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墨西哥两个地区巴氏涂片检查的诊断可重复性:对质量控制机制的需求。

Diagnostic reproducibility of Pap testing in two regions of Mexico: the need for quality control mechanisms.

作者信息

de Ruíz P A, Lazcano Ponce E C, Duarte Torres R, Ruíz Juárez I, Martínez Cortez I

机构信息

Pathology Unit, National Autonomous University of Mexico, General Hospital, Ministry of Health, Mexico City, Mexico.

出版信息

Bull Pan Am Health Organ. 1996 Dec;30(4):330-8.

PMID:9041744
Abstract

To assess the reproducibility of diagnostic results obtained by examining Pap smears for cervical neoplasia, a study was conducted using a single group of 20 Pap smears, 3 negative and 17 from patients with varying degrees of neoplasia. These smears were examined by 14 volunteer readers (13 cytotechnologists and 1 cytopathologist) from the Mexican states of Oaxaca and Veracruz, and also by a highly experienced cytopathologist certified by the Mexican Board of Pathological Anatomy whose work provided a reference standard. Individual variability, as assessed by the Kappa coefficient of concordance, showed considerable difference in the diagnostic results obtained by different readers-the degree of agreement depending on the type of cervical lesion involved and the number of specimens from patients with that type of lesion. There was little diagnostic agreement when the specimens were assessed for particular classes of cervical neoplasia-mild, moderate, or severe neoplasia, carcinoma in situ, or invasive cervical cancer. (The greatest concordance was found in diagnosing specimens from subjects with invasive cervical cancer.) However, when the diagnosis was assessed continuously, using Kappa weighted in accordance with the five possible diagnoses of cervical neoplasia, the apparent reproducibility of the diagnoses improved greatly, Kappa coefficients for the 14 readers ranging from 0.31 to 0.72. In general, these data support the view that there is a need in Mexico and other parts of the Americas to establish quality control mechanisms monitoring cytologic diagnosis of cervical neoplasia, to standardize diagnostic nomenclature using a system such as the Bethesda System, to institute periodic certification, and to provide continuing training. As this suggests, it is necessary not only to evaluate but also to bring about organizational changes in order to expeditiously prevent or correct the problems that currently constrain achievement of efficient and effective cytologic diagnosis.

摘要

为评估通过检查巴氏涂片诊断宫颈肿瘤所获结果的可重复性,开展了一项研究,使用一组共20份巴氏涂片,其中3份为阴性,17份来自患有不同程度肿瘤的患者。这些涂片由来自墨西哥瓦哈卡州和韦拉克鲁斯州的14名志愿者阅片者(13名细胞技术专家和1名细胞病理学家)进行检查,同时也由一名经墨西哥病理解剖委员会认证的经验丰富的细胞病理学家进行检查,其工作提供了参考标准。通过一致性卡帕系数评估的个体差异显示,不同阅片者所获诊断结果存在显著差异——一致程度取决于所涉及的宫颈病变类型以及该类型病变患者的标本数量。在评估特定类型的宫颈肿瘤——轻度、中度或重度肿瘤、原位癌或浸润性宫颈癌时,诊断一致性较低。(在诊断浸润性宫颈癌患者的标本时一致性最高。)然而,当使用根据宫颈肿瘤的五种可能诊断进行加权的卡帕系数连续评估诊断时,诊断的表观可重复性有了很大提高,14名阅片者的卡帕系数范围为0.31至0.72。总体而言,这些数据支持这样一种观点,即在墨西哥和美洲其他地区,有必要建立质量控制机制,监测宫颈肿瘤的细胞学诊断,使用如贝塞斯达系统这样的系统规范诊断术语,进行定期认证,并提供持续培训。由此可见,不仅有必要进行评估,还需要进行组织变革,以便迅速预防或纠正当前制约有效进行细胞学诊断的问题。

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