Parental health literacy may be a significant contributing factor to consider when recruiting pediatric patients for clinical trials. These findings, from a cross-sectional study, were published in JAMA Network Open.
To assess which characteristics were contributing to consent to participate in a clinical trial and whether volunteers were genuinely consenting, researchers from Rady Children’s Hospital San Diego contacted 135 parents within 7 days of their children being recruited for a clinical trial. The parents were assessed for health literacy via the Newest Vital Sign (NVS) and perception of voluntariness with the Decision-making Control Instrument (DCI).
A total of 19% declined to participate and 9% withdrew consent. Of the remaining 97 parents, 67% were women, 69% were White, 53% spoke English at home, and 43% had some college or technical school.
Lower perception of voluntariness correlated with greater decisional regret (r = –0.54; P <.001), lower satisfaction with informed consent (r =0.39; P <.001), lower health literacy (r =0.30; P =.004), and lower acculturation (r =0.30; P =.05).
Increased decisional regret correlated with lower satisfaction with informed consent (r = –0.39; P <.001) and health literacy (r = –0.21; P =.05).
Lower health literacy associated with Hispanic ethnicity (P <.001), Spanish spoken in the home (P <.001), high school or less educational attainment (P <.001), Medicaid insurance (P <.001), and unmarried status (P =.03).
This study was limited by its bias toward mothers and the large Hispanic population in the area of the study.
These data indicated the perception of voluntariness when recruiting patients for clinical trials was likely influenced by the parents’ health literacy and sociodemographic characteristics. Informed consent tailored to each patients’ level of health literacy is likely needed.
Aristizabal P, Ma AK, Kumar NV, et al. Assessment of factors associated with parental perceptions of voluntary decisions about child participation in leukemia clinical trials. JAMA Netw Open. 2021;4(5):e219038. doi:10.1001/jamanetworkopen.2021.9038