Department of Clinical Medicine, AUGUST, Aarhus University, Aarhus, Denmark.
Department of Health Services Research and Policy, Research School of Population Health, Australian National University, Canberra, Australia.
PLoS One. 2022 Nov 3;17(11):e0275962. doi: 10.1371/journal.pone.0275962. eCollection 2022.
Lack of translation and irreproducibility challenge preclinical animal research. Insufficient reporting methodologies to safeguard study quality is part of the reason. This nationwide study investigates the reporting prevalence of these methodologies and scrutinizes the reported information's level of detail. Publications were from two time periods to convey any reporting progress and had at least one author affiliated to a Danish University. We retrieved all relevant animal experimental studies using a predefined research protocol and a systematic search. A random sampling of 250 studies from 2009 and 2018 led to 500 publications in total. Reporting of measures known to impact study results estimates were assessed. Part I discloses a simplified two-level scoring "yes/no" to identify the presence of reporting. Part II demonstrates an additional three-level scoring to analyze the reported information's level of detail. Overall reporting prevalence is low, although minor improvements are noted. Reporting of randomization increased from 24.0% in 2009 to 40.8% in 2018, blinded experiment conduct from 2.4% to 4.4%, blinded outcome assessment from 23.6% to 38.0%, and sample size calculation from 3.2% to 14.0%. Poor reporting of details is striking with reporting of the random allocation method to groups being only 1.2% in 2009 and 6.0% in 2018. Reporting of sample size calculation method was 2.4% in 2009 and 7.6% in 2018. Only conflict-of-interest statements reporting increased from 37.6% in 2009 to 90.4%. Measures safeguarding study quality are poorly reported in publications affiliated with Danish research institutions. Only a modest improvement was noted during the period 2009-2018, and the lack of details urgently prompts institutional strategies to accelerate this. We suggest thorough teaching in designing, conducting and reporting animal studies. Education in systematic review methodology should be implemented in this training and will increase motivation and behavior working towards quality improvements in science.
缺乏翻译和可重复性挑战了临床前动物研究。部分原因是报告质量保障研究方法的报告方法不足。这项全国性研究调查了这些方法的报告流行率,并仔细审查了报告信息的详细程度。出版物来自两个时期,以传达任何报告进展,并至少有一位作者隶属于丹麦的一所大学。我们使用预先确定的研究方案和系统搜索检索了所有相关的动物实验研究。从 2009 年和 2018 年随机抽取 250 项研究,共产生 500 项出版物。评估了已知影响研究结果估计的措施的报告情况。第一部分披露了简化的两级评分“是/否”,以确定报告的存在。第二部分展示了额外的三级评分,以分析报告信息的详细程度。总体报告流行率较低,但有一些改进。随机分组的报告从 2009 年的 24.0%增加到 2018 年的 40.8%,实验过程的盲法从 2.4%增加到 4.4%,结果评估的盲法从 23.6%增加到 38.0%,样本量计算的盲法从 3.2%增加到 14.0%。细节报告不佳引人注目,2009 年和 2018 年分组的随机分配方法的报告分别仅为 1.2%和 6.0%。样本量计算方法的报告分别为 2009 年的 2.4%和 2018 年的 7.6%。仅利益冲突声明的报告从 2009 年的 37.6%增加到 90.4%。与丹麦研究机构相关的出版物中,保障研究质量的措施报告不佳。在 2009-2018 年期间仅注意到适度的改进,并且缺乏细节迫切需要机构策略来加速这一改进。我们建议在设计、进行和报告动物研究方面进行全面教学。应该在这种培训中实施系统评价方法的教育,并将提高动机和行为,努力改善科学质量。