Abstract
OBJECTIVE: This study aimed to explore the diagnostic value of clinical features in the assessment of malignant thyroid Imaging Reporting and Data System (TIRADS) category 4 thyroid nodules and to provide a more effective reference for clinical diagnostic practices. METHODS: A total of 998 patients with 1,103 TIRADS 4 thyroid nodules underwent conventional ultrasound (US) and clinical information assessment at the Shanghai Health and Medical Center from January 1, 2012, to June 30, 2024. A qualitative assessment of clinical and US features was performed, followed by univariable and multivariable logistic regression analyses using a training cohort, which contributed to the construction of the clinical TIRADS model. A receiver-operating characteristic (ROC) curve, a Hosmer-Lemeshow (HL) test and a decision curve analysis (DCA) were employed to further validate this model in the validation cohort. RESULTS: Patient age, body mass index, sex, family history of thyroid carcinoma, and US features-such as vertical orientation, ill-defined or irregular margins or extrathyroidal extensions, microcalcifications, blood flow signals of central or peripheral vessels, and swollen cervical lymph nodes-were identified as independent risk factors in the clinical scoring model for TI-RADS 4 nodules. This diagnostic model achieved an area under the curve (AUC) of 0.943 [0.928, 0.959], with a sensitivity of 82.33%, specificity of 94.44%, diagnostic threshold of 5 points, accuracy of 87.42%, positive predictive value of 95.34%, and negative predictive value of 79.48% in the validation cohort. The HL tests and DCA also demonstrated excellent predictive performances. CONCLUSIONS: The integration of clinical and US features in the construction of the diagnostic model can significantly enhance the diagnosis of TIRADS 4 thyroid nodules and provide a reliable evaluation tool for clinical practice.