Monday, October 19, 2015: 4:30 PM
Grand Ballroom A (Hyatt Regency St. Louis at the Arch)

Lauren McCormack, PhD, MSPH1, Craig Lefebvre, PhD2, Carla Bann, PhD2, Olivia Taylor2 and Paula Rausch, PhD, RN3, (1)University of North Carolina at Chapel Hill, Chapel Hill, NC, (2)RTI, RTP, NC, (3)FDA, Silver Spring, MD

   Purpose: To understand how adults in the United States differ with respect to their comprehension of, as well as their needs and preferences for, emerging information about prescription drug safety.


   Methods: Using a large Internet panel, we conducted a randomized study (FDA grant #U18FD004608-03) to examine comprehension and other measures of effectiveness of drug safety messages that emerge in a post-market surveillance phase.  A total of 1,244 panel members participated in the survey.  Half of the sample was randomized to receive an existing FDA Drug Safety Communication (DSC) with the drug name fictionalized while the other half received the same safety information revised using best practices in health literacy, plain language and clear communication.  Strategies included simplifying the reading level of the DSC by using shorter sentences and words with fewer syllables; using format and design modifications such as additional subheadings and more white space; and adding numeric information geared toward lay audiences.  We examined how these modifications to the way drug risk information is communicated impacts comprehension, message clarity, and behavioral intentions.

   Results: When seeking information about prescription drugs, 80% of respondents reported that they looked for information about possible side effects; 70% for dosage information; 63% for safety information (see Figure 1).  Based on a five-item comprehension index, those who received the revised version of the message had significantly greater comprehension of the information relative to the standard version (62% versus 52% correct).  In a multivariate model, greater comprehension was associated with being White, having no health insurance, and greater trust in the information.  Lower comprehension was associated with higher risk perceptions for heart or blood vessel disease.  82% of those who received the Revised version agreed that the message was clear compared with 73% who received the Standard version.  A consumer's health literacy level was a key factor in respondents' level of understanding of the information.  No significant differences between groups were found on any of the behavioral intentions measures including the likelihood of talking to their doctor.  


   Conclusions :  Communicators should seek to reduce cognitive burden by presenting drug safety messages with a modest amount of information, key points that can be easily identified, an organized layout, and numerical information with adequate context.

This figure is a bar graph. Seven types of information that consumers want about prescription drugs are shown on the horizontal axis. When seeking information about prescription drugs, 80% of respondents reported that they looked for information about possible side effects, 70% for dosage information, 63% about safety information, 60% about general use of the drug, 57% for what the drug is best used for, 5% wanted some other kind of information, and 8% would not look for information.