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.


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 (Δ 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 (Δ AUC, 0.091%; p < 0.001) and nondense (Δ 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 (Δ12.0%, p < 0.001) and two-view (Δ21.7%, p < 0.001) tomosynthesis.


CONCLUSIONS
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.
1 Department of Radiology, Massachusetts General Hospital, Harvard Medical School, 55 Fruit St, Boston, MA 02114.
Elizabeth A
EA
Rafferty
Jeong Mi
JM
Park
Liane E
LE
Philpotts
Steven P
SP
Poplack
Jules H
JH
Sumkin
Elkan F
EF
Halpern
Loren T
LT
Niklason
D001706:Biopsy; D001943:Breast Neoplasms / Q000000981:diagnostic imaging* / Q000473:pathology; D003266:Continuity of Patient Care; D005260:Female; D006801:Humans; D008327:Mammography / Q000379:methods*; D008875:Middle Aged; D015588:Observer Variation; D011856:Radiographic Image Enhancement / Q000379:methods*; D011857:Radiographic Image Interpretation, Computer-Assisted; D015203:Reproducibility of Results; D012189:Retrospective Studies; D012307:Risk Factors; D012680:Sensitivity and Specificity