Evolution of poor reporting and inadequate methods over time in 20 920 randomised controlled trials included in Cochrane reviews: research on research study
Evolution of poor reporting and inadequate methods over time in 20 920 randomised controlled trials included in Cochrane reviews: research on research study
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DOI：
10.1136/bmj.j2490
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发表时间：
2017-06-08
影响因子：
105.7
通讯作者：
Ravaud, Philippe
中科院分区：
文献类型：
--
作者：
Dechartres, Agnes;Trinquart, Ludovic;Ravaud, Philippe
目的探讨随机对照试验（RCT）中关键方法学特征的不良报告和方法不足在过去30年中的变化。科克伦综述中纳入的试验设计映射。数据来源2011年3月至2014年9月期间发表的所有科克伦综述中纳入的RCTs数据，报告了对科克伦偏倚风险项目的评价：序列生成、分配隐藏、盲法和不完整的结果数据。数据提取对于每个RCT，我们提取了综述作者对偏倚风险的共识，并确定了主要参考文献，以提取出版年份和期刊。我们将期刊名称与期刊引文报告进行匹配，以获得2014年的影响因子。主要结果指标我们认为，由综述作者评定为不明确和高偏倚风险的试验比例分别作为报告质量差和方法不充分的替代品。偏倚风险不明确的试验比例分别为48.7%（序列生成）和57.5%（分配隐藏）;偏倚风险高的试验比例分别为4.0%和7.2%。对于设盲和不完整的结局数据，分别有30.6%和24.7%的试验风险不明确，33.1%和17.1%的试验风险较高。较高的期刊影响因子与不清楚或高偏倚风险的试验比例较低相关。偏倚风险不明确的试验比例随着时间的推移而下降，特别是序列生成，从1986-1990年的69.1%下降到2011-14年的31.2%，分配隐藏（70.1%到44.6%）。排除试验在不清楚的偏倚风险，使用不适当的方法也随着时间的推移而下降：从14.8%到4.6%序列生成和32.7%到11.6%分配concealing.Conclusions不良的报告和不适当的方法随着时间的推移而减少，特别是序列生成和分配隐藏。但还有更多的工作要做，特别是在影响因子较低的期刊上。
Objective To examine how poor reporting and inadequate methods for key methodological features in randomised controlled trials (RCTs) have changed over the past three decades.Design Mapping of trials included in Cochrane reviews.Data sources Data from RCTs included in all Cochrane reviews published between March 2011 and September 2014 reporting an evaluation of the Cochrane risk of bias items: sequence generation, allocation concealment, blinding, and incomplete outcome data.Data extraction For each RCT, we extracted consensus on risk of bias made by the review authors and identified the primary reference to extract publication year and journal. We matched journal names with Journal Citation Reports to get 2014 impact factors.Main outcomes measures We considered the proportions of trials rated by review authors at unclear and high risk of bias as surrogates for poor reporting and inadequate methods, respectively.Results We analysed 20 920 RCTs (from 2001 reviews) published in 3136 journals. The proportion of trials with unclear risk of bias was 48.7% for sequence generation and 57.5% for allocation concealment; the proportion of those with high risk of bias was 4.0% and 7.2%, respectively. For blinding and incomplete outcome data, 30.6% and 24.7% of trials were at unclear risk and 33.1% and 17.1% were at high risk, respectively. Higher journal impact factor was associated with a lower proportion of trials at unclear or high risk of bias. The proportion of trials at unclear risk of bias decreased over time, especially for sequence generation, which fell from 69.1% in 1986-1990 to 31.2% in 2011-14 and for allocation concealment (70.1% to 44.6%). After excluding trials at unclear risk of bias, use of inadequate methods also decreased over time: from 14.8% to 4.6% for sequence generation and from 32.7% to 11.6% for allocation concealment.Conclusions Poor reporting and inadequate methods have decreased over time, especially for sequence generation and allocation concealment. But more could be done, especially in lower impact factor journals.