PURPOSE: The purpose of this study was to validate the role of the total malignancy score (TMS) in identifying thyroid nodules suspicious for malignancy through the sum of their ultrasound features. METHODS: The local ethical committee approved this prospective observational study. We examined 231 nodules in 231 consecutive patients (164 females and 67 males; age range, 20 to 87 years; median age, 59 years; interquartile range, 48 to 70 years) who underwent ultrasound followed by fine-needle aspiration cytology (FNAC). The nodules were further classified using the TMS, which considers ultrasound features (number, echogenicity, structure, halo, margins, Doppler signal, calcifications, and growth), and the Bethesda System for Reporting Thyroid Cytopathology (TBSRTC), which considers cytological features. Patients with non-negative nodules (TBSRTC categories III to VI) underwent histological analysis, repeated FNAC, or 2 years of regular ultrasound follow-up. The associations between the final diagnosis, each of the ultrasound features, and the TMS were estimated using the chi-square test, the Mann-Whitney U test, and multivariate logistic regression. A receiver operating characteristic (ROC) curve was used to evaluate the diagnostic accuracy of the TMS. RESULTS: On ultrasound, 47% of the nodules (108 of 231) had a TMS < 3, 18% (42 of 231) had a TMS of 3, and 35% (81 of 231) had a TMS >3. The FNAC results of 85% of the nodules (196 of 231) were benign, while 15% (35 of 231) had non-negative results. Hypoechogenicity, solid structure, the presence of microcalcifications, and the number of nodules were independent predictors of the final diagnosis, and the diagnostic accuracy of the TMS was good (area under the ROC curve, 0.82). CONCLUSION: The TMS system is simple to use, reliable, easily reproducible, and closely reflects malignancy risk. Based on our results, FNAC could be limited to nodules with a TMS ≥3 without missing any cases of carcinoma.
Biopsy, Fine-Needle ; Cytodiagnosis ; Diagnosis ; Diagnostic Imaging ; Female ; Follow-Up Studies ; Humans ; Logistic Models ; Male ; Observational Study ; Prospective Studies ; ROC Curve ; Thyroid Gland* ; Thyroid Neoplasms ; Thyroid Nodule* ; Ultrasonography