Comparative effectiveness of patient-centered strategies to improve FDA medication guides

BACKGROUND Med Guides are the only Food and Drug Administration-regulated source of written patient information distributed with prescriptions drugs. Despite their potential value, studies have found them to have limited utility. OBJECTIVE To evaluate the effectiveness of patient-centered strategies for the design of Med Guides to improve comprehension. DESIGN A cross-sectional, randomized trial. SETTING Two primary care clinics in Chicago, Illinois; one based in a public university hospital and the other within a private academic medical center. PATIENTS A total of 1003 adults aged 18-85 years. INTERVENTION The format and layout of content from 3 typical Med Guides (by reading difficulty, length, exposure) were modified several ways to promote information accessibility. Working with patients, the 3 most preferred versions were evaluated. The first used 2 columns to organize content (Column), a second mimicked over-the-counter "Drug Facts" labeling (Drug Facts), and the third followed health literacy best practices using a simple table format (Health Literacy prototype). MEASURES Tailored comprehension assessment of content from 3 representative Med Guides. RESULTS Comprehension was significantly greater for all 3 prototypes compared with the current standard (all P