Healthcare technologies, including complex technologies such as personalised medicines and cell/gene/regenerative technologies, are being developed at an unprecedented rate. For a rational use of these technologies, their potential value and impact need to be assessed. Health Technology Assessment (HTA) allows for the systematic evaluation of the properties and (in)direct effects of a healthcare technology, and is aimed at informing decision making. Current HTA consists of separate inquiry of aspects of value including safety, clinical and cost-effectiveness, and the wider ethical, legal, organisational and social issues associated with the use of healthcare technologies. This current approach to HTA does not sufficiently take into account the fact that different stakeholders (e.g. payers, hospitals, clinicians, patients) may have different questions, views and concerns regarding health care technologies. The value frameworks from which these questions, views and concerns emerge are rarely made explicit. As such, the underlying values may, or may not be shared among various groups and stakeholders in society. As a result, based on the value frameworks from which different stakeholders approach HTA, the conduct and outcome of HTA for the development and use of healthcare technologies may differ. Therefore, HTA should start by involving stakeholders and support them in collaboratively exploring which issues need to be addressed, how, and why. Since 2006, the role of HTA as a tool to inform decision-making is highly recognised by the European Commission (EC) and EU member states. Furthermore, on Jan. 31, 2018, the EC adopted a legislative proposal that seeks to promote convergence in HTA tools, procedures and methodologies through cooperation of EU member states [2]. VALIDATE is aimed to align with the strategic direction of the EC. In VALIDATE, the next generation of HTA experts will be trained and introduced to a novel, integrative approach to HTA, wherein the study of safety, clinical and cost-effectiveness of new healthcare technologies and their wider ethical, legal and social implications are closely integrated and stakeholders are involved in a more productive way throughout the process of HTA. The VALIDATE project is the first initiative, globally, to provide a new generation of HTA researchers with an opportunity to familiarize themselves with this novel approach and to develop and use the requisite knowledge and skills. The project will make use of a transdisciplinary approach, whereby the border between disciplines that feed into HTA (e.g. (bio)medical sciences, policy sciences, research methodology, psychology, philosophy, law and ethics) are transcended. First, a consensus statement will first be developed in VALIDATE, that will describe the knowledge and skills required to conduct this novel type of integrative HTA. Next, an e-learning module will be developed for HTA students (the next generation HTA experts) for integrative HTA, wherein the study of safety, clinical and cost-effectiveness of novel healthcare technologies, and their wider ethical, legal and social implications are thoroughly integrated. In addition, VALIDATE will develop a handbook with guidelines to apply this novel HTA approach. The results from VALIDATE will cause a paradigm shift in the way HTA is being conducted across Europe, where the HTA process will shift from a rather narrow-focused analytical process towards a more social and integrated approach involving stakeholders throughout the HTA process. In VALIDATE, 5 higher education institutions and 4 HTA agencies and hospital based HTA units across Europe that are at the forefront of this new type of thinking in HTA will collaborate. Students will be offered the opportunity to test the VALIDATE e-learning module and to demonstrate and implement their obtained knowledge and skills through internships at HTA agencies and hospital based HTA units. Project partners will collect, review, adapt and evaluate available e-learning materials, seek certification and accreditation for the developed e-learning module and actively promote its implementation and use in current HTA and related curricula across Europe. The sustainability of the VALIDATE project and its results is ensured by close collaboration with HTAi, the global scientific and professional society for all stakeholders involved in HTA (including researchers, HTA agencies, policy makers, industry, academia, health service providers, and patients or consumers), with members from over 65 countries. Ultimately, VALIDATE will train students to become the next generation HTA experts, where empirical analysis and normative inquiry are thoroughly integrated and where stakeholders are engaged in a more meaningful and productive way, creating an opportunity for more cohesive and inclusive societies in Europe.
Context and background of the project: For a rational use of healthcare technologies, their potential value and impact need to be explored. Health Technology Assessment (HTA) provides a systematic evaluation of the properties and (in)direct effects of healthcare technologies to inform decision making. Currently, HTA involves the assessment of safety, clinical effectiveness and cost-effectiveness, and sometimes ethical, legal, organisational and social issues associated with healthcare technologies. These issues are addressed separately from each other as distinct and potentially relevant aspects that need to be taken into account in determining the value of healthcare technology. A limitation of this approach is that it draws a sharp distinction between empirical inquiry on the one hand, and normative inquiry on the other. Such distinction cannot, however, be sustained. The relevance of empirical inquiry into different aspects of healthcare technologies, such as its safety and effectiveness, is derived from a commitment to certain values (e.g. avoiding harm). At the same time, normative inquiry, for instance asking whether a particular treatment respects a patient’s autonomy, necessarily draws on acquaintance with relevant facts. Hence, a new approach towards HTA is needed, one that allows for integration of empirical analysis and normative inquiry. This approach should help the new generation of HTA practitioners to explain to a wider audience how normative commitments give rise to specific empirical inquiry. By explicitly placing empirical inquiry in the context of normative commitments, the VALIDATE approach also offers a means to involve all relevant stakeholders in HTA in a more structural and effective way, i.e. from the start. For students of HTA, it means that they need to familiarize themselves more deeply with concepts and methods that have been developed in the fields of policy sciences and ethics The objectives of the VALIDATE project were to develop a new approach towards HTA which allows for the integration of empirical analysis and normative inquiry, developing associated teaching materials and providing opportunities for internships to apply the approach in HTA practice. To this end, a consensus statement was developed, defining the sort of knowledge and skills that are required to conduct this novel type of integrative HTA. Based on the consensus statement, an e-learning course and handbook were developed to educate HTA practitioners in conducting an integrative HTA. Students who successfully completed the e-learning course were offered the opportunity to practice their newly obtained knowledge and skills in internships. Experiences and learning achievements of students were captured in order to further improve the format and content of the teaching materials. Number and profile of participants: Master students, PhD candidates and young professionals in HTA participated by testing and completing the e-learning course, providing feedback on the handbook, and conducting internship projects offered by the partner institutes. In total, 60 participants from 12 different European countries were enrolled in the e-learning course. Twelve participants, from 4 different European countries, completed an internship project. During workshops and panel sessions at the annual meeting of HTAi, over 500 experts from the HTA community (e.g. students, policy makers, HTA researchers, clinicians, industry and patient representatives) were introduced to VALIDATE. Results and impact: All project objectives have been achieved. A consensus statement was developed and published on the project website. Based on this statement, a completely new e-learning course on integrative HTA has been developed, containing text, videos, intermediate assignments, a discussion board, and a final assignment. The e-learning course is freely available on the project website, and has been reviewed and accredited by HTA international (HTAi), the global professional society of HTA. In addition, a handbook containing eight chapters, addressing different aspects of an integrative approach towards HTA has been written and published on the project website. In total, four scientific papers on the VALIDATE project have been submitted to peer-reviewed journals. Finally, the VALIDATE project has been presented at various international meetings. Longer-term benefits: The project results will remain freely available at the project website. Ultimately, these outputs should result in a shift in people’s thinking about the added value of HTA. This would mean a shift from a strong focus on clinical effectiveness and health economics towards an inquiry that brings more clearly the underlying values into view and that admits for a more constructive role for stakeholders in the process. Clearly, for such a shift to take place, more time and sustained efforts are needed. The VALIDATE consortium is committed to continue making those efforts.