|Ahead of print publication
Beliefs and outlook toward medications in Indian patients with very early rheumatoid arthritis: Cross sectional survey
Sakir Ahmed1, Arup Mahapatra2, Basanta Kumar Behera2, Prasanta Padhan1
1 Department of Clinical Immunology and Rheumatology, Kalinga Institute of Medical Sciences, KIIT University, Bhubaneswar, Odisha, India
2 Department of Community Medicine, Kalinga Institute of Medical Sciences, KIIT University, Bhubaneswar, Odisha, India
Department of Clinical Immunology and Rheumatology, Kalinga Institute of Medical Sciences, KIIT University, Bhubaneswar - 751 024, Odisha
Source of Support: None, Conflict of Interest: None
Introduction: Beliefs toward medicine influences drug compliance in rheumatoid arthritis (RA). Studies on attitudes toward medicine are available for established RA, where the disease itself could have altered the beliefs. Similar studies are not available for early RA. Thus, we surveyed patients with very early RA to determine their initial outlook toward medicines.
Methods: Two hundred and fifty patients fulfilling the American College of Rheumatology/European League against Rheumatism 2010 criteria for RA, who had developed arthritis within the past 3 months were surveyed using the Beliefs about Medicines Questionnaire (BMQ). For the BMQ subsets (specific necessity, specific concern, general overuse, and general harm), more than scale midpoint is considered high. Depending on these scores, patients were classified as indifferent, accepting, sceptical, or ambivalent. Correlations of these scores with age, sex, time to presentation, education, occupation, and income were calculated.
Results: Mean (±standard deviation) age of the cohort was 47.6 (±13.4) years with 88.4% (221) being females. Twelve (4.8%) had a high specific necessity, while 31 (12.4%) had a high specific concern score. General overuse and general harm scores were high in 248 (99.2%) and 246 (98.4%) patients, respectively. Thus, 242 (96.8%) patients were classified as indifferent, 4 (1.6%) accepting, 4 (1.6%) sceptical, and none as ambivalent. There was no statistically significant correlation between these scores and sex, age, educational status, occupation, or income. Multivariate analysis showed that persons with high specific concerns about medicines, educated to secondary level, being a student or having a desk job tended to present earlier.
Conclusion: General harm and overuse scores were high, but patients had low scores on the scales specific for RA medication. Thus, most of them were classifiable as “indifferent” unlike as in previous studies on established RA.
Keywords: Attitude toward medications, beliefs, compliance, rheumatoid arthritis, very early rheumatoid arthritis
|How to cite this URL:|
Ahmed S, Mahapatra A, Behera BK, Padhan P. Beliefs and outlook toward medications in Indian patients with very early rheumatoid arthritis: Cross sectional survey. Indian J Rheumatol [Epub ahead of print] [cited 2020 Jun 2]. Available from: http://www.indianjrheumatol.com/preprintarticle.asp?id=282509
| Introduction|| |
Rheumatoid arthritis (RA) is a chronic inflammatory arthritis. Poorly controlled RA can lead to various extra-articular morbidities as well as an increase in cardiovascular risk. Certain behavioral patterns regarding therapy can predict poor drug compliance, higher disease relapse, and thus poor disease control. In RA, 30%–80% can have poor compliance with drug usage.
Patients often perceive disease-modifying antirheumatic drugs (DMARDs) as very potent medication with dangerous adverse effects. Attitudes of patients determine the barriers against and are the facilitators for good drug compliance. In the ALIGN (Trial registration number: ACTRN12612000977875) study, exploring medication adherence in RA, psoriatic arthritis, and ankylosing spondylitis, the adherence depended more on treatment beliefs than on disease-related factors.
The Outcome Measures in Rheumatology Adherence Group has been setup and are currently undergoing a 5-phase study to finalize the core-domains to study medication adherence in rheumatic diseases. At present, most of the available literature on attitudes toward medication in RA have used the Beliefs about Medicines Questionnaire (BMQ). It is a validated tool to assess attitudes and beliefs about drugs in patient populations. It is divided mainly into two division: A specific part that deals with the disease under study (here: RA), and a general section that deals with the patients' overall attitude about medicines in general. The specific part has two subsets of five questions each: One subset about the necessity of medications and the other on the concerns about the medicines again. Similarly, the general part has two subgroups of four questions each: The first subset about perceived overuse of drugs by physicians, and the second about potential harms of medicines.
Based on the scores of the BMQ-specific necessity subset and the BMQ-specific concern subset, patients have been divided into four categories or segments: (1) accepting, with BMQ-specific necessity score ≥15 and BMQ-specific concerns score <15; (2) ambivalent, with both scores ≥15; (3) indifferent, with both scores <15; and (4) sceptical, with BMQ-specific necessity score <15 and BMQ-specific concerns score ≥15. For example, in a study assessing subcutaneous biological drugs, most patients could be categorized as “ambivalent” (58.5%) followed by “accepting” (36.1%).
Being on treatment will change the attitude of the patients toward the medication they use. As they experience the disease-modifying action of the drugs, they will realize their dependence. At the same time, they might be experiencing side effects or getting to learn more about their drugs from various sources. These will invariably change their outlook toward the drugs. Thus, it is essential to know about the attitudes at the early stages of the disease when DMARDs are initiated. This knowledge can help strategize how to help shape a positive attitude and gradually remove negative ones. Treatment patterns in very early RA is a strong predictor of the American College of Rheumatology (ACR) remission.
There exist definite cultural and socioeconomic values that vary in various regions of the world. The attitudes of patients in Asia might be different from those in Europe. Even within Asia, there is a diversity of culture, habits, economic and social freedom, health-care service and also access to health care. In India, at least a third of RA patient use complementary and alternative medicine (CAM) at any given time, while 82% have tried such therapies at least once. The median time to initiation of DMARDs was 2–3 years in two Indian studies conducted in the last decade.,
Thus, Indian patients have different backgrounds, and data on the outlook of patients with early RA is limited. With these in mind, we surveyed patients with very early RA (VERA) about their attitudes toward medication.
| Methods|| |
This was a cross-sectional questionnaire-based study and has been reported as per the Strengthening the Reporting of Observational Studies in Epidemiology recommendations for cross-sectional studies. The primary objective was to survey the beliefs that patients with VERA have toward their medications. Using the survey scores, they would be classified into four established categories: accepting, ambivalent, indifferent, and sceptical. The distribution of patients in these four categories would then be compared with those previously reported in the literature for established RA. The secondary objective was to explore associations between these scores and patient characteristics such as age, income, education status, and occupation; and also, to see if these parameters can predict the time to the first presentation to the doctor.
Patients were recruited consecutively from a rheumatology outpatient clinic in a tertiary center with a diagnosis of RA were screened. Data collection was completed from 2015 to 2017. For inclusion, patients had to satisfy the ACR/European League Against Rheumatism 2010 classification criteria for RA, have an onset of symptoms after 16 years of age, and have disease duration <3 months. Although early RA is considered up to 6 months from onset of symptoms, very early RA is considered to be the first 12 weeks of disease.
Patients coming with established deformities (including congenital), or having other comorbidities (uncontrolled diabetes, uncontrolled hypertension, liver or kidney disease, cardiovascular or cerebrovascular accident, trauma) that made them come to the hospital were excluded. Furthermore, patients who had differently-abled mental capacity were excluded as this might compromise the understanding of the questionnaire or the quality of self-reported information.
Thus, 250 consecutive patients who met the above criteria were recruited after written informed consent. This was a convenient sample, and no sample size calculation was done.
The study was approved by the Kalinga Institute of Medical Sciences Ethics committee (approval number: KIMS/KIIT/IEC/69/2016).
For all patients, the BMQ was administered by AM (one of the investigators) after visiting the primary rheumatologist. The patient would have had been prescribed drugs and been explained about the disease, including clearing any of their doubts. Besides BMQ, patient data including age, sex, approximate duration from onset of first symptoms to the first visit to a registered medical practitioner, education status, occupation, estimated family income, and current disease status (active or low disease activity), were obtained.
All analysis was carried out with SPSS for Windows software version 23 (Chicago, Illinois, USA). Normality of data was assessed by Kolmogorov–Smirnov and Shapiro–Wilk tests. Normal data are being expressed as mean (standard deviation) while nonparametric data as median (quartiles). Spearman correlations between the four subset scores of the BMQ and age, income, educational status, and occupation were assessed.
Whether the patients' beliefs lead to change in the time to the first presentation was explored through multivariate analysis. Since this was a count of patients presenting on different days and not following a normal distribution, a Poisson log-linear regression model was constructed using the age, sex, marital status, education level, occupation, and the four scales of the BMQ. Before the modeling was done, outliers were excluded.
| Results|| |
Of the 250 patients included, 221 (88.4%) were female. The mean age was 47.6 ± 13.4 years. [Table 1] summarizes the characteristics of this cohort.
|Table 1: Background of 250 very early rheumatoid arthritis patients standard deviation|
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The scores of the four BMQ subsets are given in [Table 2]. The number of patients having high specific necessity score (more than scale mid-point) was 12 (4.8%) while that of patients having high specific concern score was 31 (12.4%). However, the general overuse score was more than scale midpoint in 248 (99.2%) patients! Similarly, the general harm score was higher than scale midpoint in 246 (98.4%) patients!
|Table 2: Maximum scores, median and quartiles of the four subset of the beliefs about medicines questionnaire|
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There were weak correlations (r2< 0.1) between the subset scores, and there were no statistically significant correlations of these scores with age, income, educational status, or occupation [Table 3]. Classifying according to the BMQ-specific necessity and the BMQ specific concern scores, 242 (96.8%) patients were indifferent, 4 (1.6%) accepting, 4 (1.6%) sceptical, and none (0%) ambivalent.
|Table 3: Spearman correlation (rho) between the four components of the beliefs about medications questionnaire, and delay to presentation to doctor, age, income, education level, and occupation of patients|
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One hundred and three (41.2%) of patients had first visited a practitioner of complementary or alternative medicine before consulting in the rheumatology clinic. The four scores (specific necessity, specific concern, general overuse, or general harm) were statistically not different between patients who first visited the rheumatology clinic or those who first visited a CAM practitioner.
The multivariate regression model included sex, marital status, education, occupation, monthly income, and the 18 BMQ questions. The dependent variable was time to presentation to the doctor. One outlier had to be excluded. [Table 4] shows the significant associations predicted by this model. People educated to senior secondary level, being a student or having a desk job were likely to present later. Persons with high specific concerns about medicines tended to present earlier.
|Table 4: Poisson loglinear regression assessing the factors predicting the time from onset of symptoms to presentation to a rheumatologist|
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| Discussion|| |
In this survey of 250 patients with very early RA, the majority seemed indifferent to the drugs they were being prescribed. However, the general concerns and harm scores are high with low specific concerns scores. Independent of the tool used to measure adherence, around a third of RA patients are noncompliant with their drugs. A significant contributor to nonadherence might be the attitude toward drugs. In a large European cohort followed up for 3 years, the primary determinant of drug compliance was individual behavior. A systematic review has established the BMQ questionnaire as a predictor of medication adherence in the Chinese.
[Table 5] summarizes the various studies looking at attitudes toward medicine in RA. Data about people of South Asian origin are limited. We found only one study that compared 100 patients (50 RA and 50 lupus) of South Asian descent with 100 similar patients (50 RA and 50 lupus) of British/Irish origin. This study reported that the patients of South Asian backgrounds had high general overuse and general harm scores as we found in our cohort. However, they also had high specific concerns score, unlike in our population. One factor responsible for this can be that specific concerns develop over time as the patients learn more about their medicines.
|Table 5: Different studies looking at attitudes toward medicines in rheumatoid arthritis|
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Overall, the results of our study are quite different from most of the reported literature till date [Table 5]. There can be a few explanations for this. First customs and social belief vary in different parts of the world, and these might be the beliefs in this part of the world. Second, a large proportion of Indian RA patients usually visit practitioners of complementary and alternate medicine. Thus, only a very select group, maybe visiting a rheumatologist in the first 3 months of the onset of symptoms. This might bias our findings to the attitudes of such a group. Third, this is one of the only studies looking at the attitude toward drugs in very early RA. Patients may start off being indifferent and then gradually evolve more specific concerns. This can only if found out if we follow this cohort and find out if their attitudes change over the coming years.
Factors that can potentially affect attitudes are age, gender, educational status, socioeconomic background, and disease activity. Our population seems to have balanced representation from people from different education and socioeconomic strata. Our cohort was comparatively younger compared to other cohorts. Certain studies have suggested that older aged people with RA have higher drug compliance,, but attitudes do not seem to be different. In the correlation analysis age, education, socioeconomic strata were not associated with the BMQ scores. This may be because the BMQ data were skewed or it merely represents that the attitudes are shared across all groups in our population. The large proportion of people in the indifferent group (242) as compared to the three other groups (with frequencies of 4, 4, and 0), makes statistical analysis redundant.
The BMQ does not capture which drugs had been used. Thus, we cannot distinguish whether the knowledge that they are getting steroids, “pain-killers” or medications such as methotrexate, can influence the beliefs of the patients. The BMQ, however, does differentiate the opinions of patients toward drugs in general (the general scores) and toward medications used for RA (the specific scores). The results have shown that the patients have high general scores but low specific scores. And since the patients seem to be indifferent to the drugs used in the treatment of RA, it is less likely that the class of drug would influence their perception.
The sample size was not calculated a priori since we did not want to focus on a single parameter (on which the sample size would be calculated). Post hoc calculations showed that with a sample of 250 patients assuming each proportion of attitudes (indifferent, accepting, sceptical, or ambivalent) was equal (25%), and allowable error of 5%, the power of the study is 93.2%.
Although this study has included a good number of patients with very early RA, it is not without its limitations. First, as mentioned before, there is selection bias because we have surveyed only patients who have presented early to a rheumatology clinic. The beliefs may be different in the patients who present late or who visit alternate practitioners. Nevertheless, this study aimed to look at medications in this particular group only. Second, the study has not formally recorded disease activity in the patients using a disease activity score. The disease activity is also likely to influence the attitudes toward medications. However, these are mostly treatment naïve patients presenting the first time to a rheumatologist and can be safely assumed to have moderate-to-high disease activity. Third, it is a cross-sectional survey only and cannot estimate if the attitudes change over time. Fourth, there was the lack of a control group of established RA. However, there are intrinsic biases in comparing two groups with different disease duration, and we will prefer to follow-up this cohort and see how their attitudes evolve instead of comparison with another RA population.
Thus, the most critical next step would be to follow-up this cohort prospectively and see how their attitudes change over time. This can help us strategize how to promote positive changes in attitude while negating negative influences. In addition, more in-depth analysis can be made with a qualitative research approach to determine what persuades the predominant indifferent nature. It will be interesting to compare attitudes across cultures by similar studies in the Western hemisphere and the Middle East and so forth.
| Conclusion|| |
Thus, we have shown that Indian patients presenting with very early RA have high general concern scores and fear of drug overuse, but more mostly indifferent toward specific disease-related parameters like the need for taking drugs (to control the disease). Prospective studies are required to understand whether these traits are unique to our population or evolve as the patients progress to established RA.
| Author Contributions|| |
PP, BKB designed the study; AM was involved in data collection while SA analyzed the data. SA drafted the manuscript, and it was critically revised by AM, BKB, and PP.
All the four authors have approved the final manuscript and take full responsibility for the integrity of the data and the contents therein.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3], [Table 4], [Table 5]