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Patient-reported side effects, concerns and adherence to corticosteroid treatment for asthma, and comparison with physician estimates of side-effect prevalence: a UK-wide, cross-sectional study

Patient-reported side effects, concerns and adherence to corticosteroid treatment for asthma, and... www.nature.com/npjpcrm All rights reserved 2055-1010/15 ARTICLE OPEN Patient-reported side effects, concerns and adherence to corticosteroid treatment for asthma, and comparison with physician estimates of side-effect prevalence: a UK-wide, cross-sectional study 1 2 2 3 3 1 Vanessa Cooper , Leanne Metcalf , Jenny Versnel , Jane Upton , Samantha Walker and Rob Horne BACKGROUND: Non-adherence to corticosteroid treatment has been shown to reduce treatment efficacy, thus compromising asthma control. AIMS: To examine the experiences of treatment side effects, treatment concerns and adherence to inhaled (ICS) and oral corticosteroids (OCS) among people with asthma and to identify the degree of concordance between clinician estimates of side effects and the prevalence reported by patients. METHODS: Asthma UK members were sent validated questionnaires assessing treatment concerns, experiences of side effects and adherence. Questionnaires measuring clinicians’ estimates of the prevalence of corticosteroid side effects were completed online. RESULTS: Completed questionnaires were returned by 1,524 people taking ICS, 233 taking OCS and 244 clinicians (67% of clinicians were primary care nurses). Among people with asthma, 64% of those taking ICS and 88% of those taking OCS reported ⩾ 1 side effect. People reporting high adherence to ICS (t = − 3.09, Po0.005) and those reporting low adherence to OCS (t = 1.86, Po0.05; one-tailed test) reported more side effects. There was a disparity between clinicians’ estimates of the frequency of side effects and the frequency reported by people with asthma: e.g., although 46% of people taking ICS reported sore throat, clinicians estimated that this figure would be 10%. Patients who reported side effects had stronger concerns about both ICS (r = 0.46, Po0.0001) and OCS (r = 0.50, Po0.0001). Concerns about corticosteroids were associated with low adherence to ICS (t = 6.90, Po0.0001) and OCS (t = 1.71; Po0.05; one-tailed test). CONCLUSIONS: An unexpectedly large proportion of people with asthma experienced side effects and had strong concerns about their treatment, which compromised adherence. These findings have implications for the design of interventions to optimise asthma control through improved adherence. npj Primary Care Respiratory Medicine (2015) 25, 15026; doi:10.1038/npjpcrm.2015.26; published online 9 July 2015 INTRODUCTION individual’s interpretation of symptom experiences. Previous research has shown that treatment concerns are associated with Inhaled corticosteroids (ICS) are the anti-inflammatory drug of 1,2 non-adherence to treatment for a range of conditions including choice for asthma. In cases in which asthma control is not 10,21–25 asthma; however, no previous studies have explored achieved with ICS, oral corticosteroids (OCS) are added. These relationships between experiencing side effects and concerns medicines are remarkably effective when taken as prescribed. about corticosteroids. However, only a minority of adults with asthma achieve good 4–7 Side effects from corticosteroid medicines may go unreported. asthma control. Studies in other clinical areas have identified disconnects between Non-adherence to corticosteroid treatment reduces efficacy, 8,9 patient and clinician beliefs about treatment. We also examined compromising asthma control. Non-adherence is often an intentional decision on the part of the patient, stemming from clinicians estimates of the frequency of corticosteroids side effects they would expect patients to experience, to identify disconnects concerns about corticosteroids, doubts about the need for 10–16 preventative treatment, and experiences of side effects. The between physicians estimates and patient reports. 17,18 The primary aim of this study was to examine the frequency of Common Sense Model proposes that non-adherence stems patient-reported side effects of ICS and OCS among a large sample from a lack of coherence between individuals’ beliefs about their of people with asthma. Secondary aims were to profile patients’ illness, their experience of symptoms and the doctor’s instructions. concerns about ICS and OCS and to examine the impact of Adherence is also influenced by patients’‘common sense’ concerns and side-effect experiences on reported adherence. We evaluations of treatment, particularly how they judge their also examined the estimated frequency of side effects among personal need for treatment relative to their concerns about 19,20 asthma-treating clinicians and identified disconnects between potential adverse effects (the Necessity Concerns Framework). clinician estimates and patient reports. Furthermore, treatment concerns are influenced by the 1 2 3 Centre for Behavioural Medicine, UCL School of Pharmacy, London, UK; Asthma UK, London, UK and Education for Health, London, UK. Correspondence: R Horne (r.horne@ucl.ac.uk) Received 18 December 2014; accepted 3 February 2015 © 2015 Primary Care Respiratory Society UK/Macmillan Publishers Limited Reported side effects to corticosteroid for asthma V Cooper et al MATERIALS AND METHODS took less than instructed. Possible scores ranged from 4 to 20, with higher scores indicating greater adherence. For OCS, an additional question asked Design and sample how often people completed the treatment course. Possible scores ranged This was a UK-wide, cross-sectional, questionnaire-based survey of from 5 to 25. Participants were divided into high and low adherence symptom experiences, treatment concerns and adherence, including 28,31 groups on the basis of the distribution of scores. Two-thirds of the people with asthma and asthma-treating clinicians. sample with the highest scores were considered to have high adherence (score ⩾ 18 for ICS; ⩾ 23 for OCS), and one-third with the lowest scores was Procedure considered to have low adherence. Questionnaires were mailed to Asthma UK members and made available on the Asthma UK website. The online survey was promoted to people Statistical analysis with asthma in communications from Asthma UK. Asthma-treating Analyses were conducted using PASW Statistics 18. Associations between clinicians (doctors, nurses and pharmacists) were notified of the study symptoms and adherence and between concerns and adherence were through communications from Asthma UK and Education for Health (a UK explored using independent samples t-tests. Pearson’s correlations were provider of respiratory education and training courses for health used to explore associations between side effects and concerns. professionals). An advert and questionnaire were placed on the Education Differences in the estimates of side effects between doctors, nurses and for Health website. pharmacists were explored using the Kruskal–Wallis test. Measures Side effects, treatment concerns and adherence were measured by self- RESULTS reported questionnaire. People with asthma Questionnaires were sent to Asthma UK’s membership of Side effects approximately 8,000 people. A total of 2,659 questionnaires were People with asthma: A list of commonly reported side effects was constructed on the basis of literature review and interviews with people returned by people with asthma (initial response rate 33.2%): 1971 with asthma. Participants were asked to indicate which of a list of (74%) by post and 688 (26%) online. Thirty-five questionnaires symptoms (sore mouth or throat, oral thrush, abnormal weight gain, were excluded because the participant was o16 years of age. Of bruising, behaviour changes and dental problems) they had experienced, those currently prescribed ICS (n = 2,213), 1524 (68.9%) had which they believed could be a side effect of using corticosteroids. complete data and were included in the analyses. Of those Separate lists were given for ICS and OCS. Each side effect was scored ‘yes’ currently prescribed OCS (n = 314), 233 (74.2%) had complete data (1), ‘no’(0) or ‘Don’t know’ (0). Possible scores ranged from 0 to 6. and were included in the analysis. Table 1 shows summary Clinicians: Clinicians were asked to estimate the percentage of their patients prescribed corticosteroids to treat asthma within the past 3 years statistics for the participants included in the final ICS and OCS who had experienced each side effect. Separate questionnaires were samples. completed for ICS and OCS. Clinicians Concerns about corticosteroids. Concerns were measured using the Beliefs about Medicines Questionnaire, which has been validated for use in There were 700 visitors to the Survey Monkey questionnaire. Of 10,25,28 asthma. The Beliefs about Medicines Questionnaire-Concerns scale those, 166 (23.7%) indicated that they had read the study (13 items) encompassed concerns about adverse effects of corticosteroid information; 534 initiated the questionnaire; and 244 clinicians treatments, including side effects, disruptive effects of treatment regimen completed the questionnaires and were included in the analysis on daily life, potential long-term effects and dependency. Participants (Response rate 34.9%; Table 2). rated their level of agreement with each of a series of statements on a scale ranging from strongly agree (scored 5) to strongly disagree (scored 1). A mean scale score was computed (range 1–5). The prevalence Adherence of each concern was calculated by dichotomising: responses ‘agree’ or The mean MARS score for ICS was 17.4 (s.d. = 3.2); 555 (36%) ‘strongly agree’ = 1 and all other responses = 0. participants scored o18 and formed the ‘low adherence’ group, whereas 969 (64%) participants scored ⩾ 18 and were considered Adherence. The Medication Adherence Report Scale (MARS©R Horne) was 29,30 ‘highly adherent’. There was a significant positive relationship used to reported adherence. For ICS, a 4-item scale was used. between age and adherence (r = 0.287, Po0.0001), but no Participants were asked to indicate how often they forgot to take their medicines, stopped taking them for a while, decided to miss out a dose or association between adherence and gender (P = 0.90). Table 1. Demographics and scale summary scores for people taking ICS and OCS: comparison of those with complete and missing data a a Prescribed ICS, n = 2,213 Complete data, n = 1,524 Missing data, n = 689 P-value Age (mean, s.d.) 54.2 (17.8) 52.7 (17.6) 58.1 (17.8) 0.000 Female (n,%) 1558 (73.1) 1080 (70.9) 478 (78.9) 0.000 MARS (mean, s.d.) 17.4 (3.2) 17.4 (3.2) 17.6 (3.2) 0.153 Side effects (mean, s.d.) 1.4 (1.4) 1.3 (1.42) 1.3 (1.5) 0.793 Concerns (mean, s.d.) 2.6 (0.7) 2.5 (0.7) 2.8 (0.7) 0.000 a a Prescribed OCS, n = 314 Complete data, n = 233 Missing data, n =81 P-value Age (mean, s.d.) 50.1 (19.9) 48.5 (19.5) 56.1 (20.0) 0.006 Female (n,%) 244 (80.0) 186 (79.8) 58 (80.6) 0.893 MARS (mean, s.d.) 22.9 (2.9) 23.0 (2.6) 22.7 (2.6) 0.403 Side effects (mean, s.d.) 2.7 (1.7) 2.7 (1.7) 2.6 (1.8) 0.770 Concerns (mean, s.d.) 3.4 (0.7) 3.4 (0.6) 3.4 (0.7) 0.457 Abbreviations: ICS, inhaled corticosteroid; MARS, Medication Adherence Report Scale; OCS, oral corticosteroid. Summary statistics were calculated on data available, sample size within the overall sample and missing data columns therefore differs for each variable. npj Primary Care Respiratory Medicine (2015) 15026 © 2015 Primary Care Respiratory Society UK/Macmillan Publishers Limited Reported side effects to corticosteroid for asthma V Cooper et al Table 2. Types of clinicians who responded to the online 10 Sore mouth or throat questionnaire Types of clinician Total responded Total included Bruising a 27 (n = 534) (n = 244) GP 66 (12.4) 25 (10.2) oral thrush Practice nurse 297 (55.6) 164 (67.2) Community nurse 42 (7.9) 11 (4.5) Weight gain Community 24 (4.5) 8 (3.3) pharmacist Total primary care 429 (80.4) 208 (85.2) 2 Median % estimated by Dental problems Hospital doctor 9 (1.7) 4 (1.6) clinicians Hospital pharmacist 6 (1.1) 1 (0.4) % Of pepole with asthma Hospital nurse 32 (6.0) 6 (2.5) 1 reporting side effect Behaviour changes Specialist nurse 58 (10.9) 25 (10.2) Total secondary care 105 (19.7) 36 (14.8) 0 20406080 534/700 (76.3%) people who initiated the online questionnaire provided Figure 2. Disconnects between patient reports and clinician data on their profession. estimates of side effects from OCS. OCS, oral corticosteroid. adherence: mean = 1.4, s.d. = 1.5; low adherence: mean = 1.2, s.d. = 1.4; t = − 3.09, P = 0.002). Conversely, people who reported Bruising low adherence to OCS reported a greater number of side effects (low adherence: mean = 3.0 symptoms, s.d. = 1.7; high adherence: mean = 2.6 symptoms, s.d. = 1.7; t = 1.86, Po0.05; one-tailed test). Abnormal 10 weight gain 67 Concerns about corticosteroid medicines Behaviour Figures 3 and 4 show the percentage of participants reporting changes 44 specific concerns about ICS and OCS. 5 There was a wide variation in concerns about ICS. Scores ranged Median % estimated Oral thrush by clinicians from 1.0 to 4.8 (scale range = 1–5; mean = 2.5; s.d. = 0.7). Older participants reported fewer concerns about ICS (r = − 0.150; % Of people reporting Dental side effects Po0.001), whereas women had stronger concerns about ICS problems than men (scale range = 1–5; mean = 3.4; s.d. = 0.6, respectively (t = 7.08, Po0.0001)). With regard to OCS, concerns scores ranged 0 10 20 30 40 50 60 70 80 from 1.3 to 5.0 (mean = 3.4; s.d. = 0.6). Older participants reported Figure 1. Disconnects between patient reports and clinician fewer concerns about OCS (r = − 0.182; Po0.01), whereas women estimates of side effects from ICS. ICS, inhaled corticosteroid. had stronger concerns about OCS than men (mean = 3.4 (s.d. = 0.6) versus mean = 3.1 (s.d. = 0.6), respectively; t = 2.89, Po0.005). The mean MARS score for OCS was 23 (s.d. = 2.6); 73 (31%) Stronger concerns about ICS and OCS were associated with a participants scored o23 (low adherence), whereas 160 (69%) greater number of side effects ((r = 0.46, Po0.0001) and (r = 0.50, participants scored ⩾ 23 (high adherence). Neither age, nor Po0.0001), respectively). gender had a significant impact on adherence (both P40.1). Associations between concerns about corticosteroids and Side effects adherence Sixty-four percent (n = 971) of the sample reported ⩾ 1 side effect ICS. People with stronger concerns about ICS and OCS were attributed to ICS (mean = 1.3, s.d. = 1.4), whereas 88% (n = 205) more likely to report low adherence (ICS—low adherence group: reported ⩾ 1 side effect of OCS (mean = 2.7, s.d. = 1.7). The mean concerns score = 2.7; s.d. = 0.7; high adherence group: prevalence of each side effect attributed to ICS and OCS is shown mean = 2.4; s.d. = 0.7 (t = 6.90; df = 1,522; Po0.0001); OCS—low in Figures 1 and 2, respectively. Older age (r = − 0.139, Po0.000, adherence group: mean = 3.5; s.d. = 0.6; high adherence group: n = 1,524) and male gender (t = 9.69, Po0.0001) were associated mean = 3.3; s.d. = 0.7 (t = 1.71; df = 231; Po0.05); one-tailed test). with fewer side effects of ICS (women: mean = 1.6; s.d. = 1.5; men: mean = 0.8; s.d. = 1.1). Older age (r = − 0.215, Po0.01) and male gender (t = 2.46, Po0.05) were also associated with fewer side DISCUSSION effects of OCS (women: mean = 2.9; s.d. = 1.6; men: mean = 2.2; Main findings s.d. = 1.6). We identified a high prevalence of reported side effects from both ICS and OCS in this large sample of people with asthma. There was Clinician estimates of side effects a clear disconnect between clinician estimates of the prevalence Comparisons between clinician estimates and patient reports of of side effects and the actual prevalence reported by people with side effects from ICS and OCS are shown in Figures 1 and 2. There asthma. Consistent with our hypothesis, experiencing a greater were no significant differences in the estimates between doctors, number of side effects was associated with non-adherence to OCS. nurses and pharmacists (all P40.1). Conversely, those reporting a greater number of side effects were more likely to report high adherence to ICS. Reasons for this are Associations between side effects and adherence unclear, but the finding may reflect a dose–response relationship between adherence and side effects of ICS. Consistent with People who were highly adherent reported a slightly greater number of ICS side effects than those with lower adherence (high previous studies, concerns about both OCS and ICS were © 2015 Primary Care Respiratory Society UK/Macmillan Publishers Limited npj Primary Care Respiratory Medicine (2015) 15026 Reported side effects to corticosteroid for asthma V Cooper et al Figure 3. Percentage of people with asthma reporting specific concerns about ICS. ICS, inhaled corticosteroid. Questionnaire statements © R Horne. Figure 4. Percentage of people reporting concerns about OCS. OCS, oral corticosteroid. Questionnaire statements © R Horne. 10,25 associated with non-adherence. These findings indicate that, in side-effect experiences over time or to infer the direction of at least for patients taking ICS, their concerns about side effects, relationships between side effects, concerns about corticosteroids rather than the actual experience of side effects, may lead to non- and adherence. Participants recruited through Asthma UK may not adherence. have been representative of the UK population of people with 33,34 In common with other studies, older participants were more asthma. adherent to ICS; however, the relationship between age and The majority of clinicians were nurses working in primary care, adherence has not been consistent across studies. Furthermore, consistent with the model of nurse-led asthma clinics. However, male participants and those who were older reported significantly relatively few doctors were included, limiting the extent to which fewer side effects and had fewer concerns about their treatment. these results can be applied to the doctor–patient setting. Although these results suggest that interventions to address Because patient and clinician samples were unrelated, it was not concerns and to improve adherence may be of particular benefit possible to draw conclusions about the discrepancies in findings to those who are younger, further research is required to confirm between the two groups. these findings. Generalisability of the findings is also limited by low response rates and missing data. It is not possible to determine an exact Strengths and limitations of this study response rate, as questionnaires were sent to all Asthma UK members, and we were unable to determine what proportion of This study included a large sample of people with asthma and those who did not return questionnaires were eligible for the used validated questionnaires to measure perceptions of treat- study. Our final sample of people taking ICS was biased in terms of ment and adherence. We were able to recruit a group of clinicians younger age and female gender. Given that those with missing who estimated the prevalence of identical side effects to examine possible disconnects between the experiences of people taking data had stronger concerns about ICS than those included in the corticosteroids and the perceptions of clinicians. The cross- analysis, we hypothesise that the true prevalence of concerns sectional design meant that we were unable to examine changes about ICS is underestimated in our sample. npj Primary Care Respiratory Medicine (2015) 15026 © 2015 Primary Care Respiratory Society UK/Macmillan Publishers Limited Reported side effects to corticosteroid for asthma V Cooper et al Interpretation of findings in relation to previously published work management of comorbidities, ensuring that the patient learns and uses a good inhaler technique and gains control of symptoms The prevalence of side effects in this study was higher than with better adherence, would all reduce the need for the use expected. Sore mouth and oral thrush are well-documented side 36–38 of OCS. effects of ICS. Skin thinning and bruising have also been Further studies are required to explore the direction of previously associated with ICS. Other reported side effects to ICS, relationships between concerns about corticosteroids, experience such as abnormal weight gain and behaviour changes, reported of side effects and adherence, and to explore differences between by a significant minority of people in this study are more commonly associated with OCS, but are rare in relation to ICS patient and clinician perceptions of corticosteroids using clinician– 40,41 use. High doses of ICS over the long term might increase the patient dyads. risk of side effects associated with systemic use; however, we did not collect information on the type or dosage of ICS. The finding Conclusions that people with higher rates of adherence to ICS reported more This preliminary study identified a higher-than-expected fre- side effects is consistent with a dose–response relationship. quency of side effects from ICS and OCS, and indicated that there Although it is plausible that the high prevalence of side effects may be disconnects between patient experiences of side effects reported in this study was directly attributable to the pharmaco- and awareness of side effects among clinicians. Side effects were logical effects of corticosteroid medications, there may be other associated with strong concerns about corticosteroids, which, in explanations. One alternative explanation is a phenomenon turn, were associated with non-adherence. These findings have known as the ‘nocebo effect’, in which experiences of side effects implications for the design of interventions to support patients, stem from negative expectations of treatment, perhaps owing to improve treatment experiences and enhance asthma control. negative past experiences of medicines or information about possible adverse reactions. The association between treatment concerns and experience of side effects lends support to this ACKNOWLEDGEMENTS theory, and it is consistent with the findings of studies in other 14,15 We thank the members of Asthma UK and Education for Health who participated in clinical areas. In this study, however, the direction of causality this research, and Amy Whitehead and Katie Gellaitry for their help with data input. between concerns about corticosteroids and side effects could not RH is a member of the Asthma UK Centre for Applied Research. be established. In contrast to side-effect reports by people with asthma, the sample of clinicians felt that side effects from corticosteroids CONTRIBUTIONS would be relatively infrequent among their patients, raising the RH, LM, JU, JV and SW made substantial contributions to the conception and design question of whether people with asthma and clinicians view side of the study. VC conducted the data analysis of patient data and JU conducted the effects in the same way. Discrepancies between clinicians’ and analysis of physician data. VC and RH interpreted the data and drafted the paper. All patients’ beliefs about medications have previously been the authors contributed to the critical revision of the manuscript and approved the reported. It may be that, although a large number of patients final version. RH is the corresponding author. LM is the guarantor of the data. with asthma experience side effects of corticosteroids, few communicate them to clinicians. COMPETING INTERESTS GlaxoSmithKline plc, MSD and Novartis Pharmaceuticals UK Ltd had no input into the Implications for future research, policy and practice study design, data collection, analysis or interpretation of the findings. RH has Our findings are immediately relevant to asthma-treating clin- undertaken speaker engagements with honoraria with the following companies: icians and the design of interventions to promote adherence to Abbvie, Amgen, Biogen Idec, Gilead Sciences, GlaxoSmithKline, Janssen, Pfizer, Roche corticosteroids. Eliciting and addressing patients’ concerns about and Shire Pharmaceuticals. RH is funder and shareholder of a UCL-business spin out their oral and inhaled corticosteroids may be an economical and company (Spoonful of Sugar) providing consultancy on medication-related clinically relevant way to facilitate adherence to prescriptions for behaviours to healthcare policy makers, providers and industry. SW is an Associate editor of npj Primary Care Respiratory Medicine, but was not involved in the editorial OCS and ICS and thereby improve asthma control. This approach review of, nor the decision to publish, this article. The other authors declare no has previously been piloted in telephone-based medicines conflicts of interest. support intervention in which a pharmacist telephoned patients to elicit and address perceptual barriers and practical problems within 10 days of receiving new medicine. Patients receiving the FUNDING intervention had fewer concerns, fewer medication problems This research was coordinated by Asthma UK and supported by a financial grant from and higher reported adherence than standard care controls. GlaxoSmithKline plc, MSD and Novartis Pharmaceuticals UK Ltd to Asthma UK. Randomised controlled trials to explore the efficacy of this approach in long-term illnesses are ongoing. 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Local oropharyngeal side effects of inhaled corticosteroids in patients necessity and concerns about adverse effects: Identifying the types of beliefs that with asthma. Allergy 2006; 61: 518–526. are associated with non-adherence to HAART. Int J STD AIDS 2004; 15:38–44. 24 Neame R, Hammond A. Beliefs about medications: a questionnaire survey of people with rheumatoid arthritis. Rheumatology 2005; 44:762–767. This work is licensed under a Creative Commons Attribution 4.0 25 Menckeberg TT, Bouvy ML, Bracke M, Kaptein AA, Leufkens HG, Raaijmakers JAM International License. The images or other third party material in this et al. Beliefs about medicines predict refill adherence to inhaled corticosteroids. article are included in the article’s Creative Commons license, unless indicated J Psychosom Res 2008; 64:47–54. otherwise in the credit line; if the material is not included under the Creative Commons 26 Horne R, Kovacs C, Katlama C, Clotet B, Fumaz CR, Youle M et al. Prescribing and license, users will need to obtain permission from the license holder to reproduce the using self-injectable antiretrovirals: how concordant are physician and patient material. To view a copy of this license, visit http://creativecommons.org/licenses/ perspectives? AIDS Res Ther 2009; 6:2. by/4.0/ npj Primary Care Respiratory Medicine (2015) 15026 © 2015 Primary Care Respiratory Society UK/Macmillan Publishers Limited http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png npj Primary Care Respiratory Medicine Springer Journals

Patient-reported side effects, concerns and adherence to corticosteroid treatment for asthma, and comparison with physician estimates of side-effect prevalence: a UK-wide, cross-sectional study

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Springer Journals
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Copyright © 2015 by The Author(s)
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Medicine & Public Health; Medicine/Public Health, general; Primary Care Medicine; Internal Medicine; Pneumology/Respiratory System; Thoracic Surgery
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10.1038/npjpcrm.2015.26
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www.nature.com/npjpcrm All rights reserved 2055-1010/15 ARTICLE OPEN Patient-reported side effects, concerns and adherence to corticosteroid treatment for asthma, and comparison with physician estimates of side-effect prevalence: a UK-wide, cross-sectional study 1 2 2 3 3 1 Vanessa Cooper , Leanne Metcalf , Jenny Versnel , Jane Upton , Samantha Walker and Rob Horne BACKGROUND: Non-adherence to corticosteroid treatment has been shown to reduce treatment efficacy, thus compromising asthma control. AIMS: To examine the experiences of treatment side effects, treatment concerns and adherence to inhaled (ICS) and oral corticosteroids (OCS) among people with asthma and to identify the degree of concordance between clinician estimates of side effects and the prevalence reported by patients. METHODS: Asthma UK members were sent validated questionnaires assessing treatment concerns, experiences of side effects and adherence. Questionnaires measuring clinicians’ estimates of the prevalence of corticosteroid side effects were completed online. RESULTS: Completed questionnaires were returned by 1,524 people taking ICS, 233 taking OCS and 244 clinicians (67% of clinicians were primary care nurses). Among people with asthma, 64% of those taking ICS and 88% of those taking OCS reported ⩾ 1 side effect. People reporting high adherence to ICS (t = − 3.09, Po0.005) and those reporting low adherence to OCS (t = 1.86, Po0.05; one-tailed test) reported more side effects. There was a disparity between clinicians’ estimates of the frequency of side effects and the frequency reported by people with asthma: e.g., although 46% of people taking ICS reported sore throat, clinicians estimated that this figure would be 10%. Patients who reported side effects had stronger concerns about both ICS (r = 0.46, Po0.0001) and OCS (r = 0.50, Po0.0001). Concerns about corticosteroids were associated with low adherence to ICS (t = 6.90, Po0.0001) and OCS (t = 1.71; Po0.05; one-tailed test). CONCLUSIONS: An unexpectedly large proportion of people with asthma experienced side effects and had strong concerns about their treatment, which compromised adherence. These findings have implications for the design of interventions to optimise asthma control through improved adherence. npj Primary Care Respiratory Medicine (2015) 25, 15026; doi:10.1038/npjpcrm.2015.26; published online 9 July 2015 INTRODUCTION individual’s interpretation of symptom experiences. Previous research has shown that treatment concerns are associated with Inhaled corticosteroids (ICS) are the anti-inflammatory drug of 1,2 non-adherence to treatment for a range of conditions including choice for asthma. In cases in which asthma control is not 10,21–25 asthma; however, no previous studies have explored achieved with ICS, oral corticosteroids (OCS) are added. These relationships between experiencing side effects and concerns medicines are remarkably effective when taken as prescribed. about corticosteroids. However, only a minority of adults with asthma achieve good 4–7 Side effects from corticosteroid medicines may go unreported. asthma control. Studies in other clinical areas have identified disconnects between Non-adherence to corticosteroid treatment reduces efficacy, 8,9 patient and clinician beliefs about treatment. We also examined compromising asthma control. Non-adherence is often an intentional decision on the part of the patient, stemming from clinicians estimates of the frequency of corticosteroids side effects they would expect patients to experience, to identify disconnects concerns about corticosteroids, doubts about the need for 10–16 preventative treatment, and experiences of side effects. The between physicians estimates and patient reports. 17,18 The primary aim of this study was to examine the frequency of Common Sense Model proposes that non-adherence stems patient-reported side effects of ICS and OCS among a large sample from a lack of coherence between individuals’ beliefs about their of people with asthma. Secondary aims were to profile patients’ illness, their experience of symptoms and the doctor’s instructions. concerns about ICS and OCS and to examine the impact of Adherence is also influenced by patients’‘common sense’ concerns and side-effect experiences on reported adherence. We evaluations of treatment, particularly how they judge their also examined the estimated frequency of side effects among personal need for treatment relative to their concerns about 19,20 asthma-treating clinicians and identified disconnects between potential adverse effects (the Necessity Concerns Framework). clinician estimates and patient reports. Furthermore, treatment concerns are influenced by the 1 2 3 Centre for Behavioural Medicine, UCL School of Pharmacy, London, UK; Asthma UK, London, UK and Education for Health, London, UK. Correspondence: R Horne (r.horne@ucl.ac.uk) Received 18 December 2014; accepted 3 February 2015 © 2015 Primary Care Respiratory Society UK/Macmillan Publishers Limited Reported side effects to corticosteroid for asthma V Cooper et al MATERIALS AND METHODS took less than instructed. Possible scores ranged from 4 to 20, with higher scores indicating greater adherence. For OCS, an additional question asked Design and sample how often people completed the treatment course. Possible scores ranged This was a UK-wide, cross-sectional, questionnaire-based survey of from 5 to 25. Participants were divided into high and low adherence symptom experiences, treatment concerns and adherence, including 28,31 groups on the basis of the distribution of scores. Two-thirds of the people with asthma and asthma-treating clinicians. sample with the highest scores were considered to have high adherence (score ⩾ 18 for ICS; ⩾ 23 for OCS), and one-third with the lowest scores was Procedure considered to have low adherence. Questionnaires were mailed to Asthma UK members and made available on the Asthma UK website. The online survey was promoted to people Statistical analysis with asthma in communications from Asthma UK. Asthma-treating Analyses were conducted using PASW Statistics 18. Associations between clinicians (doctors, nurses and pharmacists) were notified of the study symptoms and adherence and between concerns and adherence were through communications from Asthma UK and Education for Health (a UK explored using independent samples t-tests. Pearson’s correlations were provider of respiratory education and training courses for health used to explore associations between side effects and concerns. professionals). An advert and questionnaire were placed on the Education Differences in the estimates of side effects between doctors, nurses and for Health website. pharmacists were explored using the Kruskal–Wallis test. Measures Side effects, treatment concerns and adherence were measured by self- RESULTS reported questionnaire. People with asthma Questionnaires were sent to Asthma UK’s membership of Side effects approximately 8,000 people. A total of 2,659 questionnaires were People with asthma: A list of commonly reported side effects was constructed on the basis of literature review and interviews with people returned by people with asthma (initial response rate 33.2%): 1971 with asthma. Participants were asked to indicate which of a list of (74%) by post and 688 (26%) online. Thirty-five questionnaires symptoms (sore mouth or throat, oral thrush, abnormal weight gain, were excluded because the participant was o16 years of age. Of bruising, behaviour changes and dental problems) they had experienced, those currently prescribed ICS (n = 2,213), 1524 (68.9%) had which they believed could be a side effect of using corticosteroids. complete data and were included in the analyses. Of those Separate lists were given for ICS and OCS. Each side effect was scored ‘yes’ currently prescribed OCS (n = 314), 233 (74.2%) had complete data (1), ‘no’(0) or ‘Don’t know’ (0). Possible scores ranged from 0 to 6. and were included in the analysis. Table 1 shows summary Clinicians: Clinicians were asked to estimate the percentage of their patients prescribed corticosteroids to treat asthma within the past 3 years statistics for the participants included in the final ICS and OCS who had experienced each side effect. Separate questionnaires were samples. completed for ICS and OCS. Clinicians Concerns about corticosteroids. Concerns were measured using the Beliefs about Medicines Questionnaire, which has been validated for use in There were 700 visitors to the Survey Monkey questionnaire. Of 10,25,28 asthma. The Beliefs about Medicines Questionnaire-Concerns scale those, 166 (23.7%) indicated that they had read the study (13 items) encompassed concerns about adverse effects of corticosteroid information; 534 initiated the questionnaire; and 244 clinicians treatments, including side effects, disruptive effects of treatment regimen completed the questionnaires and were included in the analysis on daily life, potential long-term effects and dependency. Participants (Response rate 34.9%; Table 2). rated their level of agreement with each of a series of statements on a scale ranging from strongly agree (scored 5) to strongly disagree (scored 1). A mean scale score was computed (range 1–5). The prevalence Adherence of each concern was calculated by dichotomising: responses ‘agree’ or The mean MARS score for ICS was 17.4 (s.d. = 3.2); 555 (36%) ‘strongly agree’ = 1 and all other responses = 0. participants scored o18 and formed the ‘low adherence’ group, whereas 969 (64%) participants scored ⩾ 18 and were considered Adherence. The Medication Adherence Report Scale (MARS©R Horne) was 29,30 ‘highly adherent’. There was a significant positive relationship used to reported adherence. For ICS, a 4-item scale was used. between age and adherence (r = 0.287, Po0.0001), but no Participants were asked to indicate how often they forgot to take their medicines, stopped taking them for a while, decided to miss out a dose or association between adherence and gender (P = 0.90). Table 1. Demographics and scale summary scores for people taking ICS and OCS: comparison of those with complete and missing data a a Prescribed ICS, n = 2,213 Complete data, n = 1,524 Missing data, n = 689 P-value Age (mean, s.d.) 54.2 (17.8) 52.7 (17.6) 58.1 (17.8) 0.000 Female (n,%) 1558 (73.1) 1080 (70.9) 478 (78.9) 0.000 MARS (mean, s.d.) 17.4 (3.2) 17.4 (3.2) 17.6 (3.2) 0.153 Side effects (mean, s.d.) 1.4 (1.4) 1.3 (1.42) 1.3 (1.5) 0.793 Concerns (mean, s.d.) 2.6 (0.7) 2.5 (0.7) 2.8 (0.7) 0.000 a a Prescribed OCS, n = 314 Complete data, n = 233 Missing data, n =81 P-value Age (mean, s.d.) 50.1 (19.9) 48.5 (19.5) 56.1 (20.0) 0.006 Female (n,%) 244 (80.0) 186 (79.8) 58 (80.6) 0.893 MARS (mean, s.d.) 22.9 (2.9) 23.0 (2.6) 22.7 (2.6) 0.403 Side effects (mean, s.d.) 2.7 (1.7) 2.7 (1.7) 2.6 (1.8) 0.770 Concerns (mean, s.d.) 3.4 (0.7) 3.4 (0.6) 3.4 (0.7) 0.457 Abbreviations: ICS, inhaled corticosteroid; MARS, Medication Adherence Report Scale; OCS, oral corticosteroid. Summary statistics were calculated on data available, sample size within the overall sample and missing data columns therefore differs for each variable. npj Primary Care Respiratory Medicine (2015) 15026 © 2015 Primary Care Respiratory Society UK/Macmillan Publishers Limited Reported side effects to corticosteroid for asthma V Cooper et al Table 2. Types of clinicians who responded to the online 10 Sore mouth or throat questionnaire Types of clinician Total responded Total included Bruising a 27 (n = 534) (n = 244) GP 66 (12.4) 25 (10.2) oral thrush Practice nurse 297 (55.6) 164 (67.2) Community nurse 42 (7.9) 11 (4.5) Weight gain Community 24 (4.5) 8 (3.3) pharmacist Total primary care 429 (80.4) 208 (85.2) 2 Median % estimated by Dental problems Hospital doctor 9 (1.7) 4 (1.6) clinicians Hospital pharmacist 6 (1.1) 1 (0.4) % Of pepole with asthma Hospital nurse 32 (6.0) 6 (2.5) 1 reporting side effect Behaviour changes Specialist nurse 58 (10.9) 25 (10.2) Total secondary care 105 (19.7) 36 (14.8) 0 20406080 534/700 (76.3%) people who initiated the online questionnaire provided Figure 2. Disconnects between patient reports and clinician data on their profession. estimates of side effects from OCS. OCS, oral corticosteroid. adherence: mean = 1.4, s.d. = 1.5; low adherence: mean = 1.2, s.d. = 1.4; t = − 3.09, P = 0.002). Conversely, people who reported Bruising low adherence to OCS reported a greater number of side effects (low adherence: mean = 3.0 symptoms, s.d. = 1.7; high adherence: mean = 2.6 symptoms, s.d. = 1.7; t = 1.86, Po0.05; one-tailed test). Abnormal 10 weight gain 67 Concerns about corticosteroid medicines Behaviour Figures 3 and 4 show the percentage of participants reporting changes 44 specific concerns about ICS and OCS. 5 There was a wide variation in concerns about ICS. Scores ranged Median % estimated Oral thrush by clinicians from 1.0 to 4.8 (scale range = 1–5; mean = 2.5; s.d. = 0.7). Older participants reported fewer concerns about ICS (r = − 0.150; % Of people reporting Dental side effects Po0.001), whereas women had stronger concerns about ICS problems than men (scale range = 1–5; mean = 3.4; s.d. = 0.6, respectively (t = 7.08, Po0.0001)). With regard to OCS, concerns scores ranged 0 10 20 30 40 50 60 70 80 from 1.3 to 5.0 (mean = 3.4; s.d. = 0.6). Older participants reported Figure 1. Disconnects between patient reports and clinician fewer concerns about OCS (r = − 0.182; Po0.01), whereas women estimates of side effects from ICS. ICS, inhaled corticosteroid. had stronger concerns about OCS than men (mean = 3.4 (s.d. = 0.6) versus mean = 3.1 (s.d. = 0.6), respectively; t = 2.89, Po0.005). The mean MARS score for OCS was 23 (s.d. = 2.6); 73 (31%) Stronger concerns about ICS and OCS were associated with a participants scored o23 (low adherence), whereas 160 (69%) greater number of side effects ((r = 0.46, Po0.0001) and (r = 0.50, participants scored ⩾ 23 (high adherence). Neither age, nor Po0.0001), respectively). gender had a significant impact on adherence (both P40.1). Associations between concerns about corticosteroids and Side effects adherence Sixty-four percent (n = 971) of the sample reported ⩾ 1 side effect ICS. People with stronger concerns about ICS and OCS were attributed to ICS (mean = 1.3, s.d. = 1.4), whereas 88% (n = 205) more likely to report low adherence (ICS—low adherence group: reported ⩾ 1 side effect of OCS (mean = 2.7, s.d. = 1.7). The mean concerns score = 2.7; s.d. = 0.7; high adherence group: prevalence of each side effect attributed to ICS and OCS is shown mean = 2.4; s.d. = 0.7 (t = 6.90; df = 1,522; Po0.0001); OCS—low in Figures 1 and 2, respectively. Older age (r = − 0.139, Po0.000, adherence group: mean = 3.5; s.d. = 0.6; high adherence group: n = 1,524) and male gender (t = 9.69, Po0.0001) were associated mean = 3.3; s.d. = 0.7 (t = 1.71; df = 231; Po0.05); one-tailed test). with fewer side effects of ICS (women: mean = 1.6; s.d. = 1.5; men: mean = 0.8; s.d. = 1.1). Older age (r = − 0.215, Po0.01) and male gender (t = 2.46, Po0.05) were also associated with fewer side DISCUSSION effects of OCS (women: mean = 2.9; s.d. = 1.6; men: mean = 2.2; Main findings s.d. = 1.6). We identified a high prevalence of reported side effects from both ICS and OCS in this large sample of people with asthma. There was Clinician estimates of side effects a clear disconnect between clinician estimates of the prevalence Comparisons between clinician estimates and patient reports of of side effects and the actual prevalence reported by people with side effects from ICS and OCS are shown in Figures 1 and 2. There asthma. Consistent with our hypothesis, experiencing a greater were no significant differences in the estimates between doctors, number of side effects was associated with non-adherence to OCS. nurses and pharmacists (all P40.1). Conversely, those reporting a greater number of side effects were more likely to report high adherence to ICS. Reasons for this are Associations between side effects and adherence unclear, but the finding may reflect a dose–response relationship between adherence and side effects of ICS. Consistent with People who were highly adherent reported a slightly greater number of ICS side effects than those with lower adherence (high previous studies, concerns about both OCS and ICS were © 2015 Primary Care Respiratory Society UK/Macmillan Publishers Limited npj Primary Care Respiratory Medicine (2015) 15026 Reported side effects to corticosteroid for asthma V Cooper et al Figure 3. Percentage of people with asthma reporting specific concerns about ICS. ICS, inhaled corticosteroid. Questionnaire statements © R Horne. Figure 4. Percentage of people reporting concerns about OCS. OCS, oral corticosteroid. Questionnaire statements © R Horne. 10,25 associated with non-adherence. These findings indicate that, in side-effect experiences over time or to infer the direction of at least for patients taking ICS, their concerns about side effects, relationships between side effects, concerns about corticosteroids rather than the actual experience of side effects, may lead to non- and adherence. Participants recruited through Asthma UK may not adherence. have been representative of the UK population of people with 33,34 In common with other studies, older participants were more asthma. adherent to ICS; however, the relationship between age and The majority of clinicians were nurses working in primary care, adherence has not been consistent across studies. Furthermore, consistent with the model of nurse-led asthma clinics. However, male participants and those who were older reported significantly relatively few doctors were included, limiting the extent to which fewer side effects and had fewer concerns about their treatment. these results can be applied to the doctor–patient setting. Although these results suggest that interventions to address Because patient and clinician samples were unrelated, it was not concerns and to improve adherence may be of particular benefit possible to draw conclusions about the discrepancies in findings to those who are younger, further research is required to confirm between the two groups. these findings. Generalisability of the findings is also limited by low response rates and missing data. It is not possible to determine an exact Strengths and limitations of this study response rate, as questionnaires were sent to all Asthma UK members, and we were unable to determine what proportion of This study included a large sample of people with asthma and those who did not return questionnaires were eligible for the used validated questionnaires to measure perceptions of treat- study. Our final sample of people taking ICS was biased in terms of ment and adherence. We were able to recruit a group of clinicians younger age and female gender. Given that those with missing who estimated the prevalence of identical side effects to examine possible disconnects between the experiences of people taking data had stronger concerns about ICS than those included in the corticosteroids and the perceptions of clinicians. The cross- analysis, we hypothesise that the true prevalence of concerns sectional design meant that we were unable to examine changes about ICS is underestimated in our sample. npj Primary Care Respiratory Medicine (2015) 15026 © 2015 Primary Care Respiratory Society UK/Macmillan Publishers Limited Reported side effects to corticosteroid for asthma V Cooper et al Interpretation of findings in relation to previously published work management of comorbidities, ensuring that the patient learns and uses a good inhaler technique and gains control of symptoms The prevalence of side effects in this study was higher than with better adherence, would all reduce the need for the use expected. Sore mouth and oral thrush are well-documented side 36–38 of OCS. effects of ICS. Skin thinning and bruising have also been Further studies are required to explore the direction of previously associated with ICS. Other reported side effects to ICS, relationships between concerns about corticosteroids, experience such as abnormal weight gain and behaviour changes, reported of side effects and adherence, and to explore differences between by a significant minority of people in this study are more commonly associated with OCS, but are rare in relation to ICS patient and clinician perceptions of corticosteroids using clinician– 40,41 use. High doses of ICS over the long term might increase the patient dyads. risk of side effects associated with systemic use; however, we did not collect information on the type or dosage of ICS. The finding Conclusions that people with higher rates of adherence to ICS reported more This preliminary study identified a higher-than-expected fre- side effects is consistent with a dose–response relationship. quency of side effects from ICS and OCS, and indicated that there Although it is plausible that the high prevalence of side effects may be disconnects between patient experiences of side effects reported in this study was directly attributable to the pharmaco- and awareness of side effects among clinicians. Side effects were logical effects of corticosteroid medications, there may be other associated with strong concerns about corticosteroids, which, in explanations. One alternative explanation is a phenomenon turn, were associated with non-adherence. These findings have known as the ‘nocebo effect’, in which experiences of side effects implications for the design of interventions to support patients, stem from negative expectations of treatment, perhaps owing to improve treatment experiences and enhance asthma control. negative past experiences of medicines or information about possible adverse reactions. The association between treatment concerns and experience of side effects lends support to this ACKNOWLEDGEMENTS theory, and it is consistent with the findings of studies in other 14,15 We thank the members of Asthma UK and Education for Health who participated in clinical areas. In this study, however, the direction of causality this research, and Amy Whitehead and Katie Gellaitry for their help with data input. between concerns about corticosteroids and side effects could not RH is a member of the Asthma UK Centre for Applied Research. be established. In contrast to side-effect reports by people with asthma, the sample of clinicians felt that side effects from corticosteroids CONTRIBUTIONS would be relatively infrequent among their patients, raising the RH, LM, JU, JV and SW made substantial contributions to the conception and design question of whether people with asthma and clinicians view side of the study. VC conducted the data analysis of patient data and JU conducted the effects in the same way. Discrepancies between clinicians’ and analysis of physician data. VC and RH interpreted the data and drafted the paper. All patients’ beliefs about medications have previously been the authors contributed to the critical revision of the manuscript and approved the reported. It may be that, although a large number of patients final version. RH is the corresponding author. LM is the guarantor of the data. with asthma experience side effects of corticosteroids, few communicate them to clinicians. COMPETING INTERESTS GlaxoSmithKline plc, MSD and Novartis Pharmaceuticals UK Ltd had no input into the Implications for future research, policy and practice study design, data collection, analysis or interpretation of the findings. RH has Our findings are immediately relevant to asthma-treating clin- undertaken speaker engagements with honoraria with the following companies: icians and the design of interventions to promote adherence to Abbvie, Amgen, Biogen Idec, Gilead Sciences, GlaxoSmithKline, Janssen, Pfizer, Roche corticosteroids. Eliciting and addressing patients’ concerns about and Shire Pharmaceuticals. RH is funder and shareholder of a UCL-business spin out their oral and inhaled corticosteroids may be an economical and company (Spoonful of Sugar) providing consultancy on medication-related clinically relevant way to facilitate adherence to prescriptions for behaviours to healthcare policy makers, providers and industry. SW is an Associate editor of npj Primary Care Respiratory Medicine, but was not involved in the editorial OCS and ICS and thereby improve asthma control. This approach review of, nor the decision to publish, this article. The other authors declare no has previously been piloted in telephone-based medicines conflicts of interest. support intervention in which a pharmacist telephoned patients to elicit and address perceptual barriers and practical problems within 10 days of receiving new medicine. Patients receiving the FUNDING intervention had fewer concerns, fewer medication problems This research was coordinated by Asthma UK and supported by a financial grant from and higher reported adherence than standard care controls. GlaxoSmithKline plc, MSD and Novartis Pharmaceuticals UK Ltd to Asthma UK. Randomised controlled trials to explore the efficacy of this approach in long-term illnesses are ongoing. 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Prescribing and license, users will need to obtain permission from the license holder to reproduce the using self-injectable antiretrovirals: how concordant are physician and patient material. To view a copy of this license, visit http://creativecommons.org/licenses/ perspectives? AIDS Res Ther 2009; 6:2. by/4.0/ npj Primary Care Respiratory Medicine (2015) 15026 © 2015 Primary Care Respiratory Society UK/Macmillan Publishers Limited

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