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 cancer, and to determine whether parents' decisions were influenced by demographic factors, randomization circumstances, the clinical characteristics of 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 refused randomization. A comparative case-control design was used. The Clinical Investigation Randomization Scale was administered to all participants. This scale included 32 questionnaire items (QIs) pertaining to randomization as well as a mixture of open-ended questions to obtain information about demographic and other factors. RESULTS: A predictor model was developed that accurately predicted acceptance or refusal of randomization 87% of the time. Demographic information was found to have less influence than expected on parents' decision 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 accepted randomization was not their knowledge and information about randomized clinical trials. By far, the majority of QIs that accurately predicted acceptors and refusers involved parents' beliefs, values, and perceptions. Further research is needed to determine interventions that may enable the healthcare team to provide information and decisional support most effectively to improve the informed consent process.