Clinical Domains of Fibromyalgia Syndrome: Determination through the OMERACT Process

Objective: The key objective of the Outcome Measures in Rheumatoid Arthritis Clinical Trials [OMERACT] initiative is to improve outcome measurement through a data-driven, interactive consensus process. With increasing research interest and emerging new therapies for treatment of fibromyalgia syndrome, there is a need to develop a consensus on a core set of outcome measures that should be assessed and reported in all clinical trials. Method: At OMERACT 7, the Fibromyalgia working group was established to achieve this aim. Through patient-focus groups and Delphi processes, potential domains to be included in the core data set were identified. A systematic review has shown that instruments measuring these domains are available and are at least moderately sensitive to change. Construct and content validity of these domains were established by data mining of 10 randomized control trials. The proposed core data set was supported by high consensus among attendees at OMERACT 9. Conclusions: The OMERACT core data set should improve quality of clinical trials and facilitate meta-analysis and indirect comparison in fibromyalgia syndrome.