Validation of the accuracy of the childhood asthma model for clinical decision support: a study protocol

BACKGROUND: In China, the average prevalence of asthma in children aged 0–14 years increased by approximately 50% every 10 years. Hence, a specific decision support system that fits China’s situation is needed for childhood asthma. This prospective, multicenter, observational study aims to assess the accuracy of the Childhood Asthma Model for Clinical Decision Support (CAMCDS) in clinical practice in four hospitals in Shanghai in China. METHODS: The study will be conducted in two phases. Phase I of the study aims to evaluate the accuracy of the CAMCDS for diagnosis, while phase II of the study aims to examine the treatment predicting accuracy of the CAMCDS model. In total, 817 children diagnosed with stable asthma and 545 suspected asthma will be enrolled. The accuracy of the CAMCDS model will be calculated using the receiver operating characteristic (ROC) curve compared with the results of pediatrician’s diagnosis. Besides, the treatment patterns from CAMCDS and real-world environment for Chinese children with stable asthma will be assessed, and the factors that affect the CAMCDS implementation in routine clinical practice will be explored. CONCLUSIONS: This will be the first study to examine the diagnostic accuracy and treatment predicting accuracy of a clinical decision support system in children with asthma in China. We hope that the CAMCDS will be help pediatricians in basic-level hospitals to improve the diagnosis and treatment strategy of asthma. TRIAL REGISTRATION: Chinese Clinical Trial Registry Identifier: ChiCTR2100045283.