Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota.
Center for Law and the Biosciences and Stanford Program in Neuroscience and Society, Stanford Law School, Stanford, California.
Int J Radiat Oncol Biol Phys. 2020 Nov 15;108(4):867-875. doi: 10.1016/j.ijrobp.2020.05.021. Epub 2020 May 23.
Therapeutic misconception is the tendency for a clinical trial participant to overlook the scientific objective of a clinical trial and instead believe that an experimental intervention is intended for personal therapeutic benefit. We sought to evaluate this tendency in the setting of a clinical trial of a new radiation therapy technology.
Patients with left-sided, node positive breast cancer enrolled in a randomized clinical trial evaluating intensity modulated radiation therapy with deep inspiration breath hold (IMRT-DIBH) versus 3-dimensional conformal radiation therapy (3DCRT). Patients who enrolled completed surveys at baseline, after randomization, and upon completion of radiation therapy to evaluate expectations, satisfaction, and experiences.
Forty women participated in the survey study, with 20 in each arm. Most participants endorsed the perception that participation in the trial might result in better treatment than the current standard treatment (77%) and more medical attention than being off trial (54%). At baseline, most women (74%) believed that a new treatment technology is superior than an established one. Before randomization, 43% of participants believed IMRT-DIBH would be more effective than standard treatment with 3DCRT, none believed that 3DCRT would be more effective, 23% believed that they would be the same, and 34% did not know. None believed that IMRT-DIBH would cause worse long-term side effects, whereas 37% thought that 3DCRT would. Most (71%) reported that they would choose to be treated with IMRT-DIBH; none would have elected 3DCRT if given a choice. Nearly half (44%) in the 3DCRT arm wished that they had been assigned to the IMRT-DIBH arm; none in the IMRT-DIBH arm expressed a wish for crossover.
Most participants reported the perception that trial participation would result in better treatment and more medical attention than off trial, hallmarks of therapeutic misconception. Our observations provide empirical evidence of a fixed belief in the superiority of new technology and highlight the importance of adjusting expectations through informed consent to mitigate therapeutic misconception.
治疗性误解是指临床试验参与者忽视临床试验的科学目标，而认为实验干预旨在为个人治疗获益。我们试图在一项新放射治疗技术的临床试验中评估这种倾向。
入组了左侧淋巴结阳性乳腺癌患者的随机临床试验，评估调强放疗伴深吸气屏气（IMRT-DIBH）与三维适形放疗（3DCRT）。入组患者在基线、随机分组后和放疗结束时完成调查，以评估其期望、满意度和体验。
40 名女性参与了调查研究，每组 20 名。大多数参与者认为参与试验可能比当前标准治疗（77%）和比不参加试验（54%）获得更好的治疗和更多的医疗关注。在基线时，大多数女性（74%）认为新的治疗技术优于已确立的技术。在随机分组前，43%的参与者认为 IMRT-DIBH 比标准治疗 3DCRT 更有效，没有人认为 3DCRT 更有效，23%的参与者认为两者相同，34%的参与者不知道。没有人认为 IMRT-DIBH 会导致更严重的长期副作用，而 37%的人认为 3DCRT 会。大多数（71%）的参与者报告说他们会选择接受 IMRT-DIBH 治疗；如果有选择，没有人会选择 3DCRT。3DCRT 组近一半（44%）的人希望被分配到 IMRT-DIBH 组；IMRT-DIBH 组中没有人表达了对交叉的愿望。
大多数参与者报告说，与不参加试验相比，参与试验会导致更好的治疗和更多的医疗关注，这是治疗性误解的特征。我们的观察结果提供了新的证据，证明了对新技术优越性的固定信念，并强调了通过知情同意调整期望以减轻治疗性误解的重要性。
