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    Development of a core outcome set for disease modification trials in mild to moderate dementia: a systematic review, patient and public consultation and consensus recommendations

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    Publication date
    2017-05
    Author
    Webster, L.
    Groskreutz, D.
    Grinbergs-Saull, A.
    Howard, R.
    O'Brien, J.T.
    Mountain, Gail
    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, Claire A.
    Thompson-Coon, J.
    Ballard, C.
    Brayne, C.
    Burke, O.
    Burns, A.
    Clare, L.
    Garrard, P.
    Kehoe, P.
    Passmore, P.
    Holmes, C.
    Maidment, I.
    Murtagh, F.
    Robinson, L.
    Livingston, G.
    Show allShow less
    Keyword
    Dementia; Disease modification trials
    Rights
    © Queen’s Printer and Controller of HMSO 2017. Reproduced in accordance with the UK government’s non-commercial license for public sector (http://www.nationalarchives.gov.uk/doc/non-commercial-government-licence/version/2/)
    Peer-Reviewed
    Yes
    
    Metadata
    Show full item record
    Abstract
    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.
    URI
    http://hdl.handle.net/10454/14461
    Version
    Published version
    Citation
    Webster L, Groskreutz D, Grinbergs-Saull A et al (2017) Development of a core outcome set for disease modification trials in mild to moderate dementia: a systematic review, patient and public consultation and consensus recommendations. Health Technology Assessment. 21(26)
    Link to publisher’s version
    https://doi.org/10.3310/hta21260
    Type
    Report
    Collections
    Health Studies Publications

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