PMID- 25327276
OWN - NLM
STAT- MEDLINE
DCOM- 20151217
LR  - 20191210
IS  - 1541-0420 (Electronic)
IS  - 0006-341X (Linking)
VI  - 71
IP  - 1
DP  - 2015 Mar
TI  - Minimum clinically important difference in medical studies.
PG  - 33-41
LID - 10.1111/biom.12251 [doi]
AB  - In clinical trials, minimum clinically important difference (MCID) has attracted 
      increasing interest as an important supportive clinical and statistical inference 
      tool. Many estimation methods have been developed based on various intuitions, 
      while little theoretical justification has been established. This article 
      proposes a new estimation framework of the MCID using both diagnostic 
      measurements and patient-reported outcomes (PROs). The framework first formulates 
      the population-based MCID as a large margin classification problem, and then 
      extends to the personalized MCID to allow individualized thresholding value for 
      patients whose clinical profiles may affect their PRO responses. More 
      importantly, the proposed estimation framework is showed to be asymptotically 
      consistent, and a finite-sample upper bound is established for its prediction 
      accuracy compared against the ideal MCID. The advantage of our proposed method is 
      also demonstrated in a variety of simulated experiments as well as two phase-3 
      clinical trials.
CI  - (c) 2014, The International Biometric Society.
FAU - Hedayat, A S
AU  - Hedayat AS
AD  - Department of Mathematics, Statistics, and Computer Science, University of 
      Illinois at Chicago, Chicago, Illinois 60607, U.S.A.
FAU - Wang, Junhui
AU  - Wang J
AD  - Department of Mathematics, City University of Hong Kong, Kowloon, Hong Kong.
FAU - Xu, Tu
AU  - Xu T
AD  - Amgen Inc., Thousand Oaks, California 91320, U.S.A.
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PT  - Research Support, U.S. Gov't, Non-P.H.S.
DEP - 20141018
PL  - England
TA  - Biometrics
JT  - Biometrics
JID - 0370625
SB  - IM
MH  - *Algorithms
MH  - Clinical Trials, Phase III as Topic/*methods
MH  - Computer Simulation
MH  - *Data Interpretation, Statistical
MH  - Epidemiologic Methods
MH  - *Models, Statistical
MH  - Outcome Assessment, Health Care/*methods
OTO - NOTNLM
OT  - Fisher consistency
OT  - Margin classification
OT  - Minimum clinically important difference
OT  - Non-convex minimization
OT  - Support vector machine
EDAT- 2014/10/21 06:00
MHDA- 2015/12/19 06:00
CRDT- 2014/10/21 06:00
PHST- 2014/01/01 00:00 [received]
PHST- 2014/08/01 00:00 [revised]
PHST- 2014/09/01 00:00 [accepted]
PHST- 2014/10/21 06:00 [entrez]
PHST- 2014/10/21 06:00 [pubmed]
PHST- 2015/12/19 06:00 [medline]
AID - 10.1111/biom.12251 [doi]
PST - ppublish
SO  - Biometrics. 2015 Mar;71(1):33-41. doi: 10.1111/biom.12251. Epub 2014 Oct 18.