Kluttig Alexander, Trocchi Pietro, Heinig Anke, Holzhausen Hans-Juergen, Taege Christiane, Hauptmann Steffen, Boecker Werner, Decker Thomas, Loening Thomas, Schmidt-Pokrzywniak Andrea, Thomssen Christoph, Lantzsch Tilmann, Buchmann Joerg, Stang Andreas
Clinical Epidemiology Unit, Institute of Medical Epidemiology, Biometry and Informatics, University Halle-Wittenberg, Halle (Saale), Germany.
BMC Cancer. 2007 Jun 14;7:100. doi: 10.1186/1471-2407-7-100.
The planned nationwide implementation of mammography screening 2007 in Germany will increase the occurrence of mammographically detected breast abnormalities. These abnormalities are normally evaluated by minimal invasive core biopsy. To minimize false positive and false negative histological findings, quality assurance of the pathological evaluation of the biopsies is essential. Various guidelines for quality assurance in breast cancer diagnosis recommend applying the B-classification for histopathological categorization. However, to date there are only few studies that reported results about reliability and validity of B-classification. Therefore, objectives of our study are to determine the inter- and intraobserver variability (reliability study) and construct and predictive validity (validity study) of core biopsy evaluation of breast abnormalities. This paper describes the design and objectives of the DIOS Study.
METHODS/DESIGN: All consecutive asymptomatic and symptomatic women with breast imaging abnormalities who are referred to the University Hospital of Halle for core breast biopsy over a period of 24 months are eligible. According to the sample size calculation we need 800 women for the study. All patients in the study population underwent clinical and radiological examination. Core biopsy is performed by stereotactic-, ultrasound- or magnetic resonance (MR) guided automated gun method or vacuum assisted method. The histopathologic agreement (intra- and interobserver) of pathologists and the histopathologic validity will be evaluated. Two reference standards are implemented, a reference pathologist and in case of suspicious or malignant findings the histopathologic result of excision biopsy. Furthermore, a self administrated questionnaire which contains questions about potential risk factors of breast cancer, is sent to the participants approximately two weeks after core biopsy. This enables us to run a case-control-analysis (woman with breast cancer histological verified after excision are defined as cases, woman without malignant breast lesions are defined as controls) to investigate the predictive values of various risk factors on breast cancer risk.
The analysis of reliability and validity of the histopathological evaluation of core biopsy specimens of breast abnormalities is intended to provide important information needed for a high quality in breast cancer diagnostic and for planning of treatment strategies.
德国计划于2007年在全国范围内实施乳腺钼靶筛查，这将增加钼靶检测出的乳腺异常情况的发生率。这些异常通常通过微创芯针活检进行评估。为尽量减少假阳性和假阴性的组织学结果，活检病理评估的质量保证至关重要。乳腺癌诊断质量保证的各种指南建议采用B分类法进行组织病理学分类。然而，迄今为止，仅有少数研究报告了B分类法的可靠性和有效性结果。因此，我们研究的目的是确定乳腺异常芯针活检评估的观察者间和观察者内变异性（可靠性研究）以及构建预测有效性（有效性研究）。本文描述了DIOS研究的设计和目标。
方法/设计：所有连续的无症状和有症状的乳腺影像异常女性，在24个月内被转诊至哈雷大学医院进行乳腺芯针活检的均符合条件。根据样本量计算，我们需要800名女性参与该研究。研究人群中的所有患者均接受了临床和放射学检查。芯针活检通过立体定向、超声或磁共振（MR）引导的自动枪式方法或真空辅助方法进行。将评估病理学家的组织病理学一致性（观察者间和观察者内）以及组织病理学有效性。采用两种参考标准，一名参考病理学家，以及在发现可疑或恶性结果时进行切除活检的组织病理学结果。此外，在芯针活检后约两周向参与者发送一份自我管理问卷，其中包含有关乳腺癌潜在风险因素的问题。这使我们能够进行病例对照分析（切除术后组织学证实为乳腺癌的女性定义为病例，无乳腺恶性病变的女性定义为对照），以研究各种风险因素对乳腺癌风险的预测价值。
对乳腺异常芯针活检标本组织病理学评估的可靠性和有效性分析旨在为高质量的乳腺癌诊断和治疗策略规划提供所需的重要信息。
