Improving Informed Consent in Childhood Cancer Trials

描述(由申请人提供)：知情同意需要进一步研究，儿科肿瘤学是进行此类研究的理想环境。这项研究的主要目标是提高儿童癌症试验的知情同意的质量。该项目将在儿童肿瘤学小组内进行有限机构研究，儿童肿瘤小组是NCI临床试验合作小组计划的唯一儿科成员。长期目标将是利用我们对同意的理解，产生可推广的结果，以便在各种疾病和所有年龄段的临床试验中改善同意。研究计划的前提是，需要具体的结果衡量标准和严格的科学方法来准确研究复杂的互动，即知情同意。迄今为止完成的工作使我们能够改进这一方法，选择关键的结果衡量标准，并制定合理的干预计划；这是这项竞争性更新提案所基于的基础。该项目的具体目标是：1)利用我们对儿童白血病试验中知情同意过程的科学理解，进一步开发、测试和实施两种数据库干预措施，以改善知情同意：a)基于教学的医生指导的干预措施，改进知情同意的管理 这项研究的目的是：根据知情同意的预期指导模式，进行家长指导的干预；2)进行临床试验，以测试每种干预措施对三种具体结果的影响：a)父母对参与临床试验的选择和替代办法的理解；b)父母对随机化的理解；c)父母在知情同意过程中的参与程度，以父母提出的问题的数量和质量来衡量；以及3)确定其中一种干预措施是否优于对照组，以及这两种干预措施之间的比较情况。这项对两种理性的、数据驱动的干预措施的临床试验将允许我们根据所学采取行动，以确定我们是否可以改善知情同意。

DESCRIPTION (provided by applicant): Informed consent requires further study, and pediatric oncology is the ideal context for the conduct of such research. The primary goal of this study is to improve the quality of informed consent for childhood cancer trials. The project will take place as a limited-institution study within the Children's Oncology Group, the single pediatric member of the NCI's Clinical Trials Cooperative Group Program. The long-term objective will be to capitalize on our understanding of consent to yield generalizable findings that can be implemented to improve consent in clinical trials across various diseases and all age groups. The research plan is based on the premise that specific outcome measures and rigorous scientific methodology are required to accurately study the complex interaction that is informed consent. The work accomplished to date has allowed us to refine this methodology, select key outcome measures, and develop rational intervention plans; it is the foundation upon which this competitive renewal proposal is based. The Specific Aims of the project are: 1) To utilize our scientific understanding of the informed consent process in childhood leukemia trials to further develop, test and implement two databased interventions to improve informed consent: a) a physician-directed intervention based on teaching improved management of the informed consent conference, and b) a parent-directed intervention based on the model of anticipatory guidance for informed consent; 2) To conduct a clinical trial to test the effect of each intervention on three specific outcomes: a) parental comprehension of choice and alternative to clinical trial participation, b) parental understanding of randomization, and c) parental participation during the informed consent process as measured by the number and quality of questions asked by parents, and; 3) To determine if either intervention is superior to a control group, and how the two interventions compare to one another. This clinical trial of two rational, data-driven interventions will allow us to act on what we have learned, to determine whether we can improve informed consent.