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PLoS One. 2017 Jun 29;12(6):e0179521. doi: 10.1371/journal.pone.0179521. eCollection 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.

Author information

1
Division of Psychiatry, University College London, London, United Kingdom.
2
Division of Psychology and Language Sciences, University College London, London, United Kingdom.
3
Alzheimer's Society, London, United Kingdom.
4
Department of Psychiatry, University of Cambridge, Cambridge, United Kingdom.
5
ScHARR, University of Sheffield, Sheffield, United Kingdom.
6
Centre for Dementia Studies, Brighton and Sussex Medical School, Brighton, United Kingdom.
7
Dementia Services Development Centre Wales, Bangor University, Bangor, United Kingdom.
8
Faculty of Medicine, School of Public Health, Imperial College London, London, United Kingdom.
9
Department of Psychiatry and Psychotherapy, Ludwig-Maximilians-Universität München, Munich, Germany.
10
Department of Psychiatry and Psychotherapy, Technische Universität München, Munich, Germany.
11
Cambridge Institute of Public Health, University of Cambridge, Cambridge, United Kingdom.
12
International Consortium for Health Outcomes Measurement, London, United Kingdom.
13
Oxford Health NHS Foundation Trust, Oxford, United Kingdom.
14
Centre for Research in Primary and Community Care, University of Hertfordshire, Hatfield, United Kingdom.
15
Personal Social Services Research Unit, University of Manchester, Manchester, United Kingdom.
16
Research Department of Clinical, Educational, and Health Psychology, University College London, London, United Kingdom.
17
School of Healthcare Sciences, Cardiff University, Cardiff, United Kingdom.
18
Norwich Medical School, University of East Anglia, Norwich, United Kingdom.
19
Research Institute for the Care of Older People (RICE), University of Bath, Bath, United Kingdom.
20
Warwick Clinical Trials Research Unit, University of Warwick, Warwick, United Kingdom.
21
Faculty of Health and Social Care, University of Hull, Hull, United Kingdom.
22
Institute of Mental Health, University of Nottingham, Nottingham, United Kingdom.
23
Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.
24
School of Health & Community Studies, Leeds Beckett University, Leeds, United Kingdom.
25
PenCLAHRC, University of Exeter Medical School, Exeter, United Kingdom.
26
Wolfson Centre for Age-Related Diseases, King's College London, London, United Kingdom.
27
Institute of Brain, Behaviour and Mental Health, University of Manchester, Manchester, United Kingdom.
28
School of Psychology, University of Exeter, Exeter, United Kingdom.
29
Neuroscience Research Centre, St. George's, University of London, London, United Kingdom.
30
School of Clinical Sciences, University of Bristol, Bristol, United Kingdom.
31
Centre for Public Health, Queen's University Belfast, Belfast, United Kingdom.
32
School of Medicine, University of Southampton, Southampton, United Kingdom.
33
Aston Research Centre for Healthy Ageing, Aston University, Birmingham, United Kingdom.
34
Institute of Health and Society, Newcastle University, Newcastle upon Tyne, United Kingdom.
35
North Thames CLAHRC, London, United Kingdom.
36
Camden and Islington NHS Foundation Trust, London, United Kingdom.

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.

PMID:
28662127
PMCID:
PMC5491018
DOI:
10.1371/journal.pone.0179521
[Indexed for MEDLINE]
Free PMC Article

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