Cited by 238AI in cancer detectionArtificial Intelligence in Healthcare and EducationClinical Laboratory Practices and Quality Control

Validation of digital pathology imaging for primary histopathological diagnosis

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Snead, David R J, Tsang, Yee‐Wah, Meskiri, Aisha, Kimani, Peter K, Crossman, Richard, Rajpoot, Nasir M, Blessing, Elaine, Chen, Klaus +11 more·2016·Histopathology

Abstract

AIMS: Digital pathology (DP) offers advantages over glass slide microscopy (GS), but data demonstrating a statistically valid equivalent (i.e. non-inferior) performance of DP against GS are required to permit its use in diagnosis. The aim of this study is to provide evidence of non-inferiority. METHODS AND RESULTS: Seventeen pathologists re-reported 3017 cases by DP. Of these, 1009 were re-reported by the same pathologist, and 2008 by a different pathologist. Re-examination of 10 138 scanned slides (2.22 terabytes) produced 72 variances between GS and DP reports, including 21 clinically significant variances. Ground truth lay with GS in 12 cases and with DP in nine cases. These results are within the 95% confidence interval for existing intraobserver and interobserver variability, proving that DP is non-inferior to GS. In three cases, the digital platform was deemed to be responsible for the variance, including a gastric biopsy, where Helicobacter pylori only became visible on slides scanned at the ×60 setting, and a bronchial biopsy and penile biopsy, where dysplasia was reported on DP but was not present on GS. CONCLUSIONS: This is one of the largest studies proving that DP is equivalent to GS for the diagnosis of histopathology specimens. Error rates are similar in both platforms, although some problems e.g. detection of bacteria, are predictable.

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Authors
Snead, D. R. J., Tsang, Y., Meskiri, A., Kimani, P. K., Crossman, R., Rajpoot, N. M., Blessing, E., Chen, K., Gopalakrishnan, K., Matthews, P., Momtahan, N., Read‐Jones, S., Sah, S., Simmons, E., Sinha, B., Suortamo, S., Yeo, Y., El Daly, H., & Cree, I. A.
Affiliations
  • University Hospital Coventry (GB)
  • University of Warwick (GB)
  • Birmingham City Hospital (GB)
  • Department of Cellular Pathology University Hospitals of Coventry and Warwickshire NHS Trust Coventry UK
Corresponding author
Snead, David R J
Venue
Histopathology
Publisher
Wiley
Published
2015-12-06
Volume
68
Issue
7
Pages
1063-1072
ISSN
  • 0309-0167 (ISSN-L)
  • 1365-2559
OpenAlex
W2126470947
Cited by
238
References
25
Citations by year
2026: 10 · 2025: 15 · 2024: 20 · 2023: 20 · 2022: 32 · 2021: 37 · 2020: 32 · 2019: 26 · 2018: 15 · 2017: 17 · 2016: 13 · 2015: 1
FWCI
15.04
Type
journal article
Language
en
Open access
Locations
  • Histopathology (publishedVersion, cc-by-nc)
  • PubMed (publishedVersion)
  • Warwick Research Archive Portal (University of Warwick) (acceptedVersion)
Funders
Omnyx LLC
Topics
  • Physical Sciences › Computer Science › Artificial Intelligence › AI in cancer detection
  • Health Sciences › Medicine › Health Informatics › Artificial Intelligence in Healthcare and Education
  • Health Sciences › Medicine › Physiology › Clinical Laboratory Practices and Quality Control
Keywords
digital pathology, non-inferiority, histopathological diagnosis, diagnostic equivalence, interobserver variability, intraobserver variability, Helicobacter pylori detection, dysplasia detection, biopsy specimens
MeSH terms
Biopsy, Diagnostic Imaging, Humans, Image Interpretation, Computer-Assisted, Microscopy, Pathology, Clinical, Retrospective Studies, Reproducibility of Results, Observer Variation, Confidence Intervals

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