Clinical performance of Siemens digital breast tomosynthesis versus standard supplementary mammography for the assessment of screen-detected soft-tissue abnormalities – a multi-reader study

AIM: To compare the diagnostic accuracy of standard screening images plus single-viewdigital breast tomosynthesis (DBT), using Siemens DBT equipment, with standard screeningimages plus supplementary mammographic views in non-calcific, screen-detected mammographicabnormalities. MATERIALS AND METHODS: Participants were unselected women aged 50e69 years recalledwithin a population-based European breast screening programme for assessment of soft-tissuemammographic abnormalities. Supplementary mammographic views (SMVs) and DBT wereperformed in all cases. A range of equipment was used for screening and supplementarymammography, but all DBT examinations were performed using the Siemens MammomatInspiration. A retrospective multi-reader study including 238 cases for whom either histologyor at least 2 years’ follow-up was available was performed with eight suitably accredited UKbreast screening personnel reading all cases under both conditions, with temporal separation.Readers were blinded to case outcomes and findings from other examinations. Diagnosticaccuracy using receiver operating characteristic (ROC) analysis was compared betweenscreening plus SMV images and screening plus DBT images. The study was powered to detect a3% inferiority margin in diagnostic accuracy between methods. RESULTS: The final sample with complete data available for analysis included 195 benigncases (1,560 reads) and 35 malignant cases (280 reads). The DBT method yielded a slightly higher area under the curve (AUC) value than the SMV method (0.870 versus 0.857), but thedifference was not statistically significant (p¼0.4890), indicating that the methods haveequivalent accuracy. CONCLUSION: Siemens DBT demonstrates equivalent diagnostic accuracy according to ROCcurve analysis when used in place of SMVs in screen-detected soft-tissue mammographicabnormalities.