Improving informed consent: Suggestions from parents of children with leukemia
Improving informed consent: Suggestions from parents of children with leukemia
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DOI：
10.1542/peds.2006-2208
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发表时间：
2007-04-01
期刊：
影响因子：
8
通讯作者：
Kodish, Eric D.
中科院分区：
文献类型：
--
作者：
Eder, Michelle L.;Yamokoski, Amy D.;Kodish, Eric D.
OBJECTIVE.本研究旨在从白血病患儿家长的角度出发，提出改善知情同意过程的建议。改善知情同意的建议是从140名儿童的父母那里得到的，他们参加了一项治疗急性白血病的随机临床试验。四种不同的方法和数据收集时间点，这组父母，包括开放式，在知情同意会议后72小时内亲自采访;随访电话采访6个月后诊断;焦点小组在第3年的项目;和家长咨询小组在第4年的知情同意会议。在访谈和焦点小组中，最常被引用的改善知情同意的建议涉及给父母更多的时间来做出决定，提供的信息的数量和类型，同意会议的组织，沟通方式和提供额外的材料。在知情同意会议家长咨询小组期间，家长制定了组织知情同意过程中提供的信息的具体指南，包括7个主要组成部分：时间安排、顺序、检查表、检查理解、预期指导、从历史角度转入随机临床试验讨论和选择。通过纳入父母的观点，提供了一个真实的利益相关者的声音，我们的研究代表了一个真正的伙伴关系的方法来改善同意过程。父母提供了实用的建议，以改善知情同意，可适用于大多数成人和儿童患者人群。
OBJECTIVE. The objective of this study was to report suggestions for improving the informed consent process from the perspective of parents of children with leukemia.METHODS. Recommendations for improving informed consent were elicited from 140 parents of children who had been offered participation in a randomized clinical trial for the treatment of their acute leukemia. Four different methods and data collection time points were used with this group of parents, including open-ended, in-person interviews within 72 hours after the informed consent conference; follow-up telephone interviews 6 months after diagnosis; focus groups during year 3 of the project; and a parent advisory group on informed consent meeting in year 4.RESULTS. The most frequently cited suggestions for improving informed consent during the interviews and focus groups related to giving parents more time to make their decision, the amount and type of information provided, organization of the consent conference, communication style, and providing additional materials. During the parent advisory group on informed consent meeting, parents developed specific guidelines for organization of the information that is presented during the consent process that include 7 major components: timing, sequence, checklist, checking for understanding, anticipatory guidance, segue into randomized clinical trial discussion with historical perspective, and choice.CONCLUSIONS. Through the incorporation of parental perspectives that provide an authentic stakeholder voice, our research represents a true partnership approach to improving the consent process. Parents provided practical advice for improving informed consent that can be applied to most adult and pediatric patient populations.