Original Title: La mamografía digital en el cribado del cáncer de mama; evaluación de su eficacia y de su introducción en el Programa de Detección Precoz del Cáncer de Mama de la Comunidad Autónoma del País Vasco.

Authors' objectives: • Assess the efficiency and safety of digital mammograms and computer aided diagnostics in population screening programmes, as well as the impact of digitisation on the key indicators of the Early Breast Cancer Detection Programme of the Basque Country (EBCDPBC). • Analyse the radiological quality control parameters of digital mammograms in the EBCDPBC. • Detect areas for improvement and draw up proposals to correct any malfunctions that may appear in the digitisation process of the network of the EBCDPBC.

Authors' results and conclusions: The available evidence, which is of moderate quality and is based on random clinical tests and different observational studies, indicates that digital mammograms are as efficient or slightly better than analogue mammograms in the detection of breast cancer in screening programmes, although at the cost of a slight increase in the recalls rate. With regard to computer aided diagnostics, there is no good-quality evidence on its efficiency and safety in population breast cancer screening programmes. The early assessment of the impact of introducing of digital mammograms in the EBCDPBC shows that these have involved only slight changes in a few indicators in the programme, but that in all cases these are maintained at acceptable levels according to European quality criteria. The evaluation of the quality parameters of the digital units incorporated in recent years into the EBCDPBC shows that the values are, in general, within the ranges or levels recommended in the European Guidelines. The most appropriate digital equipment for a breast cancer screening programme are direct digital systems. CONCLUSIONS AND RECOMMENDATIONS The quality standards required in the development of the digitisation programmes of the EBCDPBC are being maintained and it is recommended to: – Assess the mid-term impact of the digitisation of the EBCDPBC, both with regard to sensitivity levels in the detection of breast cancer and other key indicators (detection rate, percentage of recalls, positive predictive value and others) and to compare these with data from the analogue stage. – Assess in the mid-term the radiological quality guarantee control parameters of the different units of the EBCDPBC, comparing these with data from the analogue stage. – Guarantee digital connections between the different units that make up each circuit of the EBCDPBC so as to guarantee the sourcing of images between Detection-Assessment units and Reference Hospitals.

Authors' methods: • Systematic review of the evidence and the efficiency of digital mammograms and computer aided diagnostics in population screening programmes. The bibliographical search concluded on August 13, 2009. • Retrospective before/after comparison of the key indicators of the different scenarios that emerged following the digitisation of several units of the EBCDPBC. • Technical assessment of the digital mammogram units available in relation to the recommendations of the European Quality Control Protocol for Screening Programmes and the analysis of radiological quality control parameters, as well as legal aspects relating to the storage and use of digital images. • Establishment of the need to modify the methodology of the radiological quality guarantee programme of the EBCDPBC following the introduction of new technologies and the detection of problems and new requirements following the digitisation of several units of the EBCDPBC and proposals for correcting these.

Project Status: Completed

Year Published: 2011

URL for published report: https://www.euskadi.eus/contenidos/informacion/2011_osteba_publicacion/es_def/adjuntos/D_11_04%20Mamograf%C3%ADa%20digital%20cribado%20c%C3%A1ncer%20mama.pdf

English language abstract: An English language summary is available

Publication Type: Other

Country: Spain

Organisation Name: Basque Office for Health Technology Assessment

Contact Address: C/ Donostia – San Sebastián, 1 (Edificio Lakua II, 4ª planta) 01010 Vitoria - Gasteiz

Contact Name: Lorea Galnares-Cordero

Contact Email: lgalnares@bioef.eus

Copyright: <p>Osteba (Basque Office for Health Technology Assessment) Health Department of the Basque Government</p>