Clinical validation of explainable AI for fetal growth scans through multi-level, cross-institutional prospective end-user evaluation

Abstract We aimed to develop and evaluate Explainable Artificial Intelligence (XAI) for fetal ultrasound using actionable concepts as feedback to end-users, using a prospective cross-center, multi-level approach. We developed, implemented, and tested a deep-learning model for fetal growth scans usin...

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Main Authors: Zahra Bashir, Manxi Lin, Aasa Feragen, Kamil Mikolaj, Caroline Taksøe-Vester, Anders Nymark Christensen, Morten B. S. Svendsen, Mette Hvilshøj Fabricius, Lisbeth Andreasen, Mads Nielsen, Martin Grønnebæk Tolsgaard
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Language:English
Published: Nature Portfolio 2025-01-01
Series:Scientific Reports
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Online Access:https://doi.org/10.1038/s41598-025-86536-4
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author Zahra Bashir
Manxi Lin
Aasa Feragen
Kamil Mikolaj
Caroline Taksøe-Vester
Anders Nymark Christensen
Morten B. S. Svendsen
Mette Hvilshøj Fabricius
Lisbeth Andreasen
Mads Nielsen
Martin Grønnebæk Tolsgaard
author_facet Zahra Bashir
Manxi Lin
Aasa Feragen
Kamil Mikolaj
Caroline Taksøe-Vester
Anders Nymark Christensen
Morten B. S. Svendsen
Mette Hvilshøj Fabricius
Lisbeth Andreasen
Mads Nielsen
Martin Grønnebæk Tolsgaard
author_sort Zahra Bashir
collection DOAJ
description Abstract We aimed to develop and evaluate Explainable Artificial Intelligence (XAI) for fetal ultrasound using actionable concepts as feedback to end-users, using a prospective cross-center, multi-level approach. We developed, implemented, and tested a deep-learning model for fetal growth scans using both retrospective and prospective data. We used a modified Progressive Concept Bottleneck Model with pre-established clinical concepts as explanations (feedback on image optimization and presence of anatomical landmarks) as well as segmentations (outlining anatomical landmarks). The model was evaluated prospectively by assessing the following: the model’s ability to assess standard plane quality, the correctness of explanations, the clinical usefulness of explanations, and the model’s ability to discriminate between different levels of expertise among clinicians. We used 9352 annotated images for model development and 100 videos for prospective evaluation. Overall classification accuracy was 96.3%. The model’s performance in assessing standard plane quality was on par with that of clinicians. Agreement between model segmentations and explanations provided by expert clinicians was found in 83.3% and 74.2% of cases, respectively. A panel of clinicians evaluated segmentations as useful in 72.4% of cases and explanations as useful in 75.0% of cases. Finally, the model reliably discriminated between the performances of clinicians with different levels of experience (p- values < 0.01 for all measures) Our study has successfully developed an Explainable AI model for real-time feedback to clinicians performing fetal growth scans. This work contributes to the existing literature by addressing the gap in the clinical validation of Explainable AI models within fetal medicine, emphasizing the importance of multi-level, cross-institutional, and prospective evaluation with clinician end-users. The prospective clinical validation uncovered challenges and opportunities that could not have been anticipated if we had only focused on retrospective development and validation, such as leveraging AI to gauge operator competence in fetal ultrasound.
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spelling doaj-art-2167277683eb46b38111f9dd028a5b1f2025-01-19T12:23:12ZengNature PortfolioScientific Reports2045-23222025-01-0115111010.1038/s41598-025-86536-4Clinical validation of explainable AI for fetal growth scans through multi-level, cross-institutional prospective end-user evaluationZahra Bashir0Manxi Lin1Aasa Feragen2Kamil Mikolaj3Caroline Taksøe-Vester4Anders Nymark Christensen5Morten B. S. Svendsen6Mette Hvilshøj Fabricius7Lisbeth Andreasen8Mads Nielsen9Martin Grønnebæk Tolsgaard10Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of CopenhagenTechnical University of Denmark (DTU)Technical University of Denmark (DTU)Technical University of Denmark (DTU)Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of CopenhagenTechnical University of Denmark (DTU)Copenhagen Academy for Medical Education and Simulation (CAMES)Department of Obstetrics and Gynecology, Slagelse HospitalDepartment of Obstetrics and Gynecology, Hvidovre HospitalDepartment of Computer Science, University of CopenhagenDepartment of Clinical Medicine, Faculty of Health and Medical Sciences, University of CopenhagenAbstract We aimed to develop and evaluate Explainable Artificial Intelligence (XAI) for fetal ultrasound using actionable concepts as feedback to end-users, using a prospective cross-center, multi-level approach. We developed, implemented, and tested a deep-learning model for fetal growth scans using both retrospective and prospective data. We used a modified Progressive Concept Bottleneck Model with pre-established clinical concepts as explanations (feedback on image optimization and presence of anatomical landmarks) as well as segmentations (outlining anatomical landmarks). The model was evaluated prospectively by assessing the following: the model’s ability to assess standard plane quality, the correctness of explanations, the clinical usefulness of explanations, and the model’s ability to discriminate between different levels of expertise among clinicians. We used 9352 annotated images for model development and 100 videos for prospective evaluation. Overall classification accuracy was 96.3%. The model’s performance in assessing standard plane quality was on par with that of clinicians. Agreement between model segmentations and explanations provided by expert clinicians was found in 83.3% and 74.2% of cases, respectively. A panel of clinicians evaluated segmentations as useful in 72.4% of cases and explanations as useful in 75.0% of cases. Finally, the model reliably discriminated between the performances of clinicians with different levels of experience (p- values < 0.01 for all measures) Our study has successfully developed an Explainable AI model for real-time feedback to clinicians performing fetal growth scans. This work contributes to the existing literature by addressing the gap in the clinical validation of Explainable AI models within fetal medicine, emphasizing the importance of multi-level, cross-institutional, and prospective evaluation with clinician end-users. The prospective clinical validation uncovered challenges and opportunities that could not have been anticipated if we had only focused on retrospective development and validation, such as leveraging AI to gauge operator competence in fetal ultrasound.https://doi.org/10.1038/s41598-025-86536-4Artificial intelligence, Fetal growth scans, Explainable AI, Human-AI collaboration
spellingShingle Zahra Bashir
Manxi Lin
Aasa Feragen
Kamil Mikolaj
Caroline Taksøe-Vester
Anders Nymark Christensen
Morten B. S. Svendsen
Mette Hvilshøj Fabricius
Lisbeth Andreasen
Mads Nielsen
Martin Grønnebæk Tolsgaard
Clinical validation of explainable AI for fetal growth scans through multi-level, cross-institutional prospective end-user evaluation
Scientific Reports
Artificial intelligence, Fetal growth scans, Explainable AI, Human-AI collaboration
title Clinical validation of explainable AI for fetal growth scans through multi-level, cross-institutional prospective end-user evaluation
title_full Clinical validation of explainable AI for fetal growth scans through multi-level, cross-institutional prospective end-user evaluation
title_fullStr Clinical validation of explainable AI for fetal growth scans through multi-level, cross-institutional prospective end-user evaluation
title_full_unstemmed Clinical validation of explainable AI for fetal growth scans through multi-level, cross-institutional prospective end-user evaluation
title_short Clinical validation of explainable AI for fetal growth scans through multi-level, cross-institutional prospective end-user evaluation
title_sort clinical validation of explainable ai for fetal growth scans through multi level cross institutional prospective end user evaluation
topic Artificial intelligence, Fetal growth scans, Explainable AI, Human-AI collaboration
url https://doi.org/10.1038/s41598-025-86536-4
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