Heaven Anne, Brown Lesley, Foster Marilyn, Clegg Andrew
Academic Unit of Elderly Care and Rehabilitation, Bradford Institute for Health Research, Bradford Royal Infirmary, Duckworth Lane, Bradford, BD9 6RJ UK.
Res Involv Engagem. 2016 Aug 30;2:30. doi: 10.1186/s40900-016-0044-9. eCollection 2016.
There are well documented benefits to involving patients and the public in research. However, there is little research published about their involvement in large complex studies such as cohort multiple Randomised Controlled Trials (cmRCTs). The cmRCT method establishes a group of participants, with a common characteristic (e.g. older people) who will be followed over a number of years. Other (sub) studies can also recruit from this pool of people. This method offers researchers many advantages, including being able to recruit from more hard to reach groups. However, cmRCTs also have features which can make it more complicated to involve patients and the public. For example more than one study may take place at the same time; studies may be spread out over a large geographical area and they may include a wide range of topics. In spite of these difficulties we have developed a way of working with patients, the public and researchers that provides stability over time but allows flexibility along the way. Our model of working has saved us time and money; helped us to recruit more widely, and enabled us to focus our research in areas that are important to older people with frailty.
There is increasing guidance on how to make the most of the rich seam of data provided by large cohort studies, and growing recognition of the benefits of cohort multiple Randomised Controlled Trials (cmRCT) in health research. In contrast, there is a lack of discussion about patient and public involvement and engagement (PPIE) in these large and complex research infrastructures. Our aim was to create a structure to enable meaningful, sustainable public involvement within the cmRCT framework. We have established a core reference group of four key individuals with extensive links to other relevant local community structures and individuals. Using the CARE 75+ model we have engaged with a wide variety of patients and the public in a relatively short space of time. Activities have included scrutiny of protocols and assessment tools, and process evaluations; resulting in system efficiencies, increased recruitment and a more focused research agenda. There is a need for strong public oversight and flexible models of PPIE in cmRCTs. The model of PPIE developed in the Community Ageing Research 75+ study presents one potential way to foster expertise and enable diversity.
让患者和公众参与研究有诸多已被充分证明的益处。然而，关于他们参与大型复杂研究（如队列多重随机对照试验，cmRCTs）的研究发表得很少。cmRCT方法建立了一组具有共同特征（如老年人）的参与者群体，并对其进行数年的跟踪。其他（子）研究也可以从这一人群中招募。这种方法为研究人员提供了许多优势，包括能够从更难接触到的群体中招募。然而，cmRCT也有一些特征，使得患者和公众的参与变得更加复杂。例如，可能同时进行多项研究；研究可能分布在很大的地理区域，并且可能涵盖广泛的主题。尽管存在这些困难，我们已经开发出一种与患者、公众和研究人员合作的方式，这种方式随着时间推移提供稳定性，但同时也允许在过程中保持灵活性。我们的工作模式为我们节省了时间和金钱；帮助我们更广泛地招募人员，并使我们能够将研究重点放在对体弱老年人重要的领域。
关于如何充分利用大型队列研究提供的丰富数据资源，有越来越多的指导意见，并且人们越来越认识到队列多重随机对照试验（cmRCT）在健康研究中的益处。相比之下，对于这些大型复杂研究基础设施中的患者和公众参与及介入（PPIE）却缺乏讨论。我们的目标是创建一种结构，以便在cmRCT框架内实现有意义、可持续的公众参与。我们已经建立了一个由四名关键人员组成的核心参考小组，他们与其他相关的当地社区结构和个人有着广泛的联系。使用CARE 75+模型，我们在相对较短的时间内与各种各样的患者和公众进行了接触。活动包括对方案和评估工具的审查以及过程评估；从而提高了系统效率、增加了招募人数并使研究议程更加聚焦。在cmRCT中，需要强有力的公众监督和灵活的PPIE模式。社区老龄化研究75+中开发的PPIE模式提出了一种培养专业知识并实现多样性的潜在方法。
