Parents' perceptions of randomization in pediatric clinical trials

OBJECTIVES: The purpose of this study was to investigate parents' knowledge and perceptions about randomization in clinical trials for children with c ancer, and to determine whether parents' decisions were influenced by demog raphic factors, randomization circumstances, the clinical characteristics o f the child with cancer, or a combination. MATERIALS AND METHODS: This Study collected information from 192 parents of patients with various forms of childhood cancer who either accepted or ref used randomization. A comparative case-control design was used. The Clinica l Investigation Randomization Scale was administered to all participants. I ris scale included 32 questionnaire items (QIs) pertaining to randomization as well as a mixture of open-ended questions to obtain information about d emographic and other factors. RESULTS: A predictor model was developed that accurately predicted acceptan ce or refusal of randomization 87% of the time. Demographic information was found to have less influence than expected on parents' decisions regarding randomization. Knowledge deficits were found among both groups of parents, those who accepted and those who refused randomization. CONCLUSIONS: What most distinguished parents who refused from those who acc epted randomization was not their knowledge and information about randomize d clinical trials. By far, the majority of QIs that accurately predicted ac ceptors and refusers involved parents' beliefs, values! and perceptions. Fu rther research is needed to determine interventions that may enable die hea lthcare team to provide information and decisional support most effectively to improve the informed consent process.