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Outcomes of informed consent among parents of children in cancer clinical trials
Author(s) -
Truong Tony H.,
Weeks Jane C.,
Cook E. Francis,
Joffe Steven
Publication year - 2011
Publication title -
pediatric blood and cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.116
H-Index - 105
eISSN - 1545-5017
pISSN - 1545-5009
DOI - 10.1002/pbc.22983
Subject(s) - medicine , informed consent , clinical trial , confidence interval , multivariate analysis , parental consent , randomized controlled trial , family medicine , young adult , cancer , clinical psychology , alternative medicine , pathology
Background Clinical trials are central to pediatric oncology, yet the process and outcomes of informed consent are poorly understood. We evaluated correlates of understanding among parents of pediatric trial participants, and explored differences in the process and outcome of informed consent between parents and a comparison group of adult participants. Procedure We administered the Quality of Informed Consent (QuIC) to parents of children who were newly enrolled onto a cancer trial. We identified independent correlates of knowledge among parents, and compared parents' knowledge to that of a contemporaneous group of adult participants, using multiple linear regression models. Results Parents (n = 47) were less likely than adult participants (n = 204) to report having enough time to learn about the trial (64% vs. 87%, P = 0.001) or sufficient opportunity for questions (79% vs. 93%, P = 0.01), and reported lower overall satisfaction with the consent process (71% vs. 90%, P = 0.002). The mean parental knowledge score was 73.6 (95% confidence interval [CI] 69.5–77.8, theoretical maximum 100). Knowledge did not differ between parents and adult trial participants. In multivariate analysis, two predictors were significantly associated with higher parent knowledge scores: consent sought by the study's principal investigator (increment 13.6, CI 2.7–24.6) and physician‐reported poor prognosis (increment 13.8, 95% CI 5.4–22.1). Conclusions Although we observed no differences in knowledge between parents of pediatric cancer trial participants and their adult counterparts, parents report more problems with the informed consent process for their trials. The increased prevalence of problems is likely due to clinical and contextual differences between pediatric and adult trials. Pediatr Blood Cancer 2011; 57: PPL–1004. © 2011 Wiley‐Liss, Inc.