Diagnostic accuracy and recall rates for digital mammography and digital mammography combined with one-view and two-view tomosynthesis: results of an enriched reader study.

OBJECTIVE. The purpose of this study was to compare two methods of combining tomosynthesis with digital mammography by assessing diagnostic accuracy and recall rates for digital mammography alone and digital mammography combined with one-view tomosynthesis and two-view tomosynthesis. SUBJECTS AND METHODS. Three hundred ten cases including biopsy-proven malignancies (51), biopsy-proven benign findings (47), recalled screening cases (138), and negative screening cases (74) were reviewed by 15 radiologists sequentially using digital mammography, adding one-view tomosynthesis, and then two-view tomosynthesis. Cases were assessed for recall and assigned a BI-RADS score and probability of malignancy for each imaging method. Diagnostic accuracy was assessed using receiver operating characteristic (ROC) analysis. Screening recall rates were compared using pooled logistical regression analysis. A p value of < 0.0167 was considered significant. RESULTS. The area under the ROC curve (AUC) for digital mammography (DM), DM plus one-view tomosynthesis, and DM plus two-view tomosynthesis was 0.828, 0.864, and 0.895, respectively. Both one-view and two-view tomosynthesis plus DM were significantly better than DM alone (Delta AUCs 0.036 [p = 0.009] and 0.068 [p < 0.001]). Average noncancer recall rates for digital mammography, DM plus one-view tomosynthesis, and DM plus two-view tomosynthesis were 44.2%, 27.2%, and 24.0%, respectively. Combined with DM, one-view and two-view tomosynthesis both showed significantly lower noncancer recall rates than digital mammography alone (p < 0.001). Digital mammography with two-view tomosynthesis showed a significantly lower recall rate than digital mammography with one-view tomosynthesis (p < 0.001). Diagnostic accuracy for dense (Delta AUC, 0.091%; p < 0.001) and nondense (Delta AUC, 0.035%; p = 0.001) breasts improved with DM plus two-view tomosynthesis compared with digital mammography alone. Compared with digital mammography, diagnostic sensitivity for invasive cancers increased with the addition of both one-view (Delta 12.0%, p < 0.001) and two-view (Delta 21.7%, p < 0.001) tomosynthesis. CONCLUSION. The addition of one-view tomosynthesis to conventional digital mammography improved diagnostic accuracy and reduced the recall rate; however, the addition of two-view tomosynthesis provided twice the performance gain in diagnostic accuracy while further reducing the recall rate.