Validation of pain and patient global scales in chronic gout: data from two randomized controlled trials.

Singh JA, Yang S, Strand V, Simon L, Forsythe A, Hamburger S, Chen L. Validation of pain and patient global scales in chronic gout: data from two randomized controlled trials. Annals of The Rheumatic Diseases. 2011 Jul 1; 70(7):1277-81.

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Abstract:

OBJECTIVE: To assess validity of pain and patient global scales in gout. METHODS: The authors used data from pegloticase clinical trials in chronic refractory gout to examine the validity of visual analogue scale (VAS) pain, Short-Form 36 (SF-36) bodily pain subscale and VAS patient global assessment (all scales 0-100). Convergent/divergent validity with clinical characteristics was tested by using Spearman''s correlation coefficient. For discriminant ability, the authors compared the change at 6 months between placebo and pegloticase arms and calculated effect size (ES) and standardised response mean (SRM). RESULTS: 212 patients (mean age, 55.4 years, 82% men; 73% with tophaceous gout) provided data. VAS pain was statistically significantly correlated with tender joints (r = 0.42), swollen joints (r = 0.30), SF-36 physical (r = -0.56) and Mental Component Summary (r = -0.36) and Health Assessment Questionnaire scores (r = 0.54; all p-values < 0.0001), but not disease duration (r = -0.01; p = 0.84), gout flares (r = 0.12; p = 0.08), comorbidities (r = 0.05; p = 0.47) or plasma urate (r = 0.01; p = 0.89). Similar and significant correlation coefficients with tender and swollen joints were noted for VAS patient global assessment (r = 0.35 and 0.23; p < 0.0012 for both) and SF-36 pain subscale (r = -0.27 and -0.19; p < 0.006 for both). Pegloticase group had significantly more improvement than placebo at 6 months, mean (SD): VAS pain, -9.2 (29.3) versus 1.9 (26.4), p = 0.0002; SF-36 pain, 14.6 (25.6) versus -0.04 (21.1), p < 0.0001; and patient global, -9.3 (26.5) versus 3.4 (22.8), p < 0.0001. ES and SRMs in pegloticase group were as follows: VAS pain, 0.34 and 0.30; SF-36 pain, 0.69 and 0.57; patient global, 0.49 and 0.44. CONCLUSION: VAS pain, SF-36 pain and patient global VAS are valid outcome measures in patients with chronic gout.