Term: Clinical Trial Discrimination

An OMERACT measurement property that assesses an instrument’s sensitivity to change in a clinical trial setting. Specifically, it evaluates the instrument’s ability to detect differences in change between treatment groups, such as Treatment A compared with Treatment B or a control group.

Evidence is ideally obtained from randomized controlled trials (RCTs) in which the instrument has been used to measure treatment effects. When RCT evidence is unavailable, evidence from non-randomized comparative studies or appropriately defined subgroups within cohort studies may be used to estimate the instrument’s likely ability to discriminate between treatment effects, although with a lower level of confidence.

Relationship to Discrimination: Discrimination is the broader concept describing an instrument’s ability to distinguish between situations of interest. Clinical Trial Discrimination is a specific OMERACT measurement property within this broader concept. It focuses on sensitivity to change between treatment groups in a clinical trial, rather than change within a single group or individual over time.