Human-AI Collaboration for Ultrasound Diagnosis of Thyroid Nodules - a Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Rigshospitalet, Denmark
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Accuracy of S-Detect diagnosis
Study Overview
Brief Summary
This is an experimental study wherein groups of medical students and physicians of varying degrees of experience in head-and-neck ultrasound were asked to scan the same five patients each with a thyroid nodule.
The study participants did their own ultrasound assessment of the thyroid nodules, as well as using an AI-based ultrasound diagnostics system.
The researchers intended to study two primary outcomes: 1) how varying degrees of experience in ultrasound by the operator might affect the diagnostic performance of the AI-based system, and 2) how the AI-based system influenced the diagnostic performance of the ultrasound operator.
Detailed Description
This is a prospective clinical study aiming to test how the experience of the ultrasound operator influences the performance of AI-based (artificial intelligence-based) diagnostics when analysing thyroid nodules on ultrasound scans. The investigators set up an experiment with five stations, each with a patient with a thyroid nodule and an ultrasound machine with the deep learning based system S-Detect for Thyroid installed. 20 study participants where recruited: 8 medical students of novice ultrasound skill, 3 junior ENT (ear-nose-throat) registrars of intermediate ultrasound skill, and 9 senior ENT registrars experienced in ultrasound. The participants scanned all the patients and recorded their analyses of the nodules using the EUTIRADS (European thyroid imagining reporting and data system) system in three different ways: a analysis of their own, S-Detect's analysis, and an analysis combining the two previous.
The hypothesis was that the AI system would perform equally well when between the participant groups. In addition, it was expected that the experienced participants would perform better than the students without AI help, and that the doctors would gain little from AI input, but that the students would have their performance improved by AI input.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Last year student
Exclusion Criteria
- •Experience with ultrasound beyond that which is taught at the University of Copenhagen
- •Junior ENT registrar doctors
- •Inclusion Criteria:
- •Doctor enrolled in introductory training as ENT physician.
- •Senior ENT registrar doctors
- •Inclusion Criteria:
- •Doctor enrolled in ENT training.
Outcomes
Primary Outcomes
Accuracy of S-Detect diagnosis
Time Frame: 1 day (day of experiment)
Number of correct thyroid nodule malignancy diagnoses out of total malignancy diagnoses by the AI-based ultrasound diagnostic system "S-Detect" on the five patients' thyroid nodules. Gold standard is cytology and histology of the nodules.
Secondary Outcomes
- Accuracy of biopsy recommendation(1 day (day of experiment))
- Nodule measurement(1 day (day of experiment))
- OSAUS score(1 day (day of experiment))
Investigators
Axel Bukhave Edström
Principal Investigator
Rigshospitalet, Denmark