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使用改良的 TI-RADS 联合超声造影特征对甲状腺良恶性结节进行分类诊断的前瞻性多中心研究。

The use of modified TI-RADS using contrast-enhanced ultrasound features for classification purposes in the differential diagnosis of benign and malignant thyroid nodules: A prospective and multi-center study.

机构信息

Department of Ultrasound, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China.

Department of Ultrasound, Yiyang Central Hospital of Hunan University of Chinese Medicine, Yiyang, Hunan, China.

出版信息

Front Endocrinol (Lausanne). 2023 Feb 1;14:1080908. doi: 10.3389/fendo.2023.1080908. eCollection 2023.

DOI:10.3389/fendo.2023.1080908
PMID:36817602
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9929352/
Abstract

OBJECTIVES

To evaluate the diagnostic efficacy of a modified thyroid imaging reporting and data system (TI-RADS) in combination with contrast-enhanced ultrasound (CEUS) for differentiating between benign and malignant thyroid nodules and to assess inter-observer concordance between different observers.

METHODS

This study included 3353 patients who underwent thyroid ultrasound (US) and CEUS in ten multi-centers between September 2018 and March 2020. Based on a modified TI-RADS classification using the CEUS enhancement pattern of thyroid lesions, ten radiologists analyzed all US and CEUS examinations independently and assigned a TI-RADS category to each thyroid nodule. Pathology was the reference standard for determining the diagnostic performance (accuracy (ACC), sensitivity (SEN), specificity (SPN), positive predictive value (PPV), and negative predictive value (NPV)) of the modified TI-RADS for predicting malignant thyroid nodules. The risk of malignancy was stratified for each TI-RADS category-based on the total number of benign and malignant lesions in that category. ROC curve was used to determine the cut-off value and the area under the curve (AUC). Cohen's Kappa statistic was applied to assess the inter-observer agreement of each sonological feature and TI-RADS category for thyroid nodules.

RESULTS

The calculated malignancy risk in the modified TI-RADS categories 5, 4b, 4a, 3 and 2 nodules was 95.4%, 86.0%, 12.0%, 4.1% and 0%, respectively. The malignancy risk for the five categories was in agreement with the suggested malignancy risk. The ROC curve showed that the AUC under the ROC curve was 0.936, and the cutoff value of the modified TI-RADS classification was >TI-RADS 4a, whose SEN, ACC, PPV, NPV and SPN were 93.6%, 91.9%, 90.4%, 93.7% and 88.5% respectively. The Kappa value for taller than wide, microcalcification, marked hypoechoic, solid composition, irregular margins and enhancement pattern of CEUS was 0.94, 0.93, 0.75, 0.89, 0.86 and 0.81, respectively. There was also good agreement between the observers with regards to the modified TI-RADS classification, the Kappa value was 0.80.

CONCLUSIONS

The actual risk of malignancy according to the modified TI-RADS concurred with the suggested risk of malignancy. Inter-observer agreement for the modified TI-RADS category was good, thus suggesting that this classification was very suitable for clinical application.

摘要

目的

评估改良甲状腺影像报告和数据系统(TI-RADS)联合超声造影(CEUS)在鉴别甲状腺良恶性结节中的诊断效能,并评估不同观察者之间的一致性。

方法

本研究纳入了 2018 年 9 月至 2020 年 3 月在十个多中心进行甲状腺超声(US)和 CEUS 的 3353 例患者。根据 CEUS 增强模式对甲状腺病变的改良 TI-RADS 分类,十位放射科医生分别独立分析了所有 US 和 CEUS 检查,并为每个甲状腺结节分配了 TI-RADS 类别。病理学是确定改良 TI-RADS 预测恶性甲状腺结节的诊断性能(准确性(ACC)、灵敏度(SEN)、特异性(SPN)、阳性预测值(PPV)和阴性预测值(NPV))的参考标准。基于该类别中良性和恶性病变的总数,对每个 TI-RADS 类别进行了恶性风险分层。ROC 曲线用于确定截断值和曲线下面积(AUC)。采用 Cohen's Kappa 统计评估甲状腺结节的每个超声特征和 TI-RADS 类别的观察者间一致性。

结果

改良 TI-RADS 类别 5、4b、4a、3 和 2 结节的恶性风险分别为 95.4%、86.0%、12.0%、4.1%和 0%。五个类别的恶性风险与建议的恶性风险一致。ROC 曲线显示,ROC 曲线下的 AUC 为 0.936,改良 TI-RADS 分类的截断值为>TI-RADS 4a,其 SEN、ACC、PPV、NPV 和 SPN 分别为 93.6%、91.9%、90.4%、93.7%和 88.5%。 taller than wide、微钙化、明显低回声、实性成分、不规则边界和 CEUS 增强模式的 Kappa 值分别为 0.94、0.93、0.75、0.89、0.86 和 0.81。改良 TI-RADS 分类的观察者之间也有很好的一致性,Kappa 值为 0.80。

结论

根据改良 TI-RADS 得出的实际恶性风险与建议的恶性风险一致。改良 TI-RADS 类别的观察者间一致性良好,表明该分类非常适合临床应用。

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