Progress towards a core set of outcome measures in small-vessel vasculitis. Report from OMERACT 9.
Progress towards a core set of outcome measures in small-vessel vasculitis. Report from OMERACT 9.
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DOI：
10.3899/jrheum.090373
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发表时间：
2009-10
期刊：
影响因子：
--
通讯作者：
Luqmani R
中科院分区：
文献类型：
--
作者：
Merkel PA;Herlyn K;Mahr AD;Neogi T;Seo P;Walsh M;Boers M;Luqmani R
过去十年，血管炎新疗法的临床试验数量和质量大幅增加，包括成功纳入疾病活动和毒性措施的随机、对照、多中心试验。然而，由于目前针对严重疾病的治疗方案有效地诱导初始缓解并降低死亡率，未来的试验将集中于以下几个目标中的任何一个，包括：（a）治疗轻中度疾病;（B）预防慢性损伤;（c）减少治疗毒性;或（d）缓解诱导或维持的更细微差异。因此，新的试验将需要更精确的结果测量工具，能够更好地检测不同疾病状态的有效治疗方法，并测量疾病的慢性表现。OMERACT血管炎工作组由具有血管炎专业知识的国际临床研究人员组成，自2002年以来，他们一直在合作推进血管炎结局指标的完善，创建新的措施来解决当前研究方法未涵盖的疾病领域，并协调血管炎的结局评估。迄今为止，OMERACT小组的重点一直是小血管血管炎的结局指标，其总体目标是创建一套核心的血管炎结局指标，每一项指标都符合OMERACT的真实性、鉴别力、可行性过滤器，并确定需要进一步研究的其他领域。这一过程得到了几个正在进行的项目的信息，这些项目提供了有关疾病活动结果、疾病相关损害、多维健康相关生活质量和患者报告的血管炎负担评级的数据。
The past decade has seen a substantial increase in the number and quality of clinical trials of new therapies for vasculitis, including randomized, controlled, multicenter trials that have successfully incorporated measures of disease activity and toxicity. However, because current treatment regimens for severe disease effectively induce initial remission and reduce mortality, future trials will focus on any of several goals including: (a) treatment of mild—moderate disease; (b) prevention of chronic damage; (c) reduction in treatment toxicity; or (d) more subtle differences in remission induction or maintenance. Thus, new trials will require outcome measure instruments that are more precise and are better able to detect effective treatments for different disease states and measure chronic manifestations of disease. The OMERACT Vasculitis Working Group comprises international clinical investigators with expertise in vasculitis who, since 2002, have worked collaboratively to advance the refinement of outcome measures in vasculitis, create new measures to address domains of illness not covered by current research approaches, and harmonize outcome assessment in vasculitis. The focus of the OMERACT group to date has been on outcome measures in small-vessel vasculitis with an overall goal of creating a core set of outcome measures for vasculitis, each of which fulfills the OMERACT filter of truth, discrimination, feasibility, and identifying additional domains requiring further research. This process has been informed by several ongoing projects providing data on outcomes of disease activity, disease-related damage, multidimensional health-related quality of life, and patient-reported ratings of the burden of vasculitis.
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影响因子：
7.2
作者：
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通讯作者：
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