Article type
Abstract
Background: Personalized Precision Medicine (PPM) represents an innovative approach to the diagnosis, prognosis, and treatment of diseases based on individual or group characteristics using data sources. Although Omics technologies play a critical role in PPM, they also represent challenges. Hence, developing a suitable methodology for assessing these technologies is essential to ensure informed clinical decision-making within the Spanish Healthcare System.
Objectives: Our aim was to provide evidence-based methods for assessing omics technologies in the Healthcare System and Spanish HTA network, and to explore the challenges and barriers for integrating the developed framework for assessing omics technologies in the HTA procedures.
Methods: The omics technology assessment framework was developed by integrating different approaches: a systematic review (SR) and a survey involving experts in omics technology, basic science researchers, clinicians, and patient associations. A consensus panel of experts from HTA agencies was designed to ensure the framework's feasibility and applicability. Additionally, a workshop was conducted, bringing together HTA technicians and clinical professionals.
Results: Following the extraction and synthesis of data from the 38 studies in the systematic review (SR), 30 existing frameworks for evaluating omics technologies and the essential components required for assessing these technologies were identified. This process led to the development of the initial version of the framework.
Additionally, a survey was conducted to incorporate the perspectives of experts in omics technology and patients. A consensus panel of experts from HTA agencies refined this framework version further, ensuring a comprehensive evaluation of the gathered data. The final framework was divided into 94 elements, sections, categories, domains, and subdomains.
Conclusion: A methodological guide, including an assessment framework, was developed for the Spanish HTA network. The framework contains seven sections covering evidence gathering, provision models, organizational elements, economic evaluation, and ethical and social implications. Moreover, the workshop facilitated the practical implementation of the developed framework, allowing us to validate its applicability. Compared to other existing frameworks, our proposal incorporates bioinformatics, technological maturity level, and the patient perspective within the personal utility domain.
Objectives: Our aim was to provide evidence-based methods for assessing omics technologies in the Healthcare System and Spanish HTA network, and to explore the challenges and barriers for integrating the developed framework for assessing omics technologies in the HTA procedures.
Methods: The omics technology assessment framework was developed by integrating different approaches: a systematic review (SR) and a survey involving experts in omics technology, basic science researchers, clinicians, and patient associations. A consensus panel of experts from HTA agencies was designed to ensure the framework's feasibility and applicability. Additionally, a workshop was conducted, bringing together HTA technicians and clinical professionals.
Results: Following the extraction and synthesis of data from the 38 studies in the systematic review (SR), 30 existing frameworks for evaluating omics technologies and the essential components required for assessing these technologies were identified. This process led to the development of the initial version of the framework.
Additionally, a survey was conducted to incorporate the perspectives of experts in omics technology and patients. A consensus panel of experts from HTA agencies refined this framework version further, ensuring a comprehensive evaluation of the gathered data. The final framework was divided into 94 elements, sections, categories, domains, and subdomains.
Conclusion: A methodological guide, including an assessment framework, was developed for the Spanish HTA network. The framework contains seven sections covering evidence gathering, provision models, organizational elements, economic evaluation, and ethical and social implications. Moreover, the workshop facilitated the practical implementation of the developed framework, allowing us to validate its applicability. Compared to other existing frameworks, our proposal incorporates bioinformatics, technological maturity level, and the patient perspective within the personal utility domain.