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

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Title: 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
Authors: Webster, L
Groskreutz, D
Grinbergs-Saull, A
Howard, R
O'Brien, JT
Mountain, G
Banerjee, S
Woods, B
Perneczky, R
Lafortune, L
Roberts, C
McCleery, J
Pickett, J
Bunn, F
Challis, D
Charlesworth, G
Featherstone, K
Fox, C
Goodman, C
Jones, R
Lamb, S
Moniz-Cook, E
Schneider, J
Shepperd, S
Surr, C
Thompson-Coon, J
Ballard, C
Brayne, C
Burns, A
Clare, L
Garrard, P
Kehoe, P
Passmore, P
Holmes, C
Maidment, I
Robinson, L
Livingston, G
Item Type: Journal Article
Publication Date: 2017-06-29
2017-09-05T13:07:47Z
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.
Issue Date: 29-Jun-2017
Date of Acceptance: 31-May-2017
URI: http://hdl.handle.net/10044/1/50099
DOI: https://dx.doi.org/10.1371/journal.pone.0179521
ISSN: 1932-6203
Publisher: Public Library of Science
Journal / Book Title: PLOS One
Volume: 12
Issue: 6
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.
Keywords: Science & Technology
Multidisciplinary Sciences
Science & Technology - Other Topics
MINI-MENTAL-STATE
QUALITY-OF-LIFE
TASK-FORCE CONSENSUS
ALZHEIMERS-DISEASE
NEUROPSYCHIATRIC SYMPTOMS
COGNITIVE IMPAIRMENT
CLINICAL-TRIAL
ADAS-COG
THERAPY
ATROPHY
Science & Technology
Multidisciplinary Sciences
Science & Technology - Other Topics
MINI-MENTAL-STATE
QUALITY-OF-LIFE
TASK-FORCE CONSENSUS
ALZHEIMERS-DISEASE
NEUROPSYCHIATRIC SYMPTOMS
COGNITIVE IMPAIRMENT
CLINICAL-TRIAL
ADAS-COG
THERAPY
ATROPHY
MD Multidisciplinary
General Science & Technology
Publication Status: Published
Article Number: ARTN e0179521
Appears in Collections:Faculty of Medicine
Epidemiology, Public Health and Primary Care



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