Centre for Public Health and Zoonoses, and Department of Population Medicine, Ontario Veterinary College, University of Guelph, Guelph, ON, Canada.
Zoonoses Public Health. 2010 Mar;57(2):105-36. doi: 10.1111/j.1863-2378.2009.01312.x. Epub 2010 Jan 12.
Concerns about the completeness and accuracy of reporting of randomized clinical trials (RCTs) and the impact of poor reporting on decision making have been documented in the medical field over the past several decades. Experience from RCTs in human medicine would suggest that failure to report critical trial features can be associated with biased estimated effect measures, and there is evidence to suggest that similar biases occur in RCTs conducted in livestock populations. In response to these concerns, standardized guidelines for reporting RCTs were developed and implemented in human medicine. The Consolidated Standards of Reporting Trials (CONSORT) statement was first published in 1996, with a revised edition published in 2001. The CONSORT statement consists of a 22-item checklist for reporting a RCT and a flow diagram to follow the number of participants at each stage of a trial. An explanation and elaboration document not only defines and discusses the importance of each of the items, but also provides examples of how this information could be supplied in a publication. Differences between human and livestock populations necessitate modifications to the CONSORT statement to maximize its usefulness for RCTs involving livestock. These have been addressed in an extension of the CONSORT statement titled the REFLECT statement: Methods and processes of creating reporting guidelines for randomized control trials for livestock and food safety. The modifications made for livestock trials specifically addressed the common use of group housing and group allocation to intervention in livestock studies; the use of deliberate challenge models in some trials and the common use of non-clinical outcomes, such as contamination with a foodborne pathogen. In addition, the REFLECT statement for RCTs in livestock populations proposed specific terms or further clarified terms as they pertained to livestock studies.
几十年来，医学领域一直存在对随机临床试验 (RCT) 报告的完整性和准确性的担忧，以及报告质量差对决策的影响。来自人类医学 RCT 的经验表明，未能报告关键试验特征可能与估计效果的偏倚有关，并且有证据表明，在牲畜人群中进行的 RCT 也存在类似的偏倚。为了解决这些担忧，制定了标准化的 RCT 报告指南，并在人类医学中实施。CONSORT 声明于 1996 年首次发表，2001 年发布了修订版。CONSORT 声明由一份 22 项清单和一个流程图组成，用于报告 RCT，并按照试验的每个阶段的参与者数量进行跟踪。一份解释和说明文件不仅定义并讨论了每个项目的重要性，还提供了如何在出版物中提供这些信息的示例。人类和牲畜群体之间的差异需要对 CONSORT 声明进行修改，以最大限度地提高其在涉及牲畜的 RCT 中的实用性。这在 CONSORT 声明的扩展版 REFLECT 声明中得到了处理：制定针对牲畜和食品安全的随机对照试验报告指南的方法和流程。针对牲畜试验进行的修改专门涉及到牲畜研究中常见的群体饲养和分组分配干预；一些试验中故意使用挑战模型以及常见的非临床结果，如食源性病原体污染。此外，REFLECT 声明针对牲畜群体中的 RCT 提出了特定术语或进一步澄清了与牲畜研究相关的术语。
