School of Epidemiology and Public Health, University of Ottawa Heart Institute, University of Ottawa, Ottawa, Canada.
Division of Rheumatology, Department of Medicine, School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada.
Semin Arthritis Rheum. 2021 Dec;51(6):1370-1377. doi: 10.1016/j.semarthrit.2021.11.001. Epub 2021 Nov 6.
The OMERACT Technical Advisory Group recognises that working groups during the process of creating a core outcome set may identify an outcome domain that would be best represented as a composite that encapsulates these component outcome domains by bringing them together into a single outcome. A multi-outcome domain (MOD) is a within-patient combination of component outcomes, and an individual patient's evaluation depends on the observation of all of the components in that patient with a single overall rating determined according to a specified rule; which is often applicable when we consider a disease activity score. A composite outcome domain (COD) consists of a number of component outcomes and is defined as the occurrence in a patient of one, some or all of these specified components; which is often applicable when we consider the risk of adverse events or remission criteria. We review the general benefits, challenges, reporting and interpretation of using MODs and CODs. The development of the MOD or COD instrument for an OMERACT core outcome measurement set is considered through four distinct steps: choosing relevant outcome domains; finding high quality instruments for each of these outcome domains; weighting the outcome domain instruments in the MOD/COD instrument; and putting MOD/COD instrument through the OMERACT Filter. Guidance and training are in preparation for working groups who will be completing the OMERACT Instrument Selection Algorithm (OFISA). As for other initiatives in OMERACT, we will seek feedback from OMERACT working groups who complete the development of their MOD/COD, which will then be incorporated into the refinement of the guidance and training.
OMERACT 技术顾问组认识到，在创建核心结局集的过程中，工作组可能会确定一个结局领域，最好通过将这些组成部分结局领域结合在一起形成单个结局来表示为一个复合结局。多结局领域（MOD）是患者内在的组成部分结局的组合，患者的个体评估取决于对该患者所有组成部分的观察，并根据特定规则确定单一的总体评分；这在我们考虑疾病活动评分时通常是适用的。复合结局领域（COD）由多个组成部分结局组成，定义为患者中发生的这些指定组成部分之一、一些或全部；这在我们考虑不良事件风险或缓解标准时通常是适用的。我们回顾了使用 MOD 和 COD 的一般益处、挑战、报告和解释。通过四个不同步骤来考虑为 OMERACT 核心结局测量集开发 MOD 或 COD 仪器：选择相关结局领域；为每个这些结局领域找到高质量的仪器；在 MOD/COD 仪器中加权结局领域仪器；并通过 OMERACT 过滤器对 MOD/COD 仪器进行测试。正在为将完成 OMERACT 仪器选择算法（OFISA）的工作组提供指导和培训。与 OMERACT 中的其他倡议一样，我们将寻求完成其 MOD/COD 开发的 OMERACT 工作组的反馈，然后将其纳入指导和培训的改进中。
