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Набор по приглашению NCT07401368

Clinicians' Trust in AI-Based Fetal Growth Estimates

Без фазы С лечением Fetal Growth Obstetric Ultrasonography Pregnancy Clinical Decision-making

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: Intervention - AI Performance Information.
Кому может быть актуально
Состояния в реестре: Fetal Growth, Obstetric Ultrasonography, Pregnancy, Clinical Decision-making. 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 →
Официальное название

Clinicians' Trust and Decision-Making Using AI-Based Fetal Growth Estimates With and Without Uncertainty: A Randomized Questionnaire Study

Обзор

This study examines how clinicians trust and use artificial intelligence (AI) when estimating fetal weight during pregnancy. Accurate assessment of fetal growth is important for identifying growth problems that may affect pregnancy management. New AI-based tools can estimate fetal weight from ultrasound images, but little is known about how clinicians trust these estimates or how uncertainty information influences their decisions. In this study, clinicians will review anonymized ultrasound cases and compare fetal weight estimates generated by an AI model with traditional estimates. Some clinicians will also be shown information about the AI model's performance and uncertainty, while others will not. Participants will be asked to choose which estimate they find most reliable, indicate their level of confidence, and decide whether they would recommend follow-up scans. The study aims to better understand how AI and uncertainty information affect clinical decision-making and trust among clinicians with different levels of experience.

Подробное описание

This is a randomized, matched, vignette-based questionnaire study designed to investigate clinicians' trust in and use of AI-based fetal growth estimates.

Clinicians from obstetrics and gynecology departments will be recruited and stratified by experience level. Participants will be randomized to either a control group or an intervention group. The intervention group will receive brief information about the AI model's overall performance, while the control group will not receive this information.

Each participant will assess a set of anonymized third-trimester ultrasound cases. For each case, clinicians will be presented with standard ultrasound images and relevant clinical context. They will be shown fetal weight estimates generated by an AI-based model and by a traditional biometric method, with or without accompanying uncertainty information in the form of confidence intervals.

For each case, clinicians will select the estimate they consider most clinically reliable, rate their confidence in that choice, and indicate whether they would recommend a follow-up growth scan. Case sets are matched by clinical experience, ensuring that identical cases are evaluated by clinicians with similar backgrounds across study arms.

The study focuses on clinicians as participants and involves no patient intervention. All ultrasound data are fully anonymized. The results will provide insight into how AI-generated estimates and uncertainty information influence clinical trust, preferences, and decision-making in fetal growth assessment.

Вмешательства

  • Другое Intervention - AI Performance Information
    Participants receive brief information about the AI model's overall performance before completing the questionnaire.

Первичные конечные точки

  • Clinicians' choice of fetal weight estimation method [Срок оценки: Immediately after questionnaire completion]
Вторичные конечные точки (3)
  • Clinicians' confidence in selected fetal weight estimate [Срок оценки: Immediately after questionnaire completion]
  • Recommendation of follow-up growth scan [Срок оценки: Immediately after questionnaire completion]
  • Impact of uncertainty information on model preference [Срок оценки: Immediately after questionnaire completion]

Критерии участия

Критерии включения

  • Clinicians working in obstetrics and gynecology departments.
  • Regular use of obstetric ultrasound in clinical practice.
  • Willingness to participate in a questionnaire-based study.

Критерии исключения

  • Clinicians who do not perform obstetric ultrasound examinations.
  • Clinicians with a known conflict of interest related to the AI system being evaluated.

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
Организация здравоохранения

Центры проведения

Дания · 1 центр
  • Department of Obstetrics and Gynecology, Slagelse Hospital — Slagelse

Идентификаторы

NCT: NCT07401368 · F-25022462

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗