Clinical trials and medical care: Defining the therapeutic misconception

Some research participants do not appreciate important differences between medical research and treatment, says a team of researchers in a policy paper in this week's PLoS Medicine.

Failure to appreciate the difference between research and treatment has been called "therapeutic misconception." Some trial participants, for example, may not be aware of the implications of being randomly assigned to a new treatment versus a control treatment—instead, they may falsely believe that they are being assigned to a medication based on what is best for them personally.

The researchers, led by Gail Henderson at the University of North Carolina at Chapel Hill, say that despite considerable empirical research on therapeutic misconception since the early 1980s, a consistent definition of therapeutic misconception has not emerged in the literature.

"Without such a definition," they say, "meaningful empirical work to measure and assess the prevalence of therapeutic misconception, or to test interventions to reduce it, is difficult to conduct."

The authors met in 2005 to begin working on a definition of therapeutic misconception, and spent a year refining their final definition, which reads:

"Therapeutic misconception exists when individuals do not understand that the defining purpose of clinical research is to produce generalizable knowledge, regardless of whether the subjects enrolled in the trial may potentially benefit from the intervention under study or from other aspects of the clinical trial."

The authors also drafted five dimensions of research that should be understood by trial participants in order to fully evaluate the risks and benefits of participation: (1) the scientific purpose of the trial (i.e. to produce generalizable scientific knowledge); (2) the purpose of study procedures; (3) uncertainty about the risks and benefits of the intervention being tested; (4) the use of a strict research protocol; and (5) the fact that the clinician is acting as an investigator.

Citation: Henderson GE, Churchill LR, Davis AM, Easter MM, Grady C, et al. (2007) Clinical trials and medical care: Defining the therapeutic misconception. PLoS Med 4(11): e324.

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