Spanish HTA on digital tomosynthesis in breast cancer

Digital tomosynthesis plus mammography (2D+3D) gives possibilities for both screening and diagnosis of breast cancer. Digital tomosynthesis produces a 3D image by taking multiple images or slices that are reconstructed to obtain a quasi–3D image of the breast

AETSA has performed a systematic review of the literature searching the following databases: EMBASE, MedLine, Web of Science, the Center for Reviews and Dissemination (CRD), the Cochrane Library, The National Institute for Health and Clinical Excellence (NICE) and the Spanish Network of Agencies for Assessing National Health System Technologies and Performance (REDETS). AETSA has chosen studies that evaluated diagnostic accuracy, survival or safety of 2D+3D images for screening or diagnosis of breast cancer. The QUADAS 2 tool was used to assess study quality, while NICE recommendations were used to determine the quality of evidence. Eventually, 25 studies were included after having checked 408 references. Out of the 25 studies, 12 were about the use of 2D+3D in the screening setting, 11 in the diagnostic environment and 2 in both settings. However, the limitation is that there was no confirmation of the negative results by histology, which may have overestimated both the sensitivity and the specificity of the tomosynthesis.

AETSA has discovered that:

• In the screening setting, the 2D+3D images showed a pooled sensitivity of 92%, a pooled specificity of 96%, a pooled positive likelihood ratio of 28.9, and a negative likelihood ratio <0.1.
• In the diagnostic setting, the pooled sensitivity was 94%, specificity 76%, positive likelihood ratio 4.56 and negative likelihood ratio were 0.08. The AUC was higher than 0.9. The interobserver agreement of the mammography together with tomosynthesis was better than for mammography alone, especially for the less experienced.

In conclusion, the findings of the studies in the screening setting suggested that the 2D+3D images was an excellent test. In the diagnostic environment, the accuracy of the test was outstanding, despite the fact that the specificity was lower than in the screening setting. No studies regarding the effect on health outcomes of adding breast tomosynthesis to the for screening and diagnostic setting have been found.

See the full report in Spanish (with summary in English) here.

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