Abstract
Supplementary Materials
Notes
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.
ACKNOWLEDGMENTS
References
Table 1.
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2015: Technical performance assessment of digital pathology whole-slide imaging devices: draft guidance for industry and Food and Drug Administration staff [18] | ||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] |
Table 2.
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.
Table 3.
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].