Rice University, Department of Bioengineering, Houston, Texas.
Barretos Cancer Hospital, Barretos, SP, Brazil.
Cancer Prev Res (Phila). 2018 Jun;11(6):359-370. doi: 10.1158/1940-6207.CAPR-17-0265. Epub 2018 Apr 4.
Cervical cancer is a leading cause of death in underserved areas of Brazil. This prospective randomized trial involved 200 women in southern/central Brazil with abnormal Papanicolaou tests. Participants were randomized by geographic cluster and referred for diagnostic evaluation either at a mobile van upon its scheduled visit to their local community, or at a central hospital. Participants in both arms underwent colposcopy, microscopy, and cervical biopsies. We compared rates of diagnostic follow-up completion between study arms, and also evaluated the diagnostic performance of microscopy compared with colposcopy. There was a 23% absolute and 37% relative increase in diagnostic follow-up completion rates for patients referred to the mobile van (102/117, 87%) compared with the central hospital (53/83, 64%; = 0.0001; risk ratio = 1.37, 95% CI, 1.14-1.63). In 229 cervical sites in 144 patients, colposcopic examination identified sites diagnosed as cervical intraepithelial neoplasia grade 2 or more severe (CIN2+; 85 sites) with a sensitivity of 94% (95% CI, 87%-98%) and specificity of 50% (95% CI, 42%-58%). microscopy with real-time automated image analysis identified CIN2+ with a sensitivity of 92% (95% CI, 84%-97%) and specificity of 48% (95% CI, 40%-56%). Women referred to the mobile van were more likely to complete their diagnostic follow-up compared with those referred to a central hospital, without compromise in clinical care. microscopy in a mobile van provides automated diagnostic imaging with sensitivity and specificity similar to colposcopy. .
宫颈癌是巴西服务欠缺地区的主要死亡原因。本前瞻性随机试验纳入了巴西南部/中部地区 200 名巴氏涂片检查异常的妇女。参与者按地理聚类随机分组,并根据计划访问其当地社区的移动车或中心医院进行诊断评估。两组参与者均接受阴道镜检查、显微镜检查和宫颈活检。我们比较了研究组之间诊断性随访完成率,并评估了显微镜检查与阴道镜检查的诊断性能。与转诊至中心医院(53/83,64%; = 0.0001;风险比=1.37,95%CI,1.14-1.63)相比,转诊至移动车的患者(102/117,87%)的诊断性随访完成率绝对增加了 23%,相对增加了 37%。在 144 名患者的 229 个宫颈部位中,阴道镜检查识别出诊断为宫颈上皮内瘤变 2 级或更严重(CIN2+;85 个部位)的部位,其敏感性为 94%(95%CI,87%-98%),特异性为 50%(95%CI,42%-58%)。实时自动图像分析显微镜检查识别 CIN2+的敏感性为 92%(95%CI,84%-97%),特异性为 48%(95%CI,40%-56%)。与转诊至中心医院的患者相比,转诊至移动车的患者更有可能完成其诊断性随访,而不会影响临床护理。移动车中的显微镜检查提供了与阴道镜检查相似的敏感性和特异性的自动化诊断成像。