Abstract
Context: In vitro 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 in vitro studies, is currently under development. The first step in developing INVITES-IN involves the creation of an “item bank”, a database of study assessment concepts that may be relevant to evaluating the internal validity of in vitro toxicology studies. The item bank and its development methodology presented in this manuscript are intended to be a general resource for supporting the design and conduct of in vitro toxicology studies and potentially other related study designs.
Methods: We derived the item bank from seven literature sources (one existing item bank created from a systematic review of assessment criteria for in vitro studies, and six purposively sampled study appraisal tools) and the transcribed discussions 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. The items were then mapped onto a set of bias domains. We conducted simple descriptive statistical analyses and visualisations to describe patterns in the database and develop recommendations for the use and development of the item bank.
Results: The item bank contains 405 items that may be important for evaluating the internal validity of in vitro toxicology studies. The original systematic review contributed 96 items to the item bank before removing duplicates between the systematic review and the six tools and the focus groups. The tools specifically designed for assessing the internal validity of studies added 215 items. The focus groups added an additional 114 items.
Discussion: 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 alongside literature analysis. This two-prong approach is to comprehensively identify issues that relate to the internal validity of in vitro toxicology studies. 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, if present at all. We believe our item bank will be a useful resource for informing the development of future tools, or updating of existing tools, that target the internal validity of in vitro toxicology studies.
Methods: We derived the item bank from seven literature sources (one existing item bank created from a systematic review of assessment criteria for in vitro studies, and six purposively sampled study appraisal tools) and the transcribed discussions 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. The items were then mapped onto a set of bias domains. We conducted simple descriptive statistical analyses and visualisations to describe patterns in the database and develop recommendations for the use and development of the item bank.
Results: The item bank contains 405 items that may be important for evaluating the internal validity of in vitro toxicology studies. The original systematic review contributed 96 items to the item bank before removing duplicates between the systematic review and the six tools and the focus groups. The tools specifically designed for assessing the internal validity of studies added 215 items. The focus groups added an additional 114 items.
Discussion: 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 alongside literature analysis. This two-prong approach is to comprehensively identify issues that relate to the internal validity of in vitro toxicology studies. 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, if present at all. We believe our item bank will be a useful resource for informing the development of future tools, or updating of existing tools, that target the internal validity of in vitro toxicology studies.
| Original language | English |
|---|---|
| Journal | Evidence-Based Toxicology |
| Publication status | Accepted/In press - 14 Oct 2024 |