Real-world evidence (RWE) in health technology assessment (HTA) holds significant potential for informing healthcare decision-making. A multistakeholder workshop was organised by the European Health ...Data and Evidence Network (EHDEN) and the GetReal Institute to explore the status, challenges, and opportunities in incorporating RWE into HTA, with a focus on learning from regulatory initiatives such as the European Medicines Agency (EMA) Data Analysis and Real World Interrogation Network (DARWIN EU
).
The workshop gathered key stakeholders from regulatory agencies, HTA organizations, academia, and industry for three panel discussions on RWE and HTA integration. Insights and recommendations were collected through panel discussions and audience polls. The workshop outcomes were reviewed by authors to identify key themes, challenges, and recommendations.
The workshop discussions revealed several important findings relating to the use of RWE in HTA. Compared with regulatory processes, its adoption in HTA to date has been slow. Barriers include limited trust in RWE, data quality concerns, and uncertainty about best practices. Facilitators include multidisciplinary training, educational initiatives, and stakeholder collaboration, which could be facilitated by initiatives like EHDEN and the GetReal Institute. Demonstrating the impact of "driver projects" could promote RWE adoption in HTA.
To enhance the integration of RWE in HTA, it is crucial to address known barriers through comprehensive training, stakeholder collaboration, and impactful exemplar research projects. By upskilling users and beneficiaries of RWE and those that generate it, promoting collaboration, and conducting "driver projects," can strengthen the HTA evidence base for more informed healthcare decisions.
Recently, there has been increased consideration of real-world data (RWD) and real-world evidence (RWE) in regulatory and health technology assessment (HTA) decision-making. Due to challenges in ...identifying high-quality and relevant RWD sources, researchers and regulatory/HTA bodies may turn to RWD generated in locales outside of the locale of interest (referred to as “transferring RWD”). We therefore performed a review of stakeholder guidance as well as selected case studies to identify themes for researchers to consider when transferring RWD from one jurisdiction to another. Our review highlighted that there is limited consensus on defining decision-grade, transferred RWD; certain stakeholders have issued relevant guidance, but the recommendations are high-level and additional effort is needed to generate comprehensive guidance. Additionally, the case studies revealed that RWD transferability has not been a consistent concern for regulatory/HTA bodies and that more focus has been put on the evaluation of internal validity. To help develop transferability best practices (alongside internal validity best practices), we suggest that researchers address the following considerations in their justification for transferring RWD: treatment pathways, nature of the healthcare system, incidence/prevalence of indication, and patient demographics. We also recommend that RWD transferability should garner more attention as the use of imported RWD could open doors to high-quality data sources and potentially reduce methodological issues that often arise in the use of local RWD; we thus hope this review provides a foundation for further dialogue around the suitability and utility of transferred RWD in the regulatory/HTA decision-making space.
The Höfðahólar rock avalanche, in the Skagafjörður area of northern Iceland, was investigated on the basis of a geomorphological analysis of its landforms and close surrounding environment. Thanks to ...sound chronological constraints (14C dating from birch remnants in peat areas that developed within depressions over the chaotic rock-avalanche deposit, tephrochronological sequences resulting from subsequent ash fallouts over the deposit, calibration of an age–depth model of peats and previously dated raised beaches), we define the rock-avalanche implementation with a wider timeframe between 10,200 and 7975 cal. yr BP and with a narrower frame between 9000 and 8195 ± 45 cal. yr BP. Such a well constrained timing proposes one of the most precise datings of an early-Holocene major slope failure in Iceland. This result fits well in the known chronology of the deglaciation in this area and in the prevailing Icelandic theory of a generalized phase of landsliding that occurred shortly after the deglaciation of the area. The main driver for the rock-avalanche occurrence is associated to a paraglacial origin; glacio-isostatic rebound, associated to rockwall debuttressing, is thought to be the main factor in the genesis of this Boreal major disequilibrium.
The worlds of education and learning have for the last few decades been characterized by reactions to the detrimental human impact on the environment, which is measured on such a scale that scholars ...now refer to the present epoch as the Anthropocene. In order to develop ideas and practices that could guide us into place-based research and an emancipatory relationship between pedagogy and knowledge, the focus needs to shift from what to teach and why (Knowledge and Curriculum) and concern over how learning is evaluated (Assessment) to how we should teach (Pedagogy). The acronym PACK (Pedagogy, Assessment, Curriculum, and Knowledge) turned into the idea of packing for a trip into uncharted educational territory, taking with us several gadgets that might be useful. Our own journey emerged as a dialogue between a philosopher and a science educator. Building on experiences from global work to regional research and a university chairmanship for sustainability, we tried to pack some big ideas for educators to take along, helping them navigate the educational landscapes ahead.
‘Inclusive education’ and ‘democracy’ are more than buzzwords in education. They refer to official educational policy in much of the western world. Democracy as a school policy seems to be widely ...accepted while inclusive education is more controversial, sometimes fuelling lively public debates where parents and politicians are vocal. However, there seems to be little agreement on what ‘inclusive education’ means, although one can discern a certain core to the understanding of ‘inclusive education’ among many of those who participate in the public debate. Central to the above understanding of inclusive education and democracy are certain features that I want to draw attention to. First, what falls under the headings ‘democracy in schools’, ‘democratic education’ or ‘student democracy’, on the one hand, and ‘inclusive education’, on the other, have little to do with one another. I discuss how the medical gaze in the context of education belongs to the dominant ideology of the time and is thus prevailing without ever having to be argued for or defended. The consequence of this is, as I see it, that education (which sometimes is more training than growth) is being cast in pathological terms. I connect the idea of transgression to that of democratic school and character. Transgression is relevant in two ways here. The school has to be a place where transgression is encouraged and, secondly, it is a place where transgression is valued as a democratic virtue. Virtue here could, I think, be understood in Aristotelian terms – or even given a Socratic interpretation.
The focus within the European tradition of democratic education has increasingly been on personal traits or character traits, values, and skills, rather than on broad structural features or systemic ...issues. This is reflected in a recent publication by the Council of Europe titled Competences for Democratic Culture: Living Together as Equals in Culturally Diverse Democratic Societies. In that publication relevant character traits are grouped under the heading ‘competences for democratic culture’. We scrutinize the notion of ‘democratic competences’ which is developed in the publication and suggest a different one. The Council of Europe presents a model with 20 competences, each of which falls into one of four categories: (1) a value, (2) an attitude, (3) a skill, or (4) knowledge and understanding. We suggest a notion of competences where a competence is conceived of as a complex construct composed of elements from all these categories. We then describe seven democratic competences, grounded in a Deweyan conception of democracy, which we think are both central to a democratic culture while also educationally relevant and manageable.
Visiting the forced visitors Eva Harðardóttir; Ólafur Páll Jónsson
Journal of social science education,
06/2021, Letnik:
20, Številka:
2
Journal Article
Recenzirano
Odprti dostop
• Migrant and refugee youth face complex challenges pertaining to educational and social inclusion in Europe and international contexts. • Global Citizenship Education (GCE) has gained increased ...prevalence as an educational response to globalizing processes such as forced migration and resulting cultural diversity. • It is argued that a critical and decentered model of GCE can be applied as an inclusive educational response to refugee youth within national educational settings. • Visual and participatory educational practices emphasizing the role of the teacher as a 'visitor' are presented and discussed. Purpose: To explore the role and possibilities of Global Citizenship Education (GCE) in attending to neglected aspects of inclusive education when responding to forced youth migration in Europe. Approach: We discuss different approaches to GCE within the literature, their implications for refugee students within national educational settings and give an example of how critical GCE can be practiced in education. Finding: Drawing on theoretical work of John Dewey and Hannah Arendt, in conjunction with more recent theoretical work on global citizenship within education, we argue that a critical and decentered model of GCE is important to support processes of inclusion and citizenship for refugee youth within national educational settings. Implications: We apply and discuss the suggested theoretical approach in relation to pedagogical practices developed as a part of an ongoing research project on irregular processes of inclusion and citizenship for migrant and refugee youth in Iceland, Norway, and the UK.
An adequate response to the environmental and sustainability issues we now face cannot be limited to single perspectives, disciplines, or ways of knowing, and instead requires an interdisciplinary ...approach. Despite the connections between the fields of citizenship-, character- and sustainability education, they have thus far run parallel to each other, without any substantial convergence. This paper focuses on the conceptual and historical reasons for this lack of integration, exploring the tensions among them perceived by many scholars and practitioners, such as an individual vs. a social vs. a global focus, a deliberative vs. fact based pedagogic approach, and an individual vs. socio-political educational context. The paper ends by exploring different ways in which these three fields of education might be integrated.
The International Studies in Education program at the University of Iceland illustrates how one university is responding to global trends in higher education. Through a case study we examined the ...significance of an innovative B.A. program, which is taught in English, aligned with values affirmed in critical multiculturalist scholarship, and designed to respond to demographic changes including a sharp increase in Iceland’s immigrant population. The experience of students, teachers, and administrators raises important questions about institutional responsibilities, both local and global; about the role of English in an international studies program; about
de facto
segregation of students; and about the significance of local context in global trends in higher education.
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