背景:涉及缺乏提供同意能力的成年人的试验依赖于代理人或代理决策者,通常是家庭成员,做出参与的决定。目前正在制定干预措施,以增强有关试验参与的代理决定。然而,缺乏标准化的结果衡量标准限制了对这些干预措施的评估.这项研究的目的是建立一个商定的标准化核心结果集(COS),用于评估干预措施以改善有关试验参与的代理决策。
方法:我们使用已建立的方法来开发COS,包括与主要利益相关者团体的共识研究,这些利益相关者团体包括将在研究中使用COS的人(研究人员和医疗保健专业人员)和患者或其代表。在进行范围审查以确定候选项目之后,我们使用了改良的两轮德尔菲调查来达成核心结果的共识,模棱两可的项目被提交共识会议讨论。在2020年10月的一次在线共识会议之后,COS最终确定。
结果:共有28位英国利益相关者(5位研究人员,10名审判人员,3名患者/家属代表,7名招聘人员和3名顾问/批准者)参加了在线Delphi调查,以从范围审查(n=36)和参与者提出的其他项目(n=1)中对候选项目进行排名。项目大致分为三类:家庭成员如何做出决定,他们做决定的经历,以及影响决定的个人方面。根据Delphi的调查,包括27个项目,10个项目没有达成共识,需要在共识会议上进行讨论。16名与会者出席了会议,包括邀请其他患者/家属代表增加该关键组的代表(n=2).我们就列入28个成果项目达成共识,包括在共识会议上选出的一个。
结论:该研究确定了在所有干预措施评估中应至少测量的结果,以增强有关试验的替代决策。这些与决策过程有关,代理决策经验,以及理解等影响决策的因素。需要与有缺陷的人及其家人进一步合作,以探讨他们对COS的看法,并确定适当的结果措施和测量时间。
背景:该研究已在COMET数据库(https://www.comet-initiative.org/Studies/Details/1409)上注册。
BACKGROUND: Trials involving adults who lack capacity to provide consent rely on proxy or surrogate decision-makers, usually a family member, to make decisions about participation. Interventions to enhance proxy decisions about
trial participation are now being developed. However, a lack of standardised outcome measures limits evaluation of these interventions. The aim of this
study was to establish an agreed standardised core outcome set (COS) for use when evaluating interventions to improve proxy decisions about
trial participation.
METHODS: We used established methods to develop the COS including a consensus
study with key stakeholder groups comprising those who will use the COS in research (researchers and healthcare professionals) and patients or their representatives. Following a scoping review to identify candidate items, we used a modified two-round Delphi survey to achieve consensus on core outcomes, with equivocal items taken to a consensus meeting for discussion. The COS was finalised following an online consensus meeting in October 2020.
RESULTS: A total of 28 UK stakeholders (5 researchers, 10 trialists, 3 patient/family representatives, 7 recruiters and 3 advisors/approvers) participated in the online Delphi survey to rank candidate items from the scoping review (n = 36) and additional items proposed by participants (n = 1). Items were broadly grouped into three categories: how family members make decisions, their experiences of making decisions, and the personal aspects that influence the decision. Following the Delphi survey, 27 items were included and ten items exhibited no consensus which required discussion at the consensus meeting. Sixteen participants attended the meeting, including additional patient/family representatives invited to increase representation from this key group (n = 2). We reached consensus for the inclusion of 28 outcome items, including one selected at the consensus meeting.
CONCLUSIONS: The study identified outcomes that should be measured as a minimum in all evaluations of interventions to enhance proxy decisions about trials. These relate to the process of decision-making, proxies\' experience of decision-making, and factors that influence decision-making such as understanding. Further work with people with impairing conditions and their families is needed to explore their views about the COS and to identify appropriate outcome measures and timing of measurement.
BACKGROUND: The
study is registered on the COMET database ( https://www.comet-initiative.org/Studies/Details/1409 ).