The need for child-centric reporting guides for pediatric clinical trial and systematic review protocols and reports

临床试验结果的系统评价(SRS)和荟萃分析(MAS)被认为是在全面,透明和可再现性质中确定干预措施的有效性和安全性的最高水平的医学证据。不幸的是,有证据表明,并非所有的SR和试验都可以通过必要的方法严格进行。一种studypublished today in系统评价关于不完整的以儿童报告细节的证据的报告。在这里,作者告诉我们更多。

改进途径:研究报告首先

尽管有适用于系统评价和荟萃分析的首选报告项目 - Prisma-2009和Prisma-P 2015 - 旨在提高SR报告和协议报告的透明度和报告质量的陈述,但如何处理如何处理如何处理以儿童为中心的SRS挑战会损害儿童健康中的决策。更重要的是,鉴于不同年龄段(即新生儿,儿童,青少年,成人和老年人)之间存在很大程度的生理,药理和心理差异,child-centric SRs require additional methodological considerations.

出版今天in系统评价,我们的小组报告了有关SRS和MAS中以儿童为中心的报告细节的不完整报告的证据,并在2010年至2014年之间发表的儿童中有关儿童的干预研究。

It turns out that reports and protocols with a mixed children/adult population are more prone to incomplete reporting than child-only populations while Cochrane reviews are of a better reporting standard than non-Cochrane reviews. Overall, our results provide reasons for swift adoption of the PRISMA and PRISMA-P reporting guidelines, and a basis for child-centric extensions and modifications to these reporting standards. This could enhance the ability of decision-makers to inform policy and program decisions for specific age groups.

Child health clinical trials

以儿童为中心的SR和MAS报告中发现的陷阱在这些SRS旨在合成的主要研究中找到了它们的起源。在一个recent study,我们发现以儿童为中心的随机对照试验(RCT)协议,报告也遭受不完整的报告。

响应提出的研究的要求, we are extending the current reporting statements and in collaboration with members of the original reporting guideline groups. The end-products will be evidence and consensus based checklists of essential items that authors should include when reporting the protocol and results of child-centric RCTs and SRs:SPIRIT-C,CONSORT-C,prisma-pcPrisma-c。The detailed methodology on the development of PRISMA-PC and PRISMA-C guidelines is reported这里

儿童健康研究的结果

儿童的临床研究遇到具体挑战,包括需要ethical approval from multiple independent research ethics boards,选择并证明有效的比较器治疗,并获得孩子的父母和/或通知ed consent在很多时候,在艰难的情况下。在所有更新的清单中,都特别注意审判的选择,验证和测量儿童的结果。除了针对以儿童为中心的研究报告的问题外,最近的证据表明,尽管其广泛认可的重要性,但在从新生儿学到老年医学的人群中,最多80%的RCT中,结果质量仍然很差。

如果没有适当的选择和完整报告所研究的结果,决策者将无法可靠地选择最安全有效的干预措施。这还将阻止研究人员在现有的研究发现上复制或建立。

To improve the completeness of reporting of outcomes, making them fit for clinical decision-making, for informing health policy and for regulatory purposes, the加拿大卫生研究所, funded a 2016 Project Grant that enables an international group of experts and stakeholders to develop, validate and implement a new outcome-reporting standard: Instrument for reporting of Planned Endpoints in CTs (InsPECT).

New tools on the block: suffocating scientists?

Following the methodological framework for developing reporting guidelines, our group has completed the evidence synthesis, Delphi survey and international consensus. The checklists have been finalized (available on request). Statements and Explanation and Elaboration documents of these reporting guidelines will be published in Q2-3-Q4 2017.

But there is one huge caveat when it comes to uptake: there are too many reporting guidelines out there. Authors may get lost, and we certainly don’t need duplication!

实际上,任何新的报告指南都只会在现有准则列表中添加更多。赤道(增强健康研究的质量和透明度)网络通过促进透明的报告和更广泛使用强大的报告指南,为提高已发表健康研究文献的可靠性和可用性提供了一个很好的平台。赤道不懈地努力帮助作者而不是阻碍他们,并正在寻求解决挑战的解决方案,导航日益增长的研究报告标准目录。

一种s a potential solution, we propose the development of a child-centric plug-in to existing widely endorsed reporting guidelines like CONSORT, SPIRIT, PRISMA, STARD, etc. How would this work? If a SR or RCT identifies its target population as either child only or mixed, the system would recommend reporting on the child-centric reporting items in addition to the existing reporting items from PRISMA, PRISMA-P, CONSORT or SPIRIT. We have therefore collaborated with international experts and world leaders in research reporting standards, outcomes research methodology, RCTs, SRs.

Finally

儿童健康研究即将到来。但是,我们如何让研究人员使用报告指南?虽然有一些证据表明日记对Consort声明的认可提高了遵守报告指南,报告仍然是低于可接受的水平。对适当报告的障碍和促成者的研究将是有价值的,对改善随机试验的设计,进行和报告的干预措施的评估也将是有价值的。

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