Development of a diagnostic test set to assess agreement in breast pathology: practical application of the Guidelines for Reporting Reliability and Agreement Studies (GRRAS)
Development of a diagnostic test set to assess agreement in breast pathology: practical application of the Guidelines for Reporting Reliability and Agreement Studies (GRRAS)
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DOI：
10.1186/1472-6874-13-3
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发表时间：
2013-02-05
影响因子：
2.5
通讯作者：
Elmore, Joann G.
中科院分区：
文献类型：
--
作者：
Oster, Natalia V.;Carney, Patricia A.;Elmore, Joann G.
背景资料：诊断测试集是一种有价值的研究工具，对评估乳腺病理学一致性的研究的有效性和可靠性有重要贡献。然而，为了充分了解任何一致性和可靠性研究的优点和缺点，应充分报告这些方法。在本文中，我们提供了一个循序渐进的描述方法，用于创建四个复杂的测试集的研究诊断协议之间的病理学家解释乳腺活检标本。我们使用新开发的报告可靠性和协议研究（GRRAS）的基础上，报告这些methods.Methods：乳腺组织活检的指导原则，从美国国家癌症研究所资助的乳腺癌监测联盟网站。我们采用随机抽样，根据妇女的年龄（40-49岁vs. ≥ 50岁），实质乳腺密度（低vs.高）和原始病理学家的解释分层。一个由3名乳腺病理学家组成的专家小组首先使用5个主要诊断类别（非增殖性变化、无乳腺增生的增殖性变化、非典型导管增生、导管原位癌和浸润性癌）独立解释每个病例。当专家们对某一病例的诊断意见不一致时，采用改进的德尔菲法确定参考标准一致诊断。最后的测试用例进行分层，并随机分配到四个独特的测试sets.Conclusions之一：我们发现GRRAS的建议是非常有用的报告诊断测试集的发展，并建议列入两个额外的标准：1）表征研究人群和2）描述的方法，参考诊断，适用时。
Background: Diagnostic test sets are a valuable research tool that contributes importantly to the validity and reliability of studies that assess agreement in breast pathology. In order to fully understand the strengths and weaknesses of any agreement and reliability study, however, the methods should be fully reported. In this paper we provide a step-by-step description of the methods used to create four complex test sets for a study of diagnostic agreement among pathologists interpreting breast biopsy specimens. We use the newly developed Guidelines for Reporting Reliability and Agreement Studies (GRRAS) as a basis to report these methods.Methods: Breast tissue biopsies were selected from the National Cancer Institute-funded Breast Cancer Surveillance Consortium sites. We used a random sampling stratified according to woman's age (40-49 vs. = 50), parenchymal breast density (low vs. high) and interpretation of the original pathologist. A 3-member panel of expert breast pathologists first independently interpreted each case using five primary diagnostic categories (non-proliferative changes, proliferative changes without atypia, atypical ductal hyperplasia, ductal carcinoma in situ, and invasive carcinoma). When the experts did not unanimously agree on a case diagnosis a modified Delphi method was used to determine the reference standard consensus diagnosis. The final test cases were stratified and randomly assigned into one of four unique test sets.Conclusions: We found GRRAS recommendations to be very useful in reporting diagnostic test set development and recommend inclusion of two additional criteria: 1) characterizing the study population and 2) describing the methods for reference diagnosis, when applicable.