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Reducing therapeutic misconception: A randomized intervention trial in hypothetical clinical trials
Paul P Christopher1, Paul S Appelbaum2, Debbie Truong3
1Department of Psychiatry & Human Behavior, Alpert Medical School, Brown University, Providence, RI, United States of America.
Plos One
|September 21, 2017
Summary
A new scientific reframing intervention significantly reduced therapeutic misconception in patients considering clinical trials. This approach improved understanding without decreasing willingness to participate in research.
Area of Science:
- Clinical Research Ethics
- Informed Consent Process
- Patient Education
Background:
- Therapeutic misconception, where patients misunderstand research vs. clinical care, undermines informed consent.
- Existing interventions to reduce therapeutic misconception are lacking.
- Concerns exist that reducing misconception may hinder clinical trial recruitment.
Purpose of the Study:
- To determine if a scientific reframing intervention reduces therapeutic misconception.
- To assess if this intervention impacts willingness to participate in hypothetical clinical trials.
- To evaluate the intervention's efficacy across diverse patient populations.
Main Methods:
- Prospective randomized trial (2015-2016) comparing scientific reframing to traditional informed consent.
- Recruitment of patients with diabetes, hypertension, coronary artery disease, head/neck cancer, breast cancer, and major depression.
- Validated Therapeutic Misconception Scale used to measure outcomes.
Main Results:
- Therapeutic misconception was significantly lower in the scientific reframing group (p = 0.004).
- This reduction remained significant after controlling for education (p = 0.017).
- Willingness to participate in hypothetical trials did not differ significantly between groups (p = 0.603).
Conclusions:
- An enhanced educational intervention reduced therapeutic misconception effectively.
- The intervention did not negatively impact willingness to enroll in hypothetical trials.
- Further research in real-world clinical trials is warranted.
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