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, Lucy (Research Assistant, University College London, Division of Psychiatry); Groskreutz, Derek; Grinbergs-Saull, Anna; Howard, Rob; O'Brien, J. T. (John T.), 1962-; Mountain, Gail A.; Banerjee, Sube; Woods, Robert T.; Perneczky, Robert; Lafortune, Louise (Scientific Coordinator of the Ageing Well Programme); Roberts, Charlotte (Charlotte Jane); McCleery, Jenny (Consultant old age psychiatrist); Pickett, James (James Ashby); Bunn, Frances; Challis, David, 1948-; Charlesworth, G. (Georgina); Featherstone, Katie‏; Fox, Chris (George Christopher); Goodman, Claire, Professor; Jones, Roy W.; Lamb, S. E. (Sallie E.); Moniz-Cook, Esme; Schneider, Justine‏; Shepperd, Sasha; Surr, Claire; Thompson-Coon, J. (Joanna); Ballard, Clive; Brayne, Carol; Burke, Órlaith; Burns, Alistair S.; Clare, Linda; Garrard, Peter, 1960-; Kehoe, Patrick (Patrick Gavin); Passmore, Peter; Holmes, Clive, 1960-; Maidment, Ian D.; Murtagh, Fliss; Robinson, L. (Louise), Dr.; Livingston, Gill

School of Health and Social Work
Dementia
2017

Journal article


Rights
© Queen’s Printer and Controller of HMSO 2017. This work was produced by Webster et al. under the terms of a commissioning contract issued by the Secretary of State for Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK.
Abstract

In the UK, around 850,000 people have dementia. If a treatment can change the underlying pathology of dementia this is called disease modification, although no trials have yet found effective disease-modifying treatments. Trials have used differing outcome measures to evaluate if a treatment works, making it difficult to compare and contrast results. To address this issue we aimed, in collaboration with the UK dementia research community and the Alzheimer’s Society’s Research Network, to develop a core set of outcome measures for use in future disease-modifying trials for mild to moderate dementia. We looked at the outcomes used across completed and ongoing disease modification trials and found measures in six test areas: cognition, biological, behaviour, quality of life, activities of daily living and global. We used these findings to conduct a small consultation with people living with dementia and family carers. We presented all results at our consensus conference and discussed them to reach our conclusions. We recommend that the core set of outcome measures should include a cognitive measure, namely the Mini Mental State Examination or the Alzheimer’s Disease Assessment Scale – Cognitive subscale, and an optional magnetic resonance imaging scan looking at brain structure as a biological measure. We have specified measures for the other areas that are important but not core. The recommendations may change as new measures are developed, and, as most of the trials included participants with Alzheimer’s disease only, recommendations need to be developed for different dementias. They apply only to mild to moderate stages of dementia.

Publisher
The University of Hull
Peer reviewed
Yes
Language
English
Extent
5 MB
Identifier
hull:15266

Journal

Journal title
Health technology assessment
Publication date
2017
Publisher
NIHR Health Technology Assessment Programme
DOI
10.3310/hta21260
ISSN (Print)
1366-5278
ISSN (Electronic)
2046-4924
Volume
21
Issue
26
Notes

This is a copy of an open access report published in Health technology assessment, 2017, v.21 issue 26.

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