2014年的CONSORT声明:从Miró到Pollock?

2

Consort Group 2014With the advent of theAlltrials倡议, 这欧盟临床试验法规and the recentTamiflu debacle在过去的12个月中,随机对照试验(RCT)受到了很多关注。尽管最近围绕着RCT的报告了所有这些愤怒,但我们当中有些人已经撞了一段时间了。

These are nothing new, and it was in 1994 that a group of determined researchers, collaborating with medical journal editors, publishedSORT,这将成为第一个Consolidated Standards of Reporting Trials (CONSORT) statement in 1996。Twenty years later, the CONSORT Group held its most recent meeting in the Château d’Ermenonville, Paris, which I was delighted to have the opportunity to participate in.

Consort声明有什么影响?

自首次出版以来CONSORT Statement已经看到了两个更新2001and2010年,将近10,000次引用,无数扩展和实施文件,甚至是其自己的Twitter提要。Indeed, research has shown that reporting improves in journals that use CONSORT, but many problems with reporting still exist. The CONSORT Statement itself seems to be well accepted, but its actual implementation needs improvement.

One measure of impact is the number of journals that ‘endorse’ the guidelines. This is typically given in a statement in their Information for Authors, with over 600 journals currently endorsing CONSORT. In 2005, Altman found that22% of high-impact journalsendorsed the CONSORT Statement, and Hopewell showed that this2008年增加到38%。Larissa Shamseer is in the process of updating this based on the 2011期刊引文报告并发现,在前10名和前5个专业期刊中,有59%的人认可该准则(未发布)。

但是,该准则的实施已被证明是偶然的和被动的。最近的系统评论特纳等人。suggested that, while those journals that included a statement endorsing the CONSORT Statement were associated with improved reporting of some items, a number of key elements defining a clinical trial showed no improvement and are still poorly reported.

遵守障碍

引用了Consort声明So why are these problems persisting? Philippe Ravaud pointed toward a lack of awareness and lack of familiarity as leading barriers to implementation.
This was supported by Shamseer, who highlighted that, while the 2010 update is increasingly cited, citations are still increasing for the 1996 and 2001 CONSORT Statements. Furthermore, while many researchers are aware
在主要的会员陈述中,数字发生了爆炸
研究人员需要的CONSORT扩展以及其他相关报告指南
到adhere to.

正如杰里米·格里姆肖(Jeremy Grimshaw)所说,我们正面临“成功问题” - 报告指南的世界已从MiróPollock,,,,with over 200 guidelines listed on theEQUATOR Network。With such a profusion of reporting guidelines, researchers simply don’t know where to turn. Therefore, the challenge is to establish adherence to the existing guidelines, rather than continue to update them – writing them is easier than making them work.

Simplifying the CONSORT landscape

An example of a WebCONSORT custom checklist
An example of a WebCONSORT custom checklist

Philippe Ravaud proposed a potential solution to help researchers identify the relevant guidelines. In theWebConsort试用,他的团队正在评估一个简单的基于Web的工具,以将各种配偶扩展程序集成到作者的定制清单中。与没有工具相比,他们将根据使用该工具修订的手稿中报告的配置项目数量来评估工具的影响。

Similarly, David Moher presented on the CONSORT Checklist Management System (CMS). This web-based software-as-a-service tool offers an interactive, item-by-item guide through the CONSORT 2010 checklist, allowing users to highlight and link text associated with each checklist item, and tracking the completion of each item, providing a checklist fulfilment report. The aim of the CMS is to allow interaction between authors, journals and peer reviewers during the editorial review process, and remove CONSORT as a pain point.

This was an aim shared by Ida Sim, who is involved in the development of theExaCT Extraction System,它可以帮助用户从完整的文章中找到和提取关键试验特征(例如资格标准,样本量,药物剂量,主要结果)。

The advent of these exciting new initiatives should help to clarify and simplify the CONSORT landscape; however, these are only aids and, as Grimshaw stated, it all comes back to a simple questions: Who needs to do what differently?

What can we do?

Nikolaos Pandis gave an interesting case study for this, in the guise of theAmerican Journal of Orthodontics and Dentofacial Orthopedics (AJODO)。《华尔街日报》开始的积极支持CONSORT Statement in 2004, whereby the checklist was required on submission; however, this did not show the improvements in reporting that they had hoped for. In 2011, CONSORT was integrated into the review process, in order to give CONSORT-specific feedback to authors regarding their submissions. This has seen a marked improvement in the reporting standards of the articles published; however, it has also proved time-consuming, with many revisions sometimes required.

杰森·罗伯茨(Jason Roberts)为中小型期刊提供了另一种模型,从而在提交时提供并捕获了清单。然后,软件将自动扫描文章以获取合规性和突出显示(潜在)遗漏。这是通过StatReviewerbeta.

Grid in Piet Mondrian style这些举措表明,正在进行的大量工作以改善临床试验中的报告标准,并使作者尽可能简单。有必要将所有这些努力融合在一起,以鼓励采用和适当使用:

– Streamlined web presence
– Tools to aid authors
- 教育资源
- 宣传运动

While the current CONSORT landscape may have moved from Miró to Pollock, a concerted, simplified approach is needed, not only for RCTs, but all study types. Whatever happened to蒙德里安

You can read more about theEQUATOR scientific meetingand annual lecture on ourblog

查看有关Medicine Homepage的最新帖子

2Comments

By commenting, you’re agreeing to follow our社区准则

Karen Woolley教授

One practical way to help authors adhere to CONSORT is to ensure an appropriately Certified Medical Publication Professional (who has to pass a test on 150 topics related to ethical and effective publication practices) helps them. Emerging evidence indicates that adherence to CONSORT is higher for manuscripts prepared with professional support vs those without. There are almost 1000 CMPP-qualified people around the world – find them here:https://www.ismpp.org/cmpp-directory。他们不处于beta模式。他们现在准备帮助。它们可能是最有可能向作者阅读说明的人,并鼓励作者使用新的配偶支持软件。

披露:我已经参加(并通过)CMPP考试,并在非营利性国际医学出版物专业人士的董事会任职

完整的报告:不仅仅是试验 - 生物中央博客

[…]尽管今年会议的重点不是RCT,但在报告指南中最著名的是RCT。由25个项目清单和流程图形成的报告试验的合并标准(配偶)声明是基于证据的最低建议集。临床试验的良好报告至关重要 - 它们将构成临床决策的基础 - 但需要更多的工作,因为研究一次又一次地表明,目前的报告质量还不够。您可以在我们的博客上阅读有关Consort Group最近会议的更多信息。[…]

Comments are closed.