Faculty of Medicine, University of Ottawa and Ottawa Hospital Research Institute, Centre for Practice Changing Research, 501 Smyth Rd, Ottawa, ON K1H 8L6, Canada.
Sydney Musculoskeletal Health, The University of Sydney and Sydney Local Health District, Sydney, Australia.
Semin Arthritis Rheum. 2024 Jun;66:152423. doi: 10.1016/j.semarthrit.2024.152423. Epub 2024 Feb 29.
To develop a set of detailed definitions for foundational domains commonly used in OMERACT (Outcome Measures in Rheumatology) core domain sets.
We identified candidate domain definitions from prior OMERACT publications and websites and publications of major organizations involved in outcomes research for six domains commonly used in OMERACT Core Domain Sets: pain intensity, pain interference, physical function, fatigue, patient global assessment, and health-related quality of life. We conducted a two-round survey of OMERACT working groups, patient research partners, and then the OMERACT Technical Advisory Group to establish their preferred domain definitions. Results were presented at the OMERACT 2023 Methodology Workshop, where participants discussed their relevant lived experience and identified potential sources of variability giving the needed detail in our domain definitions.
One-hundred four people responded to both rounds of the survey, and a preferred definition was established for each of the domains except for patient global assessment for which no agreement was reached. Seventy-five participants at the OMERACT 2023 Methodology Workshop provided lived experience examples, which were used to contextualise domain definition reports for each of the five domains.
Using a consensus-based approach, we have created a detailed definition for five of the foundational domains in OMERACT core domain sets; patient global assessment requires further research. These definitions, although not mandatory for working groups to use, may facilitate the initial domain-match assessment step of instrument selection, and reduce the time and resources required by future OMERACT groups when developing core outcome sets.
为 OMERACT（风湿病结局测量）核心域集中常用的基础域制定一套详细的定义。
我们从 OMERACT 的先前出版物和网站以及参与结局研究的主要组织的出版物中确定了候选域定义，这些域适用于 OMERACT 核心域集中的六个常用域：疼痛强度、疼痛干扰、身体功能、疲劳、患者总体评估和健康相关生活质量。我们对 OMERACT 工作组、患者研究伙伴进行了两轮调查，然后对 OMERACT 技术咨询小组进行了调查，以确定他们首选的域定义。结果在 OMERACT 2023 年方法学研讨会上进行了介绍，与会者讨论了他们的相关生活经验，并确定了潜在的变异性来源，为我们的域定义提供了所需的细节。
共有 104 人对两轮调查做出了回应，除了没有达成一致意见的患者总体评估之外，每个域都建立了首选定义。在 OMERACT 2023 年方法学研讨会上，75 名参与者提供了生活经验实例，这些实例用于为五个域中的每个域的域定义报告提供背景。
我们使用基于共识的方法为 OMERACT 核心域集中的五个基础域创建了详细的定义；患者总体评估需要进一步研究。这些定义虽然不是工作组必须使用的，但可以促进仪器选择的初始域匹配评估步骤，并减少未来 OMERACT 小组在开发核心结局集时所需的时间和资源。
