PMID- 16206363
OWN - NLM
STAT- MEDLINE
DCOM- 20051213
LR  - 20191210
IS  - 0315-162X (Print)
IS  - 0315-162X (Linking)
VI  - 32
IP  - 10
DP  - 2005 Oct
TI  - Minimal clinically important difference, low disease activity state, and patient 
      acceptable symptom state: methodological issues.
PG  - 2025-9
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.
FAU - Tubach, Florence
AU  - Tubach F
AD  - Departement d'Epidemiologie, Biostatistique et Recherche Clinique, Groupe 
      Hospitalier Bichat-Claude Bernard (AP-HP), INSERM U738, Faculte Xavier Bichat 
      (Universite Paris 7), Paris, France.
FAU - Wells, George A
AU  - Wells GA
FAU - Ravaud, Philippe
AU  - Ravaud P
FAU - Dougados, Maxime
AU  - Dougados M
LA  - eng
PT  - Journal Article
PT  - Review
PL  - Canada
TA  - J Rheumatol
JT  - The Journal of rheumatology
JID - 7501984
SB  - IM
MH  - Arthritis, Rheumatoid/diagnosis/*physiopathology
MH  - Clinical Trials as Topic/*methods
MH  - Disease Progression
MH  - *Health Status Indicators
MH  - Humans
MH  - Outcome Assessment, Health Care/*methods
MH  - *Patient Satisfaction
MH  - Rheumatology/*methods
RF  - 17
EDAT- 2005/10/06 09:00
MHDA- 2005/12/15 09:00
CRDT- 2005/10/06 09:00
PHST- 2005/10/06 09:00 [pubmed]
PHST- 2005/12/15 09:00 [medline]
PHST- 2005/10/06 09:00 [entrez]
AID - 0315162X-32-2025 [pii]
PST - ppublish
SO  - J Rheumatol. 2005 Oct;32(10):2025-9.