Automation-assisted versus manual reading of cervical cytology (MAVARIC): a randomised controlled trial
Automation-assisted versus manual reading of cervical cytology (MAVARIC): a randomised controlled trial
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DOI：
10.1016/s1470-2045(10)70264-3
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发表时间：
2011-01-01
期刊：
影响因子：
51.1
通讯作者：
Moss, Sue
中科院分区：
文献类型：
--
作者：
Kitchener, Henry C.;Blanks, Roger;Moss, Sue
背景宫颈细胞学检查的阅读标准是细胞筛查者使用常规显微镜在整个载玻片上手动搜索异常细胞。自动化技术可以选择视野来评估异常细胞，这允许细胞筛选器进行靶向阅读。在手动评估与自动阅读在细胞学（MAVARIC）试验，我们比较了这些技术的准确性，为检测潜在的diseases.Methods的随机对照试验，妇女年龄25-64岁，在英国曼彻斯特接受初级宫颈筛查，随机分配（1：2），要么只接受手动阅读或配对阅读（自动化。辅助阅读和手动阅读），2006年3月1日至2009年2月28日。在配对组中，使用两种自动化系统ThinPrep成像系统和FocalPoint GS成像系统。全科诊所和社区诊所被随机分配到ThinPrep或SurePath（用于FocalPoint系统）液基细胞学检查组，并按剥夺指数分层进行区组随机化。然后将样本单独随机分配至仅手动阅读或仅配对阅读。实验室工作人员不知道每个载玻片的分配情况，并一直隐瞒到报告过程结束。主要结果是自动辅助阅读相对于手动阅读在配对组中检测潜在的宫颈上皮内瘤变2级或更严重（CIN 2+）的灵敏度。24688例分配给仅手动臂，48578例分配给配对阅读臂。自动辅助阅读的敏感性比手动阅读低8（相对灵敏度0.92，95% CI 0.89-0.95），相当于灵敏度绝对降低6.3%，假设手动阅读的灵敏度为79%。自动辅助阅读相对于手动阅读的特异性增加了0.6%（1.006，95%CI 1.005-1.007）。解释自动辅助阅读检测CIN 2+的灵敏度较低，结合特异性的无关紧要的增加，表明不能推荐自动辅助阅读用于初级宫颈筛查。
Background The standard for reading cervical cytology is for a cytoscreener to manually search across an entire slide for abnormal cells using a conventional microscope. Automated technology can select fields of view to assess abnormal cells, which allows targeted reading by cytoscreeners. In the Manual Assessment Versus Automated Reading In Cytology (MAVARIC) trial, we compared the accuracy of these techniques for the detection of underlying disease.Methods For this randomised controlled trial, women aged 25-64 years undergoing primary cervical screening in Manchester, UK, were randomly assigned (1:2) to receive either manual reading only or paired reading (automation. assisted reading and manual reading), between March 1, 2006, and Feb 28, 2009. In the paired arm, two automated systems were used the ThinPrep Imaging System and the FocalPoint GS Imaging System. General practices and community clinics were randomised to either ThinPrep or to SurePath (for the FocalPoint system) liquid-based cytology with block randomisation stratified by deprivation index. Samples were then individually randomised to manual reading only or paired reading only. Laboratory staff were unaware of the allocation of each slide and concealment was maintained until the end of the reporting process. The primary outcome was sensitivity of automation-assisted reading relative to manual reading for the detection of underlying cervical intraepithelial neoplasia grade 2 or worse (CIN2+) in the paired arm. This trial is registered, number ISRCTN66377374.Findings 73 266 liquid-based cytology samples were obtained from women undergoing primary cervical screening; 24 688 allocated to the manual-only arm and 48 578 to the paired-reading arm. Automation-assisted reading was 8% less sensitive than manual reading (relative sensitivity 0.92, 95% CI 0.89-0.95), which was equivalent to an absolute reduction in sensitivity of 6.3%, assuming the sensitivity of manual reading to be 79%. Specificity of automation-assisted reading relative to manual reading increased by 0.6% (1.006, 95% CI 1.005-1.007).Interpretation The inferior sensitivity of automation-assisted reading for the detection of CIN2+, combined with an inconsequential increase in specificity, suggests that automation-assisted reading cannot be recommended for primary cervical screening.