Mease Philip, Arnold Lesley M, Bennett Robert, Boonen Annelies, Buskila Dan, Carville Serena, Chappell Amy, Choy Ernest, Clauw Daniel, Dadabhoy Dina, Gendreau Michael, Goldenberg Don, Littlejohn Geoffrey, Martin Susan, Perera Philip, Russell I Jon, Simon Lee, Spaeth Michael, Williams David, Crofford Leslie
Seattle Rhumatology Associates, Seattle, WA 98104, USA.
J Rheumatol. 2007 Jun;34(6):1415-25.
The fibromyalgia syndrome (FM) workshop at OMERACT 8 continued the work initiated in the first FM workshop at OMERACT 7 in 2004. The principal objectives were to work toward consensus on core domains for assessment in FM studies, evaluate the performance quality of outcome measures used in a review of recent trials in FM, and discuss the research agenda of the FM working group. An initiative to include the patient perspective on identification and prioritization of domains, consisting of focus groups and a patient Delphi exercise, was completed prior to OMERACT 8. Patient-identified domains were, for the most part, similar to those identified by clinician-investigators in terms of symptoms and relative importance. However, patients identified certain domains, such as stiffness, that were not included by physicians, and emphasized the importance of domains such as dyscognition and impaired motivation. Many of the principal domains agreed upon by the clinician-investigators, patients, and OMERACT participants, including pain, fatigue, sleep, mood, and global measures, have been used in clinical trials and performed well when viewed through the OMERACT filter. The research agenda items reviewed and approved for continued study included development of objective "biomarkers" in FM, development of a responder index for FM, and coordination with the WHO's International Classification of Functioning Disability and Health (ICF) Research Branch and the US National Institutes of Health's Patient Reported Outcome Measures Information System network (PROMIS) to develop improved measures of function, quality of life, and participation. The OMERACT process has provided a framework for identification of key domains to be assessed and a path toward validation and standardization of outcome measures for clinical trials in FM.
在国际风湿病治疗和研究成果评估网络(OMERACT)第8届会议上举办的纤维肌痛综合征(FM)研讨会延续了2004年在OMERACT第7届会议上首次举办的FM研讨会所开创的工作。主要目标是努力就FM研究评估的核心领域达成共识,评估在近期FM试验综述中所使用的疗效指标的性能质量,并讨论FM工作组的研究议程。在OMERACT第8届会议之前,已完成了一项纳入患者对领域识别和优先排序观点的倡议,该倡议包括焦点小组讨论和患者德尔菲法练习。患者识别出的领域在症状和相对重要性方面大多与临床研究人员识别出的领域相似。然而,患者识别出了某些未被医生纳入的领域,如僵硬,并强调了认知障碍和动机受损等领域的重要性。临床研究人员、患者和OMERACT参与者达成共识的许多主要领域,包括疼痛、疲劳、睡眠、情绪和整体指标,已在临床试验中使用,并且从OMERACT的标准来看表现良好。审查并批准继续研究的议程项目包括开发FM的客观“生物标志物”、开发FM的反应者指数,以及与世界卫生组织的《国际功能、残疾和健康分类》(ICF)研究处和美国国立卫生研究院的患者报告结局测量信息系统网络(PROMIS)进行协调,以开发改进的功能、生活质量和参与度测量方法。OMERACT流程为识别待评估的关键领域提供了框架,并为FM临床试验疗效指标的验证和标准化指明了道路。