1Department of Hospital Pathology, College of Medicine, The Catholic University of Korea, Seoul, Korea
2Department of Pathology, Dong-A University College of Medicine, Busan, Korea
3Department of Pathology, Seoul Clinical Laboratories, Yongin, Korea
4Department of Pathology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
5Department of Pathology, TCM Laboratory, Seongnam, Korea
6Department of Pathology, Catholic Kwandong University College of Medicine, Gangneung, Korea
© 2020 The Korean Society of Pathologists/The Korean Society for Cytopathology
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Ethics Statement
This work was reviewed and approved by the Institutional Review Board of The Catholic University of Korea (SC19ZCSI0173).
Author contributions
Conceptualization: YC, DCK (Dae Cheol Kim), CKJ, DCK (Dong-chul Kim), SYS, HJJ, SYY. Data curation: YC, DCK (Dae Cheol Kim), DCK (Dong-chul Kim). Funding acquisition: SYY. Investigation: YC, DCK (Dae Cheol Kim), CKJ, DCK (Dong-chul Kim), SYS, HJJ, SYY. Methodology: YC, DCK (Dae Cheol Kim), SYY. Project administration: DCK (Dae Cheol Kim), CKJ, SYS, HJJ, SYY. Resources: YC, DCK (Dae Cheol Kim), CKJ, DCK (Dong-chul Kim). Supervision: SYS, HJJ, SYY. Validation: YC, DCK (Dae Cheol Kim), CKJ, DCK (Dong-chul Kim), SYS, HJJ, SYY. Visualization: YC, DCK (Dae Cheol Kim). Writing—original draft: YC, DCK (Dae Cheol Kim), SYY. Writing—review & editing: YC, DCK (Dae Cheol Kim), CKJ, DCK (Dong-chul Kim), SYS, HJJ, SYY. Approval of final manuscript: all authors.
Conflicts of Interest
C.K.J., the editor-in-chief and Y.C., contributing editor of the Journal of Pathology and Translational Medicine, were not involved in the editorial evaluation or decision to publish this article. All remaining authors have declared no conflicts of interest.
Funding Statement
This research was supported by The Korean Society of Pathologists Grant (KSPG2019-03).
Country | Guideline and instruction | |
---|---|---|
Canada | Canadian Association of Pathologists (CAP-ACP) | |
2014: Guidelines from the Canadian Association of Pathologists for establishing a telepathology service for anatomic pathology using whole-slide imaging [11] | ||
United States | College of American Pathologists (CAP) | |
2013: Validating whole-slide imaging for diagnostic purposes in pathology [30] | ||
2011: Anatomic pathology checklist: CAP accreditation program [12] | ||
American Telemedicine Association (ATA) | ||
2014: Clinical guidelines for telepathology [13] | ||
Digital Pathology Association (DPA) | ||
2019: Computational pathology definitions, best practices, and recommendations for regulatory guidance: a white paper from the Digital Pathology Association [29] | ||
2011: Validation of digital pathology in a healthcare environment [14] | ||
2011: Archival and retrieval in digital pathology systems [15] | ||
2011: Interoperability between anatomic pathology laboratory information systems and digital pathology systems [16] | ||
2011: Validation of digital pathology systems in the regulated nonclinical environment [17] | ||
Food and Drug Administration (FDA) | ||
2015: Technical performance assessment of digital pathology whole-slide imaging devices: draft guidance for industry and Food and Drug Administration staff [18] | ||
Centers for Medicare & Medicaid Services (CMS) | ||
2015: Clinical Laboratory Improvement Amendments (CLIA) [19] | ||
Centers for Disease Control and Prevention (CDC) | ||
2013: Clinical Laboratory Improvement Advisory Committee (CLIAC) [20] | ||
Society of Toxicologic Pathology | ||
2013: Validation of digital pathology systems in the regulated nonclinical environment [17] | ||
2007: Pathology position paper on pathology image data [22] | ||
European Union | European Commission (EC) | |
2012: Guidelines on the qualification and classification of stand alone software used in healthcare within the regulatory framework of medical devices [23] | ||
Spain | Spanish Society of Anatomic Pathology (SEAP-IAP) | |
2015: Practical guidelines for digital pathology implementation [9] | ||
United Kingdom | The Royal College of Pathologists (RCP) | |
2018: Best practice recommendations for implementing digital pathology [6] | ||
2013: Telepathology: guidance from The Royal College of Pathologists [24] | ||
Germany | Federal Association of German Pathologist (FAGP-BDP) | |
2018: Guidelines digital pathology for diagnosis on (and reports of) digital image [10] | ||
Australia | The Royal College of Pathologists of Australasia (RCPA) | |
2014: Position statement: telepathology [25] | ||
Japan | Japanese Society of Pathology (JSP) | |
2019: Guidelines for pathologic diagnosis using digital pathology image (clinical questions and answers) [5] | ||
2018: Technical standards for digital pathology system for pathologic diagnosis ver. 3 [7] | ||
2016: Guidelines for pathologic diagnosis using digital pathology image [26] | ||
2016: Technical standards for digital pathology system for pathologic diagnosis ver. 2 [26] | ||
2015: Technical standards for digital pathology system for pathologic diagnosis ver. 1 [28] | ||
Korea | Korean Society of Pathologists (KSP) | |
2019: Preparation of reimbursement assessment guidelines for AI-based medical technology (pathology) [3] |
Year | Author | Journal | No. of samples/observers | Results | Evidence level | Reference No. |
---|---|---|---|---|---|---|
2006 | Gilbertson et al. | BMC Clin Pathol | 25 Mixed/3 | 32% Discordancy | IV | [31] |
2011 | Jukic et al. | Arch Pathol Lab Med | 101 Mixed/3 | 3%–7% discordancy | III | [32] |
2012 | Al-Janabi et al. | J Clin Pathol | 100 Breast | Kappa = 0.92 | IV | [33] |
2012 | Al-Janabi et al. | Hum Pathol | 100 GI | 5% Discordancy (minor) | IV | [34] |
2012 | Al-Janabi et al. | J Clin Pathol | 100 Skin | 6% Discordancy (minor) | IV | [35] |
2013 | Al-Janabi et al. | J Clin Pathol | 100 Pediatric | WSI: 10% discordancy | IV | [36] |
Glass: 7% discordancy | ||||||
2013 | Bauer et al. | Arch Pathol Lab Med | 607 Mixed | WSI: 1.65% discordancy | III | [37] |
Glass: 0.99% discordancy | ||||||
2013 | Krishnamurthy et al. | Arch Pathol Lab Med | 100 Breast | WSI: 9.5% discordancy | III | [38] |
Glass: 7.9% discordancy | ||||||
2013 | Pantanowitz et al. | Arch Pathol Lab Med | Meta-analysis of 27 papers | - | III | [30] |
2014 | Al-Janabi et al. | J Renal Inj Prev | 100 GU | 13% Discordancy | III | [39] |
2014 | Buck et al. | J Pathol Inform | 150 Mixed/6 | WSI: 2.1%–10.1% discordancy | III | [40] |
Glass: 3.3%–13.3% discordancy | ||||||
2014 | Reyes et al. | J Pathol Inform | 103 Breast /3 | WSI: 1%–4% discordancy | III | [41] |
Glass: 0%–7% discordancy | ||||||
2015 | Ordi et al. | J Clin Pathol | 452 GYN/2 | 5.8% Discordancy | III | [42] |
2016 | Pekmezci et al. | J Pathol Inform | 97 neuro/2 | 5.1%–12% Discordancy | III | [43] |
2016 | Snead et al. | Histopathology | 3,017/17 (2,666 biopsy, 340 surgery, 11 frozen, 10 organs) | 1.3% Discordancy | III | [44] |
2016 | Wack et al. | J Pathol Inform | 33 Mixed/16 | WSI: 20.9% discordancy | III | [45] |
Glass: 23.5% discordancy | ||||||
2017 | Kent et al. | JAMA Dermatol | 499 Skin/3 | WSI: 6% discordancy | III | [46] |
Glass: 6% discordancy | ||||||
2017 | Saco et al. | Dig Liver Dis | 176 Liver/2 | 3.4%–9.7% discordancy | III | [47] |
2017 | Tabata et al. | Pathol Int | 1,070 Mixed/9 | 4.4% discordancy | III | [48] |
2018 | Araujo et al. | Virchow Arch | 70 Oral/2 | 3% Discordancy | III | [49] |
2018 | Lee et al. | Am J Dermatopathol | 77 Skin/2 | 0.3% Discordancy | III | [50] |
2018 | Mukhopadhyay et al. | Am J Surg Pathol | 1,992 Mixed/16 | WSI: 4.9% discordancy | III | [51] |
Glass: 4.6% discordancy |
Evidence level in the table is as follows.
I, Systematic review or meta-analysis; II, At least one randomized controlled study; III, Non-randomized clinical trial (NRCT); IV, Analytic epidemiological study (cohort or case-controlled study); V, Descriptive study (case report or case series); VI, Expert opinion.
GI, gastrointestinal; WSI, whole slide imaging; GU, genitourinary; GYN, gynecopathology.
CAPa (US) [55] | SEAP (Spain) [9] | FAGP (Germany) [10] | JSP (Japan) [7] | |
---|---|---|---|---|
Published year | 2015 | 2015 | 2018 | 2019 |
Screen resolution (pixels) | 1,280 × 1,024 | 1,920 × 1,080 | 2560 × 1600 | 1,280 × 1,024 |
Screen size (inch) | 17 or 19 | 22 | 27 | 19.3 |
Pixel pitch (mm) | - | - | - | ≤ 0.33 |
Luminance (cd/m2) | - | ≥ 100 | ≥ 300 | ≥ 170 |
Luminance ratio (contrast ratio) | - | 1,000–1,600:1 | - | ≥ 250:1 |
Minimum luminance (cd/m2) | - | - | ≥ 0.5 | - |
CAP, College of American Pathologists; SEAP, Society of Anatomic Pathology; FAGP, Federal Association of German Pathologist; JSP, Japanese Society of Pathology.
a Results of validation studies conducted based on U.S. CAP guidelines [55].