Johnson Sindhu R, Feldman Brian M, Hawker Gillian A
Division of Rheumatology, University Health Network, University of Toronto, Toronto, Ontario, Canada.
J Rheumatol. 2007 Sep;34(9):1855-63. Epub 2007 Aug 1.
To evaluate the measurement properties of criteria for systemic sclerosis (SSc) subsets for classification of patients in SSc trials, and to determine if any one criteria set confers measurement advantage over others.
A systematic review of articles describing classification criteria for SSc subsets was performed. Evidence supporting the sensibility (statement of purpose for which the criteria will be used, population, setting, face and content validity, and feasibility), validity, and reliability of the criteria was evaluated.
Fourteen sets of criteria for SSc subsets were identified. There is variability in the intended purpose and setting for which criteria sets are to be applied. Although face validity improves with the addition of less commonly encountered subsets or disease manifestations as criteria, the feasibility of implementing such criteria is conversely limited. Content validity for most criteria sets has not been evaluated due to lack of an explicitly stated conceptual framework for SSc. The criteria with 3 or more subsets do not provide incremental predictive validity over the 2-subset criteria. Our ability to compare subset criteria on divergent validity and reliability is limited by a lack of data.
The 2-subset criteria of LeRoy, et al have good feasibility, acceptable face validity, and good predictive validity. Further research is needed to compare the content validity, divergent validity, and reliability of these with other subset criteria for use in SSc trials.
评估系统性硬化症（SSc）亚组分类标准在SSc试验中对患者分类的测量属性，并确定是否有任何一套标准在测量方面比其他标准更具优势。
对描述SSc亚组分类标准的文章进行系统综述。评估支持这些标准的敏感性（标准使用目的、人群、背景、表面效度和内容效度以及可行性的陈述）、效度和信度的证据。
确定了14套SSc亚组标准。各套标准的预期用途和应用背景存在差异。虽然随着将较少见的亚组或疾病表现作为标准加入，表面效度有所提高，但实施此类标准的可行性却相反受到限制。由于缺乏明确阐述的SSc概念框架，大多数标准集的内容效度尚未得到评估。具有3个或更多亚组的标准相对于2个亚组的标准并未提供额外的预测效度。由于缺乏数据，我们在比较不同效度和信度的亚组标准方面的能力受到限制。
LeRoy等人的2个亚组标准具有良好的可行性、可接受的表面效度和良好的预测效度。需要进一步研究以比较这些标准与其他用于SSc试验的亚组标准的内容效度、区分效度和信度。
