Original Title: Guía de procedimientos y métodos para evaluación de pruebas ómicas. Medicina personalizada de precisión

Authors' objectives: To develop a guide that compiles the literature on the evaluation of omic evidence in the field of health decision-making, complementing it with a proposal that will provide the RedETS with a methodological document for the development of evaluations that contribute to better and more transparent decision-making in the National Health System (NHS).

Authors' results and conclusions: Results: A guide was developed that defines the procedure and structure to be included in the methodological manual for assessing omics technologies. This guide incorporates a specific Assessment Framework consisting of seven sections. The first three sections guide gathering evidence for omics testing (analytical validity, clinical validity, clinical utility, personal utility). The fourth and fifth sections refer to the delivery models where omics testing is developed and the organisational aspects of conducting omics testing. The sixth section suggests a set of criteria for summarising the collected evidence (net benefit, cost-effectiveness, feasibility, i.e. economic factors or evaluation). Finally, the seventh section guides the formulation of the ethical, legal, social, and cultural implications, including the patient's perspective. Conclusions: The methodological Omics Testing Guide, OM Guide, established a structured and detailed framework for assessing omics testing. This framework includes 94 key aspects organized into seven sections. One significant advancement of this guide is including the patient perspective through the personal utility domain, highlighting its importance in evaluating these technologies. For the first time, the assessment framework also addresses the technological maturity of omics testing and incorporates relevant bioinformatics considerations for analysing results. Consequently, the OM Guide contributes to the standardization and enhanced understanding of assessing these technologies. It combines the assessment framework with a recommended structure or template for developing Health Technology Assessment (HTA) reports for omics technologies. This comprehensive approach facilitates informed decision-making regarding implementing and adopting omics testing within the healthcare system.

Authors' methods: Methods: The methodology used consisted of three different sections: • Systematic Review (SR). • Specifically, designed surveys aimed at experts in omic technologies and patient associations. • Consensus techniques: RAND/UCLA Appropriateness Method (RAM) adapted for validating the evaluation framework. A SR was carried out to identify relevant documents that provide scientific evidence to determine the necessary evaluation dimensions. In addition, two surveys were conducted. The first survey was aimed at groups of experts to identify areas for improvement in the evaluation dimensions identified in the SR, and a second survey was aimed at patient associations to assess those evaluation dimensions that focus on the patient perspective. Finally, the framework with the resulting evaluation dimensions identified was submitted to consensus through a RAM study of HTA experts from RedETS.

Project Status: Completed

URL for project: https://www.aetsa.org/publicacion/guia-de-procedimientos-y-metodos-para-evaluacion-de-pruebas-omicas-medicina-personalizada-de-precision/

Year Published: 2025

URL for published report: https://www.aetsa.org/download/publicaciones/11B_2021_AETSA_Metodolu00f3gico_MP_web.pdf

Requestor: Spanish Health Ministry

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Spain

DOI: 10.52766/TNOL4288

Organisation Name: Andalusian Health Technology Assessment Area

Contact Address: Area de Evaluacion de Tecnologias Sanitarias Sanitarias de Andalucia (AETSA) Avda. Innovación, s/n Edificio Arena 1. Sevilla (Spain) Tel. +34 955 006 309

Contact Name: aetsa.csalud@juntadeandalucia.es

Contact Email: aetsa.csalud@juntadeandalucia.es

Copyright: <p>Andalusian Agency for Health Technology Assessment (AETSA)</p>