Determining the minimum clinically important differences for outcomes in the DOMINO trial
- Howard, Robert
- Phillips, P.
- Johnson, T.
- O'Brien, J. T.
- Sheehan, Bart
- Lindesay, James
- Bentham, Peter
- Burns, Alistair S.
- Ballard, Clive
- Holmes, Clive
- McKeith, I. G.
- Barber, R.
- Dening, Tom
- Ritchie, C. W.
- Jones, R.
- Baldwin, Ashley
- Passmore, Peter
- Findlay, D.
- Hughes, A.
- Macharouthu, Ajay
- Banerjee, Sube
- Jones, Roy W.
- Knapp, Martin
- Brown, R. G.
- Jacoby, Robin
- Adams, J.
- Griffin, M.
- Gray, Richard
DOIAbstract
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 M...
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