Systematic review of guidelines for internal validity in the design, conduct and analysis of preclinical biomedical experiments involving laboratory animals.
Systematic review of guidelines for internal validity in the design, conduct and analysis of preclinical biomedical experiments involving laboratory animals.
复制标题
对临床前生物医学实验的设计，行为和分析中内部有效性指南的系统综述。
DOI：
10.1136/bmjos-2019-100046
复制
发表时间：
2020
期刊：
影响因子：
--
通讯作者：
EQIPD WP3 study group members
中科院分区：
文献类型：
--
作者：
Vollert J;Schenker E;Macleod M;Bespalov A;Wuerbel H;Michel M;Dirnagl U;Potschka H;Waldron AM;Wever K;Steckler T;van de Casteele T;Altevogt B;Sil A;Rice ASC;EQIPD WP3 study group members
在过去的二十年里，人们越来越意识到涉及实验动物的临床前研究的规划、实施和报告中的缺陷所带来的负面影响。一些倡议已经开始增加临床前研究的透明度和内部有效性，主要是发表专家共识和经验。虽然这些不同的准则中提出的许多观点是相同或相似的，但它们在细节和严谨性上有所不同。其中大多数侧重于报告，只有少数涉及研究的规划和开展。本系统综述的目的是确定与临床前动物研究相关的现有实验设计、实施、分析和报告指南。在PubMed、Embase和Web of Science中进行系统检索，检索到13 863个唯一结果。经标题和摘要筛选，613篇论文进入全文评审阶段，其中60篇论文被保留。从这些建议中，我们提取了58条关于临床前动物研究计划、实施和报告的独特建议。在超过一半的出版物中推荐了样本量计算、适当的统计方法、动物治疗的隐蔽和随机分配、设盲结局评估和记录动物通过实验的流量。虽然我们认为这些建议是有价值的，有一个显着缺乏实验证据的重要性和相对影响实验和效果大小。
Over the last two decades, awareness of the negative repercussions of flaws in the planning, conduct and reporting of preclinical research involving experimental animals has been growing. Several initiatives have set out to increase transparency and internal validity of preclinical studies, mostly publishing expert consensus and experience. While many of the points raised in these various guidelines are identical or similar, they differ in detail and rigour. Most of them focus on reporting, only few of them cover the planning and conduct of studies. The aim of this systematic review is to identify existing experimental design, conduct, analysis and reporting guidelines relating to preclinical animal research. A systematic search in PubMed, Embase and Web of Science retrieved 13 863 unique results. After screening these on title and abstract, 613 papers entered the full-text assessment stage, from which 60 papers were retained. From these, we extracted unique 58 recommendations on the planning, conduct and reporting of preclinical animal studies. Sample size calculations, adequate statistical methods, concealed and randomised allocation of animals to treatment, blinded outcome assessment and recording of animal flow through the experiment were recommended in more than half of the publications. While we consider these recommendations to be valuable, there is a striking lack of experimental evidence on their importance and relative effect on experiments and effect sizes.