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Cited by 76Fibromyalgia and Chronic Fatigue Syndrome ResearchDelphi Technique in ResearchMusculoskeletal pain and rehabilitation

Content and Criterion Validity of the Preliminary Core Dataset for Clinical Trials in Fibromyalgia Syndrome

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CHOY, ERNEST H., ARNOLD, LESLEY M., CLAUW, DANIEL J., CROFFORD, LESLIE J., GLASS, JENNIFER M., SIMON, LEE S., MARTIN, SUSAN A., STRAND, C. VIBEKE +2 more·2009·The Journal of Rheumatology
DOI 10.3899/jrheum.090368PMC PMC3412585
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Abstract

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.

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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 [5]

    The Introduction (page unavailable) lists fatigue and dyscognition (cognitive dysfunction) among the relevant fibromyalgia domains identified through earlier patient and clinician exercises. It does not identify the extent of somatic symptoms as a domain or establish the claimed progression in recognition of all three features. The Discussion (page unavailable) also says clinical-trial data were insufficient to require dyscognition in the core dataset. (LLM, conf=0.85)

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  1. [13]Gendreau M Williams DA Strand V Validation and minimum clinically important differences in SF-36 in randomized controlled trials of fibromyalgia 2008 In press

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Authors
CHOY, E. H., ARNOLD, L. M., CLAUW, D. J., CROFFORD, L. J., GLASS, J. M., SIMON, L. S., MARTIN, S. A., STRAND, C. V., WILLIAMS, D. A., & MEASE, P. J.
Affiliations
  • King's College London (GB)
  • University of Cincinnati (US)
  • University of Kentucky (US)
  • Beth Israel Deaconess Medical Center (US)
  • Harvard University (US)
  • RTI Health Solutions (US)
  • University of Michigan (US)
ORCID
Venue
The Journal of Rheumatology
Publisher
The Journal of Rheumatology
Published
2009-10
Volume
36
Issue
10
Pages
2330-2334
ISSN
  • 0315-162X (ISSN-L)
  • 1499-2752
DOI
10.3899/jrheum.090368
PMC
PMC3412585
OpenAlex
W1984390535
Cited by
76
References
22
Citations by year
2026: 2 · 2025: 1 · 2022: 3 · 2021: 5 · 2020: 2 · 2019: 4 · 2018: 4 · 2017: 2 · 2016: 9 · 2014: 8 · 2013: 9 · 2012: 8
FWCI
5.57
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, U01AR055069, R01AR053207)
Topics
  • Health Sciences › Medicine › Psychiatry and Mental health › Fibromyalgia and Chronic Fatigue Syndrome Research
  • Social Sciences › Sociology and Political Science › Delphi Technique in Research
  • Health Sciences › Medicine › Pharmacology › Musculoskeletal pain and rehabilitation
Keywords
fibromyalgia, core outcome set, clinical trial outcome measures, content validity, criterion validity, construct validity, OMERACT, pain, tenderness, fatigue, sleep, patient global assessment, health-related quality of life, Delphi consensus, patient focus groups
MeSH terms
Cognition Disorders, Delphi Technique, Fatigue, Fibromyalgia, Humans, International Cooperation, Pain, Syndrome, Reproducibility of Results, Randomized Controlled Trials as Topic, Outcome Assessment, Health Care, Consensus

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