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Can we depend on investigators to identify and register randomized controlled trials?我们能否依赖研究者来识别和注册随机对照试验?
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Res Synth Methods. 2018 Mar;9(1):2-12. doi: 10.1002/jrsm.1277. Epub 2017 Dec 15.
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Major discrepancies between what clinical trial registries record and paediatric randomised controlled trials publish.临床试验注册记录与儿科随机对照试验发表内容之间存在重大差异。
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PLoS One. 2015 Jun 24;10(6):e0130619. doi: 10.1371/journal.pone.0130619. eCollection 2015.

本文引用的文献

1
Trial registration and declaration of registration by authors of randomized controlled trials.随机对照试验作者的试验注册和注册声明。
Transplantation. 2011 Nov 27;92(10):1094-100. doi: 10.1097/TP.0b013e318232baf2.
2
The quality of registration of clinical trials.临床试验注册的质量。
PLoS One. 2011 Feb 24;6(2):e14701. doi: 10.1371/journal.pone.0014701.
3
Assessment of registration quality of trials sponsored by China.评估中国资助的试验注册质量。
J Evid Based Med. 2009 Feb;2(1):8-18. doi: 10.1111/j.1756-5391.2009.01007.x.
4
Influence of trial registration on reporting quality of randomized trials: study from highest ranked journals.临床试验注册对随机试验报告质量的影响:来自排名最高的期刊的研究。
J Clin Epidemiol. 2010 Nov;63(11):1216-22. doi: 10.1016/j.jclinepi.2010.01.013. Epub 2010 Apr 28.
5
Trial publication after registration in ClinicalTrials.Gov: a cross-sectional analysis.注册后临床试验的发布:一项横断面分析。
PLoS Med. 2009 Sep;6(9):e1000144. doi: 10.1371/journal.pmed.1000144. Epub 2009 Sep 8.
6
Compliance of clinical trial registries with the World Health Organization minimum data set: a survey.临床试验注册机构对世界卫生组织最低数据集的依从性:一项调查。
Trials. 2009 Jul 22;10:56. doi: 10.1186/1745-6215-10-56.
7
Randomized trials published in some Chinese journals: how many are randomized?发表于一些中文期刊的随机试验:有多少是真正随机的?
Trials. 2009 Jul 2;10:46. doi: 10.1186/1745-6215-10-46.
8
Full publication of results initially presented in abstracts.最初以摘要形式呈现的研究结果的完整发表。
Cochrane Database Syst Rev. 2007 Apr 18(2):MR000005. doi: 10.1002/14651858.MR000005.pub3.
9
WHO facilitates international collaboration in setting standards for clinical trial registration.世界卫生组织促进在制定临床试验注册标准方面的国际合作。
Lancet. 2005;365(9474):1829-31. doi: 10.1016/S0140-6736(05)66589-0.
10
Principles for international registration of protocol information and results from human trials of health related interventions: Ottawa statement (part 1).健康相关干预措施人体试验方案信息及结果的国际注册原则:渥太华声明(第1部分)
BMJ. 2005 Apr 23;330(7497):956-8. doi: 10.1136/bmj.330.7497.956.

我们能否依赖研究者来识别和注册随机对照试验?

Can we depend on investigators to identify and register randomized controlled trials?

机构信息

Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States of America.

出版信息

PLoS One. 2012;7(9):e44183. doi: 10.1371/journal.pone.0044183. Epub 2012 Sep 11.

DOI:10.1371/journal.pone.0044183
PMID:22984474
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3439467/
Abstract

PURPOSE

To reduce publication bias, systematic reviewers are advised to search conference abstracts to identify randomized controlled trials (RCTs) conducted in humans and not published in full. We assessed the information provided by authors to aid identification of RCTs for reviews.

METHODS

We handsearched the Association for Research in Vision and Ophthalmology (ARVO) meeting abstracts for 2004 to 2009 to identify reports of RCTs. We compared our classification with that of authors (requested by ARVO 2004-2006), and authors' report of trial registration (required by ARVO 2007-2009).

RESULTS

Authors identified their study as a clinical trial for 169/191 (88%; 95% CI, 84-93) RCTs we identified for 2004, 174/212 (82%; 95% CI, 77-87) for 2005 and 162/215 (75%; 95% CI, 70-81) for 2006. Authors provided registration information for 107/172 (62%; 95% CI, 55-69) RCTs for 2007, 103/153 (67%; 95% CI, 60-75) for 2008, and 126/171 (74%; 95% CI, 67-80) for 2009. Most RCT authors providing a trial register name specified ClinicalTrials.gov (276/312; 88%; 95% CI, 85-92) and provided a valid ClinicalTrials.gov registration number (261/276; 95%; 95% CI, 92-97). Based on information provided by authors, trial registration information would be accessible for 48% (83/172) (95% CI, 41-56) of all ARVO abstracts describing RCTs in 2007, 63% (96/153) (95% CI, 55-70) in 2008, and 70% in 2009 (118/171) (95% CI, 62-76).

CONCLUSIONS

Authors of abstracts describing RCTs frequently did not classify them as clinical trials nor comply with reporting trial registration information, as required by the conference organizers. Systematic reviewers cannot rely on authors to identify relevant unpublished trials or report trial registration, if present.

摘要

目的

为减少发表偏倚,系统评价人员被建议检索会议摘要,以确定在人体中进行的未全文发表的随机对照试验(RCT)。我们评估了作者提供的信息以帮助确定综述中的 RCT。

方法

我们对 2004 年至 2009 年的美国视觉与眼科研究协会(ARVO)会议摘要进行了手工检索,以确定 RCT 的报告。我们将我们的分类与作者的分类(ARVO 2004-2006 年要求)以及作者报告的试验注册情况(ARVO 2007-2009 年要求)进行了比较。

结果

作者将其研究识别为临床试验的有 191 项 RCT 中的 169 项(88%;95%CI,84-93),我们确定的 2004 年有 212 项 RCT 中的 174 项(82%;95%CI,77-87),2006 年有 215 项 RCT 中的 162 项(75%;95%CI,70-81)。作者为 2007 年的 172 项 RCT 中的 107 项(62%;95%CI,55-69)提供了注册信息,为 2008 年的 153 项 RCT 中的 103 项(67%;95%CI,60-75)以及 2009 年的 171 项 RCT 中的 126 项(74%;95%CI,67-80)提供了注册信息。大多数提供试验注册名称的 RCT 作者指定了 ClinicalTrials.gov(312 项 RCT 中的 276 项;88%;95%CI,85-92),并提供了有效的 ClinicalTrials.gov 注册号(276 项 RCT 中的 261 项;95%;95%CI,92-97)。基于作者提供的信息,在描述 2007 年 RCT 的所有 ARVO 摘要中,可获得试验注册信息的比例为 48%(83/172)(95%CI,41-56),2008 年为 63%(96/153)(95%CI,55-70),2009 年为 70%(118/171)(95%CI,62-76)。

结论

描述 RCT 的摘要的作者通常没有将其归类为临床试验,也没有遵守会议组织者要求的报告试验注册信息的规定。如果存在,系统评价人员不能依赖作者来确定相关的未发表试验或报告试验注册情况。