A Novel Clinical Model for Predicting Malignancy of Solitary Pulmonary Nodules: A Multicenter Study in Chinese Population

Background: This study aimed to establish and validate a novel clinical model to differentiate between benign and malignant solitary pulmonary nodules (SPNs). Methods: Records from 406 patients with SPNs in Sun Yat-sen University Cancer Center were retrospectively reviewed. The data was randomly divided into training cohort and internal validation cohort. Other 190 SPNs patients in Henan Tumor Hospital were used for external validation. The novel prediction model was established using LASSO logistic regression analysis by integrating clinical features, radiologic characteristics and laboratory test data, the calibration of model was analyzed using the Hosmer-Lemeshow test (HL test). Subsequently, the model was compared with PKUPH and Mayo models using receiver-operating characteristics curve (ROC), decision curve analysis (DCA), net reclassification improvement index (NRI), and integrated discrimination improvement index (IDI) with the same data. Findings: A total of 15 variables were screened out and then aggregated to generate new prediction model. The model showed good calibration with the HL test (P = 0.221). The AUC for our model was 0.799, which was higher than other two reported models. DCA also showed our model was superior to the other two reported models. In our model, sensitivity = 70.06%, specificity = 77.08%. Compared with the PKUPH and Mayo models, the NRI of our model increased by 0.301 and 0.469 respectively, and the IDI improved 0.011 and 0.123, respectively. Furthermore, the model was significant positive correlation with PKUPH and Mayo models. Interpretation: The novel model in our study had a high clinical value in diagnose of MSPNs. Funding Statement: This work was supported by National Natural Science Foundation of China (No.81871711) and National Key Research and Development Program (2018YFC0910202). Declaration of Interests: The authors declare no potential conflicts of interest. Ethics Approval Statement: This study was approved by the Hospital Ethics Committee in Sun Yat-sen University Cancer Center and Henan Tumor Hospital. This study was conducted according to the Declaration of Helsinki.