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发表在急诊医学期刊上的临床试验注册质量。

Quality of registration for clinical trials published in emergency medicine journals.

机构信息

Department of Emergency Medicine, Christiana Care Hospital, Newark, DE, USA.

出版信息

Ann Emerg Med. 2012 Oct;60(4):458-64.e1. doi: 10.1016/j.annemergmed.2012.02.005. Epub 2012 Apr 14.

Abstract

STUDY OBJECTIVE

In 2005, the International Committee of Medical Journal Editors established clinical trial registration as a requirement for articles submitted to member journals, with the goal of improving the transparency of clinical research. The objective of this study is to characterize the registration of clinical trials published in emergency medicine journals.

METHODS

Randomized trials involving human subjects and published between June 1, 2008, and May 31, 2011 in the 5 emergency medicine journals with the highest impact factors were included. We assessed the clarity of registered primary outcomes, timing of registration relative to patient enrollment, and consistency between registered and published outcomes.

RESULTS

Of the 123 trials included, registry entries were identified for 57 (46%). Of the 57 registered studies, 45 (79%) were registered after the initiation of subject enrollment, 9 (16%) had registered outcomes that were unclear, and 26 (46%) had discrepancies between registered and published outcomes. Only 5 studies were registered before patient enrollment with a clear primary outcome that was consistent with the published primary outcome. Annals of Emergency Medicine was the only journal in which the majority of trials were registered.

CONCLUSION

Current compliance with clinical trial registration guidelines is poor among trials published in emergency medicine journals.

摘要

研究目的

2005 年,国际医学期刊编辑委员会将临床试验注册作为向其成员期刊提交文章的要求,目的是提高临床研究的透明度。本研究旨在描述急诊医学期刊发表的临床试验的注册情况。

方法

纳入 2008 年 6 月 1 日至 2011 年 5 月 31 日期间在影响因子最高的 5 种急诊医学期刊上发表的涉及人类受试者的随机试验。我们评估了注册主要结局的清晰度、注册时间与患者入组的相对时间,以及注册结局与发表结局的一致性。

结果

在纳入的 123 项试验中,有 57 项(46%)确定了注册条目。在 57 项已注册的研究中,45 项(79%)是在开始入组患者后注册的,9 项(16%)的注册结局不明确,26 项(46%)的注册结局与发表结局存在差异。只有 5 项研究是在患者入组前注册的,且具有明确的与发表的主要结局一致的主要结局。《急诊医学年鉴》是唯一大多数试验都已注册的期刊。

结论

急诊医学期刊发表的临床试验目前对临床试验注册指南的遵守情况很差。

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