Blinded Randomized Control Trail of Artificial Intelligence-Assisted Ultrasound Screening for Neonatal Hip Dysplasia in a Clinical Cohort

1. Participating centers and doctors:

The data in the ultrasound screening sequence database in this part of the study were mainly from Renji Hospital and the Sixth People's Hospital in Shanghai between August 2014 and December 2021. Renji Hospital, the Sixth People's Hospital, and the Pediatric Hospital Affiliated to Fudan University, three top-three hospitals in Shanghai, started Graf ultrasound examination earlier, with an average history of more than 10 years. And they are responsible for providing expert sonographers with more than 5-10 years of DDH ultrasound diagnosis experience, and pediatric orthopedic experts with 5-10 years of DDH diagnosis experience to participate in the study. However, several other primary or remote medical institutions with late DDH ultrasound screening and insufficient diagnostic experience were mainly responsible for providing primary sonographers to participate in the study. Before the study, the sonographers involved in this study will be evaluated uniformly and quantitatively through examination papers. 2. Research process:

One week before the start of the study, the sonographers registered in the study received uniform training of the latest DDH ultrasound diagnosis in the form of PPT, video, literature study, and offline instruction.

For the included cases in the ultrasound screening sequence database, they would appear in different control groups in a random form, such as the AI model, the Expert sonographer group, the primary sonographer group, and the primary sonographer with AI 'aid group. All cases in the ultrasound screening sequence database were stratified and block-randomized into the above four groups (primary, experts, AI-independent, AI-assisted primary).

In the AI-assisted group, each sonographer was asked to choose whether to modify or confirm the diagnosis according to the measurement marks, diagnostic angles and typing results provided by the AI device. However, in the Expert sonographer group and junior sonographer unassisted group, the dedicated research assistant will turn off the AI display function to ensure that no additional information is provided to the sonographer. The consensus of two pediatric orthopedic expert with 5-10 years of experience in DDH ultrasound diagnosis was used as the gold standard. In case of disagreement, a third pediatric expert will evaluate the diagnosis results of DDH. The final consensus was used as the gold standard.