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Cited by 256Fibromyalgia and Chronic Fatigue Syndrome ResearchMusculoskeletal pain and rehabilitationMyofascial pain diagnosis and treatment

Fibromyalgia Syndrome Module at OMERACT 9: Domain Construct

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MEASE, PHILIP, ARNOLD, LESLEY M., CHOY, ERNEST H., CLAUW, DANIEL J., CROFFORD, LESLIE J., GLASS, JENNIFER M., MARTIN, SUSAN A., MOREA, JESSICA +3 more·2009·The Journal of Rheumatology
DOI 10.3899/jrheum.090367PMC PMC3419373
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Abstract

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.

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  • Fatigue, cognitive symptoms, and the extent of somatic symptoms became increasingly known and appreciated as key fibromyalgia features.

    “the importance of symptoms that had not been considered by the ACR Multicenter Criteria Committee became increasingly known and appreciated as key fibromyalgia features: for example, fatigue, cognitive symptoms, and the extent of somatic symptoms (4 -7).”

    From The American College of Rheumatology Preliminary Diagnostic Criteria for Fibromyalgia and Measurement of Symptom Severity (2010) · cites this paper as [4]

    The Introduction (page not provided) says the 1990 ACR criteria focused on widespread pain and tenderness, while patients also experience fatigue, cognitive dysfunction, and other symptoms. The Cognition section calls dyscognition a salient symptom. The paper does not identify the extent of somatic symptoms as a key feature in the same way, so that part of the claim is not supported. (LLM, conf=0.84)

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References 60 · Cited by 256

Research works printed but not linked: 47

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Authors
MEASE, P., ARNOLD, L. M., CHOY, E. H., CLAUW, D. J., CROFFORD, L. J., GLASS, J. M., MARTIN, S. A., MOREA, J., SIMON, L., STRAND, C. V., & WILLIAMS, D. A.
Affiliations
  • University of Washington (US)
  • University of Cincinnati (US)
  • University of Kentucky (US)
  • Oregon Health & Science University (US)
  • Harvard University (US)
ORCID
Venue
The Journal of Rheumatology
Publisher
The Journal of Rheumatology
Published
2009-10
Volume
36
Issue
10
Pages
2318-2329
ISSN
  • 0315-162X (ISSN-L)
  • 1499-2752
DOI
10.3899/jrheum.090367
PMC
PMC3419373
OpenAlex
W2014727419
Cited by
256
References
60
Citations by year
2026: 6 · 2025: 9 · 2024: 13 · 2023: 10 · 2022: 15 · 2021: 13 · 2020: 8 · 2019: 11 · 2018: 4 · 2017: 14 · 2016: 16 · 2015: 18 · 2014: 22 · 2013: 30 · 2012: 23
FWCI
13.81
Type
journal article
Language
en
Open access
Locations
  • The Journal of Rheumatology (publishedVersion)
  • PubMed (publishedVersion)
  • Europe PMC (PubMed Central) (acceptedVersion)
  • PubMed Central (acceptedVersion)
  • Research Portal (King's College London) (submittedVersion)
Funders
  • Eli Lilly and Company
  • Pfizer
  • Jazz Pharmaceuticals
  • Versus Arthritis
  • National Institutes of Health
  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (U01AR55069, AR053207, U01AR055069, R01AR053207)
Topics
  • Health Sciences › Medicine › Psychiatry and Mental health › Fibromyalgia and Chronic Fatigue Syndrome Research
  • Health Sciences › Medicine › Pharmacology › Musculoskeletal pain and rehabilitation
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Cell Biology › Myofascial pain diagnosis and treatment
Keywords
fibromyalgia, OMERACT, core outcome domains, outcome measures, cognitive impairment, pain, fatigue, sleep disorders, depression, clinical trial endpoints
MeSH terms
Clinical Trials as Topic, Delphi Technique, Fibromyalgia, Humans, International Cooperation, Syndrome, Outcome Assessment, Health Care

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