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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; Groskreutz, Derek; Grinbergs-Saull, Anna; Howard, Rob; O'Brien, John T.; Mountain, Gail; Banerjee, Sube; Woods, Bob; Perneczky, Robert; Lafortune, Louise; Roberts, Charlotte; McCleery, Jenny; Pickett, James; Bunn, Frances; Challis, David; Charlesworth, Georgina; Featherstone, Katie; Fox, Chris; Goodman, Claire; Jones, Roy; Lamb, Sarah; Moniz-Cook, Esme; Schneider, Justine; Shepperd, Sasha; Surr, Claire; Thompson-Coon, Jo; Ballard, Clive; Brayne, Carol; Burns, Alistair; Clare, Linda; Garrard, Peter; Kehoe, Patrick; Passmore, Peter; Holmes, Clive; Maidment, Ian; Robinson, Louise; Livingston, Gill

Authors

Lucy Webster

Derek Groskreutz

Anna Grinbergs-Saull

Rob Howard

John T. O'Brien

Gail Mountain

Sube Banerjee

Bob Woods

Robert Perneczky

Louise Lafortune

Charlotte Roberts

Jenny McCleery

James Pickett

Frances Bunn

David Challis

Georgina Charlesworth

Katie Featherstone

Chris Fox

Claire Goodman

Roy Jones

Sarah Lamb

Professor Esme Moniz-Cook E.D.Moniz-Cook@hull.ac.uk
Professor of Clinical Psychology of Ageing and Dementia Care Research/ Dementia Research Work Group Lead

Justine Schneider

Sasha Shepperd

Claire Surr

Jo Thompson-Coon

Clive Ballard

Carol Brayne

Alistair Burns

Linda Clare

Peter Garrard

Patrick Kehoe

Peter Passmore

Clive Holmes

Ian Maidment

Louise Robinson

Gill Livingston



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.

Journal Article Type Article
Publication Date Jun 1, 2017
Journal PLoS ONE
Print ISSN 1932-6203
Electronic ISSN 1932-6203
Publisher Public Library of Science
Peer Reviewed Peer Reviewed
Volume 12
Issue 6
Pages e0179521
APA6 Citation Webster, L., Groskreutz, D., Grinbergs-Saull, A., Howard, R., O'Brien, J. T., Mountain, G., …Livingston, G. (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
DOI https://doi.org/10.1371/journal.pone.0179521
Publisher URL http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0179521
Copyright Statement © 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.

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Copyright Statement
© 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.



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