Protocol for designing INVITES-IN, a tool for assessing the internal validity of in vitro studies
| Autor: | Svendsen, Camilla, Whaley, Paul, Vist, Gunn E, Husøy, Trine, Beronius, Anna, Di Consiglio, Emma, Druwe, Ingrid, Hartung, Thomas, Hatzi, Vasiliki I, Hoffmann, Sebastian, Hooijmans, Carlijn R, Kass, Georges, Machera, Kyriaki, Robinson, Joshua F, Roggen, Erwin, Rooney, Andrew A, Roth, Nicolas, Spilioti, Eliana, Spyropoulou, Anastasia, Tcheremenskaia, Olga, Testai, Emanuela, Vinken, Mathieu, Mathisen, Gro Haarklou |
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| Rok vydání: | 2023 |
| Předmět: | |
| DOI: | 10.5281/zenodo.7633627 |
| Popis: | Methods to generate evidence for regulatory toxicology are increasingly shifting from classical animal experiments to new approach methodologies (NAMs), with a corresponding need for methods to incorporate them in systematic reviews and other evidence synthesis processes. While many tools have been created for assessing in vitro studies, no single tool is obviously authoritative specifically for assessing the internal validity of in vitro study designs. We therefore aim to address this situation by developing a new tool, INVITES-IN, for evaluating the internal validity of in vitro studies, using methods that ensure we are building on prior work, with a degree of rigour consistent with our intent to provide an authoritative assessment tool. The current protocol describes three of the four studies that will be performed to create the release version of INVITES-IN. In the first study, evaluation of existing assessment tools will be combined with focus group discussions to identify how characteristics of the design or conduct of an in vitro study can affect its internal validity. In the second study, group agreement on internal validity domains and items of importance for in vitro studies will be identified via a modified Delphi methodology. In the third study, the draft version of INVITES-IN will be created. A separate protocol will be prepared for the fourth study, which includes the user testing, validation of the tool, and collection of users’ experience. Revised version |
| Databáze: | OpenAIRE |
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