Miller Victoria A, Cousino Melissa, Leek Angela C, Kodish Eric D
Victoria A. Miller, The Children's Hospital of Philadelphia, Philadelphia, PA; Melissa Cousino, Boston Children's Hospital, Boston, MA, and Case Western Reserve University; Angela C. Leek and Eric D. Kodish, Cleveland Clinic, Cleveland, OH.
J Clin Oncol. 2014 Oct 10;32(29):3229-35. doi: 10.1200/JCO.2014.55.2588. Epub 2014 Sep 8.
To describe hopeful and persuasive messages communicated by physicians during informed consent for phase I trials and examine whether such communication is associated with physician and parent ratings of the likelihood of benefit, physician and parent ratings of the strength of the physician's recommendation to enroll, parent ratings of control, and parent ratings of perceived pressure.
Participants were children with cancer (n = 85) who were offered a phase I trial along with their parents and physicians. Informed consent conferences (ICCs) were audiotaped and coded for physician communication of hope and persuasion. Parents completed an interview (n = 60), and physicians completed a case-specific questionnaire.
The most frequent hopeful statements related to expectations of positive outcomes and provision of options. Physicians failed to mention no treatment and/or palliative care as options in 68% of ICCs and that the disease was incurable in 85% of ICCs. When physicians mentioned no treatment and/or palliative care as options, both physicians and parents rated the physician's strength of recommendation to enroll in the trial lower.
Hopes and goals other than cure or longer life were infrequently mentioned, and a minority of physicians communicated that the disease was incurable and that no treatment and/or palliative care were options. These findings are of concern, given the low likelihood of medical benefit from phase I trials. Physicians have an important role to play in helping families develop alternative goals when no curative options remain.
描述医生在一期试验知情同意过程中传达的充满希望和有说服力的信息,并探讨这种沟通是否与医生和家长对获益可能性的评分、医生和家长对医生推荐入组强度的评分、家长对控制权的评分以及家长对感知压力的评分相关。
参与者为患有癌症的儿童(n = 85),他们与父母及医生一同被提供了一项一期试验。对知情同意会议(ICC)进行录音,并对医生关于希望和说服力的沟通进行编码。家长完成了一次访谈(n = 60),医生完成了一份针对具体病例的问卷。
最常见的充满希望的表述与对积极结果的期望和提供选择有关。在68%的ICC中,医生未提及不治疗和/或姑息治疗作为选择,在85%的ICC中未提及疾病无法治愈。当医生提及不治疗和/或姑息治疗作为选择时,医生和家长对医生推荐入组试验的强度评分均较低。
除了治愈或延长生命之外的希望和目标很少被提及,少数医生传达了疾病无法治愈以及不治疗和/或姑息治疗不是选择的信息。鉴于一期试验的医疗获益可能性较低,这些发现令人担忧。当没有治愈选择时,医生在帮助家庭制定替代目标方面可发挥重要作用。