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。试验主要有两种类型：患者随机对照试验（RCT）和整群随机试验（CRT）。两者之间的主要区别在于，在 RCT 中，个体被随机分配接受干预（例如药物 A 或药物 B）。然而，在 CRT 中，整组人（例如医院病房）被随机分配，例如，一个病房接受药物 A，另一个病房接受药物 B。在 RCT 中，向患者提供有关试验的信息，包括潜在风险，在参加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极小的试验中，放弃同意干预。CRT 中同意的方法取决于正在调查的内容和调查水平。例如，当干预措施是在媒体形式（例如电视、广播、报纸广告、社交媒体）上显示的公共卫生信息时，不需要征求知情同意，因为社区的所有成员无论如何都会接受干预措施。因此使用放弃同意。原则上可以在征求知情同意的情况下使用随机对照试验来评估对个人的医疗保健干预措施（例如药物或疫苗）。然而，出于实际或成本考虑，可能会设计涉及放弃同意的 CRT。尽管放弃同意的 CRT 似乎是一种合适的设计，但整群随机设计和放弃同意的选择都必须合理；特别是因为 CRT 比 RCT 涉及更大的患者样本，效率较低且更容易出现偏差。历史上 CRT 指导源自“专家”专业意见，没有深入了解患者和公众的观点。这是一种疏忽，因为如果没有这种洞察力，当前的招募和同意流程可能不符合患者和家庭成员的需求和观点。例如，我们不知道患者是否愿意在未经患者同意的情况下参加个人 CRT。在涉及儿童和新生儿等弱势群体的 CRT 中，深入了解患者和公众观点的需求尤为重要。这些人群中的 CRT 相对较新，并且存在与患者和家长决策能力相关的特定伦理和同意问题，这些问题可能因环境而异（例如手术或急诊 CRT）。有必要探讨患者/家庭和公众对涉及此类弱势群体的 CRT 的看法，以确保未来的 CRT 在道德上是适当的，并且以考虑儿童及其家庭需求的方式进行。拟议的研究是新颖的。在涉及儿童和新生儿的 CRT 中，我们迫切需要了解：1。 CRT 中最合适的招募和同意方法是什么？ 2. 研究人员应如何就 CRT 中的招募和同意（或放弃同意）征求患者和公众的意见，并针对不同类型的试验或患者群体调整此类流程？3.鉴于这些观点，应该如何制定 CRT 指南？我们为期 30 个月的项目将使用既定的社会科学研究方法，包括范围审查、访谈、焦点小组和在线调查来帮助回答这些重要问题。我们的研究重点关注儿科和新生儿环境，将包括那些有或没有试验参与经验的人。我们将在考虑伦理原则（例如尊重人、尊重人、仁慈和正义）和研究伦理文献的情况下分析收集的数据，以就这些人群未来 CRT 的招募和同意方法提出建议。为了帮助确保这项工作具有国际相关性，最后阶段将包括由公众和国际 CRT 专家参与的指南草案评估。