Testing for baseline differences in randomized controlled trials: an unhealthy research behavior that is hard to eradicate.
Testing for baseline differences in randomized controlled trials: an unhealthy research behavior that is hard to eradicate.
复制标题
在随机对照试验中测试基线差异：一种不健康的研究行为，难以消除。
DOI：
10.1186/s12966-015-0162-z
复制
发表时间：
2015-01-24
期刊：
影响因子：
--
通讯作者：
Twisk JW
中科院分区：
文献类型：
--
作者：
de Boer MR;Waterlander WE;Kuijper LD;Steenhuis IH;Twisk JW
根据CONSORT声明，不应对随机对照试验中的基线差异进行显著性检验。事实上，在过去的四十年里，许多作者都不鼓励这种做法。在这段时间内，领先的普通医学期刊对基线差异的报道大幅减少。然而，我们自己在营养行为研究领域的经验是，合著者，审稿人甚至编辑仍然非常坚持他们对这些测试的需求。因此，本文的目的是否定这种需求，提供明确的证据，为什么测试干预组之间的基线差异统计是多余的，为什么这样的结果不应该公布。基线差异检验经常被推广，因为人们认为它可以显示随机化是否成功，并且可以识别治疗组之间的真实的或重要的差异，这些差异应该在统计分析中考虑。特别是后一种观点是有缺陷的，因为它忽略了一个事实，即当关注的是调整混杂因素时，变量的预测强度也很重要。此外，包括预后变量作为协变量可以提高效应估计的精度。这意味着基于基线差异的显著性检验选择协变量可能会导致重要协变量的遗漏，更重要的是，在分析中纳入不相关的协变量。我们使用了四个超市试验的数据，研究价格策略对水果和蔬菜购买的影响，结果表明，完全调整后的分析结果有时确实与仅调整显著基线差异的分析结果存在明显差异。我们建议调整已知或预期的重要预后变量。这些可以或应该在试验方案中预先规定。随后，作者应报告完全调整后的结果以及原始分析，特别是对于二分数据和事件发生时间数据。基于我们的论点，这是由我们的研究结果所说明的，我们建议营养行为领域内外的期刊积极采用CONSORT 2010关于这一主题的声明，不再发表基线差异的显著性检验。
According to the CONSORT statement, significance testing of baseline differences in randomized controlled trials should not be performed. In fact, this practice has been discouraged by numerous authors throughout the last forty years. During that time span, reporting of baseline differences has substantially decreased in the leading general medical journals. Our own experience in the field of nutrition behavior research however, is that co-authors, reviewers and even editors are still very persistent in their demand for these tests. The aim of this paper is therefore to negate this demand by providing clear evidence as to why testing for baseline differences between intervention groups statistically is superfluous and why such results should not be published. Testing for baseline differences is often propagated because of the belief that it shows whether randomization was successful and it identifies real or important differences between treatment arms that should be accounted for in the statistical analyses. Especially the latter argument is flawed, because it ignores the fact that the prognostic strength of a variable is also important when the interest is in adjustment for confounding. In addition, including prognostic variables as covariates can increase the precision of the effect estimate. This means that choosing covariates based on significance tests for baseline differences might lead to omissions of important covariates and, less importantly, to inclusion of irrelevant covariates in the analysis. We used data from four supermarket trials on the effects of pricing strategies on fruit and vegetables purchases, to show that results from fully adjusted analyses sometimes do appreciably differ from results from analyses adjusted for significant baseline differences only. We propose to adjust for known or anticipated important prognostic variables. These could or should be pre-specified in trial protocols. Subsequently, authors should report results from the fully adjusted as well as crude analyses, especially for dichotomous and time to event data. Based on our arguments, which were illustrated by our findings, we propose that journals in and outside the field of nutrition behavior actively adopt the CONSORT 2010 statement on this topic by not publishing significance tests for baseline differences anymore.
登录
查看更多内容
影响因子：
2
作者：
Senn, S
通讯作者：
Senn, S
影响因子：
158.5
作者：
LAVORI, PW;LOUIS, TA;POLANSKY, M
通讯作者：
POLANSKY, M
影响因子：
2
作者：
Senn, Stephen
通讯作者：
Senn, Stephen
影响因子：
7.1
作者：
Waterlander, Wilma E.;de Boer, Michiel R.;Steenhuis, Ingrid H. M.
通讯作者：
Steenhuis, Ingrid H. M.
影响因子：
6.2
作者：
LYNCH, HT;GUIRGIS, HA;HARRIS, RE
通讯作者：
HARRIS, RE