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Research ArticleArticle

Minimal Clinically Important Difference in the Fibromyalgia Impact Questionnaire

ROBERT M. BENNETT, ANDREW G. BUSHMAKIN, JOSEPH C. CAPPELLERI, GERGANA ZLATEVA and ALESIA B. SADOSKY
The Journal of Rheumatology June 2009, 36 (6) 1304-1311; DOI: https://doi.org/10.3899/jrheum.081090
ROBERT M. BENNETT
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ANDREW G. BUSHMAKIN
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JOSEPH C. CAPPELLERI
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GERGANA ZLATEVA
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ALESIA B. SADOSKY
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  • For correspondence: Alesia.Sadosky@pfizer.com
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    Figure 1.

    Mean percentage change in Fibromyalgia Impact Questionnaire (FIQ) total (A) and stiffness (B) item scores for each Patient Global Impression of Change (PGIC) category in each study and for all studies pooled. Patients were asked to rate the PGIC at the end of the study as follows: Since the start of the study, my overall status is: 1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse.

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    Figure 2.

    Distribution of patients according the baseline (BL) and endpoint (EP) FIQ severity categories.

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    Table 1.

    Minimal clinically important difference, calculated as clinically important percentage change (95% CI) in the Fibromyalgia Impact Questionnaire (FIQ) total and FIQ stiffness item scores (pooled data).

    FIQ Total, % (95% CI)FIQ Stiffness, % (95% CI)
    Study 115.0 (13.9; 16.0)13.9 (2.4; 13.4)
    Study 211.6 (9.8; 13.4)10.5 (8.1; 12.7)
    Study 312.9 (11.4; 14.3)13.3 (0.7; 25.7)
    Pooled14.1 (13.3; 14.3)13.2 (11.9; 14.4)
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    Table 2.

    Fibromyalgia Impact Questionnaire (FIQ) total score severity categorization using pain severity as an anchor (pooled data).

    Pain Severity (anchor)FM Impairment CategoryFIQ Total Score
    < 3.5Mild impairment< 39
    3.5–6.5Moderate impairment≥ 39 to < 59
    ≥ 6.5Severe impairment≥ 59
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    Table 3.

    For each of the 3 pregabalin treatment groups and the placebo group: percentages of subjects according to Fibromyalgia Impact Questionnaire severity category at endpoint and difference from placebo. CI: confidence interval.

    SeverityPlacebo n = 558300 mg Group, n = 551450 mg Group, n = 554600 mg Group, n = 564
    Mild
      Percentage26.8827.7734.3032.62
      Difference from placebo (95% CI)—0.89 (−4.37; 6.14)7.42 (2.17; 12.9)5.74 (0.44; 11.09)
    Moderate
      Percentage32.4436.4835.0234.04
      Difference from placebo (95% CI)—4.04 (−1.56; 9.66)2.58 (−3.05; 8.07)1.6 (−3.83; 7.04)
    Severe
      Percentage40.6835.7530.6933.33
      Difference from placebo (95% CI)—–4.93 (−10.7; 0.77)–9.99 (−15.63; −4.47)–7.35 (−12.96; −1.69)
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The Journal of Rheumatology
Vol. 36, Issue 6
1 Jun 2009
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Minimal Clinically Important Difference in the Fibromyalgia Impact Questionnaire
ROBERT M. BENNETT, ANDREW G. BUSHMAKIN, JOSEPH C. CAPPELLERI, GERGANA ZLATEVA, ALESIA B. SADOSKY
The Journal of Rheumatology Jun 2009, 36 (6) 1304-1311; DOI: 10.3899/jrheum.081090

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Minimal Clinically Important Difference in the Fibromyalgia Impact Questionnaire
ROBERT M. BENNETT, ANDREW G. BUSHMAKIN, JOSEPH C. CAPPELLERI, GERGANA ZLATEVA, ALESIA B. SADOSKY
The Journal of Rheumatology Jun 2009, 36 (6) 1304-1311; DOI: 10.3899/jrheum.081090
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