Yap Tsiao Yi, Yamokoski Amy, Noll Robert, Drotar Dennis, Zyzanski Steve, Kodish Eric D
Children's Hospital Cleveland Clinic, Cleveland, Ohio 44195, USA.
Acad Med. 2009 Aug;84(8):1036-42. doi: 10.1097/ACM.0b013e3181acfbcd.
To improve physician communication with parents using a physician-directed intervention (PDI), emphasizing a sequenced approach to the informed consent conference (ICC) for childhood leukemia clinical trials in which physicians discuss diagnosis, prognosis, and treatment prior to the offer of a clinical trial.
Physicians and fellows at the Children's Hospital of Philadelphia and Children's National Medical Center were recruited to participate in Informed Consent Seminars and subsequent half-day booster sessions. Training was followed by a multisite study of informed consent communication. Real-life ICCs were observed and audiotaped, and parents were interviewed after the ICC to ascertain their understanding. Data from the ICC and interview were then coded and analyzed. Trained physician performances were compared with untrained physicians (controls) at two other research sites. Data were collected from 2003 to 2007 at PDI sites and control sites for comparison.
A total of 102 cases were included for initial analyses, with 60 cases from the PDI sites and 42 control cases. Fifty-nine cases were included in the final analysis. Findings revealed that trained physicians followed the sequenced approach more often when compared with controls. Similarly, physicians at the PDI sites tended to elicit parental questions and understanding in an open-ended way and clarify parents' questions more frequently than physicians at the control sites.
Academic physicians who are involved in the current transformation of clinical research should be trained to conduct effective ICCs. The "see one, do one, teach one" approach is no longer adequate for informed consent.
通过一种由医生主导的干预措施（PDI）来改善医生与家长之间的沟通，该措施强调采用循序渐进的方法进行儿童白血病临床试验的知情同意会议（ICC），即医生在提出临床试验之前先讨论诊断、预后和治疗情况。
招募了费城儿童医院和儿童国家医疗中心的医生及研究员参加知情同意研讨会及随后的半天强化培训课程。培训之后进行了一项关于知情同意沟通的多中心研究。观察并录制了实际的ICC过程，在ICC结束后对家长进行访谈以确定他们的理解程度。然后对ICC和访谈的数据进行编码和分析。将经过培训的医生的表现与另外两个研究地点未受过培训的医生（对照组）进行比较。在2003年至2007年期间从PDI地点和对照地点收集数据进行比较。
共纳入102例进行初步分析，其中60例来自PDI地点，42例为对照病例。最终分析纳入59例。结果显示，与对照组相比，经过培训的医生更常采用循序渐进的方法。同样，PDI地点医生比对照地点医生更倾向于以开放式方式引出家长的问题并了解情况，且更频繁地澄清家长的问题。
参与当前临床研究变革的学术医生应接受培训以进行有效的ICC。“看一个，做一个，教一个”的方法在知情同意方面已不再适用。
