Department of Population Medicine, University of Guelph, Guelph, ON N1G 2W1 Canada.
Department of Large Animal Clinical Sciences, College of Veterinary Medicine, Michigan State University, East Lansing 48824.
J Dairy Sci. 2022 Nov;105(11):8594-8608. doi: 10.3168/jds.2022-22015. Epub 2022 Aug 31.
Clinical trials are a valuable study design for evaluating interventions when it is ethical and feasible for investigators to randomly allocate study animals to intervention groups. Researchers may choose to evaluate the comparative efficacy of intervention groups for their effect on outcomes that are relevant to the specific objectives of their trial. However, the results across multiple trials on the same intervention and with the same outcome should be considered when making decisions on whether to use an intervention, because the results of a single trial are subject to sampling error and do not reflect all biological variability. The objective of this review was to provide an overview of important concepts when selecting intervention groups and outcomes within a randomized controlled trial, and when building a body of evidence for intervention efficacy across multiple trials. Empirical evidence is presented to highlight that integrating and interpreting the efficacy of an intervention across trials is hindered by a lack of replication of interventions across trials. Inconsistency in the outcomes and their measurement among trials also limits the ability to build a body of evidence for the efficacy of interventions. The development of core outcome sets for specific topic areas in dairy science, updated as necessary, may improve consistency across trials and aid in the development of a body of evidence for evidence-based decision-making.
临床试验是一种评估干预措施的有价值的研究设计,当研究人员能够将研究动物随机分配到干预组时,这种方法在伦理和可行的范围内是合理的。研究人员可能会选择评估干预组对与其试验具体目标相关的结果的相对疗效。然而,在做出是否使用干预措施的决策时,应该考虑到针对同一干预措施和相同结局的多项试验的结果,因为单个试验的结果存在抽样误差,并且不能反映所有的生物学变异性。本综述的目的是提供在随机对照试验中选择干预组和结局以及在多个试验中构建干预效果证据体时的重要概念概述。实证证据表明,由于试验之间缺乏干预措施的重复,整合和解释干预措施的效果受到阻碍。试验之间的结局及其测量不一致也限制了构建干预效果证据体的能力。为乳制品科学特定主题领域制定核心结局集,并根据需要进行更新,可能会提高试验之间的一致性,并有助于为基于证据的决策制定证据体的发展。