CRESS 三部曲的最后一部分--如何评估稳定性研究的质量。

IF 3.8 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY
Michael Cornes, Pieter Vermeersch, Ana-Maria Šimundić, Alexander Von Meyer, Tomáš Šálek, Brendan Meyer, Sean Costelloe, Vincent De Guire, Ruben Gomez-Rioja, Janne Cadamuro
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引用次数: 0

摘要

高质量的化验结果对患者管理至关重要。然而,样本质量差会影响结果和患者安全。为确保结果可靠、准确,实验室必须了解每种分析物在不同储存条件和基质下的稳定性,以保证结果的正确性和可靠性。有了这些知识,实验室就能确定所有被分析物从样本采集到离心/分析之间的允许延迟时间,以保证适当的结果质量和解释。因此,EFLM WG-PRE 制定了一个四步计划来解决这个问题,旨在标准化和协调稳定性研究,以改进比较和荟萃分析。该计划包括为开展和报告稳定性研究制定核对表和操作指南,以及建立稳定性数据中央资源库。本手稿涉及评估出版物并将其纳入中央资源的问题。为了评估稳定性研究,我们使用了 CRESS 检查表来构建用于判断研究质量的 20 个部分。每个部分有 4 个质量等级,分数转换为数值,并根据专家意见进行加权。在此基础上,确定了从 A 到 D 的最终分数。然后在六篇稿件上对该程序进行了测试,并检查了专家判断之间的一致性。结果表明,建议的评价程序是区分一流稿件和低质量稿件的有用工具。EFLM WG-PRE 坚信,所提供的建议和核对表将有助于提高稳定性研究的质量和标准化水平。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
The final part of the CRESS trilogy - how to evaluate the quality of stability studies.

High quality laboratory results are critical for patient management. However, poor sample quality can impact these results and patient safety. To ensure reliable and accurate results laboratories must be aware of each analyte's stability under various storage conditions and matrices to guarantee correct and dependable outcomes. This knowledge allows laboratories to define the allowable delay between sample collection and centrifugation/analysis for all analytes to guarantee appropriate results quality and interpretation. The EFLM WG-PRE therefore established a 4-step plan to tackle this issue, aiming to standardize and harmonize stability studies for improved comparison and meta-analysis. The plan included the development of checklists and how-to guides for performing and reporting stability studies as well as a central resource of stability data. This manuscript deals with the issue of evaluating publications and incorporating them into a central resource. To evaluate stability studies, the CRESS checklist was used to structure 20 sections used to judge the quality of studies. Each section has 4 levels of quality, with scores converted to numerical values and weighted based on expert opinion. Based on this, a final score ranging from A to D was determined. The procedure was then tested on six manuscripts and checked for agreement between expert judgements. The results demonstrated that the proposed evaluation process is a useful tool to distinguish between best in class manuscripts and those of lower quality. The EFLM WG-PRE strongly believes that the provided recommendations and checklists will help improving stability studies both in quality and standardisation.

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来源期刊
Clinical chemistry and laboratory medicine
Clinical chemistry and laboratory medicine 医学-医学实验技术
CiteScore
11.30
自引率
16.20%
发文量
306
审稿时长
3 months
期刊介绍: Clinical Chemistry and Laboratory Medicine (CCLM) publishes articles on novel teaching and training methods applicable to laboratory medicine. CCLM welcomes contributions on the progress in fundamental and applied research and cutting-edge clinical laboratory medicine. It is one of the leading journals in the field, with an impact factor over 3. CCLM is issued monthly, and it is published in print and electronically. CCLM is the official journal of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) and publishes regularly EFLM recommendations and news. CCLM is the official journal of the National Societies from Austria (ÖGLMKC); Belgium (RBSLM); Germany (DGKL); Hungary (MLDT); Ireland (ACBI); Italy (SIBioC); Portugal (SPML); and Slovenia (SZKK); and it is affiliated to AACB (Australia) and SFBC (France). Topics: - clinical biochemistry - clinical genomics and molecular biology - clinical haematology and coagulation - clinical immunology and autoimmunity - clinical microbiology - drug monitoring and analysis - evaluation of diagnostic biomarkers - disease-oriented topics (cardiovascular disease, cancer diagnostics, diabetes) - new reagents, instrumentation and technologies - new methodologies - reference materials and methods - reference values and decision limits - quality and safety in laboratory medicine - translational laboratory medicine - clinical metrology Follow @cclm_degruyter on Twitter!
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