Context Most children diagnosed as having leukemia become research subjects
in randomized clinical trials (RCTs), but little is known about how randomization
is explained to or understood by parents.
Objective To investigate physicians' explanation and parental understanding of
randomization in childhood leukemia RCTs.
Design and Setting A multisite study of the informed consent communication process for
RCTs of childhood leukemia. Consecutive cases were recruited from pediatric
oncology inpatient wards at 6 US children's hospitals associated with major
academic medical centers from July 1, 1999, until December 31, 2001. The informed
consent conferences were observed and audiotaped, and the information obtained
was coded and analyzed. Parents were interviewed shortly after the conference
to ascertain their understanding.
Participants Parents and members of the health care team who participated in 137
informed consent conferences for children with newly diagnosed acute leukemia.
Main Outcome Measures Observed explanations of randomization and parental understanding of
randomization after the consent conference.
Results Randomization was explained by physicians in 83% of cases and a consent
document was presented during the conference in 95% of cases. Interviews after
the conference demonstrated that 68 (50%) of 137 parents did not understand
randomization. Parents of racial minority and lower socioeconomic status were
less likely to understand randomization (P<.001
for each). Discussion of specific clinical trial details and the presence
of a nurse during the conference were associated with understanding. Eighty-four
percent of children were enrolled in a leukemia trial.
Conclusions Despite oral and written explanation, half of the parents in this study
did not understand randomization for childhood leukemia trials. To make informed
consent more effective, future research must seek to improve communication
during this critical interchange.