Teoh Novell, Gamble Gregory D, Horne Anne, Taylor William J, Palmano Kate, Dalbeth Nicola
1Faculty of Medical and Health Sciences, University of Auckland, 85 Park Rd, Grafton, Auckland, New Zealand.
2Department of Medicine, Faculty of Medical and Health Sciences, University of Auckland, 85 Park Rd, Grafton, Auckland, New Zealand.
BMC Rheumatol. 2019 Jul 9;3:27. doi: 10.1186/s41927-019-0075-6. eCollection 2019.
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.
研究环境中痛风发作报告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模式，并评估痛风临床试验中不同发作报告方法的同时效度。
分析了一项针对120例痛风患者的随机对照试验中每日发作日记条目，包括发作的自我报告和疼痛量表。检查并分析了每位参与者详细的逐时疼痛图，以了解自我报告和2012年加福开发的分类树（CART）定义发作的不同发作报告方法。分析了不同发作报告方法的同时效度。
尽管单次痛风发作有一个“典型”的平均模式（第1天达到峰值，14天内缓解），但个体逐时疼痛图显示发作的疼痛强度、持续时间和频率差异很大。在四个月的研究期间，120名参与者中有84名（70%）经历了至少一次自我报告的发作，而这些发作并非“典型”发作。首次自我报告发作的时间与痛风活动的其他指标以及其他发作报告方法的相关性较差。发作天数（自我报告或加福定义）和逐时疼痛曲线下面积与疾病严重程度的其他指标相关性最强。
痛风患者发作模式随时间变化差异很大，给临床试验中的发作报告带来了挑战。基于时间的报告策略，如发作天数或逐时疼痛曲线下面积，与痛风疾病严重程度的其他指标相关性良好，可能提供更准确的发作负担衡量指标。
临床试验编号：ACTRN12609000479202，于2009年6月17日注册。
