From plans to actions in patient and public involvement: qualitative study of documented plans and the accounts of researchers and patients sampled from a cohort of clinical trials.
From plans to actions in patient and public involvement: qualitative study of documented plans and the accounts of researchers and patients sampled from a cohort of clinical trials.
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DOI：
10.1136/bmjopen-2014-006400
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发表时间：
2014-12-04
期刊：
影响因子：
2.9
通讯作者：
EPIC Patient Advisory Group
中科院分区：
文献类型：
--
作者：
Buck D;Gamble C;Dudley L;Preston J;Hanley B;Williamson PR;Young B;EPIC Patient Advisory Group;EPIC Patient Advisory Group
尽管支持其实施的证据有限，但越来越需要患者和公众参与（PPI）研究。通过描述如何在临床试验中实施 PPI 计划并确定研究团队面临的挑战和经验教训，为证据基础提供信息。我们将从临床试验拨款申请（2006 年至 2010 年间由美国国立卫生研究院卫生技术评估计划资助）中提取的 PPI 计划与研究人员和 PPI 贡献者对 PPI 实施的访谈记录进行了比较。 PPI 计划的分析和转录的定性访谈利用了框架技术。在 28 项试验中，25 项记录了资助申请中的 PPI 计划，其中一半描述了在申请资助之前实施 PPI。尽管几乎所有人都预期了 PPI 的多种模式，但计划从最小到广泛不等。采访记录表明，PPI 计划已在 20/25 试验中得到全面实施，甚至在某些试验中得到了扩展。尽管如此，一些研究人员将他们的试验中的 PPI 描述为象征性的。研究人员和贡献者指出，过晚或极少的 PPI 参与降低了其价值。两个群体都认为与 PPI 相关的角色存在不确定性，并指出贡献者缺乏信心且难以参加会议。 PPI 贡献者在与研究人员互动和理解技术语言方面遇到了问题。研究人员报告称很难找到“正确的”PPI 贡献者，并建议在涉及研究人员当前的患者时要谨慎。尽早让 PPI 贡献者参与并确保他们的活动、角色和目标持续清晰，对于 PPI 的成功至关重要。资助者、审查者和监管者应认识到预申请 PPI 的价值，并为其分配更多资源。他们还应该考虑拨款申请中的 PPI 计划是否符合试验的独特需求。在试验之前、期间和之后监测和报告 PPI 将有助于研究界优化 PPI，但也应该认识到实施 PPI 时需要持续的灵活性。
Patient and public involvement (PPI) in research is increasingly required, although evidence to inform its implementation is limited. Inform the evidence base by describing how plans for PPI were implemented within clinical trials and identifying the challenges and lessons learnt by research teams. We compared PPI plans extracted from clinical trial grant applications (funded by the National Institute for Health Research Health Technology Assessment Programme between 2006 and 2010) with researchers’ and PPI contributors’ interview accounts of PPI implementation. Analysis of PPI plans and transcribed qualitative interviews drew on the Framework technique. Of 28 trials, 25 documented plans for PPI in funding applications and half described implementing PPI before applying for funding. Plans varied from minimal to extensive, although almost all anticipated multiple modes of PPI. Interview accounts indicated that PPI plans had been fully implemented in 20/25 trials and even expanded in some. Nevertheless, some researchers described PPI within their trials as tokenistic. Researchers and contributors noted that late or minimal PPI engagement diminished its value. Both groups perceived uncertainty about roles in relation to PPI, and noted contributors’ lack of confidence and difficulties attending meetings. PPI contributors experienced problems in interacting with researchers and understanding technical language. Researchers reported difficulties finding ‘the right’ PPI contributors, and advised caution when involving investigators’ current patients. Engaging PPI contributors early and ensuring ongoing clarity about their activities, roles and goals, is crucial to PPI's success. Funders, reviewers and regulators should recognise the value of preapplication PPI and allocate further resources to it. They should also consider whether PPI plans in grant applications match a trial's distinct needs. Monitoring and reporting PPI before, during and after trials will help the research community to optimise PPI, although the need for ongoing flexibility in implementing PPI should also be recognised.
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