Journal of Pathology Informatics Journal of Pathology Informatics
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Year : 2021  |  Volume : 12  |  Issue : 1  |  Page : 15

Selection of representative histologic slides in interobserver reproducibility studies: Insights from expert review for ovarian carcinoma subtype classification

1 Division of Imaging, Diagnostics, and Software Reliability, Office of Science and Engineering Laboratories , Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland, USA, (Currently at AstraZeneca, Precision Medicine and Biosamples, Gaithersburg, Maryland, USA), USA
2 Department of Pathology and Gynecology and Obstetrics, The Johns Hopkins Hospital, Baltimore, Maryland, USA
3 Electrical and Computer Engineering Department, University of British Columbia, Vancouver, Canada, (Currently at Roche Diagnostics, San Francisco, California, USA)
4 Division of Molecular Genetics and Pathology, Office of In Vitro Diagnostics and Radiological Health, Office of Product Evaluation and Quality, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland, USA

Correspondence Address:
Dr. Marios A Gavrielides
One MedImmune Way, Gaithersburg, Maryland 20878
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/jpi.jpi_56_20

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Background: Observer studies in pathology often utilize a limited number of representative slides per case, selected and reported in a nonstandardized manner. Reference diagnoses are commonly assumed to be generalizable to all slides of a case. We examined these issues in the context of pathologist concordance for histologic subtype classification of ovarian carcinomas (OCs). Materials and Methods: A cohort of 114 OCs consisting of 72 cases with a single representative slide (Group 1) and 42 cases with multiple representative slides (148 slides, 2-“6 sections per case, Group 2) was independently reviewed by three experts in gynecologic pathology (case-based review). In a follow-up study, each individual slide was independently reviewed in a randomized order by the same pathologists (section-based review). Results: Average interobserver concordance varied from 100% for Group 1 to 64.3% for Group 2 (86.8% across all cases). Across Group 2, 19 cases (45.2%) had at least one slide classified as a different subtype than the subtype assigned from case-based review, demonstrating the impact of intratumoral heterogeneity. Section-based concordance across individual sections from Group 2 was comparable to case-based concordance for those cases indicating diagnostic challenges at the individual section level. Findings demonstrate the increased diagnostic complexity of heterogeneous tumors that require multiple section sampling and its impact on pathologist performance. Conclusions: The proportion of cases with multiple representative slides in cohorts used in validation studies, such as those conducted to evaluate artificial intelligence/machine learning tools, can influence diagnostic performance, and if not accounted for, can cause disparities between research and real-world observations and between research studies. Case selection in validation studies should account for tumor heterogeneity to create balanced datasets in terms of diagnostic complexity.

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