2021/05/18 by Andrew Evans, Andrew J Evans, Richard W. Brown +14
Computer Science · Medicine · #AI in cancer detection #Breast Lesions and Carcinomas #Lung Cancer Diagnosis and Treatment
paper · pdf · doi:10.5858/arpa.2020-0723-cp
crossref issued 2021/05/18 · crossref published 2021/05/18 · crossref published-online 2021/05/18 · openalex publication_date 2021/05/18 · crossref created 2021/05/18 · crossref published-print 2022/04/01 · openalex created_date 2025/10/10 · crossref deposited 2025/12/03 · crossref indexed 2026/07/29 · openalex updated_date 2026/08/04
CONTEXT.—: The original guideline, "Validating Whole Slide Imaging for Diagnostic Purposes in Pathology," was published in 2013 and included 12 guideline statements. The College of American Pathologists convened an expert panel to update the guideline following standards established by the National Academies of Medicine for developing trustworthy clinical practice guidelines. OBJECTIVE.—: To assess evidence published since the release of the original guideline and provide updated recommendations for validating whole slide imaging (WSI) systems used for diagnostic purposes. DESIGN.—: An expert panel performed a systematic review of the literature. Frozen sections, anatomic pathology specimens (biopsies, curettings, and resections), and hematopathology cases were included. Cytology cases were excluded. Using the Grading of Recommendations Assessment, Development, and Evaluation approach, the panel reassessed and updated the original guideline recommendations. RESULTS.—: Three strong recommendations and 9 good practice statements are offered to assist laboratories with validating WSI digital pathology systems. CONCLUSIONS.—: Systematic review of literature following release of the 2013 guideline reaffirms the use of a validation set of at least 60 cases, establishing intraobserver diagnostic concordance between WSI and glass slides and the use of a 2-week washout period between modalities. Although all discordances between WSI and glass slide diagnoses discovered during validation need to be reconciled, laboratories should be particularly concerned if their overall WSI-glass slide concordance is less than 95%.