Rheumatol Int (2012) 32:3131–3135 DOI 10.1007/s00296-011-2162-x
ORIGINAL ARTICLE
Compliance with treatment of rheumatoid arthritis Raili Mu¨ller • Riina Kallikorm • Kaja Po˜lluste Margus Lember
•
Received: 31 May 2011 / Accepted: 10 September 2011 / Published online: 24 September 2011 Ó Springer-Verlag 2011
Abstract Rheumatoid arthritis (RA) is a chronic, progressive, debilitating disease that demands continuous therapy with multiple medications. Noncompliance with disease-modifying drugs may cause disease flares, preventable functional impairment, unnecessary treatment changes, and loss of health care resources. The aim of the current study was to explore self-reported compliance with treatment and the factors contributing to this compliance using a representative sample of an RA patient population in Estonia. Two thousand patients diagnosed with RA were randomly selected from the Estonian Health Insurance Fund database. The eligible response rate of the study was 60%. Using prestructured questionnaires, the following information about the disease and treatment was evaluated: self-reported compliance with treatment, reasons for noncompliance, disease history, sociodemographic variables, health care utilization, and satisfaction with health care providers. The self-reported compliance rate was 80.3%, reflecting the percentage of patients who reported that they always took their medications exactly as described. The most often reported reasons for noncompliance were side effects and fear of side effects. Compliance was found to be the lowest in a group of younger and active patients with higher income. Higher frequency of visits to the rheumatologist, satisfaction with health care providers, and sufficient information about RA treatment correlated with better compliance. Keywords Rheumatoid arthritis Compliance Drug treatment R. Mu¨ller (&) R. Kallikorm K. Po˜lluste M. Lember Department of Internal Medicine, University of Tartu and Tartu University Hospital, Tartu, Estonia e-mail:
[email protected]
Introduction Rheumatoid arthritis (RA) is a chronic, progressive, debilitating disease demanding continuous therapy with multiple medications [1–3]. Efficient management of RA significantly reduces long-term functional disability [4]. With respect to treatment for RA, drug efficacy and patient compliance with the treatment prescribed are equally important [5, 6]. Compliance is defined as the extent to which a patient’s behavior matches the prescriber’s recommendations [7, 8]. In noncompliant RA patients, the risk of a disease flare has been found to increase significantly [5]. Lack of compliance with treatment is a worldwide problem of a striking magnitude [7]. Compliance among patients with different chronic diseases is low, often below 50% [9]. Compared with chronic diseases such as asthma and diabetes, compliance with medical treatment for chronic rheumatic conditions has not been well examined [10]. In studies on RA, compliance rates have varied from 30 to 93% [11, 12]. Compliance related to RA had been evaluated previously for one medication at a time (mostly methotrexate). Some published studies focused on medications not commonly used today, and several recent studies focused on biologic treatment [10, 13–17]. The determinants of noncompliance and efficacy of implementing strategies to improve medication management in this patient population have been reported as fields of further investigation [18]. Noncompliance increases the risk of unnecessary changes in treatment and causes preventable morbidity, mortality, and loss of health care resources and productivity [19]. In many countries, including Estonia, among the criteria for starting resource-intensive biologic treatment is the inefficacy of or intolerance to previous conventional disease-modifying treatment. Being aware of the factors
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that influence compliance, we can take them into consideration and estimate the likelihood of noncompliance as the reason for treatment inefficacy. The aim of the current study was to explore self-reported compliance with treatment and the factors contributing to such compliance in a representative sample of a RA patient population in Estonia.
Materials and methods The study was conducted between October 2007 and January 2008 by the Department of Internal Medicine at Tartu University Hospital and Estonian Health Insurance Fund (EHIF) among Estonian patients with RA. Two thousand patients were randomly selected from the EHIF database (N = 8,814). Patients eligible for participation in the study needed to be at least 18 years old; diagnosed with RA according to ICD-10; and have had at least one contact with health care providers over the past 12 months. All patients included in the study sample gave written informed consent. The Ethics Review Committee on Human Research of the University of Tartu approved the study design. This study is part of a RA patient survey entitled ‘‘Quality of life: Coping with illness and satisfaction with access to health services’’. An original prestructured questionnaire included 48 questions with 96 variables. Among these were variables for sociodemographics, health care utilization, disease history, use of medicines and facilities for managing everyday life, information about the disease and treatment, self-reported costs of care for patients, satisfaction with the family doctor (FD) and rheumatologist, and information about the disease and treatment. Compliance was evaluated on the basis of how respondents reported to have taken their prescribed medications. Patients were divided into two groups: compliant (always took their medication as prescribed) and noncompliant (did not always take their medication as prescribed, took less/ more than prescribed, or mostly did not take the medication). Noncompliant patients were asked why they failed to comply (withdrawal of symptoms, side effects, fear of side effects, and forgot). SPSS 15.0 software for Windows was used to analyze the data. The Chi-square test was used to compare backgrounds with other characteristics in compliant and noncompliant patients. Kendall’s Tau-b was used to estimate the correlations between background variables and compliance. The ANOVA test was used to compare the mean values of variables. Partial correlation coefficients were computed to control the effects of mutually correlated background variables. The level of statistical significance was accepted as 0.05.
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Results Feedback was received from 1,427 patients (71.4%). Of those patients, 168 dropped out of the analysis for various reasons: the patient had moved or died, had not visited a doctor over the past 12 months, refused to participate, or was unable to respond because of health status. In addition, 50 patients failed to complete the entire questionnaire and were excluded from the statistical analysis. The eligible response rate of the study was 63%. Respondents who failed to answer the question about compliance (n = 60) were excluded, and the final number of respondents included in the study was 1,199 (a response rate of 60%). The nonrespondents were younger than the respondents, but the groups did not differ based on gender distribution. Table 1 presents the structure of the total study population (all RA patients in 2006), sample, respondents, and nonrespondents by gender and age. Respondents ranged from 19 to 93 years of age, their mean age was 59.2 ± 13.1 years (mean ± SD), 17.3% were men, and 82.7% were women. Twenty-one percent of the participants had an education up to nine years, 61% had an education of 10 or 12 years, and 18% had more than 12 years of education. The average monthly income was €279.40, and the median income was €223.60. More than half of the respondents were retired or unemployed (57%). The older respondents were more likely unemployed (Kendall’s Tau-b, s = 0.54, P \ 0.0001), had lower income levels (s = -0.17, P \ 0.0001), and were less educated (s = -0.14, P \ 0.0001). The mean duration of the disease was 11.6 ± 11.5 years. The majority of patients (80.3%) reported that they took prescribed medications exactly according to the doctor’s instructions, 14.8% had taken the medicines less than prescribed or during a shorter period, 1.7% of patients reported that they mostly ignored the doctor’s recommendations, and 1.7% chose several answers. Some patients took their medicines more often than prescribed (1.6%). The reasons for noncompliance included side effects (39%) and fear of side effects (8%), the withdrawal of symptoms (16%), and forgetting to take the medicines (14%). About one-quarter (23%) of noncompliant patients referred to multiple reasons for their noncompliance. Compliant patients were more likely older, retired or unemployed, less educated, and with lower income. The patients’ place of residence, native language, and gender were not associated with compliance (Table 2). After controlling for age, compliance was associated with income and employment (partial correlation coefficients 0.09, P \ 0.01, and 0.06, P \ 0.05, respectively), but not with education.
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Table 1 Structure of the study population, sample, respondents, and nonrespondents, by gender and age, n (%) All RA patients in 2006 in EHIF (n = 8,814)
Sample (n = 2,000)
Respondents (n = 1,259)
Nonrespondents (n = 741)
Gender Male
1,604 (18.2)
360 (17.9)
219 (17.4)
141 (18.1)
Female
7,210 (81.8)
1,640 (82.2)
1,040 (82.6)
600 (81.9)
Age group* 18–29
365 (4.1)
88 (4.0)
33 (2.6)
55 (7.4)
30–39
623 (7.1)
141 (6.8)
70 (5.6)
71 (9.6)
40–49 50–59
1,309 (14.9) 2,355 (26.7)
309 (14.2) 553 (27.8)
167 (13.3) 353 (28.0)
142 (19.2) 200 (26.9)
60–69
2,099 (23.8)
455 (23.5)
335 (26.6)
120 (16.2)
70 and older
2,063 (23.4)
454 (23.9)
301 (23.9)
153 (20.6)
* Statistically significant difference between respondents and nonrespondents (P \ 0.0001) Table 2 Demographic characteristics, disease history, and compliance with treatment for RA patients, in % Compliant patients (n = 963)
Noncompliant patients (n = 236)
Up to 49
21.5
23.7
50–64
38.3
48.3
65 and older
40.2
28.0
Male
17.5
16.5
Female
82.5
83.5
Age group**
Gender
Employment status*** Employed
41.0
56.0
Retired or unemployed
59.0
44.0
Elementary (up to 9 years)
21.4
14.3
Secondary (10–12 years)
60.9
Education*
Higher 17.7 Net income per household member per month*
67.5 18.2
BMedian (EUR 223.6)
59.9
50.4
[Median
40.1
49.6
0–3 years
30.7
30.7
4–10 years
28.8
31.2
11–20 years
21.7
19.1
More than 21 years
18.8
19.1
Duration of RA
Concurrent chronic condition Yes
63.2
64.8
No
36.8
35.2
* P \ 0.05; ** P \ 0.01; *** P \ 0.0001
When comparing the duration of the disease, disability due to RA, or presence of concurrent chronic conditions, we found no significant difference between compliant and noncompliant patient groups.
Compliant patients visited rheumatologists more often (P \ 0.01), but not family doctors (FDs). Compliance rates were higher in patients who were more satisfied with rheumatologists (P \ 0.01), as well as FDs (P \ 0.05). Patients better informed about the treatment for RA were more compliant (P \ 0.01) (Table 3).
Discussion Patients participating in the study were selected randomly from the EHIF database. Ninety-five percent of the population of Estonia is covered with EHIF health insurance [20]. Thus, the data collected in this study represent the RA patient population in Estonia. We found no published studies on compliance on such a randomly selected RA patient population. Eighty percent of the patients in the study declared that they used medications exactly as prescribed. The results likely represent an overestimation, as self-completed questionnaires are known to overestimate compliance [3, 21]. No universal method exists to evaluate compliance with treatment; every method has its pros and cons [1, 22, 23]. Data from self-report studies are quite variable, as compliance rates vary from 30 to 93% [11, 12]. Older adults reportedly make the fewest compliance errors, while middle-aged adults make the most. A busy lifestyle and cognitive deficits predict noncompliance [24]. We confirmed that compliance among RA patients is correlated with age, as found in other studies on arthritis and other chronic conditions [11, 19]. In the study, middle-aged patients appeared to be the least compliant; the greatest compliance was found in patients over 65 years of age. Higher income and employment status were associated with noncompliance. Therefore, younger patients leading a busy lifestyle are most likely not to follow doctor’s orders.
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Table 3 Use of health services, satisfaction with health care providers, and information about the treatment for RA in compliant and noncompliant patients Compliant patients (n = 963)
Noncompliant patients (n = 236)
Number of visits per 12 months (mean ± SE) Family doctor
3.49 ± 0.13
3.43 ± 0.23
Rheumatologist**
2.81 ± 0.10
2.11 ± 0.17
Satisfaction with the family doctor* Satisfied
87.4
81.0
Not satisfied
12.6
19.0
Satisfaction with the rheumatologist** Satisfied
87.3
78.2
Not satisfied
12.7
21.8
Information about the RA treatment scheme* Well informed 35.5 Less informed
64.5
24.8 75.2
Rheumatologist as a source of information about RA*** Getting much information
50.1
34.3
Getting a little information
49.9
65.7
* P \ 0.05; ** P \ 0.01; *** P \ 0.0001
Gender and compliance were uncorrelated. Similar results were reported in earlier studies, but in some studies women had better compliance rates [21, 25, 26]. Good knowledge of RA treatment was found to be associated with better compliance. Patients who reported having received more information from their rheumatologist were more compliant. These results are consistent with many studies [12–14, 27, 28]. The information received from their rheumatologist helps patients achieve maximal compliance with treatment. A patient needs to believe in the medication to use it as prescribed. The cause of such behavior has been explained by the self-expectation efficacy theory [27]. A patient’s knowledge and expectations of the side effects are important; 8% of patients noted a fear of side effects as the reason for noncompliance. The finding is important, as it identifies potential areas of intervention to target to improve compliance. Compliance can be described as a balance between patients’ beliefs about the necessity of the treatment and their concerns about its side effects [13]. Communicating and discussing the goals and alternatives of the treatment with patients are vital. Shared decision making is the way to achieve optimal compliance. In this study, 16% of patients declared withdrawal of symptoms as the reason for noncompliance, showing that patients remain unaware of all of the aims of the treatment and the nature of the disease. The relationship between the health care provider and the patient is crucial in the development of treatment compliance [26]. The study found a significant difference
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in compliance between patients satisfied with FDs and rheumatologists the ones who were not. Moreover, patients visiting the rheumatologist more frequently are likelier to be compliant with the treatment prescribed. The importance of these aspects is stressed in the Treat to Target (T2T) strategy for the treatment of rheumatoid arthritis [29] as measures that lead to better treatment outcomes. The highest level of compliance with treatment for chronic diseases can be achieved by respecting patient autonomy and by making decisions in collaboration [30, 31]. To date, however, the role of the relationship between the patient and the health care provider in RA medication compliance has not received a great deal of attention and is a subject for further research. This study on a large cohort of RA patients showed that compliance is associated with several factors. Younger and active patients with better income have the lowest compliance with treatment. Higher frequency of visits to the rheumatologist, greater satisfaction with health care providers, and sufficient information about the RA treatment correlates with better compliance. Acknowledgments This study was funded by the Estonian Science Foundation (Grant No. 6461), the Ministry of Education and Research of Estonia (targeted financing SF0180081s07), and the Estonian Health Insurance Fund.
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