International consensus outcome measures for patients with idiopathic inflammatory myopathies. Development and initial validation of myositis activity and damage indices in patients with adult onset disease
International consensus outcome measures for patients with idiopathic inflammatory myopathies. Development and initial validation of myositis activity and damage indices in patients with adult onset disease
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DOI：
10.1093/rheumatology/keg427
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发表时间：
2004-01-01
期刊：
影响因子：
5.5
通讯作者：
Miller, F
中科院分区：
文献类型：
--
作者：
Isenberg, DA;Allen, E;Miller, F
Objective.设计新的工具来评估特发性肌病（IIM）患者的活动和损伤。已经建立了一个国际多学科共识，以标准化肌炎临床试验的实施和报告。已经开发了两种工具，称为肌炎意向治疗指数（MITAX）和肌炎疾病活动评估视觉模拟量表（MYOACT），以捕获IIM患者的活动。此外，还设计了肌炎损伤指数（MDI）来评估不同器官和系统中损伤的程度和严重程度。这些措施已经审查了肌炎专家参加国际肌炎评估和临床研究（IMACS）组，并已被发现有良好的表面效度和全面。在两个真实的患者练习中对器械进行了评估，包括成人皮肌炎和包涵体肌炎患者。MITAX、MYOACT和MDI的可靠性（通过医生之间的组内相关系数测量）和评定者间可靠性（通过医生对患者的评定变化评估）在工具的大多数方面都是良好的。在参与者完成额外培训后的第二次练习中，可靠性和评分员间一致性有所改善。目前正在进行有效性测试的MITAX、MYOACT和MDI工具应能增强肌炎患者疾病活动和损害评估的一致性、全面性和可靠性。
Objective. To devise new tools to assess activity and damage in patients with idiopathic myopathies (IIM).Methods. An international multidisciplinary consensus effort to standardize the conduct and reporting of the myositis clinical trials has been established. Two tools, known as the myositis intention to treat index (MITAX) and the myositis disease activity assessment visual analogue scale (MYOACT), have been developed to capture activity in patients with IIM. In addition, the myositis damage index (MDI) has been devised to assess the extent and severity of damage developing in different organs and systems. These measures have been reviewed by the myositis experts participating in the International Myositis Assessment and Clinical Studies (IMACS) group and have been found to have good face validity and to be comprehensive. The instruments were assessed in two real patient exercises involving patients with adult dermatomyositis and inclusion body myositis.Results. The reliability of MITAX, MYOACT and MDI, measured by the intraclass correlation coefficient among the physicians, and the inter-rater reliability, as assessed by variation in the physicians' rating of patients, was fair to good for most aspects of the tools. Reliability and inter-rater agreement improved at the second exercise after the participants had completed additional training.Conclusions. The MITAX, MYOACT and MDI tools, which are now undergoing validity testing, should enhance the consistency, comprehensiveness and reliability of disease activity and damage assessment in patients with myositis.