Core outcome measures for interventions to prevent or slow the progress of dementia for people living with mild to moderate dementia : systematic review and consensus recommendations

Webster, Lucy (Research Assistant, University College London, Division of Psychiatry); Groskreutz, Derek; Grinbergs-Saull, Anna; Howard, Rob; O'Brien, J. T. (John T.), 1962-; Mountain, Gail A.; Banerjee, Sube; Woods, Robert T.; Perneczky, Robert; Lafortune, Louise (Scientific Coordinator of the Ageing Well Programme); Roberts, Charlotte (Charlotte Jane); McCleery, Jenny (Consultant old age psychiatrist); Pickett, James (James Ashby); Bunn, Frances; Challis, David, 1948-; Featherstone, Katie‏; Fox, Chris (George Christopher); Goodman, Claire, Professor; Jones, Roy W.; Lamb, S. E. (Sallie E.); Schneider, Justine‏; Shepperd, Sasha; Surr, Claire; Thompson-Coon, J. (Joanna); Ballard, Clive; Brayne, Carol; Burns, Alistair S.; Clare, Linda; Garrard, Peter, 1960-; Kehoe, Patrick (Patrick Gavin); Passmore, Peter; Holmes, Clive, 1960-; Maidment, Ian D.; Robinson, L. (Louise), Dr.; Livingston, Gill; Charlesworth, G. (Georgina); Moniz-Cook, Esme

School of Health and Social Work
Dementia
2017

Journal article


Rights
© 2017 Webster et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Abstract

Background
There are no disease-modifying treatments for dementia. There is also no consensus on disease modifying outcomes. We aimed to produce the first evidence-based consensus on core outcome measures for trials of disease modification in mild-to-moderate dementia.

Methods and Findings
We defined disease-modification interventions as those aiming to change the underlying pathology. We systematically searched electronic databases and previous systematic reviews for published and ongoing trials of disease-modifying treatments in mild-to-moderate dementia. We included 149/22,918 of the references found; with 81 outcome measures from 125 trials. Trials involved participants with Alzheimer’s disease (AD) alone (n = 111), or AD and mild cognitive impairment (n = 8) and three vascular dementia. We divided outcomes by the domain measured (cognition, activities of daily living, biological markers, neuropsychiatric symptoms, quality of life, global). We calculated the number of trials and of participants using each outcome.
We detailed psychometric properties of each outcome. We sought the views of people living with dementia and family carers in three cities through Alzheimer’s society focus groups.
Attendees at a consensus conference (experts in dementia research, disease-modification and harmonisation measures) decided on the core set of outcomes using these results. Recommended core outcomes were cognition as the fundamental deficit in dementia and to indicate disease modification, serial structural MRIs. Cognition should be measured by Mini Mental State Examination or Alzheimer's Disease Assessment Scale-Cognitive Subscale. MRIs would be optional for patients. We also made recommendations for measuring important, but non-core domains which may not change despite disease modification.

Limitations
Most trials were about AD. Specific instruments may be superseded. We searched one database for psychometric properties.

Interpretation
This is the first review to identify the 81 outcome measures the research community uses for disease-modifying trials in mild-to-moderate dementia. Our recommendations will facilitate designing, comparing and meta-analysing disease modification trials in mild-to-moderate dementia, increasing their value.

Publisher
The University of Hull
Peer reviewed
Yes
Language
English
Extent
499 KB
Identifier
hull:15185

Journal

Journal title
PLoS ONE
Publication date
2017
Publisher
PLoS ONE
DOI
10.1371/journal.pone.0179521
ISSN (Electronic)
1932-6203
Volume
12
Issue
6
Notes

This is a copy of the article: Webster L, Groskreutz D, Grinbergs-Saull A, Howard R, O’Brien JT, Mountain G, et al. (2017) Core outcome measures for interventions to prevent or slow the progress of dementia for people living with mild to moderate dementia: Systematic review and consensus recommendations. PLoS ONE 12(6): e0179521. https://doi.org/10.1371/journal.pone.0179521

Link
Published article
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