PMID- 19369473 OWN - NLM STAT- MEDLINE DCOM- 20090805 LR - 20220409 IS - 0315-162X (Print) IS - 0315-162X (Linking) VI - 36 IP - 6 DP - 2009 Jun TI - Minimal clinically important difference in the fibromyalgia impact questionnaire. PG - 1304-11 LID - 10.3899/jrheum.081090 [doi] 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, >or= 39 to <59 a moderate effect, and >or=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. FAU - Bennett, Robert M AU - Bennett RM AD - Oregon Health and Science University, Portland, OR, USA. FAU - Bushmakin, Andrew G AU - Bushmakin AG FAU - Cappelleri, Joseph C AU - Cappelleri JC FAU - Zlateva, Gergana AU - Zlateva G FAU - Sadosky, Alesia B AU - Sadosky AB LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20090415 PL - Canada TA - J Rheumatol JT - The Journal of rheumatology JID - 7501984 RN - 0 (Analgesics) RN - 55JG375S6M (Pregabalin) RN - 56-12-2 (gamma-Aminobutyric Acid) SB - IM MH - Analgesics/therapeutic use MH - *Disability Evaluation MH - Female MH - Fibromyalgia/complications/drug therapy/*physiopathology MH - *Health Status MH - Humans MH - Male MH - Middle Aged MH - Pain/drug therapy/etiology/physiopathology MH - Pregabalin MH - Randomized Controlled Trials as Topic MH - *Severity of Illness Index MH - Sickness Impact Profile MH - Surveys and Questionnaires MH - Treatment Outcome MH - gamma-Aminobutyric Acid/analogs & derivatives/therapeutic use EDAT- 2009/04/17 09:00 MHDA- 2009/08/06 09:00 CRDT- 2009/04/17 09:00 PHST- 2009/04/17 09:00 [entrez] PHST- 2009/04/17 09:00 [pubmed] PHST- 2009/08/06 09:00 [medline] AID - jrheum.081090 [pii] AID - 10.3899/jrheum.081090 [doi] PST - ppublish SO - J Rheumatol. 2009 Jun;36(6):1304-11. doi: 10.3899/jrheum.081090. Epub 2009 Apr 15.