Christopher Paul P, Appelbaum Paul S, Truong Debbie, Albert Karen, Maranda Louise, Lidz Charles
Department of Psychiatry & Human Behavior, Alpert Medical School, Brown University, Providence, RI, United States of America.
Division of Law, Ethics, and Psychiatry, Department of Psychiatry, Columbia University College of Physicians and Surgeons, New York, NY, United States of America.
PLoS One. 2017 Sep 20;12(9):e0184224. doi: 10.1371/journal.pone.0184224. eCollection 2017.
Participants in clinical trials frequently fail to appreciate key differences between research and clinical care. This phenomenon, known as therapeutic misconception, undermines informed consent to clinical research, but to date there have been no effective interventions to reduce it and concerns have been expressed that to do so might impede recruitment. We determined whether a scientific reframing intervention reduces therapeutic misconception without significantly reducing willingness to participate in hypothetical clinical trials.
This prospective randomized trial was conducted from 2015 to 2016 to test the efficacy of an informed consent intervention based on scientific reframing compared to a traditional informed consent procedure (control) in reducing therapeutic misconception among patients considering enrollment in hypothetical clinical trials modeled on real-world studies for one of five disease categories. Patients with diabetes mellitus, hypertension, coronary artery disease, head/neck cancer, breast cancer, and major depression were recruited from medical clinics and a clinical research volunteer database. The primary outcomes were therapeutic misconception, as measured by a validated, ten-item Therapeutic Misconception Scale (range = 10-50), and willingness to participate in the clinical trial.
154 participants completed the study (age range, 23-87 years; 92.3% white, 56.5% female); 74 (48.1%) had been randomized to receive the experimental intervention. Therapeutic misconception was significantly lower (p = 0.004) in the scientific reframing group (26.4, 95% CI [23.7 to 29.1] compared to the control group (30.9, 95% CI [28.4 to 33.5], and remained so after controlling for education (p = 0.017). Willingness to participate in the hypothetical trial was not significantly different (p = 0.603) between intervention (52.1%, 95% CI [40.2% to 62.4%]) and control (56.3%, 95% CI [45.3% to 66.6%] groups.
An enhanced educational intervention augmenting traditional informed consent led to a meaningful reduction in therapeutic misconception without a statistically significant change in willingness to enroll in hypothetical clinical trials. Additional study of this intervention is required in real-world clinical trials.
临床试验的参与者常常无法认识到研究与临床护理之间的关键差异。这种被称为治疗性误解的现象会破坏对临床研究的知情同意，但迄今为止，尚无有效的干预措施来减少这种误解，并且有人担心这样做可能会阻碍招募工作。我们确定了一种科学重构干预措施是否能减少治疗性误解，同时又不会显著降低参与假设性临床试验的意愿。
这项前瞻性随机试验于2015年至2016年进行，旨在测试基于科学重构的知情同意干预措施与传统知情同意程序（对照组）相比，在减少考虑参与以五种疾病类别之一的真实世界研究为蓝本的假设性临床试验的患者中的治疗性误解方面的疗效。从医疗诊所和临床研究志愿者数据库中招募了患有糖尿病、高血压、冠状动脉疾病、头颈癌、乳腺癌和重度抑郁症的患者。主要结局指标为治疗性误解（通过经过验证的十项治疗性误解量表测量，范围为10 - 50）和参与临床试验的意愿。
154名参与者完成了研究（年龄范围为23 - 87岁；92.3%为白人，56.5%为女性）；74名（48.1%）被随机分配接受实验性干预。科学重构组的治疗性误解显著更低（p = 0.004）（26.4，95%可信区间[23.7至29.1]），而对照组为（30.9，95%可信区间[28.4至33.5]），在控制教育因素后仍然如此（p = 0.017）。干预组（52.1%，95%可信区间[40.2%至62.4%]）和对照组（56.3%，95%可信区间[45.3%至66.6%]）参与假设性试验的意愿没有显著差异（p = 0.603）。
在传统知情同意基础上加强教育干预可显著减少治疗性误解，而参与假设性临床试验的意愿在统计学上无显著变化。在真实世界的临床试验中需要对这种干预措施进行进一步研究。
