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

✍ Scribed by Robert Howard; Patrick Phillips; Tony Johnson; John O'Brien; Bart Sheehan; James Lindesay; Peter Bentham; Alistair Burns; Clive Ballard; Clive Holmes; Ian McKeith; Robert Barber; Tom Dening; Craig Ritchie; Rob Jones; Ashley Baldwin; Peter Passmore; David Findlay; Alan Hughes; Ajay Macharouthu; Sube Banerjee; Roy Jones; Martin Knapp; Richard G. Brown; Robin Jacoby; Jessica Adams; Mary Griffin; Richard Gray

Publisher
John Wiley and Sons
Year
2010
Tongue
English
Weight
104 KB
Volume
26
Category
Article
ISSN
0885-6230

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✦ Synopsis

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 Β© 2010 John Wiley & Sons, Ltd.

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