AIMS: Digital pathology (DP) offers advantages over glass slide microscopy (GS), but data demonstrating a statistically valid equivalent (i.e. non-inferior) performance of DP against GS are required to permit its use in diagnosis. The aim of this study is to provide evidence of non-inferiority. METHODS AND RESULTS: Seventeen pathologists re-reported 3017 cases by DP. Of these, 1009 were re-reported by the same pathologist, and 2008 by a different pathologist. Re-examination of 10 138 scanned slides (2.22 terabytes) produced 72 variances between GS and DP reports, including 21 clinically significant variances. Ground truth lay with GS in 12 cases and with DP in nine cases. These results are within the 95% confidence interval for existing intraobserver and interobserver variability, proving that DP is non-inferior to GS. In three cases, the digital platform was deemed to be responsible for the variance, including a gastric biopsy, where Helicobacter pylori only became visible on slides scanned at the ×60 setting, and a bronchial biopsy and penile biopsy, where dysplasia was reported on DP but was not present on GS. CONCLUSIONS: This is one of the largest studies proving that DP is equivalent to GS for the diagnosis of histopathology specimens. Error rates are similar in both platforms, although some problems e.g. detection of bacteria, are predictable.
AIMS: Digital pathology (DP) offers advantages over glass slide microscopy (GS), but data demonstrating a statistically valid equivalent (i.e. non-inferior) performance of DP against GS are required to permit its use in diagnosis. The aim of this study is to provide evidence of non-inferiority. METHODS AND RESULTS: Seventeen pathologists re-reported 3017 cases by DP. Of these, 1009 were re-reported by the same pathologist, and 2008 by a different pathologist. Re-examination of 10 138 scanned slides (2.22 terabytes) produced 72 variances between GS and DP reports, including 21 clinically significant variances. Ground truth lay with GS in 12 cases and with DP in nine cases. These results are within the 95% confidence interval for existing intraobserver and interobserver variability, proving that DP is non-inferior to GS. In three cases, the digital platform was deemed to be responsible for the variance, including a gastric biopsy, where Helicobacter pylori only became visible on slides scanned at the ×60 setting, and a bronchial biopsy and penile biopsy, where dysplasia was reported on DP but was not present on GS. CONCLUSIONS: This is one of the largest studies proving that DP is equivalent to GS for the diagnosis of histopathology specimens. Error rates are similar in both platforms, although some problems e.g. detection of bacteria, are predictable.
Authors: Anna Luíza Damaceno Araújo; Lady Paola Aristizábal Arboleda; Natalia Rangel Palmier; Jéssica Montenegro Fonsêca; Mariana de Pauli Paglioni; Wagner Gomes-Silva; Ana Carolina Prado Ribeiro; Thaís Bianca Brandão; Luciana Estevam Simonato; Paul M Speight; Felipe Paiva Fonseca; Marcio Ajudarte Lopes; Oslei Paes de Almeida; Pablo Agustin Vargas; Cristhian Camilo Madrid Troconis; Alan Roger Santos-Silva Journal: Virchows Arch Date: 2019-01-26 Impact factor: 4.064
Authors: Matthew G Hanna; Orly Ardon; Victor E Reuter; Sahussapont Joseph Sirintrapun; Christine England; David S Klimstra; Meera R Hameed Journal: Mod Pathol Date: 2021-10-01 Impact factor: 7.842
Authors: Tracy Onega; Raymond L Barnhill; Michael W Piepkorn; Gary M Longton; David E Elder; Martin A Weinstock; Stevan R Knezevich; Lisa M Reisch; Patricia A Carney; Heidi D Nelson; Andrea C Radick; Joann G Elmore Journal: JAMA Dermatol Date: 2018-10-01 Impact factor: 10.282
Authors: Rupali Mankar; Carlos E Bueso-Ramos; C Cameron Yin; Juliana Elisa Hidalgo-Lopez; Sebastian Berisha; Mustafa Kansiz; David Mayerich Journal: Anal Chem Date: 2019-12-13 Impact factor: 6.986
Authors: M Babawale; A Gunavardhan; J Walker; T Corfield; P Huey; A Savage; A Bansal; M Atkinson; H Abdelsalam; E Raweily; A Christian; I Evangelou; D Thomas; J Shannon; E Youd; P Brumwell; J Harrison; I Thompson; M Rashid; G Leopold; A Finall; S Roberts; D Housa; P Nedeva; A Davies; D Fletcher; Muhammad Aslam Journal: J Pathol Inform Date: 2021-01-23