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Protocol for designing INVITES-IN, a tool for assessing the internal validity of <i>in vitro</i> studies

Research output: Contribution to Journal/Magazine › Journal article › peer-review

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Protocol for designing INVITES-IN, a tool for assessing the internal validity of <i>in vitro</i> studies. / Svendsen, Camilla; Whaley, Paul; Vist, Gunn E. et al.
In: Evidence-Based Toxicology, Vol. 1, No. 1, 2232415, 31.12.2023.

Research output: Contribution to Journal/Magazine › Journal article › peer-review

Harvard

Svendsen, C, Whaley, P, Vist, GE, Husøy, T, Beronius, A, Di Consiglio, E, Druwe, I, Hartung, T, Hatzi, VI, Hoffmann, S, Hooijmans, CR, Machera, K, Robinson, JF, Roggen, E, Rooney, AA, Roth, N, Spilioti, E, Spyropoulou, A, Tcheremenskaia, O, Testai, E, Vinken, M & Mathisen, GH 2023, 'Protocol for designing INVITES-IN, a tool for assessing the internal validity of <i>in vitro</i> studies', Evidence-Based Toxicology, vol. 1, no. 1, 2232415. https://doi.org/10.1080/2833373x.2023.2232415

APA

Svendsen, C., Whaley, P., Vist, G. E., Husøy, T., Beronius, A., Di Consiglio, E., Druwe, I., Hartung, T., Hatzi, V. I., Hoffmann, S., Hooijmans, C. R., Machera, K., Robinson, J. F., Roggen, E., Rooney, A. A., Roth, N., Spilioti, E., Spyropoulou, A., Tcheremenskaia, O., ... Mathisen, G. H. (2023). Protocol for designing INVITES-IN, a tool for assessing the internal validity of <i>in vitro</i> studies. Evidence-Based Toxicology, 1(1), Article 2232415. https://doi.org/10.1080/2833373x.2023.2232415

Vancouver

Svendsen C, Whaley P, Vist GE, Husøy T, Beronius A, Di Consiglio E et al. Protocol for designing INVITES-IN, a tool for assessing the internal validity of <i>in vitro</i> studies. Evidence-Based Toxicology. 2023 Dec 31;1(1):2232415. Epub 2023 Aug 31. doi: 10.1080/2833373x.2023.2232415

Author

Svendsen, Camilla ; Whaley, Paul ; Vist, Gunn E. et al. / Protocol for designing INVITES-IN, a tool for assessing the internal validity of <i>in vitro</i> studies. In: Evidence-Based Toxicology. 2023 ; Vol. 1, No. 1.

Bibtex

@article{f1c98d2feb6344f1b3a03933a236b6ce,
title = "Protocol for designing INVITES-IN, a tool for assessing the internal validity of in vitro studies",
abstract = "This protocol describes the design and development of a tool for evaluation of the internal validity of in vitro studies, which is needed to include the data as evidence in systematic reviews and chemical risk assessments. The tool will be designed specifically to be applied to cell culture studies, including, but not restricted to, studies meeting the new approach methodology (NAM) definition. The tool is called INVITES-IN (IN VITro Experimental Studies INternal validity).In this protocol, three of the four studies that will be performed to create the release version of INVITES-IN are described. 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. Bias domains and items considered to be of relevance for in vitro studies will be identified. 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 the tool will be created, based on the data on relevance and importance of bias domains and items collected in Studies 1 and 2. A separate protocol will be prepared for the fourth study, which includes the user testing and validation of the tool, and collection of users{\textquoteright} experience.",
keywords = "Cell culture, NAMs, next generation risk assessment, risk of bias",
author = "Camilla Svendsen and Paul Whaley and Vist, {Gunn E.} and Trine Hus{\o}y and Anna Beronius and {Di Consiglio}, Emma and Ingrid Druwe and Thomas Hartung and Hatzi, {Vasiliki I.} and Sebastian Hoffmann and Hooijmans, {Carlijn R.} and Kyriaki Machera and Robinson, {Joshua F.} and Erwin Roggen and Rooney, {Andrew A.} and Nicolas Roth and Eliana Spilioti and Anastasia Spyropoulou and Olga Tcheremenskaia and Emanuela Testai and Mathieu Vinken and Mathisen, {Gro H.}",
year = "2023",
month = dec,
day = "31",
doi = "10.1080/2833373x.2023.2232415",
language = "English",
volume = "1",
journal = "Evidence-Based Toxicology",
issn = "2833-373X",
publisher = "Informa UK Limited",
number = "1",

}

RIS

TY - JOUR

T1 - Protocol for designing INVITES-IN, a tool for assessing the internal validity of in vitro studies

AU - Svendsen, Camilla

AU - Whaley, Paul

AU - Vist, Gunn E.

AU - Husøy, Trine

AU - Beronius, Anna

AU - Di Consiglio, Emma

AU - Druwe, Ingrid

AU - Hartung, Thomas

AU - Hatzi, Vasiliki I.

AU - Hoffmann, Sebastian

AU - Hooijmans, Carlijn R.

AU - Machera, Kyriaki

AU - Robinson, Joshua F.

AU - Roggen, Erwin

AU - Rooney, Andrew A.

AU - Roth, Nicolas

AU - Spilioti, Eliana

AU - Spyropoulou, Anastasia

AU - Tcheremenskaia, Olga

AU - Testai, Emanuela

AU - Vinken, Mathieu

AU - Mathisen, Gro H.

PY - 2023/12/31

Y1 - 2023/12/31

N2 - This protocol describes the design and development of a tool for evaluation of the internal validity of in vitro studies, which is needed to include the data as evidence in systematic reviews and chemical risk assessments. The tool will be designed specifically to be applied to cell culture studies, including, but not restricted to, studies meeting the new approach methodology (NAM) definition. The tool is called INVITES-IN (IN VITro Experimental Studies INternal validity).In this protocol, three of the four studies that will be performed to create the release version of INVITES-IN are described. 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. Bias domains and items considered to be of relevance for in vitro studies will be identified. 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 the tool will be created, based on the data on relevance and importance of bias domains and items collected in Studies 1 and 2. A separate protocol will be prepared for the fourth study, which includes the user testing and validation of the tool, and collection of users’ experience.

AB - This protocol describes the design and development of a tool for evaluation of the internal validity of in vitro studies, which is needed to include the data as evidence in systematic reviews and chemical risk assessments. The tool will be designed specifically to be applied to cell culture studies, including, but not restricted to, studies meeting the new approach methodology (NAM) definition. The tool is called INVITES-IN (IN VITro Experimental Studies INternal validity).In this protocol, three of the four studies that will be performed to create the release version of INVITES-IN are described. 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. Bias domains and items considered to be of relevance for in vitro studies will be identified. 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 the tool will be created, based on the data on relevance and importance of bias domains and items collected in Studies 1 and 2. A separate protocol will be prepared for the fourth study, which includes the user testing and validation of the tool, and collection of users’ experience.

KW - Cell culture

KW - NAMs

KW - next generation risk assessment

KW - risk of bias

U2 - 10.1080/2833373x.2023.2232415

DO - 10.1080/2833373x.2023.2232415

M3 - Journal article

VL - 1

JO - Evidence-Based Toxicology

JF - Evidence-Based Toxicology

SN - 2833-373X

IS - 1

M1 - 2232415

ER -