Animal experimental research design in critical care

Justin S Merkow,Janine M Hoerauf,Ana Fernandez-Bustamante,Jason Brainard,Angela F Moss,Susan K Mikulich-Gilbertson,Lena M Mayes,Karsten Bartels

doi:10.1186/s12874-018-0526-6

Justin S Merkow, Janine M Hoerauf + Show 6 more

Open Access

https://doi.org/10.1186/s12874-018-0526-6

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Abstract

BackgroundLimited translational success in critical care medicine is thought to be in part due to inadequate methodology, study design, and reporting in preclinical studies. The purpose of this study was to compare reporting of core features of experimental rigor: blinding, randomization, and power calculations in critical care medicine animal experimental research. We hypothesized that these study design characteristics were more frequently reported in 2015 versus 2005.MethodsWe performed an observational bibliometric study to grade manuscripts on blinding, randomization, and power calculations. Chi-square tests and logistic regression were used for analysis. Inter-rater agreement was assessed using kappa and Gwet’s AC1.ResultsA total of 825 articles from seven journals were included. In 2005, power estimations were reported in 2%, randomization in 35%, and blinding in 20% (n = 482). In 2015, these metrics were included in 9, 47, and 36% of articles (n = 343). The increase in proportion for the metrics tested was statistically significant (p < 0.001, p = 0.002, and p < 0.001).ConclusionsOnly a minority of published manuscripts in critical care medicine journals reported on recommended study design steps to increase rigor. Routine justification for the presence or absence of blinding, randomization, and power calculations should be considered to better enable readers to assess potential sources of bias.

Highlights

Limited translational success in critical care medicine is thought to be in part due to inadequate methodology, study design, and reporting in preclinical studies
To assess consistency in the identification of manuscripts reporting on animal experimental research, a second investigator blinded to the results of the first investigator independently searched two journals that were randomly selected from the seven journals included in this study
We evaluated the methodological quality of animal research in critical care journals in 2005 and 2015 and found a significant increase in the reporting of power analyses, randomization, and sample size calculations

Summary

Introduction

Limited translational success in critical care medicine is thought to be in part due to inadequate methodology, study design, and reporting in preclinical studies. In attempts to address this problem, the Animal Research: Reporting of In Vivo Experiments (ARRIVE) guidelines as well as the revised National Institutes of Health grant application process have proposed standards for research involving animals to enhance the quality of experimental design, study conduct, and analysis of results [6,7,8]. These steps are intended to reduce bias and improve reproducibility and facilitate the translation of biomedical research to novel clinical applications that improve patient outcomes. We sought to provide information on the status quo of reported experimental design features to promote rigor

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