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在随机临床试验中父母对知情同意过程的经验 - 北欧研究
Nina Mogensen1,2, Ulrika Kreicbergs1,3, Birgitte Klug Albertsen4,5
1Department of Women's and Children's Health, Childhood Cancer Research Unit, Karolinska Institute, Stockholm, Sweden.
对于急性淋巴细胞白血病 (ALL) 临床试验的知情同意过程,家长们普遍感到满意,但许多家长发现这个决定是负担重重的. 孩子 孩子 孩子 孩子
科学领域:
- 儿科瘤学 儿科瘤学
- 临床试验伦理学研究
背景情况:
- 随机临床试验 (RCT) 对于推进急性淋巴细胞白血病 (ALL) 治疗至关重要.
- 这项研究考察了NOPHO ALL2008试验中父母的知情同意经验.
研究的目的:
- 在儿科ALLRCT中调查父母对知情同意过程的经验.
- 确定影响满意度和决策负担的因素.
主要方法:
- 在瑞典,丹麦和芬兰对家长进行了基于人口的问卷调查.
- 调查的重点是父母的孩子参加或被要求参加ALL2008RCT.
主要成果:
- 大多数家长 (91%) 认为他们得到了足够的信息,并且对同意过程感到满意.
- 拒绝参与的家长报告了更多的负面经历和决策负担.
- 儿童在同意过程中的参与是有限的,特别是对于学龄儿童 (66%没有参与).
结论:
- 父母对所有RCT的知情同意过程普遍感到满意.
- 许多家长,特别是那些参与度下降的家长,认为决策过程是繁重的.
- 需要改进的策略,让学龄儿童参与临床试验的知情同意程序.
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