Whole slide imaging diagnostic concordance with light microscopy for breast needle biopsies

Context.—Light microscopy (LM) is considered the reference standard for diagnosis in pathology. Whole slide imaging (WSI) generates digital images of cellular and tissue samples and offers multiple advantages compared with LM. Currently, WSI is not widely used for primary diagnosis. The lack of evidence regarding concordance between diagnoses rendered by WSI and LM is a significant barrier to both regulatory approval and uptake. Objective.—To examine the published literature on the concordance of pathologic diagnoses rendered by WSI compared with those rendered by LM. Data Sources.—We conducted a systematic review of studies assessing the concordance of pathologic diagnoses rendered by WSI and LM. Studies were identified following a systematic search of Medline (Medline Industries, Mundelein, Illinois), Medline in progress (Medline Industries), EMBASE (Elsevier, Amsterdam, the Netherlands), and the Cochrane Library (Wiley, London, England), between 1999 and March 2015. Conclusions.—Thirty-eight studies were included in the review. The mean diagnostic concordance of WSI and LM, weighted by the number of cases per study, was 92.4%. The weighted mean κ coefficient between WSI and LM was 0.75, signifying substantial agreement. Of the 30 studies quoting percentage concordance, 18 (60%) showed a concordance of 90% or greater, of which 10 (33%) showed a concordance of 95% or greater. This review found evidence to support a high level of diagnostic concordance. However, there were few studies, many were small, and they varied in quality, suggesting that further validation studies are still needed.

Download Full-text

Diagnostic concordance between whole slide imaging and conventional light microscopy in cytopathology: A systematic review

Cancer Cytopathology ◽

10.1002/cncy.22195 ◽

2019 ◽

Vol 128 (1) ◽

pp. 17-28 ◽

Cited By ~ 9

Author(s):

Ilaria Girolami ◽

Liron Pantanowitz ◽

Stefano Marletta ◽

Matteo Brunelli ◽

Claudia Mescoli ◽

...

Keyword(s):

Systematic Review ◽

Light Microscopy ◽

Whole Slide Imaging ◽

Diagnostic Concordance ◽

Conventional Light Microscopy

Download Full-text

A Systematic Analysis of Discordant Diagnoses in Digital Pathology Compared With Light Microscopy

Archives of Pathology & Laboratory Medicine ◽

10.5858/arpa.2016-0494-oa ◽

2017 ◽

Vol 141 (12) ◽

pp. 1712-1718 ◽

Cited By ~ 17

Author(s):

Bethany J. Williams ◽

Philip DaCosta ◽

Edward Goacher ◽

Darren Treanor

Keyword(s):

Light Microscopy ◽

Digital Pathology ◽

Whole Slide Imaging ◽

Systematic Analysis ◽

Root Cause ◽

Ensure Patient Safety ◽

Review Protocol ◽

Potential Impact ◽

Based Medicine ◽

Severe Patient

Context.— Relatively little is known about the significance and potential impact of glass-digital discordances, and this is likely to be of importance when considering digital pathology adoption. Objective.— To apply evidence-based medicine to collect and analyze reported instances of glass-digital discordance from the whole slide imaging validation literature. Design.— We used our prior systematic review protocol to identify studies assessing the concordance of light microscopy and whole slide imaging between 1999 and 2015. Data were extracted and analyzed by a team of histopathologists to classify the type, significance, and potential root cause of discordances. Results.— Twenty-three studies were included, yielding 8069 instances of a glass diagnosis being compared with a digital diagnosis. From these 8069 comparisons, 335 instances of discordance (4%) were reported, in which glass was the preferred diagnostic medium in 286 (85%), and digital in 44 (13%), with no consensus in 5 (2%). Twenty-eight discordances had the potential to cause moderate/severe patient harm. Of these, glass was the preferred diagnostic medium for 26 (93%). Of the 335 discordances, 109 (32%) involved the diagnosis or grading of dysplasia. For these cases, glass was the preferred diagnostic medium in 101 cases (93%), suggesting that diagnosis and grading of dysplasia may be a potential pitfall of digital diagnosis. In 32 of 335 cases (10%), discordance on digital was attributed to the inability to find a small diagnostic/prognostic object. Conclusions.— Systematic analysis of concordance studies reveals specific areas that may be problematic on whole slide imaging. It is important that pathologists are aware of these areas to ensure patient safety.

Download Full-text

Concordance between whole-slide imaging and light microscopy for routine surgical pathology

Human Pathology ◽

10.1016/j.humpath.2011.12.023 ◽

2012 ◽

Vol 43 (10) ◽

pp. 1739-1744 ◽

Cited By ~ 52

Author(s):

W. Scott Campbell ◽

Subodh M. Lele ◽

William W. West ◽

Audrey J. Lazenby ◽

Lynette M. Smith ◽

...

Keyword(s):

Light Microscopy ◽

Surgical Pathology ◽

Whole Slide Imaging

Download Full-text

Comparison of the whole slide imaging and conventional light microscopy in the grading of oral epithelial dysplasia: a multi-institutional study

Medicina Oral Patología Oral y Cirugia Bucal ◽

10.4317/medoral.23854 ◽

2021 ◽

pp. e8-e13

Author(s):

PB. Diniz ◽

M. Sena-Filho ◽

KM. Graner ◽

BA. Mariz ◽

LA. Reis ◽

...

Keyword(s):

Light Microscopy ◽

Epithelial Dysplasia ◽

Whole Slide Imaging ◽

Oral Epithelial Dysplasia ◽

Oral Epithelial ◽

Conventional Light Microscopy

Download Full-text

Concordance, intra- and inter-observer agreements between light microscopy and whole slide imaging for samples acquired by EUS in pancreatic solid lesions

Digestive and Liver Disease ◽

10.1016/j.dld.2019.04.019 ◽

2019 ◽

Vol 51 (11) ◽

pp. 1574-1579

Author(s):

Alberto Larghi ◽

Adele Fornelli ◽

Stefania Lega ◽

Moira Ragazzi ◽

Gabriele Carlinfante ◽

...

Keyword(s):

Light Microscopy ◽

Whole Slide Imaging ◽

Solid Lesions

Download Full-text

Concordance Between Whole-Slide Imaging and Light Microscopy for Routine Surgical Pathology

Yearbook of Pathology and Laboratory Medicine ◽

10.1016/j.ypat.2012.11.055 ◽

2013 ◽

Vol 2013 ◽

pp. 15-16

Author(s):

S.S. Raab

Keyword(s):

Light Microscopy ◽

Surgical Pathology ◽

Whole Slide Imaging

Download Full-text

Rapid Validation of Telepathology by an Academic Neuropathology Practice During the COVID-19 Pandemic

Archives of Pathology & Laboratory Medicine ◽

10.5858/arpa.2020-0372-sa ◽

2020 ◽

Vol 144 (11) ◽

pp. 1311-1320

Author(s):

Jonathan Henriksen ◽

Teresa Kolognizak ◽

Tracy Houghton ◽

Steve Cherne ◽

Daisy Zhen ◽

...

Keyword(s):

Patient Care ◽

Care Delivery ◽

Whole Slide Imaging ◽

Quality Patient Care ◽

Downstream Effects ◽

Medical Facilities ◽

Innovative Solutions ◽

Diagnostic Concordance ◽

Patient Care Delivery ◽

The University

Context.— The coronavirus disease 19 (COVID-19) pandemic is placing unparalleled burdens on regional and institutional resources in medical facilities across the globe. This disruption is causing unprecedented downstream effects to traditionally established channels of patient care delivery, including those of essential anatomic pathology services. With Washington state being the initial North American COVID-19 epicenter, the University of Washington in Seattle has been at the forefront of conceptualizing and implementing innovative solutions in order to provide uninterrupted quality patient care amidst this growing crisis. Objective.— To conduct a rapid validation study assessing our ability to reliably provide diagnostic neuropathology services via a whole slide imaging (WSI) platform as part of our departmental COVID-19 planning response. Design.— This retrospective study assessed diagnostic concordance of neuropathologic diagnoses rendered via WSI as compared to those originally established via traditional histopathology in a cohort of 30 cases encompassing a broad range of neurosurgical and neuromuscular entities. This study included the digitalization of 93 slide preparations, which were independently examined by groups of board-certified neuropathologists and neuropathology fellows. Results.— There were no major or minor diagnostic discrepancies identified in either the attending neuropathologist or neuropathology trainee groups for either the neurosurgical or neuromuscular case cohorts. Conclusions.— Our study demonstrates that accuracy of neuropathologic diagnoses and interpretation of ancillary preparations via WSI are not inferior to those generated via traditional microscopy. This study provides a framework for rapid subspecialty validation and deployment of WSI for diagnostic purposes during a pandemic event.

Download Full-text

Validating Whole Slide Imaging Systems for Diagnostic Purposes in Pathology: Guideline Update From the College of American Pathologists in Collaboration With the American Society for Clinical Pathology and the Association for Pathology Informatics

Archives of Pathology & Laboratory Medicine ◽

10.5858/arpa.2020-0723-cp ◽

2021 ◽

Author(s):

Andrew J. Evans ◽

Richard W. Brown ◽

Marilyn M. Bui ◽

Elizabeth A. Chlipala ◽

Christina Lacchetti ◽

...

Keyword(s):

Systematic Review ◽

Expert Panel ◽

Good Practice ◽

Digital Pathology ◽

Clinical Pathology ◽

Glass Slide ◽

Whole Slide Imaging ◽

Assessment Development ◽

Evaluation Approach ◽

Diagnostic Concordance

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%.

Download Full-text