Clinician-parent communication during informed consent for pediatric leukemia trials.

OBJECTIVE To address the need to describe informed consent in pediatric settings and to identify barriers to parent understanding, this study assessed how aspects of clinician-parent communication during the informed consent conference (ICC) relate to parent understanding of informed consent and parent perception of the impact of the ICC on their anxiety and control. METHODS Parents of 127 children with newly diagnosed leukemia who were eligible for clinical trials were the participants. The study used comprehensive methods including both observational and self-report assessment methods. RESULTS Structural equation modeling demonstrated that parent race and socioeconomic status (SES) were powerful predictors of clinician-parent communication, parent anxiety and control as a result of the ICC, and parent understanding. Clinician information giving and partnership building predicted parent participation during the ICC. CONCLUSIONS These findings may be used to design interventions that increase the effectiveness of the ICC by identifying specific elements of the conference that influence parent affect and understanding.