Capacity of Children and Teens to Decide About Cancer Trials

描述（由申请人提供）：管理儿科临床研究的法规和政策声明要求儿童和青少年在他们参与研究的决定中，在他们的能力范围内，有发言权。然而，关于儿童和青少年参与研究决策能力的数据很少，部分原因是没有有效的方法来评估儿童的能力。因此，迫切需要发展这样一种方法，以了解儿童的能力，并澄清他们的发展心理基础和环境影响。这些数据对于告知有关儿童在研究决策中的作用的合理政策是必要的。由于临床研究普遍融入儿科癌症治疗，改善儿童参与研究决策的相关政策和实践在儿科肿瘤学中具有特别重要的意义。在这项初步研究中，我们试图验证用于临床研究的麦克阿瑟能力评估工具（MacCAT-CR），这是一种在有或没有认知或精神障碍的成年人中广泛使用的评估能力的工具。该仪器将用于100名9-17岁的儿童和青少年。其他关于儿童的社会人口学和临床信息，以及关于家庭决策风格的信息，将通过家长调查收集。使用受试者工作特征（ROC）曲线，儿童在MacCAT-CR的3个主要子量表（理解，欣赏和推理）上的得分将根据3人专家组确定的能力判断进行验证。子量表得分也将通过韦氏智力简略量表（WASI）的子测试来验证语言认知能力。次要目的是：1)描述MacCAT-CR子量表得分与WASI绩效子测试得分之间的相关性；2)描述MacCAT-CR分量表得分与判断发展指标（即冲动性、未来取向）之间的相关性；3)对影响儿童研究决策能力的心理、社会人口学和情境因素进行探索性多元回归分析。这些分析所得的数据将用于完善影响儿童能力因素的概念模型。反过来，这个模型将决定儿童和青少年参与临床研究决策能力的后续综合研究的设计。公共卫生相关性：儿科临床研究对促进儿童健康和福祉至关重要，但儿童无法给予法律上有效的知情同意，这使得此类研究在伦理上具有挑战性。通过验证一种在成人中广泛用于儿童的评估决策能力的工具，本研究将加强儿科研究的伦理行为，从而为改善儿童健康作出重要贡献。

DESCRIPTION (provided by applicant): Regulations and policy statements governing pediatric clinical research require that children and adolescents be offered a voice, to the extent of their capacity, in decisions about their research participation. However, data on children's and adolescents' capacity to take part in research decisions are sparse, in part because there is no validated methodology for assessing children's capacity. Thus, there is an urgent need to develop such a methodology in order to understand children's abilities, as well as to clarify their developmental psychological foundations and contextual influences. These data are necessary to inform rational policy regarding children's roles in research decisions. Improving policy and practice related to children's participation in research decisions is of special importance in pediatric oncology, due to the pervasive integration of clinical research into pediatric cancer care. In this preliminary study, we seek to validate the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR), an instrument for assessing capacity that has been employed extensively among adults with and without cognitive or psychiatric impairment. The instrument will be administered to 100 children and adolescents ages 9-17 years. Additional sociodemographic and clinical information about the children, as well as information about families' decision making styles, will be collected by a parent survey. Using receiver operating characteristic (ROC) curves, children's scores on the 3 major subscales of the MacCAT-CR (Understanding, Appreciation and Reasoning) will be validated against judgments of capacity as determined by a 3-person expert panel. Subscale scores will also be validated against verbal cognitive ability as measured by subtests of the Wechsler Abbreviated Scale of Intelligence (WASI). Secondary aims are: 1) to describe the correlations between MacCAT-CR subscale scores and performance subtest scores of the WASI; 2) to describe the correlations between MacCAT-CR subscale scores and measures assessing the development of judgment (i.e., impulsivity, future orientation); and 3) to conduct exploratory multivariate regression analyses of psychological, sociodemographic and contextual factors that influence children's capacity to make research decisions. Data from these analyses will be used to refine a conceptual model of the factors that influence children's capacity. This model, in turn, will determine the design of a subsequent comprehensive study of children's and adolescents' capacity to participate in decisions about clinical research. PUBLIC HEALTH RELEVANCE: Clinical pediatric research is essential to advancing children's health and well-being, but children's inability to give legally effective informed consent makes such research ethically challenging. By validating an instrument for assessing decision making capacity that has been widely used among adults for use with children, this research will enhance the ethical conduct of pediatric research and thereby make an important contribution to improving children's health.