Sensitivity to change of generic quality of life instruments in patients with rheumatoid arthritis: Preliminary findings in the generic health OMERACT study

This is the initial report of the generic health OMERACT study concerned wi th the sensitivity to change of generic quality of life (QOL) measures. Our objective was to determine which QOL instrument is best able to show a sta tistically significant improvement in patients with rheumatoid arthritis (R A) demonstrating relevant improvement in a core set of disease activity and disease-specific disability measures. A multicenter controlled trial of a single group with repeated measurements at 0 (baseline), 3, and 6 months wa s conducted. All participating centers recruited 10 patients with RA who we re about to start methotrexate therapy for the first time because of active disease. Assessments included disease activity measures, disease-specific disability measures, and generic QOL measures. To date, 40 patients have be en recruited from 4 centers for the study. After 6 months of treatment many of the generic QOL measures showed a 20% improvement from baseline and med ium standardized response means around 0.5. In particular, the Nottingham H ealth Profile (NHP) and the Rheumatoid Arthritis Quality of Life (RAQOL) me asures had the largest percentage improvement (22 and 29%, respectively) an d standardized response means (both with 0.54). Early results on the sensit ivity of generic health QOL measures are promising, in particular for the N HP and RAQOL measures.