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临床试验注册与心血管期刊报告规范的依从性。

Trial registration and adherence to reporting guidelines in cardiovascular journals.

机构信息

College of Osteopathic Medicine, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma, USA.

出版信息

Heart. 2018 May;104(9):753-759. doi: 10.1136/heartjnl-2017-312165. Epub 2017 Nov 1.

Abstract

OBJECTIVE

This study investigated the policies of cardiac and cardiovascular system journals concerning clinical trial registration and guideline adoption to understand how frequently journals use these mechanisms to improve transparency, trial reporting and overall study quality.

METHODS

We selected the top 20 (by impact factor) journals cited in the subcategory 'Cardiac and Cardiovascular Systems' of the Expanded Science Citation Index of the 2014 Journal Citation Reports to extract journal policies concerning the 17 guidelines we identified. In addition, trial and systematic review registration adherence statements were extracted. 300 randomised controlled trials published in 2016 in the top 20 journals were searched for clinical trial registry numbers and CONSORT diagrams.

RESULTS

Of the 19 cardiac and cardiovascular system journals included in our analysis, eight journals (42%) did not require or recommend trial or review registration. Seven (37%) did not recommend or require a single guideline within their instructions to authors. Consolidated Standards for Reporting Trials guidelines (10/19, 53%) were recommended or required most often. Of the trials surveyed, 122/285 (42.8%) published a CONSORT diagram in their manuscript, while 236/292 (80.8%) published a trial registry number.

DISCUSSION

Cardiac and cardiovascular system journals infrequently require, recommend or enforce the use of reporting guidelines. Furthermore, too few require or enforce the use of clinical trial registration. Cardiology journal editors should consider guideline adoption due to their potential to limit bias and increase transparency.

摘要

目的

本研究调查了心脏和心血管系统期刊的临床试验注册和指南采用政策,以了解期刊如何频繁使用这些机制来提高透明度、试验报告和整体研究质量。

方法

我们选择了 2014 年期刊引文报告扩展科学引文索引中“心脏和心血管系统”子类别中引用最多的前 20 名期刊,以提取我们确定的 17 项指南的期刊政策。此外,还提取了试验和系统评价注册遵守声明。在排名前 20 的期刊中,检索了 2016 年发表的 300 项随机对照试验,以寻找临床试验注册号和 CONSORT 图。

结果

在我们分析的 19 种心脏和心血管系统期刊中,8 种(42%)期刊不要求或推荐试验或综述注册。7 种(37%)期刊在其作者指南中不推荐或要求使用单一指南。临床试验报告的统一标准(10/19,53%)被推荐或要求的频率最高。在所调查的试验中,285 项试验中有 122 项(42.8%)在其手稿中发表了 CONSORT 图,而 292 项试验中有 236 项(80.8%)发表了试验注册号。

讨论

心脏和心血管系统期刊很少要求、推荐或执行报告指南的使用。此外,很少有期刊要求或执行临床试验注册。心脏病学期刊编辑应该考虑采用指南,因为它们有可能限制偏倚并提高透明度。

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