To determine the effect of computer-aided-detection (CAD) software for automated breast ultrasound (ABUS) on reading time (RT) and performance in screening for breast cancer. Unilateral ABUS examinations of 120 women with dense breasts were randomly selected from a multi-institutional archive of cases including 30 malignant (20/30 mammography-occult), 30 benign, and 60 normal cases with histopathological verification or ≥ 2 years of negative follow-up. Eight radiologists read once with (CAD-ABUS) and once without CAD (ABUS) with > 8 weeks between reading sessions. Readers provided a BI-RADS score and a level of suspiciousness (0-100). RT, sensitivity, specificity, PPV and area under the curve (AUC) were compared. Average RT was significantly shorter using CAD-ABUS (133.4 s/case, 95% CI 129.2-137.6) compared with ABUS (158.3 s/case, 95% CI 153.0-163.3) (p < 0.001). Sensitivity was 0.84 for CAD-ABUS (95% CI 0.79-0.89) and ABUS (95% CI 0.78-0.88) (p = 0.90). Three out of eight readers showed significantly higher specificity using CAD. Pooled specificity (0.71, 95% CI 0.68-0.75 vs. 0.67, 95% CI 0.64-0.70, p = 0.08) and PPV (0.50, 95% CI 0.45-0.55 vs. 0.44, 95% CI 0.39-0.49, p = 0.07) were higher in CAD-ABUS vs. ABUS, respectively, albeit not significantly. Pooled AUC for CAD-ABUS was comparable with ABUS (0.82 vs. 0.83, p = 0.53, respectively). CAD software for ABUS may decrease the time needed to screen for breast cancer without compromising the screening performance of radiologists. • ABUS with CAD software may speed up reading time without compromising radiologists' accuracy. • CAD software for ABUS might prevent non-detection of malignant breast lesions by radiologists. • Radiologists reading ABUS with CAD software might improve their specificity without losing sensitivity.
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