Informing the Uninformed

Abstract

IMPORTANCE: Research information should be presented in a manner that promotes understanding. However, many parents and research subjects have difficulty understanding and making informed decisions. OBJECTIVE: To examine the effect of different communication strategies on parental understanding of research information. DESIGN: Observational study from January 2010 to June 2012 using a fractional factorial design. SETTING: Large tertiary care children's hospital. PARTICIPANTS: Six hundred forty parents of children scheduled for elective surgery. INTERVENTIONS: Parents were randomized to receive information about a hypothetical pain trial presented in 1 of 16 consent documents containing different combinations of 5 selected communication strategies (ie, length, readability, processability [formatting], graphical display, and supplemental verbal disclosure). MAIN OUTCOME AND MEASURES: Parents were interviewed to determine their understanding of the study elements (eg, protocol and alternatives) and their gist (main point) and verbatim (actual) understanding of the risks and benefits. RESULTS: Main effects for understanding were found for processability, readability, message length, use of graphics, and verbal discussion. Consent documents with high processability, eighth-grade reading level, and graphics resulted in significantly greater gist and verbatim understanding compared with forms without these attributes (mean difference, 0.57; 95% CI, 0.26-0.88, number of correct responses of 7 and mean difference, 0.54; 95% CI,0.20-0.88, number of correct responses of 4 for gist and verbatim, respectively). CONCLUSIONS AND RELEVANCE: Results identified several communication strategy combinations that improved parents' understanding of research information. Adoption of these active strategies by investigators, clinicians, institutional review boards, and study sponsors represents a simple, practical, and inexpensive means to optimize the consent message and enhance parental, participant, and patient understanding.