能力测试新方法凸显癌症生物标记物交付的关键实践差异

K.R. Bisson, Jennifer R. Won, A. Beharry, Michael D. Carter, S. Dudani, J.G. Garratt, J. Loree, Stephanie Snow, Stephen Yip, Brandon S. Sheffield
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摘要

生物标记物是现代肿瘤学实践的基础,与病理学实践密切相关。病理结果必须准确、及时、全面、易懂。外部能力验证是保持生物标记物质量的关键工具。在这里,我们展示了一种新颖的端到端能力验证方法的可行性和实用性,该方法旨在探索准确性、周转时间和交流。我们使用切除的结肠癌组织制作了挑战标本,每个标本都与一个虚构的临床小故事配对,并分发给参与者,要求他们提供所需的所有分子检测,并在完成后返回每个病例的最终报告。报告被重新分配给包括肿瘤内科医生在内的评估小组,要求每个小组根据每个实验室的生物标记物报告推荐一种系统疗法。根据参与者指导肿瘤学家正确治疗的能力进行评分。共有八家实验室参与。其中三家实验室的结果不理想,两家实验室导致肿瘤学家开出了错误的治疗处方,一家实验室被撤销。周转时间从 6 天到 86 天不等(中位数为 24 天)。发现了大量定性报告差异。这项研究证明了端到端能力验证的可行性。除分析准确性外,该方法还具有相当大的价值,包括标本管理、周转时间和结果沟通。结果表明,报告差异可能会导致治疗差异。这种质量保证方式将有助于加强对癌症精准治疗至关重要的良好实践。
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Novel Approach to Proficiency Testing Highlights Key Practice Variations in Cancer Biomarker Delivery
Biomarkers are fundamental to modern oncology practice, forming a close link to pathology practice. Pathology results must be accurate, timely, comprehensive, and comprehendible. External proficiency testing is a key tool in maintaining biomarker quality. Here, we demonstrate the feasibility and utility of a novel end-to-end proficiency testing exercise exploring accuracy, turnaround time, and communication. Challenge specimens were made using resected colon cancer tissue, each paired with a fictional clinical vignette, and distributed to participants who were asked to provide all molecular testing required and return a final report for each case upon completion. Reports were redistributed to an assessor team including medical oncologists, each of whom was asked to recommend a systemic therapy based on each lab’s biomarker report. Participants were graded based on their ability to guide oncologists to the correct treatment. Eight laboratories participated. Three laboratories were found to have suboptimal results, two leading oncologists to incorrect therapeutic prescriptions, and one withdrawn. Turnaround time ranged from 6 to 86 days (median 24). Substantial qualitative reporting differences were identified. This study demonstrates the feasibility of end-to-end proficiency testing. The approach provides considerable value beyond analytic accuracy, including specimen management, turnaround time, and communication of results. Results suggest that reporting differences may lead to treatment disparities. This style of quality assurance will help reinforce good practices critical to the delivery of precision cancer care.
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