RT Journal Article
SR Electronic
T1 Fibromyalgia Syndrome Module at OMERACT 9: Domain Construct
JF The Journal of Rheumatology
JO J Rheumatol
FD The Journal of Rheumatology
SP 2318
OP 2329
DO 10.3899/jrheum.090367
VO 36
IS 10
A1 PHILIP MEASE
A1 LESLEY M. ARNOLD
A1 ERNEST H. CHOY
A1 DANIEL J. CLAUW
A1 LESLIE J. CROFFORD
A1 JENNIFER M. GLASS
A1 SUSAN A. MARTIN
A1 JESSICA MOREA
A1 LEE SIMON
A1 C. VIBEKE STRAND
A1 DAVID A. WILLIAMS
YR 2009
UL http://www.jrheum.org/content/36/10/2318.abstract
AB The objective of the module was to (1) establish a core domain set for fibromyalgia (FM) assessment in clinical trials and practice, (2) review outcome measure performance characteristics, (3) discuss development of a responder index for assessment of FM in clinical trials, (4) review objective markers, (5) review the domain of cognitive dysfunction, and (6) establish a research agenda for outcomes research. Presentations at the module included: (1) Results of univariate and multivariate analysis of 10 FM clinical trials of 4 drugs, mapping key domains identified in previous patient focus group: Delphi exercises and a clinician/researcher Delphi exercise, and breakout discussions to vote on possible essential domains and reliable measures; (2) Updates regarding outcome measure status; (3) Update on objective markers to measure FM disease state; and (4) Review of the issue of cognitive dysfunction (dyscognition) in FM. Consensus was reached as follows: (1) Greater than 70% of OMERACT participants agreed that pain, tenderness, fatigue, patient global, multidimensional function and sleep disturbance domains should be measured in all FM clinical trials; dyscognition and depression should be measured in some trials; and stiffness, anxiety, functional imaging, and cerebrospinal fluid biomarkers were identified as domains of research interest. (2) FM domain outcome measures have generally proven to be reliable, discriminative, and feasible. More sophisticated and comprehensive measures are in development, as is a responder index for FM. (3) Increasing numbers of objective markers are being developed for FM assessment. (4) Cognitive dysfunction assessment by self-assessed and applied outcome measures is being developed. In conclusion, a multidimensional symptom core set is proposed for evaluation of FM in clinical trials. Research on improved measures of single domains and composite measures is ongoing.