Exploring patient and public perspectives on recruitment and consent in cluster randomised trials involving children

探讨涉及儿童的整群随机试验中患者和公众对招募和同意的看法

• 批准号: MR/X01147X/1
• 负责人: Kerry Woolfall
• 金额: $ 63.26万
• 依托单位: University of Liverpool
• 依托单位国家: 英国
• 项目类别: Research Grant
• 财政年份: 2023
• 资助国家: 英国
• 起止时间: 2023 至 无数据
• 项目状态: 未结题
• 来源: https://gtr.ukri.org/projects?ref=MR%2FX01147X%2F1
• 关键词: Exploring; patient; public; perspectives; recruitment

Clinical trials provide important evidence to improve patient care. There are two main types of trials, patient randomised controlled trials (RCT) and cluster randomised trials (CRT). The main difference between the two is that in an RCT individuals are randomly allocated to receive an intervention (e.g. drug A or drug B). However, in a CRT a whole group of people (e.g. hospital ward) are randomised, for example, one ward receives drug A and another receives drug B. In an RCT a patient is provided with information about the trial, including potential risks, with their informed consent being sought before taking part. Existing CRT guidance make provision for waiver of consent for the intervention in trials where consent would not be feasible and pose no more than minimal risk to participants.Approaches to consent in CRTs depend upon what is being investigated and at what level. For example, when the intervention is a public health message shown on media formats (e.g. TV, Radio, newspaper adverts, social media) informed consent is not sought because as all members of the community would receive the intervention anyway. A waiver of consent is therefore used. Health care interventions given to an individual person (e.g. a drugs or vaccine) could in principle be evaluated using a RCT with informed consent sought. However, a CRT involving a waiver of consent may be designed due practical, or cost concerns. Although a CRT with a waiver of consent may seem an appropriate design, both the choice of a cluster randomised design and waiver of consent must be justified; particularly as CRTs involve larger patient samples than RCTs, are less efficient and more prone to bias.Historically CRT guidance has been derived from 'expert' professional opinion without insight into patient and public perspectives. This is an oversight as without such insight there is a risk that current recruitment and consent processes may not be in line with the needs and perspectives of patients and family members. For example, we don't know if patients find it acceptable to be entered into an individual CRT without their consent.The need for insight into patient and public perspectives is particularly important in CRTs involving vulnerable populations, such as children and neonates. CRTs in these populations are relatively new and have specific ethical and consent issues related to patient and parental decision making capacity, which may vary by setting (e.g. surgical or emergency CRTs). There is a need to explore patient/family and public perspectives on CRTs involving such vulnerable populations to ensure future CRTs are ethically appropriate and conducted in a way that considers the needs of children and their families. The proposed study is novel. In CRTs involving children and neonates we urgently need to know:1. What are the most appropriate approaches to recruitment and consent in CRTs? 2. How should researchers consult with patients and the public about recruitment and consent (or waiver of consent) in CRTs and adapt such processes for different types of trials or patient populations?3. Given these views, how should guidance for CRTs be formulated?Our 30 month project will use established social science research methods, including scoping review, interviews, focus groups and an online survey to help answer these important questions. Focussing on paediatric and neonatal settings, our research will include those who do and do not have trial participation experience. We will analyse data collected with consideration of ethical principles (such as respect for persons, respect for persons, beneficence and justice) and the research ethics literature to make recommendations on approaches to recruitment and consent in future CRTs in these populations. To help ensure this work is internationally relevant, the final stages will include an evaluation of draft guidance involving the public and international experts on CRTs.

临床试验为改善患者护理提供了重要证据。有两种主要类型的试验，患者随机对照试验(RCT)和集群随机试验(CRT)。两者之间的主要区别是，在随机对照试验中，个人被随机分配接受干预(例如，药物A或药物B)。然而，在CRT中，一整组人(例如医院病房)是随机的，例如，一个病房接受药物A，另一个接受药物B。在RCT中，患者被提供关于试验的信息，包括潜在的风险，并在参与之前征求他们的知情同意。现有的CRT指南规定，在同意不可行且对参与者构成的风险不超过最小风险的试验中，放弃同意的条款。CRT中同意的方法取决于正在调查的内容和水平。例如，如果干预是在媒体形式(如电视、广播、报纸广告、社交媒体)上显示的公共卫生信息，则不需要征得知情同意，因为社区的所有成员无论如何都会接受干预。因此，使用了放弃同意的方式。向个人提供的保健干预措施(例如药物或疫苗)原则上可以在征得知情同意的情况下使用随机对照试验进行评估。然而，涉及放弃同意的CRT可能是出于实际或成本方面的考虑而设计的。尽管放弃同意的CRT似乎是一种合适的设计，但选择集群随机设计和放弃同意都必须是合理的；特别是在CRT涉及的患者样本比RCT更多的情况下，效率较低，更容易产生偏见。从历史上看，CRT的指导来自于专家的专业意见，而没有洞察患者和公众的观点。这是一种疏忽，因为如果没有这种洞察力，目前的招募和同意程序可能不符合患者及其家属的需求和观点。例如，我们不知道患者是否认为在未经同意的情况下接受个人CRT是可以接受的。在涉及儿童和新生儿等弱势人群的CRT中，洞察患者和公众观点的必要性尤其重要。CRT在这些人群中是相对较新的，存在与患者和父母决策能力相关的特定伦理和同意问题，这可能会因环境而异(例如手术或紧急CRT)。有必要探讨患者/家庭和公众对涉及这类弱势人群的CRT的看法，以确保未来的CRT在道德上是适当的，并以考虑到儿童及其家庭的需要的方式进行。这项拟议的研究是新颖的。在涉及儿童和新生儿的CRT中，我们迫切需要知道：1.在CRT中招募和同意的最合适的方法是什么？2.研究人员应该如何就CRT的招募和同意(或放弃同意)与患者和公众进行磋商，并使这些程序适应不同类型的试验或患者群体？3.鉴于这些观点，应该如何制定CRT的指导？我们30个月的项目将使用现有的社会科学研究方法，包括范围界定审查、访谈、焦点小组和在线调查，以帮助回答这些重要问题。聚焦于儿科和新生儿环境，我们的研究将包括那些有和没有试验参与经验的人。我们将根据伦理原则(如尊重人、尊重人、仁慈和正义)和研究伦理文献分析收集的数据，以就未来在这些人口中招募和同意CRT的方法提出建议。为了帮助确保这项工作具有国际相关性，最后阶段将包括对指南草案进行评估，让公众和CRT方面的国际专家参与。