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Journal of Pediatric Hematology/Oncology:
doi: 10.1097/MPH.0000000000000112
Original Article: PDF Only

Patient Involvement in Informed Consent for Pediatric Phase I Cancer Research.

Miller, Victoria A. PhD; Baker, Justin N. MD; Leek, Angela C. BA; Drotar, Dennis PhD; Kodish, Eric MD

Published Ahead-of-Print
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Abstract

Objective: To examine children's and adolescents' involvement in the informed consent conference for phase I cancer trials and test associations with patient age, ease of understanding, and pressure to participate.

Procedure: Participants included 61 patients aged 7 through 21 years who were offered participation in a phase I trial. Consent conferences were audiotaped, transcribed, and coded for communication between patients and physicians and between patients and parents.

Results: On the basis of word counts, the mean proportion of the consent conference in which the physician was talking to the patient was 36%; the vast majority (73%) of this communication consisted of giving information. Physician-patient communication increased with age, but overall levels of patient-to-physician communication were low (3%). After controlling for patient age, greater physician-to-patient communication was associated with greater ease of understanding.

Conclusions: The focus on providing information in the context of informed consent may come at the expense of other communication exchanges that are important to patients, especially in the context of end-of-life decisions. Children and adolescents may benefit from the assent process when physicians direct more of their communication to them. Future research should identify the reasons for low patient communication during the consent conference and strategies to enhance their participation in decision making about phase I trial enrollment.

(C) 2014 by Lippincott Williams & Wilkins.

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