Comparison of Four Ultrasonography-Based Risk Stratification Systems in Thyroid Nodules with Nondiagnostic/Unsatisfactory Cytology: A Real-World Study

SIMPLE SUMMARY: Although ultrasound-based risk stratification systems (RSSs) including Thyroid Imaging, Reporting and Data Systems (TIRADSs) may play an important role in triaging nodules with nondiagnostic/unsatisfactory cytology, no previous studies have compared ultrasound-based RSSs for these nodules. In this retrospective, longitudinal, real-world study in Korea including 1143 thyroid aspirations with nondiagnostic/unsatisfactory results from 1125 patients, further diagnostic evaluations, including repeat fine-needle aspiration, were conducted more commonly as the categories of ultrasound-based RSSs increased. The American Thyroid Association (ATA) guidelines, Korean (K)-TIRADS, and American College of Radiology (ACR) TIRADS were more competent in predicting malignancy from nondiagnostic/unsatisfactory nodules. The EU-TIRADS, although it was also helpful, demonstrated less effective diagnostic performance in predicting malignancy for nondiagnostic/unsatisfactory nodules in Korea, where iodine intake is more than adequate. These findings have implications for developing and verifying universal guidelines for the ultrasound-based stratification of thyroid nodules and applying these guidelines to nondiagnostic/unsatisfactory nodules. ABSTRACT: We compared American Thyroid Association (ATA) guidelines, Korean (K)-Thyroid Imaging, Reporting and Data Systems (TIRADS), EU-TIRADS, and American College of Radiology (ACR) TIRADS in diagnosing malignancy for thyroid nodules with nondiagnostic/unsatisfactory cytology. Among 1143 nondiagnostic/unsatisfactory aspirations from April 2011 to March 2016, malignancy was detected in 39 of 89 excised nodules. The minimum malignancy rate was 7.82% in EU-TIRADS 5 and 1.87–3.00% in EU-TIRADS 3–4. In the other systems, the minimum malignancy rate was 14.29–16.19% in category 5 and ≤3% in the remaining categories. Although the EU-TIRADS category ≥ 5 exhibited the highest positive likelihood ratio (LR) of only 2.214, category ≥ 5 in the other systems yielded the highest positive LR of >5. Receiver operating characteristic (ROC) curves of all systems to predict malignancy were located statistically above the diagonal nondiscrimination line (P for ROC curve: EU-TIRADS, 0.0022; all others, 0.0001). The areas under the ROC curve (AUCs) were not significantly different among the four systems. The ATA guidelines, K-TIRADS, and ACR TIRADS may be useful to guide management for nondiagnostic/unsatisfactory nodules. The EU-TIRADS, although also useful, exhibited inferior performance in predicting malignancy for nondiagnostic/unsatisfactory nodules in Korea, an iodine-sufficient area.