title: Comparative effectiveness of patient-centered strategies to improve FDA medication guides.
abstract: 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.
  
  
  METHODS
  A cross-sectional, randomized trial.
  
  
  METHODS
  Two primary care clinics in Chicago, Illinois; one based in a public university hospital and the other within a private academic medical center.
  
  
  METHODS
  A total of 1003 adults aged 18-85 years.
  
  
  METHODS
  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).
  
  
  METHODS
  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<0.001). The Health Literacy prototype consistently demonstrated the highest comprehension scores, and in multivariable analyses, outperformed both the Drug Facts [β=-4.43, 95% confidence interval (CI), -6.21 to -2.66] and Column (β=-4.04, 95% CI, -5.82 to -2.26) prototypes. Both older age (older than 60 y: β=-10.54, 95% CI, -15.12 to -5.96), low and marginal literacy skills were independently associated with poorer comprehension (low: β=-31.92, 95% CI, -35.72 to -28.12; marginal: β=-12.91, 95% CI, -16.01 to -9.82).
  
  
  CONCLUSIONS
  The application of evidence-based practices to the redesign of Med Guides significantly improved patient comprehension. Although some age and literacy disparities were reduced with the Health Literacy format in particular, both older age and low literacy remained independently associated with poorer comprehension. More aggressive strategies will likely be needed to gain assurances that all patients are informed about their prescribed medications.
  
  
  BACKGROUND
  Clinical Trials.Gov #NCT01731405.
authors.affiliation: *Health Literacy and Learning Program, Division of General Internal Medicine, Feinberg School of Medicine, Northwestern University, Chicago †Department of Learning Sciences, School of Education and Social Policy, Northwestern University, Evanston, IL ‡Division of Pharmaceutical Outcomes and Policy, Eshelman School of Pharmacy, University of North Carolina, Chapel Hill, NC §Global and Research Development, Abbvie Inc., North Chicago, IL ∥Department of Medicine-Pediatrics, Louisiana State University Health Sciences Center, Shreveport, LA ¶Department of Pharmacy Administration, Chicago College of Pharmacy, University of Illinois, Champaign, IL #Division of General Medicine, Emory University School of Medicine, Atlanta, GA.
authors.forename: Michael S
authors.initials: MS
authors.lastname: Wolf
authors.forename: Stacy C
authors.initials: SC
authors.lastname: Bailey
authors.forename: Marina
authors.initials: M
authors.lastname: Serper
authors.forename: Meredith
authors.initials: M
authors.lastname: Smith
authors.forename: Terry C
authors.initials: TC
authors.lastname: Davis
authors.forename: Allison L
authors.initials: AL
authors.lastname: Russell
authors.forename: Beenish S
authors.initials: BS
authors.lastname: Manzoor
authors.forename: Lisa
authors.initials: L
authors.lastname: Belter
authors.forename: Ruth M
authors.initials: RM
authors.lastname: Parker
authors.forename: Bruce
authors.initials: B
authors.lastname: Lambert
mesh_terms: D000293:Adolescent; D000328:Adult; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D032882:Comprehension; D003430:Cross-Sectional Studies; D004348:Drug Labeling / Q000379:methods*; D004522:Educational Status; D005260:Female; D057220:Health Literacy; D006801:Humans; D008297:Male; D008875:Middle Aged; D004366:Nonprescription Drugs; D010044:Outpatient Clinics, Hospital; D055553:Prescription Drugs; D012959:Socioeconomic Factors; D014481:United States; D014486:United States Food and Drug Administration; D055815:Young Adult
chemical_list: D004366:Nonprescription Drugs; D055553:Prescription Drugs