DOI: 10.5061/dryad.60v8b
title: Data from: Reducing therapeutic misconception: a randomized intervention trial in hypothetical clinical trials

description: 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.
description: TherapeuticMisconceptionStudy FINAL 2014-2016Therapeutic Misconception (TM) is recognized as a major limitation on valid consent to clinical trials.TM occurs when a research subject fails to grasp the distinction between the imperatives of clinical trials and of ordinary treatment and inaccurately attributes therapeutic intent to research procedures. We conducted a simulated clinical trial on a new method for reducing TM involving two groups. The control group receives a narrated slide show that mimics an ordinary consent process. The experimental group receives the same slide show, but it is preceded by a detailed explanation of the design of clinical trials. The following data file, in SPSS format, was used in our analyses for the project.TherapeuticMisconceptionStudy FINAL 2014-2016Therapeutic Misconception (TM) is recognized as a major limitation on valid consent to clinical trials.TM occurs when a research subject fails to grasp the distinction between the imperatives of clinical trials and of ordinary treatment and inaccurately attributes therapeutic intent to research procedures. We conducted a simulated clinical trial on a new method for reducing TM involving two groups. The control group receives a narrated slide show that mimics an ordinary consent process. The experimental group receives the same slide show, but it is preceded by a detailed explanation of the design of clinical trials. The following data file, in Excel format, was used in our analyses for the project.