Results

Sixty five patients were selected. Thirty two were randomised to the experimental condition. Three patients in the experimental group and two in the control group refused informed consent. Sixty patients entered the study: 29 in the experimental condition and 31 in the control. Ten groups of patients received the education programme. Eleven partners attended the meetings. From each group one patient refused the evaluation at six months. Another three patients refused the final evaluation. The results presented here concern the available data on the remaining 25 experimental and 30 control subjects.

The groups were comparable regarding age, number of ACR criteria, ESR, number of swollen joints, and number of painful joints. However, the control group contained more men (p<0.05) (table 1).

In the first quarter compliance with sulphasalazine in the educated patients was 91 (12)% (mean (SD)). In the controls compliance was 87 (22)%. In the second quarter compliance was 82 (22)% and 82 (28)% respectively. During the third and fourth quarter compliance rates were 89 (16)% and 84 (21)% respectively. There were no statistically significant differences between the groups in any of these periods. After one year, 60% (n=15) of the patients in the experimental group and 76% (n=23) in the control group were still using sulphasalazine. The difference is not statistically significant (fig 1). Three patients in the experimental group stopped using sulphasalazine because of inefficacy; seven for adverse reactions. Three patients of these 10 received another DMARD together with a low dose prednisone, four another DMARD alone, and three used neither of these. Seven patients from the control group stopped sulphasalazine (inefficacy: one; toxicity: six). One of these seven patients was using another DMARD in combination with a low dose prednisone, one was using only prednisone, and five were using neither of these.

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Figure 1

Patients receiving sulphasalazine treatment in experimental and control group in percentages.

Time spent on physical exercises and on endurance activities as well as scores regarding energy conservation and scores on the test for joint protection performance were comparable at baseline (table 2). Only at three months the increment of time spent on physical exercises was significantly greater in the experimental group (p<0.05) (table 2). During the observational period the time spent on endurance exercise did not differ significantly between groups (table 2). The increase that was observed in application of energy conservation was greater in the experimental group and statistically significantly different from the control group at three months (p<0.01) and at 12 months (p<0.05) (table 2). The change from baseline in the scores on the test for joint protection performance in the experimental group was significantly different from that in the control group at three months (p<0.01) (table 2).

At baseline the two groups were comparable with respect to DAS, CRP, and M-HAQ. The experimental group scored significantly higher on the mobility scale of the Dutch AIMS at study entry. However, the scores on the other scales of the Dutch AIMS were comparable at that time. The changes from baseline in the DAS, CRP, M-HAQ, and AIMS scales after three, six, and 12 months did not differ significantly between the groups (data not shown). The ranges of motion measured at study entry were within normal limits for both groups. Also, throughout the study no relevant differences occurred (data not shown).

Analysis of the patients that were available at three months (one withdrawal), of those available at six months (three withdrawals) and of the female patients yield results comparable to those presented in this report (data not shown). These analysis suggest that withdrawals and sex distribution did not influence the results.

Discussion

Patient education comprises “all planned educational activities aimed at assisting patients in achieving voluntary health behaviour changes”.33 Therefore compliance with treatment regimens is the primary outcome to be measured in this study. Health status variables are the secondary outcome measures.

To avoid confounding all patients were treated with the same DMARD (sulphasalazine). To avoid patient bias, informed consent had to be differentiated according to experimental condition. Patients were randomised after selection by their rheumatogists but before asking informed consent. This procedure has been described by Zelen.26 ,27 However, in contrast with Zelen, patients who refused to join the experimental group were not invited to join the control group. The numbers of patients refusing to give informed consent, three for the experimental and two for the control condition, in our opinion were acceptably low. In the control group more men were included. Therefore questioning the presence of selection is applicable. However, the results of a separate analysis of female patients did show comparable results. According to the described randomisation procedure the attending rheumatologists selected the patients. Therefore, at inclusion, the data on disease activity as scored by the independent measurement technician, did not always fulfil the selection criteria, but according to the protocol patients were included because they were selected previously. Five patients from the experimental and two from the control group refused follow up evaluations. It is unlikely that the withdrawal of these five patients has an impact on our findings: the results of separate analyses at three months and at six months were similar to those represented in this paper. Selection bias was avoided by blockwise randomisation per rheumatologist. Therefore we did not evaluate the instructions given by individual rheumatologist. To ensure that the control patients were instructed sufficiently they received a brochure about RA and its treatment that included information regarding physical therapy and occupational therapy.

Pill counting procedures seem to be more accurate for evaluating compliance than interviews with patients or their clinicians, but less accurate than the use of pharmacological indicators.10 ,17Recently electronic measurement systems have also received attention.34 Electronic systems, however, may influence compliance by confronting patients daily with the fact of their being monitored.

Although the literature generally indicates low rates of compliance with basic treatment regimens, our results suggest that in our clinics high levels of compliance with DMARD therapy are obtained in patients with active, recent onset RA. This is in concurrence with Owen et al who found that patients with high disease activity tend to be more compliant with treatment advice than those with a low disease activity.35 It may be argued that patients are compliant because they are cooperating in a clinical trial. In our study the patients in the control group who were not aware of an intervention were also compliant. Moreover, low compliance rates with medications have been reported in clinical trials as well.17 ,36 ,37

Questionnaires are commonly used to evaluate compliance with exercise therapies. Questionnaires on exercises do not provide qualitative information and are sensitive for patient bias. In accordance with most other studies, our data suggest that education increases compliance with regimens of physical exercise.19-21 38-40

There are no standard measures or methods for the assessment of compliance with prescriptions for ergonomic measures. In some studies the use of devices is assessed,41 in others self report by patients of ergonomic performance is used, which is subject to recall and accuracy problems.40 ,42 Gerber et al used diaries. However, patients’ behaviour might be influenced by the fact that they keep a diary.43 ,44 Hammond developed a test for joint protection performance that is quite elaborate.45 For this study we developed a practicable clinic based measure of observable joint protection behaviour that has been proved to be reliable for RA patients.28 It could be argued that we measured the ability to perform joint protection rather than compliance with the prescription of joint protection advice. Our data show an improvement in compliance in energy conservation and joint protection after patient education (table 2). It remains possible that the methods we used for measuring compliance with prescription of ergonomic measures do not reflect the daily practice of the patients. Our results are in concordance with other studies that indicate that patient education might improve ergonomic performance.17-47

Surprisingly, the data show that patients were compliant with DMARD therapy, whether they followed the education programme or not. As a consequence the improvement of health status observed is comparable with the effect found in other studies with sulphasalzine in RA.48 Moreover, an additional effect of patient education on health could not be found. Data are lacking on the relation of physical exercise and ergonomic measures on the one hand and health status in RA on the other. Although we did not find an influence on range of motion, it is possible that patients with more severely impaired function might benefit from the observed enhanced compliance with physical exercise and ergonomic measures. Moreover, it is probable that the power of this study is insufficient to show a relation between increased compliance with regimens of physical and occupational therapy and health. Although other studies contained larger number of patients, these studies suffer from possible confounding by medication.21-24

In our study we applied reinforcement meetings at four months and at eight months. Compliance rates with prescribed therapies was measured at six months and at 12 months. At 12 months positive effects of education were still found on compliance with energy conservation. Whether the reinforcement meetings have helped to maintain effects of patient education remains to be proved.

The results of the study suggest that the compliance of patients with active, recently developed RA with sulphasalazine therapy is high whether they have been exposed to formal patient education or not. Education did have positive effects on compliance with regimens of physical exercise and prescriptions for ergonomic measures. The study suggests that the applied patient education programme has no effect on the health status of patients suffering from active, recent onset RA.