Communication of Randomization in Childhood Leukemia Trials

Abstract

Context Most children diagnosed as having leukemia become research subjects in randomized clinical trials (RCTs), but little is known about how randomization is explained to or understood by parents. Objective To investigate physicians' explanation and parental understanding of randomization in childhood leukemia RCTs. Design and Setting A multisite study of the informed consent communication process for RCTs of childhood leukemia. Consecutive cases were recruited from pediatric oncology inpatient wards at 6 US children's hospitals associated with major academic medical centers from July 1, 1999, until December 31, 2001. The informed consent conferences were observed and audiotaped, and the information obtained was coded and analyzed. Parents were interviewed shortly after the conference to ascertain their understanding. Participants Parents and members of the health care team who participated in 137 informed consent conferences for children with newly diagnosed acute leukemia. Main Outcome Measures Observed explanations of randomization and parental understanding of randomization after the consent conference. Results Randomization was explained by physicians in 83% of cases and a consent document was presented during the conference in 95% of cases. Interviews after the conference demonstrated that 68 (50%) of 137 parents did not understand randomization. Parents of racial minority and lower socioeconomic status were less likely to understand randomization (PϽ.001 for each). Discussion of specific clinical trial details and the presence of a nurse during the conference were associated with understanding. Eighty-four percent of children were enrolled in a leukemia trial. Conclusions Despite oral and written explanation, half of the parents in this study did not understand randomization for childhood leukemia trials. To make informed consent more effective, future research must seek to improve communication during this critical interchange.

A Qualitative Study of Phase III Cancer Clinical Trial Enrollment Decision-Making: Perspectives from Adolescents, Young Adults, Caregivers, and Providers

“…Structuring the diagnostic meeting in a manner that simplifies the presentation of information and confirms understanding is consistent with Kodish's work examining consent/assent procedures for phase I and III clinical trials. [35][36][37] This approach may allow AYAs to become involved in the decision-making process while providing caregivers with the opportunity to process information about cancer, treatment, and clinical trials. Decision tools [38][39][40] or strategies for improving the delivery of healthcare information and enhancing the decision-making process, used together with the PRPQ, may provide an effective method to addressing attitudes toward cancer clinical trials and engage, educate, and guide AYA decision-making for treatment via a phase III clinical trial.…”

Factors Related to Voluntary Parental Decision-Making in Pediatric Oncology

“…Research on parental voluntariness that incorporates objective measurement of the informed permission process and physician or researcher behaviors is also needed. For example, Kodish and colleagues 1,28 have conducted numerous studies related to informed permission in pediatric leukemia. In those studies they used an observer checklist that provides an objective assessment of elements of the protocol discussion.…”

“…Previous research related to parental permission* to research or treatment in pediatric settings has focused largely on disclosure and understanding [1][2][3] and motivations for agreeing to or declining research participation. 4,5 Little empirical attention has been paid to the voluntariness of such decisions.…”

Reflections on Developing Collaborative Research in Pediatric Psychology: Implications and Future Directions

“…I have found that one important role that I have had in research with pediatric colleagues was to facilitate connections and collaborations with other researchers from other professional disciplines and/or psychologists with complementary specialized expertise. Examples from my own experience include involving an anthropologist to help understand the complex family context of failure to thrive and economic disadvantage (Drotar, 1991), engaging child development expertise to measure the information processing of young children with HIV infection , or helping to facilitate interdisciplinary teams that included oncology, nursing, anthropology, bioethics, and biostatistics (Kodish et al, 2004).…”