To analyze the major quality issues and their underlying causes in breast ultrasound reports in China, identify key factors affecting report quality, and investigate the association between various quality control indicators and the diagnostic accuracy of breast imaging reporting and data system (BI-RADS) classification, so as to provide evidence-based support for improving ultrasound report quality.

This multicenter cross-sectional study retrospectively collected breast ultrasound reports from patients who underwent breast ultrasound between January 1, 2024 and June 30, 2024. Pathological results served as the gold standard for diagnostic accuracy. A total of 16434 breast ultrasound reports from 1237 medical institutions across 13 provinces were included. Reports were systematically evaluated from four dimensions: report completeness, image acquisition adequacy, description-conclusion consistency, and image-text consistency. Chi-square tests and multivariate logistic regression were used to analyze the association between each quality control indicator and the diagnostic accuracy of BI-RADS classification. Pareto analysis was applied to identify the primary causes of problems.

Among the 16434 reports, the rate of report completeness was 64.0%, image acquisition adequacy was 75.3%, description-conclusion consistency was 91.0%, image-text consistency was 99.7%, and BI-RADS classification accuracy was 75.9%. Multivariate logistic regression showed that report completeness (OR=1.081, 95%CI: 1.002 – 1.165, P=0.044), image acquisition adequacy (OR=1.116, 95%CI: 1.027 – 1.212, P=0.010), and description-conclusion consistency (OR=1.212, 95%CI: 1.074 – 1.367, P=0.002) were independent influencing factors for the diagnostic accuracy of BI-RADS classification, whereas image-text consistency had no significant effect (P=0.452). Pareto analysis identified the main causes of report incompleteness as missing descriptions of posterior features (21.49%), orientation (21.03%), calcifications (19.56%), location (16.54%), and shape (9.44%). The primary causes of inadequate image acquisition were the lack of body markers (53.80%), absence of CDFI images (19.03%), and incomplete storage of suspicious malignant signs (9.21%). The main cause of description-conclusion inconsistency was contradictions or ambiguities in descriptions (84.03%).

The completeness of breast ultrasound reports, adequacy of image acquisition, and consistency between descriptions and conclusions directly influence the diagnostic accuracy of BI-RADS classification. To address the core defects, particularly missing descriptions of key sonographic features such as posterior features, orientation, and calcifications, as well as the lack of body markers, future efforts should focus on strengthening relevant quality control measures to improve the overall diagnostic efficacy of breast ultrasound in China.