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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
Webster, L. Groskreutz, D. Grinbergs-Saull, A. Howard, R. O'Brien, J.T. Mountain, Gail Banerjee, S. Woods, B. Perneczky, R. Lafortune, L.
Webster, L.
Groskreutz, D.
Grinbergs-Saull, A.
Howard, R.
O'Brien, J.T.
Mountain, Gail
Banerjee, S.
Woods, B.
Perneczky, R.
Lafortune, L.
Publication Date
2017-05
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© Queen's Printer and Controller of HMSO 2017. Reproduced in accordance with the UK government's non-commercial license for the public sector (http://www.nationalarchives.gov.uk/doc/non-commercial-government-licence/version/2/)
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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.
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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)
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