Criteria for clinically important changes in outcomes: development, scoring and evaluation of rheumatoid arthritis patient and trial profiles. OMERACT Committee.

Abstract

This approach has provided a beginning for less arbitrary definition of criteria for important change in patients and trials. It might be suggested that for patients, an improvement of at least 36% should be clinically important, while an active drug needs to be at least 18% better than placebo to be clinically important.