and costs of treating a given patient.
The EuroDRG project scrutinises these challenges. Part one concentrates on the complexities of case payments for hospitals in general. Special emphasis is put on identifying those factors, which are crucial for:
- calculating adequate case payments,
- examining hospital efficiency within countries and across Europe fairly,
- study the relationship between costs and the quality of care provided in hospitals.
The project uses comparative analyses of DRG systems across 10 European countries embedded in various types of health systems (Austria, Estonia, Finland, France, Germany, the Netherlands, Poland, Spain, Sweden and the UK).
The second part of the project seeks to identify pan-European issues in hospital case payment and includes conducting efficiency analysis across European countries, establishing a European hospital benchmarking club as well as identifying those systemic factors, which will be crucial for successful policy design in a slowly emerging pan-European hospital market.
The project explores the assumption that healthcare outcomes and costs are affected by the efficiency of service production, the regional structure of healthcare delivery, and the degree people are empowered to participate in the co-production of their care. The principal method is comparative case studies and the project aims to develop scenarios and models of future healthcare systems. Impacts are methods for benchmarking healthcare production and distribution practices across Europe, to further the exchange of best practices across cultural contexts, demand-based tools for designing healthcare systems, and knowledge on the impacts of service channels on health outcomes and cost-benefits.
The effectiveness of treatment with oral anticoagulants in the prevention of thrombotic disorders is well established, but these drugs are potentially dangerous because of their narrow therapeutic index. In Europe three coumarins are used: warfarin, acenocoumarol, and phenprocoumon. Genetic factors that have been recently demonstrated to change the pharmacokinetics and pharmacodynamics of coumarins are the presence of polymorphisms in the genes encoding for CYP2C9 and VKOR (vitamin K epoxide reductase complex). Polymorphisms in these genes are associated with increased risk for severe overanticoagulation and bleedings. A clinical trial will be performed in seven European countries to determine whether knowledge of the genotype of patients at the start of coumarin treatment will increase the safety of use of these compounds and whether such gene testing is cost-effective. Patients will be randomized to receive treatment with a coumarin either dosed with an algorithm that does not include information on their genotype, or with an algorithm that does contain this information. The primary outcome will be time within therapeutic INR range. Secondary outcomes include INR>4 and bleedings
QUASER (Quality and Safety in European Union Hospitals) is a comparative study of five European countries and funded by the EU framework program 7. The QUASER study is a multi-level (macro, meso and micro-system), longitudinal comparative study of the ‘quality of hospital care,’ i.e. the effectiveness, safety and patient experience of hospital care.
The QUASER project was launched in April 2010. Its participants - next to Erasmus School of Health Policy & Management of the Erasmus University in Rotterdam –include the Kings College (London), the Centre for Patient Safety and Service Quality (Imperial College, London), the Instituto Superior de Ciências do Trabalho e da Empresa (Lisbon), Qulturum (Jongkoping county Council, Sweden), and the Department of Health Studies (University of Stavanger, Norway).
The proposed research responds to the call for research into the ‘Quality, Efficiency and Solidarity of Health Systems’. European countries are reforming their health systems to improve health care delivery. One of the ways they are doing this is by changing skill mix within teams delivering health services: extending the roles of existing health professions and introducing new ones. This project will undertake a systematic evaluation of the impact of these ‘new professional roles’ on practice, outcomes and costs in a range of different health care settings within European Union and Associate Countries. It will detail the nature, scope and contribution of the new professional roles, evaluate their impact on clinical practice and outcomes, and identify their scope to improve the integration of care. It will conduct economic evaluation to identify the cost effectiveness of the new professional roles, identify optimal models for delivery of health care and the consequences of these for management of human resources and workforce planning. Study design is cross-sectional and multi-level. A mixed methods approach will combine analysis of routinely collected data and primary data generated through interviews and questionnaires to health professionals, managers and patients. Data analysis will employ multi-level modelling techniques.
ReAAL is funded by the European CIP-ICT-PSP implementation call of 2012. The project has as main objective to evaluate the socio-economic impact of an open source platform in the area of active and independent living (also called Ambient Assisted Living, AAL). ReAAL builds on a broad consortium of countries, including Spain, Italy, France, Germany, the Netherlands, Denmark, Norway, and the UK.
In the course of 36 months, ReAAL will deploy several open-source applications in the field of active and independent living at several pilot sites. All together, the pilots will involve approx. 7000 users in 7 countries, including the Rijnmond Region in the Netherlands. A key deliverable of ReAAL is to collect best practices concerning technical and organizational aspects associated with deployment and public procurement of open source AAL applications. The goal is to enable optimization of existing value chains and business models. The project will make findings and recommendations publicly available via a knowledge portal that will serve as main European reference for best practices and lessons learned with regards to large-scale rollouts with interoperability focus.
ESHPM’s department of HSMO takes the lead in the project evaluation. This will encompass validating the role of open source platforms in achieving interoperability and measuring the related socio-economic impact. The evaluation framework will be multidimensional, thus also taking into consideration impacts related to ethical, legal, market, user experience, and organizational aspects.
ReAAL begun in January 2013 and has a three-year duration
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