Improving the reporting of randomised trials: the CONSORT Statement and beyond

Improving the reporting of randomised trials: the CONSORT Statement and beyond
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DOI:
10.1002/sim.5402
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发表时间:
2012-11-10
影响因子:
2
通讯作者:
Schulz, Kenneth F.
Schulz, Kenneth F.
中科院分区:
医学3区
文献类型:
--
作者:
Altman, Douglas G.;Moher, David;Schulz, Kenneth F.

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对已发表文献的广泛和越来越多的评论表明,卫生研究出版物经常存在缺陷。特别值得关注的是随机试验的不良报告,这使得读者很难或不可能评估研究是如何进行的,评估结果的可靠性,或者将它们置于现有研究证据的背景下。因此,临床医生往往不能使用已发表的试验报告为患者护理提供信息或为公共卫生政策提供信息,而且这些数据也不能纳入系统评价。报告准则旨在确定研究人员应该在其研究报告中包括的关键信息。我们描述了随机试验报告指南的历史,最终以1996年的CONSORT声明告终。我们详细介绍了CONSORT的后续发展和扩展,并考虑了旨在提高医学研究文献可靠性的相关举措。版权所有:John Wiley & Sons, Ltd。
An extensive and growing number of reviews of the published literature demonstrate that health research publications have frequent deficiencies. Of particular concern are poor reports of randomised trials, which make it difficult or impossible for readers to assess how the research was conducted, to evaluate the reliability of the findings, or to place them in the context of existing research evidence. As a result, published reports of trials often cannot be used by clinicians to inform patient care or to inform public health policy, and the data cannot be included in systematic reviews. Reporting guidelines are designed to identify the key information that researchers should include in a report of their research. We describe the history of reporting guidelines for randomised trials culminating in the CONSORT Statement in 1996. We detail the subsequent development and extension of CONSORT and consider related initiatives aimed at improving the reliability of the medical research literature. Copyright (c) 2012 John Wiley & Sons, Ltd.