PMID- 19128938
OWN - NLM
STAT- MEDLINE
DCOM- 20090930
LR  - 20090529
IS  - 1878-5921 (Electronic)
IS  - 0895-4356 (Linking)
VI  - 62
IP  - 7
DP  - 2009 Jul
TI  - The variability in minimal clinically important difference and patient acceptable 
      symptomatic state values did not have an impact on treatment effect estimates.
PG  - 725-8
LID - 10.1016/j.jclinepi.2008.09.012 [doi]
AB  - OBJECTIVE: The minimal clinically important difference (MCID) and the patient 
      acceptable symptom state (PASS) are cutoffs dichotomizing continuous values into 
      variables such as improved or not improved (MCID), or in an acceptable state or 
      not in an acceptable state (PASS), allowing to report the success rate 
      (proportion of patients improved or in an acceptable state) in trial arms. The 
      objective was to investigate the influence of the choice of MCID and/or PASS 
      values on the difference in success rate between arms. STUDY DESIGN AND SETTING: 
      Analytic study was carried out. In two hypothetic trials (prespecified mean and 
      standard deviation (SD) for control arm score, effect sizes [ES] of 0.25 and 
      0.5), we calculated the success rates in control and experimental arms for 
      different MCID and PASS values, and derived the difference in success rates 
      between arms. RESULTS: For a 0-100 score and MCID values from -40 to -10, the 
      difference in success rate between arms ranges from 7.9% to 9.9% (ES=0.25) and 
      from 15.9% to 19.7% (ES=0.50). For PASS values from 20 to 50, the difference in 
      success rate between arms ranges from 7.1% to 9.9% (ES=0.25) and from 15.6% to 
      19.7% (ES=0.50). CONCLUSION: The MCID or PASS value has a low impact on the 
      difference in the success rate between the arms in a trial.
FAU - Tubach, Florence
AU  - Tubach F
AD  - AP-HP, Hopital Bichat, Departement d'Epidemiologie, Biostatistique et Recherche 
      Clinique, Paris, France. florence.tubach@bch.aphp.fr
FAU - Giraudeau, Bruno
AU  - Giraudeau B
FAU - Ravaud, Philippe
AU  - Ravaud P
LA  - eng
PT  - Journal Article
DEP - 20090106
PL  - United States
TA  - J Clin Epidemiol
JT  - Journal of clinical epidemiology
JID - 8801383
RN  - 0 (Anti-Inflammatory Agents, Non-Steroidal)
SB  - IM
MH  - Anti-Inflammatory Agents, Non-Steroidal/therapeutic use
MH  - Humans
MH  - Osteoarthritis, Hip/drug therapy
MH  - Osteoarthritis, Knee/drug therapy
MH  - Pain Measurement
MH  - Patient Satisfaction
MH  - Randomized Controlled Trials as Topic/*methods
MH  - Research Design
MH  - *Treatment Outcome
EDAT- 2009/01/09 09:00
MHDA- 2009/10/01 06:00
CRDT- 2009/01/09 09:00
PHST- 2007/07/18 00:00 [received]
PHST- 2008/08/28 00:00 [revised]
PHST- 2008/09/18 00:00 [accepted]
PHST- 2009/01/09 09:00 [entrez]
PHST- 2009/01/09 09:00 [pubmed]
PHST- 2009/10/01 06:00 [medline]
AID - S0895-4356(08)00273-4 [pii]
AID - 10.1016/j.jclinepi.2008.09.012 [doi]
PST - ppublish
SO  - J Clin Epidemiol. 2009 Jul;62(7):725-8. doi: 10.1016/j.jclinepi.2008.09.012. Epub 
      2009 Jan 6.