CONFIDENT-trial protocol: a pragmatic template for clinical implementation of artificial intelligence assistance in pathology

CONFIDENT-trial protocol: a pragmatic template for clinical implementation of artificial intelligence assistance in pathology

IntroductionArtificial intelligence (AI) has been on the rise in the field of pathology. Despite promising results in retrospective studies, and several CE-IVD certified algorithms on the market, prospective clinical implementation studies of AI have yet to be performed, to the best of our knowledge...

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Bibliographic Details
Published in:BMJ open 2023-06, Vol.13 (6), p.e067437-e067437
Main Authors: Flach, Rachel N, Stathonikos, Nikolas, Nguyen, Tri Q, Ter Hoeve, Natalie D, van Diest, Paul J, van Dooijeweert, Carmen
Format: Article
Language:eng
Subjects:
Algorithms
Artificial intelligence
Biopsy
Breast cancer
Breast tumours
Cost control
Localization
Lymphatic system
Metastasis
Pathology
Prostate
Prostate cancer
Prostate disease
Safety standards
Stains & staining
Trends
Tumors
Workloads
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Summary:IntroductionArtificial intelligence (AI) has been on the rise in the field of pathology. Despite promising results in retrospective studies, and several CE-IVD certified algorithms on the market, prospective clinical implementation studies of AI have yet to be performed, to the best of our knowledge. In this trial, we will explore the benefits of an AI-assisted pathology workflow, while maintaining diagnostic safety standards.Methods and analysisThis is a Standard Protocol Items: Recommendations for Interventional Trials–Artificial Intelligence compliant single-centre, controlled clinical trial, in a fully digital academic pathology laboratory. We will prospectively include prostate cancer patients who undergo prostate needle biopsies (CONFIDENT-P) and breast cancer patients who undergo a sentinel node procedure (CONFIDENT-B) in the University Medical Centre Utrecht. For both the CONFIDENT-B and CONFIDENT-P trials, the specific pathology specimens will be pseudo-randomised to be assessed by a pathologist with or without AI assistance in a pragmatic (bi-)weekly sequential design. In the intervention group, pathologists will assess whole slide images (WSI) of the standard hematoxylin and eosin (H&E)-stained sections assisted by the output of the algorithm. In the control group, pathologists will assess H&E WSI according to the current clinical workflow. If no tumour cells are identified or when the pathologist is in doubt, immunohistochemistry (IHC) staining will be performed. At least 80 patients in the CONFIDENT-P and 180 patients in the CONFIDENT-B trial will need to be enrolled to detect superiority, allocated as 1:1. Primary endpoint for both trials is the number of saved resources of IHC staining procedures for detecting tumour cells, since this will clarify tangible cost savings that will support the business case for AI.Ethics and disseminationThe ethics committee (MREC NedMec) waived the need of official ethical approval, since participants are not subjected to procedures nor are they required to follow rules. Results of both trials (CONFIDENT-B and CONFIDENT-P) will be published in scientific peer-reviewed journals.
ISSN:2044-6055
2044-6055