VALUE IN HEALTH REGIONAL ISSUES 10C (2016) 36–40
Available online at www.sciencedirect.com
journal homepage: www.elsevier.com/locate/vhri
The Living with Medicines Questionnaire: Translation and
Cultural Adaptation into the Arabic Context
Amani Zidan, BScPharm1, Ahmed Awaisu, PhD1, Sanah Hasan, PhD2, Nadir Kheir, PhD1,*
1
Qatar University College of Pharmacy, Doha, Qatar; 2College of Pharmacy, Sharjah University, Sharjah, United Arab Emirates
AB STR A CT
Background: The Living with Medicines Questionnaire (LMQ) was developed in English language to assess, from a patient’s perspective, issues
related to the burden resulting from the use of medicines. Objectives: To
translate and culturally adapt the LMQ into the Arabic language and
context. Methods: Permission to translate the LMQ was obtained from
the original developers, and a protocol for its translation and
cultural adaptation was developed using the International Society
for Pharmacoeconomics and Outcomes Research guidelines for the
translation and cultural adaptation of patient-reported outcome
measures. Two forward translations (from English into Arabic) were
developed and compared to produce the first reconciled version,
which was back-translated into English. The resulting English
version was compared with the original questionnaire leading to
the second reconciled version. The emerged Arabic questionnaire
was then cognitively tested among purposively selected individuals
to assess the linguistic and cultural equivalence, and produce the
Highlights
Medication burden has a negative effect on patients’ lives and
is associated with adverse drug events.
In this study, a culturally adapted Arabic version of the Living
with Medicines Questionnaire was developed. This questionnaire was originally developed in English to assess medication burden from a patient’s perspective.
The translated version could be used in clinical practice and/or
research where it is important to assess burden related to medication intake. This, in turn, could inform designing of interventions aiming at providing minimally disruptive health care.
Introduction
Patients on multiple drug therapy and those with comorbidities
are highly prone to drug-related problems [1]. The number of
these at-risk patients is on the rise worldwide [2]. Polypharmacy,
which is the use of several medications simultaneously, has been
final Arabic version. Results: Issues identified and related to cultural and conceptual equivalence of some terms were resolved by
rewording some items in the tool. The translation process and
cognitive debriefing exercise generated comments regarding the
original tool’s construct and its Arabic equivalent, which were
communicated to the developers of the LMQ for their consideration
while conducting further comparative studies. Conclusions: A culturally suitable translation of the LMQ was generated for potential
use in research and clinical practice in Arabic-speaking countries.
Further validation of the developed Arabic version is recommended
and planned.
Keywords: cultural adaptation, medication burden, questionnaire,
polypharmacy, translation.
Copyright & 2016, International Society for Pharmacoeconomics and
Outcomes Research (ISPOR). Published by Elsevier Inc.
associated with increased morbidity and mortality, hospitalizations, and demand for nursing home care [1,3]. Polypharmacy
could also increase medication burden and may result in drugrelated consequences, such as poor adherence, adverse drug
reactions, and unnecessary drug therapy [4,5]. Medication burden
could still occur in patients using any number of medications,
when considering the negative feelings and experiences related
to those medications [6].
Identification, prevention, and resolution of drug-related
problems are considered the main responsibilities of a pharmaceutical care (PC) provider [7]. Consequently, an effective PC
practice, with its patient-centered philosophy and outcomeoriented tenets, should, hypothetically, lead to reduced burden
of drug therapy. Given that patients’ perspectives on issues
related to the use of medicines are arguably different from those
of health care providers, more attention has been drawn toward
assessing the burden of drug therapy from the perspective of the
patient in recent years [6,8,9]. Consequently, the assessment of
the burden of medicine use from the patient’s viewpoint is an
important element in providing PC because it will help to identify
Conflicts of interest: The authors have indicated that they have no conflicts of interest with regard to the content of this article.
* Address correspondence to: Nadir Kheir, Clinical Pharmacy and Practice Section, Qatar University College of Pharmacy, P.O. Box 2713,
Doha, Qatar.
E-mail: nadirk@qu.edu.qa.
2212-1099$36.00 – see front matter Copyright & 2016, International Society for Pharmacoeconomics and Outcomes Research (ISPOR).
Published by Elsevier Inc.
http://dx.doi.org/10.1016/j.vhri.2016.07.001
VALUE IN HEALTH REGIONAL ISSUES 10C (2016) 36–40
the most vulnerable patients affected by the burden of therapy
so that appropriate interventions could be provided to reduce
this [6].
Several instruments have been developed to evaluate
the aspects of medication use practices of patients [10]. This is
not the case with regard to measures that assess the
burden associated with medication use from the patient’s
perspective, where there is still paucity of validated tools in
the literature. Krska et al. [6] developed and validated the Living
with Medicines Questionnaire (LMQ), a measure that aims to
investigate several aspects of the burden of medicine use
from the patient’s perspective. The LMQ was derived from
earlier qualitative investigations among patients diagnosed
with chronic morbidities [8]. Validations for comparative
psychometric evaluations of this tool were conducted in
several countries including England, Australia, Ireland, and the
Netherlands [6,11]. Patients’ feedback, so far, suggests the
value of the questionnaire in assessing various issues such
as adherence to treatment plans, patients’ relationships with
health care providers, and concerns about adverse drug
reactions [6].
Different approaches for adaptation, validation, and translation of questionnaires related to the measurement of patientreported outcomes (PROs) have been described in the literature
[12–14]. To our knowledge, there are no tools available to assess
patients’ perspectives on the burden associated with medicine
use in the Arabic context. Similarly, an Arabic version of the
LMQ had not been previously developed. Therefore, the aim of
this study was to join the international efforts in instruments
development to make available a culturally acceptable
Arabic version of the LMQ for potential use in Arabic-speaking
countries. This shall produce an invaluable tool to help
assess perceptions of patients on drug therapy and the impact
on their lives. This will, in turn, help to design tailored interventions that will decrease the burden of medicine use, especially
among patients with chronic illnesses receiving multiple
medications.
Methods
Description of the LMQ
The LMQ, developed by Krska et al. [6], contained 41 statements
with which the respondents indicated their level of agreement
using a five-point Likert-type scale (from strongly agree
to strongly disagree). In addition, a free text (open-ended)
question allowed the patient the freedom to add any other
relevant issues that were not covered in the questionnaire [6].
The tool comprised eight domains: relationships with health
professionals, practicalities, information, efficacy, side effects,
attitudes, impact, and control. A visual analogue scale (VAS)
that allowed the patient to express his or her overall perceived
medication burden on a scale of 0 (no burden at all) to
10 (extremely burdensome) was also included [6]. This VAS
originally contained no discrete scored points between 0
and 10, but the scoring was later proposed to the developers
and approved.
37
Preparation
Permission to use the LMQ was obtained from the original
developers of the questionnaire (i.e., Krska et al.). A comprehensive study protocol, which contained detailed information
about the design, methods, and expected results of the
project, was developed and shared with the developers.
The developers provided details and explanations as needed
throughout the process of developing the Arabic version of the
questionnaire.
Forward translation
Two translations of the LMQ from English to Arabic were
conducted by two independent, bilingual, and qualified translators. The translators, who were experienced in translating
PROs, were not informed about the content of the tool before
the translation process.
Reconciliation
A panel composed of three study investigators (two of whom
were fluent in English and Arabic) and the translators convened
on several occasions to develop a single Arabic version of the
LMQ translations. This was done to eliminate any discrepancies
in translation and to ensure cultural equivalence. This generated
the first reconciled Arabic version of the LMQ.
Back translation and review
The first reconciled Arabic version of the LMQ was backtranslated into English by a third independent, bilingual, and
qualified translator who was not familiar with the original
English version of the LMQ. This new English translation was
compared with the original LMQ by the study investigators to test
the quality of the translation and to ensure that the intended
meanings of all the items were maintained. A review of the
outcome of this step led to further refinement of the Arabic
questionnaire and to the second reconciled Arabic version.
According to the ISPOR guidelines, this step should be followed
by a step of “harmonization.” Nevertheless, harmonization
is recommended when the tool of interest is translated into
more than one language to ensure equivalence between
the different developed versions. This was not the case in the
present work.
Cognitive debriefing and review
Seven Arabic-speaking people were purposively selected for
cognitive debriefing. These participants were selected to obtain
a balanced sex, age, educational level, and nationality representation. Although the purpose of this step was to ensure that
the developed Arabic version was comprehensible to the general
population, most of the selected participants had at least one
chronic condition. They provided feedback on the second reconciled LMQ Arabic version in areas related to comprehension,
time burden, and acceptability. Discussions during this review
of the cognitive debriefing process resulted in refining the
changes made in the previous steps pertaining to cultural and
linguistic issues. The cognitive debriefing process also allowed
investigators to assess the acceptability of the content of the
original LMQ, and to communicate this to the developers of the
original version.
The Translation and Cultural Adaptation Process
Proofreading and final report
The International Society for Pharmacoeconomics and Outcomes
Research (ISPOR) guidelines for adaptation, validation, and translation of questionnaires related to the measurement of PROs
were used in this study (Figure 1) [12].
The Arabic version of the LMQ was revised carefully by the study
investigators to produce the final translation. A final report
regarding the original LMQ and the Arabic translation, the
methods used to generate the translated version, and the
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Results
Title and Instructions Translation
The instrument’s title and the instructions were translated with
no need for changes. Questions about demographic characteristics, which were at the end of the original LMQ, were moved to
the first page to avoid missing important demographic data. The
question about the ethnic group of the respondent was replaced
by a question about nationality.
Items Translation and Cultural Adaptation
Statements of the instrument were evaluated carefully by the
study investigators at the semantic, conceptual, and cultural
levels. In this respect, some words were changed to retain the
intended meaning and direction of the statement and to suit the
Arabic context (Table 1).
The backward translation review revealed no major issues in
the translation. Only a few statements were rearranged to be
easier for and closer to the Arabic respondent’s understanding
while maintaining the intended meaning of the original sentences. Details of the issues raised were reported to and discussed
with the LMQ developers. Issues which arose during the process
of translation and cultural adaptation are presented in Table 1.
The Visual Analogue Scale
Figure 1 – Steps for the translation and cultural adaptation of
the LMQ into Arabic (based on ISPOR guidelines).
findings arising during the linguistic validation process was
generated and shared with the LMQ developers.
The flow diagram in Figure 1 shows the multistep process and
the outcomes of each stage in the development of the Arabic
version of the questionnaire.
A decision was made, through discussions among the research
investigators, to change the VAS to one with discrete graduation
between 0 (no burden at all) and 10 (extremely burdensome). This
proposed change was communicated to (and approved by) the
original instrument developers. The rationale for adding discrete
scores to the VAS was to help in providing a global selfassessment of the burden of medicine use and to allow measuring associations with the overall LMQ score and with each of its
domains.
Cognitive Debriefing
The characteristics of the individuals who participated in the
cognitive debriefing interviews are presented in Table 2. The
Table 1 – Major issues resolved in the translation and cultural adaptation of the LMQ.
Item
no.
4
11
Item
Translation issue
“I am comfortable
with the times I
should take my
medicines.”
“I can vary the dose
of the medicines I
take.”
When back-translated into English, the term
“comfortable” became “relieved,” which would
change the meaning and the direction of the
item.
Literal translation may change the direction of
the item and may give the meaning that the
patient will change the dose regardless of the
need.
Cultural adaptations were performed to ensure
acceptance of the respondents to answer such
an item because alcohol consumption, even
though common, is not a norm in the Arabic
culture.
If translated literally, it would be hard to
understand and would deliver a different
meaning and direction of the item.
17
“I am concerned that
my medicines
interact with
alcohol.”
41
“My life revolves
around using my
medicines.”
LMQ, Living with Medicines Questionnaire.
Action
The word “comfortable” was translated into a
word in Arabic that meant “accept.”
It was translated to express the confidence that
respondents would have to tailor the dose as
per their needs, which is the intended meaning
of the item.
This was translated into Arabic that meant “I am
concerned that my medicines interact with my
nutritional habits (other foods, alcohol,
drinks).”
This item was translated into a sentence that
meant using medicines takes a major part of
the life of the patient.
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Table 2 – Characteristics of the participants selected for cognitive debriefing.
Participant
Sex
Nationality
Age
(y)
P1
P2
Female
Female
Syrian
Qatari
26
35
P3
P4
P5
P6
P7
Male
Female
Female
Male
Male
Lebanese
Syrian
Libyan
Qatari
Egyptian
57
23
28
58
45
Occupation
Physical therapist
Red Crescent
volunteer
Manager
University student
University student
Real estate expert
Laborer
Interview place
Interview duration
(min)
Home
Coffee shop
60
50
Participant’s office
Researcher’s office
Researcher’s office
Participant’s office
Construction work
site
60
75
45
40
45
*Qatar University.
interviews conducted revealed an overall good understanding of
most of the questionnaire’s statements and their Arabic translation. Almost all of the interviewed individuals commented on
the length of the questionnaire (41 items) and the presence of
some items that clustered around similar meaning. For example,
item 3, “I am satisfied with the effectiveness of my medicines,”
and item 25, “My medicines live up to my expectations,” were, to
some respondents, measuring the effectiveness of their medications. No changes, however, were suggested regarding these
items, because these closely related questions have subtle differences between them. Respondents’ suggestions and comments
regarding not only the Arabic but also the original version were
reported to the LMQ developers in detail.
Discussion
The development of the LMQ was the first attempt to introduce
an instrument that assesses the burden related to the use of
medicines from a patient’s perspective [6]. This work adds to the
growing evidence that issues related to medication intake are
perceived differently by patients when compared with health
care providers [15]. Although studies concentrating on culturally
adapting measures may vary in their methodologies, we committed to follow best practices provided by the ISPOR to ensure
credible and robust outcomes.
Present recommendations in the literature exist for adopting
already existing tools for use in different study environments and
settings [14,16,17]. Nevertheless, achieving cultural equivalence
of measurement tools in practice is important to enhance the
comparability of results generated from the use of these tools in
different cultures [17]. Among societies with different cultures,
questionnaires should be used only after previous testing within
the target environment [16].
Diverse approaches have been used to conduct translation
and cultural adaptation processes [16,18,19]. For example, Santo
et al. [16] have adapted the Brazilian-Portuguese version of a selfreport measure for dry eye from the US English version. Within
their nine-step approach in cultural adaptation, they performed
the back translation on the final adapted version after it had been
tested for comprehension. Tran et al. [18] have developed an
English version of the French Treatment Burden Questionnaire.
Before conducting the forward-backward translation, the investigators tried to characterize the concept that the tool of interest
measures among the target population (English-speaking). This
diversity is due to the enormous differences in languages,
cultures, and settings where these studies have been conducted,
in addition to the diversity of the types of the tools adapted.
Because the statements of the LMQ were derived from earlier
qualitative investigations among patients diagnosed with chronic
morbidities [8], they were found to be clear and easy to understand by participants of different backgrounds. Our study
revealed no major challenges during the translation process.
This may have been because guidelines were carefully followed
to maintain the cultural equivalence besides the questionnaire’s
intended meaning.
Similarly, decisions regarding the addition, elimination, or
rewording of the items of instruments to maintain the cultural
equivalence in questionnaire translation and validation processes have been described in the literature [18,20]. In this study,
several issues were raised; most notably was a question in the
demographic information page that asked participants about
their ethnic group. A decision was made to replace the question
on ethnic group with a question on nationality to act as a better
differentiator among the Arabic-speaking people. Moreover, there
was an item that asked respondents about concerns related to
interactions between alcohol and other medications. We proposed changing or rewording the question because despite the
fact that consuming alcohol is common, it is still considered
socially unacceptable in the Arabic culture. The point was that
including alcohol consumption as the main focus within an item
in the questionnaire could raise some cultural sensitivity issues.
It was not totally deleted, but the item was paraphrased such that
alcohol consumption remained within an item that covered other
dietary items and their potential interactions with medications.
In addition, discussion was held with the developers regarding the inclusion of a nongraduated VAS that was added at the
end of the LMQ. The investigators of this study preferred to use a
graded VAS with scores ranging from 0 to 10; this was to help in
the interpretation of the findings resulting from using this tool, a
suggestion that was approved by the developers.
The cognitive debriefing interviews were conducted to assess
the comprehension and time burden of the questionnaire. The
overall good level of comprehension of almost all the statements
within the tool was predicted because the development of the
LMQ was based on qualitative explorations of patients’ perspectives on medication-related issues. The respondents’ comments
about the length of the questionnaire and the redundancy of
some items could be explained by the fact that this tool was
designed to identify almost all possible issues related to medicine
intake. This is not unusual. In some studies, criticism of the
original instrument occurred and changes that could affect its
central construct were proposed as a result of testing the tool in
different populations [16,18,19].
Most of the guidelines regarding translation and cultural
adaptation of PRO instruments recommend that the back translation is carried out by a native speaker of the original language
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VALUE IN HEALTH REGIONAL ISSUES 10C (2016) 36–40
who is also fluent in the target language. Finding a person with
such characteristics in our setting was difficult. The back translation in our study was performed by a qualified bilingual translator whose mother language was Arabic, and who was familiar
with the Western culture. Moreover, further research is needed to
determine the psychometric properties of the produced Arabic
version among Arabic-speaking populations before its use in
research and clinical practice. Specifically, the construct validity
and internal consistency reliability should be measured.
Conclusions
We believe that translating and culturally adapting the LMQ
outside English-speaking countries will provide a valuable input
and add to the work that is already being conducted elsewhere by
the developers of the LMQ. Through a robust translation process,
this work has also made available an Arabic version of the LMQ
that is culturally equivalent to the original English tool.
Acknowledgment
We thank the participants who dedicated time to help in
cognitive debriefing.
Source of financial support: This study was supported by a
student grant (grant no. QUST-CPH-SPR-14/15-20).
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