The Application, Challenges, and Advancement Toward Regulatory Acceptance of Digital Toxicologic Pathology: Results of the 7th ESTP International Expert Workshop (September 20-21, 2019)

2020 ◽  
pp. 019262332097584
Author(s):  
Vanessa L. Schumacher ◽  
Famke Aeffner ◽  
Erio Barale-Thomas ◽  
Catherine Botteron ◽  
Jonathan Carter ◽  
...  
Keyword(s):  
European Society ◽  
International Workshop ◽  
Digital Pathology ◽  
Remote Access ◽  
Whole Slide Imaging ◽  
International Expert ◽  
Digital Slide ◽  
Regulatory Acceptance ◽  
Expert Workshop ◽  
Whole Slide Images

With advancements in whole slide imaging technology and improved understanding of the features of pathologist workstations required for digital slide evaluation, many institutions are investigating broad digital pathology adoption. The benefits of digital pathology evaluation include remote access to study or diagnostic case materials and integration of analysis and reporting tools. Diagnosis based on whole slide images is established in human medical pathology, and the use of digital pathology in toxicologic pathology is increasing. However, there has not been broad adoption in toxicologic pathology, particularly in the context of regulatory studies, due to lack of precedence. To address this topic, as well as practical aspects, the European Society of Toxicologic Pathology coordinated an expert international workshop to assess current applications and challenges and outline a set of minimal requirements needed to gain future regulatory acceptance for the use of digital toxicologic pathology workflows in research and development, so that toxicologic pathologists can benefit from digital slide technology.

scholarly journals Efficient Visualization of Whole Slide Images in Web-based Viewers for Digital Pathology

2021 ◽  
Author(s):  
Peter J. Schüffler ◽  
Evangelos Stamelos ◽  
Ishtiaque Ahmed ◽  
D. Vijay K. Yarlagadda ◽  
Matthew G. Hanna ◽  
...  
Keyword(s):  
Performance Metrics ◽  
Digital Pathology ◽  
Block Size ◽  
Field Of View ◽  
Digital Slide ◽  
Web Based ◽  
Tile Size ◽  
Adjacent Field ◽  
The Impact ◽  
Whole Slide Images

Context.— Wide adoption of digital pathology requires efficient visualization and navigation in Web-based digital slide viewers, which is poorly defined. Objective.— To define and quantify relevant performance metrics for efficient visualization of cases and slides in digital slide viewers. Design.— With a universal slide viewer used in clinical routine diagnostics, we evaluate the impact of slide caching, compression type, tile, and block size of whole slide images generated from Philips, Leica, and 3DHistech scanners on streaming performance on case, slide, and field of view levels. Results.— Two hundred thirty-nine pathologists routinely reviewed 60 080 whole slide images over 3 months. The median time to open a case's slides from the laboratory information system was less than 4 seconds, the time to change to a slide within the case was less than 1 second, and the time to render the adjacent field of view when navigating the slide was less than one-quarter of a second. A whole slide image's block size and a viewer tile size of 1024 pixels showed best performance to display a field of view and was preferrable over smaller tiles due to fewer mosaic effects. For Philips, fastest median slide streaming pace was 238 ms per field of view and for 3DHistech, 125 ms. For Leica, the fastest pace of 108 ms per field of view was established with block serving without decompression. Conclusions.— This is the first study to systematically assess user-centric slide visualization performance metrics for digital viewers, including time to open a case, time to change a slide, and time to change a field of view. These metrics help to improve the viewer's configuration, leading to an efficient visualization baseline that is widely accepted among pathologists using routine digital pathology.

scholarly journals Toxicologic Pathology Forum*: Opinion on Considerations for the Use of Whole Slide Images in GLP Pathology Peer Review

2019 ◽  
Vol 47 (2) ◽  
pp. 100-107 ◽  
Author(s):  
Alys Bradley ◽  
Matt Jacobsen
Keyword(s):  
Peer Review ◽  
Glass Slide ◽  
Whole Slide Imaging ◽  
Laboratory Practice ◽  
Advantages And Disadvantages ◽  
Primary Means ◽  
Good Laboratory ◽  
High Level ◽  
Regulatory Acceptance ◽  
Whole Slide Images

Whole slide imaging (WSI) technology has advanced to a point where it has replaced the glass slide as the primary means of pathology evaluation within many areas of medical pathology. The deployment of WSI in the field of toxicologic pathology has been delayed by a lack of clarity around the degree of validation required for its use on Good Laboratory Practice (GLP) studies. The current opinion piece attempts to provide a high-level overview of WSI technology to include basic methodology, advantages and disadvantages over a conventional microscope, validation status of WSI scanners, and perceived concerns over regulatory acceptance for the use of WSI for (GLP) peer review in the field of toxicologic pathology. Observations are based on the extensive use by AstraZeneca of WSI for the peer review of non-GLP studies conducted at Charles River facilities and represent the experiences of the authors. [Box: see text]

scholarly journals Whole-Slide Imaging Digital Pathology as a Platform for Teleconsultation: A Pilot Study Using Paired Subspecialist Correlations

2009 ◽  
Vol 133 (12) ◽  
pp. 1949-1953 ◽  
Author(s):  
David C. Wilbur ◽  
Kalil Madi ◽  
Robert B. Colvin ◽  
Lyn M. Duncan ◽  
William C. Faquin ◽  
...  
Keyword(s):  
Digital Pathology ◽  
Glass Slide ◽  
Whole Slide Imaging ◽  
Improve Performance ◽  
Standard Glass ◽  
Digital Format ◽  
Glass Slides ◽  
Technical Issues ◽  
Fine Resolution ◽  
Whole Slide Images

Abstract Context.—Whole-slide imaging technology offers promise for rapid, Internet-based telepathology consultations between institutions. Before implementation, technical issues, pathologist adaptability, and morphologic pitfalls must be well characterized. Objective.—To determine whether interpretation of whole-slide images differed from glass-slide interpretation in difficult surgical pathology cases. Design.—Diagnostically challenging pathology slides from a variety of anatomic sites from an outside laboratory were scanned into whole digital format. Digital and glass slides were independently diagnosed by 2 subspecialty pathologists. Reference, digital, and glass-slide interpretations were compared. Operator comments on technical issues were gathered. Results.—Fifty-three case pairs were analyzed. There was agreement among digital, glass, and reference diagnoses in 45 cases (85%) and between digital and glass diagnoses in 48 (91%) cases. There were 5 digital cases (9%) discordant with both reference and glass diagnoses. Further review of each of these cases indicated an incorrect digital whole-slide interpretation. Neoplastic cases showed better correlation (93%) than did cases of nonneoplastic disease (88%). Comments on discordant cases related to digital whole technology focused on issues such as fine resolution and navigating ability at high magnification. Conclusions.—Overall concordance between digital whole-slide and standard glass-slide interpretations was good at 91%. Adjustments in technology, case selection, and technology familiarization should improve performance, making digital whole-slide review feasible for broader telepathology subspecialty consultation applications.

Digital pathology for intraoperative frozen section diagnosis of thoracic specimens: an evaluation of a system using remote sampling and whole slide imaging diagnosis

2019 ◽  
Vol 73 (8) ◽  
pp. 503-506
Author(s):  
Jon Griffin ◽  
Panagiota Kitsanta ◽  
Branko Perunovic ◽  
S Kim Suvarna ◽  
Jonathan Bury
Keyword(s):  
Critical Incident ◽  
Frozen Section ◽  
Digital Pathology ◽  
Ground Truth ◽  
Final Diagnosis ◽  
Glass Slide ◽  
Whole Slide Imaging ◽  
Digital Slide ◽  
Frozen Section Diagnosis ◽  
Service Reorganisation

BackgroundDigital pathology is now used for primary diagnostic work as well as teaching, research and consultation. In our multisite institution service reorganisation led to histopathology being located in a separate hospital from some surgical specialities. We implemented remotely supervised specimen sampling and frozen section diagnosis using digital pathology. In this study we assessed the concordance of glass and digital slide diagnosis using this system.MethodsWe reviewed cases from the first 2 years of digital frozen section reporting at our institution. Cases with potential digital to glass slide discordance were reviewed by three experienced thoracic histopathologists. The reasons for discordance were determined and common themes identified. We also reviewed critical incidents relating to digital pathology during the study period.ResultsThe study population comprised 211 cases. Frozen section to final diagnosis concordance between digital and glass slide diagnosis was found in 196 (92.6%) cases. The 15 potentially discordant cases were reviewed. Intraobserver concordance between glass and digital slide review ranged from 9/15 to 12/15 cases across the three pathologists. Glass slide review diagnosis showed better concordance with ground truth in two cases; digital slide review was more accurate in two cases. One relevant critical incident was identified during the study period.DiscussionThis is the largest study to examine digital pathology for thoracic frozen section diagnosis and shows that this is a safe and feasible alternative to glass slide diagnosis. Discordance between digital and glass slide diagnoses were unrelated to the processes of whole slide imaging and digital microscopy.

scholarly journals A Digital Pathology Solution to Resolve the Tissue Floater Conundrum

2020 ◽  
Author(s):  
Liron Pantanowitz ◽  
Pamela Michelow ◽  
Scott Hazelhurst ◽  
Shivam Kalra ◽  
Charles Choi ◽  
...  
Keyword(s):  
Digital Pathology ◽  
Primary Diagnosis ◽  
Image Search ◽  
Molecular Tests ◽  
Tissue Identification ◽  
Digital Database ◽  
Glass Slides ◽  
Search Tool ◽  
Hematoxylin And Eosin ◽  
Whole Slide Images

Context.— Pathologists may encounter extraneous pieces of tissue (tissue floaters) on glass slides because of specimen cross-contamination. Troubleshooting this problem, including performing molecular tests for tissue identification if available, is time consuming and often does not satisfactorily resolve the problem. Objective.— To demonstrate the feasibility of using an image search tool to resolve the tissue floater conundrum. Design.— A glass slide was produced containing 2 separate hematoxylin and eosin (H&E)-stained tissue floaters. This fabricated slide was digitized along with the 2 slides containing the original tumors used to create these floaters. These slides were then embedded into a dataset of 2325 whole slide images comprising a wide variety of H&E stained diagnostic entities. Digital slides were broken up into patches and the patch features converted into barcodes for indexing and easy retrieval. A deep learning-based image search tool was employed to extract features from patches via barcodes, hence enabling image matching to each tissue floater. Results.— There was a very high likelihood of finding a correct tumor match for the queried tissue floater when searching the digital database. Search results repeatedly yielded a correct match within the top 3 retrieved images. The retrieval accuracy improved when greater proportions of the floater were selected. The time to run a search was completed within several milliseconds. Conclusions.— Using an image search tool offers pathologists an additional method to rapidly resolve the tissue floater conundrum, especially for those laboratories that have transitioned to going fully digital for primary diagnosis.

scholarly journals Two Ensemble-CNN Approaches for Colorectal Cancer Tissue Type Classification

2021 ◽  
Vol 7 (3) ◽  
pp. 51
Author(s):  
Emanuela Paladini ◽  
Edoardo Vantaggiato ◽  
Fares Bougourzi ◽  
Cosimo Distante ◽  
Abdenour Hadid ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Deep Learning ◽  
Digital Pathology ◽  
Texture Features ◽  
Tissue Type ◽  
Cancer Tissue ◽  
Learning Methods ◽  
Feature Based ◽  
Type Classification ◽  
Whole Slide Images

In recent years, automatic tissue phenotyping has attracted increasing interest in the Digital Pathology (DP) field. For Colorectal Cancer (CRC), tissue phenotyping can diagnose the cancer and differentiate between different cancer grades. The development of Whole Slide Images (WSIs) has provided the required data for creating automatic tissue phenotyping systems. In this paper, we study different hand-crafted feature-based and deep learning methods using two popular multi-classes CRC-tissue-type databases: Kather-CRC-2016 and CRC-TP. For the hand-crafted features, we use two texture descriptors (LPQ and BSIF) and their combination. In addition, two classifiers are used (SVM and NN) to classify the texture features into distinct CRC tissue types. For the deep learning methods, we evaluate four Convolutional Neural Network (CNN) architectures (ResNet-101, ResNeXt-50, Inception-v3, and DenseNet-161). Moreover, we propose two Ensemble CNN approaches: Mean-Ensemble-CNN and NN-Ensemble-CNN. The experimental results show that the proposed approaches outperformed the hand-crafted feature-based methods, CNN architectures and the state-of-the-art methods in both databases.

scholarly journals A deep-learning-based prognostic nomogram integrating microscopic digital pathology and macroscopic magnetic resonance images in nasopharyngeal carcinoma: a multi-cohort study

2020 ◽  
Vol 12 ◽  
pp. 175883592097141
Author(s):  
Fan Zhang ◽  
Lian-Zhen Zhong ◽  
Xun Zhao ◽  
Di Dong ◽  
Ji-Jin Yao ◽  
...  
Keyword(s):  
Deep Learning ◽  
Magnetic Resonance ◽  
Nasopharyngeal Carcinoma ◽  
Treatment Failure ◽  
Digital Pathology ◽  
Imaging Features ◽  
Multi Scale ◽  
External Test ◽  
Whole Slide Images ◽  
Independent Cohort

Background: To explore the prognostic value of radiomics-based and digital pathology-based imaging biomarkers from macroscopic magnetic resonance imaging (MRI) and microscopic whole-slide images for patients with nasopharyngeal carcinoma (NPC). Methods: We recruited 220 NPC patients and divided them into training ( n = 132), internal test ( n = 44), and external test ( n = 44) cohorts. The primary endpoint was failure-free survival (FFS). Radiomic features were extracted from pretreatment MRI and selected and integrated into a radiomic signature. The histopathological signature was extracted from whole-slide images of biopsy specimens using an end-to-end deep-learning method. Incorporating two signatures and independent clinical factors, a multi-scale nomogram was constructed. We also tested the correlation between the key imaging features and genetic alternations in an independent cohort of 16 patients (biological test cohort). Results: Both radiomic and histopathologic signatures presented significant associations with treatment failure in the three cohorts (C-index: 0.689–0.779, all p < 0.050). The multi-scale nomogram showed a consistent significant improvement for predicting treatment failure compared with the clinical model in the training (C-index: 0.817 versus 0.730, p < 0.050), internal test (C-index: 0.828 versus 0.602, p < 0.050) and external test (C-index: 0.834 versus 0.679, p < 0.050) cohorts. Furthermore, patients were stratified successfully into two groups with distinguishable prognosis (log-rank p < 0.0010) using our nomogram. We also found that two texture features were related to the genetic alternations of chromatin remodeling pathways in another independent cohort. Conclusion: The multi-scale imaging features showed a complementary value in prognostic prediction and may improve individualized treatment in NPC.

Report and Recommendations of an International Workshop on Promotion of the Regulatory Acceptance of Validated Non-animal Toxicity Test Procedures

1990 ◽  
Vol 18 (1_part_1) ◽  
pp. 339-344 ◽  
Author(s):  
Michael Balls ◽  
Philip Botham ◽  
André Cordier ◽  
Silvano Fumero ◽  
Detlef Kayser ◽  
...  
Keyword(s):  
Toxicity Test ◽  
International Workshop ◽  
Test Procedures ◽  
Animal Toxicity ◽  
Regulatory Acceptance

scholarly journals Integrated Pathology Informatics Enables High-Quality Personalized and Precision Medicine: Digital Pathology and Beyond

2017 ◽  
Vol 142 (3) ◽  
pp. 369-382 ◽  
Author(s):  
Zoya Volynskaya ◽  
Hung Chow ◽  
Andrew Evans ◽  
Alan Wolff ◽  
Cecilia Lagmay-Traya; ◽  
...  
Keyword(s):  
Data Collection ◽  
Precision Medicine ◽  
Critical Role ◽  
Digital Pathology ◽  
Geographic Area ◽  
Whole Slide Imaging ◽  
High Quality ◽  
Pathology Informatics ◽  
Prognosis And Prediction ◽  
The Right

Context.— The critical role of pathology in diagnosis, prognosis, and prediction demands high-quality subspecialty diagnostics that integrates information from multiple laboratories. Objective.— To identify key requirements and to establish a systematic approach to providing high-quality pathology in a health care system that is responsible for services across a large geographic area. Design.— This report focuses on the development of a multisite pathology informatics platform to support high-quality surgical pathology and hematopathology using a sophisticated laboratory information system and whole slide imaging for histology and immunohistochemistry, integrated with ancillary tools, including electron microscopy, flow cytometry, cytogenetics, and molecular diagnostics. Results.— These tools enable patients in numerous geographic locations access to a model of subspecialty pathology that allows reporting of every specimen by the right pathologist at the right time. The use of whole slide imaging for multidisciplinary case conferences enables better communication among members of patient care teams. The system encourages data collection using a discrete data synoptic reporting module, has implemented documentation of quality assurance activities, and allows workload measurement, providing examples of additional benefits that can be gained by this electronic approach to pathology. Conclusion.— This approach builds the foundation for accurate big data collection and high-quality personalized and precision medicine.

scholarly journals Vulnerability of bridges to scour: insights from an international expert elicitation workshop

2017 ◽  
Vol 17 (8) ◽  
pp. 1393-1409 ◽  
Author(s):  
Rob Lamb ◽  
Willy Aspinall ◽  
Henry Odbert ◽  
Thorsten Wagener
Keyword(s):  
Risk Mitigation ◽  
Good Practice ◽  
Expert Elicitation ◽  
Residual Risk ◽  
Bridge Scour ◽  
International Expert ◽  
Quantitative Estimates ◽  
Bridge Failure ◽  
Expert Workshop ◽  
Failure Probabilities

Abstract. Scour (localised erosion) during flood events is one of the most significant threats to bridges over rivers and estuaries, and has been the cause of numerous bridge failures, with damaging consequences. Mitigation of the risk of bridges being damaged by scour is therefore important to many infrastructure owners, and is supported by industry guidance. Even after mitigation, some residual risk remains, though its extent is difficult to quantify because of the uncertainties inherent in the prediction of scour and the assessment of the scour risk. This paper summarises findings from an international expert workshop on bridge scour risk assessment that explores uncertainties about the vulnerability of bridges to scour. Two specialised structured elicitation methods were applied to explore the factors that experts in the field consider important when assessing scour risk and to derive pooled expert judgements of bridge failure probabilities that are conditional on a range of assumed scenarios describing flood event severity, bridge and watercourse types and risk mitigation protocols. The experts' judgements broadly align with industry good practice, but indicate significant uncertainty about quantitative estimates of bridge failure probabilities, reflecting the difficulty in assessing the residual risk of failure. The data and findings presented here could provide a useful context for the development of generic scour fragility models and their associated uncertainties.

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