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Effect of Standardized, Patient-Centered Label Instructions to Improve Comprehension of Prescription Drug Use

Wolf, Michael S. MA, MPH, PhD*†‡; Davis, Terry C. PhD§¶; Curtis, Laura M. MS; Webb, Jennifer A. MA*†; Bailey, Stacy Cooper MPH*†; Shrank, William H. MD, MSHS; Lindquist, Lee MD, MPH*†; Ruo, Bernice MD*†; Bocchini, Mary V. BA§¶; Parker, Ruth M. MD**; Wood, Alastair J. J. MD††‡‡

doi: 10.1097/MLR.0b013e3181f38174
Brief Report

Objective: To evaluate the effectiveness of standardized, patient-centered label (PCL) instructions to improve comprehension of prescription drug use compared with typical instructions.

Methods: A total of 500 adult patients recruited from 2 academic and 2 community primary care clinics in Chicago, IL and Shreveport, LA were assigned to receive as follows: (1) standard prescription instructions written as times per day (once, twice 3 times per day) (usual care), (2) PCL instructions that specify explicit timing with standard intervals (morning, noon, evening, bedtime) (PCL), or (3) PCL instructions with a graphic aid to visually depict dose and timing of the medication (PCL + Graphic). The outcome was correct interpretation of label instructions.

Results: Instructions with the PCL format were more likely to be correctly interpreted compared with standard instructions (adjusted relative risk [RR]: 1.33, 95% confidence interval [CI]: 1.25–1.41). Inclusion of the graphic aid (PCL + Graphic) decreased rates of correct interpretation compared with PCL instructions alone (RR: 0.93; 95% CI: 0.89–0.97). Patients with low literacy were better able to interpret PCL instructions (low literacy: RR: 1.39; 95% CI: 1.14–1.68; P = 0.001).

Conclusion: The PCL approach could improve patients' understanding and use of their medication regimen.

From the *Health Literacy and Learning Program, Feinberg School of Medicine at Northwestern University, Chicago, IL; †Division of General Internal Medicine, Feinberg School of Medicine at Northwestern University, Chicago, IL; ‡Department of Learning Sciences, School of Education and Social Policy at Northwestern University, Evanston, IL; Departments of §Medicine and ¶Pediatrics, Louisiana State University Health Sciences Center at Shreveport, Shreveport, LA; ∥Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA; **Emory University School of Medicine, Atlanta, GA; ††Symphony Capital, LLC, New York, NY; and ‡‡Weill Cornell Medical School, New York, NY.

Supported by the Agency for Healthcare Research and Quality (R01 HS017687; R01 HS019435; PI: Wolf) and an unrestricted grant from Target Corporation.

Reprints: Michael S. Wolf, PhD, MPH, MA, Division of General Internal Medicine, Feinberg School of Medicine, Northwestern University, 750 N, Lake Shore Dr, 10th Floor, Chicago, IL 60611. E-mail:

© 2011 Lippincott Williams & Wilkins, Inc.