CONSORT and reporting trials in 2017: who should do what

In celebration of Clinical Trials Day, we invited theCONSORT Group反思他们看到的临床试验报告未来的持有。在这里,拉里萨·沙瑟尔(Larissa Shamseer)代表Cansort集团讨论了主要利益相关者可以采取哪些措施来支持更好的审判报告。

该帖子已发布Larissa Shamseeron behalf ofThe CONSORT Group
Contributions by: Doug Altman, Ken Schulz, David Moher, Sally Hopewell

自首次发布以来,2016年标志着20年CONSORT Statement。It was the first reporting guideline of what is now a field of 350 and growing, and has been widely regarded as amilestone在健康研究中。

但是它的开发人员仍在思考如何改善它,扩大其摄取和依从性并增加了它影响。多年来,重点主要集中在期刊和作者应做的事情上,例如分别认可或遵守配偶。但是,这些政党存在于复杂的研究和出版系统中,涉及多个利益相关者。

与Consort执行团队一起,我们汇总了一些主要利益相关者的清单,这些利益相关者可能在更好的试用报告中发挥作用。我们建议谁,什么,何时,何时以及为什么在试用报告中透明度可以做得更好。重要的是,我们以不采取任何行动来改善这种情况的后果结束。

Above is a representation of the basic stages in the study process for trials and where basic reporting requirements and recommendations fit in. The stakeholder guide below shows howSPIRIT(试验协议建议)和CONSORT适应更好的试用报告,例如注册试验方案和结果以及共享试验数据。

主要利益相关者

资助者

什么 如何 When 在哪里? Why?
要求该试用资金申请介绍试验协议的精神清单项目 基于申请提交模板/表单精神清单项目;

提供有关如何报告每个项目或链接到SPIRIT Explanation and Elaboration

Prior to grant submission 在可能的情况下启用在线授予提交系统中完成协议模板 Improve investigator knowledge of what to include in trial application; prompts investigators to consider details of trial methods and anticipate potential problems
Carry out peer review based on SPIRIT items 提供有关如何报告每个项目的指导(来自SPIRIT Explanation and Elaboration);

利用精神清单项目作为赠款评估标准的一部分

在授予同行评审中 在电子评估系统中或附加以授予同行评审决定 提高应用程序裁决的一致性;减少决策时间
确保所有资助试验的已发表报告遵守所有人配偶清单项目 扣留部分资金,直到出版时间;审查提交前手稿/报告,以确保它完全报告配偶清单项目 在手稿提交期刊之前 用于提交和审查完成的试用报告的电子系统 阻止选择性报告;透明和完全报告的赠款资助研究将对资金机构进行积极反思

Academic institutions

什么 如何 When 在哪里? Why?
Endorse SPIRIT and CONSORT in instructions to authors Write a supportive statement with and expected action by authors regarding protocol or trial reporting Immediately/ ongoing 向作者的说明 Poor reporting hinders readers and may prevent inclusion in systematic review; Journal endorsement of CONSORT is联系with better reported trials
检查是否在已发布的协议和审判报告中遵守所有精神或配偶清单项目(即报告) 指导同行reviewers or use a reviewer assessment template based on SPIRIT or CONSORT items During peer review 用于记录或提交同行评审决定的电子系统。 使用配偶进行同行评估收益率m矿石完全报告了试验
Ensure all journals in a given specialty uniformly endorse CONSORT and SPIRIT Motivated/leading editors专业内应与整个现场的所有其他编辑联系以协调认可和实施活动 Anytime By publishing an editorial across journals of the specialty indicating the uniform requirements 如果专业存在统一标准,作者将更加不得不遵守报告标准

Journals

什么 如何 When 在哪里? Why?
Endorse SPIRIT and CONSORT in instructions to authors Write a supportive statement with and expected action by authors regarding protocol or trial reporting Immediately/ ongoing 向作者的说明 Poor reporting hinders readers and may prevent inclusion in systematic review; Journal endorsement of CONSORT is联系with better reported trials
检查是否在已发布的协议和审判报告中遵守所有精神或配偶清单项目(即报告) 指导同行reviewers or use a reviewer assessment template based on SPIRIT or CONSORT items During peer review 用于记录或提交同行评审决定的电子系统。 使用配偶进行同行评估收益率m矿石完全报告了试验
Ensure all journals in a given specialty uniformly endorse CONSORT and SPIRIT Motivated/leading editors专业内应与整个现场的所有其他编辑联系以协调认可和实施活动 Anytime By publishing an editorial across journals of the specialty indicating the uniform requirements 如果专业存在统一标准,作者将更加不得不遵守报告标准

研究人员/作者

什么 如何 When 在哪里? Why?
解决全部精神清单准备试验协议/建议时的项目 使用精神项目作为写作指南/模板 在准备试验方案时 电子试用协议文件 Anticipate problems in the research process, guide research conduct, prevent arbitrary decision-making during conduct; To ensure usability and improve uptake of research by health professionals and other researchers
解决全部配偶清单项目and any relevantCONSORT extensions准备出版的审判手稿时。利用花姆for describing interventions in detail. 利用checklist as a writing guide/template During the writing process 电子方式 May improve chances of getting published; Well-reported trials reflect well on individual researchers

Failing to act

人类,财政和科学成本无所作为以改善试验报告是严重的:

  • Poor, incomplete, and selective reporting will prevail
  • 较差且未完全报道的研究是unusableby readers (including systematic reviewers and health professionals)
  • Patient contributions and time are wasted
  • 报道不佳的研究无法在实践中复制
  • Funder investments in trials are wasted if they are poorly planned or if findings are unusable
  • 糟糕的报告对研究人员,研究所,期刊和资助者的反映很差

今年6月,裁定试用报告的新工具正在启动,StatReviewer。It provides an automated assessment of trial reporting, feeding back where improvements should be made. It is intended for publishers and journals wanting to gauge completeness of reporting at their journals, but could be used by anyone who has an interest in improving reporting, including authors.


CONSORT Website (CONSORT checklist, flow diagram, extensions, translations):www.consort-statement.org

SPIRIT Website (SPIRIT documents, translations, tools):www.spirit-statement.org

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