therapeutic misconception

Therapeutic misconception is a common ethical problem encountered in human subjects research.

Further research is necessary to determine the prevalence of and ways to address this "therapeutic misconception".

Therapeutic misconception did not receive great attention until the early 2000s, when references to the concept expanded significantly.

Therapeutic misconception is detrimental to a subject's understanding of a study, which is crucial for an autonomous decision.

Medical ethicists - along with the Quinns' lawyer, Alan Milstein - say the Quinns' situation is a classic example of the "therapeutic misconception."

This constitutes therapeutic misconception concerning the ethics of clinical trials, analogous to the tendency of patient volunteers to confuse treatment in the context of RCTs with routine medical care."

Appelbaum is credited with conceptualizing the idea of the therapeutic misconception in which subjects in medical research studies misunderstand the primary purpose of their contact with the research team as treatment.

Doctors may warn patients of debilitating side effects and even death, but nonetheless, experts say, patients often fall prey to "the therapeutic misconception," the idea that if a doctor offers a treatment, it must have therapeutic value.

The formulation given by Appelbaum et al. in 1987 was the following: "To maintain a therapeutic misconception is to deny the possibility that there may be major disadvantages to participating in clinical research that stem from the nature of the research process itself."

What separates therapeutic misconception from therapeutic misestimation is that in therapeutic misestimation subjects overestimate the benefits of a trial even though they properly understand how research procedures differ from the care they would otherwise receive in clinical practice settings.

Certain factors can increase the risk of therapeutic misconception, such as studies that are similar to clinical care in terms of research design or when subjects have a limited scope of available treatment, such as a terminal phase cancer patient who is not responsive to known treatments.

Strategies to minimize therapeutic misconception include giving a clear description of the research procedures and goals (e.g. explaining study design, treatment allocation and the possibility of receiving a placebo since the allocation is randomized) and having a comprehensive discussion, with the subject, about the voluntary nature of participation and of available alternatives.