Biospecimens and Molecular and Cellular Biomarkers in Aneurysmal Subarachnoid Hemorrhage Studies: Common Data Elements and Standard Reporting Recommendations.

Biospecimens and Molecular and Cellular Biomarkers in Aneurysmal Subarachnoid Hemorrhage Studies: Common Data Elements and Standard Reporting Recommendations.
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DOI:
10.1007/s12028-019-00725-4
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发表时间:
2019-06
期刊:
影响因子:
3.5
通讯作者:
Unruptured Intracranial Aneurysms and SAH CDE Project Investigators
Unruptured Intracranial Aneurysms and SAH CDE Project Investigators
中科院分区:
医学3区
文献类型:
--
作者:
Chou SH;Macdonald RL;Keller E;Unruptured Intracranial Aneurysms and SAH CDE Project Investigators

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发展临床生物标记物来指导治疗是动脉瘤性蛛网膜下腔出血(SAH)尚未得到满足的重要需求。SAH的生物标志物有很多种,但由于研究设计、方法学、实验室技术和结果终点的显著差异,没有一种被证实。根据系统评价和荟萃分析(PRISMA)指南的首选报告项目,对SAH生物标记物进行系统评价。该小组的建议集中于协调(1)未来SAH研究的目标细胞和分子生物标记物,(2)生物显微镜和生物标记物研究的最佳实践程序的标准化,以及(3)实验方法报告要求,以促进荟萃分析和未来对推定的生物标记物的验证。没有细胞或分子生物标记物被确认为“核心”建议纳入。54项研究符合纳入标准,并产生了33个补充和新兴的生物标记物目标。核心建议包括生物标记物收集和处理的最佳实践方案以及标准化报告指南,以捕捉实验方法和生物标记物分析平台中的异质性和多样性。SAH生物标记物研究在研究设计、方法学、实验室技术和结果终点方面存在显著差异,并为验证和将推定的生物标记物转化为临床应用提供了重大障碍。采用通用数据元素、推荐的生物检疫方案和报告指南将减少异质性,并促进未来荟萃分析和SAH有效临床生物标记物的开发。
Development of clinical biomarkers to guide therapy is an important unmet need in aneurysmal subarachnoid hemorrhage (SAH). A wide spectrum of plausible biomarkers has been reported for SAH, but none have been validated due to significant variabilities in study design, methodology, laboratory techniques, and outcome endpoints. A systematic review of SAH biomarkers was performed per the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The panel’s recommendations focused on harmonization of (1) target cellular and molecular biomarkers for future investigation in SAH, (2) standardization of best-practice procedures in biospecimen and biomarker studies, and (3) experimental method reporting requirements to facilitate meta-analyses and future validation of putative biomarkers. No cellular or molecular biomarker has been validated for inclusion as “core” recommendation. Fifty-four studies met inclusion criteria and generated 33 supplemental and emerging biomarker targets. Core recommendations include best-practice protocols for biospecimen collection and handling as well as standardized reporting guidelines to capture the heterogeneity and variabilities in experimental methodologies and biomarker analyses platforms. Significant variabilities in study design, methodology, laboratory techniques, and outcome endpoints exist in SAH biomarker studies and present significant barriers toward validation and translation of putative bio-markers to clinical use. Adaptation of common data elements, recommended biospecimen protocols, and reporting guidelines will reduce heterogeneity and facilitate future meta-analyses and development of validated clinical biomarkers in SAH.
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