The Study Aims to Improve the Accuracy of Detecting Spina Bifida During Early Ultrasound Scans. to Achieve This, an AI Model Has Been Developed to Provide Feedback About the Presence of Spina Bifida. a RCT Has Been Designed to Compare the Effectiveness of AI Feedback with No AI Feedback.

Copenhagen Academy for Medical Education and Simulation

Status: Completed

Conditions: Spina Bifida

Treatments: Other: Evaluation of XAI-assisted spina bifida diagnosis

Study type: Interventional

Funder types: Other

Identifiers

NCT06566014

P-2019-310

Details and patient eligibility

About

The study aims to improve the accuracy of detecting spina bifida during early ultrasound scans. To achieve this, an AI model has been developed to provide feedback about the presence of spina bifida. A RCT has been designed to compare the effectiveness of AI feedback with no AI feedback.

Full description

The study aims to improve the accuracy of detecting spina bifida during early ultrasound scans. To achieve this, an AI model has been developed to provide feedback about the presence of spina bifida. A randomized controlled trial (RCT) has been designed to compare the effectiveness of AI feedback with no AI feedback. Forty fetal medicine specialists are randomly assigned to receive either the AI feedback or no feedback, and the two groups are compared to determine if the feedback improved the accuracy of detecting spina bifida.

Enrollment: 38 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Obstetricians

Exclusion criteria

• Fetal medicine specialists

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

38 participants in 2 patient groups, including a placebo group

AI feedback

Experimental group

Description:

The participant will receive AI feedback upon completing the task of analyzing 20 images. The AI feedback will include a prediction (Normal/Spina Bifida) along with a confidence score ranging from 0.0 to 1.0, where 0.0 indicates the lowest confidence and 1.0 indicates the highest confidence.

Treatment:

Other: Evaluation of XAI-assisted spina bifida diagnosis

No AI feedback

Placebo Comparator group

Description:

The participants will complete the task of analyzing 20 images without any AI feedback.

Treatment:

Other: Evaluation of XAI-assisted spina bifida diagnosis