Data from: Reducing therapeutic misconception: a randomized intervention trial in hypothetical clinical trials

Background: 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.
Methods: 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.
Results: 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.
Conclusions: 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.

背景：临床试验参与者往往未能充分理解研究与临床诊疗之间的核心差异。这一现象被称为治疗性误解（therapeutic misconception），会损害临床研究的知情同意（informed consent）流程，但迄今为止尚无有效干预手段可缓解该问题，且有学者担忧此举可能阻碍受试者招募。本研究旨在验证一种科学重构式干预措施，能否在不显著降低受试者参与假设性临床试验意愿的前提下，减轻治疗性误解。

方法：本前瞻性随机对照试验于2015至2016年间开展，旨在对比基于科学重构的知情同意干预措施与传统知情同意流程（对照组），在降低拟参与五类真实世界研究模型下的假设性临床试验患者的治疗性误解方面的效果。研究从门诊诊所及临床研究志愿者数据库中招募了患有糖尿病（diabetes mellitus）、高血压（hypertension）、冠状动脉疾病（coronary artery disease）、头颈部癌症（head/neck cancer）、乳腺癌（breast cancer）及重度抑郁症（major depression）的患者。主要结局指标为治疗性误解（通过经过验证的10条目治疗性误解量表进行评估，得分范围为10至50分）以及参与假设性临床试验的意愿。

结果：共有154名参与者完成本研究（年龄范围23至87岁；92.3%为白人，56.5%为女性）；其中74名（48.1%）被随机分配至试验干预组。科学重构组的治疗性误解得分显著更低（p=0.004）：26.4分，95%置信区间[23.7, 29.1]，对照组得分则为30.9分，95%置信区间[28.4, 33.5]，在校正教育程度后该差异仍具有统计学意义（p=0.017）。干预组与对照组的假设性临床试验参与意愿无显著差异（p=0.603）：干预组为52.1%，95%置信区间[40.2, 62.4]；对照组为56.3%，95%置信区间[45.3, 66.6]。

结论：相较于传统知情同意流程，辅以科学重构的强化教育干预可有效减轻治疗性误解，且不会对假设性临床试验的受试者招募意愿造成具有统计学意义的负面影响。未来仍需在真实世界临床试验中对该干预措施开展进一步研究。