Human-AI Collaborative Intelligence for Improving Fetal Flow Management

NCT ID: NCT06371859

Last Updated: 2024-05-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-29
• Study Completion Date: 2025-12-01

Brief Summary

This randomized controlled study evaluates the effectiveness of explainable AI (XAI) in improving clinicians' interpretation of Doppler ultrasound images (UA and MCA) in obstetrics. It involves 92 clinicians, randomized into intervention and control groups. The intervention group receives XAI feedback, aiming to enhance accuracy in ultrasound interpretation and medical decision-making.

Objectives:

1. To develop an interpretable model for commonly used Doppler flows, specifically the Pulsatility Index (PI) of the umbilical artery (UA) and middle cerebral artery (MCA), with the aim to provide quality feedback on Doppler spectrum images and suggest potential gate placements.

2. To test the effects of providing Explainable AI (XAI)-feedback for clinicians compared with no feedback on their accuracy in ultrasound interpretation and management.

Detailed Description

Currently, Doppler ultrasound velocimetry serves as a crucial tool in obstetric practice, particularly for assessing the umbilical artery (UA) and middle cerebral artery (MCA) in uteroplacental-fetal circulation. While Doppler ultrasound is valuable for detecting conditions like fetal anemia and placental insufficiency, its accuracy relies on operator expertise. Artificial intelligence (AI) offers potential enhancements, especially in high-risk pregnancies. However, existing AI applications in fetal ultrasound often lack transparency, leading to user distrust. This study aims to address these limitations by developing an explainable AI model to assist clinicians in interpreting Doppler ultrasound images of UA and MCA for improved management of high-risk pregnancies.

The study's objectives are:

1. To develop an interpretable model for commonly used Doppler flows, specifically the Pulsatility Index (PI) of the umbilical artery (UA) and middle cerebral artery (MCA), with the aim to provide quality feedback on Doppler spectrum images and suggest potential gate placements.

2. To test the effects of providing Explainable AI (XAI)-feedback for clinicians compared with no feedback on their accuracy in ultrasound interpretation and management.

All participants will be instructed to provide gate placement for flow images of the umbilical artery and the MCA, and to evaluate the quality of the resulting flow curves. Each participant will be required to evaluate a total of 40 unique images (10 flow images for UA and MCA, 10 spectral doppler images for UA and MCA, respectively). From the four groups (UA-flow, UA-spectrum, MCA-flow & MCA-spectrum) the investigators will provide matched sets of 40 images that are provided to participants, who are matched for their level of experience within each hospital (PGY 1-2; PGY 3-5; board certified Obstetricians). For flow images, the participants will be instructed to identify the most appropriate gate placement. For the spectral flow curves, participants will be asked to evaluate whether the flow curves were of sufficient quality to inform medical management decisions.

The inclusions criteria for MCA and UA images will be images taken from the third trimester (>= week 28).

Study Design: Randomized controlled trial

Data Source: 1840 unique ultrasound scans including umbilical artery (UA) and middle cerebral artery (MCA) measurements. The 1840 unique images includes: 460 images of UA-flow images, 460 UA-spectrum images, 460 MCA-flow images and 460 MCA-spectrum images.

Participants: 92 clinicians with varying competence levels across four different university hospitals.

Intervention: XAI feedback on MCA/UA Doppler spectral curves and gate placement suggestions.

Control Group: No XAI feedback.

Procedure: Clinicians will be divided into two groups of 46 each, matched for experience levels across hospitals. The control group will place a gate on MCA/UA images and evaluate the Doppler spectrum without AI feedback, while the intervention group will perform the same tasks with access to AI feedback.

Outcome Measures: The participants' responses in the two groups are reviewed by two fetal medicine sonographers who evaluate the participants' answers independently of each other. In a disagreement, the two sonographers reach a consensus after discussion.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

"XAI feedback on MCA/UA Doppler spectral curves and gate placement suggestions"

The XAI feedback group will place a gate on MCA/UA images and evaluate the Doppler spectrum with AI feedback.

N=46 clinicians (Clinicians will be divided into two groups (XAI feedback & No XAI feedback groups) of 46 each, matched for experience levels across hospitals)

Group Type: EXPERIMENTAL

"XAI feedback on MCA/UA Doppler spectral curves and gate placement suggestions"

Intervention Type: BEHAVIORAL

This study includes 1840 ultrasound images, split into UA and MCA flow and spectrum images, each duplicated for a total of 3680 images to compare explainable AI (XAI) feedback vs. no feedback. The investigators will provide matched sets of 40 images (one for the XAI group and one for the non-XAI group) to participants. Participants are matched based on their level of experience within each hospital (Resident physicians, obstetricians, and gynecologists with obstetric ultrasound experience).

All participants are instructed to place gates on the flow images of the umbilical artery and the middle cerebral artery and to assess the quality of the resulting flow curves. Specifically, for flow images, participants must identify the most appropriate gate placement. For spectral flow curves, they are to decide if the curves are of sufficient quality to guide medical management decisions.

"No XAI feedback"

The control group will place a gate on MCA/UA images and evaluate the Doppler spectrum without AI feedback.

N=46 clinicians (Clinicians will be divided into two groups (XAI feedback & No XAI feedback groups) of 46 each, matched for experience levels across hospitals)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

"XAI feedback on MCA/UA Doppler spectral curves and gate placement suggestions"

This study includes 1840 ultrasound images, split into UA and MCA flow and spectrum images, each duplicated for a total of 3680 images to compare explainable AI (XAI) feedback vs. no feedback. The investigators will provide matched sets of 40 images (one for the XAI group and one for the non-XAI group) to participants. Participants are matched based on their level of experience within each hospital (Resident physicians, obstetricians, and gynecologists with obstetric ultrasound experience).

All participants are instructed to place gates on the flow images of the umbilical artery and the middle cerebral artery and to assess the quality of the resulting flow curves. Specifically, for flow images, participants must identify the most appropriate gate placement. For spectral flow curves, they are to decide if the curves are of sufficient quality to guide medical management decisions.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• The inclusion criterion is the use of ultrasound at least once per week

Exclusion Criteria

• The exclusion criterion is the absence of experience in ultrasound scanning.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Slagelse Hospital

OTHER

Sponsor Role: collaborator

Technical University of Denmark

OTHER

Sponsor Role: collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Zahra Bashir

Ph.d.student, medical doctor and primary investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Rigshospitalet

Copenhagen, Capital Region of Denmark, Denmark

Site Status: RECRUITING

Slagelse Hospital

Slagelse, Region Sjælland, Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Zahra Bashir, MD

Role: CONTACT

zahra.bashir@regionh.dk

71871407

Facility Contacts

Zahra Bashir, MD

Role: primary

Zahra Bashir, MD

Role: primary

Other Identifiers

3-3031-2915/1

Identifier Type: -

Identifier Source: org_study_id