Diagnostic Performance of the Modified Korean Thyroid Imaging Reporting and Data System for Thyroid Malignancy: A Multicenter Validation Study.

Objective To evaluate the diagnostic performance of the modified Korean Thyroid Imaging Reporting and Data System (K-TIRADS), and compare it with the 2016 version of K-TIRADS using the Thyroid Imaging Network of Korea. Materials and methods Between June and September 2015, 5708 thyroid nodules (≥ 1.0 cm) from 5081 consecutive patients who had undergone thyroid ultrasonography at 26 institutions were retrospectively evaluated. We used a biopsy size threshold of 2 cm for K-TIRADS 3 and 1 cm for K-TIRADS 4 (modified K-TIRADS 1) or 1.5 cm for K-TIRADS 4 (modified K-TIRADS 3). The modified K-TIRADS 2 subcategorized the K-TIRADS 4 into 4A and 4B, and the cutoff sizes for the biopsies were defined as 1 cm for K-TIRADS 4B and 1.5 cm for K-TIRADS 4A. The diagnostic performance and the rate of unnecessary biopsies of the modified K-TIRADS for detecting malignancy were compared with those of the 2016 K-TIRAD, which were stratified by nodule size (with a threshold of 2 cm). Results A total of 1111 malignant nodules and 4597 benign nodules were included. The sensitivity, specificity, and unnecessary biopsy rate of the benign nodules were 94.9, 24.4, and 75.6 for the 2016 K-TIRADS; 91.0%, 39.7%, and 48.6% for the modified K-TIRADS 1; 84.9%, 45.9%, and 43.5% for the modified K-TIRADS 2; and 76.1%, 50.2%, and 40.1% for the modified K-TIRADS 3. For small nodules (1-2 cm), the diagnostic sensitivity of the modified K-TIRADS decreased by 5.2-25.6% and the rate of unnecessary biopsies reduced by 19.2-32.8% compared with those of the 2016 K-TIRADS (p 2 cm), the modified K-TIRADSs maintained a very high sensitivity for detecting malignancy (98%). Conclusion The modified K-TIRADSs significantly reduced the rate of unnecessary biopsies for small (1-2 cm) nodules while maintaining a very high sensitivity for malignancy for large (> 2 cm) nodules.