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

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.

Navigating choice in the face of uncertainty: using a theory informed qualitative approach to identifying potential patient barriers and enablers to participating in an early phase chimeric antigen receptor T (CAR-T) cell therapy trial

“…These findings resonate with Houghton et al's conceptual model which indicates that prospective randomised controlled trial participants will consider what they stand to gain or lose, altruistic motives, social influences and the burden of participation. 10 However, unique to the early phase cancer trial context is that patients often express therapeutic misconception (believing the intent of the trial is to benefit them) 31 50 and unrealistic optimism (believing they will experience better outcomes than others), 18 19 posing ethical challenges for trialists. 51 Consistent with existing guidance on developing decision aids for clinical trials, 48 it will, thus, be important to present CAR-T cell therapy safety and efficacy findings with an emphasis on how safety and efficacy data compare to usual care and other available options.…”

“…25 Instead, many interventions focus on providing participants with information regarding clinical trials using various modalities (eg, video, website) and have had moderate or inconsistent effects on subsequent trial participation. [28][29][30][31] This indicates a need for designing novel, fit-for-purpose strategies that go beyond information provision to ones that harness the cumulative evidence base associated with theory-informed approaches. 32 The Theoretical Domains Framework (TDF) was developed to synthesise the key factors across theories of behaviour and behaviour change into 12 domains.…”

Concurrent palliative care in the surgical management of head and neck cancer

“…Clinical trials exist for all subsites and histopathologies of head and neck cancer, however, it is critical to avoid the therapeutic misconception that participation in an early phase trial may be expected to provide clinical benefit to the enrolled patient. Patients may choose to participate in such trials understanding that any benefits will accrue to future patients . Each modality of treatment, when revisited as second‐ or third‐line therapy, carries higher risks of both chronic and catastrophic morbidity as well as mortality.…”

Raising Awareness of Therapeutic Misconception and Optimism Around Clinical Trials in Huntington’s Disease

“…Second, education on the rationale behind clinical trials and the specific differences between clinical trial research and clinical care should be discussed, prior to going through the informed consent forms. This ideally would follow the scientific reframing method, which was proven to reduce therapeutic misconception in a randomized trial design [6].…”