儿童白血病试验中的随机化沟通
Eric Kodish1, Michelle Eder, Robert B Noll
1Rainbow Center for Pediatric Ethics, Department of Pediatrics, Rainbow Babies and Children's Hospital, University Hospitals of Cleveland, Cleveland, Ohio 44106, USA. edk4@po.cwru.edu
一半的家长在儿童白血病临床试验中难以理解随机化. 在知情同意期间改善沟通对于儿童瘤学研究中有效的共享决策至关重要.
科学领域:
- 儿科瘤学 儿科瘤学
- 临床试验方法论 临床试验方法论
- 卫生沟通健康沟通
背景情况:
- 大多数患有白血病的儿童都参与随机临床试验 (RCT).
- 父母对随机化的理解不太清楚.
- 知情同意是儿科癌症研究中的关键步骤.
研究的目的:
- 检查医生如何向家长解释随机化.
- 评估家长对儿童白血病RCT随机化的理解.
- 确定影响家长对随机化理解的因素.
主要方法:
- 对儿童白血病知情同意会议的多站点观察研究.
- 录音和分析同意讨论.同意讨论.
- 会议后与家长进行面试,以评估理解.
主要成果:
- 在83%的案例中,随机化被解释;在95%的案例中,使用了同意文件.
- 50%的家长在会议结束后不理解随机化.
- 少数民族和较低社会经济地位的父母的理解程度较低;护士的存在和试验细节讨论改善了理解.
结论:
- 很大一部分家长不理解儿童白血病试验的随机化.
- 目前的知情同意程序可能对复杂的试验设计不够.
- 需要加强沟通策略,以提高家长的理解和知情决策.
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