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Stability of Parental Understanding of Random Assignment in Childhood Leukemia Trials: An Empirical Examination of Informed Consent

From the Department of Bioethics, Cleveland Clinic Foundation and the Lerner College of Medicine; and the Department of Pediatrics, Rainbow Babies and Children's Hospital of University Hospitals of Cleveland, Case Western Reserve University School of Medicine, Cleveland, OH

Address reprint requests to Rachel Neff Greenley, PhD, Department of Pediatrics, Division of Behavioral Pediatrics and Psychology, Rainbow Babies and Children's Hospital of University Hospitals of Cleveland, 11100 Euclid Ave, Cleveland, OH 44106-6038; e-mail: Rachel.Greenley{at}uhhs.com

PURPOSE: To examine stability versus change in parental understanding of random assignment in randomized clinical trials (RCTs) for pediatric leukemia and to identify factors associated with changes in understanding.

METHODS: Eighty-four parents of children diagnosed with acute lymphoblastic leukemia or acute myeloid leukemia who were enrolled onto a pediatric leukemia RCT at one of six US children's hospitals participated. Parents were interviewed twice, once within 48 hours after the Informed Consent Conference (ICC; time 1 [T1]) and again 6 months later (time 2 [T2]). Interviews focused on parental understanding of key components of the RCT, including random assignment. Interviews were audiotaped, transcribed, and later analyzed.

RESULTS: Changes in understanding of random assignment occurred in 19% of parents, with 17% of parents deteriorating in understanding from T1 to T2. Forty-nine percent of parents failed to understand random assignment at both times. Factors associated with understanding at both times included majority ethnicity, high socioeconomic status, parental reading of consent document, and presence of a nurse during the ICC. Physician discussion of specific components of the RCT was also associated with understanding at both times. Female caregivers and parents of low socioeconomic status were overrepresented among those who showed decay in understanding from T1 to T2.

CONCLUSION: Parents showed little gain in understanding over time. Factors that predicted understanding at diagnosis as well as sustained understanding over time may be important intervention targets. Attention to both modifiable and nonmodifiable barriers is important for clinical practice.

Supported by the National Cancer Institute Grant No. RO1 CA83267.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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