Background/Purpose

There are currently no agreed remission criteria for gout. The aim of this study was to establish consensus for elements of potential remission criteria for use in clinical trials of gout.

Methods

Experts in gout from multiple countries (n=88) were invited by email to participate in this web-based questionnaire study to identify remission criteria as an outcome measure for gout clinical trials.  For the purposes of this project, remission was defined as the absence of symptoms and signs attributable to gout, when these symptoms or signs can or are expected to return in the future (for example, if the patient stopped treatment). Three rounds of a Delphi consensus exercise were conducted by online survey.  Questions focused on domains for inclusion in remission criteria, based on the OMERACT core domains for chronic gout studies. Respondents were then asked to choose which option would indicate remission for each domain.  Consensus in the Delphi exercise was defined as >80% agreement in responses. The Delphi exercise was followed by a discrete choice experiment using 1000Minds to further explore the extent of variation in relative weighting for components of remission (particularly the time over which no flares should be observed).

Results

There were 49 respondents (56% response rate). There was consensus about which domains should be included in remission criteria from the Delphi exercise; 98% agreement for serum urate, 96% for flares, 92% tophi, 83% pain due to gout and 93% patient global assessment of gout disease activity (PGA). Consensus was reached that serum urate measurements should be measured at least twice over a set timeframe and that all measurements should be <6mg/dL (94% agreement). There also was consensus that, for both pain and PGA measurements, the results of two separate measurements over a set timeframe would be averaged.  There was agreement that timeframes of three months or less were not suitable for measurement of remission.  However, consensus was not achieved in the Delphi exercise about the timeframe for remission with equal responses for six months (51%) and one year (49%).  In the discrete choice experiment, the range of opinions remained widely distributed, indicating an ongoing lack of consensus between the 6 and 12 month timeframe. The difference in relative weighting accorded to ‘no flares observed over 12 months’ compared to ‘no flares observed over 6 months’ ranged from 0.04 to 0.26 (out of a total weighting available of 1.0), with the middle 80% of respondents ranging from 0.04 to 0.24.  

Conclusion

These consensus exercises have identified domains for remission criteria for gout, and methods for reporting these domains.  Additional analysis is required to determine the relative advantages of a 6 or 12 month timeframe, particularly for the observation of no flare.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/development-of-preliminary-remission-criteria-for-gout-using-delphi-and-1000minds-consensus-exercises/