系统性硬化症临床试验的标准化核心集。联合反应指数开发的第一步。
A standardized core set for systemic sclerosis clinical trials. First step in development of combined response index.
作者信息
Khanna D
机构信息
Department of Medicine, Division of Rheumatology, David Geffen School of Medicine, Los Angeles, CA 90095, USA.
出版信息
Rheumatology (Oxford). 2008 Oct;47 Suppl 5(Suppl 5):v31-2. doi: 10.1093/rheumatology/ken266.
Abstract
SSc can be associated with a high morbidity and mortality. Due to the complexity and heterogeneity of the disease, a composite response measure that will capture differing organ involvements and patient-reported outcomes is desirable. Recently, with participation of the Scleroderma Clinical Trial Consortium, a standardized core set of items were proposed for SSc clinical trials using a structured Delphi exercise. The Delphi exercise identified 11 domains relevant to SSc clinical trials. Currently, efforts are under way to develop a combined response index for clinical trials in diffuse cutaneous SSc.
摘要
系统性硬化症（SSc）可伴有较高的发病率和死亡率。由于该疾病的复杂性和异质性，需要一种能够涵盖不同器官受累情况和患者报告结局的综合反应指标。最近，在硬皮病临床试验联盟的参与下，通过结构化德尔菲法为SSc临床试验提出了一套标准化的核心项目集。德尔菲法确定了11个与SSc临床试验相关的领域。目前，正在努力为弥漫性皮肤型SSc的临床试验制定一个综合反应指数。
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