Validating the Children’s Medicines Use Questionnaire (CMUQ) in Australia

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 reliability of the English version of the Children’s Medicines Questionnaire (CMUQ) and to explore the attitudes of Australian caregivers towards the use of medicines in children. Setting: Survey of Australian parents and primary care givers of children 0–15 years. Methods: The questionnaire was translated from Finnish to English then backtranslated to ensure semantic equivalence. A total of 153 parents/main caregiver of a child aged 0–15 years were recruited via convenience sampling. Construct validity of the attitudinal section of the CMUQ was performed using exploratory factor analysis. Reliability was assessed using the Cronbach’s alpha coefficient as a marker of internal consistency. Three focus groups were conducted to explore participants’ attitudes towards medicating children and to triangulate quantitative data. Main outcome measure: Construct validity and internal reliability of the CMUQ. Results: Factor analysis generated a parsimonious four factor solution explaining 50% of variance in the data. The four subscales representing the four factor solution each returned a Cronbach’s Alpha coefficient [0.6, indicating good internal consistency. Participants in focus groups were satisfied with the structure and content of the questionnaire. There were 5 emergent themes through focus group discussions with parents and primary care givers of children, regarding the perception of medicines use in children. These included, ‘concerns about the negative effects of medicines’, ‘medicines are useful, necessary and safe in treating illnesses in children’, ‘the body’s natural processes are sufficient in fighting illness’, ‘over the counter medicines are effective and useful in treating illness’, ‘perception of alternative medicines use in children’. Conclusions: The CMUQ is a valid and reliable tool to measure parents’ medicine use for their children in an Australian sample. Although small modifications should be made, this instrument will be valuable in informing the development of medicines information for this cohort in the future. Keywords Attitude
Australian children
Child
Factor analysis
Medicines use
Over the counter medicines
Prescription medicines
Questionnaire Impact of findings on practice • M. Halim
B. Saini
R. Moles (&) Discipline of Pharmacy Practice, Pharmacy Faculty, University of Sydney, Room N371, Building A15, Science Road, Camperdown Campus, Sydney, NSW, Australia e-mail: rebekahm@pharm.usyd.edu.au • H. Vincent Pharmacy Practice and Social Pharmacy, The Pharmacy School, University of Nottingham, Nottingham, UK K. Hämeen-Anttila
K. Vainio Department of Social Pharmacy, Faculty of Pharmacy, University of Kuopio, Kuopio, Finland • The CMUQ has good psychometric properties, and is an instrument that can be used in larger population samples, across several English speaking countries to compile data on parental reports and views about medicines use in children. Data on pediatric medicines use are currently underreported, and no universal data collection instruments exist, the CMUQ provides a way forward to address this issue. This study reports on various issues that parents/ primary caregivers of children reflect about or are unsure of when using medicines in children. 123 82 • • Pharm World Sci (2010) 32:81–89 Responses to the CMUQ by parents/primary care givers in this Australian sample indicate that pharmacists are considered an important and reliable source of information on children’s medicine Paediatric medicines use should be a focus of continuing and undergraduate pharmacy education. Introduction Children aged 0–15 years represent a fifth of the Australian population [1], and while the majority of children have been reported to be in good health[1], they frequently fall ill and the incidence of chronic illnesses, such as type 1 diabetes and mental health problems are rising [1, 2]. An extensive review of the international literature highlighted that medicines use to manage illness in children is common. Australian children are frequent visitors to general practitioners (GPs) [3], and medicines are frequently prescribed (99.3 times per 100 consultations) [2]. The most recent data available in Australia regarding overthe-counter (OTC) medicines use is the 1995 National Health Survey, which indicated that 51% of parents used OTC medicines in the treatment of a child’s illness in the 2 weeks prior to surveying [4]. Further, sub-optimal quality use of medicines in children poses a problem. Literature evidenced issues with: administration; adherence; parental/carer belief; and ability to use as prescribed. Most parents are unaware of the side effects of OTC medicines [5] and medicines are used for inappropriate indications, including the use of paracetamol (acetaminophen) to sedate children [6]. Accidental ingestion of medicine is also common [7]. Three separate studies in the USA, Canada and Finland found that mothers were the most common providers of medicine information for children [8–10]. Where mothers 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 information parents utilise in Australia. Medicines’ education for children is important as this ensures that children gain the knowledge and skills to become rational users of medicines [11]. The Australian government has implemented the National Drug Strategic Framework to educate students about illicit drugs in secondary school [12]. However, currently there is no comprehensive medication education for children in Australian schools, apart from the campaigns about illicit drug use. There is a need to develop targeted medicines education to this often neglected cohort of medicine takers and caregivers; however in order to do this, children’s medicine taking behavior and the factors that influence children’s medicine use need to be evaluated in Australia. 123 There are no questionnaires evident in the literature that measure actual usage, caregiver attitudes towards medicine use in children and information source and utility. Much of the data collected in this area relies on national health surveys where disease prevalence and general health care usage dictate questionnaire design. A focus on medicines has not been encountered in a comprehensive search for such instruments. One such research effort has recently emerged in Finland, who as research leaders in this area, have developed and conducted a nationwide survey on children’s medicines use using the Children’s Medicines Use Questionnaire (CMUQ). This instrument aims to explore the characteristics of medicine use amongst children and the attitudes of caregivers towards medicating children. The CMUQ is divided into three main sections: medicines being used by children, sources of information parents utilize, and statements regarding parents’ attitudes to medicating children, gauged using a 5 point-Likert scale. Questions were developed from Finnish national studies [13, 14] and from qualitative research [15, 16]. Utilizing the CMUQ in an Australian population will help characterize the epidemiology of children’s medicines use and the factors that influence medicine-taking behaviour. Aims of the study The study aimed to: 1. 2. 3. 4. translate the CMUQ from Finnish to English; test the validity and reliability of the translated CMUQ within a pilot Australian sample; explore the attitudes of Australian caregivers toward the use of medicines in children; provide recommendations for future utility of the CMUQ in Australian settings. Methods Quantitative A Finnish researcher translated the questionnaire to English, which was back-translated to Finnish by another researcher to allow for detection of errors and to improve the quality of the final version [17]. An Australian researcher was consulted to analyze for any language differences and a final version agreed upon. Sample size As there were 21 items in the attitudinal statements, a sample size of greater than 105 participants was estimated, Pharm World Sci (2010) 32:81–89 based on the general rule that one should have at least five times as many observations as there are variables to be analyzed [18]. 83 reliability analysis, scoring of negatively-worded items were reversed [24]. Qualitative methods Respondents Focus groups Inclusion criteria consisted of parents/primary caregivers with children aged between 0 and 15 years. Convenience and snowball sampling was conducted to recruit respondents for the self administered questionnaire by using 2 recruitment strategies. Firstly, by identifying 3 day care centers located close to the University campus (University of Sydney), approaching the managers of these centers and requesting them to distribute the questionnaire to parents. Secondly, by approaching colleagues within the Faculty of Pharmacy, University of Sydney known to researchers who fitted the criteria above. These colleagues were handed questionnaires and asked to fill in the questionnaires themselves and further requested to distribute questionnaires to other friends/family/acquaintances who fitted the study criteria. All questionnaires had a self addressed stamped envelope attached. This recruitment phase was carried out between July and October 2007. Data analysis Data were entered into SPSS (version 14.00) [19]. Descriptive statistics were tabulated for demographic data, and to identify incorrect/missing entries. Exploratory factor analysis was used to test construct validity [20] of the attitudinal statements (Sect. 3 of CMUQ) and to determine the factor structure. Some items showed significant skewness in differing and these items were corrected by log transformation. Following this, all items were standardized using Systat Software 11 [21]. Examination of the correlation matrix revealed that all correlations were significant at the 0.01 level (correlations [ 0.30) and the KaiserMeyer-Olkin (KMO) measure of sampling adequacy was 0.734, exceeding the value 0.6 recommended by Kaiser [22], thus adequate for factor analysis. Principal Component Analysis (PCA) was the method of extraction used as it yielded a parsimonious factor structure and also allowed the extraction of maximum variance from the data set with each component [23]. PCA was used with Varimax orthogonal rotation to maximize the variance of factor loadings by making high loadings higher and low ones lower for each factor [23]. The ‘‘Eigenvalue greater than 1’’ rule, visual inspection of the Scree Plot, and the number of items loading on the factor were all used to determine how many factors to retain [24]. Internal consistency of items were measured using Cronbach’s alpha [20] Cronbach’s alpha coefficients less than 0.5 are considered unacceptable [25]. Prior to conducting the Focus groups were conducted to allow face validity of the CMUQ to be established [20, 26], and to elaborate and enrich quantitative data. Focus group participants were recruited in the same manner as for the questionnaire. Focus group facilitation was carried out by an independent research colleague trained in group facilitation. Focus group participants were reimbursed for traveling costs to the venue with a $20 voucher. In the planning of focus groups, it was decided that there would be several focus groups with 4–8 participants in each group, with the intent of reaching data saturation. Focus group discussions were audio-recorded. Focus groups were carried out in October 2007 at the Faculty of Pharmacy, University of Sydney. Focus group participants were asked to comment on the questionnaires’ appearance and provide advice on ideas for improvement [26]. In addition, they discussed issues they faced and attitudes they had, regarding medicating their children. Following transcription, data were analyzed into thematic frameworks. Two researchers were involved in the development of the coding frame independently, which was then compared to ensure inter-coder reliability. Approval for the study was granted from the University of Sydney’s Human Research Ethics Committee (Ref 9980). Results Quantitaive Respondents Of the 375 questionnaires distributed, 153 were returned, yielding a 41% response rate. The survey revealed that 52% of children about whom medicine use was reported by parents/primary care givers were girls. The mean age of children for whom parents/primary caregivers reported on medicine use was 6 years (standard deviation = 4.3). The majority of respondents (85%) were mothers and nearly three-quarters had tertiary qualifications. The sample was of middle- to high-socioeconomic status as determined from net annual incomes. The majority of participants indicated that their children’s health status was good (Table 1). However, there were substantial missing data (13%, n = 20/153) 123 84 Pharm World Sci (2010) 32:81–89 Table 1 Participants’ rating of child’s health status at the time of survey (n = 133) Health status of children Frequency (%) Good 85 (63.9) Fairly good 36 (27.1) Moderate 10 (7.5) Fairly poor 2 (1.5) Total 133 Missing 20 Total 153 Validity and reliability of the CMUQ The factor analysis resulted in a parsimonious 4 factor solution explaining 50% of total variance (Table 2). All factors had a Cronbach’s Alpha greater than or near 0.7, thus the four factor solution was seen as reliable (Table 3). These factors included; (1) the negative effects of medicines, (2) the necessity of medicines in treating illness, (3) the body’s capacity in treating illness, and (4) the effectiveness of OTC medicines. Use of medicines Parents and caregivers sampled, recorded that one-fifth of the children were using prescription medicines (n = 31/ 153) and 44% (n = 67/151) had used OTC medicines, which included vitamin supplements. Table 4 lists commonly used medicines and the conditions for which they are used. Harm resulting from the use of medicines was reported by 9% of participants (n = 13/152). Adverse effects of antibiotics and ibuprofen were the two main identified 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 Long-term use of analgesics reduces pain threshold Medicines are unnatural to human body 0.68 -0.13 0.62 0.14 0.08 -0.14 0.02 -0.04 0.21 0.06 0.25 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 I usually give analgesics to the child less than is recommended in the instructions 0.47 0.08 0.20 -0.19 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 Doctors prescribe antibiotics to children too easily 0.42 0.21 0.01 -0.10 0.12 0.09 2 Medicines are necessary in treating illness -0.03 0.67 0.25 I try to avoid giving medicines to my child Medicines are necessary in treating illnesses 0.18 0.53 0.07 -0.09 Prescription medicines are safe 0.11 0.70 -0.30 Medicine that a doctor has prescribed for the child are necessary Prescription medicines are effective 0.15 -0.02 0.08 0.25 0.71 -0.07 -0.03 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 without medicines lowered artificially with medicines The child needs to learn how to bear the pain 0.15 0.05 0.74 0.22 0.24 0.01 0.76 0.01 4 OTC medicines are efficacious Cross-loading items -0.03 0.12 0.37 0.73 OTC medicines are effective I take care of my child’s little ailments by using OTCs 0.08 0.03 0.11 0.78 I try to take care of my child’s ailments by some other means than using medicines 0.51 0.28 0.46 -0.27 I take my child to see a doctor only when other ways of treatment do not help 0.31 0.25 0.25 -0.49 OTC medicines are safe 0.14 0.51 -0.26 Bold italic values show the factor loadings 123 0.49 Pharm World Sci (2010) 32:81–89 85 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 0.628 12 2.5 0.738 9 1.8 0.663 7 1.5 Negative effects of medicines 2 Medicines are necessary in treating illness 3 Body is capable of dealing with illness without medicines 4 OTC medicines are efficacious Table 4 Common medical conditions and medicines used by children in survey a Medications were classified according to the ATC/DDD Index 2007 http://www.whocc.no/atcddd/ b Percentages are not mutually exclusive, as some children suffer more than 1 condition Medication classa Conditions Percent (%)b 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) Fever Acetaminophen Cold and cough Cough and cold preparation Eczema Plain and weak corticosteroids 6 Allergies Antihistamines 5 Vitamin supplement Omega-3-triglycerides 5 Respondents indicated that doctors were the most used source of medicines information (90%), followed by pharmacists (74%), and family/friends (36%). Doctors and pharmacists were perceived as the most reliable provider of medicines information, where 91% of participants (n = 137/151) perceived doctors to be reliable and 71% of Fig. 1 Age perceived satisfactory by participants (n = 148) for independent use of medicines in children 10 9 participants saw pharmacists (n = 102/145) to be reliable. The internet was also mentioned by participants as an important source (after family/friends). Seventy-two percent of parents indicated that the appropriate age for independent use of medicines was clustered between the 12–17 years age bracket (Fig. 1). 40 Frequency 30 20 10 0 less than 4 - 5 4 years years 6-7 years 8-9 years 10 - 11 12 - 13 14 - 15 16 - 17 years years years years 18 or older no opinion age for independent medicine use 123 86 Pharm World Sci (2010) 32:81–89 Qualititaive believed OTC medicines should be first-line treatment for children’s illness Participants Fourteen participants were recruited into focus groups. Three focus groups were conducted (n = 4, 6, 4) with saturation of themes apparent after the third group discussion. Various themes regarding medicine use in children were raised by participants in focus groups, which were similar to the solutions obtained in the factor analysis. There were 5 distinct themes that emerged, as discussed below; 1. Concerns about negative effects of medicines Negative aspects of medicines use in children were expressed by participants. Comments ranged from expressing dangers in overusing medicines to fears of adverse effects of medicines; ‘‘Children’s medicines are very difficult to know when and how to use them effectively. Overall I feel that OTC medicines and prescription medicines are recommended too easily and often abused’’ (Focus Group3, Participant #1) ‘‘It is a concern for me when my child uses Panadol (acetaminophen) for one whole week… is it okay if the child uses it for more than 48 hours? Could it be affecting his liver?’’ (Focus Group1, Participant #1) 2. Medicines are useful, necessary and safe in treating illnesses in children It was observed that generational use of medicines in the family played a role in increasing the perception of safety and effectiveness of medicines; ‘‘Some parents use medicines because their parents used it all the time… so they say ‘ah yeah that’s alright’’’ (Focus Group 1, Participant #2) 3. The body’s natural processes are sufficient in fighting illness Some participants indicated that some conditions need not be treated with medicines. Rather, the body’s natural mechanism is sufficient in overcoming illness; ‘‘I have found leaving fevers untreated to be the most effective way for her to get better, quickly and naturally’’ (Focus Group1, Participant #4) 4. OTC medicines are effective and useful in treating illness Many participants reported usage of various OTC products for treating minor ailments in children. Some also 123 ‘‘With the three year old, she… couldn’t get the mucus out of her nose. I just settled her down with the Demazin’’ (chlorpheniramine maleate and phenylephrine hydrochloride) (Focus Group2, Participant #2) 5. Perception of alternative medicines use in children Participants had mixed responses toward using alternative medicines in children. Some advocated their use due to personal experience; ‘‘I’d rather give herbal. My 14 year old was born with eczema… and they started him on prednisolone but these medicines only block the symptoms. I needed to deal with his immune system so now he goes natural and hasn’t had an episode in 2 years’’ (Focus Group2, Participant #3) However others were concerned of the adverse effects and unknown safety profile of alternative medicines; [with herbal medicines] ‘‘I don’t want them to have a major allergic reaction’’ (Focus Group2, Participant #1) As opposed to the questionnaire response, focus group discussions suggested that age was not a barrier to children’s independent use of medicines. Rather, issues such as the child’s maturity and the type of medicine used were greater influences of children’s independent use of medicines. Focus group participants suggested that children exhibited maturity to undertake responsibility at different ages, and therefore ‘age’ itself was not a determinant in self administration of medicines. Further some participants suggested that some chronic conditions necessitated medicine use, children used to taking these medicines for long periods of time were quite capable of self administering medicines, whereas a medicine taken on an acute basis posed more problems. Participants in focus groups also assessed the face validity of the CMUQ. The majority of participants found the CMUQ straightforward, however, some commented on the length of the questionnaire and some items were difficult to answer due to the ambiguity of wording and the lack of options in the answers. Discussion The present study was conducted to examine the validity and reliability of the translated English CMUQ within an Australian sample and to provide recommendations for a Pharm World Sci (2010) 32:81–89 future national study. We also explored the attitudes of Australian parents/caregivers towards medicines use in children. This is the first instrument targeting parents and primary caregivers that maps the use of and attitudes towards medicines in children which has undergone initial psychometric testing. Reliability and validity are two important qualities that help establish the credibility of findings measured by an instrument [27]. The 4 Factor analysis solution obtained accounted for 50% of the variance and factors demonstrated good internal consistency. Further, the factor structure resonated well with themes discussed in focus groups. The factor solution contained 3 items that crossloaded, which generally should be removed [28], however these were maintained in the final version of the CMUQ for the sake of comparability with the Finnish data. Focus group discussions also supported the overall face validity of the CMUQ. Following up on specific comments from the focus group participants, the questionnaire needs some minor modifications. For example, the development of items regarding perceptions about alternative medicines’ use in children and creating more ‘choices’ for respondents selection when answering questions about attitudes to medicine. The format of the questionnaire too needs some adjustment, as some questions appeared to have gone repeatedly unanswered because of the way they were presented. There were substantial missing answers for questions 5 and 6 which relate to respondents’ perception of the child’s current health status. It is postulated that this was due to the layout of the question (top right corner) which made it easy for participants to overlook. Nonetheless data collated through both the quantitative and qualitative analyses above suggest that the CMUQ has potential for use in large population studies including cross-sectional data comparisons with several nations. Although the method of sampling used in this pilot study was not aimed at yielding a representative sample of the population, results show that the sample obtained had similarities to published population data [1, 4, 29–31]. The majority of CMUQ participants indicated that their child was healthy, which was similar to previous findings showing that 97% of children were reported to be in ‘good’ 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 [4]. The most common illnesses for which children were treated by GPs in this study were asthma, upper respiratory tract infections (URTIs), allergies and conjunctivitis, similar to previous reports [1]. Despite evidence of the limited effects of antibiotics in conditions such as URTIs, sinusitis and otitis media [32], these appeared to be commonly used and interestingly, the majority of harm reported in the survey was due to antibiotic adverse effects. This 87 highlights that further investigations of these issues in populations studies is imperative to improve how medicines are used safely and effectively in children. Participants noted that medicines information were derived from many areas, including the GP, relatives/ friends, pharmacists and the internet. In previous studies the main sources of medicines information have been nominated to be physicians, family and friends[30]; more recent studies additionally identify the pharmacist and the internet as other sources of information [31, 33]. The CMUQ showed that participants use the internet and the pharmacist often, reflecting this shifting trend in sources of medicines information, signifying emerging roles for the pharmacist. It may, however be that respondent selection methods (staff at the Faculty of Pharmacy, and their family/friends/acquaintances) biased these results. Participants in focus groups and the survey discussed issues regarding the independent use of medicines in children. The majority of participants were comfortable in allowing children to take medicines independently at the age of twelve onwards, however, it seems that the child’s personality and maturity plays a strong role in this independence. Interestingly, children seem to hold similar beliefs. In a study by Chambers et al. [10], Canadian children reported that they began to self-administer medicines for pain when they were approximately 11 or 12 years old. A Finnish study reported that children aged 11–12 years believed they could self-medicate in certain circumstances. Older children in the study (16–17 years) indicated that the individuals’ personal characteristics, such as skills [34] need to be taken into account as well as age. Little has been reported in the literature regarding negative perceptions of medicines by parents and their perception of the use of alternative medicines in children. Many focus group participants erroneously perceived OTC medicines to be safe and efficacious. This view correlated with previous studies by Simon and Birchley, which showed that OTC medicines’ were believed to be safe [5, 35]. However, it is known that deaths have occurred in young children due to overdosing of common products such as dextromethorphan, pseudoephedrine, and acetaminophen [36]. Study limitations Respondents in the study were conveniently selected; hence may not be considered as a representative sample. Within this sample, socio-economic variables such as literacy levels and household income may be higher than the Australian average, therefore the CMUQ’s psychometric properties may need to be re-evaluated in a larger, more representative sample. 123 88 Pharm World Sci (2010) 32:81–89 Whilst the development of the Finnish version of the CMUQ had been developed based on prior qualitative research, this was not the case in this study. However, feedback from the respondents can be used to further refine the CMUQ for greater relevance to the Australian parent/ caregiver populace. Similarly, participants in the focus groups were conveniently selected and variations in age, gender, education, number of children and cultural backgrounds may impact on their views. Data were not collected on the demographics of the focus group participants so there is limited understanding of the factors that influenced their opinions. Further validity research could also explore caregiver’s opinions of the CMUQ’s results. Conclusion The results of this study show that the English version of CMUQ is a valid and reliable tool to gauge the extent of issues in the use of medicines in Australian children. Although minor modifications should be made this instrument will be valuable in informing the development of medicines information for this cohort in the future. Inappropriate use of medicines in children within the sample of parents/caregivers highlights the need for further investigation, quantification of issues, and the design, implementation and evaluation of educational interventions to ensure the quality use of medicines in children. Acknowledgements The authors would like to acknowledge the International Pharmaceutical Federation (FIP) for presenting the ‘‘Young Scientists award for professional innovation’’ (1000 Euros) to Dr Moles, which has made the collaborative work with the Finnish authors possible. 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