Systematic review of the empirical evidence of study publication bias and outcome reporting bias - an updated review.
Systematic review of the empirical evidence of study publication bias and outcome reporting bias - an updated review.
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DOI：
10.1371/journal.pone.0066844
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发表时间：
2013
期刊：
影响因子：
3.7
通讯作者：
Reporting Bias Group
中科院分区：
文献类型：
--
作者：
Dwan K;Gamble C;Williamson PR;Kirkham JJ;Reporting Bias Group
在卫生保健干预措施的系统评价中越来越多地使用荟萃分析，这突出了在完成随机对照试验期间可能出现的几种类型的偏倚。研究发表偏倚和结果报告偏倚已被认为是对meta分析有效性的潜在威胁，并可能使现成的证据对决策不可靠。在本次更新中，我们回顾和总结了来自队列研究的证据，这些证据评估了随机对照试验中研究发表偏倚或结果报告偏倚。20项研究符合条件，其中4项是在本次更新中新确定的。只有两名研究人员从方案批准到公布结果的信息一直跟随队列。15项研究调查了研究发表偏倚，5项研究调查了结果报告偏倚。三项研究发现，与不显著的结果相比，具有统计学意义的结果被充分报道的几率更高（优势比范围：2.2至4.7）。在比较试验出版物和方案时，我们发现40-62%的研究至少有一个主要结局被改变、引入或省略。由于研究之间存在差异，我们决定不进行meta分析。这次更新没有改变纳入16项研究的综述的结论。研究发表偏倚和结果报告偏倚存在的直接经验证据显示。有强有力的证据表明，重大结果与发表之间存在关联；报告积极或显著结果的研究更有可能被发表，而统计上显著的结果更有可能被全面报道。出版物已被发现与其规程不一致。研究人员需要意识到这两种偏见的问题，并应集中精力改进试验报告。
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 and outcome reporting bias have been recognised as a potential threat to the validity of meta-analysis and can make the readily available evidence unreliable for decision making. In this update, we review and summarise the evidence from cohort studies that have assessed study publication bias or outcome reporting bias in randomised controlled trials. Twenty studies were eligible of which four were newly identified in this update. Only two followed the cohort all the way through from protocol approval to information regarding publication of outcomes. Fifteen 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 non-significant 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. This update does not change the conclusions of the review in which 16 studies were included. Direct empirical evidence for the existence of study publication bias and outcome reporting bias is shown. 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.
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DOI：
10.1007/bf03022661
发表时间：
2007-05-01
期刊：
CANADIAN JOURNAL OF ANAESTHESIA-JOURNAL CANADIEN D ANESTHESIE
影响因子：
--
作者：
Hall, Richard;de Antueno, Cecilia;Webber, Adam
通讯作者：
Webber, Adam
影响因子：
--
作者：
Dubben, HH;Beck-Bornholdt, HP
通讯作者：
Beck-Bornholdt, HP
资金对生物医学研究的影响：回顾性队列研究。
影响因子：
4.5
作者：
Decullier, Evelyne;Chapuis, Francois
通讯作者：
Chapuis, Francois
影响因子：
105.7
作者：
Decullier, E;Lheritier, V;Chapuis, F
通讯作者：
Chapuis, F
影响因子：
3.7
作者：
Dwan, Kerry;Altman, Douglas G.;Williamson, Paula R.
通讯作者：
Williamson, Paula R.