Treweek Shaun, Zwarenstein Merrick
Division of Clinical and Population Sciences and Education, University of Dundee, Dundee, UK.
Trials. 2009 Jun 3;10:37. doi: 10.1186/1745-6215-10-37.
Randomised controlled trials are the best research design for decisions about the effect of different interventions but randomisation does not, of itself, promote the applicability of a trial's results to situations other than the precise one in which the trial was done. While methodologists and trialists have rightly paid great attention to internal validity, much less has been given to applicability. This narrative review is aimed at those planning to conduct trials, and those aiming to use the information in them. It is intended to help the former group make their trials more widely useful and to help the latter group make more informed decisions about the wider use of existing trials. We review the differences between the design of most randomised trials (which have an explanatory attitude) and the design of trials more able to inform decision making (which have a pragmatic attitude) and discuss approaches used to assert applicability of trial results. If we want evidence from trials to be used in clinical practice and policy, trialists should make every effort to make their trial widely applicable, which means that more trials should be pragmatic in attitude.
随机对照试验是决定不同干预措施效果的最佳研究设计,但随机化本身并不能促进试验结果适用于除进行试验的精确情境之外的其他情况。虽然方法学家和试验者对内部有效性给予了应有的高度关注,但对适用性的关注却少得多。这篇叙述性综述针对的是计划开展试验的人员以及旨在利用试验中信息的人员。其目的是帮助前一组人员使他们的试验更具广泛用途,并帮助后一组人员就更广泛地使用现有试验做出更明智的决策。我们回顾了大多数随机试验的设计(具有解释性态度)与更能为决策提供信息的试验设计(具有务实态度)之间的差异,并讨论了用于确定试验结果适用性的方法。如果我们希望试验证据能应用于临床实践和政策,试验者应尽一切努力使他们的试验具有广泛适用性,这意味着更多的试验在态度上应更加务实。