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Determining the minimum clinically important differences for outcomes in the DOMINO trial
Open accessAbstract
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 © 2010 John Wiley & Sons, Ltd.
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The MMSE treatment effect, approximately 1 point, is similar to the mean worsening of 0.73 points with antipsychotics in similarly designed trials but lower than the minimum clinically significant change of 1.4 points considered by many experts.
“The MMSE treatment effect, approximately 1 point, is similar to the mean worsening of 0.73 points with antipsychotics in similarly designed trials6 but lower than the minimum clinically significant change of 1.4 points considered by many experts38.”
From Effect of Citalopram on Agitation in Alzheimer Disease: The CitAD Randomized Clinical Trial (2014) · cites this paper as [38]
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Metadata
- Authors
- 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, R. G., Jacoby, R., Adams, J., Griffin, M., & Gray, R.
- Affiliations
- King's College London (GB)
- MRC Clinical Trials Unit at UCL (GB)
- University of Cambridge (GB)
- Newcastle University (GB)
- University of Warwick (GB)
- University of Leicester (GB)
- University of Manchester (GB)
- Moorgreen Hospital (GB)
- Fulbourn Hospital (GB)
- Centre for Mental Health (GB)
- Royal United Hospital (GB)
- Queen's University Belfast (GB)
- NHS Tayside (GB)
- Inverclyde Royal Hospital (GB)
- Warneford Hospital (GB)
- Cancer Research UK Clinical Trials Unit (GB)
- Corresponding author
- Howard, Robert
- ORCID
- Howard, Robert
- Phillips, Patrick
- Johnson, Tony
- O'Brien, John
- Sheehan, Bart
- Bentham, Peter
- Burns, Alistair
- Ballard, Clive
- Holmes, Clive
- McKeith, Ian
- Barber, Robert
- Dening, Tom
- Ritchie, Craig
- Baldwin, Ashley
- Passmore, Peter
- Findlay, David
- Macharouthu, Ajay
- Banerjee, Sube
- Jones, Roy
- Knapp, Martin
- Brown, Richard G.
- Gray, Richard
- Venue
- International Journal of Geriatric Psychiatry
- Publisher
- Wiley
- Published
- 2010-09-16
- Volume
- 26
- Issue
- 8
- Pages
- 812-817
- ISSN
- 0885-6230 (ISSN-L)
- 1099-1166
- OpenAlex
- W2135939083
- Cited by
- 185
- References
- 2
- Citations by year
- 2026: 13 · 2025: 15 · 2024: 16 · 2023: 16 · 2022: 17 · 2021: 18 · 2020: 19 · 2019: 12 · 2018: 5 · 2017: 11 · 2016: 3 · 2015: 10 · 2014: 13 · 2013: 9 · 2012: 7
- FWCI
- 3.26
- Type
- journal article
- Language
- en
- Open access
- green
- figshare.com
- Locations
- International Journal of Geriatric Psychiatry (publishedVersion)
- PubMed (publishedVersion)
- UCL Discovery (University College London) (submittedVersion)
- Figshare (submittedVersion, cc-by)
- Research Portal (King's College London) (submittedVersion)
- Research Explorer (The University of Manchester) (submittedVersion)
- University of Birmingham Research Portal (University of Birmingham) (submittedVersion)
- Research Portal (Queen's University Belfast) (submittedVersion)
- Sussex Research Online (University of Sussex) (submittedVersion)
- Newcastle University ePrints (Newcastle Univesity)
- Funders
- Medical Research Council (G0600989)
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Health Systems, Economic Evaluations, Quality of Life
- Keywords
- minimal clinically important difference, dementia, statistical analysis plan, Neuropsychiatric Inventory, outcome measures, expert opinion, distribution-based MCID
- MeSH terms
- Donepezil, Activities of Daily Living, Alzheimer Disease, Cholinesterase Inhibitors, Data Interpretation, Statistical, Decision Making, Humans, Indans, Memantine, Piperidines, Psychiatric Status Rating Scales, Dopamine Agents, Randomized Controlled Trials as Topic, Outcome Assessment, Health Care
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