Pre-specification of statistical analysis approaches in published clinical trial protocols was inadequate
Pre-specification of statistical analysis approaches in published clinical trial protocols was inadequate
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DOI：
10.1016/j.jclinepi.2018.05.023
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发表时间：
2018-09-01
影响因子：
7.2
通讯作者：
Kahan, Brennan C.
中科院分区：
文献类型：
--
作者：
Greenberg, Lauren;Jairath, Vipul;Kahan, Brennan C.
目的：随机试验的结果可能取决于所使用的统计分析方法。重要的是在试验方案中预先指定分析方法，以避免选择性地报告基于那些提供最有利结果的分析。我们对已发表的试验方案进行了回顾，以评估主要结局的统计分析是否得到了充分的预先规定。方法：检索2016年11月PubMed收录的随机试验方案。我们确定了主要结局的统计分析方法的以下方面是否得到了充分的预先规定：(1)分析人群；(2)分析模型；(3)协变量的使用；(4)缺失数据的处理方法。结果：我们确定了99个符合条件的方案。很少有方案充分地预先规定了分析总体（8/ 99,8%）、分析模型（27/ 99,27%）、协变量（40/ 99,40%）或处理缺失数据的方法（10/ 99,10%）。大多数协议没有充分预定义统计分析方法的这四个方面中的任何一个（39%），或者只预定义一个方面（36%）。没有协议充分预定义分析的所有四个方面。结论：在已发表的试验方案中很少预先规定统计分析方法。这可能允许基于不同分析的选择性报告结果。(C) 2018爱思唯尔公司版权所有。
Objectives: Results from randomized trials can depend on the statistical analysis approach used. It is important to prespecify the analysis approach in the trial protocol to avoid selective reporting of analyses based on those which provide the most favourable results. We undertook a review of published trial protocols to assess how often the statistical analysis of the primary outcome was adequately prespecified.Methods: We searched protocols of randomized trials indexed in PubMed in November 2016. We identified whether the following aspects of the statistical analysis approach for the primary outcome were adequately prespecified: (1) analysis population; (2) analysis model; (3) use of covariates; and (4) method of handling missing data.Results: We identified 99 eligible protocols. Very few protocols adequately prespecified the analysis population (8/99, 8%), analysis model (27/99, 27%), covariates (40/99, 40%), or approach to handling missing data (10/99, 10%). Most protocols did not adequately pre-define any of these four aspects of their statistical analysis approach (39%) or predefined only one aspect (36%). No protocols adequately predefined all four aspects of the analysis.Conclusion: The statistical analysis approach is rarely prespecified in published trial protocols. This may allow selective reporting of results based on different analyses. (C) 2018 Elsevier Inc. All rights reserved.