A prospective multicenter clinical research study validating the effectiveness and safety of a chest X-ray-based pulmonary tuberculosis screening software JF CXR-1 built on a convolutional neural network algorithm

BackgroundChest radiography (chest X-ray or CXR) plays an important role in the early detection of active pulmonary tuberculosis (TB). In areas with a high TB burden that require urgent screening, there is often a shortage of radiologists available to interpret the X-ray results. Computer-aided detection (CAD) software employed with artificial intelligence (AI) systems may have the potential to solve this problem.ObjectiveWe validated the effectiveness and safety of pulmonary tuberculosis imaging screening software that is based on a convolutional neural network algorithm.MethodsWe conducted prospective multicenter clinical research to validate the performance of pulmonary tuberculosis imaging screening software (JF CXR-1). Volunteers under the age of 15 years, both with or without suspicion of pulmonary tuberculosis, were recruited for CXR photography. The software reported a probability score of TB for each participant. The results were compared with those reported by radiologists. We measured sensitivity, specificity, consistency rate, and the area under the receiver operating characteristic curves (AUC) for the diagnosis of tuberculosis. Besides, adverse events (AE) and severe adverse events (SAE) were also evaluated.ResultsThe clinical research was conducted in six general infectious disease hospitals across China. A total of 1,165 participants were enrolled, and 1,161 were enrolled in the full analysis set (FAS). Men accounted for 60.0% (697/1,161). Compared to the results from radiologists on the board, the software showed a sensitivity of 94.2% (95% CI: 92.0–95.8%) and a specificity of 91.2% (95% CI: 88.5–93.2%). The consistency rate was 92.7% (91.1–94.1%), with a Kappa value of 0.854 (P = 0.000). The AUC was 0.98. In the safety set (SS), which consisted of 1,161 participants, 0.3% (3/1,161) had AEs that were not related to the software, and no severe AEs were observed.ConclusionThe software for tuberculosis screening based on a convolutional neural network algorithm is effective and safe. It is a potential candidate for solving tuberculosis screening problems in areas lacking radiologists with a high TB burden

Neural network-based model for evaluating inert nodules and volume doubling time in T1 lung adenocarcinoma: a nested case−control study

ObjectiveThe purpose of this study is to establish model for assessing inert nodules predicting nodule volume-doubling.MethodsA total of 201 patients with T1 lung adenocarcinoma were analysed retrospectively pulmonary nodule information was predicted by an AI pulmonary nodule auxiliary diagnosis system. The nodules were classified into two groups: inert nodules (volume-doubling time (VDT)>600 days n=152) noninert nodules (VDT<600 days n=49). Then taking the clinical imaging features obtained at the first examination as predictive variables the inert nodule judgement model <sn</sn>>(INM) volume-doubling time estimation model (VDTM) were constructed based on a deep learning-based neural network. The performance of the INM was evaluated by the area under the curve (AUC) obtained from receiver operating characteristic (ROC) analysis the performance of the VDTM was evaluated by R2(determination coefficient).ResultsThe accuracy of the INM in the training and testing cohorts was 81.13% and 77.50%, respectively. The AUC of the INM in the training and testing cohorts was 0.7707 (95% CI 0.6779-0.8636) and 0.7700 (95% CI 0.5988-0.9412), respectively. The INM was effective in identifying inert pulmonary nodules; additionally, the R2 of the VDTM in the training cohort was 0.8008, and that in the testing cohort was 0.6268. The VDTM showed moderate performance in estimating the VDT, which can provide some reference during a patients’ first examination and consultationConclusionThe INM and the VDTM based on deep learning can help radiologists and clinicians distinguish among inert nodules and predict the nodule volume-doubling time to accurately treat patients with pulmonary nodules