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, Shanghai Jiao Tong University School of Medicine and the Sixth People's Hospital, Shanghai Jiao Tong University School of Medicine. Renji Hospital, the Sixth People's Hospita, 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. Each unit can perform Graf ultrasound examination maturely, and has good quality control and management. The technology is relatively mature, and they are responsible for providing 6 expert sonographers with more than 5-10 years of DDH ultrasound diagnosis experience, more than 600 DDH ultrasound operations, and 1 pediatric orthopedic expert 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 8 primary sonographers (trained residents who performed 20 DDH ultrasound operations) to participate in the study. The other 4 primary sonographers who participated in the study were provided by the Sixth People's Hospital and the Pediatric Hospital Affiliated to Fudan University, so a total of 12 primary sonographers participated in the study. Before the study, the sonographers involved in this study will be evaluated uniformly and quantitatively through online examination papers. 2. Research process:

One week before the start of the randomized diagnostic trial study, which prospectively reevaluated the retrospective data set of the ultrasound screening sequence database, the sonographers registered in the study received uniform training in 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 (composed of 6 ultrasound experts), the primary sonographer group (composed of 6 primary sonographers), and the primary sonographer (composed of 6 primary sonographers) + AI-assisted group. All the image data in the ultrasound screening sequence database were independently divided into measurement points and measurement lines by each group, and the final diagnosis of α Angle, β Angle and classification results were given by the system.

The random occurrence of cases in the ultrasound screening sequence database has certain rules: (1) According to the date of ultrasound examination, the 2152 ultrasound screenings were divided into 848 days. (2) Block randomization was applied to the 848-day study, using a computer-generated sequence of random numbers, with randomization performed in blocks of four or eight. That is, the cases examined for the first time in each day were divided into one group (AI group, advanced ultrasound expert group, primary sonographer group, AI-assisted primary sonographer group), and the cases for follow-up examination were divided according to the first examination group. Randomization was repeated within each group according to block randomization of 6 or 12 block sizes.