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Research ArticleOMERACT 9: International Consensus Conference on Outcome Measures in Rheumatology, Kananaskis Village, Alberta, Canada, May 27–31, 2008

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

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 and PHILIP J. MEASE
The Journal of Rheumatology October 2009, 36 (10) 2330-2334; DOI: https://doi.org/10.3899/jrheum.090368
ERNEST H. CHOY
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  • For correspondence: ernest.choy@kcl.ac.uk
LESLEY M. ARNOLD
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DANIEL J. CLAUW
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LESLIE J. CROFFORD
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JENNIFER M. GLASS
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LEE S. SIMON
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SUSAN A. MARTIN
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C. VIBEKE STRAND
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DAVID A. WILLIAMS
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PHILIP J. MEASE
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  • Article
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Article Figures & Data

Tables

    • View popup
    Table 1.

    List of outcome measures used in clinical trials.

    PainVAS pain by paper, VAS pain by electronic diary, BPI total score, SF-36 bodily pain, FIQ pain item, BPI worst pain item, BPI least pain item, BPI average pain item, BPI pain right now item
    FatigueMultidimensional fatigue inventory, Multidimensional assessment of fatigue, SF-36 vitality, FIQ tiredness
    DepressionBeck Depression Inventory, Hamilton Rating Scale for Depression total score, HAMD Maier subscale, SF-36 mental component score, SF-36 mental health, HADS depression, FIQ depression
    SleepMOS Sleep Scale indices I and II and all subscales, Jenkin’s sleep scale, Global sleep quality, FIQ restedness, HAMD sleep subscale, BPI interference with sleep item
    Physical functionFIQ physical function, SF-36 physical function, SF-36 role physical, Sheehan disability total score, BPI interference with walking item, BPI interference with normal work item
    Quality of life and multidimensional functionSF-36 mental and physical component scores, FIQ total score, EuroQol 5D
    Patient global impression of changeLikert scale
    TendernessTender point count, Pressure pain threshold measured by dolorimeter
    DyscognitionMultiple abilities self-report questionnaire
    AnxietyFIQ anxiety, HADS anxiety, HAMD anxiety/somatization subscale
    StiffnessFIQ stiffness
    • VAS: visual analog scale; BPI: Brief Pain Inventory, SF-36: Short Form-36, FIQ: Fibromyalgia Impact Questionnaire, HAMD: Hamilton Rating Scale for Depression, HADS: Hospital Anxiety and Depression Scale.

    • View popup
    Table 2.

    Number of domains and instruments used in clinical trials of 4 different medications.

    MedicationABCD
    Pain> 1> 1> 1> 1
    Patient global1111
    Fatigue> 1> 1> 1> 1
    Multidimensional function> 1> 1> 11
    Sleep1> 11>1
    Depression> 1> 1> 1> 1
    Physical function> 1> 1> 1> 1
    Tenderness1> 110
    Dyscognition1000
    Anxiety1> 1> 1> 1
    Stiffness1110
    • View popup
    Table 3.

    Convergent and divergent relationships.

    ABCD
    Intra-domainInter-domainIntra-domainInter-domainIntra-domainInter-domainIntra-domainInter-domain
    Pain0.820.320.530.260.660.530.620.37
    TendernessSingle0.320.590.21Single0.58NDND
    Fatigue0.640.50.370.270.620.520.660.43
    SleepSingle0.490.250.23Single0.520.30.26
    Depression0.630.420.370.220.640.360.580.35
    Physical function0.650.450.310.270.660.440.690.35
    Multidimensional function0.570.610.30.270.550.48Single0.5
    DyscognitionSingle0.23NDNDNDNDNDND
    AnxietySingle0.40.320.240.60.40.580.38
    StiffnessSingle0.57Single0.19Single0.57NDND
    • Single: Single instrument; ND: not done.

    • View popup
    Table 4.

    Mean correlation coefficient between instruments of each domain with patient global impression of change.

    MedicationABCD
    Pain0.640.420.640.54
    Fatigue0.650.40.680.5
    Multidimensional function0.80.570.80.59
    Sleep0.640.460.640.4
    Depression0.390.260.630.34
    Physical function0.560.370.560.37
    Tenderness0.40.340.4ND
    Dyscognition0.3NDNDND
    Anxiety0.480.3> 10.3
    Stiffness0.780.460.74ND
    • ND: not done.

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The Journal of Rheumatology
Vol. 36, Issue 10
1 Oct 2009
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Content and Criterion Validity of the Preliminary Core Dataset for Clinical Trials in Fibromyalgia Syndrome
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
The Journal of Rheumatology Oct 2009, 36 (10) 2330-2334; DOI: 10.3899/jrheum.090368

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Content and Criterion Validity of the Preliminary Core Dataset for Clinical Trials in Fibromyalgia Syndrome
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
The Journal of Rheumatology Oct 2009, 36 (10) 2330-2334; DOI: 10.3899/jrheum.090368
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  • Fibromyalgia Syndrome Module at OMERACT 9: Domain Construct
  • Developing a Standardized Definition for Disease “Flare” in Rheumatoid Arthritis (OMERACT 9 Special Interest Group)
Show more OMERACT 9: International Consensus Conference on Outcome Measures in Rheumatology, Kananaskis Village, Alberta, Canada, May 27–31, 2008

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