Department of Epidemiology and Biostatistics, School of Public Health, Imperial College London, St Mary's Campus Norfolk Place, W2 1PG London, UK.
Eur J Epidemiol. 2011 Oct;26(10):797-810. doi: 10.1007/s10654-011-9622-1. Epub 2011 Oct 29.
Advances in laboratory techniques have led to a rapidly increasing use of biomarkers in epidemiological studies. Biomarkers of internal dose, early biological change, susceptibility, and clinical outcomes are used as proxies for investigating the interactions between external and/or endogenous agents and the body components or processes. The need for improved reporting of scientific research led to influential statements of recommendations such as STrengthening Reporting of Observational studies in Epidemiology (STROBE) statement. The STROBE initiative established in 2004 aimed to provide guidance on how to report observational research. Its guidelines provide a user-friendly checklist of 22 items to be reported in epidemiological studies, with items specific to the three main study designs: cohort studies, case-control studies and cross-sectional studies. The present STrengthening the Reporting of OBservational studies in Epidemiology-Molecular Epidemiology (STROBE-ME) initiative builds on the STROBE Statement implementing 9 existing items of STROBE and providing 17 additional items to the 22 items of STROBE checklist. The additions relate to the use of biomarkers in epidemiological studies, concerning collection, handling and storage of biological samples; laboratory methods, validity and reliability of biomarkers; specificities of study design; and ethical considerations. The STROBE-ME recommendations are intended to complement the STROBE recommendations.
实验室技术的进步使得生物标志物在流行病学研究中的应用迅速增加。内暴露剂量、早期生物学改变、易感性和临床结局的生物标志物被用作研究外源性和/或内源性物质与身体成分或过程相互作用的替代物。为了提高科学研究报告的质量，人们提出了一些有影响力的建议声明，如《流行病学观察研究报告的强化标准》（STROBE）声明。该倡议于 2004 年成立，旨在为如何报告观察性研究提供指导。其指南提供了一份易于使用的检查表，其中包含 22 项应在流行病学研究中报告的项目，针对三种主要研究设计：队列研究、病例对照研究和横断面研究，还有特定的项目。本《流行病学分子流行病学中观察性研究报告的强化标准》（STROBE-ME）倡议基于 STROBE 声明，实施了 STROBE 的 9 项现有项目，并为 STROBE 检查表的 22 项增加了 17 项。新增项目涉及生物标志物在流行病学研究中的应用，包括生物样本的采集、处理和储存；生物标志物的实验室方法、有效性和可靠性；研究设计的特殊性；以及伦理考虑。STROBE-ME 建议旨在补充 STROBE 建议。
