Content and criterion validity of the preliminary core dataset for clinical trials in fibromyalgia syndrome.
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.


CONCLUSIONS
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.
Choy
Ernest H
EH
Sir Alfred Baring Garrod Clinical Trials Unit, Academic Department Rheumatology, Weston Education Centre, King's College London, Cutcombe Road, London, SE5 9RJ UK. ernest.choy@kcl.ac.uk
Arnold
Lesley M
LM
Clauw
Daniel J
DJ
Crofford
Leslie J
LJ
Glass
Jennifer M
JM
Simon
Lee S
LS
Martin
Susan A
SA
Strand
C Vibeke
CV
Williams
David A
DA
Mease
Philip J
PJ
D003072:Cognition Disorders / Q000503:physiopathology; D032921:Consensus; D003697:Delphi Technique; D005221:Fatigue / Q000503:physiopathology; D005356:Fibromyalgia / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D006801:Humans; D007391:International Cooperation; D017063:Outcome Assessment, Health Care / Q000379:methods / Q000592:standards*; D010146:Pain / Q000503:physiopathology; D016032:Randomized Controlled Trials as Topic / Q000592:standards*; D015203:Reproducibility of Results; D013577:Syndrome