Vist Gunn E, Ames Heather M R, Mathisen Gro H, Husøy Trine, Svendsen Camilla, Beronius Anna, Consiglio Emma Di, Druwe Ingrid L, Hartung Thomas, Hoffmann Sebastian, Hooijmans Carlijn R, Machera Kyriaki, Prieto Pilar, Robinson Joshua F, Roggen Erwin, Rooney Andrew A, Roth Nicolas, Spilioti Eliana, Spyropoulou Anastasia, Tcheremenskaia Olga, Testai Emanuela, Vinken Mathieu, Whaley Paul
Norwegian Scientific Committee for Food and Environment, Norwegian Institute of Public Health, Oslo, Norway.
Division for Health Services, Norwegian Institute of Public Health, Oslo, Norway.
Evid Based Toxicol. 2024;2(1):2418045. doi: 10.1080/2833373X.2024.2418045. Epub 2024 Oct 31.
toxicology studies are increasingly being included as evidence in systematic reviews and chemical risk assessments. INVITES-IN, a tool for assessing the internal validity of studies, is currently under development. The first step in developing INVITES-IN involves the creation of an "item bank," an overview of study assessment concepts that may be relevant to evaluating the internal validity of toxicology studies. The item bank and methodology for its creation presented in this manuscript are intended to be a general resource for supporting the development of appraisal tools for toxicology studies and potentially other study designs.
We derived the item bank from seven literature sources (one existing item bank created from a systematic review of assessment criteria for studies, and six purposively sampled study appraisal tools) and the transcripts of three focus groups. Assessment criteria plausibly relating to internal validity were abstracted from the literature sources and focus group transcripts, disaggregated into individual criteria, then normalised to express in the simplest achievable language the core issue in each criterion - an "item bank" of assessment concepts. The items were then mapped onto a set of bias domains. We conducted simple descriptive statistical analyses and visualisations to describe patterns in the dataset and developed recommendations for the use and development of the item bank.
The item bank contains 405 items of potential relevance to evaluating the internal validity of toxicology studies.
To our knowledge, this is the second item bank of any kind to have been created for toxicology studies, and the first to use focus groups as a data source alongside literature analysis. The large number of items contributed by focus group discussions suggests this is an efficient method for capturing internal validity issues that are not easily identifiable in the literature. We believe our item bank and methodology for its creation will be a useful resource for supporting the development of appraisal tools. Due to the broad applicability of many items in the item bank, it may be informative for study designs beyond the domain.
毒理学研究越来越多地被纳入系统评价和化学风险评估的证据中。INVITES-IN是一种用于评估研究内部效度的工具，目前正在开发中。开发INVITES-IN的第一步涉及创建一个“项目库”，即对可能与评估毒理学研究内部效度相关的研究评估概念的概述。本手稿中介绍的项目库及其创建方法旨在作为一种通用资源，以支持毒理学研究及可能的其他研究设计的评估工具的开发。
我们从七个文献来源（一个通过对研究评估标准的系统评价创建的现有项目库，以及六个有目的抽样的研究评估工具）和三个焦点小组的记录中得出项目库。从文献来源和焦点小组记录中提取可能与内部效度相关的评估标准，将其分解为单个标准，然后进行标准化，以用最简单的语言表达每个标准中的核心问题——一个评估概念的“项目库”。然后将这些项目映射到一组偏倚领域。我们进行了简单的描述性统计分析和可视化，以描述数据集中的模式，并为项目库的使用和开发提出建议。
该项目库包含405个可能与评估毒理学研究内部效度相关的项目。
据我们所知，这是为毒理学研究创建的第二个此类项目库，也是第一个将焦点小组作为文献分析之外的数据源的项目库。焦点小组讨论贡献的大量项目表明，这是一种捕捉文献中不易识别的内部效度问题的有效方法。我们相信我们的项目库及其创建方法将成为支持评估工具开发的有用资源。由于项目库中许多项目具有广泛的适用性，它可能对毒理学领域之外的研究设计也有参考价值。
