Goacher Edward, Randell Rebecca, Williams Bethany, Treanor Darren
From the Faculty of Medicine and Health (Mr Goacher and Dr Treanor) and the School of Healthcare (Dr Randell), University of Leeds, Leeds, West Yorkshire, England; and the Department of Histopathology, Leeds Teaching Hospitals, National Health Service Trust, Leeds (Ms Williams and Dr Treanor).
Arch Pathol Lab Med. 2017 Jan;141(1):151-161. doi: 10.5858/arpa.2016-0025-RA. Epub 2016 Jul 11.
-Light microscopy (LM) is considered the reference standard for diagnosis in pathology. Whole slide imaging (WSI) generates digital images of cellular and tissue samples and offers multiple advantages compared with LM. Currently, WSI is not widely used for primary diagnosis. The lack of evidence regarding concordance between diagnoses rendered by WSI and LM is a significant barrier to both regulatory approval and uptake.
-To examine the published literature on the concordance of pathologic diagnoses rendered by WSI compared with those rendered by LM.
-We conducted a systematic review of studies assessing the concordance of pathologic diagnoses rendered by WSI and LM. Studies were identified following a systematic search of Medline (Medline Industries, Mundelein, Illinois), Medline in progress (Medline Industries), EMBASE (Elsevier, Amsterdam, the Netherlands), and the Cochrane Library (Wiley, London, England), between 1999 and March 2015.
-Thirty-eight studies were included in the review. The mean diagnostic concordance of WSI and LM, weighted by the number of cases per study, was 92.4%. The weighted mean κ coefficient between WSI and LM was 0.75, signifying substantial agreement. Of the 30 studies quoting percentage concordance, 18 (60%) showed a concordance of 90% or greater, of which 10 (33%) showed a concordance of 95% or greater. This review found evidence to support a high level of diagnostic concordance. However, there were few studies, many were small, and they varied in quality, suggesting that further validation studies are still needed.
光学显微镜检查（LM）被认为是病理学诊断的参考标准。全玻片成像（WSI）可生成细胞和组织样本的数字图像，与LM相比具有多种优势。目前，WSI尚未广泛用于初步诊断。缺乏关于WSI和LM诊断一致性的证据是监管批准和应用的重大障碍。
研究已发表的关于WSI与LM病理诊断一致性的文献。
我们对评估WSI和LM病理诊断一致性的研究进行了系统评价。通过对1999年至2015年3月期间的医学文献数据库（Medline Industries，伊利诺伊州芒德林）、医学文献数据库（在研）（Medline Industries）、荷兰医学文摘数据库（EMBASE）（爱思唯尔，荷兰阿姆斯特丹）和考科蓝图书馆（威利，英国伦敦）进行系统检索来确定研究。
本评价纳入了38项研究。按每项研究的病例数加权后，WSI和LM的平均诊断一致性为92.4%。WSI和LM之间的加权平均κ系数为0.75，表示一致性较高。在30项引用一致性百分比的研究中，18项（60%）显示一致性达到90%或更高，其中10项（33%）显示一致性达到95%或更高。本评价发现有证据支持高水平的诊断一致性。然而，研究数量较少，许多研究规模较小，且质量参差不齐，这表明仍需要进一步的验证研究。
