Zhong Jingyu, Mao Shiqi, Chen Haoda, Wang Yibin, Yin Qian, Cen Qingqing, Lu Junjie, Yang Jiarui, Hu Yangfan, Xing Yue, Liu Xianwei, Ge Xiang, Jiang Run, Song Yang, Lu Minda, Chu Jingshen, Zhang Huan, Zhang Guangcheng, Ding Defang, Yao Weiwu
Department of Imaging, Tongren Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200336, China.
Department of Medical Oncology, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, 200433, China.
Eur Radiol. 2025 May;35(5):2723-2735. doi: 10.1007/s00330-024-11160-1. Epub 2024 Nov 6.
To perform a systematic review and meta-analysis to estimate diagnostic performance, category-wise malignancy rates, and inter-observer reliability of Node Reporting and Data System 1.0 (Node-RADS).
Five electronic databases were systematically searched for primary studies on the use of Node-RADS to report the possibility of cancer involvement of lymph nodes on CT and MRI from January 1, 2021, until April 15, 2024. The study quality was assessed by modified Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) and Quality Appraisal of Diagnostic Reliability (QAREL) tools. The diagnostic accuracy was estimated with bivariate random-effects model, while the pooled category-wise malignancy rates were obtained with random-effects model.
Six Node-RADS-CT studies and three Node-RADS-MRI studies covering nine types of cancer were included. The study quality was mainly damaged by inappropriate index test and unknown timing according to QUADAS-2, and unclear blindness during the rating process according to QAREL. The area under hierarchical summary receiver operating characteristic curve (95% conventional interval) was 0.92 (0.89-0.94) for Node-RADS ≥ 3 as positive and 0.91 (0.88-0.93) for Node-RADS ≥ 4 as positive, respectively. The pooled malignancy rates (95% CIs) of Node-RADS 1 to 5 were 4% (0-10%), 31% (9-58%), 55% (34-75%), 89% (73-99%), and 100% (97-100%), respectively. The inter-observer reliability of five studies was interpreted as fair to substantial.
Node-RADS presented a promising diagnostic performance with an increasing probability of malignancy along higher category. However, the evidence for inter-observer reliability of Node-RADS is insufficient, and may hinder its implementation in clinical practice for lymph node assessment.
Question Node-RADS is designed for structured reporting of the possibility of cancer involvement of lymph nodes, but the evidence supporting its application has not been summarized. Findings Node-RADS presented diagnostic performance with AUC of 0.92, and malignancy rates for categories 1-5 ranged from 4% to 100%, while the inter-observer reliability was unclear. Clinical relevance Node-RADS is a useful tool for structured reporting of the possibility of cancer involvement of lymph nodes with high diagnostic performance and appropriate malignancy rate for each category, but unclear inter-observer reliability may hinder its implementation in clinical practice.
进行系统评价和荟萃分析，以评估淋巴结报告与数据系统1.0（Node-RADS）的诊断性能、各分类的恶性率以及观察者间的可靠性。
系统检索五个电子数据库，查找2021年1月1日至2024年4月15日期间使用Node-RADS报告CT和MRI上淋巴结癌累及可能性的原始研究。采用改良的诊断准确性研究质量评估（QUADAS-2）和诊断可靠性质量评估（QAREL）工具评估研究质量。采用双变量随机效应模型估计诊断准确性，采用随机效应模型获得各分类的合并恶性率。
纳入了六项Node-RADS-CT研究和三项Node-RADS-MRI研究，涵盖九种癌症类型。根据QUADAS-2，研究质量主要受不恰当的指标测试和时间不明的影响；根据QAREL，受评级过程中盲法不明确的影响。以Node-RADS≥3为阳性时，分层汇总受试者工作特征曲线下面积（95%传统区间）为0.92（0.89-0.94）；以Node-RADS≥4为阳性时，该面积为0.91（0.88-0.93）。Node-RADS 1至5的合并恶性率（95%CI）分别为4%（0-10%）、31%（9-58%）、55%（34-75%）、89%（73-99%）和100%（97-100%）。五项研究的观察者间可靠性被解释为中等至高度。
Node-RADS具有良好前景的诊断性能，随着分类升高恶性可能性增加。然而，支持Node-RADS观察者间可靠性的证据不足，可能会阻碍其在临床实践中用于淋巴结评估。
问题Node-RADS旨在对淋巴结癌累及可能性进行结构化报告，但支持其应用的证据尚未总结。发现Node-RADS的诊断性能AUC为0.92，1至5类的恶性率为4%至100%，而观察者间可靠性不明确。临床意义Node-RADS是一种用于淋巴结癌累及可能性结构化报告的有用工具，具有较高的诊断性能且各分类恶性率合适，但观察者间可靠性不明确可能会阻碍其在临床实践中的应用。
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