Minimal clinically important difference in the fibromyalgia impact questionnaire

Robert (Rob) Bennett, Andrew G. Bushmakin, Joseph C. Cappelleri, Gergana Zlateva, Alesia B. Sadosky

    Research output: Contribution to journalArticle

    179 Citations (Scopus)

    Abstract

    Objective. The Fibromyalgia Impact Questionnaire (FIQ) is a disease-specific composite instrument that measures the effect of problems experienced by patients with fibromyalgia (FM). Utilization of the FIQ in measuring changes due to interventions in FM requires derivation of a clinically meaningful change for that instrument. Analyses were conducted to estimate the minimal clinically important difference (MCID), and to propose FIQ severity categories. Methods. Data from 3 similarly designed, 3-month placebo-controlled, clinical treatment trials of pregabalin 300, 450, and 600 mg/day in patients with FM were modeled to estimate the change in the mean FIQ total and stiffness items corresponding to each category on the Patient Global Impression of Change. FIQ severity categories were modeled and determined using established pain severity cutpoints as an anchor. Results. A total of 2228 patients, mean age 49 years, 93% women, with a mean baseline FIQ total score of 62 were treated in the 3 studies. Estimated MCID on a given measure were similar across the studies. In a pooled analysis the estimated MCID (95% confidence interval) was 14% (13; 15) and for FIQ stiffness it was 13% (12; 14). In the severity analysis a FIQ total score from 0 to <39 was found to represent a mild effect, ≥ 39 to <59 a moderate effect, and ≥ 59 to 100 a severe effect. Conclusion. The analysis indicates that a 14% change in the FIQ total score is clinically relevant, and results of these analyses should enhance the clinical utility of the FIQ in research and practice. The Journal of Rheumatology

    Original languageEnglish (US)
    Pages (from-to)1304-1311
    Number of pages8
    JournalJournal of Rheumatology
    Volume36
    Issue number6
    DOIs
    StatePublished - Jun 2009

    Fingerprint

    Fibromyalgia
    Minimal Clinically Important Difference
    Surveys and Questionnaires
    Controlled Clinical Trials
    Rheumatology

    Keywords

    • Clinical trial
    • Fibromyalgia
    • Fibromyalgia impact questionnaire
    • Minimal clinically important difference
    • Pain
    • Severity

    ASJC Scopus subject areas

    • Rheumatology
    • Immunology
    • Immunology and Allergy

    Cite this

    Bennett, R. R., Bushmakin, A. G., Cappelleri, J. C., Zlateva, G., & Sadosky, A. B. (2009). Minimal clinically important difference in the fibromyalgia impact questionnaire. Journal of Rheumatology, 36(6), 1304-1311. https://doi.org/10.3899/jrheum.081090

    Minimal clinically important difference in the fibromyalgia impact questionnaire. / Bennett, Robert (Rob); Bushmakin, Andrew G.; Cappelleri, Joseph C.; Zlateva, Gergana; Sadosky, Alesia B.

    In: Journal of Rheumatology, Vol. 36, No. 6, 06.2009, p. 1304-1311.

    Research output: Contribution to journalArticle

    Bennett, RR, Bushmakin, AG, Cappelleri, JC, Zlateva, G & Sadosky, AB 2009, 'Minimal clinically important difference in the fibromyalgia impact questionnaire', Journal of Rheumatology, vol. 36, no. 6, pp. 1304-1311. https://doi.org/10.3899/jrheum.081090
    Bennett RR, Bushmakin AG, Cappelleri JC, Zlateva G, Sadosky AB. Minimal clinically important difference in the fibromyalgia impact questionnaire. Journal of Rheumatology. 2009 Jun;36(6):1304-1311. https://doi.org/10.3899/jrheum.081090
    Bennett, Robert (Rob) ; Bushmakin, Andrew G. ; Cappelleri, Joseph C. ; Zlateva, Gergana ; Sadosky, Alesia B. / Minimal clinically important difference in the fibromyalgia impact questionnaire. In: Journal of Rheumatology. 2009 ; Vol. 36, No. 6. pp. 1304-1311.
    @article{4ede86dd688945ceb8a438eb6dce5dd3,
    title = "Minimal clinically important difference in the fibromyalgia impact questionnaire",
    abstract = "Objective. The Fibromyalgia Impact Questionnaire (FIQ) is a disease-specific composite instrument that measures the effect of problems experienced by patients with fibromyalgia (FM). Utilization of the FIQ in measuring changes due to interventions in FM requires derivation of a clinically meaningful change for that instrument. Analyses were conducted to estimate the minimal clinically important difference (MCID), and to propose FIQ severity categories. Methods. Data from 3 similarly designed, 3-month placebo-controlled, clinical treatment trials of pregabalin 300, 450, and 600 mg/day in patients with FM were modeled to estimate the change in the mean FIQ total and stiffness items corresponding to each category on the Patient Global Impression of Change. FIQ severity categories were modeled and determined using established pain severity cutpoints as an anchor. Results. A total of 2228 patients, mean age 49 years, 93{\%} women, with a mean baseline FIQ total score of 62 were treated in the 3 studies. Estimated MCID on a given measure were similar across the studies. In a pooled analysis the estimated MCID (95{\%} confidence interval) was 14{\%} (13; 15) and for FIQ stiffness it was 13{\%} (12; 14). In the severity analysis a FIQ total score from 0 to <39 was found to represent a mild effect, ≥ 39 to <59 a moderate effect, and ≥ 59 to 100 a severe effect. Conclusion. The analysis indicates that a 14{\%} change in the FIQ total score is clinically relevant, and results of these analyses should enhance the clinical utility of the FIQ in research and practice. The Journal of Rheumatology",
    keywords = "Clinical trial, Fibromyalgia, Fibromyalgia impact questionnaire, Minimal clinically important difference, Pain, Severity",
    author = "Bennett, {Robert (Rob)} and Bushmakin, {Andrew G.} and Cappelleri, {Joseph C.} and Gergana Zlateva and Sadosky, {Alesia B.}",
    year = "2009",
    month = "6",
    doi = "10.3899/jrheum.081090",
    language = "English (US)",
    volume = "36",
    pages = "1304--1311",
    journal = "Journal of Rheumatology",
    issn = "0315-162X",
    publisher = "Journal of Rheumatology",
    number = "6",

    }

    TY - JOUR

    T1 - Minimal clinically important difference in the fibromyalgia impact questionnaire

    AU - Bennett, Robert (Rob)

    AU - Bushmakin, Andrew G.

    AU - Cappelleri, Joseph C.

    AU - Zlateva, Gergana

    AU - Sadosky, Alesia B.

    PY - 2009/6

    Y1 - 2009/6

    N2 - Objective. The Fibromyalgia Impact Questionnaire (FIQ) is a disease-specific composite instrument that measures the effect of problems experienced by patients with fibromyalgia (FM). Utilization of the FIQ in measuring changes due to interventions in FM requires derivation of a clinically meaningful change for that instrument. Analyses were conducted to estimate the minimal clinically important difference (MCID), and to propose FIQ severity categories. Methods. Data from 3 similarly designed, 3-month placebo-controlled, clinical treatment trials of pregabalin 300, 450, and 600 mg/day in patients with FM were modeled to estimate the change in the mean FIQ total and stiffness items corresponding to each category on the Patient Global Impression of Change. FIQ severity categories were modeled and determined using established pain severity cutpoints as an anchor. Results. A total of 2228 patients, mean age 49 years, 93% women, with a mean baseline FIQ total score of 62 were treated in the 3 studies. Estimated MCID on a given measure were similar across the studies. In a pooled analysis the estimated MCID (95% confidence interval) was 14% (13; 15) and for FIQ stiffness it was 13% (12; 14). In the severity analysis a FIQ total score from 0 to <39 was found to represent a mild effect, ≥ 39 to <59 a moderate effect, and ≥ 59 to 100 a severe effect. Conclusion. The analysis indicates that a 14% change in the FIQ total score is clinically relevant, and results of these analyses should enhance the clinical utility of the FIQ in research and practice. The Journal of Rheumatology

    AB - Objective. The Fibromyalgia Impact Questionnaire (FIQ) is a disease-specific composite instrument that measures the effect of problems experienced by patients with fibromyalgia (FM). Utilization of the FIQ in measuring changes due to interventions in FM requires derivation of a clinically meaningful change for that instrument. Analyses were conducted to estimate the minimal clinically important difference (MCID), and to propose FIQ severity categories. Methods. Data from 3 similarly designed, 3-month placebo-controlled, clinical treatment trials of pregabalin 300, 450, and 600 mg/day in patients with FM were modeled to estimate the change in the mean FIQ total and stiffness items corresponding to each category on the Patient Global Impression of Change. FIQ severity categories were modeled and determined using established pain severity cutpoints as an anchor. Results. A total of 2228 patients, mean age 49 years, 93% women, with a mean baseline FIQ total score of 62 were treated in the 3 studies. Estimated MCID on a given measure were similar across the studies. In a pooled analysis the estimated MCID (95% confidence interval) was 14% (13; 15) and for FIQ stiffness it was 13% (12; 14). In the severity analysis a FIQ total score from 0 to <39 was found to represent a mild effect, ≥ 39 to <59 a moderate effect, and ≥ 59 to 100 a severe effect. Conclusion. The analysis indicates that a 14% change in the FIQ total score is clinically relevant, and results of these analyses should enhance the clinical utility of the FIQ in research and practice. The Journal of Rheumatology

    KW - Clinical trial

    KW - Fibromyalgia

    KW - Fibromyalgia impact questionnaire

    KW - Minimal clinically important difference

    KW - Pain

    KW - Severity

    UR - http://www.scopus.com/inward/record.url?scp=67149107748&partnerID=8YFLogxK

    UR - http://www.scopus.com/inward/citedby.url?scp=67149107748&partnerID=8YFLogxK

    U2 - 10.3899/jrheum.081090

    DO - 10.3899/jrheum.081090

    M3 - Article

    VL - 36

    SP - 1304

    EP - 1311

    JO - Journal of Rheumatology

    JF - Journal of Rheumatology

    SN - 0315-162X

    IS - 6

    ER -