Zhi Shaogang, Cai Xiaoxia, Zhou Wei, Qian Peipei
Department of Ultrasound, The People's Hospital of Pingyang County, Wenzhou, Zhejiang, China.
Br J Hosp Med (Lond). 2025 Jun 25;86(6):1-19. doi: 10.12968/hmed.2025.0078. Epub 2025 Jun 15.
Breast nodules are highly prevalent among women, and ultrasound is a widely used screening tool. However, single ultrasound examinations often result in high false-positive rates, leading to unnecessary biopsies. Artificial intelligence (AI) has demonstrated the potential to improve diagnostic accuracy, reducing misdiagnosis and minimising inter-observer variability. This study developed a deep learning-based AI model to evaluate its clinical utility in assisting sonographers with the Breast Imaging Reporting and Data System (BI-RADS) classification of breast nodules. A retrospective analysis was conducted on 558 patients with breast nodules classified as BI-RADS categories 3 to 5, confirmed through pathological examination at The People's Hospital of Pingyang County between December 2019 and December 2023. The image dataset was divided into a training set, validation set, and test set, and a convolutional neural network (CNN) was used to construct a deep learning-based AI model. Patients underwent ultrasound examination and AI-assisted diagnosis. The receiver operating characteristic (ROC) curve was used to analyse the performance of the AI model, physician adjudication results, and the diagnostic efficacy of physicians before and after AI model assistance. Cohen's weighted Kappa coefficient was used to assess the consistency of BI-RADS classification among five ultrasound physicians before and after AI model assistance. Additionally, statistical analyses were performed to evaluate changes in BI-RADS classification results before and after AI model assistance for each physician. According to pathological examination, 765 of the 1026 breast nodules were benign, while 261 were malignant. The sensitivity, specificity, and accuracy of routine ultrasonography in diagnosing benign and malignant nodules were 80.85%, 91.59%, and 88.31%, respectively. In comparison, the AI system achieved a sensitivity of 89.36%, specificity of 92.52%, and accuracy of 91.56%. Furthermore, AI model assistance significantly improved the consistency of physicians' BI-RADS classification ( < 0.001). A deep learning-based AI model constructed using ultrasound images can enhance the differentiation between benign and malignant breast nodules and improve classification accuracy, thereby reducing the incidence of missed and misdiagnoses.
乳腺结节在女性中极为常见,超声是一种广泛应用的筛查工具。然而,单次超声检查常常导致较高的假阳性率,进而引发不必要的活检。人工智能(AI)已显示出提高诊断准确性、减少误诊并最小化观察者间差异的潜力。本研究开发了一种基于深度学习的AI模型,以评估其在协助超声医师进行乳腺结节的乳腺影像报告和数据系统(BI-RADS)分类中的临床效用。对2019年12月至2023年12月期间在平阳县人民医院经病理检查确诊为BI-RADS 3至5类的558例乳腺结节患者进行了回顾性分析。将图像数据集分为训练集、验证集和测试集,并使用卷积神经网络(CNN)构建基于深度学习的AI模型。患者接受了超声检查和AI辅助诊断。采用受试者操作特征(ROC)曲线分析AI模型的性能、医师判定结果以及AI模型辅助前后医师的诊断效能。使用Cohen加权Kappa系数评估AI模型辅助前后五名超声医师之间BI-RADS分类的一致性。此外,进行统计分析以评估每位医师在AI模型辅助前后BI-RADS分类结果的变化。根据病理检查,1026个乳腺结节中765个为良性,261个为恶性。常规超声诊断良性和恶性结节的敏感性、特异性和准确性分别为80.85%、91.59%和88.31%。相比之下,AI系统的敏感性为89.36%,特异性为92.52%,准确性为91.56%。此外,AI模型辅助显著提高了医师BI-RADS分类的一致性(<0.001)。使用超声图像构建的基于深度学习的AI模型可以增强乳腺良恶性结节的鉴别能力,提高分类准确性,从而降低漏诊和误诊的发生率。