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Pharm World Sci (2010) 32:81–89

DOI 10.1007/s11096-009-9346-4

RESEARCH ARTICLE

Validating the Children’s Medicines Use Questionnaire (CMUQ)


in Australia
Michelle Halim • Heather Vincent • Bandana Saini •
Katri Hämeen-Anttila • Kirsti Vainio • Rebekah Moles

Received: 9 June 2009 / Accepted: 20 October 2009 / Published online: 4 November 2009
 Springer Science+Business Media B.V. 2009

Abstract Objective: To pilot test the validity and reli- questionnaire. There were 5 emergent themes through focus
ability of the English version of the Children’s Medicines group discussions with parents and primary care givers of
Questionnaire (CMUQ) and to explore the attitudes of children, regarding the perception of medicines use in chil-
Australian caregivers towards the use of medicines in dren. These included, ‘concerns about the negative effects of
children. Setting: Survey of Australian parents and primary medicines’, ‘medicines are useful, necessary and safe in
care givers of children 0–15 years. Methods: The ques- treating illnesses in children’, ‘the body’s natural processes
tionnaire was translated from Finnish to English then back- are sufficient in fighting illness’, ‘over the counter medicines
translated to ensure semantic equivalence. A total of 153 are effective and useful in treating illness’, ‘perception of
parents/main caregiver of a child aged 0–15 years were alternative medicines use in children’. Conclusions: The
recruited via convenience sampling. Construct validity of CMUQ is a valid and reliable tool to measure parents’
the attitudinal section of the CMUQ was performed using medicine use for their children in an Australian sample.
exploratory factor analysis. Reliability was assessed using Although small modifications should be made, this instru-
the Cronbach’s alpha coefficient as a marker of internal ment will be valuable in informing the development of
consistency. Three focus groups were conducted to explore medicines information for this cohort in the future.
participants’ attitudes towards medicating children and to
triangulate quantitative data. Main outcome measure:
Construct validity and internal reliability of the CMUQ. Keywords Attitude  Australian children  Child 
Results: Factor analysis generated a parsimonious four Factor analysis  Medicines use  Over the counter
factor solution explaining 50% of variance in the data. The medicines  Prescription medicines  Questionnaire
four subscales representing the four factor solution each
returned a Cronbach’s Alpha coefficient [0.6, indicating
good internal consistency. Participants in focus groups Impact of findings on practice
were satisfied with the structure and content of the
• The CMUQ has good psychometric properties, and is
an instrument that can be used in larger population
M. Halim  B. Saini  R. Moles (&)
Discipline of Pharmacy Practice, Pharmacy Faculty, University samples, across several English speaking countries to
of Sydney, Room N371, Building A15, Science Road, compile data on parental reports and views about
Camperdown Campus, Sydney, NSW, Australia medicines use in children.
e-mail: rebekahm@pharm.usyd.edu.au • Data on pediatric medicines use are currently under-
H. Vincent reported, and no universal data collection instruments
Pharmacy Practice and Social Pharmacy, The Pharmacy School, exist, the CMUQ provides a way forward to address
University of Nottingham, Nottingham, UK this issue.
• This study reports on various issues that parents/
K. Hämeen-Anttila  K. Vainio
Department of Social Pharmacy, Faculty of Pharmacy, primary caregivers of children reflect about or are
University of Kuopio, Kuopio, Finland unsure of when using medicines in children.

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• Responses to the CMUQ by parents/primary care givers There are no questionnaires evident in the literature that
in this Australian sample indicate that pharmacists are measure actual usage, caregiver attitudes towards medicine
considered an important and reliable source of infor- use in children and information source and utility. Much of
mation on children’s medicine the data collected in this area relies on national health sur-
• Paediatric medicines use should be a focus of contin- veys where disease prevalence and general health care usage
uing and undergraduate pharmacy education. dictate questionnaire design. A focus on medicines has not
been encountered in a comprehensive search for such
Introduction instruments. One such research effort has recently emerged
in Finland, who as research leaders in this area, have
Children aged 0–15 years represent a fifth of the Australian developed and conducted a nationwide survey on children’s
population [1], and while the majority of children have medicines use using the Children’s Medicines Use Ques-
been reported to be in good health[1], they frequently fall tionnaire (CMUQ). This instrument aims to explore the
ill and the incidence of chronic illnesses, such as type 1 characteristics of medicine use amongst children and the
diabetes and mental health problems are rising [1, 2]. attitudes of caregivers towards medicating children.
An extensive review of the international literature The CMUQ is divided into three main sections: medi-
highlighted that medicines use to manage illness in chil- cines being used by children, sources of information par-
dren is common. Australian children are frequent visitors to ents utilize, and statements regarding parents’ attitudes to
general practitioners (GPs) [3], and medicines are fre- medicating children, gauged using a 5 point-Likert scale.
quently prescribed (99.3 times per 100 consultations) [2]. Questions were developed from Finnish national studies
The most recent data available in Australia regarding over- [13, 14] and from qualitative research [15, 16]. Utilizing
the-counter (OTC) medicines use is the 1995 National the CMUQ in an Australian population will help charac-
Health Survey, which indicated that 51% of parents used terize the epidemiology of children’s medicines use and the
OTC medicines in the treatment of a child’s illness in the factors that influence medicine-taking behaviour.
2 weeks prior to surveying [4].
Further, sub-optimal quality use of medicines in chil-
dren poses a problem. Literature evidenced issues with: Aims of the study
administration; adherence; parental/carer belief; and ability
to use as prescribed. Most parents are unaware of the side The study aimed to:
effects of OTC medicines [5] and medicines are used for
1. translate the CMUQ from Finnish to English;
inappropriate indications, including the use of paracetamol
2. test the validity and reliability of the translated CMUQ
(acetaminophen) to sedate children [6]. Accidental inges-
within a pilot Australian sample;
tion of medicine is also common [7].
3. explore the attitudes of Australian caregivers toward
Three separate studies in the USA, Canada and Finland
the use of medicines in children;
found that mothers were the most common providers of
4. provide recommendations for future utility of the
medicine information for children [8–10]. Where mothers
CMUQ in Australian settings.
derive information regarding medicines is important, as
this will influence how they medicate their children, and in
turn, how children medicate themselves in the future [6].
Little is known about which sources of medicines infor- Methods
mation parents utilise in Australia.
Medicines’ education for children is important as this Quantitative
ensures that children gain the knowledge and skills to
become rational users of medicines [11]. The Australian A Finnish researcher translated the questionnaire to Eng-
government has implemented the National Drug Strategic lish, which was back-translated to Finnish by another
Framework to educate students about illicit drugs in sec- researcher to allow for detection of errors and to improve
ondary school [12]. However, currently there is no com- the quality of the final version [17]. An Australian
prehensive medication education for children in Australian researcher was consulted to analyze for any language dif-
schools, apart from the campaigns about illicit drug use. ferences and a final version agreed upon.
There is a need to develop targeted medicines education
to this often neglected cohort of medicine takers and Sample size
caregivers; however in order to do this, children’s medicine
taking behavior and the factors that influence children’s As there were 21 items in the attitudinal statements, a
medicine use need to be evaluated in Australia. sample size of greater than 105 participants was estimated,

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Pharm World Sci (2010) 32:81–89 83

based on the general rule that one should have at least five reliability analysis, scoring of negatively-worded items
times as many observations as there are variables to be were reversed [24].
analyzed [18].
Qualitative methods
Respondents
Focus groups
Inclusion criteria consisted of parents/primary caregivers
with children aged between 0 and 15 years. Convenience Focus groups were conducted to allow face validity of the
and snowball sampling was conducted to recruit respon- CMUQ to be established [20, 26], and to elaborate and
dents for the self administered questionnaire by using 2 enrich quantitative data. Focus group participants were
recruitment strategies. Firstly, by identifying 3 day care recruited in the same manner as for the questionnaire.
centers located close to the University campus (University Focus group facilitation was carried out by an indepen-
of Sydney), approaching the managers of these centers and dent research colleague trained in group facilitation.
requesting them to distribute the questionnaire to parents. Focus group participants were reimbursed for traveling
Secondly, by approaching colleagues within the Faculty of costs to the venue with a $20 voucher. In the planning of
Pharmacy, University of Sydney known to researchers who focus groups, it was decided that there would be several
fitted the criteria above. These colleagues were handed focus groups with 4–8 participants in each group, with the
questionnaires and asked to fill in the questionnaires intent of reaching data saturation. Focus group discussions
themselves and further requested to distribute question- were audio-recorded. Focus groups were carried out in
naires to other friends/family/acquaintances who fitted the October 2007 at the Faculty of Pharmacy, University of
study criteria. All questionnaires had a self addressed Sydney.
stamped envelope attached. This recruitment phase was Focus group participants were asked to comment on
carried out between July and October 2007. the questionnaires’ appearance and provide advice on
ideas for improvement [26]. In addition, they discussed
Data analysis issues they faced and attitudes they had, regarding med-
icating their children. Following transcription, data were
Data were entered into SPSS (version 14.00) [19]. analyzed into thematic frameworks. Two researchers were
Descriptive statistics were tabulated for demographic data, involved in the development of the coding frame inde-
and to identify incorrect/missing entries. Exploratory factor pendently, which was then compared to ensure inter-coder
analysis was used to test construct validity [20] of the reliability. Approval for the study was granted from the
attitudinal statements (Sect. 3 of CMUQ) and to determine University of Sydney’s Human Research Ethics Com-
the factor structure. Some items showed significant skew- mittee (Ref 9980).
ness in differing and these items were corrected by log
transformation. Following this, all items were standardized
using Systat Software 11 [21]. Examination of the corre- Results
lation matrix revealed that all correlations were significant
at the 0.01 level (correlations [ 0.30) and the Kaiser- Quantitaive
Meyer-Olkin (KMO) measure of sampling adequacy was
0.734, exceeding the value 0.6 recommended by Kaiser Respondents
[22], thus adequate for factor analysis.
Principal Component Analysis (PCA) was the method of Of the 375 questionnaires distributed, 153 were returned,
extraction used as it yielded a parsimonious factor structure yielding a 41% response rate. The survey revealed that
and also allowed the extraction of maximum variance from 52% of children about whom medicine use was reported by
the data set with each component [23]. PCA was used with parents/primary care givers were girls. The mean age of
Varimax orthogonal rotation to maximize the variance of children for whom parents/primary caregivers reported on
factor loadings by making high loadings higher and low medicine use was 6 years (standard deviation = 4.3). The
ones lower for each factor [23]. The ‘‘Eigenvalue greater majority of respondents (85%) were mothers and nearly
than 1’’ rule, visual inspection of the Scree Plot, and the three-quarters had tertiary qualifications. The sample was
number of items loading on the factor were all used to of middle- to high-socioeconomic status as determined
determine how many factors to retain [24]. Internal con- from net annual incomes. The majority of participants
sistency of items were measured using Cronbach’s alpha indicated that their children’s health status was good
[20] Cronbach’s alpha coefficients less than 0.5 are (Table 1). However, there were substantial missing data
considered unacceptable [25]. Prior to conducting the (13%, n = 20/153)

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Table 1 Participants’ rating of child’s health status at the time of These factors included; (1) the negative effects of medi-
survey (n = 133) cines, (2) the necessity of medicines in treating illness, (3)
Health status of children Frequency (%) the body’s capacity in treating illness, and (4) the effec-
tiveness of OTC medicines.
Good 85 (63.9)
Fairly good 36 (27.1)
Moderate 10 (7.5)
Use of medicines
Fairly poor 2 (1.5)
Total 133
Parents and caregivers sampled, recorded that one-fifth of
Missing 20
the children were using prescription medicines (n = 31/
Total 153
153) and 44% (n = 67/151) had used OTC medicines,
which included vitamin supplements. Table 4 lists com-
Validity and reliability of the CMUQ monly used medicines and the conditions for which they
are used.
The factor analysis resulted in a parsimonious 4 factor Harm resulting from the use of medicines was reported
solution explaining 50% of total variance (Table 2). All by 9% of participants (n = 13/152). Adverse effects of
factors had a Cronbach’s Alpha greater than or near 0.7, antibiotics and ibuprofen were the two main identified
thus the four factor solution was seen as reliable (Table 3). causes of harm.

Table 2 Factor loadings of attitudinal items


Factor Items 1 2 3 4

1
Negative effects of medicines Interactions of medicines worry me 0.71 0.08 -0.14 0.25
Long-term use of analgesics reduces pain threshold 0.68 -0.13 0.02 -0.04
Medicines are unnatural to human body 0.62 0.14 0.21 0.06
The more you need to use analgesics the less effective they are for pain 0.73 -0.02 0.25 -0.09
Side-effects of children’s medicines worry me 0.54 0.21 -0.08 0.12
I usually give analgesics to the child less than is recommended in the 0.47 0.08 0.20 -0.19
instructions
Medicines can disturb the body’s own capacity to heal illnesses 0.58 0.11 0.37 -0.05
Medicines are dangerous, even when used according to instructions 0.49 0.01 0.31 0.09
Doctors prescribe antibiotics to children too easily 0.42 0.21 0.01 -0.10
2
Medicines are necessary in treating Medicines are necessary in treating illnesses -0.03 0.67 0.25 0.08
illness I try to avoid giving medicines to my child 0.18 0.53 0.07 -0.09
Prescription medicines are safe 0.11 0.70 -0.30 0.25
Medicine that a doctor has prescribed for the child are necessary 0.15 0.71 -0.07 -0.03
Prescription medicines are effective -0.02 0.66 0.19 -0.05
3
Body is capable of dealing with illness Fever, natural means of defense of the child’s body, should not be 0.15 0.05 0.74 0.22
without medicines lowered artificially with medicines
The child needs to learn how to bear the pain 0.24 0.01 0.76 0.01
4
OTC medicines are efficacious I take care of my child’s little ailments by using OTCs -0.03 0.12 0.37 0.73
OTC medicines are effective 0.08 0.03 0.11 0.78

Cross-loading items I try to take care of my child’s ailments by some other means than 0.51 0.28 0.46 -0.27
using medicines
I take my child to see a doctor only when other ways of treatment do 0.31 0.25 0.25 -0.49
not help
OTC medicines are safe 0.14 0.51 -0.26 0.49
Bold italic values show the factor loadings

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Table 3 Factor reliability (via Cronbach’s Alpha), percentage variance explained by each factor in the attitudinal scale, and Eigenvalues of each
factor
Factor Cronbach’s Alpha % Total variance Eigenvalues

1 0.779 23 4.8
Negative effects of medicines
2 0.628 12 2.5
Medicines are necessary in treating illness
3 0.738 9 1.8
Body is capable of dealing with illness without medicines
4 0.663 7 1.5
OTC medicines are efficacious

Table 4 Common medical


Conditions Medication classa Percent (%)b
conditions and medicines used
by children in survey Prescription medicines (n = 153)
Upper respiratory tract infection Antibiotics 8
Eczema Topical corticosteroids 6
Asthma B2 agonist and corticosteroids 5
Allergies/eczema Corticosteroids 3
Otitis/conjunctivitis Topical antibiotics 3
Over-the-counter medicines (n = 151)
a
Medications were classified Fever Acetaminophen 10
according to the ATC/DDD
Index 2007 Cold and cough Cough and cold preparation 9
http://www.whocc.no/atcddd/ Eczema Plain and weak corticosteroids 6
b
Percentages are not mutually Allergies Antihistamines 5
exclusive, as some children Vitamin supplement Omega-3-triglycerides 5
suffer more than 1 condition

Respondents indicated that doctors were the most used participants saw pharmacists (n = 102/145) to be reliable.
source of medicines information (90%), followed by The internet was also mentioned by participants as an
pharmacists (74%), and family/friends (36%). Doctors and important source (after family/friends).
pharmacists were perceived as the most reliable provider of Seventy-two percent of parents indicated that the
medicines information, where 91% of participants appropriate age for independent use of medicines was
(n = 137/151) perceived doctors to be reliable and 71% of clustered between the 12–17 years age bracket (Fig. 1).

Fig. 1 Age perceived


40
satisfactory by participants
(n = 148) for independent use
of medicines in children
30
Frequency

20

10

0
less than 4 - 5 6-7 8-9 10 - 11 12 - 13 14 - 15 16 - 17 18 or no
4 years years years years years years years years older opinion
age for independent medicine use

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Qualititaive believed OTC medicines should be first-line treatment for


children’s illness
Participants
‘‘With the three year old, she… couldn’t get the
mucus out of her nose. I just settled her down with the
Fourteen participants were recruited into focus groups.
Demazin’’ (chlorpheniramine maleate and phenyl-
Three focus groups were conducted (n = 4, 6, 4) with
ephrine hydrochloride) (Focus Group2, Participant
saturation of themes apparent after the third group
#2)
discussion.
Various themes regarding medicine use in children 5. Perception of alternative medicines use in children
were raised by participants in focus groups, which were
Participants had mixed responses toward using alterna-
similar to the solutions obtained in the factor analysis.
tive medicines in children. Some advocated their use due to
There were 5 distinct themes that emerged, as discussed
personal experience;
below;
‘‘I’d rather give herbal. My 14 year old was born with
1. Concerns about negative effects of medicines
eczema… and they started him on prednisolone but
Negative aspects of medicines use in children were these medicines only block the symptoms. I needed to
expressed by participants. Comments ranged from deal with his immune system so now he goes natural
expressing dangers in overusing medicines to fears of and hasn’t had an episode in 2 years’’ (Focus Group2,
adverse effects of medicines; Participant #3)
‘‘Children’s medicines are very difficult to know However others were concerned of the adverse effects
when and how to use them effectively. Overall I feel and unknown safety profile of alternative medicines;
that OTC medicines and prescription medicines are
[with herbal medicines] ‘‘I don’t want them to have a
recommended too easily and often abused’’ (Focus
major allergic reaction’’ (Focus Group2, Participant
Group3, Participant #1)
#1)
‘‘It is a concern for me when my child uses Panadol
(acetaminophen) for one whole week… is it okay if As opposed to the questionnaire response, focus group
the child uses it for more than 48 hours? Could it be discussions suggested that age was not a barrier to chil-
affecting his liver?’’ (Focus Group1, Participant #1) dren’s independent use of medicines. Rather, issues such as
the child’s maturity and the type of medicine used were
2. Medicines are useful, necessary and safe in treating
greater influences of children’s independent use of medi-
illnesses in children
cines. Focus group participants suggested that children
It was observed that generational use of medicines in the exhibited maturity to undertake responsibility at different
family played a role in increasing the perception of safety ages, and therefore ‘age’ itself was not a determinant in self
and effectiveness of medicines; administration of medicines. Further some participants
suggested that some chronic conditions necessitated med-
‘‘Some parents use medicines because their parents
icine use, children used to taking these medicines for long
used it all the time… so they say ‘ah yeah that’s
periods of time were quite capable of self administering
alright’’’ (Focus Group 1, Participant #2)
medicines, whereas a medicine taken on an acute basis
3. The body’s natural processes are sufficient in fighting posed more problems.
illness Participants in focus groups also assessed the face
validity of the CMUQ. The majority of participants found
Some participants indicated that some conditions need
the CMUQ straightforward, however, some commented on
not be treated with medicines. Rather, the body’s natural
the length of the questionnaire and some items were dif-
mechanism is sufficient in overcoming illness;
ficult to answer due to the ambiguity of wording and the
‘‘I have found leaving fevers untreated to be the most lack of options in the answers.
effective way for her to get better, quickly and nat-
urally’’ (Focus Group1, Participant #4)
Discussion
4. OTC medicines are effective and useful in treating
illness
The present study was conducted to examine the validity
Many participants reported usage of various OTC and reliability of the translated English CMUQ within an
products for treating minor ailments in children. Some also Australian sample and to provide recommendations for a

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Pharm World Sci (2010) 32:81–89 87

future national study. We also explored the attitudes of highlights that further investigations of these issues in
Australian parents/caregivers towards medicines use in populations studies is imperative to improve how medi-
children. This is the first instrument targeting parents and cines are used safely and effectively in children.
primary caregivers that maps the use of and attitudes Participants noted that medicines information were
towards medicines in children which has undergone initial derived from many areas, including the GP, relatives/
psychometric testing. friends, pharmacists and the internet. In previous studies
Reliability and validity are two important qualities that the main sources of medicines information have been
help establish the credibility of findings measured by an nominated to be physicians, family and friends[30]; more
instrument [27]. The 4 Factor analysis solution obtained recent studies additionally identify the pharmacist and the
accounted for 50% of the variance and factors demon- internet as other sources of information [31, 33]. The
strated good internal consistency. Further, the factor CMUQ showed that participants use the internet and the
structure resonated well with themes discussed in focus pharmacist often, reflecting this shifting trend in sources of
groups. The factor solution contained 3 items that cross- medicines information, signifying emerging roles for the
loaded, which generally should be removed [28], however pharmacist. It may, however be that respondent selection
these were maintained in the final version of the CMUQ for methods (staff at the Faculty of Pharmacy, and their
the sake of comparability with the Finnish data. Focus family/friends/acquaintances) biased these results.
group discussions also supported the overall face validity Participants in focus groups and the survey discussed
of the CMUQ. Following up on specific comments from issues regarding the independent use of medicines in
the focus group participants, the questionnaire needs some children. The majority of participants were comfortable in
minor modifications. For example, the development of allowing children to take medicines independently at the
items regarding perceptions about alternative medicines’ age of twelve onwards, however, it seems that the child’s
use in children and creating more ‘choices’ for respondents personality and maturity plays a strong role in this inde-
selection when answering questions about attitudes to pendence. Interestingly, children seem to hold similar
medicine. The format of the questionnaire too needs some beliefs. In a study by Chambers et al. [10], Canadian
adjustment, as some questions appeared to have gone children reported that they began to self-administer medi-
repeatedly unanswered because of the way they were pre- cines for pain when they were approximately 11 or
sented. There were substantial missing answers for ques- 12 years old. A Finnish study reported that children aged
tions 5 and 6 which relate to respondents’ perception of the 11–12 years believed they could self-medicate in certain
child’s current health status. It is postulated that this was circumstances. Older children in the study (16–17 years)
due to the layout of the question (top right corner) which indicated that the individuals’ personal characteristics, such
made it easy for participants to overlook. Nonetheless data as skills [34] need to be taken into account as well as age.
collated through both the quantitative and qualitative Little has been reported in the literature regarding neg-
analyses above suggest that the CMUQ has potential for ative perceptions of medicines by parents and their per-
use in large population studies including cross-sectional ception of the use of alternative medicines in children.
data comparisons with several nations. Many focus group participants erroneously perceived OTC
Although the method of sampling used in this pilot study medicines to be safe and efficacious. This view correlated
was not aimed at yielding a representative sample of the with previous studies by Simon and Birchley, which
population, results show that the sample obtained had showed that OTC medicines’ were believed to be safe [5,
similarities to published population data [1, 4, 29–31]. The 35]. However, it is known that deaths have occurred in
majority of CMUQ participants indicated that their child young children due to overdosing of common products
was healthy, which was similar to previous findings such as dextromethorphan, pseudoephedrine, and acet-
showing that 97% of children were reported to be in ‘good’ aminophen [36].
to ‘excellent’ health by their parents [1]. Nonetheless, in
our sample, high usage of medicines was reported, similar
again to that reflected in the 1995 National Health Survey Study limitations
[4]. The most common illnesses for which children were
treated by GPs in this study were asthma, upper respiratory Respondents in the study were conveniently selected;
tract infections (URTIs), allergies and conjunctivitis, sim- hence may not be considered as a representative sample.
ilar to previous reports [1]. Despite evidence of the limited Within this sample, socio-economic variables such as lit-
effects of antibiotics in conditions such as URTIs, sinusitis eracy levels and household income may be higher than the
and otitis media [32], these appeared to be commonly used Australian average, therefore the CMUQ’s psychometric
and interestingly, the majority of harm reported in the properties may need to be re-evaluated in a larger, more
survey was due to antibiotic adverse effects. This representative sample.

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