VALIDATION DATA

MEASUREMENT PROPERTIES
Limitations English only
Observations

GMIM was developed from databases from patients with chronic refractory gout who participated in two randomized 6 month clinical trials of pegloticase.

1. RELIABILITY
A. Internal Consistency Not Tested
Cronbach's (Describe)
B. Reliability intraobserver or test-retest Not Tested
Continuous scores: intraclass
correlation coefficient (ICC)
Dichotomus: Cohen kappa (Describe)
C. Reliability interobserver or Measurement error Not Tested
Standard error of measurement (SEM),
smallest detectable change (SDC) or
Limits of agreement (LoA) (Describe)
2. VALIDITY
A. Content validity: face validity Tested
Expert opinion (relevance and
comprehensiveness) (Describe)

The measures comprising the composite outcome measure included sU, tophus area, SJC, TJC, PGA, flares, and pain. The first five were based on a repeated measures mixed effects model with backward elimination using data from the pegloticase RCTs; pain was added given the importance attributed to it by interviews of 30 patients with gout.

B. Construct Validity:
Structural validity
Not Tested
Hypotheses-testing Not Tested
Cross-cultural validity Not Tested
Brief Description
C. Criterion validity Not Tested
Comparison with a 'gold standard' Continuous scores:
correlations, ROC curves Dichotomus:
Sensitivity & Specificity (Describe)