Analytical validation and quality control/quality assurance practices for improved rigor and reproducibility of biochemical assays in orthopaedic research.
Analytical validation and quality control/quality assurance practices for improved rigor and reproducibility of biochemical assays in orthopaedic research.
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分析验证和质量控制/质量保证实践，以提高骨科研究中生化测定的严谨性和可重复性。
DOI：
10.1002/jor.25498
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发表时间：
2023
期刊：
影响因子：
--
通讯作者：
McNulty,AmyL
中科院分区：
文献类型：
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作者：
Andress,Benjamin;Hoffman,Maureane;McNulty,AmyL
骨科研究和一般的生物医学研究在开发长期被认为是不可避免或无法治疗的疾病的治疗方法方面取得了巨大进步;然而，人们越来越关注已发表研究的质量。为提高总体研究质量、完整性和严谨性作出了相当大的努力，包括提出了一些有意义的建议，重点是报告的透明度、适当使用统计数据和报告负面结果。然而，我们认为，还有另一个关键组成部分的严格性和重现性，没有讨论的分析验证和质量控制（QC）。在这篇评论中，我们讨论了系统地应用于临床实验室环境中的QC和方法验证原则和实践，以验证和监测定量测定的分析性能，以及将类似实践应用于骨科研究环境中的生化测定的实用性。本评论包括（1）验证和QC实践建议，包括在我们实验室进行的验证实验发现的测定性能限制示例，以及（2）为监测我们实验室常用测定的持续性能而开发的持续QC计划的描述。我们希望这篇评论和这里提供的例子能够发人深省，并激发进一步的讨论和分析验证和QC程序的调整，以推进我们对高质量，严格和可重复的骨科研究的共同追求。
Orthopaedic research, and biomedical research in general, has made enormous strides to develop treatments for conditions long thought to be inevitable or untreatable; however, there is growing concern about the quality of published research. Considerable efforts have been made to improve overall research quality, integrity, and rigor, including meaningful proposals focused on transparency of reporting, appropriate use of statistics, and reporting of negative results. However, we believe that there is another key component to rigor and reproducibility that is not discussed sufficiently—analytical validation and quality control (QC). In this commentary, we discuss QC and method validation principles and practices that are systematically applied in the clinical laboratory setting to verify and monitor the analytical performance of quantitative assays, and the utility of applying similar practices to biochemical assays in the orthopaedic research setting. This commentary includes (1) recommendations for validation and QC practices, including examples of assay performance limitations uncovered by validation experiments performed in our laboratory, and (2) a description of an ongoing QC program developed to monitor the ongoing performance of commonly used assays in our lab. We hope that this commentary and the examples presented here will be thought‐provoking and inspire further discussion and adaptation of analytical validation and QC procedures to advance our shared pursuit of high‐quality, rigorous, and reproducible orthopaedic research.