The effect of various risk/benefit trade-offs on parents' understanding of a pediatric research study

OBJECTIVES: Informed decision-making requires that parents and research subjects understand the risks and benefits of a study, yet research suggests that comprehension of these elements is often poor. This study was designed to examine the effect of factors including manipulation of risk/benefit trade-offs, numeracy, and sociodemographics on parents' understanding of risks and benefits.

METHODS: A total of 4685 parents completed an Internet survey in which they were randomly assigned to receive information about the risks and benefits of a hypothetical pain treatment study presented in 1 of 4 scenarios. Parents' gist (essential) and verbatim (exact) understanding and their perceptions of the risks and benefits were compared across scenarios. The effects of parental sociodemographics and numeracy were also examined.

RESULTS: Participants who were randomly assigned to consider a research study that offered the possibility of improved outcomes had higher gist and verbatim understanding of the information than participants who were considering studies that offered only reductions in the risk for adverse effects. Furthermore, these parents perceived the risks of the study to be significantly lower compared with the scenarios that offered the same risks but less benefit. White race, college education, and higher numeracy all were associated significantly with improved gist and verbatim understanding.

CONCLUSIONS: Research studies that offer only improved outcomes to participants may be evaluated more thoroughly than those that offer only reduced risks, and individual characteristics significantly moderate parents' ability to comprehend risk/benefit information. These results are important toward developing strategies to improve the ways in which risks and benefits are communicated to parents and research subjects.

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