Diagnosing Cervical Neoplasia in Rural Brazil Using a Mobile Van Equipped with In Vivo Microscopy: A Cluster-Randomized Community Trial
Diagnosing Cervical Neoplasia in Rural Brazil Using a Mobile Van Equipped with In Vivo Microscopy: A Cluster-Randomized Community Trial
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DOI：
10.1158/1940-6207.capr-17-0265
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发表时间：
2018-06-01
影响因子：
3.3
通讯作者：
Richards-Kortum, Rebecca
中科院分区：
文献类型：
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作者：
Hunt, Brady;Tavares Guerreiro Fregnani, Jose Humberto;Richards-Kortum, Rebecca
宫颈癌是巴西医疗服务不足地区的主要死因。这项前瞻性随机试验涉及巴西南部/中部200名巴氏试验异常的妇女。受试者按地理分组进行随机分组，并在移动的货车按计划访问当地社区或在中心医院进行诊断评估。两组受试者均接受阴道镜检查、体内显微镜检查和宫颈活检。我们比较了研究组之间的诊断随访完成率，并评价了体内显微镜检查与阴道镜检查的诊断性能。转诊至移动的货车（102/117，87%）的患者的诊断随访完成率与中心医院（53/83，64%; P = 0.0001;风险比= 1.37，95% CI，1.14-1.63）相比，绝对增加23%，相对增加37%。在144例患者的229个宫颈部位中，阴道镜检查确定了诊断为宫颈上皮内瘤变2级或更严重（CIN 2-; 85个部位）的部位，灵敏度为94%（95%CI，87%-98%），特异性为50%（95%CI，42%-58%）。采用实时自动图像分析的体内显微镜检查识别CIN 2+的灵敏度为92%（95% CI，84%-97%），特异性为48%（95% CI，40%-56%）。与转诊到中心医院的妇女相比，转诊到移动的货车的妇女更有可能完成诊断随访，而不会影响临床护理。在移动的货车中的体内显微镜检查提供了与阴道镜检查相似的灵敏度和特异性的自动诊断成像。(C)2018年AACR。
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, in vivo microscopy, and cervical biopsies. We compared rates of diagnostic follow-up completion between study arms, and also evaluated the diagnostic performance of in vivo 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%; P = 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%). In vivo 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. In vivo microscopy in a mobile van provides automated diagnostic imaging with sensitivity and specificity similar to colposcopy. (C) 2018 AACR.