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Practical guide for identifying unmet clinical needs for biomarkers.识别生物标志物未满足临床需求的实用指南。
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STARD 2015: an updated list of essential items for reporting diagnostic accuracy studies.STARD 2015:报告诊断准确性研究的必备项目更新清单。
BMJ. 2015 Oct 28;351:h5527. doi: 10.1136/bmj.h5527.
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Defining analytical performance specifications: Consensus Statement from the 1st Strategic Conference of the European Federation of Clinical Chemistry and Laboratory Medicine.定义分析性能规范:欧洲临床化学与检验医学联合会第一次战略会议的共识声明
Clin Chem Lab Med. 2015 May;53(6):833-5. doi: 10.1515/cclm-2015-0067.
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An appeal to medical journal editors: the need for a full description of laboratory methods and specimen handling in clinical study reports.致医学期刊编辑的呼吁:临床研究报告中需要对实验室方法和样本处理进行全面描述。
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临床测量程序实验室评估和分析性能特征报告的 LEAP 清单。

The LEAP Checklist for Laboratory Evaluation and Analytical Performance Characteristics Reporting of Clinical Measurement Procedures.

机构信息

Department of Laboratory Medicine, National University Hospital, Singapore.

Department of Clinical Biochemistry, PathWest Laboratory Medicine, Fiona Stanley Hospital, Murdoch, Western Australia.

出版信息

Ann Lab Med. 2024 Mar 1;44(2):122-125. doi: 10.3343/alm.2023.0342. Epub 2023 Oct 23.

DOI:10.3343/alm.2023.0342
PMID:37869780
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10628757/
Abstract

Reporting a measurement procedure and its analytical performance following method evaluation in a peer-reviewed journal is an important means for clinical laboratory practitioners to share their findings. It also represents an important source of evidence base to help others make informed decisions about their practice. At present, there are significant variations in the information reported in laboratory medicine journal publications describing the analytical performance of measurement procedures. These variations also challenge authors, readers, reviewers, and editors in deciding the quality of a submitted manuscript. The International Federation of Clinical Chemistry and Laboratory Medicine Working Group on Method Evaluation Protocols (IFCC WG-MEP) developed a checklist and recommends its adoption to enable a consistent approach to reporting method evaluation and analytical performance characteristics of measurement procedures in laboratory medicine journals. It is envisioned that the Laboratory Evaluation and Analytical Performance Characteristics (LEAP) checklist will improve the standardisation of journal publications describing method evaluation and analytical performance characteristics, improving the quality of the evidence base that is relied upon by practitioners.

摘要

在同行评议的期刊中报告测量程序及其分析性能评估后,这是临床实验室从业者分享其发现的重要手段。它也是帮助他人就其实践做出明智决策的重要证据基础来源。目前,描述测量程序分析性能的实验室医学期刊出版物中报告的信息存在很大差异。这些差异也使作者、读者、审稿人和编辑在决定提交稿件的质量方面面临挑战。国际临床化学和实验室医学联合会(IFCC)方法评估方案工作组(IFCC WG-MEP)制定了一份清单,并建议采用该清单,以实现实验室医学期刊中报告方法评估和分析性能特征的一致方法。预计实验室评估和分析性能特征(LEAP)清单将提高描述方法评估和分析性能特征的期刊出版物的标准化程度,从而提高从业者所依赖的证据基础的质量。