Accepted: 4 April 2017 DOI: 10.1111/hex.12569
O R I G I N A L R E S E A RC H PA P E R
Development and validation of a Chinese medication literacy measure Ying-Chih Yeh BS1
| Hsiang-Wen Lin PhD2 | Elizabeth H. Chang PharmD, PhD1,3,8 |
Yen-Ming Huang MS4 | Yu-Chieh Chen PhD5 | Chun-Yu Wang MS6,7 | Jen-Wei Liu MS1,6 | Yu Ko PhD1,3 1 School of Pharmacy, College of Pharmacy, Taipei Medical University, Taipei, Taiwan 2 School of Pharmacy and Graduate Institute, China Medical University, Taichung, Taiwan 3
Research Center for Pharmacoeconomics, College of Pharmacy, Taipei Medical University, Taipei, Taiwan 4
Division of Social and Administrative Sciences, School of Pharmacy, University of Wisconsin-Madison, Madison, WI, USA 5
Department of Pharmacy, China Medical University Hospital, Taichung, Taiwan 6
Taiwan Society of Health-System Pharmacists, Taipei, Taiwan
Abstract Background: Despite the impact of medication literacy (ML) on patients’ safe use of medications, existing instruments are mostly for general health literacy measurement or designed for specific disease populations, with few specifically designed for ML. Objective: To develop and validate the first Chinese medication literacy measure (ChMLM). Methods: The ChMLM was developed by a multidisciplinary and bilingual expert panel and subsequently pilot-tested. The final version had 17 questions in four sections: vocabulary, non-prescription drug, prescription drug and drug advertisement. Face-to- face interviews were administered in a convenience sample of adults with diverse so-
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ciodemographic characteristics. Internal consistency was assessed by Cronbach’s
Ho-Su Memorial Hospital, Taipei, Taiwan
alpha. Content validity was confirmed by the expert panel, and hypothesis testing was
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performed to assess construct validity.
Department of Pharmacy, Shin Kong Wu
Department of Pharmacy, Wan Fang Hospital, Taipei Medical University, Taipei, Taiwan Correspondence Yu Ko, School of Pharmacy, College of Pharmacy, Taipei Medical University, 250 Wu-Hsing Street, Taipei, Taiwan. Email:
[email protected] Funding information Taiwan Food and Drugs Administration, Ministry of Health and Welfare MOHW104- FDA-D-113-000464; Taipei Medical University TMU104-AE1-B16.
Results: A total of 634 adults were interviewed. The mean (SD) total ChMLM score was 13.0 (2.8). The internal validity was acceptable (Cronbach’s alpha=0.72). Nine of the ten a priori hypotheses were fulfilled. Younger age, higher income and higher education levels were significantly associated with a higher ChMLM score. Furthermore, higher scores on the ChMLM were associated with higher confidence or less difficulty in writing, reading, speaking and listening abilities in a health-care encounter. No association was found between ChMLM total scores and frequency of doctor’s visits. Conclusion: The ChMLM is a valid and reliable ML measure. It may help pharmacists and other health-care providers to target patients and problem areas that need interventions with the ultimate goal of preventing medication errors and harm. KEYWORDS
health literacy, medication literacy, Taiwan, validation
Ying-Chih Yeh and Hsiang-Wen Lin are contributed equally to this work.
This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited. © 2017 The Authors Health Expectations Published by John Wiley & Sons Ltd Health Expectations. 2017;1–6.
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YEH et al.
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1 | INTRODUCTION
of patient-reported measures. The experts were asked to rate each
Health literacy (HL) is defined as the degree to which individuals have
ranging from “not important/adequate at all” to “very important/
the capacity to obtain, process and understand basic health infor-
adequate.” In addition, the experts were encouraged to modify and/or
mation and services needed to make appropriate health decisions.1
comment on the items and explain their rationales. Several iterations
Health literacy has increasingly gained interest in the field of public
of feedback and discussion among the experts generated the revised
health and health care because of its influence on patients’ health. Low
version. Pilot testing was performed in a convenience sample of 35 in-
HL is found to be associated with adverse health outcomes, including
dividuals with diverse demographic characteristics. These participants
higher risk of emergency care use2-7 and hospitalization,3,7,8 poorer
were asked to identify ambiguous or unclear questions and suggest an
overall health status
3,9-13
and higher mortality rate.
item’s importance and appropriateness/relevance on a 5-point scale,
9,14,15
In addition to general health outcomes, a few studies have found
alternative wording. As a result, minor changes were made to enhance clarity and comprehension.
an association between inadequate HL and medication-related skills,
The final version of the ChMLM consisted of seventeen items di-
including dosing errors,16 misunderstanding of prescription labels,17
vided into four sections: vocabulary (five questions), non-prescription
poorer ability to take medication appropriately,17-27 use of non-
drug (five questions), prescription drug (four questions) and drug ad-
standardized dosing tools27 and lack of knowledge of weight-based
vertisement (three items). Each section involved different medication
dosing.27 Although medication literacy (ML), or the ability to read, un-
props. Section one evaluated the respondent’s ability to interpret a
derstand and process medication-related information, is assumed to
list of five medication- related words/phrases (ie, dose, ingredient,
be related to HL, ML may not be fully and adequately captured by gen-
combination drug, external use and side-effect). Section two tested
eral HL assessments. A lack of adequate ML could result in poor med-
the respondent’s ability to read a mock package and insert for a non-
ication adherence and the misunderstanding of medication-related
prescription medication (i.e patient information sheet) to find the
information or instructions, which could in turn make patients more
correct information about the drug’s indications, warnings, dosing di-
prone to medication errors that adversely affect their health.
rections, expiration date and the total number of pills contained in the
Despite the impact of ML on patients’ safe use of medications,
box. Section three assessed the respondent’s ability to read the writ-
existing instruments are mostly for general HL measurement or de-
ten information on the carrier of a fabricated diabetic medication and
signed for specific disease populations, with few specifically designed
correctly answer questions about the drug’s next dosing time, side-
28
developed a medication health literacy screen
effects and total number of days prescribed. In addition, there was
as a measure of use and understanding of information on prescription
an item that tested whether the respondent could tell the difference
labels. The instrument contained two labels: one for an immunosup-
between two prescription labels. Section four asked the respondent
pressant medication and one for a diabetes medication. Another ML
to evaluate an exaggerated drug advertisement and find the informa-
measure, the Medication Literacy Assessment in Spanish and English
tion about the drug’s indication and side-effect. Section one had true/
(MedLitRxSE), developed by Sauceda et al.,29 aimed to assess individ-
false questions, whereas all the questions in sections two through four
uals’ ability to access, understand and act on medication information.
were multiple-choice questions with four response options, including
Three interrelated constructs were tested in this instrument, namely
“I don’t know/I’m not sure.” The medication props used for sections
prose literacy, document literacy and numeracy. Both instruments
two and three had similar format and looked like actual drug prod-
have demonstrated good psychometric properties.
ucts. The ChMLM was intended to assess the skills an individual would
for ML. Stilley et al.
To assess individuals’ ML levels and subsequently create a sup-
need in various real-world scenarios, including interpreting medication
portive environment that encourages correct use of medications, it is
terms, comprehending medication instructions and calculating dosing
essential to develop a valid and reliable ML tool. The main goal of this
intervals.
study was to develop and validate the first Chinese ML measure for the general adult population in Taiwan.
2.2 | Study setting and participants
2 | METHODS
The final version of the ChMLM was administered through face-to-
2.1 | Instrument development
Taiwan from September 2015 to November 2015. Thirty-four phar-
The initial list of ChMLM items was generated by a pharmacist re-
as interviewers by standardized procedures and multiple rehearsals.
searcher (HWL) adapting previously validated medication- related
The interviewers were reminded to be non-judgemental, avoid over-
instruments found in the literature.28-33 The first version of the in-
interpreting the questions and encourage interviewees to try their
strument, which contained 25 items, was reviewed by a panel of 11
best on the test and avoid guessing. The interviewers’ friends, rela-
multidisciplinary and bilingual experts, including pharmacists, health
tives, neighbours and the customers/members of participating phar-
literacy experts and researchers with backgrounds in psychometrics,
macies and organizations were approached as potential participants.
communication, education, health literacy and clinical pharmacy. Half
Potential participants were referred by the pharmacists in the partici-
of the experts also had experience in the translation and validation
pating community pharmacies, and the interviews were conducted in
face interviews in a convenience sample of the general population in macy undergraduate students and research assistants were trained
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YEH et al.
front of the pharmacies or in nearby areas. The participants were not
was associated with living in the northern residential areas of Taiwan
only necessarily customers of the pharmacies but also included com-
(ie, the most urbanized and populous metropolitan area in Taiwan) and
munity residents who were acquaintances of the pharmacists. To be
with speaking Mandarin more commonly. In addition, Pearson’s corre-
eligible, participants needed to be at least 20 years old and able to
lation analysis was used to examine the association between age and
speak Mandarin or Taiwanese. Exclusion criteria were having speak-
performance on the ChMLM.
ing, hearing or cognitive impairment that precluded the participants
All analyses were performed using PASW Statistics 18 (PASW
from adequately interacting with the interviewer. The questionnaire
Statistics for Windows, SPSS Inc., Chicago, IL, USA). The level of sig-
was placed on the Internet by Survey Monkey, and the participants’
nificance was set at probability (P)