Abstract
Purpose: To assess whether radiologist needs to rescan the breast lesion to validate the final American College of Radiology (ACR) Breast Imaging Reporting and Data System (BI-RADS) ultrasonography (US) assessment made on the static images in the diagnostic setting. Patients and methods: Image data on 1,070 patients with 1,070 category 3-5 breast lesions with a pathological diagnosis scanned between January and June 2016 were included. Both real-time and static image assessments were acquired for each lesion. The diagnostic performance was evaluated by receiver operating characteristic (ROC) curves. The positive predictive values (PPVs) of each category in the two groups were calculated according to the ACR BI-RADS manual and compared. Kappas were determined for agreement on two assessment approaches. Results: The sensitivity, specificity, PPV, and negative predictive value for real-time US were 98.9%, 58.2%, 44.8% and 99.4%, and for static images were 98.9%, 57.1%, 44.1% and 99.3%, respectively. The performance of the two groups was not significantly different (areas under ROCs: 0.786 vs 0.780, P=0.566) if the final assessment was only dichotomized as negative (category 3) and positive (categories 4 and 5). All PPVs of each category for each assessment were within the reference range provided by the ACR in 2013 except subcategory 4B (reference range: >10% and ≤50%) of static image evaluation, which was also significantly higher than that of real-time assessment (54.8% vs 40.7%, P=0.037). The overall agreement of the two approaches was moderate (κ=0.43-0.56 according to different detailed assessment). Conclusion: Both static image and real-time assessment had similar diagnostic performance if only the treatment recommendations were considered, that is, follow-up or biopsy. However, as for subcategory 4B lesions without obviously benign or malignant US features, real-time scanning by the interpreter is recommended to obtain a more accurate BI-RADS assessment after assessing static images.