RT Journal Article
SR Electronic
T1 Content and Criterion Validity of the Preliminary Core Dataset for Clinical Trials in Fibromyalgia Syndrome
JF The Journal of Rheumatology
JO J Rheumatol
FD The Journal of Rheumatology
SP 2330
OP 2334
DO 10.3899/jrheum.090368
VO 36
IS 10
A1 ERNEST H. CHOY
A1 LESLEY M. ARNOLD
A1 DANIEL J. CLAUW
A1 LESLIE J. CROFFORD
A1 JENNIFER M. GLASS
A1 LEE S. SIMON
A1 SUSAN A. MARTIN
A1 C. VIBEKE STRAND
A1 DAVID A. WILLIAMS
A1 PHILIP J. MEASE
YR 2009
UL http://www.jrheum.org/content/36/10/2330.abstract
AB Objective. Increasing research interest and emerging new therapies for treatment of fibromyalgia (FM) have led to a need to develop a consensus on a core set of outcome measures that should be assessed and reported in all clinical trials, to facilitate interpretation of the data and understanding of the disease. This aligns with the key objective of the Outcome Measures in Rheumatology (OMERACT) initiative to improve outcome measurement through a data driven, interactive consensus process. Methods. Through patient focus groups and Delphi processes, working groups at previous OMERACT meetings identified potential domains to be included in the core data set. A systematic review has shown that instruments measuring these domains are available and are at least moderately sensitive to change. Most instruments have been validated in multiple languages. This pooled analysis study aims to develop the core data set by analyzing data from 10 randomized controlled trials (RCT) in FM. Results. Results from this study provide support for the inclusion of the following in the core data set: pain, tenderness, fatigue, sleep, patient global assessment, and multidimensional function/health related quality of life. Construct validity was demonstrated with outcome instruments showing convergent and divergent validity. Content and criterion validity were confirmed by multivariate analysis showing R square values between 0.4 and 0.6. Low R square value is associated with studies in which one or more domains were not assessed. Conclusion. The core data set was supported by high consensus among attendees at OMERACT 9. Establishing an international standard for RCT in FM should facilitate future metaanalyses and indirect comparisons.