Reducing therapeutic misconception: A randomized intervention trial in hypothetical clinical trials.

Paul P Christopher,Louise Maranda,Paul S Appelbaum,Karen Albert,Debbie Truong,Charles Lidz,Kerry Woolfall

doi:10.1371/journal.pone.0184224

Abstract

BackgroundParticipants 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.MethodsThis 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.Results154 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.ConclusionsAn 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.

Highlights

Clinical trials ask one or more basic scientific questions: Is a particular intervention safer, more tolerable, or more effective than other approaches to a given health condition? To answer this question, a protocol often involves randomization to one or more intervention arms, blinding of researchers and participants, constraints on dosing, limiting adjunctive treatments, and additional testing to determine the consequences of an intervention
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 in reducing therapeutic misconception among patients considering enrollment in hypothetical clinical trials modeled on real-world studies for one of five disease categories
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

Summary

Introduction

A protocol often involves randomization to one or more intervention arms, blinding of researchers and participants, constraints on dosing, limiting adjunctive treatments, and additional testing (e.g., biopsies, blood draws, imaging) to determine the consequences of an intervention. Such procedures depart dramatically from ordinary medical practice. 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

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