Speaker
Description
The introduction of standardized reporting guidelines has long been a response to inadequate study descriptions, starting with the CONSORT statement for clinical trials in the 1990s (Begg et al., 1996). One major approach to improve transparency and methodological rigor has been the introduction of standardized reporting guidelines such as the ARRIVE guideline (Percie du Sert et al., 2020). However, several analyses, including Lin et al. (2024), have shown that the implementation of the ARRIVE-guideline remains incomplete. Inadequate or missing documentation particularly affects statistical aspects such as sample size planning, thereby impairing validity, reproducibility, and compliance with the 3Rs (Replacement, Reduction, Refinement). Despite these known deficiencies, a detailed evaluation of documentation quality in publications claiming adherence to ARRIVE is still lacking.
This study addresses this gap by systematically assessing how comprehensively and consistently the ARRIVE Guideline 2.0 is implemented in published animal intervention studies, with a particular focus on the reporting and justification of sample size planning.
Here we build upon the systematic review by Lin et al. (2024), which investigated the overall adherence of animal intervention studies to the ARRIVE Guideline 2.0. Based on publications selected from the Lin et al. collection, seventy-five peer-reviewed articles reporting interventional animal experiments with quantitative endpoints were analyzed in greater detail. The evaluation focused specifically on the completeness, transparency, and methodological consistency of reported parameters related to sample size planning. According to selected key criteria of the ARRIVE Guideline, information on effect size, power, significance level, statistical test, and justification of the sample size were systematically assessed.
A significant proportion of the publications examined contains only incomplete or incomprehensible information on sample size planning, particularly regarding the justification of the selected sample size, the handling of dropouts, or the documentation of effect sizes. Deviations between the planned and actual statistical tests occur frequently without sufficient justification. Future simulation-based analyses are intended to explore how such deviations and incorrect or unverified assumptions could affect statistical power and increase the risk of type-I- or type-II errors.
The work highlights persistent gaps in the documentation of animal studies, even though comprehensive reporting standards such as the ARRIVE Guideline exist. The findings point to specific areas where improving the implementation of ARRIVE in sample size planning could enhance methodological rigor and promote the consistent application of the 3Rs principles.
Literature
Begg, C., et al., doi:10.1001/jama.276.8.637
Du Percie Sert, N., et al., doi:10.1371/journal.pbio.3000410
Lin, Y., et al., doi:10.21037/cdt-24-413
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