Stability of parental understanding of random assignment in childhood leukemia trials: An empirical examination of informed consent
Stability of parental understanding of random assignment in childhood leukemia trials: An empirical examination of informed consent
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DOI：
10.1200/jco.2005.02.8100
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发表时间：
2006-02-20
影响因子：
45.3
通讯作者：
Kodish, E
中科院分区：
文献类型：
--
作者：
Greenley, RN;Drotar, D;Kodish, E
目的研究稳定性与变化的随机分配的父母的理解随机临床试验（RCTs）为儿童白血病，并确定与变化的因素，在understanding.Methods的84名父母的儿童诊断为急性淋巴细胞白血病或急性髓细胞白血病谁被招募到一个儿科白血病随机对照试验在美国6家儿童医院参加。对父母进行了两次访谈，一次是在知情同意会议后48小时内（ICC;时间1 [T1]），另一次是在6个月后（时间2 [T2]）。采访重点关注父母对随机对照试验关键组成部分的了解，包括随机分配。访谈录音，转录，后来analysed.Results随机分配的理解发生在19%的家长，17%的家长恶化的理解从T1到T2的变化。49%的父母在这两次都不理解随机分配。在这两个时间与理解相关的因素包括多数民族，高社会经济地位，父母阅读同意书，并在ICC护士的存在。医生讨论RCT的特定组成部分也与两次的理解相关。在T1 ~ T2期间，女性照顾者和低社会经济地位的父母在理解能力下降的人群中所占比例较高。在诊断时预测理解以及随着时间的推移持续理解的因素可能是重要的干预目标。关注可修改和不可修改的障碍对临床实践很重要。
Purpose To examine stability versus change in parental understanding of random assignment in randomized clinical trials (RCTs) for pediatric leukemia and to identify factors associated with changes in understanding.Methods Eighty-four parents of children diagnosed with acute lymphoblastic leukemia or acute myeloid leukemia who were enrolled onto a pediatric leukemia RCT at one of six US children's hospitals participated. Parents were interviewed twice, once within 48 hours after the Informed Consent Conference (ICC; time 1 [T1]) and again 6 months later (time 2 [T2]). Interviews focused on parental understanding of key components of the RCT, including random assignment. Interviews were audiotaped, transcribed, and later analyzed.Results Changes in understanding of random assignment occurred in 19% of parents, with 17% of parents deteriorating in understanding from T1 to T2. Forty-nine percent of parents failed to understand random assignment at both times. Factors associated with understanding at both times included majority ethnicity, high socioeconomic status, parental reading of consent document, and presence of a nurse during the ICC. Physician discussion of specific components of the RCT was also associated with understanding at both times. Female caregivers and parents of low socioeconomic status were overrepresented among those who showed decay in understanding from T1 to T2.Conclusion Parents showed little gain in understanding over time. Factors that predicted understanding at diagnosis as well as sustained understanding over time may be important intervention targets. Attention to both modifiable and nonmodifiable barriers is important for clinical practice.