Scientific Publications by FDA Staff

Patient Educ Couns 2015 Dec;98(12):1592-9

Influence of patient medication information format on comprehension and application of medication information: a randomized, controlled experiment.

Boudewyns V, O'Donoghue AC, Kelly B, West SL, Oguntimein O, Bann CM, McCormack LA

OBJECTIVE: To examine patients' comprehension and application of alternative versions of patient medication information handouts for a fictitious drug, and whether patient characteristics influence patients' ability to understand the handouts. METHODS: A web-based experiment was conducted in which 1397 adults with rheumatoid arthritis, ankylosing spondylitis, or plaque psoriasis were randomly assigned to one of three conditions: (1) a one-page "Bubbles" format; (2) a one-page "Over-The-Counter" (OTC) format; and (3) a four-page document modeled after MedGuides used in 2009 which served as the control arm. Comprehension and application of information in the handouts were the key outcomes of interest. RESULTS: Participants who viewed either the Bubbles or OTC formats had greater comprehension than participants who viewed the MedGuide, but did not have better application scores. No significant differences were noted between the Bubbles and OTC formats. Patient characteristics did not moderate the results. CONCLUSION: Both formats resulted in better comprehension than the MedGuide format used in the study. PRACTICE IMPLICATIONS: Results provide valuable information on how to design patient information to improve patients' understanding of the risks and benefits of the drugs they are prescribed. Results could be extended to inform the content of other types of patient education materials.