Discussion

This study shows that with a ‘package of care’ that includes patient education, individualised lifestyle advice and slow upward titration of ULT according to serial SUA levels (ie, recommended best practice),12 ,13 more than 90% of participants achieved the therapeutic target of a SUA <360 µmol/l, with 85% achieving a SUA<300 µmol/l. After a full explanation about the cause of gout, its risk factors and prognosis (including the risk of chronic joint damage), and available treatment strategies that can eliminate the crystals, all participants wished to receive ULT. There was good adherence to treatment, with more than 90% of participants completing the 12-month observation period. Given optimal circumstances (patient education, patients knowing their therapeutic target and regular contact with a nurse specialist), the recommended complex intervention is effective in more than nine out of 10 people with gout.

There are no previous studies of complex interventions in gout. However, there are studies that show poor adherence to ULT10 ,11 ,19—indeed, adherence to ULT for gout is possibly the worst of any medication for chronic disease.11 ,19 The need for patient and professional education to enable ‘cure’ in gout has been highlighted previously.20 However, despite international guidelines published in 2006,13 significant barriers to effective gout management remain.21 ,22 A recent study in this department found that the main barriers to treatment were a lack of understanding of both the aetiology and management of gout in men and women with gout but also in health professionals.21 Many people focus mainly on acute attacks and have no concept of ongoing, potentially damaging crystal deposition that may lead to tophi and irreversible joint damage.21 When ULT is offered, it is often given as a single efficient dose, which commonly provokes acute attacks and, without a clear explanation, patients often stop the ULT and are disinclined to restart it.21 However, as in this study, if ULT is titrated slowly and the risk of flare is explained to patients they then understand the need to continue their medication despite flaring and the need for long-term treatment to maintain cure. This suggests that education of both patients and health professionals is of paramount importance if both recommended best practice and good adherence are to be achieved. With full explanation, dealing with illness perceptions and barriers to treatment, adherence can be achieved that is even higher than that for other chronic diseases.23 Of interest, every patient in this study accepted an intercritical joint aspirate to confirm with 100% confidence whether they had gout. This is much higher than many people would have predicted, but again reflects the importance of a full explanation in determining patient decision-making.

Most patients were taking allopurinol at study completion, confirming that this is a well-tolerated and effective ULT to be considered first for patients with gout.12 ,13 ,24 However, the median dose of allopurinol required to achieve the therapeutic target was 400 mg. This is in accord with a previous community study in Nottingham,7 which found that many patients who receive the commonly prescribed single dose of 300 mg dose are undertreated and continue to have acute attacks and progression of their disease. This reinforces the requirement to individualise the dose of ULT by titration against the SUA until the therapeutic target has been achieved.12 ,13 This, in conjunction with full explanation, also accounts for the high success rate in achieving the therapeutic target, in contrast to recent large randomised control trials that report low success rates when using a fixed-dose regimen of allopurinol 300 mg daily.25 ,26 The majority of patients who had a contraindication or side effects with allopurinol were successfully treated with a second or third ULT, with only three participants leaving the study having experienced self-limiting but troublesome side effects from ULT and being unwilling to try alternative options.

After full discussion most patients expressed a preference for no prophylaxis during ULT dose escalation, especially with the slow titration that is possible with allopurinol. Interestingly, despite this, the mean number of attacks during the 12-month observation period was less than that reported in the previous year. This suggests that unlike initiation with 300 mg allopurinol or 80 mg febuxostat (both very efficient urate-lowering doses which usually provoke acute attacks and therefore justify consideration of prophylaxis),12 ,13 a regimen with a low starting dose of ULT (eg, 100 mg allopurinol or 50 mg benzbromarone) and subsequent monthly upward titration may not cause more attacks than the patient might otherwise have experienced. Therefore, the use of a second drug (colchicine or a non-steroidal anti-inflammatory drug) with its own potential for side effects may not be required for this indication. The caveat to this may be those patients with greater SUA or tophi at baseline, who are likely to have a higher burden of crystals so are more likely to have a flare when their uric acid level is reduced. However, further specific study comparing these two options is required.

A statistically significant change in the pain domain of the SF-36 shows that with effective treatment of gout a patient's quality of life can improve. This agrees with one previous study27 that found a statistically significant improvement in six of the SF-36 domains after 12 months of ULT, with the largest improvement in the bodily pain domain. However, they excluded patients who had had a gout flare in the 4 weeks before completing the questionnaire, which may explain the increased number of significantly improved domains.

There are several caveats to this study. First, although the response rate to the questionnaire was reasonable, not all patients with gout accepted the invitation to take part in the study so there may have been selection bias towards those patients who were more interested in receiving treatment. Second, the duration of the study was only 12 months, which is too short a period to expect complete elimination of urate crystals from all participants and to demonstrate ‘cure’. Nevertheless, the mean frequency of attacks was less during the study period than in the previous year and the size and number of tophi in those with subcutaneous deposits was diminishing, suggesting that given longer follow-up all participants with effectively lowered SUA would reach the state of ‘cure’. Third, this was a hospital-based study in which participants were fully assessed by a gout expert within a longer than average initial appointment. Such contextual aspects will have influenced patient expectancy and outcomes, and may limit the generalisability of the findings. However, the year-long follow-up was carried out by a nurse, and nurse-led management of other chronic conditions has been successfully transferred into primary care.15 ,16 Given the excellent outcome such a predominantly nurse-led service could prove cost-effective for the NHS. However, further work would need to ascertain whether a nurse-lead community approach could be successful for gout management, and this is the subject of a recently funded forthcoming randomised controlled trial.

In conclusion, this proof-of-concept study has shown that a predominantly nurse-led complex intervention that includes key elements of recommended best practice is successful in achieving the therapeutic target and maintaining high adherence to ULT over a 12-month period in more than nine out of 10 people with clinically evident gout. Further study is required to determine whether a similar nurse-led intervention can be delivered successfully over a longer period in primary care and result in a higher rate of ‘cure’ than is currently seen in people with gout.