Christopher J. Combs, Ph.D.

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03/24/2004: "Randomization"


A summary of an article from JAMA (the Journal of the American Medical Association) that indicates many people have difficulty understanding the concept of randomization when agreeing to participate in a clinical trial.

In this case, parents were recruited to enroll their children in a clinical trial for the treatment of leukemia. Even though 83% of doctors explained the idea of randomization in providing informed consent, as determined by audiotaping the conversations, about half of the parents who were interviewed right afterward did not understand the concept. Disadvantaged groups were particularly susceptible to an inadequate understanding.

As we discussed in class, part of the problem may be in the language used by doctors and researchers. It's difficult for them to remember and then consciously modify their language to the level of the patient's abilities. I'm sure many, if not most, patients are unwilling to interrupt or question doctors when they don't understand, out of respect or just not wanting to appear stupid. Another factor, I'm sure, is that most people want to hear they are being tested with a new, more powerful treatment, and they are hoping for a magical cure. As a result, it's hard for them to hear and internalize the idea they could be assigned to the no-treatment or standard treatment control group.


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