Confiance des cliniciens dans les estimations de croissance fœtale basées sur l'IA
Confiance et prise de décision des cliniciens utilisant des estimations de croissance fœtale basées sur l'IA avec et sans incertitude : une étude randomisée par questionnaire
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.
Aperçu de l'étude
Statut
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
-
Slagelse, Danemark, 4200
- Department of Obstetrics and Gynecology, Slagelse Hospital
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Clinicians working in obstetrics and gynecology departments.
- Regular use of obstetric ultrasound in clinical practice.
- Willingness to participate in a questionnaire-based study.
Exclusion Criteria:
- Clinicians who do not perform obstetric ultrasound examinations.
- Clinicians with a known conflict of interest related to the AI system being evaluated.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Aucune intervention: Control - No AI Performance Information
Participants complete the questionnaire without receiving information about the AI model's overall performance. |
|
|
Autre: ntervention - AI Performance Information
Participants receive brief information about the AI model's overall performance before completing the questionnaire. |
Participants receive brief information about the AI model's overall performance before completing the questionnaire. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Clinicians' choice of fetal weight estimation method
Délai: Immediately after questionnaire completion
|
The proportion of cases in which clinicians choose the AI-based fetal weight estimate rather than the traditional Hadlock estimate when assessing anonymized ultrasound cases. |
Immediately after questionnaire completion
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Clinicians' confidence in selected fetal weight estimate
Délai: Immediately after questionnaire completion
|
Clinicians' self-reported confidence in the selected fetal weight estimate, measured on a 7-point Likert scale for each case. |
Immediately after questionnaire completion
|
|
Recommendation of follow-up growth scan
Délai: Immediately after questionnaire completion
|
Whether clinicians recommend a follow-up fetal growth scan based on the selected fetal weight estimate, recorded as a binary outcome (yes/no). |
Immediately after questionnaire completion
|
|
Impact of uncertainty information on model preference
Délai: Immediately after questionnaire completion
|
Difference in clinicians' preference for AI-based versus traditional fetal weight estimates when AI predictions are presented with versus without uncertainty information. |
Immediately after questionnaire completion
|
|
Clinicians' overall trust in artificial intelligence
Délai: Immediately after completion of the vignette assessments.
|
Clinicians' self-reported overall trust in the AI model after completing the vignette assessments, measured using a seven-point Likert scale, with higher scores indicating greater trust. Responses are compared between the intervention and control groups. |
Immediately after completion of the vignette assessments.
|
Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- F-25022462
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .