Salaffi F, Ciapetti A, Sarzi Puttini P, Atzeni F, Iannuccelli C, Di Franco M, Cazzola M, Bazzichi L
Università Politecnica delle Marche.
Reumatismo. 2012 Mar 19;64(1):27-34. doi: 10.4081/reumatismo.2012.27.
Fibromyalgia (FM) is a complex syndrome that, in Italy, affects at least 2% of the adult population. It is characterized by chronic widespread musculoskeletal pain often accompanied by multiple other symptoms. The aim of this study was to identify a set of clinical domains for FM considered relevant by both clinicians and patients using a consensus process.
Consensus was achieved using the Delphi method based on questionnaires and systematic, controlled opinion feedback. The Delphi exercise involved a panel of 252 rheumatologists and 86 patients with FM as defined by the American College of Rheumatology criteria. All of the patients and clinicians were asked to rank the relative different domains of FM in order of priority. The content validity index (CVI) was used to establish the percentage agreement. The importance of each item was ranked on a 0-3 Likert scale. The frequency, mean relevance scores, and frequency importance product were also calculated.
The Delphi exercise showed that the domains ranked highest by patients were similar to those of the clinicians, with the exception of tender point intensity (considered relevant by the clinicians but not by the patients) and environmental sensitivity (considered important by the patients but not by the clinicians). A final 8-item model was developed which was considered to demonstrate adequate validity.
The Delphi exercises identified and ranked relevant key clinical domains that need to be assessed in FM research. On the basis of these results, a new patient-reported composite outcome index can be developed and used in clinical trials.
纤维肌痛（FM）是一种复杂的综合征，在意大利，至少2%的成年人口受其影响。其特征为慢性广泛性肌肉骨骼疼痛，常伴有多种其他症状。本研究的目的是通过共识过程确定一组临床医生和患者均认为与FM相关的临床领域。
基于问卷及系统、可控的意见反馈，采用德尔菲法达成共识。德尔菲调查涉及一个由252名风湿病学家和86名符合美国风湿病学会标准定义的FM患者组成的小组。所有患者和临床医生均被要求按优先顺序对FM的不同相关领域进行排序。内容效度指数（CVI）用于确定一致率。各项目的重要性按0至3李克特量表进行排序。还计算了频率、平均相关性得分及频率重要性乘积。
德尔菲调查显示，患者排序最高的领域与临床医生的相似，但压痛点强度（临床医生认为相关，患者不认为）和环境敏感性（患者认为重要，临床医生不认为）除外。最终形成了一个8项模型，被认为具有足够的效度。
德尔菲调查确定并排列了FM研究中需要评估的相关关键临床领域。基于这些结果，可开发一种新的患者报告综合结局指标并用于临床试验。
