Development and Deployment of a Novel Diagnostic Tool Based on Conventional Ultrasound for Fibrosis Assessment in Chronic Kidney Disease

Accurate identification of risk information about fibrosis severity is crucial for clinical decision-making and clinical management of patients with chronic kidney disease (CKD). This study aimed to develop an ultrasound (US)-derived computer-aided diagnosis tool for identifying CKD patients at high risk of developing moderate-severe renal fibrosis, in order to optimize treatment regimens and follow-up strategies.A total of 162 CKD patients undergoing renal biopsies and US examinations were prospectively enrolled and randomly divided into training (n = 114) and validation (n = 48) cohorts. A multivariate logistic regression approach was employed to develop the diagnostic tool named S-CKD for differentiating moderate-severe renal fibrosis from mild one in the training cohort by integrating the significant variables, which were screened out from demographic characteristics and conventional US features via the least absolute shrinkage and selection operator regression algorithm. The S-CKD was then deployed as both an online web-based and an offline document-based, easy-to-use auxiliary device. In both the training and validation cohorts, the S-CKD's diagnostic performance was evaluated through discrimination and calibration. The clinical benefit of using S-CKD was revealed by decision curve analysis (DCA) and clinical impact curves.The proposed S-CKD achieved an area under the receiver operating characteristic curve of 0.84 (95% confidence interval (CI): 0.77-0.91) and 0.81 (95% CI: 0.68-0.94) in the training and validation cohorts, respectively, indicating satisfactory diagnosis performance. Results of the calibration curves showed that S-CKD has excellent predictive accuracy (Hosmer-Lemeshow test: training cohort, p = 0.497; validation cohort, p = 0.205). The DCA and clinical impact curves exhibited a high clinical application value of the S-CKD at a wide range of risk probabilities.The S-CKD tool developed in this study is capable of discriminating between mild and moderate-severe renal fibrosis in patients with CKD and achieving promising clinical benefits, which may aid clinicians in personalizing medical decision-making and follow-up arrangement.