PMID- 20848576
OWN - NLM
STAT- MEDLINE
DCOM- 20111115
LR  - 20220409
IS  - 1099-1166 (Electronic)
IS  - 0885-6230 (Linking)
VI  - 26
IP  - 8
DP  - 2011 Aug
TI  - Determining the minimum clinically important differences for outcomes in the 
      DOMINO trial.
PG  - 812-7
LID - 10.1002/gps.2607 [doi]
AB  - BACKGROUND: Although less likely to be reported in clinical trials than 
      expressions of the statistical significance of differences in outcomes, whether 
      or not a treatment has delivered a specified minimum clinically important 
      difference (MCID) is also relevant to patients and their caregivers and doctors. 
      Many dementia treatment randomised controlled trials (RCTs) have not reported 
      MCIDs and, where they have been done, observed differences have not reached 
      these. METHODS: As part of the development of the Statistical Analysis Plan for 
      the DOMINO trial, investigators met to consider expert opinion- and 
      distribution-based values for the MCID and triangulated these to provide 
      appropriate values for three outcome measures, the Standardised Mini-mental State 
      Examination (sMMSE), Bristol Activities of Daily Living Scale (BADLS) and 
      Neuropsychiatric Inventory (NPI). Only standard deviations (SD) were presented to 
      investigators who remained blind to treatment allocation. RESULTS: Adoption of 
      values for MCIDs based upon 0.4 of the SD of the change in score from baseline on 
      the sMMSE, BADLS and NPI in the first 127 participants to complete DOMINO yielded 
      MCIDs of 1.4 points for sMMSE, 3.5 for BADLS and 8.0 for NPI. CONCLUSIONS: 
      Reference to MCIDs is important for the full interpretation of the results of 
      dementia trials and those conducting such trials should be open about the way in 
      which they have determined and chosen their values for the MCIDs.
CI  - Copyright (c) 2010 John Wiley & Sons, Ltd.
FAU - Howard, Robert
AU  - Howard R
AD  - King's College London, Institute of Psychiatry, Department of Old Age Psychiatry, 
      London, UK. robert.j.howard@kcl.ac.uk
FAU - Phillips, Patrick
AU  - Phillips P
FAU - Johnson, Tony
AU  - Johnson T
FAU - O'Brien, John
AU  - O'Brien J
FAU - Sheehan, Bart
AU  - Sheehan B
FAU - Lindesay, James
AU  - Lindesay J
FAU - Bentham, Peter
AU  - Bentham P
FAU - Burns, Alistair
AU  - Burns A
FAU - Ballard, Clive
AU  - Ballard C
FAU - Holmes, Clive
AU  - Holmes C
FAU - McKeith, Ian
AU  - McKeith I
FAU - Barber, Robert
AU  - Barber R
FAU - Dening, Tom
AU  - Dening T
FAU - Ritchie, Craig
AU  - Ritchie C
FAU - Jones, Rob
AU  - Jones R
FAU - Baldwin, Ashley
AU  - Baldwin A
FAU - Passmore, Peter
AU  - Passmore P
FAU - Findlay, David
AU  - Findlay D
FAU - Hughes, Alan
AU  - Hughes A
FAU - Macharouthu, Ajay
AU  - Macharouthu A
FAU - Banerjee, Sube
AU  - Banerjee S
FAU - Jones, Roy
AU  - Jones R
FAU - Knapp, Martin
AU  - Knapp M
FAU - Brown, Richard G
AU  - Brown RG
FAU - Jacoby, Robin
AU  - Jacoby R
FAU - Adams, Jessica
AU  - Adams J
FAU - Griffin, Mary
AU  - Griffin M
FAU - Gray, Richard
AU  - Gray R
LA  - eng
GR  - 86/ALZS_/Alzheimer's Society/United Kingdom
GR  - G0600989/MRC_/Medical Research Council/United Kingdom
GR  - MC_U122888466/MRC_/Medical Research Council/United Kingdom
GR  - MC_U137686861/MRC_/Medical Research Council/United Kingdom
PT  - Journal Article
DEP - 20100916
PL  - England
TA  - Int J Geriatr Psychiatry
JT  - International journal of geriatric psychiatry
JID - 8710629
RN  - 0 (Cholinesterase Inhibitors)
RN  - 0 (Dopamine Agents)
RN  - 0 (Indans)
RN  - 0 (Piperidines)
RN  - 8SSC91326P (Donepezil)
RN  - W8O17SJF3T (Memantine)
SB  - IM
MH  - Activities of Daily Living
MH  - Alzheimer Disease/diagnosis/*drug therapy/psychology
MH  - Cholinesterase Inhibitors/*therapeutic use
MH  - *Data Interpretation, Statistical
MH  - Decision Making
MH  - Donepezil
MH  - Dopamine Agents/*therapeutic use
MH  - Humans
MH  - Indans/therapeutic use
MH  - Memantine/therapeutic use
MH  - Outcome Assessment, Health Care/methods/statistics & numerical data
MH  - Piperidines/therapeutic use
MH  - Psychiatric Status Rating Scales
MH  - *Randomized Controlled Trials as Topic
EDAT- 2010/09/18 06:00
MHDA- 2011/11/16 06:00
CRDT- 2010/09/18 06:00
PHST- 2010/07/06 00:00 [received]
PHST- 2010/07/06 00:00 [accepted]
PHST- 2010/09/18 06:00 [entrez]
PHST- 2010/09/18 06:00 [pubmed]
PHST- 2011/11/16 06:00 [medline]
AID - 10.1002/gps.2607 [doi]
PST - ppublish
SO  - Int J Geriatr Psychiatry. 2011 Aug;26(8):812-7. doi: 10.1002/gps.2607. Epub 2010 
      Sep 16.