National Center for Clinical Laboratories, Beijing Hospital, National Center of Gerontology, Beijing, People's Republic of China.
Beijing Engineering Research Center of Laboratory Medicine, Beijing, People's Republic of China.
Oncologist. 2017 Nov;22(11):1325-1332. doi: 10.1634/theoncologist.2017-0042. Epub 2017 Jul 12.
Reports serve as a bridge between laboratories and clinicians, help synthesize an overwhelming amount of raw data into evidence-based medicine, and play a significant role in designing clinical treatments. In an effort to guarantee high-quality epidermal growth factor receptor () gene mutation testing and reporting performance, the National Center for Clinical Laboratories launched a proficiency testing (PT) scheme reflecting clinical practices in China since 2014. This study focuses on the quality assessment of gene mutation reports.
Fifty-three laboratories that submitted reports in both 2014 and 2016 gene mutation PT schemes were selected for report analysis and comparison according to predefined evaluation criteria.
The average score for reports from 2014 was 14 out of 30 points. The overall scores for reports from 2016 improved substantially, yielding an average score of 20 out of 30 points. Among the evaluation criteria, general items were well documented in the reports. However, items specific to molecular diagnosis were far from satisfactory, and some items were even missing.
The quality assessment of clinical written reports from 2014 and 2016 demonstrates that substantial improvements have been made in overall reporting performance. However, not all statements pertaining to important elements met expectations. To continue education, repeated PT schemes need to be executed in a timely fashion to expose and address existing shortcomings in clinical reports. There remains ample room for improvement towards generating concise, comprehensive, and readable reports.
This article compares the quality of clinical gene mutation reports submitted in 2014 to those submitted in 2016 epidermal growth factor receptor proficiency testing schemes, exposes the existing shortcomings, and discusses ways to communicate results more effectively in the future. The findings demonstrate that notable progress was observed in the overall reporting performance. However, key points specific to molecular diagnosis were far from expectation, and some items were even missing. Standardization needs to be emphasized to improve the report format and content. This article provides a reference that laboratories can use to write concise, comprehensive, and readily accessible clinical reports.
报告在实验室和临床医生之间架起了桥梁，有助于将大量原始数据综合为循证医学，并在设计临床治疗方案中发挥重要作用。为了保证高质量的表皮生长因子受体（）基因突变检测和报告性能，国家临床检验中心自 2014 年以来推出了反映中国临床实践的能力验证（PT）计划。本研究重点关注基因检测报告的质量评估。
根据预设的评估标准，选择 2014 年和 2016 年基因检测 PT 方案中提交报告的 53 个实验室进行报告分析和比较。
2014 年报告的平均得分为 30 分中的 14 分。2016 年报告的总体得分有了显著提高，平均得分为 30 分中的 20 分。在评估标准中，报告中详细记录了一般项目。然而，分子诊断的具体项目远远不能令人满意，有些项目甚至缺失。
2014 年和 2016 年临床书面报告的质量评估表明，总体报告性能有了显著提高。然而，并非所有涉及重要内容的陈述都符合预期。为了继续教育，需要及时执行重复的 PT 计划，以暴露和解决临床报告中存在的不足。在生成简洁、全面和可读的报告方面还有很大的改进空间。
本文比较了 2014 年和 2016 年表皮生长因子受体能力验证计划中提交的临床基因突变报告的质量，暴露了存在的不足，并讨论了未来更有效地传达结果的方法。研究结果表明，在整体报告性能方面取得了显著进展。然而，分子诊断的关键要点远未达到预期，有些项目甚至缺失。需要强调标准化，以改进报告格式和内容。本文为实验室提供了一个参考，以便编写简洁、全面和易于理解的临床报告。
