(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. doi:10.1371/journal.pone.0179521 ISSN 1932-6203.
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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 Specific instruments may be superseded.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. Trial registration PROSPERO no. CRD42015027346.
Item Type: | Journal Article |
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Subjects: | R Medicine > RC Internal medicine |
Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Clinical Trials Unit Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
SWORD Depositor: | Library Publications Router |
Library of Congress Subject Headings (LCSH): | Dementia -- Treatment, Systematic reviews (Medical research) |
Journal or Publication Title: | PLoS One |
Publisher: | Public Library of Science |
ISSN: | 1932-6203 |
Official Date: | 29 June 2017 |
Dates: | Date Event 29 June 2017 Published 31 May 2017 Accepted |
Volume: | 12 |
Number: | 6 |
Article Number: | e0179521 |
DOI: | 10.1371/journal.pone.0179521 |
Status: | Peer Reviewed |
Publication Status: | Published |
Re-use Statement: | ** From PLOS via Jisc Publications Router. ** History: ** received: 16-11-2016 ** collection: 01-01-2017 ** accepted: 31-05-2017 ** epub: 29-06-2017 ** Licence for this article: http://creativecommons.org/licenses/by/4.0/ |
Access rights to Published version: | Open Access (Creative Commons open licence) |
Date of first compliant deposit: | 6 July 2017 |
Date of first compliant Open Access: | 10 July 2017 |
Funder: | Collaborations for Leadership in Applied Health Research and Care (CLAHRC), National Institute for Health Research (Great Britain) (NIHR) |
Related URLs: | |
Contributors: | Contribution Name Contributor ID UNSPECIFIED Quinn, Terence J. UNSPECIFIED |
URI: | https://wrap.warwick.ac.uk/89656/ |
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