Protocol: Testing the performance of INVITES-IN, a tool for assessing the internal validity of in vitro studies
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Mathisen, Gro Haarklou1
- Vist, Gunn Elisabeth2
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Whaley, Paul3
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White, Richard Aubery4
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Husøy, Trine5
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Ames, Heather Melanie2
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Beronius, Anna6
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Di Consiglio, Emma7
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Druwe, Ingrid8
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Hartung, Thomas9
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Hoffmann, Sebastian10
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Hooijmans, Carlijn R.11
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Machera, Kyriaki12
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Prieto, Pilar13
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Robinson, Joshua F.14
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Roggen, Erwin15
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Rooney, Andrew A.16
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Roth, Nicolas17
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Spilioti, Eliana12
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Spyropoulou, Anastasia12
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Tcheremenskaia, Olga7
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Testai, Emanuela7
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Vinken, Mathieu18
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Svendsen, Camilla19
- 1. Norwegian Scientific Committee for Food and Environment, Norwegian Institute of Public Health, Oslo, Norway
- 2. Norwegian Scientific Committee for Food and Environment, Norwegian Institute of Public Health, Oslo, Norway AND Division for Health Services, Norwegian Institute of Public Health, Oslo, Norway
- 3. Norwegian Scientific Committee for Food and Environment, Norwegian Institute of Public Health, Oslo, Norway AND Lancaster Environment Centre, Lancaster University, Lancaster, UK
- 4. Norwegian Scientific Committee for Food and Environment, Norwegian Institute of Public Health, Oslo, Norway AND Department of Method Development and Analytics, Norwegian Institute of Public Health, Oslo, Norway
- 5. Norwegian Scientific Committee for Food and Environment, Norwegian Institute of Public Health, Oslo, Norway AND Department of Food Safety, Norwegian Institute of Public Health, Oslo, Norway
- 6. Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden
- 7. Environment & Health Department, Italian National Institute of Health (ISS), Rome, Italy
- 8. United States Environmental Protection Agency, Office of Research and Development, Center for Public Health and Environmental Assessments, Research Triangle Park, NC, USA
- 9. Center for Alternatives to Animal Testing (CAAT), Johns Hopkins University, Bloomberg School of Public Health, Baltimore, MD, USA AND CAAT Europe, University of Konstanz, Konstanz, Germany
- 10. Evidence-based toxicology collaboration (EBTC), Johns Hopkins University, Bloomberg School of Public Health, Baltimore, MD, USA AND seh consulting + services, Paderborn, Germany
- 11. Department of Anesthesiology, Pain and Palliative Care, Radboud University Medical Centre, Nijmegen, Netherlands
- 12. Laboratory of Toxicological Control of Pesticides, Scientific Directorate of Pesticides' Control and Phytopharmacy, Benaki Phytopathological Institute, Kifissia, Greece
- 13. European Commission, Joint Research Centre (JRC), Ispra, Italy
- 14. Department of Obstetrics, Gynecology & Reproductive Sciences, University of California, San Francisco (UCSF), USA
- 15. 3Rs Management and Consulting ApS, Lyngby, Denmark
- 16. Division of Translational Toxicology, National Institute of Environmental Health Sciences, Research Triangle Park, NC, USA
- 17. Department of Pharmaceutical Sciences, University of Basel, Basel, Switzerland AND Swiss Centre for Applied Human Toxicology (SCAHT), Switzerland
- 18. Department of Pharmaceutical and Pharmacological Sciences, Vrije Universiteit Brussel; Belgium
- 19. Norwegian Scientific Committee for Food and Environment, Norwegian Institute of Public Health, Oslo, Norway AND Department of Chemical Toxicology, Norwegian Institute of Public Health, Oslo, Norway
Description
A tool for evaluation of internal validity of in vitro studies called INVITES-IN is currently under development. The tool is designed specifically for cell culture studies.
This protocol describes the testing of the performance of INVITES-IN. By performance, we mean the extent to which results of using INVITES-IN are the same for different users (consistency), the amount of time and cognitive effort it takes to apply INVITES-IN (assessor workload), the precision and potential for systematic error in results of applying INVITES-IN (accuracy), and how easy it is to use INVITES-IN (user experience).
The participants in the user testing will be representative for the expected end-users of INVITES-IN which are persons preparing literature reviews including in vitro studies (e.g. in the context of chemical hazard and risk assessments or drug development). All end-users are expected to have experience with in vitro methods.
Data collected from the performance testing will be used for further refinement and development of the release version of INVITES-IN.