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Omics technologies enable the measurements of genes (genomics), mRNA (transcriptomics), proteins (proteomics) and metabolites (metabolomics) and thus proved to be valuable tools for personalized decision-making in clinical practice. For their evaluation, a health technology assessment (HTA) framework is not standardized and accepted, yet. Therefore, we aim at designing an omics-technologies HTA evaluation framework to facilitate their assessment, through a mixed-method approach. This work is part of the ExACT project, which aims to produce a range of tools to facilitate the implementation of precision health in clinical practice.
A systematic review was conducted to identify the existing HTA frameworks used for the evaluation of omics-technologies. Desk research on the HTA agencies’ websites was performed to identify the reports on omics-technologies HTA evaluation frameworks used by these agencies. A questionnaire evaluating HTA agencies’ experience on evaluation of omics-technologies was designed. The new framework will be elaborated based on the findings from the three methodological steps, and will be validated through a Delphi process.
Twenty-three articles were included in the systematic review. The main identified HTA frameworks were ACCE and “Evaluation of Genomic Applications in Practice and Prevention” (EGAPP). The desk research showed that these frameworks were seldom used by HTA agencies, which for the evaluation of omics-technologies mostly refer to the HTA Core Model®, mainly assessing the following domains: clinical effectiveness and economic evaluation. Data collection process of the questionnaire HTA agencies’ experience is in progress.
Although two main HTA frameworks for the evaluation of omics-technologies have been identified, these frameworks are sporadically used by HTA agencies in their practice. The particular interest of HTA agencies on clinical effectiveness and economic evaluation, might potentially reflect the uncertainty and difficulties when evaluating omics-technologies. This could indicate that these HTA frameworks are not feasible and practical to be used in routine HTA agency processes for omics technologies, emphasizing the need for a new framework. Our methodological approach might contribute to the development of a new HTA framework, feasible and practical to use not only for HTA agencies.
Understanding of the role of contextual factors in determining the real value of health technologies is one of the major challenges for the use of Health Technology Assessment (HTA) methodology within hospitals. Moreover, the responsibility of assessing hospital performance is problematic. Although a number of managerial tools are available to appraise outcomes, there is little evidence on the role of contextual variables and how they might contribute to hospital performance.
Based on three extensive literature reviews, a pragmatic framework has been developed to understand interactions between organizational factors and health technologies on hospitals’ performance. Three main causal relationships emerge: (i) direct relationship between contextual factors and performance; (ii) an effect of contextual factors on the capability of technologies to “produce value”; (iii) an influence of organizational factors on clinical evidence-based decision-making. This pragmatic framework was designed within the IMPACT HTA EU Horizon 2020 Research Project.
The contextual dimensions are ascribable to five domains: organizational structure; managerial accounting tools; information, communication and technology (ICT) tools; human resource management (HRM) tools; hospital-based HTA procedures. The impact of contextual factors on technologies’ ability to produce value is highly overlooked in literature. Some effort in this sense exists only in the analysis of health information technologies. Moreover, among the contextual dimensions, only HRM tools have inspired a lively debate. The definition of hospital performance is amenable to multiple domains: accessibility, appropriateness, efficiency, safety and patient centeredness (continuity of care).
Although hospital performance is a pivotal topic in the healthcare sector, a deep understanding of how contextual factors may affect it is missing. The theoretical framework developed provides a tool to understand the multiple dimensions able to affect hospital performance. On one hand contextual dimensions may provide a direct effect on hospital performance. On the other, they may affect the extent to which technologies are capable of producing value.
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