Fibromyalgia syndrome.
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.
Mease
Philip
P
Seattle Rhumatology Associates, Seattle, WA 98104, USA. pmease@nwlink.com
Arnold
Lesley M
LM
Bennett
Robert
R
Boonen
Annelies
A
Buskila
Dan
D
Carville
Serena
S
Chappell
Amy
A
Choy
Ernest
E
Clauw
Daniel
D
Dadabhoy
Dina
D
Gendreau
Michael
M
Goldenberg
Don
D
Littlejohn
Geoffrey
G
Martin
Susan
S
Perera
Philip
P
Russell
I Jon
IJ
Simon
Lee
L
Spaeth
Michael
M
Williams
David
D
Crofford
Leslie
L
D004185:Disability Evaluation; D005356:Fibromyalgia / Q000145:classification* / Q000503:physiopathology / Q000628:therapy; D017144:Focus Groups; D006305:Health Status Indicators; D006801:Humans; D007391:International Cooperation; D017063:Outcome Assessment, Health Care; D010358:Patient Participation; D011785:Quality Assurance, Health Care; D015203:Reproducibility of Results