title: Tomosynthesis in the Diagnostic Setting: Changing Rates of BI-RADS Final Assessment over Time.
abstract: Purpose To evaluate the effect of tomosynthesis in diagnostic mammography on the Breast Imaging Reporting and Data System (BI-RADS) final assessment categories over time. Materials and Methods This retrospective study was approved by the institutional review board. The authors reviewed all diagnostic mammograms obtained during a 12-month interval before (two-dimensional [2D] mammography [June 2, 2010, to June 1, 2011]) and for 3 consecutive years after (tomosynthesis year 1 [2012], tomosynthesis year 2 [2013], and tomosynthesis year 3 [2014]) the implementation of tomosynthesis. The requirement to obtain informed consent was waived. The rates of BI-RADS final assessment categories 1-5 were compared between the 2D and tomosynthesis groups. The positive predictive values after biopsy (PPV3) for BI-RADS category 4 and 5 cases were compared. The mammographic features (masses, architectural distortions, calcifications, focal asymmetries) of lesions categorized as probably benign (BI-RADS category 3) and those for which biopsy was recommended (BI-RADS category 4 or 5) were reviewed. The χ(2) test was used to compare the rates of BI-RADS final assessment categories 1-5 between the two groups, and multivariate logistic regression analysis was performed to compare all diagnostic studies categorized as BI-RADS 3-5. Results There was an increase in the percentage of cases reported as negative or benign (BI-RADS category 1 or 2) with tomosynthesis (58.7% with 2D mammography vs 75.8% with tomosynthesis at year 3, P < .0001). A reduction in the percentage of probably benign (BI-RADS category 3) final assessments also occurred (33.3% with 2D mammography vs 16.4% with tomosynthesis at year 3, P < .0001). Although the rates of BI-RADS 4 or 5 assessments did not change significantly with tomosynthesis (8.0% with 2D mammography vs 7.8% with tomosynthesis at year 3, P = .2), there was a significant increase in the PPV3 (29.6% vs 50%, respectively; P < .0001). These trends increased during the 3 years of tomosynthesis use. Conclusion Tomosynthesis in the diagnostic setting resulted in progressive shifts in the BI-RADS final assessment categories over time, with a significant increase in the proportion of studies classified as normal, a continued decrease in the rate of studies categorized as probably benign, and improved diagnostic confidence in biopsy recommendations. (©) RSNA, 2016.
authors.affiliation: From the Department of Diagnostic Radiology, Yale University School of Medicine, PO Box 208042, New Haven, CT 06520-8216.
authors.forename: Madhavi
authors.initials: M
authors.lastname: Raghu
authors.affiliation: From the Department of Diagnostic Radiology, Yale University School of Medicine, PO Box 208042, New Haven, CT 06520-8216.
authors.forename: Melissa A
authors.initials: MA
authors.lastname: Durand
authors.affiliation: From the Department of Diagnostic Radiology, Yale University School of Medicine, PO Box 208042, New Haven, CT 06520-8216.
authors.forename: Liva
authors.initials: L
authors.lastname: Andrejeva
authors.affiliation: From the Department of Diagnostic Radiology, Yale University School of Medicine, PO Box 208042, New Haven, CT 06520-8216.
authors.forename: Alexander
authors.initials: A
authors.lastname: Goehler
authors.affiliation: From the Department of Diagnostic Radiology, Yale University School of Medicine, PO Box 208042, New Haven, CT 06520-8216.
authors.forename: Mark H
authors.initials: MH
authors.lastname: Michalski
authors.affiliation: From the Department of Diagnostic Radiology, Yale University School of Medicine, PO Box 208042, New Haven, CT 06520-8216.
authors.forename: Jaime L
authors.initials: JL
authors.lastname: Geisel
authors.affiliation: From the Department of Diagnostic Radiology, Yale University School of Medicine, PO Box 208042, New Haven, CT 06520-8216.
authors.forename: Regina J
authors.initials: RJ
authors.lastname: Hooley
authors.affiliation: From the Department of Diagnostic Radiology, Yale University School of Medicine, PO Box 208042, New Haven, CT 06520-8216.
authors.forename: Laura J
authors.initials: LJ
authors.lastname: Horvath
authors.affiliation: From the Department of Diagnostic Radiology, Yale University School of Medicine, PO Box 208042, New Haven, CT 06520-8216.
authors.forename: Reni
authors.initials: R
authors.lastname: Butler
authors.affiliation: From the Department of Diagnostic Radiology, Yale University School of Medicine, PO Box 208042, New Haven, CT 06520-8216.
authors.forename: Howard P
authors.initials: HP
authors.lastname: Forman
authors.affiliation: From the Department of Diagnostic Radiology, Yale University School of Medicine, PO Box 208042, New Haven, CT 06520-8216.
authors.forename: Liane E
authors.initials: LE
authors.lastname: Philpotts
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001943:Breast Neoplasms / Q000000981:diagnostic imaging*; D005260:Female; D006801:Humans; D008327:Mammography; D008875:Middle Aged; D011237:Predictive Value of Tests; D011856:Radiographic Image Enhancement / Q000379:methods*; D012189:Retrospective Studies; D012680:Sensitivity and Specificity