Glossary 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.
Examples
In an RCT comparing a new treatment with placebo, fatigue improves in both groups, but improves more in the treatment group. If a fatigue instrument detects the difference in change between the treatment and placebo groups, it demonstrates clinical trial discrimination. Detecting improvement over time within the treatment group alone demonstrates sensitivity to change, but does not by itself demonstrate clinical trial discrimination.