Department of Health Sciences and Health Policy, University of Lucerne, Lucerne, Switzerland.
J Rheumatol. 2011 Aug;38(8):1739-44. doi: 10.3899/jrheum.110395.
To contribute to the discussion on a common approach for domain selection in the Outcomes in Rheumatology Clinical Trials (OMERACT) process. First, this article reports on the consistency in the selection and names of the domains of the current OMERACT core set, and next on the comparability of the specifications of concepts that are relevant within the domains. For this purpose, a convenience sample of 4 OMERACT core sets was used: rheumatoid arthritis (RA), psoriatic arthritis (PsA), longitudinal observational studies (LOS) in rheumatology, and ankylosing spondylitis (AS). Domains from the different core sets were compared directly. To be able to compare the specific content of the domains, the concepts contained in the questionnaires that were considered or proposed to measure the domains were identified and linked to the category of the International Classification of Functioning, Disability, and Health (ICF) that best fit that construct. Large differences in the domains, and lack of domain definitions, were noted among the 4 OMERACT core sets. When comparing the concepts in the questionnaires that represent the domains, core sets differed also in the number and type of constructs that were addressed within each of the domains. Especially for the specification of the concepts within the domains Discomfort and Disability, the ICF proved to be useful as external reference to classify the different constructs. Our exercise suggests that the OMERACT process could benefit from a standardized approach to select, define, and specify domains, and demonstrated that the ICF is useful for further classification of the more specific concepts of "what to measure" within the domains. A clear definition and classification of domains and their specification can be useful as a starting point to build a pool of items that could then be used to develop new instruments to assess functioning and health for rheumatological conditions.
为了促进在 OMERACT（Outcomes in Rheumatology Clinical Trials，关节病临床试验结局指标倡议）过程中选择域的通用方法的讨论。首先，本文报告了当前 OMERACT 核心集的选择和名称的一致性，其次是相关域内概念规范的可比性。为此，使用了 4 个 OMERACT 核心集的便利样本：类风湿关节炎（RA）、银屑病关节炎（PsA）、风湿病的纵向观察研究（LOS）和强直性脊柱炎（AS）。直接比较了来自不同核心集的域。为了能够比较域的具体内容，确定了包含在被认为或提议用于测量域的问卷中的概念，并将其链接到最适合该结构的国际功能、残疾和健康分类（ICF）类别。在 4 个 OMERACT 核心集中注意到域之间存在很大差异，并且缺乏域定义。当比较代表域的问卷中的概念时，核心集在每个域中所涉及的结构的数量和类型上也存在差异。特别是对于域内不适和残疾的概念的规范，ICF 被证明是有用的外部参考，用于对不同结构进行分类。我们的研究表明，OMERACT 过程可以从选择、定义和指定域的标准化方法中受益，并证明 ICF 可用于进一步分类域内更具体的“测量什么”概念。域的明确定义和分类及其规范可作为构建可用于开发评估风湿性疾病功能和健康的新工具的项目库的起点。
