Reducing therapeutic misconception: A randomized intervention trial in hypothetical clinical trials
Authors
Christopher, Paul P.Appelbaum, Paul S.
Truong, Debbie
Albert, Karen
Maranda, Louise S.
Lidz, Charles W.
Document Type
Journal ArticlePublication Date
2017-09-20Keywords
Bioethics and Medical EthicsClinical Trials
Health Services Administration
Health Services Research
Medical Education
Metadata
Show full item recordAbstract
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.Source
PLoS One. 2017 Sep 20;12(9):e0184224. doi: 10.1371/journal.pone.0184224. eCollection 2017. Link to article on publisher's site
DOI
10.1371/journal.pone.0184224Permanent Link to this Item
http://hdl.handle.net/20.500.14038/40464PubMed ID
28931031Related Resources
Rights
Copyright: © 2017 Christopher et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.Distribution License
http://creativecommons.org/licenses/by/4.0/ae974a485f413a2113503eed53cd6c53
10.1371/journal.pone.0184224
Scopus Count
Collections
Except where otherwise noted, this item's license is described as Copyright: © 2017 Christopher et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.