欧盟 ECR 公布研究：医生使用安克侦CADe可有效增强诊断水平

近年来，随着高灵敏度影像学筛查的普及，甲状腺癌的发病率节节攀升。其中，尤以惰性和高分化的乳头型发病率增长最快，由于其良好的预后，在一定程度上带来了过度诊疗的局面。如何提高影像诊断的准确性，同时降低筛查成本，成为摆在医务工作者面前的重大挑战。

在欧盟 ECR 2018 DIVERSE & UNITED 主题大会上，来自台湾的Chiung-Nien Chen等教授团队发表的研究成果表明，应用FDA及CFDA批准的甲状腺结节计算机辅助检测系统（AmCAD-UT 安克侦），医生在诊断甲状腺癌时具有更好的诊断准确率。

该研究是一项回顾性的诊断性试验。从372例甲状腺结节472例患者中随机抽取130张甲状腺结节图像。每个超声特征存在的基本事实由三位专家组成的小组确定。通过AUROC和t检验p值评估特征存在的检测。为了评估对判读者表现的影响，将诊断决策与病理结果进行比较（74良性和56恶性）。招募了7名医生来阅读130张超声图像。然后通过多读者多案例（MRMC）研究设计和Dorfman-Berbaum-Metz方法评估读者表现。

结论：该项研究表明CADe系统在分析甲状腺结节的五项潜在恶性超声特征方面具有重要价值。医生使用CADe系统读取超声图像的诊断表现比没有使用时有着显著改善。

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此项研究所使用的甲状腺CADe系统：

Purpose

This study is to evaluate the performance of an FDA-cleared computer-aided detection (CADe) device for thyroid nodules and its effects on readers’ performance.

Methods and Materials

A total of 130 images of thyroid nodules were randomly selected from a case pool of 372 patients with 472 thyroid nodules. The ground truth for the presence of each sonographic feature was determined by a panel of three specialists. Detection of feature presence was evaluated by AUROC’s and t-test p-values. For assessment of the effects on readers’ performance, diagnostic decisions were compared to the pathology results (74 benign and 56 malignant). Seven physicians were recruited to read the 130 ultrasound images. The reader performance was then evaluated by the multiple reader multiple case (MRMC) study design and Dorfman-Berbaum-Metz method.

Results

The study first showed that the computed values of the anechoic area, echogenic foci, hypoechogenicity, heterogeneity, and ill-defined margin were all tested significant in detecting their presence with p-values <0.0001 for the first three features, 0.033 and 0.0014 for the last two and the AUC=0.882, 0.788, 0.817, 0.71 and 0.686, respectively. The MRMC study showed that the average AUC (=0.796) with CADe was significantly larger (p-value=0.0077) than the average AUC (=0.724) without CADe.

Conclusion

The tested CADe device was shown significant in detecting presence of the five sonographic characteristics. The diagnostic interpretations by physicians reading the ultrasound images with the CADe device were also shown significantly improved when compared to interpretations without the device.