Transparent Reporting of the Early-stage Clinical Evaluation of Clinical Decision Support Systems Based on Artificial Intelligence

With the wide application of artificial intelligence (AI) in the medical field, more and more AI-based clinical decision support systems have been applied in the clinical diagnosis, screening, and other fields. Early-stage clinical evaluation is important for evaluating the clinical performance, safety, and human factors of AI-based clinical decision support systems, and laying the foundation for large-scale trials. However, the transparency and integrity of the clinical reports need to be improved. The Developmental and Exploratory Clinical Investigations of DEcision Support Systems Driven by Artificial Intelligence (DECIDE-AI) was officially published online in May 2022. Based on this guideline and relative literature, this paper explores the transparent reporting of early-stage clinical evaluation of AI-based clinical decision support systems, in order to help developers and researchers better understand and apply the relevant guidelines, and improve the reporting transparency of early-stage clinical evaluation of AI-based clinical decision support systems.