Reliability of measures of disease activity and disease damage in rheumatoid arthritis: Implications for smallest detectable difference, minimal clinically important difference, and analysis of treatment effects in randomized controlled trials
Mnd. Lassere et al., Reliability of measures of disease activity and disease damage in rheumatoid arthritis: Implications for smallest detectable difference, minimal clinically important difference, and analysis of treatment effects in randomized controlled trials, J RHEUMATOL, 28(4), 2001, pp. 892-903
We evaluate measurement properties of common rheumatoid arthritis (RA) asse
ssments. Included are a comprehensive literature review and new data on the
reliability and smallest detectable difference (SDD) for different classes
of these measures. We found that certain common measures such as joint cou
nts, pain, and patient global all had poor reliability and showed large SDD
compared to multi-item measures of physical/psychological function or comp
ared to radiographic measures. We discuss the implications of these finding
s on the use of composite endpoints such as the ACR20 or the EULAR responde
r index in RA clinical trials, particularly the introduction of misclassifi
cation bias that arises from differential measurement error, Finally, we co
nsider generically how the concept of the SDD might or might not relate to
the concept of the minimal clinically important difference.