Patient and public involvement in the early stages of clinical trial development: a systematic cohort investigation
Patient and public involvement in the early stages of clinical trial development: a systematic cohort investigation
复制标题
DOI：
10.1136/bmjopen-2014-005234
复制
发表时间：
2014-01-01
期刊：
影响因子：
2.9
通讯作者：
Young, Bridget
中科院分区：
文献类型：
--
作者：
Gamble, Carrol;Dudley, Louise;Young, Bridget
背景：随机对照试验（RCT）被认为特别可能受益于患者和公众参与（PPI）。专业研究人员在一开始所做的决定可能会对PPI的潜在贡献产生重大影响。目的：通过系统地描述资助者对拟议PPI的报告水平、性质和可接受性，在RCT的早期开发中增加对PPI的了解。要求提供2006-2010年卫生技术评估（HTA）计划资助的所有RCT的大纲申请过程的文件。对于每一个应用程序，数据提取试验的特点，参考PPI在开发的大纲应用程序和资助委员会的反馈，并计划PPI在完整的应用程序和试验后funded.Results：110申请符合大纲应用程序提供90（82%）。该队列涵盖了广泛的干预措施和条件。54%（49/90）的患者提供了PPI的相关信息。26例（28.9%）表示在大纲申请本身的开发过程中使用PPI; 32例（35.6%）计划参与全面申请，43例（48%）一旦试验获得资助。诊断和手术干预时的招募不太可能描述PPI。设盲试验和受试者可能仅接受安慰剂的试验更常描述PPI活性。卫生技术评估委员会的反馈意见很少提到PPI。结论：PPI纳入发展的大纲应用程序或规范的计划，为未来的参与是低的。Funder要求申请人提供有关PPI的信息以及没有PPI的理由应该受到欢迎，但需要进一步研究以确定其对研究贡献的影响。审查者对生产者价格指数的评论应该是方向性的，而不是说需要增加。需要解决申请人在供资之前启动生产者价格指数方面面临的挑战。
Background: 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.Objective: 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.Methods: 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.Results: 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.Conclusions: 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.