Clinician-parent communication during informed consent for pediatric leukemia trials

Abstract

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.