Methods of gout flare reporting in research settings are inconsistent and poorly defined. The aim of this study was to describe patterns of gout flare and assess the concurrent validity of different methods of flare reporting in a gout clinical trial. Daily flare diary entries including self-report of flare and pain scale from a randomised controlled trial of 120 patients with gout were analysed. Detailed pain-by-time plots for each participant were inspected and analysed for different methods of flare reporting for both self-report and the classification tree (CART)-defined flare developed by Gaffo in 2012. Concurrent validity for different methods of flare reporting were analysed. Although the single gout flare had a ‘typical’ average pattern (peak on day 1 and resolution over 14 days), individual pain-by-time plots showed wide variation in pain intensity, duration and frequency of flares. Over the four-month study period, there were 84/120 (70%) participants who experienced at least one self-reported flare that was not a ‘typical’ flare. The time to first self-reported flare correlated poorly with other measures of gout activity and other methods of flare reporting. The number of days with flare (either self-reported or Gaffo-defined) and the area under the pain-by-time curve correlated most strongly with other measures of disease severity. There is wide variation in the patterns of flare over time in individuals with gout, leading to challenges for flare reporting in clinical trials. Time-dependent reporting strategies such as number of days with flare or area under the pain-by-time curve correlate well with other measures of gout disease severity and may provide a more accurate measure of flare burden. Clinical trial number: ACTRN12609000479202 , registered 17/06/2009.

中文翻译：

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痛风突发报告的挑战：随机对照试验中的突发事件

在研究环境中报告痛风发作的方法不一致且定义不明确。本研究的目的是描述痛风发作的模式，并评估痛风临床试验中不同发作报告方法的同时有效性。分析了来自 120 名痛风患者的随机对照试验的每日发作日记条目，包括发作的自我报告和疼痛量表。针对自我报告和 Gaffo 于 2012 年开发的分类树 (CART) 定义的耀斑，检查和分析了每个参与者的详细疼痛时间图。不同耀斑报告方法的同时有效性是分析。尽管单次痛风发作具有“典型”的平均模式（第 1 天达到峰值，14 天后消退），个体疼痛时间图显示疼痛强度、持续时间和发作频率存在很大差异。在四个月的研究期间，有 84/120 (70%) 名参与者经历了至少一次自我报告的非“典型”耀斑。首次自我报告发作的时间与痛风活动的其他测量和其他发作报告方法的相关性较差。发作的天数（自我报告或 Gaffo 定义）和疼痛时间曲线下的面积与疾病严重程度的其他测量最密切相关。随着时间的推移，痛风患者的发作模式存在很大差异，这给临床试验中的发作报告带来了挑战。与时间相关的报告策略，例如发作天数或疼痛时间曲线下的面积与痛风疾病严重程度的其他测量值密切相关，并且可以提供更准确的发作负担测量。临床试验编号：ACTRN12609000479202，注册日期：17/06/2009。