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Introduction:
Digital microscopy (DM) is increasingly feasible for research and diagnostic laboratories because of recent technical developments of WSI scanners and software solutions. Regardless, there are many unsolved questions concerning the new digitalized workflow on accuracy, efficiency, acceptance, reliability, and many more. Before integration into routine practice, laboratories need to ensure that pathologists are able to render at least equivalent diagnosis/data as with light microscopy (LM).
Materials and Methods:
We performed a literature review of guidelines and validations studies on interactive DM in veterinary and human pathology. Additionally, experience gained from an own academic validation study is shared.1
Results:
Currently there are only few academic validation studies in veterinary pathology with the focus on canine cutaneous tumors or cytology. A sufficient and reliable performance of DM has been proven for many further subspecialties in human pathology. Guidelines for the methodology of clinical validation are available in human pathology and assure that studies are conducted with minimal risk of systematic bias.2 Among others, studies should consider size of the sample set, order of the used modality and included samples, length of the washout periods, and intended uses of DM. We also recommend to include several pathologists and a training set for participants without prior experience with DM. It is recommended that validation should at least gain information on intra-observer diagnostic concordance between the two modalities DM and LM. However, as the concordance percentages as well as tests for agreement (Cohen’s κ test) cannot indicate equivalency of DM to the established LM workflow, we consider it highly beneficial to additionally determine intra-observer concordance within LM as the reference modality. This value can be used as a guidance level or for additional statistical comparison such as by a 1-sided binominal non-inferiority test. Further indicators of an appropriate workflow may include required time for diagnosis, diagnosis confidence, and perceived technical quality of the slides.
Discussion and Conclusion:
Further validations studies and expert consensus are required to promote integration of this information technology into the veterinary pathologist’s routine workflow and to overcome legal restrictions.
Acknowledgement:
Christof A. Bertram gratefully acknowledges financial support from the Dres. Jutta & Georg Bruns- Stiftung für innovative Veterinärmedizin. References: 1 Bertram CA, Gurtner C, Dettwiler M, et al. Validation of digital microscopy compared with light microscopy for the diagnosis of canine cutaneous tumors. Vet Pathol. 2018;55:490-500. 2 Pantanowitz L, Sinard JH, Henricks WH, et al. Validating whole slide imaging for diagnostic purposes in pathology: guideline from the College of American Pathologists Pathology and Laboratory Quality Center. Arch Pathol Lab Med. 2013;137:1710-1722.