Improving informed consent for children in cancer treatme...( ence taped and studied the medical tea...),Health

ence taped and studied, the medical team explained to parents various options in treatment and presented the concept of randomization, which means that as part of the clinical trial, the child would be randomly assigned to one of multiple treatment options. After the conference, researchers interviewed parents, asking them questions to determine whether or not they understood what randomization meant for their child:

• In this clinical research study, how will it be decided which treatment your child will receive?
• If your child enrolled in this clinical research study, will you be able to choose the treatment option you want?

The researchers concluded that half of the parents did not understand randomization, and, in fact, those who did not understand the concept were more likely to consent to their child's participation in the clinical trial. Their most important findings:

• There were no significant differences observed in how randomization was explained to parents of racial minority, and yet only 27% of minority parents understood the concept compared to 69% of non-minority parents.
• Parents with less education and lower socioeconomic status were much less likely to understand randomization.
• The presence of a nurse at the conference was associated with improved understanding.
• The longer the conference, the better the understanding (the mean conference duration in cases demonstrating parental understanding was 83 minutes, compared with 74 minutes in cases without parental understanding).
• Parents who read the informed consent document thoroughly were more likely to understand randomization.

With these important revelations, the researchers are now conducting a new study to explore the impact of various interventions: Does understanding improve if a nurse meets with parents before the informed consent conference to begin preliminary explanations?
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Contact: Eileen Korey
Eileen.Korey@UHHS.com
216-844-3825
University Hospitals of Cleveland
27-Jan-2004

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