A study at six of the nation's leading children's hospitals has concluded that physicians should do a better job in communicating with parents before a child with cancer enrolls in a randomized clinical trial.

"Our findings demonstrate that common strategies to explain the concept of randomization to patient families are not effective," said Eric Kodish, lead author of the study published in the Journal of the American Medical Association.

Kodish is a pediatric oncologist and director of the Rainbow Center for Pediatric Ethics at Rainbow Babies & Children's Hospital in Cleveland and professor of pediatrics at Case Western Reserve University School of Medicine.

As part of the study, researchers observed and audiotaped the informed consent conferences involving 137 families at six medical centers for more than two years. The patients were children, all newly diagnosed with acute leukemia.

Childhood cancer treatment commonly involves the option of participation in clinical trials, which have revolutionized pediatric cancer treatment and significantly improved outcomes. In fact, the authors note that:

"Thousands of children with cancer have been enrolled in randomized clinical trials over the past 40 years. The cure of childhood leukemia, one of the great success stories of modern medicine, has been a direct result of these trials."

• Their most important findings:
• There were no significant differences observed in how randomization was explained to parents of racial minority, and yet only 27 percent of minority parents understood the concept compared to 69 percent 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.

Return to the online edition of the 2-12-04 Campus News.