Cooper Glinda S, Lunn Ruth M, Ågerstrand Marlene, Glenn Barbara S, Kraft Andrew D, Luke April M, Ratcliffe Jennifer M
National Center for Environmental Assessment, Office of Research and Development, U.S. Environmental Protection Agency, Washington, DC, USA.
Office of the Report on Carcinogens, Division of the National Toxicology Program, National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH), Research Triangle Park, NC, USA.
Environ Int. 2016 Jul-Aug;92-93:605-10. doi: 10.1016/j.envint.2016.03.017. Epub 2016 May 5.
A critical step in systematic reviews of potential health hazards is the structured evaluation of the strengths and weaknesses of the included studies; risk of bias is a term often used to represent this process, specifically with respect to the evaluation of systematic errors that can lead to inaccurate (biased) results (i.e. focusing on internal validity). Systematic review methods developed in the clinical medicine arena have been adapted for use in evaluating environmental health hazards; this expansion raises questions about the scope of risk of bias tools and the extent to which they capture the elements that can affect the interpretation of results from environmental and occupational epidemiology studies and in vivo animal toxicology studies, (the studies typically available for assessment of risk of chemicals). One such element, described here as "sensitivity", is a measure of the ability of a study to detect a true effect or hazard. This concept is similar to the concept of the sensitivity of an assay; an insensitive study may fail to show a difference that truly exists, leading to a false conclusion of no effect. Factors relating to study sensitivity should be evaluated in a systematic manner with the same rigor as the evaluation of other elements within a risk of bias framework. We discuss the importance of this component for the interpretation of individual studies, examine approaches proposed or in use to address it, and describe how it relates to other evaluation components. The evaluation domains contained within a risk of bias tool can include, or can be modified to include, some features relating to study sensitivity; the explicit inclusion of these sensitivity criteria with the same rigor and at the same stage of study evaluation as other bias-related criteria can improve the evaluation process. In some cases, these and other features may be better addressed through a separate sensitivity domain. The combined evaluation of risk of bias and sensitivity can be used to identify the most informative studies, to evaluate the confidence of the findings from individual studies and to identify those study elements that may help to explain heterogeneity across the body of literature.
对潜在健康危害进行系统评价的关键步骤是对纳入研究的优势和劣势进行结构化评估；偏倚风险是一个常用于描述这一过程的术语，特别是在评估可能导致不准确（有偏倚）结果的系统误差时（即关注内部效度）。在临床医学领域开发的系统评价方法已被应用于评估环境健康危害；这种扩展引发了关于偏倚风险工具的适用范围以及它们在多大程度上涵盖了可能影响环境和职业流行病学研究以及体内动物毒理学研究（通常用于评估化学物质风险的研究）结果解释的因素的问题。这里描述为“敏感性”的一个这样的因素是衡量一项研究检测真实效应或危害的能力。这个概念类似于分析方法的敏感性概念；一项不敏感的研究可能无法显示真正存在的差异，从而导致无效应的错误结论。与研究敏感性相关的因素应以与偏倚风险框架内其他因素评估相同的严谨性进行系统评估。我们讨论了这一组成部分对个体研究解释的重要性，研究了为解决这一问题而提出或正在使用的方法，并描述了它与其他评估组成部分的关系。偏倚风险工具中包含的评估领域可以包括或可以修改为包括一些与研究敏感性相关的特征；在研究评估的同一阶段，以与其他与偏倚相关的标准相同的严谨性明确纳入这些敏感性标准可以改进评估过程。在某些情况下，这些和其他特征可能通过单独的敏感性领域能得到更好的处理。偏倚风险和敏感性的综合评估可用于识别信息最丰富的研究，评估个体研究结果的可信度，并识别那些可能有助于解释整个文献异质性的研究要素。
