Guidelines for the standardized collection of blood-based biomarkers in psychiatry: Steps for laboratory validity - a consensus of the Biomarkers Task Force from the WFSBP
Guidelines for the standardized collection of blood-based biomarkers in psychiatry: Steps for laboratory validity - a consensus of the Biomarkers Task Force from the WFSBP
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DOI：
10.1080/15622975.2019.1574024
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发表时间：
2019-01-01
影响因子：
3.1
通讯作者：
Baune, Bernhard T.
中科院分区：
文献类型：
--
作者：
Andreazza, Ana C.;Laksono, Isabelle;Baune, Bernhard T.
最近，在精神病学领域有一个重大转变，即探索血液生物标志物与精神和神经精神疾病的病理生理学之间的复杂关系。然而，研究的可重复性、有效性和可靠性问题阻碍了精神病学临床相关生物标志物的鉴定。实验室有效性的实现是临床有效性后续发展的关键第一步。有证据表明，通过实施标准化的预分析方法和统一的临床方案（即，静脉穿刺前）。有记录表明，分析前阶段的错误占实验室检测错误的46 - 68.2%。因此，规范临床评估、伦理程序和临床研究的预分析阶段对于血液标志物评估的重现性、有效性和可靠性以及降低无效检测结果的风险至关重要。其他各种研究领域已经转向血液生物标志物标准化收集的指导方针。在这里，我们的目标是提供一套指南，我们相信这将改善生物标志物的研究：（1）静脉穿刺前的信息和文件，（2）参与者同意的道德和（3）预分析方法。最终，我们希望这将有助于研究计划，并将改善研究之间的数据比较，从而发现具有实验室和临床有效性的精神病学生物标志物。
Recently, there has been a major shift in the field of psychiatry towards the exploration of complex relationships between blood-based biomarkers and the pathophysiology of psychiatric and neuropsychiatric disorders. However, issues with study reproducibility, validity and reliability have hindered progress towards the identification of clinically relevant biomarkers for psychiatry. The achievement of laboratory validity is a crucial first step for the posterior development of clinical validity. There is evidence that the variability observed in blood-based research studies may be minimised with the implementation of standardised pre-analytical methods and uniform clinical protocols (i.e., pre-venipuncture). It has been documented that errors made in the pre-analytical phase account for 46-68.2% of laboratory testing errors. Thus, standardising clinical assessment, ethical procedures and pre-analytical phase of clinical research is essential for the reproducibility, validity and reliability of blood marker assessment, and reducing the risk of invalid test results. Various other areas of research have already moved towards guidelines for the standardised collection of blood-based biomarkers. Here we aim to provide a set of guidelines that we believe would improve biomarker research: (1) pre-venipuncture information and documentation, (2) ethics of participant consent and (3) pre-analytical methods. Ultimately, we hope this will assist study planning and will improve data comparison across studies allowing for the discovery of biomarkers in psychiatry with both laboratorial and clinical validity.