Gout is the most common inflammatory arthritis worldwide with a prevalence in the UK of around 2.5%. Gout results from sodium urate crystals that form when sodium urate persistently exceeds saturation. Deposition of sodium urate crystals causes extremely painful gout flares, joint damage and subcutaneous nodules, known as tophi.
Despite a good understanding of the disease and the availability of effective treatment, gout care remains suboptimum. In the UK, gout is managed predominantly in primary care by general practitioners (GPs), but less than half of patients receive urate-lowering therapy. Further, in those who do receive urate-lowering therapy the dose is usually fixed without titration to achieve a target serum urate concentration.
The present trial was conducted at 56 general practices. Potential participants were identified from practice databases and screened by postal questionnaire. Patient eligibility was confirmed by a research nurse. All eligible participants were greater than 21 years old, had a confirmed diagnosis of gout and had at least one gout flare in the previous 12 months. Randomisation was undertaken by the research nurse telephoning a central co-ordinating centre and the allocation was 1:1 to either nurse-led care or usual GP-led care. The trial duration was 2 years.
Nurses delivering the nurse-led arm received full training in gout and its management according to national and international guidelines and recommendations. Follow up patient assessments, including sodium urate concentrations, were done as often as the nurse required. Urate-lowering therapy was prescribed according to a guideline. First line treatment was oral allopurinol, started at 100mg once per day and titrated upwards in 100mg increments every 3-4 weeks according to the serum urate concentrations, to a maximum of 900mg once per day. As second-line options, oral febuxostat could be started at 80 mg and if required increased to the maximum dose of 120 mg once per day or benzbromarone could be started at 50 mg and titrated up in 50 mg increments to a maximum of 200 mg once per day. Combination urate-lowering therapy (xanthine oxidase inhibitor plus uricosuric) could be used as the final treatment option.
By contrast, the usual care group could discuss treatment of flares at the baseline and annual assessments, but all other enquiries were directed to their GP.
The primary outcome was the percentage of patients who had achieved serum urate concentrations less than 360 μmol/L at 2 years. Secondary outcomes were other serum urate measures (percentage of patients who had achieved serum urate concentrations <360 μmol/L at 1 year, <300 μmol/L at 1 and 2 years, and group mean serum urate concentrations at 1 and 2 years); frequency of gout flares during years 1 and 2; the percentage of patients with tophi overall; the median number of tophi and the maximum diameter of the largest tophus at 1 and 2 years among patients with tophi at baseline; quality of life (physical and mental components) and Gout Impact Scale at 1 and 2 years; and cost-effectiveness, calculated as cost per quality-adjusted life-year (QALY) gained.
A total of 6,806 questionnaires were sent by GP practices with 41% (2,815) being returned. 1,071 reported have flares in the last 12 months and were willing to be contacted further. From these, 505 patients were randomised. In addition, a small number (12) of participants were identified from advertisements giving a total randomised population of 517, comprising 255 assigned to nurse-led care and 262 assigned to usual GP-led care.
The two groups were similar in terms of baseline characteristics. Most were middle-aged white men with average gout duration of 12 years. 203 (39%) were taking urate-lowering therapy at baseline and only around 20% had a serum urate concentration less than 360 μmol/L.
Of 517 patients who started the study, 482 (93%) completed 1 year and 441 (85%) completed 2 years. At 2 years, multiple imputation showed that 95% of participants in the nurse-led group had achieved serum urate concentrations less than 360 μmol/L compared with 30% in the usual care group (RR 3·18, 95% CI 2·42–4·18). A similar difference was seen after 1 year. Use of urate-lowering therapy increased in both groups, but was significantly higher in the nurse-led group: at 2 years, 96% of patients in the nurse-led group were using urate-lowering therapy compared to 56% in the usual-care group. The nurse-led group showed improvements compared to usual care in a range of the secondary outcomes, including flare frequency, presence of tophi and quality of life.
The authors conclude that nurse-led care can achieve high uptake of urate-lowering therapy and good adherence at 2 years. 95% of participants in the nurse-led group achieved the recommended target serum urate concentration of less than 360 μmol/L and patient-centred outcomes, including flare frequency, presence of tophi, and quality of life, improved significantly compared with those in the usual-care group.
You can read the full report here