Buck Deborah, Gamble Carrol, Dudley Louise, Preston Jennifer, Hanley Bec, Williamson Paula R, Young Bridget
Department of Biostatistics, University of Liverpool, Liverpool, UK.
Department of Women's and Children's Health, NIHR Clinical Research Network: Children, Coordinating Centre, University of Liverpool, Institute of Translational Medicine (Child Health), Alder Hey Children's NHS Foundation Trust, Liverpool, UK.
BMJ Open. 2014 Dec 4;4(12):e006400. doi: 10.1136/bmjopen-2014-006400.
: 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.
尽管为研究中的患者和公众参与（PPI）提供实施依据的证据有限，但对其要求却日益增加。
通过描述PPI计划在临床试验中的实施方式，并确定研究团队所面临的挑战和吸取的经验教训，为证据库提供信息。
我们将从临床试验资助申请（由英国国家卫生研究院健康技术评估计划在2006年至2010年期间资助）中提取的PPI计划与研究人员及PPI参与者关于PPI实施情况的访谈记录进行了比较。利用框架技术对PPI计划和转录的定性访谈进行了分析。
在28项试验中，25项在资助申请中记录了PPI计划，其中一半描述了在申请资助之前就实施了PPI。计划从最少到广泛各不相同，尽管几乎所有计划都预期采用多种PPI模式。访谈记录表明，20/25项试验中的PPI计划已得到充分实施，有些甚至有所扩展。然而，一些研究人员将其试验中的PPI描述为形式主义。研究人员和参与者指出，PPI参与较晚或程度较低会降低其价值。两组都意识到在PPI方面角色的不确定性，并指出参与者缺乏信心以及参加会议存在困难。PPI参与者在与研究人员互动和理解专业术语方面遇到问题。研究人员报告说难以找到“合适的”PPI参与者，并建议在涉及研究人员当前的患者时要谨慎。
尽早让PPI参与者参与并确保其活动、角色和目标持续清晰，对于PPI的成功至关重要。资助者、评审者和监管者应认识到申请前PPI的价值，并为其分配更多资源。他们还应考虑资助申请中的PPI计划是否符合试验的独特需求。在试验前、试验期间和试验后对PPI进行监测和报告将有助于研究界优化PPI，尽管也应认识到在实施PPI时需要持续保持灵活性。
