Informed consent for pediatric phase 1 cancer trials: physicians' perspectives.
Informed consent for pediatric phase 1 cancer trials: physicians' perspectives.
复制标题
儿科 1 期癌症试验的知情同意书：医生的观点。
DOI：
10.1002/cncr.25158
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发表时间：
2010
期刊：
影响因子：
6.2
通讯作者：
PhaseIInformedConsent(POIC)ResearchTeam
中科院分区：
文献类型：
--
作者：
Yap,TsiaoYi;Yamokoski,AmyD;Hizlan,Sabahat;Zyzanski,StephenJ;Angiolillo,AnneL;Rheingold,SusanR;Baker,JustinN;Kodish,EricD;PhaseIInformedConsent(POIC)ResearchTeam
背景：本研究旨在收集儿科肿瘤学家对儿科1期癌症试验中知情同意(IC)的意见和建议。共有103项完成的调查被退回，应答率为71%。结果儿科肿瘤学家认为，提供信息以便家庭可以决定是否进入第一阶段研究是IC过程(ICP)最重要的目标。大多数医生(%)报告说，他们描述的第一阶段研究没有任何试图影响父母的决定。医生提供的几个答案与他们的性别和先前的IC培训有关。男性医生明显更有可能支持不试图影响的方法，而女性医生更有可能向父母建议，其他孩子将从第一阶段研究中学到的东西中受益。对开放式问题的回答提供了63条改进ICP的建议，包括文件和培训改革以及加强医生与家庭沟通的工具。结论儿科肿瘤学家倾向于将1期试验作为一种选择，而不是强烈建议，不愿影响家庭对这些研究的决定。他们认为，大多数但不是所有的父母都理解同意这类研究所涉及的关键概念，并就如何改善国际比较方案提出了充分的建议。围绕这一具有伦理挑战的主题，未来的研究和教育努力是有必要的。癌症2010年。©2010美国癌症协会。
BACKGROUNDThis study was conducted to gather pediatric oncologists' opinions about and suggestions for improvement of informed consent (IC) in pediatric phase 1 cancer trials.METHODSA questionnaire designed to elicit perspectives was distributed to 146 physicians at 6 participating institutions. A total of 103 completed surveys were returned for a 71% response rate.RESULTSPediatric oncologists believe providing information so families can decide about phase 1 study entry is the most important goal of the IC process (ICP). The majority of physicians (64%) report that they describe the phase 1 study without any attempt to influence parents' decisions. Several answers provided by physicians were associated with their gender and prior IC training. Male physicians were significantly more likely to endorse the no‐attempt‐to‐influence approach, whereas female physicians were more likely to suggest to parents that other children will benefit from what is learned in phase 1 studies. Responses to an open‐ended question provided 63 suggestions for improvement of the ICP, including document and training changes and tools to enhance physician‐family communication.CONCLUSIONSPediatric oncologists tended to present phase 1 trials as an option rather than a strong recommendation and were reluctant to influence decisions of families about these studies. They believe most but not all parents understand key concepts involved in consent to this type of research, and had ample suggestions for how to improve the ICP. Future research and education efforts around this ethically challenging topic were warranted. Cancer 2010. © 2010 American Cancer Society.