Comparison of the informed consent process for randomized clinical trials in pediatric and adult oncology
Comparison of the informed consent process for randomized clinical trials in pediatric and adult oncology
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DOI：
10.1200/jco.2004.10.034
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发表时间：
2004-07-01
影响因子：
45.3
通讯作者：
Burant, C
中科院分区：
文献类型：
--
作者：
Simon, CM;Siminoff, LA;Burant, C
目的比较III期儿科和成人肿瘤临床试验的知情同意过程，以了解在儿科和成人癌症治疗中保护人类受试者的重要性。调查结果进行了讨论，在改善儿童和成人肿瘤学知情同意的机会。患者和方法共219名受试者的报告on. Adult肿瘤患者构成的样本的36.1%（n = 79）。儿科替代者占其余63.9%（n 140）。两项研究中的受试者在与肿瘤学家的谈话中被观察和录音，并在之后接受采访。成人和儿童之间的比较进行了使用卡方（2）统计和t test.Results儿童和成人知情同意过程之间的差异被发现。成人肿瘤学决策者，平均而言，更充分地了解和更积极地参与他们的肿瘤学家。然而，儿科决策者获得了更多关于生存/治愈、随机化和非自愿性的信息。理解困难在儿科决策者中更常见。成人和儿童肿瘤学研究environment.Conclusion不断努力，以改善临床癌症研究的伦理框架，需要考虑到儿童和成人肿瘤学知情同意之间的关键差异，提出了改进建议。需要做更多的研究来探索肿瘤学中成人和儿科知情同意过程之间的差异。(C)2004年，美国临床肿瘤学会。
Purpose To compare the informed consent processes for phase III pediatric and adult oncology clinical trials in view of the critical importance of human subjects protection in both pediatric and adult cancer care. Findings are discussed in terms of the opportunities for improving pediatric and adult oncology informed consent.Patients and Methods A total of 219 subjects are reported on. Adult oncology patients made up 36.1% (n = 79) of the sample. Pediatric surrogates made up the remaining 63.9% (n 140). Subjects in both studies were observed and audiotaped in conversation with their oncologists, and interviewed afterwards. Comparisons between the adult and pediatric subjects were done using chi(2) statistics and t tests.Results Differences between the pediatric and adult informed consent processes were found. Adult oncology decision makers were, on average, more fully informed and more actively engaged by their oncologists. Pediatric decision makers were, however, given more information about survival/cure, randomization, and voluntariness. Comprehension difficulties were more frequent among pediatric decision makers. Suggestions for improvement are made in view of the differences between adult and pediatric oncology research environments.Conclusion Ongoing efforts to improve the ethical framework of clinical cancer research need to take into account the key differences between pediatric and adult oncology informed consent. More research needs to be done to explore the differences between adult and pediatric informed consent processes in oncology. (C) 2004 by American Society of Clinical Oncology.