Center for Public Health and Environmental Assessment, Chemical & Pollutant Assessment Division, US EPA, DC, USA.
Center for Public Health and Environmental Assessment, Health & Environmental Effects Assessment Division, US EPA, NC, USA.
Environ Int. 2022 Nov;169:107468. doi: 10.1016/j.envint.2022.107468. Epub 2022 Aug 13.
Systematic evidence maps (SEMs) are gaining visibility in environmental health for their utility to serve as problem formulation tools and assist in decision-making, especially for priority setting. SEMs are now routinely prepared as part of the assessment development process for the US Environmental Protection Agency (EPA) Integrated Risk Information System (IRIS) and Provisional Peer Reviewed Toxicity Value (PPRTV) assessments. SEMs can also be prepared to explore the available literature for an individual chemical or groups of chemicals of emerging interest.
This document describes the typical methods used to produce SEMs for the IRIS and PPRTV Programs, as well as "fit for purpose" applications using a variety of examples drawn from existing analyses. It is intended to serve as an example base template that can be adapted as needed for the specific SEM. The presented methods include workflows intended to facilitate rapid production. The Populations, Exposures, Comparators and Outcomes (PECO) criteria are typically kept broad to identify mammalian animal bioassay and epidemiological studies that could be informative for human hazard identification. In addition, a variety of supplemental content is tracked, e.g., studies presenting information on in vitro model systems, non-mammalian model systems, exposure-level-only studies in humans, pharmacokinetic models, and absorption, distribution, metabolism, and excretion (ADME). The availability of New Approach Methods (NAMs) evidence is also tracked (e.g., high throughput, transcriptomic, in silico, etc.). Genotoxicity studies may be considered as PECO relevant or supplemental material, depending on the topic and context of the review. Standard systematic review practices (e.g., two independent reviewers per record) and specialized software applications are used to search and screen the literature and may include the use of machine learning software. Mammalian bioassay and epidemiological studies that meet the PECO criteria after full-text review are briefly summarized using structured web-based extraction forms with respect to study design and health system(s) assessed. Extracted data is available in interactive visual formats and can be downloaded in open access formats. Methods for conducting study evaluation are also presented which is conducted on a case-by-case basis, depending on the usage of the SEM.
系统证据图谱（SEMs）在环境卫生领域的应用日益广泛，它们可作为制定问题的工具，并协助决策，特别是在确定优先事项方面。SEMs 现在已作为美国环境保护署（EPA）综合风险信息系统（IRIS）和暂定同行评审毒性值（PPRTV）评估开发过程的一部分进行常规编制。SEMs 也可用于针对单个化学物质或新兴关注的化学物质组，探索现有文献。
本文描述了为 IRIS 和 PPRTV 计划编制 SEM 时通常使用的方法，以及使用各种现有分析示例进行的“用途明确”应用。它旨在作为一个示例基础模板，根据特定 SEM 的需要进行改编。所提出的方法包括旨在促进快速制作的工作流程。人群、暴露、对照和结局（PECO）标准通常保持广泛，以确定可能对人类危害识别具有信息性的哺乳动物动物生物测定和流行病学研究。此外，还跟踪了各种补充内容，例如，提供有关体外模型系统、非哺乳动物模型系统、人类仅暴露水平研究、药代动力学模型以及吸收、分布、代谢和排泄（ADME）的研究信息。还跟踪了新方法（NAMs）证据的可用性（例如，高通量、转录组学、计算等）。遗传毒性研究可能被视为与 PECO 相关或补充材料，具体取决于审查的主题和背景。标准系统评价实践（例如，每个记录两名独立审查员）和专门的软件应用程序用于搜索和筛选文献，并可能包括使用机器学习软件。在全文审查后符合 PECO 标准的哺乳动物生物测定和流行病学研究，使用基于网络的结构化提取表格简要总结了研究设计和评估的健康系统。提取的数据以交互式可视格式提供，并可下载为开放访问格式。还介绍了针对特定案例进行研究评估的方法，具体取决于 SEM 的使用情况。
