Improving Informed Consent in Childhood Cancer Trials

说明（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。本研究的主要目标是提高儿童癌症试验知情同意的质量。该项目将作为儿童肿瘤学小组的有限机构研究进行，该小组是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来产生可推广的发现，这些发现可用于改善各种疾病和所有年龄组的临床试验中的同意。研究计划的前提是需要具体的结果测量和严格的科学方法来准确研究知情同意这一复杂的相互作用。迄今为止完成的工作使我们能够完善这一方法，选择关键结果指标，并制定合理的干预计划；这是这一竞争性更新建议的基础。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、测试和实施两种基于数据库的干预措施，以改善知情同意；a)基于改进的知情同意管理教学的医生指导干预措施

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.