Impact of AI Feedback on Ultrasound Biometry Accuracy Across the Expertise Levels
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: AI interventional group.
- Кому может быть актуально
- Состояния в реестре: Fetal Growth Abnormalities, Fetal Weight. Базовые параметры: Без ограничений · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Дания
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Evaluating the Sensitivity to Change of AI-Feedback in Ultrasound Biometry: A Stratified Randomized Controlled Trial Across the Expertise Gradient
Обзор
Objective: To evaluate the impact of real-time AI feedback on fetal biometry accuracy and investigate the Expertise Reversal Effect-whether AI benefits diminish as user experience increases. Design: A stratified randomized trial of 75 participants (25 Novices, 25 Intermediates, 25 Experts). Users are randomized 1:1 to either AI-assisted or manual measurement groups. Outcomes: * Primary: EFW accuracy (MAPE) compared to actual birthweight. * Secondary: Procedure time, image quality, error relative to baseline scans, and cognitive workload (NASA-TLX).
Подробное описание
Study Overview: This study evaluates how real-time Artificial Intelligence (AI) feedback impacts the accuracy of fetal biometry measurements in obstetric ultrasound. While AI tools are designed to assist clinicians, their effectiveness may vary depending on the user's baseline skill level-a phenomenon known as the "Expertise Reversal Effect."
Research Aim: The primary objective is to determine if AI-guided feedback significantly reduces measurement error in ultrasound fetal weight estimation to traditional manual methods. The study specifically investigates whether the benefit of AI is greater for novice users, intermediate users users than for experienced specialists.
Study Design: This is a stratified, randomized controlled trial involving 75 participants categorized into three expertise tiers:
Novices (e.g., students or residents with minimal scan experience).
Intermediate Users (e.g., physicians in mid-level training).
Experts (e.g., senior specialists).
Participants within each tier will be randomized 1:1 to either the AI-Assisted Group (receiving real-time automated plane validation and calipers) or the Control Group (performing standard manual biometry).
Primary Outcome Measure: Accuracy of Estimated Fetal Weight (EFW): The Mean Absolute Percentage Error (MAPE) of the EFW relative to the actual birthweight, assessing the clinical impact of AI assistance on weight prediction.
Secondary Outcome Measures:
* Procedural Efficiency: Total procedure time (probe-to-skin) required to complete the biometry. * Image Quality: Objective assessment of captured planes based on standardized salomon criteria. * Relative Measurement Error: Deviation of estimated fetal weight when compared to a standard (expert-validated) ultrasound scan. * Subjective Workload: Evaluation of cognitive load and user effort using the NASA Task Load Index (NASA-TLX). * Determination of Experience Threshold: Defining the 'cutoff' in clinical experience (years and total scans) for significant AI-mediated accuracy gains.
Вмешательства
- Устройство AI interventional group
Participants in the intervention arm perform fetal biometry with the assistance of real-time Artificial Intelligence (AI) feedback software.
Первичные конечные точки
- To evaluate the sensitivity to change in ultrasound measurement accuracy when using AI-feedback compared to standard scanning [Срок оценки: The two scans will be performed within a timeframe of 14 days.]
Вторичные конечные точки (5)
- Procedural Efficacy [Срок оценки: The duration of the scan, maximum of 30 minutes]
- Image Quality [Срок оценки: Through study completion, an average of 1 year.]
- Cognitive and Physiological Load [Срок оценки: During the ultrasound procedure (GSR) and immediately following the procedure (NASA-TLX), approximately 30 minutes in total.]
- Measurement Deviation: [Срок оценки: The duration from pre study scan and study scan.]
- Experience Threshold for AI-Mediated Accuracy Gains [Срок оценки: Through study completion, an average of 1 year.]
Критерии участия
Clinical Target Population: Healthcare professionals and students, including but not limited to:
- Medical students (doing their masters.
- Resident physicians and Senior Consultants in Obstetrics and Gynecology.
Exclusion:
\- If the participants do not understand and speak either Danish or English
Pregnant women:
Критерии включения
- Pre pregnancy BMI < 40
- Singelton pregnancy
- GA ≥ 37+0 at time of induction
- Intact membranes (to ensure consistent amniotic fluid index)
Критерии исключения
- Major fetal anatomical anomaly
- Anhydramnios (DVP < 2 cm)
- CPR ratio < 2.5th percentile
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Диагностика
Центры проведения
Дания · 3 центра
- Nordsjællands Hospital — Hillerød
- Rigshospitalet — Copenhagen
- Rigshospitalet — Copenhagen
Идентификаторы
NCT: NCT07476638 · F-250551591