Why all randomised controlled trials produce biased results
Why all randomised controlled trials produce biased results
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DOI：
10.1080/07853890.2018.1453233
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发表时间：
2018-01-01
影响因子：
4.4
通讯作者：
Krauss, Alexander
中科院分区：
文献类型：
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作者：
Krauss, Alexander
背景：随机对照试验(RCT)通常被认为是为公共卫生和社会政策提供信息的最佳研究方法。通常它们被认为提供了治疗有效性的最严格的证据，而没有强有力的假设、偏见和限制。目标：这是第一次通过评估世界上被引用最多的10项RCT研究来检验这一假设。数据来源：这10项被引用次数最多的RCT研究(截至2016年6月)是通过搜索Scope(最大的同行评议期刊数据库)确定的。结果：这项研究表明，这些世界领先的RCT通过说明参与者的背景特征影响结果往往在试验组之间分布不均，从而产生了有偏见的结果。这些试验往往忽视了影响其主要报告结果的其他因素，除其他许多问题外，试验往往只是部分失明或非失明。这项研究还发现了一些在设计、实施和分析试验时出现的新的和重要的假设、偏见和限制，这些假设、偏差和限制在现有研究中尚未得到彻底讨论。结论：研究人员和政策制定者需要更好地认识到试验中更广泛的假设、偏差和限制。期刊也需要开始要求研究人员在他们的研究中概述它们。我们还需要更好地将随机对照试验与其他研究方法结合起来使用。
Background: Randomised controlled trials (RCTs) are commonly viewed as the best research method to inform public health and social policy. Usually they are thought of as providing the most rigorous evidence of a treatments effectiveness without strong assumptions, biases and limitations.Objective: This is the first study to examine that hypothesis by assessing the 10 most cited RCT studies worldwide.Data sources: These 10 RCT studies with the highest number of citations in any journal (up to June 2016) were identified by searching Scopus (the largest database of peer-reviewed journals).Results: This study shows that these world-leading RCTs that have influenced policy produce biased results by illustrating that participants' background traits that affect outcomes are often poorly distributed between trial groups, that the trials often neglect alternative factors contributing to their main reported outcome and, among many other issues, that the trials are often only partially blinded or unblinded. The study here also identifies a number of novel and important assumptions, biases and limitations not yet thoroughly discussed in existing studies that arise when designing, implementing and analysing trials.Conclusions: Researchers and policymakers need to become better aware of the broader set of assumptions, biases and limitations in trials. Journals need to also begin requiring researchers to outline them in their studies. We need to furthermore better use RCTs together with other research methods.