Informing the uninformed: optimizing the consent message using a fractional factorial design.

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.

Explaining state-to-state differences in seat belt use: A multivariate analysis of cultural variables.

There is considerable variation in seat belt use within the United States despite extensive evidence that the use of seat belts saves lives. Previous studies have identified some important factors that affect belt use rates, including gender, age, race, vehicle type, seat-belt enforcement laws, and amount of fine for belt-use law violation. In this study, we examined the influence of additional socio-demographic factors on state-level use rates: education (percentage of high school educated population), racial composition (percentage White), median household income, political leaning (percentage Democrat), and a measure of religiosity. These variables, which collectively characterize the 'culture' of a state, have received little attention in seat-belt studies. The paper reports results from a multiple regression analysis of data from the 2008 Fatality Analysis Reporting System (FARS). Many of the use rate patterns in FARS data were consistent with those found in other data sets, suggesting that conclusions based on FARS data are likely to hold for the population-at-large. Of the five cultural factors considered in the study, three were identified as important in explaining the differences in seat belt use at the state level: religiosity, race (percentage White), and political leaning (percentage Democrat). The other two variables - income and education - were not significant. Hold-out analyses confirmed that this conclusion was consistent across different subsets of data. The findings from this study are preliminary and have to be confirmed on other data sets. Nevertheless, they demonstrate the potential usefulness of cultural factors in explaining state-to-state variation in seat belt use rates. If factors such as religiosity are indeed important, they can be used to develop culturally appropriate programs for increasing belt use.