Abstract：
BACKGROUND: The Outcome Measures in Rheumatology (OMERACT) Glucocorticoid (GC) Impact Working Group has been working to develop a core domain set to measure the impact of GCs on patients living with rheumatic and musculoskeletal diseases. The mandatory domains previously identified for inclusion in all clinical trials measuring the GC effects include infection, bone fragility, mood disturbance, hypertension, diabetes, weight, fatigue, and mortality. Before progressing to instrument selection, the Working Group sought to establish precise definitions of all mandatory domains within the core domain set.
METHODS: OMERACT methodology was applied with the use of evidence and consensus-based decision making of all stakeholder groups (patient research partners, health care professionals, clinician researchers, industry members and methodologists) to develop detailed definitions for the broad domain, target domain and domain components, taking into consideration sources of variability that could affect measurement of the domain. The working group synthesized prior qualitative studies, quantitative work, and results from Delphi rounds, to develop a rich definition of \'what\' is to be measured.
RESULTS: Between 2021 and 2023, the OMERACT Working Group on GC Impact conducted virtual meetings to establish domain definitions. First, we mapped each domain onto an OMERACT Core Area. All domains were primarily represented within the Pathophysiological Manifestations Core Area, except from Fatigue which was primarily Life Impact and Weight which spanned both Core Areas. Sources of variability included cultural factors, age, gender, education level, socioeconomic status, personal experiences, emotional state, and language barriers. The domain definitions will form the foundation for instrument selection and the initial step of domain / concept match and content validity in the OMERACT pillar of \'truth\' before moving on to feasibility and discrimination.
CONCLUSIONS: The OMERACT GC Impact Working Group has developed and agreed upon detailed domain definitions for core domains. Future steps of the working group are to select instruments and develop the core outcome measurement set for clinical trials measuring the impact of GC on patients with rheumatic and musculoskeletal diseases.
METHODS: OMERACT methodology was applied with the use of evidence and consensus-based decision making of all stakeholder groups (patient research partners, health care professionals, clinician researchers, industry members and methodologists) to develop detailed definitions for the broad domain, target domain and domain components, taking into consideration sources of variability that could affect measurement of the domain. The working group synthesized prior qualitative studies, quantitative work, and results from Delphi rounds, to develop a rich definition of \'what\' is to be measured.
RESULTS: Between 2021 and 2023, the OMERACT Working Group on GC Impact conducted virtual meetings to establish domain definitions. First, we mapped each domain onto an OMERACT Core Area. All domains were primarily represented within the Pathophysiological Manifestations Core Area, except from Fatigue which was primarily Life Impact and Weight which spanned both Core Areas. Sources of variability included cultural factors, age, gender, education level, socioeconomic status, personal experiences, emotional state, and language barriers. The domain definitions will form the foundation for instrument selection and the initial step of domain / concept match and content validity in the OMERACT pillar of \'truth\' before moving on to feasibility and discrimination.
CONCLUSIONS: The OMERACT GC Impact Working Group has developed and agreed upon detailed domain definitions for core domains. Future steps of the working group are to select instruments and develop the core outcome measurement set for clinical trials measuring the impact of GC on patients with rheumatic and musculoskeletal diseases.
摘要：
背景：风湿病学（OMERACT）糖皮质激素（GC）影响工作组的结果指标一直在努力开发一个核心领域，以测量GC对风湿性和肌肉骨骼疾病患者的影响。先前确定纳入所有测量GC效应的临床试验的强制性领域包括感染，骨骼脆弱,情绪障碍,高血压,糖尿病,体重,疲劳,和死亡率。在进行仪器选择之前，工作组试图建立核心域集中所有强制性域的精确定义。
方法：OMERACT方法应用于所有利益相关者团体（患者研究伙伴，卫生保健专业人员,临床医生研究人员，行业成员和方法学家)为广泛的领域制定详细的定义，目标域和域组件，考虑到可能影响域测量的变异性来源。工作组综合了先前的定性研究，定量工作,和Delphi轮的结果，对“要测量的内容”进行丰富的定义。
结果：在2021年至2023年之间，OMERACTGCImpact工作组举行了虚拟会议，以建立域定义。首先,我们将每个域映射到OMERACT核心区。所有领域主要代表在病理生理表现核心区，除了主要是寿命影响和跨越两个核心区域的重量的疲劳。变异性的来源包括文化因素，年龄,性别,教育水平,社会经济地位,个人经历,情绪状态,和语言障碍。领域定义将成为工具选择的基础，以及在OMERACT支柱中的领域/概念匹配和内容有效性的初始步骤，然后再进行可行性和区分。
结论：OMERACTGC影响工作组已经制定并商定了核心域的详细域定义。工作组的未来步骤是选择仪器并开发用于临床试验的核心结果测量集，以测量GC对风湿性和肌肉骨骼疾病患者的影响。
方法：OMERACT方法应用于所有利益相关者团体（患者研究伙伴，卫生保健专业人员,临床医生研究人员，行业成员和方法学家)为广泛的领域制定详细的定义，目标域和域组件，考虑到可能影响域测量的变异性来源。工作组综合了先前的定性研究，定量工作,和Delphi轮的结果，对“要测量的内容”进行丰富的定义。
结果：在2021年至2023年之间，OMERACTGCImpact工作组举行了虚拟会议，以建立域定义。首先,我们将每个域映射到OMERACT核心区。所有领域主要代表在病理生理表现核心区，除了主要是寿命影响和跨越两个核心区域的重量的疲劳。变异性的来源包括文化因素，年龄,性别,教育水平,社会经济地位,个人经历,情绪状态,和语言障碍。领域定义将成为工具选择的基础，以及在OMERACT支柱中的领域/概念匹配和内容有效性的初始步骤，然后再进行可行性和区分。
结论：OMERACTGC影响工作组已经制定并商定了核心域的详细域定义。工作组的未来步骤是选择仪器并开发用于临床试验的核心结果测量集，以测量GC对风湿性和肌肉骨骼疾病患者的影响。
