“……因为我很特别”或“我觉得我会像豚鼠一样”：临床试验中法定未成年人的信息和同意——理解、评估和推理能力的评估。
"...because I am something special" or "I think I will be something like a guinea pig": information and assent of legal minors in clinical trials--assessment of understanding, appreciation and reasoning.
机构信息
Department of Child and Adolescent Psychiatry/Psychotherapy, University Hospital of Ulm, Ulm, Germany.
出版信息
Child Adolesc Psychiatry Ment Health. 2009 Jan 28;3(1):2. doi: 10.1186/1753-2000-3-2.
BACKGROUND
The aim of this study is to assess and evaluate the capacities for understanding, appreciation and reasoning of legal minors with psychiatric disorders and their parents and their competence to consent or assent to participation in clinical trials. The beliefs, fears, motivation and influencing factors for decision-making of legal minors and parents were also examined.
METHODS
Using the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR), an instrument developed for adults whose capacities to consent are unclear, we provided information about clinical trials and assessed understanding, appreciation and reasoning. We adapted this tool for legal minors and examined 19 children and adolescents between the ages of 7 and 15 with attention deficit/hyperactivity disorder (ADHD) or ADHD combined with oppositional defiant disorder (DSM-IV 314.00/314.01/312.8) enrolled in clinical trials. Parents were also examined using the MacCAT-CR.
RESULTS
Facts such as the procedures involved in trials or their duration were well understood by legal minors, but more abstract issues like the primary purpose of the trial were not understood by children and adolescents or by many parents. Legal minors also had difficulties understanding the nature of placebo and the probability of receiving placebo. Children's and adolescents' decisions were influenced by fears about their disorder worsening and by problems in their relationship with their parents. Parents wanted the best therapy for their children in order to minimize problems in school.
CONCLUSION
Legal minors and parents need to be informed more precisely about specific issues like placebo and the primary purpose of trials. In general, the reasoning of children and adolescents was influenced by their experience with their disorder and decision making was based on reasonable arguments. Their fears were based on everyday experiences such as school performance or family relationships.
背景
本研究旨在评估和评价有精神障碍的法律未成年患者及其父母的理解、欣赏和推理能力，以及他们同意或参与临床试验的能力。还检查了法律未成年患者和父母的决策信念、恐惧、动机和影响因素。
方法
使用 MacArthur 临床研究能力评估工具（MacCAT-CR），这是一种为那些同意能力不清楚的成年人开发的工具，我们提供了关于临床试验的信息，并评估了理解、欣赏和推理能力。我们对该工具进行了改编，检查了 19 名年龄在 7 至 15 岁之间的患有注意力缺陷/多动障碍（ADHD）或 ADHD 合并对立违抗性障碍（DSM-IV 314.00/314.01/312.8）的儿童和青少年，他们参加了临床试验。还使用 MacCAT-CR 检查了父母。
结果
法律未成年患者能够很好地理解试验涉及的程序或持续时间等事实，但对于像试验的主要目的等更抽象的问题，儿童和青少年以及许多父母都不理解。法律未成年患者也难以理解安慰剂的性质和接受安慰剂的概率。儿童和青少年的决策受到对病情恶化的恐惧以及与父母关系问题的影响。父母希望为孩子提供最佳的治疗，以最大限度地减少他们在学校的问题。
结论
法律未成年患者和父母需要更准确地了解安慰剂和试验主要目的等具体问题。一般来说，儿童和青少年的推理能力受到他们对疾病的经验的影响，决策是基于合理的论点。他们的恐惧基于日常生活经验，例如学业成绩或家庭关系。
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