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- PATIENTS AND METHODS
It has long been accepted that physical activity improves health by preventing mortality and morbidity from cardiovascular diseases, osteoporosis, anxiety, and depression (1–3). Increasingly, exercise programs are developed and implemented for specific patient groups. For rheumatoid arthritis (RA) patients, despite their increased susceptibility for the mentioned comorbidities (4–6), exercise programs have for a long time included only low-intensity training aimed at preserving joint mobility. Patients were discouraged from performing intensive physical activity, for fear of damage to the large joints and exacerbation of joint inflammation (7).
Only relatively recently, it was shown that RA patients benefit from both short-term (8–10) and long-term (11) high-intensity exercise, without worsening of inflammation or progression of joint damage. This was confirmed by the Rheumatoid Arthritis Patients In Training (RAPIT) study (12) that compared a long-term, high-intensity exercise program with usual care consisting of individual physical therapy only if regarded necessary by the attending physician. The study demonstrated that RA patients were able to improve their functional ability, physical capacity, emotional status, and bone mineral density, without an increase in disease activity or additional damage to the large joints. However, studies have so far not reported on whether these exercise programs provide good value for money from the societal perspective. Here we will present the economic evaluation of the RAPIT study, estimating the cost utility and cost effectiveness of long-term, high-intensity exercise classes compared with usual care, in RA patients.
- Top of page
- PATIENTS AND METHODS
In line with previous studies (3), the RAPIT study has shown that for RA patients a long-term, high-intensity exercise program is safe and effective in improving physical capacity and emotional status, without an increase in disease activity or radiographic joint damage (12). It also proved to be effective in improving functional ability and in slowing down age-related bone loss. In the economic evaluation reported here, we studied whether from the societal perspective clinical effectiveness is attained at reasonable costs.
The costs of exercise programs can vary considerably, depending on the number of participating patients, the accommodation, and the agreed income of the physical therapists. In the Dutch setting, the annual medical costs were estimated at €10,800 per RAPIT group, which is €780 per participating patient (€1 ≈ $1.05). The additional time and travel costs incurred by the patients almost doubled these costs and can seriously discourage participation by the patients. Costs of the RAPIT program were partly compensated by a decrease in individual physical therapy. As a result, the annual increase in medical costs of all physical therapy for patients participating in the RAPIT program was estimated at €430. The annual increase in total societal costs was estimated at €602 per patient. More research is needed on the development of less expensive exercise interventions. If effectiveness could be maintained with less therapists' supervision and more home-based exercises, this would cut down on costs. However, until now, home-based exercise programs designed for patients with RA did prove effective with respect to the improvement of physical capacity but, perhaps due to their low intensity or lack of impact, did not accomplish significant changes in functional capacity or bone mineral density (11, 33, 34).
For policy making from a societal perspective, costs need to be weighed against an effectiveness measure that is applicable and comparable for a wide range of diseases and treatments. The 3 QALY measures used in our study satisfy this requirement and, despite their conceptual differences, led to the same conclusion. An often-quoted rule of thumb is that costs up to €50,000 per QALY are acceptable (35). At that threshold, the cost utility of usual care was better than for the RAPIT program, and significantly so according to the VAS. We conclude that, according to current societal standards, the exercise classes did not improve the health valuation of the RA patients sufficiently to provide good value for money.
A number of remarks need to be made that temper the sharpness of this conclusion. Most importantly, our analysis has not taken into account preventive effects on cardiovascular and fracture risks and the associated cost savings (2), because the available data were insufficient for a quantitative extrapolation of future participation, effectiveness, damage, and costs. Second, although corrected for, results may have been influenced by some statistically significant baseline differences that we attribute to early dropout among healthier patients randomized to obtain usual care. Third, the used utility measures may be less appropriate for evaluation of the health of RA patients in clinical trials (36), because trials are usually powered for more sensitive primary outcome measures and patients continually adjust to their worsening health status (37). The few economic evaluations of physical therapy in somewhat similar patient groups either did not include utility measures (38–40) or also found insufficient improvement (41). Finally, the societal perspective ignores important financial considerations. For example, patients could be asked to contribute to the amount of what they would have to pay at a fitness center.
In economic evaluations, effectiveness is preferably estimated using utility measures because they aim to estimate the overall value of a treatment. A remarkable discrepancy revealed in our analysis is that significant and clinically important improvements on the effectiveness measures targeted by the intervention, like physical capacity and functional ability, did not translate into a significant improvement on the utility measures. There can be several explanations for this finding. First, utility measures may not be sensitive enough to detect true improvements in overall value or, equivalently, true improvements in overall value may be too small to be detected by available utility measures. This explanation does not invalidate their use in economic evaluations, provided that the utility measures include the relevant domains, as was the case in our study. Second, the value of the improvements on the targeted effectiveness measures may be countered by unexpected or unknown changes in other domains, which is suggested here by the significant difference in the VAS.
To compare the efficiency of different treatments in rheumatology, disease-specific outcome measures can be used. We analyzed the primary clinical endpoints of the study, both measuring functional ability. The HAQ is used extensively in rheumatology research, but has been reported to be insensitive to changes due to exercise therapy (7, 42). This was confirmed in the RAPIT study. Patients in the RAPIT group on average showed only a 0.01 improvement on a scale from 0 to 3, at the annual costs of €24,000 per HAQ point. The above-mentioned rule of thumb of €50,000 per QALY suggests that the estimated costs per HAQ point are unacceptably high.
The most sensitive measure in our study was the MACTAR: over the 2-year period, patients following the RAPIT program had an average MACTAR score that was 2.9 points better than for patients receiving usual care. Most of the difference in the MACTAR score was attributable to the items that assessed difficulty performing the individually selected impaired activities. Because the weighted MACTAR score, on average, assigns 3 points to these activities, the estimated 2.9 difference can be interpreted as that patients following the RAPIT program had 1 less relevant activity problem, at the annual cost of €630 per problem. Unfortunately, at this moment there are no data on what constitutes a clinically relevant MACTAR change, nor is there previous literature to decide whether the estimated costs per MACTAR point compare favorably with other interventions in rheumatology.
From the individual patient's perspective, costs need not play a role in the decision on whether or not to participate in exercise classes. During the study, most patients reported personal willingness to pay that was insufficient to cover the costs (on average €300 annually). Nevertheless after the study ended, 58% of the patients continued to follow exercise classes at their own costs for at least a year. If funding does not provide a problem, then there is no reason to discourage participation, provided qualified supervision is available to prevent injuries and to adjust the exercises to individual needs. Moreover, the reduction in costs for individual physical therapy could provide some scope for reimbursement.
From an individual patient perspective, there is much to be said for participating in long-term, high-intensity exercise classes. However, from a societal perspective and without taking possible preventive health effects into account, they provide insufficient improvement in the valuation of health to justify the additional costs.