Background

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.

Objectives

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.

中文翻译：

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系统证据图 (SEM) 模板：用于美国 EPA 综合风险信息系统 (IRIS) 计划、临时同行评审毒性值 (PPRTV) 计划和其他“适合目的”的基于文献的人类健康分析的报告格式和方法

背景

系统证据图 (SEM) 在环境健康领域的知名度越来越高，因为它们可以用作问题制定工具并协助决策制定，尤其是优先级设置。SEM 现在作为美国环境保护署 (EPA) 综合风险信息系统 (IRIS) 和临时同行评审毒性值 (PPRTV) 评估的评估开发过程的一部分进行常规准备。SEM 还可以准备探索有关单个化学品或新出现的化学品组的可用文献。

目标

本文档描述了用于为 IRIS 和 PPRTV 程序生成 SEM 的典型方法，以及使用从现有分析中提取的各种示例的“适合目的”应用程序。它旨在用作示例基础模板，可以根据特定 SEM 的需要进行调整。提出的方法包括旨在促进快速生产的工作流程。人口、暴露、比较和结果 (PECO) 标准通常保持广泛，以确定哺乳动物动物生物测定和流行病学研究，这些研究可能为人类危害识别提供信息。此外，还会跟踪各种补充内容，例如，提供体外信息的研究模型系统、非哺乳动物模型系统、仅暴露水平的人类研究、药代动力学模型以及吸收、分布、代谢和排泄 (ADME)。还跟踪了新方法方法 (NAM) 证据的可用性（例如，高通量、转录组学、计算机模拟等）. 遗传毒性研究可被视为 PECO 相关或补充材料，具体取决于审查的主题和背景。标准的系统评价实践（例如，每条记录有两名独立的评价者）和专门的软件应用程序用于搜索和筛选文献，并且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卫生系统。提取的数据以交互式可视化格式提供，可以以开放访问格式下载。还介绍了进行研究评估的方法，该方法根据 SEM 的使用情况逐案进行。