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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

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
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
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 Specific instruments may be superseded.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.
1932-6203
Webster, Lucy
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Groskreutz, Derek
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Grinbergs-Saull, Anna
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Howard, Rob
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O’Brien, John T.
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Perneczky, Robert
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Lafortune, Louise
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Mccleery, Jenny
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Goodman, Claire
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Jones, Roy
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Lamb, Sarah
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Schneider, Justine
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Shepperd, Sasha
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Surr, Claire
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Clare, Linda
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Passmore, Peter
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Holmes, Clive
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Robinson, Louise
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Livingston, Gill
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Webster, Lucy
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Howard, Rob
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O’Brien, John T.
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Mountain, Gail
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Lamb, Sarah
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Shepperd, Sasha
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Thompson-Coon, Jo
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Ballard, Clive
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Kehoe, Patrick
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Passmore, Peter
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Holmes, Clive
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Maidment, Ian
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Robinson, Louise
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Livingston, Gill
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Webster, Lucy, Groskreutz, Derek, Grinbergs-Saull, Anna, Howard, Rob, O’Brien, John T., Mountain, Gail, Banerjee, Sube, Woods, Bob, Perneczky, Robert, Lafortune, Louise, Roberts, Charlotte, Mccleery, Jenny, Pickett, James, Bunn, Frances, Challis, David, Charlesworth, Georgina, Featherstone, Katie, Fox, Chris, Goodman, Claire, Jones, Roy, Lamb, Sarah, Moniz-Cook, Esme, Schneider, Justine, Shepperd, Sasha, Surr, Claire, Thompson-Coon, Jo, Ballard, Clive, Brayne, Carol, Burns, Alistair, Clare, Linda, Garrard, Peter, Kehoe, Patrick, Passmore, Peter, Holmes, Clive, Maidment, Ian, Robinson, Louise and Livingston, Gill (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).

Record type: Article

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.

Text
journal.pone.0179521 - Version of Record
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More information

Accepted/In Press date: 31 May 2017
Published date: 29 June 2017

Identifiers

Local EPrints ID: 428827
URI: http://eprints.soton.ac.uk/id/eprint/428827
ISSN: 1932-6203
PURE UUID: ecbff0e5-2b86-455b-b593-a863a5ebb3b8
ORCID for Clive Holmes: ORCID iD orcid.org/0000-0003-1999-6912

Catalogue record

Date deposited: 11 Mar 2019 17:30
Last modified: 22 Nov 2021 02:44

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Contributors

Author: Lucy Webster
Author: Derek Groskreutz
Author: Anna Grinbergs-Saull
Author: Rob Howard
Author: John T. O’Brien
Author: Gail Mountain
Author: Sube Banerjee
Author: Bob Woods
Author: Robert Perneczky
Author: Louise Lafortune
Author: Charlotte Roberts
Author: Jenny Mccleery
Author: James Pickett
Author: Frances Bunn
Author: David Challis
Author: Georgina Charlesworth
Author: Katie Featherstone
Author: Chris Fox
Author: Claire Goodman
Author: Roy Jones
Author: Sarah Lamb
Author: Esme Moniz-Cook
Author: Justine Schneider
Author: Sasha Shepperd
Author: Claire Surr
Author: Jo Thompson-Coon
Author: Clive Ballard
Author: Carol Brayne
Author: Alistair Burns
Author: Linda Clare
Author: Peter Garrard
Author: Patrick Kehoe
Author: Peter Passmore
Author: Clive Holmes ORCID iD
Author: Ian Maidment
Author: Louise Robinson
Author: Gill Livingston

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