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.

临床试验提供了改善患者护理的重要证据。有两种主要试验类型，患者随机对照试验（RCT）和簇随机试验（CRT）。两者之间的主要区别在于，在RCT中，个人被随机分配以接受干预措施（例如药物A或药物B）。但是，在CRT中，一群人（例如医院病房）是随机的，例如，一个病房接受药物A，另一个病房接受药物B。在RCT中，为患者提供了有关该试验的信息，包括潜在风险，并在参加之前寻求知情同意。现有的CRT指南规定了放弃同意的审判中的审判，在此试验中，同意是不可行的，并且对参与者的风险最小。例如，当干预是在媒体格式（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，并没有寻求同意，因为随着社区的所有成员无论如何都会接受干预。因此，使用了同意的放弃。在寻求知情同意书的情况下，可以根据RCT对提供给个人的医疗干预措施（例如药物或疫苗）。但是，可以设计涉及同意书的CRT是由于实用或成本问题而设计的。尽管放弃同意的CRT似乎是一种适当的设计，但必须证明选择群集随机设计和放弃同意的选择都是合理的。特别是由于CRT的患者样本比RCT涉及更大的患者样本，因此效率较低，更容易容易出现BIA。从历史上看，CRT指导是从“专家”的专业意见中得出的，而没有深入了解患者和公众的观点。这是一个监督，因为没有这种见解，当前的招聘和同意程序可能与患者和家人的需求和观点不符。例如，我们不知道患者未经同意而被接受为单独的CRT。需要深入了解患者和公众观点在涉及脆弱人群（例如儿童和新生儿）的CRT中尤为重要。这些人群中的CRT是相对较新的，并且具有与患者和父母决策能力有关的特定道德和同意问题，这可能因设置而有所不同（例如，手术或紧急CRT）。有必要探索涉及这种脆弱人群的CRT的患者/家庭和公众观点，以确保未来的CRT在道德上适当，并以考虑儿童及其家人的需求的方式进行。拟议的研究是新颖的。在涉及儿童和新生儿的CRT中，我们迫切需要知道：1。 CRT中最合适的招聘和同意方法是什么？ 2。研究人员应如何向患者和公众咨询CRT中招募和同意（或放弃同意），并将此类过程适应不同类型的试验或患者人群？3。鉴于这些观点，如何制定CRT的指导？我们的30个月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，以帮助回答这些重要问题。我们的研究专注于小儿和新生儿环境，包括那些从事和没有试用经验的人。我们将通过考虑道德原则（例如对人，尊重人，福利和正义的尊重）和研究伦理文献来分析收集的数据，以对这些人群的未来CRT招募和同意提出建议。为了帮助确保这项工作在国际上与众不同，最后阶段将包括对涉及公共和国际CRT专家的指导草案的评估。