The evolution of early awareness and alert methods and systems.

In this theme section on early awareness and alert (EAA) systems and activities, we are pleased to present a series of articles covering the structure of EAA systems, their development and integration into decision making for the adoption and use of new and emerging health technologies, and the methods used by current networks, systems, and organizations.</jats:p

Recommendations to overcome barriers to the use of artificial intelligence-driven evidence in health technology assessment

BACKGROUND: Artificial intelligence (AI) has attracted much attention because of its enormous potential in healthcare, but uptake has been slow. There are substantial barriers that challenge health technology assessment (HTA) professionals to use AI-generated evidence for decision-making from large real-world databases (e.g., based on claims data). As part of the European Commission-funded HTx H2020 (Next Generation Health Technology Assessment) project, we aimed to put forward recommendations to support healthcare decision-makers in integrating AI into the HTA processes. The barriers, addressed by the paper, are particularly focusing on Central and Eastern European (CEE) countries, where the implementation of HTA and access to health databases lag behind Western European countries. METHODS: We constructed a survey to rank the barriers to using AI for HTA purposes, completed by respondents from CEE jurisdictions with expertise in HTA. Using the results, two members of the HTx consortium from CEE developed recommendations on the most critical barriers. Then these recommendations were discussed in a workshop by a wider group of experts, including HTA and reimbursement decision-makers from both CEE countries and Western European countries, and summarized in a consensus report. RESULTS: Recommendations have been developed to address the top 15 barriers in areas of (1) human factor-related barriers, focusing on educating HTA doers and users, establishing collaborations and best practice sharing; (2) regulatory and policy-related barriers, proposing increasing awareness and political commitment and improving the management of sensitive information for AI use; (3) data-related barriers, suggesting enhancing standardization and collaboration with data networks, managing missing and unstructured data, using analytical and statistical approaches to address bias, using quality assessment tools and quality standards, improving reporting, and developing better conditions for the use of data; and (4) technological barriers, suggesting sustainable development of AI infrastructure. CONCLUSION: In the field of HTA, the great potential of AI to support evidence generation and evaluation has not yet been sufficiently explored and realized. Raising awareness of the intended and unintended consequences of AI-based methods and encouraging political commitment from policymakers is necessary to upgrade the regulatory and infrastructural environment and knowledge base required to integrate AI into HTA-based decision-making processes better

Uncertainty management in regulatory and health technology assessment decision-making on drugs: guidance of the HTAi-DIA Working Group

ObjectivesUncertainty is a fundamental component of decision making regarding access to and pricing and reimbursement of drugs. The context-specific interpretation and mitigation of uncertainty remain major challenges for decision makers. Following the 2021 HTAi Global Policy Forum, a cross-sectoral, interdisciplinary HTAi-DIA Working Group (WG) was initiated to develop guidance to support stakeholder deliberation on the systematic identification and mitigation of uncertainties in the regulatory-HTA interface. MethodsSix online discussions among WG members (Dec 2021-Sep 2022) who examined the output of a scoping review, two literature-based case studies and a survey; application of the initial guidance to a real-world case study; and two international conference panel discussions. ResultsThe WG identified key concepts, clustered into twelve building blocks that were collectively perceived to define uncertainty: "unavailable," "inaccurate," "conflicting," "not understandable," "random variation," "information," "prediction," "impact," "risk," "relevance," "context," and "judgment." These were converted into a checklist to explain and define whether any issue constitutes a decision-relevant uncertainty. A taxonomy of domains in which uncertainty may exist within the regulatory-HTA interface was developed to facilitate categorization. The real-world case study was used to demonstrate how the guidance may facilitate deliberation between stakeholders and where additional guidance development may be needed. ConclusionsThe systematic approach taken for the identification of uncertainties in this guidance has the potential to facilitate understanding of uncertainty and its management across different stakeholders involved in drug development and evaluation. This can improve consistency and transparency throughout decision processes. To further support uncertainty management, linkage to suitable mitigation strategies is necessary

Recommendations for patient involvement in health technology assessment in Central and Eastern European countries

IntroductionMeaningful patient involvement in health technology assessment (HTA) is essential in ensuring that the interests of the affected patient population, their families, and the general public are accurately reflected in coverage and reimbursement decisions. Central and Eastern European (CEE) countries are generally at less advanced stages of implementing HTA, which is particularly true for patient involvement activities. As part of the Horizon2020 HTx project, this research aimed to form recommendations for critical barriers to patient involvement in HTA in CEE countries. MethodsBuilt on previous research findings on potential barriers, a prioritisation survey was conducted online with CEE stakeholders. Recommendations for prioritised barriers were formed through a face-to-face workshop by CEE stakeholders and HTx experts. ResultsA total of 105 stakeholders from 13 CEE countries completed the prioritisation survey and identified 12 of the 22 potential barriers as highly important. The workshop had 36 participants representing 9 CEE countries, and 5 Western European countries coming together to discuss solutions in order to form recommendations based on best practices, real-life experience, and transferability aspects. Stakeholder groups involved in both phases included HTA organisation representatives, payers, patients, caregivers, patient organisation representatives, patient experts, health care providers, academic and non-academic researchers, health care consultants and health technology manufacturers/providers. As a result, 12 recommendations were formed specified to the CEE region's context, but potentially useful for a broader geographic audience. ConclusionIn this paper, we present 12 recommendations for meaningful, systematic, and sustainable patient involvement in HTA in CEE countries. Our hope is that engaging more than a hundred CEE stakeholders in the study helped to spread awareness of the importance and potential of patient involvement and that the resulting recommendations provide tangible steps for the way forward. Future studies shall focus on country-specific case studies of the implemented recommendations

Today’s Nutrition and Tomorrow’s Public Health: Challenges and Opportunities

At the dawn of the third millennium, we are confronted with a disturbing phenomenon: although global life expectancy still increases, this is not the case for healthy life expectancy! The explanation of this seemingly contradiction is mainly due to the rising prevalence of the new pandemia of chronic non-communicable diseases (NCDs). Even in low and middle income countries, the improvement in healthcare status and life expectancy is paralled by the increase of NCDs, as in all countries worldwide. Since the United Nations General Assembly held in New York in 2011, many publications have emphasized the close link between NCDs and nutrition. The NCDs epidemic forces us to reconsider the public health perspectives. Many governments, non-governmental organizations and other institutions are actively involved in educational nutrition programs and campaigns; however their efforts seldom obtain the results hoped for. It is extremely difficult to induce changes in lifestyle and behavior that have built up over a long period of time. However, it becomes urgent to adapt to our changing life-environment where traditional wisdom and intuitive choices are giving way to individual thinking and search for (often uncontrolled) information. This engenders a number of unprecedented challenges and it calls for a re-appraisal of the existing paradigms to achieve an adequate management of the upstream determinants of health instead of a (pre)dominant medical and hospital-centric approach. In the era of personalized healthcare, it is time to empower policy makers, professionals and citizens for achieving an evidence-based change in the health-disease interface and decision-making process for public health interventions. The scientific and professional society Health Technology Assessment International (HTAi) has recognized nutrition as a health technology by creating a Interest Group (IG) dedicated to research on methodologies and assessments of nutrition-related public health, while taking into account contextual factors (ethical, legal, social, organizational, economic, ...) in order to generate meaningful outcomes for establishing evidence-based health policies. This Research Topic aims to elaborate on some of the potential hurdles which have to be overcome for the sake of sustainable healthcare provisions anywhere in the world, such as shortcomings in methodological approaches, regulatory frameworks, gaps between evidence, its hierarchy and final recommendations for public health management

Toward a common understanding of competencies for health technology assessment: enhancing educational and training programs around the globe

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Integrating Empirical Analysis and Normative Inquiry in Health Technology Assessment : The Values in Doing Assessments of Health Technologies Approach

Health technology assessment (HTA) aims, through empirical analysis, to shed light on the value of health technologies (ORourke et al. [2020, International Journal of Technology Assessment in Health Care 36, 187-90]). HTA is, then, where facts and values meet. But how, where, and when do facts and values meet in HTA? Currently, HTA is usually portrayed as a sequential process, starting with empirical analysis (assessment), followed by a deliberation on the implications of the findings for a judgment of a health technologys value (appraisal). In this paper, we will argue that in HTA, empirical analysis and normative inquiry are much more closely entwined. In fact, as we hope to show, normative commitments act as an indispensable guide for the collection and interpretation of empirical evidence. Drawing on policy sciences, we will suggest a concrete methodology that can help HTA practitioners to integrate empirical analysis and normative inquiry in a transparent way. The proposed methodology can be conceived as a concrete means for conducting a scoping exercise in HTA. Moreover, it offers a distinct way of giving stakeholders a structural and constructive role in HTA. This paper outlines the approach developed by the values in doing assessments of health technologies project, a project funded by the Erasmus+ program (contract number 2018-1-NL01-KA203-038960), which is the European Unions program to support education, training, youth, and sport in Europe. The project has resulted in an E-learning course, an accompanying handbook, and a consensus statement, all freely available from the projects website www.validatehta.eu.Funding Agencies|Erasmusthorn Program of the European Union [2018-1-NL01-KA203-038960]</p