Child Health Evaluative Sciences, Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.
Child Health Evaluative Sciences, Hospital for Sick Children, Toronto, Ontario, Canada.
Arch Dis Child. 2020 Sep;105(9):875-880. doi: 10.1136/archdischild-2019-318517. Epub 2020 Mar 24.
Engaging patients and the public as collaborators in research is increasingly recognised as important as such partnerships can help improve research relevance and acceptability. Young Persons' Advisory Groups (YPAGs) provide a forum for clinical researchers and triallists to engage with children and young people on issues relevant to the design, conduct and translation of paediatric clinical trials. Until fairly recently, there was very little information available to guide the successful development and operation of YPAGs.
To develop an evidence-based tool to guide clinical researchers and triallists in the establishment and operation of a YPAG.
An online needs assessment survey was conducted using SurveyMonkey with 60 known paediatric drug researchers to identify knowledge gaps around YPAG engagement, development and operation. Semistructured interviews with founders and coordinators of five well-established existing YPAGs and a review of the literature were performed to identify best-practice processes for starting up and operating YPAG.
The majority of 12 survey respondents (20%) from 12 different centres indicated that while they felt YPAGs could benefit their research, guidance on how to develop and operate a YPAG was needed. Most preferred a web-based guidance tool. Ten core steps in starting up and operating a YPAG were identified and developed into an online YPAG guidance tool, now freely accessible for use by paediatric clinical researchers worldwide. Plans to evaluate the impact are in place.
This novel tool, developed with an internationally based group of public involvement leads working across paediatric clinical research areas, provides harmonised guidance for researchers seeking to develop and operate YPAGs to help improve the quality and impact of paediatric clinical research studies.
越来越多的人认识到，让患者和公众作为合作者参与研究是很重要的，因为这种合作关系有助于提高研究的相关性和可接受性。青年咨询小组（YPAG）为临床研究人员和试验人员提供了一个与儿童和年轻人就与儿科临床试验的设计、进行和转化相关的问题进行交流的论坛。直到最近，几乎没有什么信息可以指导 YPAG 的成功发展和运作。
开发一个基于证据的工具，指导临床研究人员和试验人员建立和运作 YPAG。
使用 SurveyMonkey 进行了一项在线需求评估调查，共有 60 名已知的儿科药物研究人员参与，以确定在 YPAG 参与、发展和运作方面的知识差距。对五个成熟的现有 YPAG 的创始人/协调人进行了半结构化访谈，并对文献进行了回顾，以确定启动和运营 YPAG 的最佳实践流程。
来自 12 个不同中心的 12 名调查受访者（20%）中的大多数人表示，虽然他们认为 YPAG 可以使他们的研究受益，但需要指导如何开发和运营 YPAG。大多数人更喜欢基于网络的指导工具。确定了启动和运营 YPAG 的十个核心步骤，并将其发展成一个在线 YPAG 指导工具，现可供全球儿科临床研究人员免费使用。已计划对其影响进行评估。
这个新工具是由一组具有国际背景的公众参与负责人共同开发的，他们在儿科临床研究领域工作，为寻求开发和运营 YPAG 的研究人员提供了协调一致的指导，有助于提高儿科临床研究的质量和影响。
