RT Journal Article
SR Electronic
T1 Minimal clinically important difference, low disease activity state, and patient acceptable symptom state: methodological issues.
JF The Journal of Rheumatology
JO J Rheumatol
FD The Journal of Rheumatology
SP 2025
OP 2029
VO 32
IS 10
A1 Florence Tubach
A1 George A Wells
A1 Philippe Ravaud
A1 Maxime Dougados
YR 2005
UL http://www.jrheum.org/content/32/10/2025.abstract
AB The importance of determining a minimal clinically important difference (MCID) and a low disease activity state (LDAS) as treatment targets in clinical trials no longer needs to be demonstrated. However, many methodological issues remain: whether these thresholds should be defined for each criterion or for composite criteria, whether there is a difference between the LDAS and patient acceptable symptom state (PASS), how to determine these thresholds (i.e., the wording of the questions and the statistical approach), and whether there are confounding factors in their evaluation. We consider these methodological issues and discuss their impact. Methods to determine the thresholds must be standardized, and recommendations could be endorsed by an OMERACT module. Threshold values for the MCID and LDAS should be determined according to data-driven and experts' opinions and approaches.