当被要求让孩子参加一项随机对照试验时，家长会有怎样的体验？
How do parents experience being asked to enter a child in a randomised controlled trial?
作者信息
Shilling Valerie, Young Bridget
机构信息
Division of Clinical Psychology, School of Population, Community and Behavioural Sciences, University of Liverpool, Liverpool, UK.
出版信息
BMC Med Ethics. 2009 Feb 16;10:1. doi: 10.1186/1472-6939-10-1.
BACKGROUND
As the number of randomised controlled trials of medicines for children increases, it becomes progressively more important to understand the experiences of parents who are asked to enroll their child in a trial. This paper presents a narrative review of research evidence on parents' experiences of trial recruitment focussing on qualitative research, which allows them to articulate their views in their own words.
DISCUSSION
Parents want to do their best for their children, and socially and legally their role is to care for and protect them yet the complexities of the medical and research context can challenge their fulfillment of this role. Parents are simultaneously responsible for their child and cherish this role yet they are dependent on others when their child becomes sick. They are keen to exercise responsibility for deciding to enter a child in a trial yet can be fearful of making the 'wrong' decision. They make judgements about the threat of the child's condition as well as the risks of the trial yet their interpretations often differ from those of medical and research experts. Individual parents will experience these and other complexities to a greater or lesser degree depending on their personal experiences and values, the medical situation of their child and the nature of the trial. Interactions at the time of trial recruitment offer scope for negotiating these complexities if practitioners have the flexibility to tailor discussions to the needs and situation of individual parents. In this way, parents may be helped to retain a sense that they have acted as good parents to their child whatever decision they make.
SUMMARY
Discussing randomised controlled trials and gaining and providing informed consent is challenging. The unique position of parents in giving proxy consent for their child adds to this challenge. Recognition of the complexities parents face in making decisions about trials suggests lines for future research on the conduct of trials, and ultimately, may help improve the experience of trial recruitment for all parties.
背景
随着针对儿童用药的随机对照试验数量不断增加，了解那些被要求让孩子参加试验的家长的经历变得愈发重要。本文对关于家长参与试验招募经历的研究证据进行了叙述性综述，重点关注定性研究，这类研究能让家长用自己的语言阐明观点。
讨论
家长都想尽力为孩子好，从社会和法律层面讲，他们的角色是照顾和保护孩子，但医疗和研究环境的复杂性可能会对他们履行这一角色构成挑战。家长既要对孩子负责并珍视这一角色，然而当孩子生病时他们又依赖他人。他们渴望在决定让孩子参加试验时履行责任，但又可能害怕做出“错误”决定。他们会对孩子病情的威胁以及试验风险进行判断，但其理解往往与医学和研究专家不同。每位家长根据自身经历和价值观、孩子的病情以及试验性质，或多或少都会经历这些及其他复杂情况。如果从业者能够灵活地根据个别家长的需求和情况调整讨论方式，那么在试验招募时的互动就能为协商这些复杂情况提供空间。这样一来，无论家长做出何种决定，都可能有助于他们保持自己是孩子好家长的感觉。
总结
讨论随机对照试验以及获取和提供知情同意具有挑战性。家长为孩子提供代理同意的独特地位加剧了这一挑战。认识到家长在做出试验决策时面临的复杂性，为未来关于试验开展的研究指明了方向，最终可能有助于改善所有参与方在试验招募中的体验。
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