Gamble Carrol, Dudley Louise, Allam Alison, Bell Philip, Goodare Heather, Hanley Bec, Preston Jennifer, Walker Alison, Williamson Paula, Young Bridget
Department of Biostatistics, University of Liverpool, Liverpool, UK.
Patient and Public Advisory Group member, York, UK.
BMJ Open. 2014 Jul 23;4(7):e005234. doi: 10.1136/bmjopen-2014-005234.
Randomised controlled trials (RCTs) are considered particularly likely to benefit from patient and public involvement (PPI). Decisions made by professional researchers at the outset may go on to have a significant impact on the potential for PPI contributions.
To increase knowledge of PPI within the early development of RCTs by systematically describing the reported level, nature and acceptability of proposed PPI to the funders.
Documentation from the outline application process for all RCTs that received funding from the Health Technology Assessment (HTA) Programme 2006-2010 was requested. For each application, data were extracted on trial characteristics, references to PPI in the development of the outline application and funding Board feedback, and plans for PPI in the full application and after the trial was funded.
110 applications were eligible with outline applications available for 90 (82%). The cohort covered a wide range of interventions and conditions. 54% (49/90) provided some information about PPI. 26 (28.9%) indicated PPI within the development of the outline application itself; 32 (35.6%) planned involvement in the full application and 43 (48%) once the trial was funded. Recruitment at diagnosis and surgical interventions were less likely to describe PPI. Blinded trials and trials in which participants may receive placebo only, more frequently described PPI activity. The HTA commissioning Board feedback rarely referred to PPI.
Incorporation of PPI within the development of the outline application or specification of plans for future involvement was low. Funder requests for applicants to provide information on PPI and justification for its absence should be welcomed but further research is needed to identify the impact of this on its contributions to research. Comments on PPI by reviewers should be directional rather than state that an increase is required. Challenges facing applicants in initiating PPI prior to funding need to be addressed.
随机对照试验（RCT）被认为尤其可能从患者及公众参与（PPI）中获益。专业研究人员在一开始做出的决策可能会对PPI做出贡献的可能性产生重大影响。
通过系统描述向资助者报告的拟议PPI的水平、性质和可接受性，增加对RCT早期发展中PPI的了解。
索取了2006 - 2010年从卫生技术评估（HTA）计划获得资助的所有RCT的大纲申请过程文件。对于每份申请，提取了关于试验特征的数据、大纲申请制定过程中对PPI的提及以及资助委员会的反馈，以及完整申请和试验获得资助后PPI的计划。
110份申请符合要求，其中90份（82%）有大纲申请。该队列涵盖了广泛的干预措施和病症。54%（49/90）提供了一些关于PPI的信息。26份（28.9%）表明在大纲申请本身的制定过程中有PPI；32份（35.6%）计划在完整申请中参与，43份（48%）计划在试验获得资助后参与。诊断时招募和手术干预较少描述PPI。盲法试验以及参与者可能仅接受安慰剂的试验更频繁地描述了PPI活动。HTA委托委员会的反馈很少提及PPI。
在大纲申请的制定过程中纳入PPI或明确未来参与计划的情况较少。资助者要求申请人提供PPI信息及其缺失的理由应受到欢迎，但需要进一步研究以确定这对其研究贡献的影响。评审人员对PPI的评论应具有指导性，而不是表示需要增加。需要解决申请人在获得资助前启动PPI所面临的挑战。
