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.
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.
Authors: Phillip J Mease; Lesley M Arnold; Leslie J Crofford; David A Williams; I Jon Russell; Louise Humphrey; Linda Abetz; Susan A Martin Journal: Arthritis Rheum Date: 2008-07-15
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Authors: Lesley M Arnold; Leslie J Crofford; Philip J Mease; Somali Misra Burgess; Susan C Palmer; Linda Abetz; Susan A Martin Journal: Patient Educ Couns Date: 2008-07-21
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Authors: Philip J Mease; Daniel J Clauw; Robin Christensen; Leslie J Crofford; R Michael Gendreau; Susan A Martin; Lee S Simon; Vibeke Strand; David A Williams; Lesley M Arnold Journal: J Rheumatol Date: 2011-07 Impact factor: 4.666
Authors: Ernest H Choy; Lesley M Arnold; Daniel J Clauw; Leslie J Crofford; Jennifer M Glass; Lee S Simon; Susan A Martin; C Vibeke Strand; David A Williams; Philip J Mease Journal: J Rheumatol Date: 2009-10 Impact factor: 4.666
Authors: Philip Mease; Lesley M Arnold; Ernest H Choy; Daniel J Clauw; Leslie J Crofford; Jennifer M Glass; Susan A Martin; Jessica Morea; Lee Simon; C Vibeke Strand; David A Williams Journal: J Rheumatol Date: 2009-10 Impact factor: 4.666