A patient and public involvement (PPI) toolkit for meaningful and flexible involvement in clinical trials - a work in progress.
A patient and public involvement (PPI) toolkit for meaningful and flexible involvement in clinical trials - a work in progress.
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用于有意义且灵活地参与临床试验的患者和公众参与 (PPI) 工具包 - 一项正在进行的工作。
DOI：
10.1186/s40900-016-0029-8
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发表时间：
2016
影响因子：
--
通讯作者：
Williamson PR
中科院分区：
文献类型：
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作者：
Bagley HJ;Short H;Harman NL;Hickey HR;Gamble CL;Woolfall K;Young B;Williamson PR
研究的资助者越来越多地要求研究人员让患者和公众参与他们的研究。患者和公众参与研究(PPI)可以潜在地帮助研究人员确保他们研究的设计是相关的，它是参与者友好的，并且符合伦理道德。使用和共享PPI资源可以使参与实施PPI的人受益，但现有的PPI资源使用不一致，这可能导致工作重复。本文描述了我们如何开发一个工具包来支持临床试验单位中的临床试验团队。该工具包将提供一个关键的现成资源，以支持资源有限的试验团队进行PPI。进一步开发和维护工具包的关键活动是：听取使用工具的研究团队以及患者和公众贡献者的意见和经验；根据我们使用工具的经验修改工具；确定对未来工具的需求；根据任何新发现的资源更新工具包；提高对工具包的认识，并与其他人合作开发或测试PPI资源，以减少PPI中的重复工作。背景患者和公众参与研究(PPI)越来越成为资助者的要求，因为设计相关的、参与者友好的、伦理合理的研究具有潜在的好处。资源的使用和共享可以使购买力平价受益，但可用的资源没有得到始终如一的使用，导致工作重复。本文描述了一个开发中的工具包，以支持临床试验团队进行有效和有意义的PPI。方法开发工具包的第一阶段是描述在临床试验的过程中应该考虑哪些PPI活动，以及这些活动应该在什么阶段进行。这一途径是通过审查临床试验研究中心协调的试验中PPI活动的类型和时间以及先前描述的试验中PPI潜在影响的领域而得知的。在第二阶段，利用围绕PPI的关键网站和机会性地确定资源，例如在与其他试用者或社交媒体的对话中确定资源。在存在差距的地方开发了工具。结果建立了一个流程图，描述了临床试验路径中应该考虑的PPI活动以及这些活动应该发生的时间点。确定了三个工具包领域：规划PPI；支持PPI；记录和评估PPI。在PPI的规划下确定了四项主要活动和相应的工具：制定计划；确定患者和公共供款人；分配适当的费用；以及管理预期。在支持PPI方面，开发了审查参与者信息表的工具。这些工具需要对潜在试验参与者的特征和情况进行总结，有助于澄清PPI审查的要求和期望。为了记录和评价购买力平价指数，计划中的购买力平价干预措施应根据影响进行监测，并正在开发一种监测公众贡献者体验的工具。结论该工具包提供了一个正在开发的“现成”资源，以支持资源有限的试验团队进行PPI。进一步开发和维护工具包的关键活动是：听取使用工具的研究小组和公众贡献者的意见和经验，确定对未来工具的需求，根据使用工具的经验修改工具；根据任何新发现的资源更新工具包；提高对工具包的认识，并与其他人合作开发和测试PPI资源，以减少PPI中的重复工作。本文的在线版本(doi：10.1186/s40900-0160029-8)包含补充材料，授权用户可以使用。
Funders of research are increasingly requiring researchers to involve patients and the public in their research. Patient and public involvement (PPI) in research can potentially help researchers make sure that the design of their research is relevant, that it is participant friendly and ethically sound. Using and sharing PPI resources can benefit those involved in undertaking PPI, but existing PPI resources are not used consistently and this can lead to duplication of effort. This paper describes how we are developing a toolkit to support clinical trials teams in a clinical trials unit. The toolkit will provide a key ‘off the shelf’ resource to support trial teams with limited resources, in undertaking PPI. Key activities in further developing and maintaining the toolkit are to: ● listen to the views and experience of both research teams and patient and public contributors who use the tools; ● modify the tools based on our experience of using them; ● identify the need for future tools; ● update the toolkit based on any newly identified resources that come to light; ● raise awareness of the toolkit and ● work in collaboration with others to either develop or test out PPI resources in order to reduce duplication of work in PPI. Background Patient and public involvement (PPI) in research is increasingly a funder requirement due to the potential benefits in the design of relevant, participant friendly, ethically sound research. The use and sharing of resources can benefit PPI, but available resources are not consistently used leading to duplication of effort. This paper describes a developing toolkit to support clinical trials teams to undertake effective and meaningful PPI. Methods The first phase in developing the toolkit was to describe which PPI activities should be considered in the pathway of a clinical trial and at what stage these activities should take place. This pathway was informed through review of the type and timing of PPI activities within trials coordinated by the Clinical Trials Research Centre and previously described areas of potential PPI impact in trials. In the second phase, key websites around PPI and identification of resources opportunistically, e.g. in conversation with other trialists or social media, were used to identify resources. Tools were developed where gaps existed. Results A flowchart was developed describing PPI activities that should be considered in the clinical trial pathway and the point at which these activities should happen. Three toolkit domains were identified: planning PPI; supporting PPI; recording and evaluating PPI. Four main activities and corresponding tools were identified under the planning for PPI: developing a plan; identifying patient and public contributors; allocating appropriate costs; and managing expectations. In supporting PPI, tools were developed to review participant information sheets. These tools, which require a summary of potential trial participant characteristics and circumstances help to clarify requirements and expectations of PPI review. For recording and evaluating PPI, the planned PPI interventions should be monitored in terms of impact, and a tool to monitor public contributor experience is in development. Conclusions This toolkit provides a developing ‘off the shelf’ resource to support trial teams with limited resources in undertaking PPI. Key activities in further developing and maintaining the toolkit are to: listen to the views and experience of both research teams and public contributors using the tools, to identify the need for future tools, to modify tools based on experience of their use; to update the toolkit based on any newly identified resources that come to light; to raise awareness of the toolkit and to work in collaboration with others to both develop and test out PPI resources in order to reduce duplication of work in PPI. The online version of this article (doi:10.1186/s40900-016-0029-8) contains supplementary material, which is available to authorized users.