Determining the minimum clinically important differences for outcomes in the DOMINO trial
Year: 2010
Type: article
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.
DOI: 10.1002/gps.2607
Authors: 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
Institutions: King's College London, MRC Clinical Trials Unit at UCL, Medical Research Council, University of Cambridge, MRC Biostatistics Unit, Newcastle University, University of Warwick, University of Leicester, Leicester General Hospital, University of Manchester, Wythenshawe Hospital, Moorgreen Hospital, Fulbourn Hospital, Centre for Mental Health, Imperial College London, Royal United Hospital, The Research Institute for the Care of Older People, St Martins Hospital, Queen's University Belfast, NHS Tayside, Inverclyde Royal Hospital, Crichton Royal Hospital, Warneford Hospital, University of Oxford, Cancer Research UK Clinical Trials Unit, University of Birmingham
Language: English
Subfield: Psychiatry and Mental health
Field: Medicine
Domain: Health Sciences
Open Access status: green
Funder: Medical Research Council
Award: G844073151
OpenAlex ID: W2135939083