Department of Anesthesiology and Critical Care Medicine, The Children's Hospital of Philadelphia, Pennsylvania 44195, USA.
Pediatr Blood Cancer. 2013 May;60(5):873-8. doi: 10.1002/pbc.24326. Epub 2012 Oct 3.
The aim of this study was to examine adolescent patients' perspectives on their understanding and decision making about a pediatric phase I cancer study.
Participants included adolescents ages 14-21 years with cancer (N = 20), all of whom attended a phase I study consent conference. Participants responded to closed- and open-ended questions on a verbally administered structured interview, which assessed aspects of understanding and decision making about the phase I study.
All participants decided to enroll in the phase I study. The majority of participants understood that participation was voluntary, entailed risks, and that they could withdraw. Most also believed that participation in the phase I study would increase the length of their lives. The most frequent reasons for enrolling were positive clinical benefit, needing an option, impact on quality of life, and few side effects or fewer than those of current or past treatments. Eighty-five percent of participants reported that they themselves made the final decision about enrollment in the phase I study.
Most participants hoped or expected that the phase I study would provide a direct benefit (increased survival time or cure) and reported that they themselves were the final decision-maker about enrollment. Clinicians may underestimate the role of adolescents, especially if they believe that parents typically make such decisions. Future research should assess the actual participation of children and adolescents during the informed consent process and explore the role of hope in their decision making about phase I studies.
本研究旨在探讨青少年患者对其参与儿科 I 期癌症研究的理解和决策的看法。
参与者包括患有癌症的 14-21 岁青少年（N=20），他们均参加了 I 期研究的知情同意会议。参与者通过口头进行的结构化访谈回答了封闭式和开放式问题，该访谈评估了他们对 I 期研究的理解和决策的各个方面。
所有参与者均决定参加 I 期研究。大多数参与者理解到参与是自愿的，涉及风险，并且可以退出。大多数人还认为参与 I 期研究将延长他们的生命。参与的最常见原因是积极的临床获益、需要选择、对生活质量的影响以及副作用少或比当前或过去的治疗更少。85%的参与者报告说，他们自己做出了参加 I 期研究的最终决定。
大多数参与者希望或期望 I 期研究能提供直接的益处（延长生存时间或治愈），并报告说他们自己是参加 I 期研究的最终决策者。临床医生可能低估了青少年的作用，特别是如果他们认为家长通常会做出此类决定。未来的研究应评估儿童和青少年在知情同意过程中的实际参与情况，并探讨希望在他们对 I 期研究的决策中的作用。
