Background/Purpose: Prevention of gout flares is a central concern to patients with gout.  There are many potential ways that gout flares could be reported in long-term clinical trials. The aim of this study was to analyse methods used to measure and report gout flare outcomes in long-term randomized controlled trials (RCTs).

Methods: A systematic search of electronic databases, supplemented with hand-searching of relevant references lists, was conducted. Articles were included if they were RCTs or articles reporting on analyses of RCT data (i.e. open label extension studies) and reported the impact of an intervention on the prevention of flares in people with gout. The modified Jadad scale was used to assess quality. Gout flare data relating to protocols, outcomes and reporting methods were extracted and synthesised separately for studies of anti-inflammatory prophylaxis and urate lowering/other long term therapy.

Results: A total of 38 articles were included, with 10 reporting outcomes for anti-inflammatory prophylaxis and 28 for urate lowering/other long term therapy. The overall quality score of all articles was good. However, there was marked heterogeneity across trials in gout flare-related entry criteria, flare definitions, data capture methods, reporting methods and time periods used to report gout flares. Anti-inflammatory prophylaxis studies used multiple methods to report gout flare outcomes (mean (SD) 4.3 (2.5) methods/article), while the majority of urate lowering/other long term therapy studies used a single method to report gout flare outcomes. The most common reporting method was the proportion of patients with at least one gout flare (n = 29 articles), followed by the mean number of gout flares per patient (n = 18 articles) (Table). Only studies of anti-inflammatory prophylaxis therapy reported flare duration or pain (Table).

Conclusion: There is wide variation in methods used to measure and report gout flare outcomes in long-term RCTs. Studies of anti-inflammatory prophylaxis interventions generally report a range of flare characteristics, including incidence, number of flares, flare duration, and pain intensity. In contrast, studies of urate lowering/other long term therapy report limited data, mostly the proportion of participants experiencing flare.  These findings support the development of standardized methods to measure and report gout flare outcomes that reflect the burden of flares for studies in which gout flare prevention is an outcome of interest.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/how-are-flares-reported-in-long-term-gout-clinical-trials-a-content-analysis-of-randomized-controlled-trials/