Assessment of Patients with Fibromyalgia Syndrome

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Abstract
Objectives: The purpose of this review is to describe the current state of consensus on the key clinical domains which constitute fibromyalgia syndrome [FMS], from both the clinician and patient perspective, and the outcome measures being used or in development to assess these domains in clinical research. Results: In a series of Delphi exercises and patient focus groups, both clinicians and patients concurred that key domains which constitute the experience of FMS and should be assessed in clinical research include pain, fatigue, sleep disturbance, multidimensional function, health-related quality of life, mood disturbance, and problems with cognition. In addition, clinicians are concerned about assessing treatment side effects and patients feel that stiffness should be assessed. Most of these domains, save dyscognition and stiffness, are currently being assessed with a variety of outcome measures in clinical trials. The performance quality of these instruments is reviewed. Areas in which further research and development is needed and, to a certain extent, underway to improve the assessment of these domains is described. Other areas of methodologic research include the establishment of “minimal clinically important difference” thresholds for outcome measures and the development of a composite responder index for FMS. Conclusions: The field of outcome assessment of FMS is maturing rapidly, both as a result of increased awareness of the importance of the clinical problem as well as the emergence of new effective therapies. Developments in this field are reviewed, including the determination and prioritization of key domains that constitute the syndrome and the performance characteristics of outcome measures for those domains.