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Adaptation of the European Commission-recommended user testing method to patient medication information leaflets in Japan

Authors Yamamoto M, Doi H, Yamamoto K, Watanabe K, Sato T, Suka M, Nakayama T, Sugimori H

Received 14 June 2016

Accepted for publication 18 April 2017

Published 14 June 2017 Volume 2017:9 Pages 39—63


Checked for plagiarism Yes

Review by Single anonymous peer review

Peer reviewer comments 4

Editor who approved publication: Dr Rajender Aparasu

Michiko Yamamoto,1 Hirohisa Doi,1 Ken Yamamoto,2 Kazuhiro Watanabe,2 Tsugumichi Sato,3 Machi Suka,4 Takeo Nakayama,5 Hiroki Sugimori6

1Department of Drug Informatics, Center for Education & Research on Clinical Pharmacy, Showa Pharmaceutical University, Tokyo, Japan; 2Department of Pharmacy Practice, Center for Education & Research on Clinical Pharmacy, Showa Pharmaceutical University, Tokyo, Japan; 3Faculty of Pharmaceutical Sciences, Tokyo University of Science, Chiba, Japan; 4Department of Public Health and Environmental Medicine, The Jikei University School of Medicine, Tokyo, Japan; 5Department of Health Informatics, Kyoto University School of Public, Kyoto, Japan; 6Department of Preventive Medicine, Graduate School of Sports and Health Sciences, Daito Bunka University, Saitama, Japan

Background: The safe use of drugs relies on providing accurate drug information to patients. In Japan, patient leaflets called Drug Guide for Patients are officially available; however, their utility has never been verified. This is the first attempt to improve Drug Guide for Patients via user testing in Japan.
Purpose: To test and improve communication of drug information to minimize risk for patients via user testing of the current and revised versions of Drug Guide for Patients, and to demonstrate that this method is effective for improving Drug Guide for Patients in Japan.
Method: We prepared current and revised versions of the Drug Guide for Patients and performed user testing via semi-structured interviews with consumers to compare these versions for two guides for Mercazole and Strattera. We evenly divided 54 participants into two groups with similar distributions of sex, age, and literacy level to test the differing versions of the Mercazole guide. Another group of 30 participants were divided evenly to test the versions of the Strattera guide. After completing user testing, the participants evaluated both guides in terms of amount of information, readability, usefulness of information, and layout and appearance. Participants were also asked for their opinions on the leaflets.
Results: Response rates were 100% for both Mercazole and Strattera. The revised versions of both Guides were superior or equal to the current versions in terms of accessibility and understandability. The revised version of the Mercazole guide showed better ratings for readability, usefulness of information, and layout (p<0.01) than did the current version, while that for Strattera showed superior readability and layout (p<0.01).
Conclusion: User testing was effective for evaluating the utility of Drug Guide for Patients. Additionally, the revised version had superior accessibility and understandability.

Keywords: user testing, drug information for patients, readability, risk management, risk
communication, accessibility, understandability

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