痛风临床试验中血清尿酸和痛风发作报告的变异性：最低报告要求的必要性。
Variability in the Reporting of Serum Urate and Flares in Gout Clinical Trials: Need for Minimum Reporting Requirements.
机构信息
From the Department of Medicine, University of Otago, Christchurch, Wellington; Department of Medicine, University of Auckland, Auckland, New Zealand; Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen; Department of Rheumatology, Odense University Hospital, Odense; Department of Medicine, Vejle Hospital, Vejle, Denmark; Department of Medicine, University of Alabama at Birmingham and Birmingham Veterans Affairs Medical Center, Birmingham, Alabama, USA; Department of Rheumatology, St. George Hospital, University of New South Wales (NSW), Sydney, Australia.
L.K. Stamp, MBChB, PhD, FRACP, Department of Medicine, University of Otago; M.B. Morillon, MD, Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Department of Rheumatology, Odense University Hospital, and Department of Medicine, Vejle Hospital; W.J. Taylor, MBChB, PhD, FRACP, Department of Medicine, University of Otago; N. Dalbeth, MBChB, MD, FRACP, Department of Medicine, University of Auckland; J.A. Singh, MD, MPH, Department of Medicine, University of Alabama at Birmingham and Birmingham Veterans Affairs Medical Center; M. Lassere, MBBS (Hons) Grad Dip Epi, PhD, FRACP, FAFPHM, Department of Rheumatology, St. George Hospital, University of NSW; R. Christensen, MSc, PhD, Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital.
出版信息
J Rheumatol. 2018 Mar;45(3):419-424. doi: 10.3899/jrheum.170911. Epub 2017 Dec 15.
OBJECTIVE
To describe the ways in which serum urate (SU) and gout flares are reported in clinical trials, and to propose minimum reporting requirements.
METHODS
This analysis was done as part of a systematic review aiming to validate SU as a biomarker for gout. The ways in which SU and flares were reported were extracted from each study by 2 reviewers.
RESULTS
A total of 22 studies (10 randomized controlled trials, 3 open-label extension studies, and 9 observational studies) were identified. There were 3 broad categories of SU reporting: percentage at target SU, mean SU, and change in SU. A median of 2 (range 1-3) categories were reported across all studies. The most common method of reporting SU was percentage at target in 17/22 (77.3%) studies, with all studies reporting a target of SU < 6 mg/dl. There were 12/22 (54.5%) studies reporting mean SU at some time after study entry, with 7 (58.3%) of these reporting at more than just the final study visit. Two ways of reporting gout flares were identified: mean flare rate and percentage of participants with flares. There was variability in time periods over which flares rates were reported.
CONCLUSION
There is inconsistent reporting of SU and flares in gout studies. Reporting the percentage of participants who achieve a target SU reflects international treatment guidelines. SU should also be reported as a continuous variable with a relevant central and dispersion estimate. Gout flares should be reported as both percentage of participants and mean flare rates at each timepoint.
目的
描述临床试验中血清尿酸（SU）和痛风发作的报告方式，并提出最低报告要求。
方法
这一分析是作为一项旨在验证 SU 作为痛风生物标志物的系统评价的一部分进行的。通过两名审阅者从每项研究中提取 SU 和发作的报告方式。
结果
共确定了 22 项研究（10 项随机对照试验、3 项开放标签扩展研究和 9 项观察性研究）。SU 的报告有 3 种广泛的类别：目标 SU 的百分比、SU 的平均值和 SU 的变化。所有研究均报告 SU 目标值<6mg/dl，中位数为 2（范围 1-3）个类别。最常见的报告 SU 的方法是在 17/22（77.3%）项研究中报告目标 SU 的百分比，在所有研究中，有 7（58.3%）项研究报告了除最后一次研究访问之外的其他时间点的 SU 平均值。有 12/22（54.5%）项研究报告了某些时间点的 SU 平均值，其中 7（58.3%）项研究报告了除最后一次研究访问之外的其他时间点的 SU 平均值。报告痛风发作的有两种方式：平均发作率和有发作的参与者百分比。报告发作率的时间段存在差异。
结论
痛风研究中对 SU 和发作的报告不一致。报告达到 SU 目标的参与者百分比反映了国际治疗指南。SU 还应作为连续变量报告，包括相关的中心和离散估计值。痛风发作应分别以每个时间点的参与者百分比和平均发作率报告。
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