Buch, Thorsten ORCID: 0000-0002-2236-9074, Moos, Katharina, Ferreira, Filipa M., Froehlic, Holger, Gebhard, Catherine ORCID: 0000-0001-7240-5822 and Tresch, Achim (2019). Benefits of a factorial design focusing on inclusion of female and male animals in one experiment. J. Mol. Med., 97 (6). S. 871 - 878. HEIDELBERG: SPRINGER HEIDELBERG. ISSN 1432-1440

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Abstract

Disease occurrence, clinical manifestations, and outcomes differ between men and women. Yet, women and men are most of the time treated similarly, which is often based on experimental data over-representing one sex. Accounting for persisting sex bias in biomedical research is the misconception that the analysis of sex-specific effects would double sample size and costs. We designed an analysis to test the potential benefits of a factorial study design in the context of a study including male and female animals. We chose a 2x2 factorial design approach to study the effect of treatment, sex, and an interaction term of treatment and sex in a hypothetical situation. We calculated the sample sizes required to detect an effect of a given magnitude with sufficient power and under different experimental setups. We demonstrated that the inclusion of both sexes in experimental setups, without testing for sex effects, requires no or few additional animals in our scenarios. These experimental designs still allow for the exploration of sex effects at low cost. In a confirmatory instead of an exploratory design, we observed an increase in total sample sizes by 33%, at most. Since the complexities associated with this mathematical model require statistical expertise, we generated and provide a sample size calculator for planning factorial design experiments. For the inclusion of sex, a factorial design is advisable, and a sex-specific analysis can be performed without excessive additional effort. Our easy-to-use calculation tool provides help in designing studies with both sexes and addresses the current sex bias in preclinical studies.Key messages center dot Both sexes should be included into animal studies.center dot Exploratory study of sex effects can be conducted with no or small increase in animal number.center dot Confirmatory analysis of sex effects requires maximum 33% more animals per study.center dot Our calculation tool supports the design of studies with both sexes.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Buch, ThorstenUNSPECIFIEDorcid.org/0000-0002-2236-9074UNSPECIFIED
Moos, KatharinaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ferreira, Filipa M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Froehlic, HolgerUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gebhard, CatherineUNSPECIFIEDorcid.org/0000-0001-7240-5822UNSPECIFIED
Tresch, AchimUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-147295
DOI: 10.1007/s00109-019-01774-0
Journal or Publication Title: J. Mol. Med.
Volume: 97
Number: 6
Page Range: S. 871 - 878
Date: 2019
Publisher: SPRINGER HEIDELBERG
Place of Publication: HEIDELBERG
ISSN: 1432-1440
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
SEX BIAS EXISTS; BASIC SCIENCEMultiple languages
Genetics & Heredity; Medicine, Research & ExperimentalMultiple languages
Refereed: Yes
URI: http://kups.ub.uni-koeln.de/id/eprint/14729

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