Perceptions of the risks and benefits of medicines in patients with rheumatoid arthritis and other painful musculoskeletal conditions

D. Berry1, A. Bradlow2 and E. Bersellini1

1 School of Psychology, University of Reading and 2 Department of Rheumatology, Royal Berks and Battle Hospitals Trust, Reading, UK.

Correspondence to: D. Berry, Pro-Vice-Chancellor's Office, Whiteknights House, University of Reading, Whiteknights, Reading RG6 6AH, UK.


    Abstract
 Top
 Abstract
 Introduction
 Method
 Results
 Discussion
 References
 
Objectives. To examine beliefs about medication risks and benefits in patients attending a specialist rheumatology clinic for pain-related conditions.

Methods. Eighty-one patients (37 first attendees and 44 existing clinic patients) completed a written questionnaire which asked about current treatments, perceived effectiveness, main risks and benefits, and compliance.

Results. Existing clinic patients perceived medications to be more effective and more risky than did the new patients, although both groups rated risks to be moderately low. The main perceived risks were adverse side-effects, although patients reported only moderately low levels of experiencing such effects.

Conclusions. In contrast to some other studies, many of our patients were aware of medication risks and were prepared to accept them provided benefits were seen to be high. Existing clinic patients were more aware of risks and benefits, and reported higher compliance levels than new patients, possibly as a result of the hospital education programme. Future studies should evaluate the effects of the programme more systematically.

KEY WORDS: Medication risks, Medication benefits, Rheumatoid arthritis, Psoriatic arthritis, Pain, Compliance, Patient education


    Introduction
 Top
 Abstract
 Introduction
 Method
 Results
 Discussion
 References
 
There is increasing evidence that people want to know about the risks associated with different treatment options [e.g. 1, 2]. In the case of taking medicine, they particularly want to know about the potential side-effects of the medicine under consideration [3, 4]. Ziegler et al. [4], for example, estimated that between 50 and 90% of patients express a desire for more information about adverse effects. There has been some concern in the literature, however, that providing people with this information might deter them from taking their medicines [e.g. 5, 6]. Despite this, very few studies have actually assessed patients’ beliefs about the risks and benefits of their medicines and how these beliefs affect their medicine-taking behaviour. The present study set out to do this in patients with rheumatoid arthritis (RA) and other chronic painful musculoskeletal conditions, distinguishing between patients taking specialist treatment for their condition and those who are on medications prescribed by their general practitioner (GP) or over-the-counter medications.

Rheumatoid arthritis is a chronic inflammatory disease that can result in significant disability and morbidity and increased mortality amongst sufferers. It affects between 0.5 and 1% of Western populations, is more frequent in women, and usually shows first onset between the ages of 20 and 45 yr. Frequently prescribed medicines include non-steroidal anti-inflammatory drugs (NSAIDs), which symptomatically relieve pain and improve joint stiffness, and ‘second-line’ disease-modifying anti-rheumatic drugs (DMARDs), which can suppress disease activity, improve function and reduce joint damage. Both classes of drug are associated with a number of well-known adverse effects.

In line with studies in other areas, it has been reported that RA patients would like to receive more information about their medicines (particularly the associated risks and benefits) than they are presently given. Donovan and Blake [7], for example, reported that most RA patients in their study ‘craved’ more information about their diseases and treatments so that they would be able to make informed decisions. They noted that many patients were already making their own decisions (for example, to stop taking a particular medicine) but were doing so on the basis of inaccurate knowledge. Similarly, O’Brien et al. [8] suggested that when patients are faced with choosing between treatments, or choosing whether to comply, decisions are made on the basis of their perceptions of risks and benefits, which may differ markedly from the epidemiologically estimated risk.

Donovan and Blake's findings are in line with a number of other studies showing that most RA patients are not well informed about medication risks. Two studies by Mahmud et al. [9], for example, found that only around one-third of patients were aware of the main adverse effects and how to avoid or limit them. More generally, there is also evidence that RA patients do not have a good understanding of the concepts of risk and risk–benefit ratios, particularly in relation to drug treatments. Ho et al. [10], for instance, found that most patients’ estimates of acceptable risk were less than the actual risks of treatments. Moreover, patients were willing to accept higher levels of risk from surgical procedures (such as hip replacement) than from drug treatment, even when the benefits were less. Similarly, Fraenkel et al. [11, 12] reported that about one-third of the RA patients in their study were not willing to accept the risk of any of the adverse effects commonly associated with RA medicines. They noted that some patients treated the risk of particular adverse effects as ‘protected values’ (that is, unacceptable irrespective of the actual level of risk). Indeed, many patients were unwilling to accept the risk of specific adverse effects even when their stated probability of occurrence was decreased to levels far below their actual level.

It is clear from the above studies that RA patients are concerned about medication risks and that many are not willing to risk experiencing particular side-effects. It is also clear that they both want and need more information about the risks and benefits of the different treatment options than they are currently given. In order to maximize the likelihood that such information will be used effectively, however, it is first necessary to ascertain patients’ prior beliefs and (mis)assumptions. Thus, the aim of the present study was to examine the beliefs about risks and benefits of medicines of patients attending a specialist rheumatology clinic for pain-related conditions. Given that many such patients have to take medicines for long periods of time, we were particularly interested in comparing the views of patients visiting the specialist clinic for the first time with those of patients who had attended on previous occasions. For new patients, the main questions of interest were what treatments (prescribed by their GPs or bought over the counter) they were taking for their pain, how effective they believed the treatment had been, and what they perceived the main benefits and risks to be. They were also asked about their concerns about any medicines they would be prescribed by the hospital doctors. For the existing clinic patients, the main questions of interest were to ascertain patients’ views about the perceived benefits and risks of hospital-prescribed medicines in comparison with those taken prior to attending clinic.


    Method
 Top
 Abstract
 Introduction
 Method
 Results
 Discussion
 References
 
The design of the study was approved by the West Berkshire Local Research Ethics committee.

Sample
A total of 81 patients participated; 37 (25 females and 12 males) were attending the clinic for the first time and 44 were existing patients (28 females and 16 males). Patients were sampled from a total of 20 clinic sessions over a 3-month period. All eligible (see below) cases were selected. The refusal rate was very low (less than 5%).

New patients (NPs) were patients at their first attendance at the clinic who had been referred to the clinic from GPs for diagnosis and/or treatment. The only selection criterion was presence of pain in one or more body regions; the only new attendees who were excluded were those who did not have painful conditions (e.g. cases referred with unexplained asymptomatic abnormal blood tests, such as elevation of the ESR or CRP). Most NPs had been experiencing their condition for less than 1 yr, although 32% of the group reported having experienced their condition for between 1 and 5 yr. The group's ages ranged from 18 to 78, with a mean of 52.6.

All existing patients (EPs) were attending the clinic for painful musculoskeletal conditions, the progress and treatment of which required regular monitoring by clinic doctors. The majority of the group had RA or psoriatic arthritis, a smaller number having ankylosing spondylitis or polymyalgia rheumatica. A few had connective tissue diseases, such as systemic lupus erythematosus with musculoskeletal pain and disability. The only cases excluded were those who did not have painful conditions. In terms of length of illness, 32% of EPs reported having experienced their condition between 1 and 5 yr, and 68% reported a length of illness of more than 5 yr. The group's ages ranged from 34 to 81, with a mean of 56.9. With few exceptions EPs were taking DMARDs or prednisolone in addition to other treatments.

Questionnaire
Two versions of the questionnaire were produced, although the majority of questions were the same in both. The NPs’ questionnaire stated that we were interested in their views about the risks and benefits of medicines that they had taken, or were taking, for the medical problems that led to their attending the clinic. The EPs’ version stated that we were interested in their views about the risks and benefits of medicines that they had taken, or were taking, since attending the clinic. They were told that they should answer the questions in relation to medicines that had been recommended or prescribed by the hospital staff, rather than medicines that they may have been taking prior to referral to the hospital.

Measures common to both versions of the questionnaire

In addition, NPs were asked whether they would have concerns about taking one or more additional medicines that might be recommended by the hospital clinic staff and, if so, what their main concerns would be. EPs were asked how much more effective, and how much more risky, their hospital recommended medicines were than those they had been taking prior to attending the clinic (both rated on six-point scales). Finally, all patients were asked for various demographic information, including age, gender, and how long they had been experiencing their condition.

Procedure
On arrival at the clinic, patients were given one of the versions of the questionnaire (according to their status) by the clinic receptionist. It was made clear that they were under no obligation to complete the questionnaire and that, if they did so, their anonymity was guaranteed. Thus, the doctors treating them would not be aware of their specific answers. Those who agreed to take part in the study gave their written consent, in accordance with the Declaration of Helsinki, and then completed the questionnaire while waiting to see the doctor. They then handed it back to the receptionist. The study was carried out over a 6-month period on patients attending unselected (but not completely consecutive) rheumatology clinics in the same hospital.


    Results
 Top
 Abstract
 Introduction
 Method
 Results
 Discussion
 References
 
Results were analysed by analysis of variance (ANOVA) and the {chi}2 test, using SPSS version 11 (SPSS Inc., Chicago, IL, USA).

Medicine use and perceived effectiveness
Of the new patients (i.e. those who were attending the clinic for the first time), 84% reported taking anti-inflammatory medicines and 71% taking painkillers. Of the existing clinic patients, 48% reported taking methotrexate, 34% hydroxychloroquine, 21% prednisolone and 18% sulphasalazine. In addition, 30% reported taking NSAIDs and 15% painkillers. One-third of the EPs were taking four or more medicines. Mean ratings of perceived effectiveness (maximum = 6) were 4.52 (S.D. = 1.32) for EPs, compared with 2.85 (S.D. = 1.5) for NPs. A one-way ANOVA showed the difference to be statistically significant [F(1,76) = 27.23, P<0.001].

Benefit of medicines
For both types of patient, the main benefit of medicine was perceived to be easing of pain (selected by 75% of each group). For EPs, other significant benefits were perceived to be easing of stiffness (73% selected), reduced joint swelling (52% selected), a feeling of well-being (36% selected), sleeping better (18% selected) and higher energy levels (16% selected). For NPs, other significant benefits were easing of stiffness (30% selected), sleeping better (19% selected) and reduced joint swelling (13% selected). The {chi}2 test showed that EPs felt significantly better than NPs with respect to easing of stiffness, reduced joint swelling and feeling of well-being (P<0.005 in each case). Existing patients were also asked to rate the perceived additional benefit of the medicines prescribed or recommended by hospital staff over those that had been prescribed by their GP. Seventy-three per cent of the group provided ratings in the upper half of the scale (i.e. they perceived them to be much more beneficial).

Perceived risks
Mean ratings of perceived risks (maximum = 6) of medicines were 3.25 (S.D. = 1.31) for existing patients and 2.38 (S.D. = 1.35) for new patients. A one-way ANOVA showed the difference to be significant [F(1,76) = 8.17, P<0.01]. For both groups of patients, the main perceived risks were side-effects (selected by 71% of EPs and 47% of NPs) and becoming dependent on the medicine (selected by 43% of EPs and 36% of NPs). In addition, 14% of EPs selected becoming dependent on the doctor or hospital. Finally, 22% of NPs selected the ‘no risk’ option, compared with 4% of EPs. The {chi}2 test showed that significantly more EPs than NPs perceived their treatment to carry a risk of side-effects, and significantly more NPs than EPs perceived their treatment to have ‘no risks’ (P<0.05 in both cases). Nevertheless, when, in addition, EPs were asked to rate the perceived additional risk associated with hospital-prescribed or recommended medicines, 60% of patients provided ratings in the lower half of the scale (i.e. not much additional risk).

Mean ratings of the extent to which patients had actually experienced side-effects (maximum = 6) were 2.17 (S.D. = 1.3) for EPs and 2.06 (S.D. = 1.49) for NPs, the difference not being significant at the 0.05 level. Patients were also asked to list any side-effects that they had experienced. Fifty per cent of EPs and 47% of NPs listed one or more side-effects (the difference between the groups not being significant at the 0.05 level). Of these patients, the majority reported having experienced only one side-effect. The main self-reported side-effects (that could reasonably be attributed to the medication) for both groups were stomach upsets and nausea (reported by 23% of EPs and 31% of NPs). In addition, 9% of EPs reported blood count-related problems and 8% of NPs reported skin problems, such as rashes. A final question asked NPs if they would have any concerns about being prescribed one or more additional medicines by the hospital staff. Only 35% reported having any concerns, the main concerns being side-effects (selected by 27%) and becoming dependent on the medicine (selected by 8%).

Usage of medicines and compliance
Thirty-one per cent of NPs and 25% of EPs reported having stopped taking at least some of their medicines as a result of side-effects (the difference not being statistically significant at the 0.05 level). Fewer than 10% of each group reported wanting to stop but not doing so, or stopping but then restarting. In terms of reported compliance, 89% of EPs reported taking their medicines always as prescribed, and a further 10% selected ‘most of the time’. The equivalent percentages for the NPs were 47 and 25%. The {chi}2 test showed the differences in reported compliance to be statistically significant (P<0.001). For EPs, the main perceived risks of non-compliance were fear of condition worsening (selected by 79%), being in more pain (61%) and feeling less well (50%). In contrast, 27% of NPs felt their condition would worsen, 62% felt they would experience more pain and 11% believed that they would feel less well. Fourteen per cent of NPs responded that there would be no risks associated with non-compliance. The {chi}2 test showed significant differences between the groups for worsening of condition, feeling less well, and no risks (all P values<0.05). Finally, there was no significant relationship between length of treatment and reported compliance in either group of patients (both P values>0.1).


    Discussion
 Top
 Abstract
 Introduction
 Method
 Results
 Discussion
 References
 
The perception of the effectiveness of treatment was far greater amongst existing patients (whose treatment was arranged by the specialist clinic) than amongst new patients who had never previously attended the clinic, possibly because the medication recommended or prescribed by the hospital staff is usually condition-specific rather than being general analgesia for as-yet undiagnosed or non-skeletal painful conditions. Interestingly, a quarter of NPs believed their medicines to be ‘not at all’ effective, compared with only one of the EPs. The primary perceived benefit for both groups of patient was easing of pain. This is in line with other studies in the literature showing that pain is perceived to be the dominant impairment in RA and related conditions [e.g. 13]. EPs felt significantly better than NPs with respect to stiffness, reduction in joint swelling, and well being; again, these are specific types of improvement that would be expected following successful drug treatment for specific inflammatory conditions.

Contrary to our expectations, the patients in this study showed only modest levels of concern about medication risk. Although the EPs perceived their medicines to be significantly more risky than the NPs did, mean ratings were in the lower half of the scale for both groups. The difference between groups might be attributable to the EPs being more risk-aware (rather than simply being more concerned), as they would have been provided with educational material by the clinic staff that would have included information about medication risks. This is supported by the fact that although the EPs provided higher ratings of risk than did NPs, they did not perceive their current medicines to be more risky than the medicines they themselves had taken prior to attending the clinic. Finally, the majority of NPs were not concerned about the prospect of having to take new medicines that would be prescribed or recommended by the hospital staff.

The main perceived medication risks for both groups were side-effects. Interestingly, however, neither group reported particularly high levels of experiencing adverse effects themselves. There was greater concern about the risks of side-effects amongst EPs, despite the fact that they did not rate their medicines as being more risky than the medication prescribed by GPs or bought over the counter. The main reported side-effects are in line with other studies in the area, stomach upsets and nausea being the most common. Relatively few patients reported experiencing side-effects that could not reasonably be attributed to their medicines, showing that their perceptions were fairly valid. In contrast to patients in some other studies [e.g. 11, 12], many patients were aware of the risks and were prepared to take the medication provided that the benefits were perceived to be high.

Existing patients also reported significantly higher levels of compliance than new patients, nearly 90% claiming that they always took their medicines as prescribed. Given that other studies in the literature report adherence levels to DMARD therapy of around 60% [e.g. 14], it is likely that our patients’ self reports were not totally reliable. Studies in other areas have shown that measures of compliance based on self reports tend to be higher than when more objective measures are used [e.g. 15]. More generally, it has been noted that questionnaire surveys tend to elicit ‘public’ rather than ‘private’ accounts from respondents, as people try to present themselves in a favourable light [e.g. 16]. Furthermore, despite being told that the doctors treating them would not see their responses, some patients may have worried that any negative responses would be reported back to the clinicians.

Both patient groups in our study believed that they would be in more pain if they stopped taking their medicines, and the majority of EPs also believed that their condition would worsen, compared with a minority of NPs. One interpretation of this is that NPs were more interested in simple pain relief whereas EPs understood that they had potentially progressive conditions that were being held in check by their treatment. The fact that these perceptions were fairly accurate in this respect might account for a higher than average level of compliance. Again, this may be the result of the educational materials that had been given to them. It should be noted, however, that greater information/knowledge is only one factor that influences decisions about whether or not to take a treatment (in some cases the relationship can be negative). Squier [17], for example, noted that the affective quality of the doctor–patient relationship was a key determinant of adherence. It could also be the case that greater experience in taking the clinic drugs increases patients’ reassurance and confidence in the treatment, although our study showed no significant relationship between length of treatment and reported compliance in either group of patients.

It is important to bear in mind a number of limitations of the present study. First, our sample sizes were relatively modest. This is not a major concern, however, given the number of statistically significant differences found. It was also the case that the two groups differed in many respects. Thus, it was not easy to attribute specific reasons for their different perceptions and beliefs. Secondly, there may also have been a selection bias, in that referral rates probably vary for the different conditions (depending on GPs). Again, however, diagnosis is not a critical concern, given that the overall aim of the study was to assess attitudes to medication in patients who were attending a specialist clinic for chronic disease compared with those who had not previously done so. Finally, there may have been some form of reporting bias as a result of the subjective nature of the measures. Patients attending hospital clinics may well give answers in questionnaires that they believe will gratify their doctors. Future studies should therefore include a number of more objective measures (for example, in relation to effects of treatment, side-effects experienced, and compliance), in addition to the subjective assessments.

Despite the above limitations, we can reasonably conclude that our patients’ perceptions of the risks and benefits of their medicines appeared to be in line with existing knowledge of these medications, and that the patients seemed to show less preoccupation with risk than has been reported by some other studies. This was particularly the case for the existing clinic patients. This may be due to the greater effectiveness of treatment or to the education programme (specifically prepared information leaflets) provided for the hospital patients. Future research should distinguish between these alternatives. For example, studies could evaluate the specific effects of this programme more systematically by varying the content and/or form of presentation of the information provided. Equally, prospective cohort studies of patients’ perceptions of the risks and benefits of medications over the lifetime of a chronic disease like RA, particularly before and after the start of treatment, would be of great value in providing relevant information to patients with such disease about the risks and benefits of their treatment.


    Acknowledgments
 
We are grateful to the receptionists at the specialist rheumatology clinics at the Battle Hospital, Berkshire, who distributed the questionnaires to the patients, and to Dr Jeremy McNally for allowing access to some of his patients.

The authors have declared no conflicts of interest.


    References
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 Abstract
 Introduction
 Method
 Results
 Discussion
 References
 

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Submitted 21 January 2004; revised version accepted 16 March 2004.