ePrints

Determining the minimum clinically important differences for outcomes in the DOMINO trial

Lookup NU author(s): Professor John O'Brien, Dr Clive Ballard, Professor Ian McKeith, Dr Robert Barber

Downloads

Full text for this publication is not currently held within this repository. Alternative links are provided below where available.

Abstract

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. Copyright (C) 2010 John Wiley & Sons, Ltd.

Publication metadata

Author(s): Howard R, Phillips P, Johnson T, O'Brien J, Sheehan B, Lindesay J, Bentham P, Burns A, Ballard C, Holmes C, McKeith I, Barber R, Dening T, Ritchie C, Jones R, Baldwin A, Passmore P, Findlay D, Hughes A, Macharouthu A, Banerjee S, Jones R, Knapp M, Brown RG, Jacoby R, Adams J, Griffin M, Gray R

Publication type: Article

Publication status: Published

Journal: International Journal of Geriatric Psychiatry

Year: 2011

Volume: 26

Issue: 8

Pages: 812-817

Print publication date: 16/09/2010

ISSN (print): 0885-6230

ISSN (electronic): 1099-1166

Publisher: John Wiley & Sons Ltd

URL: http://dx.doi.org/10.1002/gps.2607

DOI: 10.1002/gps.2607

Altmetrics

Funding

Share