Systematic Review of the Empirical Evidence of Study Publication Bias and Outcome Reporting Bias
Systematic Review of the Empirical Evidence of Study Publication Bias and Outcome Reporting Bias
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DOI：
10.1371/journal.pone.0003081
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发表时间：
2008-08-28
期刊：
影响因子：
3.7
通讯作者：
Williamson, Paula R.
中科院分区：
文献类型：
--
作者：
Dwan, Kerry;Altman, Douglas G.;Williamson, Paula R.
背景：在医疗保健干预系统评价中越来越多地使用荟萃分析，突显了随机对照试验完成过程中可能出现的几种类型的偏差。研究发表偏差已被认为是对荟萃分析有效性的潜在威胁，并且可能使现成的证据对决策不可靠。直到最近，结果报告偏倚还没有受到足够的关注。方法/主要发现：我们回顾并总结了一系列队列研究的证据，这些研究评估了随机对照试验中的研究发表偏倚和结果报告偏倚。十六项研究符合资格，其中只有两项研究从方案批准到有关结果发布的信息全程跟踪队列。其中十一项研究调查了研究发表偏差，五项研究调查了结果报告偏差。三项研究发现，与不显着的结果相比，具有统计显着性的结果被完全报告的几率更高（优势比范围：2.2 至 4.7）。在将试验出版物与方案进行比较时，我们发现 40-62% 的研究至少有一项主要结局被更改、引入或省略。由于研究之间的差异，我们决定不进行荟萃分析。结论：最近的工作为研究发表偏差和结果报告偏差的存在提供了直接的经验证据。有强有力的证据表明显着结果与发表之间存在关联；报告积极或显着结果的研究更有可能发表，并且具有统计显着性的结果被充分报告的可能性更高。已发现出版物与其协议不一致。研究人员需要意识到这两种类型的偏见问题，并且应集中精力改进试验报告。
Background: The increased use of meta-analysis in systematic reviews of healthcare interventions has highlighted several types of bias that can arise during the completion of a randomised controlled trial. Study publication bias has been recognised as a potential threat to the validity of meta-analysis and can make the readily available evidence unreliable for decision making. Until recently, outcome reporting bias has received less attention.Methodology/Principal Findings: We review and summarise the evidence from a series of cohort studies that have assessed study publication bias and outcome reporting bias in randomised controlled trials. Sixteen studies were eligible of which only two followed the cohort all the way through from protocol approval to information regarding publication of outcomes. Eleven of the studies investigated study publication bias and five investigated outcome reporting bias. Three studies have found that statistically significant outcomes had a higher odds of being fully reported compared to nonsignificant outcomes (range of odds ratios: 2.2 to 4.7). In comparing trial publications to protocols, we found that 40-62% of studies had at least one primary outcome that was changed, introduced, or omitted. We decided not to undertake meta-analysis due to the differences between studies.Conclusions: Recent work provides direct empirical evidence for the existence of study publication bias and outcome reporting bias. There is strong evidence of an association between significant results and publication; studies that report positive or significant results are more likely to be published and outcomes that are statistically significant have higher odds of being fully reported. Publications have been found to be inconsistent with their protocols. Researchers need to be aware of the problems of both types of bias and efforts should be concentrated on improving the reporting of trials.