DOI: 10.1111/j.1464-5491.2005.01778.x Measuring beliefs about taking hypoglycaemic medication among people with Type 2 diabetes Medication Original Article article beliefs among Oxford, UK Diabetic DME Blackwell 0742-3071 22 Medicine Publishing, Ltd.people with Type 2 diabetes A. Farmer et al. 2005 A. Farmer, A.-L. Kinmonth* and S. Sutton* Abstract Department of Primary Health Care, University of Oxford, Oxford and *General Practice and Primary Care Research Unit, University of Cambridge, Institute of Public Health, Cambridge, UK Accepted 22 May 2005 Final Acceptance 27 August 2005 Aims Identifying patients’ beliefs about taking medication can inform interventions to support medication taking, and their evaluation. We set out to establish the range of these beliefs, and measure the frequency of commonly held beliefs and their correlation with intention to take medication and self-reported medication adherence. Methods An exploratory survey among Type 2 diabetic patients aged 40 years or older, registered in general practice, used a questionnaire measuring a range of plausible beliefs about taking and intention to take medication developed from interviews where belief elicitation was guided by the Theory of Planned Behaviour. The Medication Adherence Report Schedule was used as a self-report adherence measure. Results Questionnaires were returned by 121 (61.7%) people. The majority strongly agreed with statements about the benefits of taking medication. Negative beliefs that taking medication would ‘cause unpleasant side effects’ and ‘lead to weight gain’ were held by 24.1 and 13.9% of people, respectively. Beliefs about benefit were strongly associated with intention to take medication regularly. Two beliefs were associated with reduced medication adherence: ‘changes to my daily routine would make it more difficult to take my diabetes medicines regularly’ (P < 0.001), and ‘if I were to take my diabetes medicines regularly this would lead to my gaining weight’ (P < 0.05). Conclusions Use of a theoretical model to elicit and identify common beliefs about taking medication regularly underscores the importance of exploring weight-gain concerns and how to keep taking tablets when routines change. Beliefs associated with intention and taking medication will inform intervention development, implementation and evaluation in randomized controlled studies. Diabet. Med. 23, 265–270 (2006) Keywords adherence, beliefs, medication compliance, Type 2 diabetes Abbreviations IQR, interquartile range; MARS, Medication Adherence Report Scale; MDQ, Medicines for Diabetes Questionnaire; TPB, theory of planned behaviour Background Intensive control of blood glucose and associated cardiovascular risk factors offers the possibility of reducing the disease burden in people with Type 2 diabetes [1–3]. A major problem Correspondence to: Dr Andrew Farmer, Department of Primary Health Care, University of Oxford, Old Road Campus, Headington, Oxford OX3 7LF, UK. E-mail: [email protected] © 2005 Diabetes UK. Diabetic Medicine, 23, 265–270 in translating this into improved outcomes is non-adherence to medication. Across a wide range of conditions adherence may be as low as 50% [4]. In a Tayside study, less than one-third of patients with diabetes were dispensed their single hypoglycaemic drug sufficiently regularly to cover 90% of treatment days in 1 year [5]. Intensive treatment regimens will not improve outcomes if prescribed medications are not taken regularly. Although a number of interventions have a limited impact on adherence, for example simplified dosage regimens, self 265 266 Medication beliefs among people with Type 2 diabetes • A. Farmer et al. monitoring of medication taking, and prompts and reminders [6], there is limited understanding of what intervention elements are effective. Therefore, success in transferring interventions between different settings is limited. Interventions with the most impact appear to be those using behavioural modification techniques and building on a participant’s own motivations within a psychological framework [7]. Qualitative studies have confirmed that people hold a range of beliefs about their medication [8]. A range of psychological models have been used to identify beliefs that may be related to, and can be used to explain variations in, medication taking [9]. For example, the Health Belief Model was used to guide work that showed that beliefs about ‘adverse consequences following failure to take medication’ were associated with improved adherence [10]. Other studies have used an illness representation or a self-efficacy approach [11,12]. An approach widely used in other studies of relationships between beliefs, intentions and behaviour is the theory of planned behaviour (TPB) [13,14]. We adopted this model because of the tightly specified procedures for eliciting beliefs and structuring questionnaires [15]; the focus of the model on beliefs about a target behaviour (in this case taking medication), rather than beliefs about a disease or treatment more generally; and evidence from a large number of studies that the model has predictive validity, explaining between 35 and 50% of the variance in intentions and between 26 and 35% of the variance in behaviour across a range of different target behaviours [16]. The TPB specifies three sets of beliefs that influence intentions and behaviour: behavioural beliefs, normative beliefs, and control beliefs. This approach has a strong face validity in the context of medication taking among people with Type 2 diabetes: behavioural beliefs are beliefs about the personal advantages and disadvantages of taking medication (e.g. ‘taking my medication regularly would make me feel better’), normative beliefs are beliefs about the views of significant others (e.g. ‘my wife would approve of me taking my medication regularly’), and control beliefs are beliefs about the factors that may make it easier or more difficult to take medication regularly (e.g. ‘changes to my daily routine would make it more difficult to take my medication regularly’). This paper describes the use of structured interviews to elicit specific, potentially influential beliefs about taking diabetes medications from people with Type 2 diabetes recruited from primary care within the framework of the TPB. A cross sectional survey was then used to establish (i) the frequency with which the identified beliefs were held, and (ii) the extent to which these beliefs were correlated with intention to take medication and self-reported adherence to medication. Participants and setting Aylesbury Vale Research Ethics Committee approved the study. Type 2 diabetic patients taking oral hypoglycaemic medication, but not using insulin, aged 40 years or older and not excluded by their general practitioner on the grounds of frailty or inability to complete the questionnaire, were eligible. The majority received care in the practice, with a minority attending hospital diabetes clinics. Practice sizes ranged from 8000 to 15 000, with one serving an urban population, and the others serving a mixed urban and rural population. Two practices had an established nurse-run diabetes service. Of 697 people identified with diabetes in the three practices, we identified 261 (37.4%) who fulfilled the inclusion criteria. We randomly selected 200, subsequently excluding four who had died or developed a serious illness after their initial selection, and sent 196 letters. Of those patients contacted, 121 (61.7%) returned a completed questionnaire. Conduct of the study Eligible patients were identified from the practice computer. Each patient was sent a letter from their general practitioner explaining the purpose of the study and enclosing a questionnaire, a list of oral hypoglycaemic medication to assist in identifying the medications that were being asked about, a consent form and a Freepost return envelope. Reminders were sent by the practices at 3 and 6 weeks. Following return of the consent form, the practice-held medical records were reviewed to identify the date of diagnosis of diabetes. Measures—self-reported measure of behaviour The Medication Adherence Report Scale (MARS) was developed for measurement of adherence to a wide range of medication regimens [17]. The five statements comprising the scale are: ‘I forget to take my diabetes medicines’, ‘I alter the dose of my diabetes medicines’, ‘I stop taking my diabetes medicine for a while’, ‘I decide to miss out a dose of my diabetes medicine’, ‘I take less diabetes medicine than instructed’. The MARS was scored in accordance with standard practice with a maximum score of 25 by summing the score from the five questions, each with a five-point response scale (from ‘always true’ to ‘never’) [17]. In previous pilot work for this study, we observed a median score of 24 [interquartile range (IQR) 23–25] using this measure in a similar population. Medicines for Diabetes Questionnaire Development Patients and methods Design Beliefs, intentions and self-reported behaviour were measured with a self-completion questionnaire sent by post to patients registered with three Buckinghamshire general practices. A series of brief interviews to identify salient beliefs about taking medication for diabetes were carried out by a research nurse. Thirty-nine non-housebound patients with non-insulinrequiring Type 2 diabetes were randomly selected from the diabetes register of a Buckinghamshire practice and sent a written invitation to be interviewed. Beliefs about taking medication were elicited from the participants using the standard © 2005 Diabetes UK. Diabetic Medicine, 23, 265–270 Original article procedures recommended for TPB studies [14]. In brief, a structured interview ‘script’ was used to ensure that the preamble was the same for each participant. All salient beliefs were first elicited and each belief subsequently explored to minimize variation between interviews. The interviews were initially taped to enable discussion with and feedback to the nurse on the approach used. Behavioural beliefs were identified by asking questions about the perceived advantages and disadvantages of the behaviour of taking medicines for diabetes, normative beliefs were identified by questions about who might approve or disapprove of the behaviour, and control beliefs were identified by questions about what might make it easier or more difficult to take medication regularly. Thirty-three interviews were carried out, of which the first nine were used, together with the results of a series of 13 preliminary interviews, to develop a coding system for the subsequent interviews. In the 24 subsequent interviews, the following additional beliefs were identified: ‘it would keep my diabetes under control’ and ‘putting my tablets out in a box would make it easier’. Beliefs that occurred in 20% or more of the structured interviews were carried forward into the final questionnaire. Final questionnaire The Medicines for Diabetes Questionnaire (MDQ) comprised the beliefs identified above with a response scale of strongly disagree (1) to strongly agree (5). Two additional questions were included to assess behavioural intention using standard phrasing [15]: ‘It is likely I will take my diabetes medicines regularly’ and ‘I intend to take my diabetes medicines regularly’. The questionnaire was assessed for readability and clarity in a pilot of 10 patients. All the items in the MDQ were scored on a five-point scale from strongly disagree (1) to strongly agree (5). The two questions measuring intention were summed to create a measure of intention to take medication regularly with a range from −4 to +4. Analysis Responses to questionnaires and information about duration of diabetes were double entered onto computer, retaining only the study number as a patient identifier. The percentage of the study population agreeing or strongly agreeing with each of the belief items is reported. Associations between measures of intention, adherence and beliefs were examined with a Spearman’s rank correlation coefficient calculated using the full range of responses to the categorical scales. Differences in beliefs between groups were evaluated with a Mann–Whitney U-test. Analysis was carried out using Stata 7.0 (Stata Corporation, College Station, TX, USA, Release 7.0, 2001). Results Sample characteristics The mean age of respondents was 66 (interquartile range 57– 75) years, and 52.1% were male; 19.5% were living alone, © 2005 Diabetes UK. Diabetic Medicine, 23, 265–270 267 66.1% lived with a partner and 14.2% lived with their family or in other circumstances. The median duration of diabetes was 6 years (IQR 1.7–8.2 years), and the median total number of tablets taken per day was six (3–9). Beliefs about taking medication The vast majority of respondents agreed with statements about the positive behavioural beliefs of taking medication. Over 85% of people agreed that taking their medication regularly would ‘help them to stay well’, ‘reduce the chances of developing complications’, ‘keep their blood sugar under control’ and ‘keep their diabetes under control’ (Table 1). Beliefs about negative behavioural beliefs such as ‘would cause me unpleasant side effects’ and ‘would lead to gaining weight’ were held by a minority of people (32.8 and 13.9%, respectively). The belief that taking diabetes medication regularly would help them avoid having to inject insulin was held by 86.4% of people. The majority of respondents also agreed with statements about the positive normative beliefs associated with taking medication. They agreed that their doctor or nurse (99.1%), family (87.8%) and partner (75.7%) would approve of their taking medication. There was a wider range of response to the control beliefs. Of respondents, 78.9% agreed that keeping to a regular routine would make it easier to take medication regularly, but only 21.9% felt that changes to their routine would make taking medication regularly more difficult. It was thought by 56.9% of people that putting out their medication in a box would make it easier to take it regularly. A majority of patients (69.6%) also felt that having a regular review with their doctor or nurse about their medication would be helpful. The distribution of strength of individual beliefs about side effects of medication did not differ between people taking a sulphonylurea or metformin as medication. There was no significant difference in distribution of the strength of beliefs about ‘gaining weight’ between men and women (Z = 1.7, P < 0.08). Gender differences did not explain association between adherence and beliefs about gaining weight with medication. Intention to take medication and self-reported medication adherence The median score for intention to take medication regularly was 3 (IQR 2– 4). Of participants, 43.3% strongly agreed with both statements about intention to take medication regularly, while only four people strongly disagreed. Responses to the MARS measure of adherence were skewed with a median score of 25 and an interquartile range of 24 –25; 43.8% scored 25, 39.5% scored 24 and 16.7% scored 23 or less. The majority of people with a submaximal MARS score indicated that it was ‘rarely true’ or ‘sometimes true’, rather than ‘always’ or ‘often’ true that they forgot to take their medication. The 268 Medication beliefs among people with Type 2 diabetes • A. Farmer et al. Table 1 Proportion of respondents endorsing elicited beliefs about taking diabetes medication regularly, and correlations between each of the items with intention to take medication regularly and self-reported medication adherence Variable Behavioural beliefs If I were to take my diabetes medicines regularly … it would help me to stay well it would reduce my chances of developing complications from diabetes it would keep my blood sugar under control it would keep my diabetes under control it would help me avoid having to inject insulin it would cause me unpleasant side effects (e.g. feeling sick or bloated) this would lead to my gaining weight Normative beliefs My doctor or nurse would approve of me taking my diabetes medicines regularly Members of my family or close relatives would approve of me taking my diabetes medicines regularly My wife/husband/partner would approve of me taking my diabetes medicines regularly Control beliefs Changes to my daily routine would make it more difficult for me to take my diabetes medicines regularly Putting out my tablets in a box would make it easier for me to take my diabetes medicines regularly Having a regular review with the doctor or nurse would make it easier for me to take my diabetes medicines regularly Keeping to a regular routine and being disciplined would make it easier for me to take my diabetes medicines regularly n† % (95% CI) Intention r Adherence‡ r 108/117 108/118 108/118 101/115 102/118 38/116 16/115 92.3 (86.0–95.9) 91.5 (85.1–95.3) 91.5 (85.1–95.3) 87.8 (80.6–92.6) 86.4 (79.1–91.5) 32.8 (24.9–41.8) 13.9 (8.8–21.4) 0.59** 0.60** 0.49** 0.62** 0.51** −0.03 −0.12 0.09 0.04 0.02 0.10 0.11 −0.08 −0.25* 115/116 101/115 99.1 (95.3–99.9) 87.8 (80.6–92.6) 0.58** 0.58** −0.07 0.12 87/115 75.7 (67.1–82.6) 0.40** −0.00 25/114 21.9 (15.3–30.4) −0.18 66/116 56.9 (47.8–65.6) 0.04 −0.05 80/115 69.6 (60.6–72.2) 0.13 −0.13 90/114 78.9 (70.6–85.4) 0.25** −0.33** 0.02 *P < 0.01; **P < 0.001. †Number of people agreeing or strongly agreeing with statement out of those responding to question. ‡Spearman’s r uses categorical data from 5-point scale. correlation between the intention to take medication measure and the MARS was 0.29 (P < 0.01). regularly would lead to weight gain was also associated with a lower MARS score (P < 0.05). Correlations between beliefs and intentions Discussion Positive behavioural beliefs about taking diabetes medications were strongly associated with intention to take medication (Table 1) (all P < 0.001). Negative behavioural beliefs (e.g. ‘it would cause me unpleasant side effects’ or ‘it would lead to my gaining weight’) were not associated with intention to take medication. Normative beliefs were associated with intention to take medication regularly (P < 0.001). The control belief ‘keeping to a regular routine would make it easier to take medication regularly’ was associated with intention (P < 0.001), but there was no association for ‘putting out my tablets in a box would make it easier’ or ‘changes to my regular routine would make it more difficult’. We have used a standardized procedure to identify beliefs about taking medication that appear to be commonly held by people with Type 2 diabetes. Many of the beliefs supportive of taking medication were held by the majority of respondents. Negative beliefs about gaining weight and unpleasant side effects were held by a significant minority. Intention to take medication was strongly associated with positive beliefs about clinical benefits of taking medication, but not with negative beliefs. Beliefs about weight gain and changes to daily routine were associated with lower reported medication adherence. The results underscore the importance to patients of regular medication reviews with a practitioner. They identify the potential importance of exploring concerns about weight gain, how to keep taking tablets regularly when routines change, and any links made between adherence and avoiding insulin injections. This study was carried out in a setting and patient group relevant to clinical practice and provided the information about belief patterns in this population to inform an intervention, and measures of its effect, for evaluation in a clinical trial Correlations between beliefs and adherence Two beliefs were associated with a reduction in self-reported medication adherence. There was a significant association with the belief that ‘changes to my daily routine would make it more difficult for me to take my diabetes medication regularly (P < 0.001). The belief that taking diabetes medicine © 2005 Diabetes UK. Diabetic Medicine, 23, 265–270 Original article 269 of simple approaches to support medication adherence among patients with diabetes in primary care. of the drug, they are limited to assessing behaviour over only a short period. Potential underestimation of associations Potential limitations of the underlying theoretical model There are a number of reasons why we may have mis-estimated or underestimated the strength of relationships between beliefs, intentions, and behaviour. First, we may not have identified commonly held beliefs among non-adherent groups. However, few of the people approached declined to take part in the initial interviews, and so the range of beliefs included in the MDQ is likely to represent those held in the wider population, although the extent to which the same range of beliefs are shared by people from other cultural groups remains to be determined. Secondly, responders may over-represent adherent groups. The majority of those approached in the survey also responded, but the extent to which these participants were biased towards people taking their medication is unclear. However, our study population does include people reporting less than optimal adherence, and provides useful information about their belief patterns. Thirdly, the questionnaires measuring beliefs and behaviour might have used wording that matched more closely. In accordance with Ajzen and Fishbein’s [14] recommendations, the measures of beliefs and intentions both referred specifically to the same target behaviour (taking my diabetes medicines regularly) to maximize the associations. However, the measure of behaviour (the MARS questionnaire) asked about ‘not taking’ medication rather than ‘taking’ medication and this may have reduced the association between beliefs and behaviour. Fourthly, self-report measures of behaviour may underestimate non-adherence to medications, through a desire to present oneself in a favourable light. Nevertheless, the measure we used offers a well-tested ordinal scale to compare relative adherence [18,19]. The desire to present oneself in a favourable light and preserve self-esteem through making the socially desirable response of reporting high adherence, good intentions and acceptable beliefs may lead to false positive associations between beliefs and measures of intention and adherence [20]. However, wide variation in correlations between different beliefs and intention, and absence of correlation between many measures of belief and the MARS suggests that this was not an overriding effect. The postal questionnaire, confidentiality and appeal for honest responses were intended to minimize these biases. Alternative measures to overcome the disadvantages of self report as an outcome measure would include use of actual measures of behaviour or medication levels. Electronic medication containers can be used to record each time the lid is removed. However, knowledge that behaviour is being observed may lead to alterations in taking medication. Neither does removal of the lid of the container indicate that the medication has been taken. Another potential direct measure of adherence is medication levels, but, depending on the half-life The TPB holds that intentions should be a strong predictor of behaviour, at least for behaviours that are under the person’s control. However, we found that some beliefs were associated with intention but not with reported behaviour, and, conversely, that some beliefs were associated with behaviour but not with intention. Participants’ beliefs about medication leading to weight gain were not associated with intention to take medication, but were associated with reported adherence to medication. It is possible, therefore, that, despite having an intention to take medication, when faced with the behaviour, concerns about weight gain lead to reduced medication adherence. Work among women with Type 1 diabetes has documented concerns about weight gain with insulin injection omission. [21]. A cross-sectional survey suggested that up to one-third of women omitted insulin doses and that this was associated with disordered eating patterns and psychological distress. However, we have not identified previous quantitative studies showing similar findings among people with Type 2 diabetes taking oral hypoglycaemic medication. Similarly, the belief that ‘changes to my daily routine would make it more difficult to take medication’ correlated with reported adherence but not with intention. This pattern could arise from those reporting having taken their medication regularly in the past perceiving future changes in routine as a potential problem. Thus, apparent mismatch between our findings and the underlying theory may have arisen from use of a cross-sectional study design. A prospective study will be required to see to what extent intention to take medication regularly predicts subsequent medication taking. The beliefs elicited in our study using the standardized methods of the TPB also encompass areas of concern identified from previous qualitative work and from other psychological approaches. For example, the specific concerns about the harms and benefits of medication found in this study reflect the general concerns identified using a ‘treatment representations’ approach [18,22]. Issues of personal control have also been observed in cross-sectional studies of adherence to insulin treatment [23]. Our findings are also consistent with previous work using the TPB to examine medication adherence [24,25]. The data from this study does not indicate what type of intervention might be effective in supporting medication adherence. However, the data does inform the content of the intervention. A framework where provision of tailored information is used to reinforce identified positive beliefs and problem solving used to address identified negative beliefs would be a potential way forward. Provision of tailored information about issues of weight gain and side effects is likely to be particularly important. Exploratory studies will be required to develop and evaluate potential effectiveness of such an intervention. © 2005 Diabetes UK. Diabetic Medicine, 23, 265–270 270 Medication beliefs among people with Type 2 diabetes • A. Farmer et al. Conclusions It is widely accepted that people’s beliefs about medication should be elicited before offering them tailored information or help [26]. We have elicited a range of beliefs about taking medication, several of which are quite commonly held. Communicating more clearly with patients and creating treatment plans incorporating a patient perspective can usefully be informed by these commonly held beliefs [27]. Concerns about effects of medication and difficulties with taking medication have both been shown to predict intention and behaviour [24,25]. We have used a predictive theoretical model to elicit and identify common beliefs about taking medication regularly. The model has captured beliefs that appear to be important in relation to both intention to take medication and in self-reported behaviour. However, further work is required to explain the discrepancy between the beliefs that correlate with intention and those that correlate with self-reported medication adherence. Beliefs influencing intention to take medicine will be used to inform development and implementation of an intervention as part of a programme of research into medication adherence in primary care. Interventions to support adherence focusing on these beliefs need to be evaluated in randomized controlled studies. 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