Original Title: Actualización de la Guía para la toma de decisiones sobre incorporación de nuevas pruebas genéticas en el Sistema Nacional de Salud (Guía GEN).

Authors' objectives: The objectives of this report were: 1 To identify opportunities for improvement in the current format of the GEN Guide. 2 To assess the degree of implementation of the GEN Guide nationwide. 3 To develop a new user-friendly version of the guide including updated aspects and other improvements.

Authors' results and conclusions: Most documents found in the literature search focused on the guide’s questionnaire. New aspects have been included in the updated guide, particularly on the test characteristics and its indications, and also on its validity evidence. Literature has also showed the ACCE (Analityc validity, Clinical validity, Clinical utility and Ethic, legal and social implications) evaluation model, used in the development of the GEN Guide, it is currently in effect. A comprehensive updated guide has been elaborated incorporating these improvements, and including a new presentation of the questionnaire in a self-explanatory format. Moreover, the survey to check the guideline implementation at hospitals has showed a lack of knowledge of the tool between the NHS professionals (over 68% did not know the GEN Guide), as well as the necessity of a shortened and straightforward tool for the applicants of genomic tests. An abbreviated version of the GEN Guide has been elaborated using consensus techniques (Delphi method) after the identification of the minimum and essential information needed for the application of a genomic test. This abbreviated version consists in a short questionnaire, oriented to clinicians, to provide justification of the request for introduction of a new genomic test.

Project Status: Completed

Year Published: 2016

URL for published report: https://www.aetsa.org/publicacion/actualizacion-de-la-guia-para-la-toma-de-decisiones-sobre-incorporacion-de-nuevas-pruebas-geneticas-en-el-sistema-nacional-de-salud-guia-gen/

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Spain

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>