Abstract
BACKGROUND: Several studies suggest that many parents and research participants have poor understanding of the elements of consent, particularly the risks and benefits. However, some data suggest that the format and framing of research risks and benefits may be an important determinant of subject understanding. We examined the effect of tabular and graphical presentation of risks and benefits on parents' understanding of a research study. METHODS: Parents of children scheduled to undergo an elective surgical procedure (n = 408) were randomized to receive information about the risks and benefits of a sham study of postoperative pain control using text, tables, or pictographs and then completed a questionnaire to examine their gist (essential) and verbatim (actual) understanding of the information. Parent demographics were recorded and their literacy and numeracy skills measured. RESULTS: Parents randomized to receive information using tables or pictographs had significantly (P < 0.025) greater gist and verbatim understanding than did parents who received the information using standard text. Tables and pictographs were also superior to text in promoting understanding among parents with low numeracy and literacy skills. CONCLUSIONS: Many parents and patients have difficulty in assimilating and interpreting risk/benefit information for both research and treatment. This is due, in part, to the manner in which risks and benefits are communicated and to the literacy and numeracy abilities of the individual. The results of this study suggest a simple and practical method for enhancing understanding of risk/benefit statistics for parents with varying numeracy and literacy skills.