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在儿童和青少年参与研究的决定中，在其能力范围内为其提供发言权。然而，关于儿童和青少年参与研究决定的能力的数据很少，部分原因是没有评估儿童能力的有效方法。因此，迫切需要发展这样一种方法，以了解儿童的能力，以及澄清他们的发展心理基础和环境影响。这些数据对于制定关于儿童在研究决策中的作用的合理政策是必要的。由于临床研究与儿科癌症护理的普遍整合，改善与儿童参与研究决策相关的政策和实践在儿科肿瘤学中具有特殊重要性。在这项初步研究中，我们试图验证麦克阿瑟临床研究能力评估工具（MacCAT-CR），这是一种评估能力的工具，已在有和没有认知或精神障碍的成年人中广泛使用。该工具将对100名9-17岁的儿童和青少年进行管理。有关儿童的其他社会人口统计学和临床信息，以及有关家庭决策方式的信息，将通过家长调查收集。使用受试者操作特征（ROC）曲线，儿童在MacCAT-CR（理解，欣赏和推理）的3个主要分量表上的得分将根据由3人专家小组确定的能力判断进行验证。还将根据韦氏简明智力量表（WASI）的子测试测量的言语认知能力验证子量表评分。次要目标是：1）描述MacCAT-CR子量表得分与WASI的表现子测试得分之间的相关性; 2）描述MacCAT-CR子量表得分与评估判断发展的指标之间的相关性（即，冲动，未来的方向）;和3）进行探索性的心理，社会人口和环境因素，影响儿童的能力，使研究决策的多元回归分析。从这些分析中获得的数据将用于完善影响儿童能力的因素的概念模型。这种模式，反过来，将决定设计一个儿童和青少年的能力，参与临床研究的决策随后的综合研究。公共卫生相关性：临床儿科研究对促进儿童的健康和福祉至关重要，但儿童无法给予具有法律效力的知情同意，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使用的用于儿童的决策能力评估工具，这项研究将提高儿科研究的道德行为，从而为改善儿童健康做出重要贡献。

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.