A reader study comparing prospective tomosynthesis interpretations with retrospective readings of the corresponding FFDM examinations.

Rationale And Objectives: To compare performance of prospective interpretations of clinical tomosynthesis (digital breast tomosynthesis [DBT]) plus full-field digital mammography (FFDM) examinations with retrospective readings of the corresponding FFDM examinations alone.

Methods And Materials: Seven Mammography Quality Standard Act-qualified radiologists retrospectively interpreted 10,878 FFDM examinations that had been interpreted by other radiologists during prospective clinical interpretations of DBT plus FFDM. The radiologists were blinded to the Breast Imaging Reporting and Data System (BIRADS) category given during the clinical interpretations and the verified outcome by follow-up and/or any diagnostic workup that may have followed. Ratings (BIRADS 0, 1, or 2) were recorded. Group performance levels in terms of recall rates and attributable cancer detection rates were compared to the prospective clinical interpretations of the same examinations (DBT plus FFDM) using McNemar test (two sided/tailed) with significance level of .05.

Results: During the prospective clinical interpretations of DBT plus FFDM, 588 cases were recalled (588 of 10,878, 5.41%) compared to 888 cases recalled (888 of 10,878, 8.16%) during the FFDM-alone retrospective interpretations (absolute difference, 35%; P<.0001). There were 59 and 38 suspicious abnormalities later verified as cancers detected during the DBT plus FFDM and the FFDM-alone interpretations, respectively (absolute increase, 55%; P<.0001). Invasive cancer detections were 48 and 29, respectively (absolute increase, 66%; P<.0001).

Conclusions: The combination of DBT plus FFDM for screening asymptomatic women resulted in a significant reduction in recall rates and a simultaneous increase in cancer detection rates when compared to retrospective interpretations of corresponding FFDM examinations alone.