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Comparative Effectiveness of Patient-centered Strategies to Improve FDA Medication Guides

Wolf, Michael S. PhD, MPH*,†; Bailey, Stacy C. PhD, MPH; Serper, Marina MD*; Smith, Meredith PhD§; Davis, Terry C. PhD; Russell, Allison L. BA*; Manzoor, Beenish S. BA; Belter, Lisa MPH*; Parker, Ruth M. MD#; Lambert, Bruce PhD

doi: 10.1097/MLR.0000000000000182
Original Articles

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<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.

Trial Registration: Clinical Trials.Gov #NCT01731405.

Supplemental Digital Content is available in the text.

*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

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Supported by an unrestricted grant from Abbott Labs (principal investigator: M.S.W.). Neither Abbott Labs nor any other funding bodies had any role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

M.S.W., S.C.B., and B.L. have previously provided research consultation services to Abbott Labs. T.C.D. has stock ownership in Abbott Labs. The remaining authors declare no conflict of interest.

Reprints: Michael S. Wolf, PhD, MPH, Health Literacy and Learning Program, Division of General Internal Medicine, Feinberg School of Medicine, Northwestern University, 750 N. Lake Shore Drive, 10th Floor, Chicago, IL 60611. E-mail:

© 2014 by Lippincott Williams & Wilkins.