Communication of randomization in XXXX trials.

@entity1 @entity1778 @entity3052
CONTEXT: Most @entity1 diagnosed as having @entity1778 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 @entity1778 RCTs. DESIGN AND SETTING: A multisite study of the informed consent communication process for @entity1778 . Consecutive cases were recruited from pediatric oncology inpatient wards at 6 US @entity1 '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. @entity1 : Parents and members of the health care team who participated in 137 informed consent conferences for @entity1 with newly diagnosed @entity3052 . 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 @entity1 were enrolled in a @entity1778 trial. CONCLUSIONS: Despite oral and written explanation, half of the parents in this study did not understand randomization for @entity1778 trials. To make informed consent more effective, future research must seek to improve communication during this critical interchange.
