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.
<h4>Background</h4>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.<h4>M...
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Public Library of Science (PLoS)
2017-01-01
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| Series: | PLoS ONE |
| Online Access: | https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0179521&type=printable |
| _version_ | 1826578796604555264 |
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| author | Lucy Webster Derek Groskreutz Anna Grinbergs-Saull Rob Howard John T O'Brien Gail Mountain Sube Banerjee Bob Woods Robert Perneczky Louise Lafortune Charlotte Roberts Jenny McCleery James Pickett Frances Bunn David Challis Georgina Charlesworth Katie Featherstone Chris Fox Claire Goodman Roy Jones Sarah Lamb Esme Moniz-Cook Justine Schneider Sasha Shepperd Claire Surr Jo Thompson-Coon Clive Ballard Carol Brayne Alistair Burns Linda Clare Peter Garrard Patrick Kehoe Peter Passmore Clive Holmes Ian Maidment Louise Robinson Gill Livingston |
| author_facet | Lucy Webster Derek Groskreutz Anna Grinbergs-Saull Rob Howard John T O'Brien Gail Mountain Sube Banerjee Bob Woods Robert Perneczky Louise Lafortune Charlotte Roberts Jenny McCleery James Pickett Frances Bunn David Challis Georgina Charlesworth Katie Featherstone Chris Fox Claire Goodman Roy Jones Sarah Lamb Esme Moniz-Cook Justine Schneider Sasha Shepperd Claire Surr Jo Thompson-Coon Clive Ballard Carol Brayne Alistair Burns Linda Clare Peter Garrard Patrick Kehoe Peter Passmore Clive Holmes Ian Maidment Louise Robinson Gill Livingston |
| author_sort | Lucy Webster |
| collection | DOAJ |
| description | <h4>Background</h4>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.<h4>Methods and findings</h4>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.<h4>Limitations</h4>Most trials were about AD. Specific instruments may be superseded. We searched one database for psychometric properties.<h4>Interpretation</h4>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.<h4>Trial registration</h4>PROSPERO no. CRD42015027346. |
| first_indexed | 2024-12-21T06:57:54Z |
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| id | doaj.art-04ff0d48f7c4494f99ca3e1dd3d53968 |
| institution | Directory Open Access Journal |
| issn | 1932-6203 |
| language | English |
| last_indexed | 2025-03-14T14:08:05Z |
| publishDate | 2017-01-01 |
| publisher | Public Library of Science (PLoS) |
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| series | PLoS ONE |
| spelling | doaj.art-04ff0d48f7c4494f99ca3e1dd3d539682025-02-27T05:38:24ZengPublic Library of Science (PLoS)PLoS ONE1932-62032017-01-01126e017952110.1371/journal.pone.0179521Core 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.Lucy WebsterDerek GroskreutzAnna Grinbergs-SaullRob HowardJohn T O'BrienGail MountainSube BanerjeeBob WoodsRobert PerneczkyLouise LafortuneCharlotte RobertsJenny McCleeryJames PickettFrances BunnDavid ChallisGeorgina CharlesworthKatie FeatherstoneChris FoxClaire GoodmanRoy JonesSarah LambEsme Moniz-CookJustine SchneiderSasha ShepperdClaire SurrJo Thompson-CoonClive BallardCarol BrayneAlistair BurnsLinda ClarePeter GarrardPatrick KehoePeter PassmoreClive HolmesIan MaidmentLouise RobinsonGill Livingston<h4>Background</h4>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.<h4>Methods and findings</h4>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.<h4>Limitations</h4>Most trials were about AD. Specific instruments may be superseded. We searched one database for psychometric properties.<h4>Interpretation</h4>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.<h4>Trial registration</h4>PROSPERO no. CRD42015027346.https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0179521&type=printable |
| spellingShingle | Lucy Webster Derek Groskreutz Anna Grinbergs-Saull Rob Howard John T O'Brien Gail Mountain Sube Banerjee Bob Woods Robert Perneczky Louise Lafortune Charlotte Roberts Jenny McCleery James Pickett Frances Bunn David Challis Georgina Charlesworth Katie Featherstone Chris Fox Claire Goodman Roy Jones Sarah Lamb Esme Moniz-Cook Justine Schneider Sasha Shepperd Claire Surr Jo Thompson-Coon Clive Ballard Carol Brayne Alistair Burns Linda Clare Peter Garrard Patrick Kehoe Peter Passmore Clive Holmes Ian Maidment Louise Robinson Gill Livingston 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 |
| title | 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. |
| title_full | 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. |
| title_fullStr | 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. |
| title_full_unstemmed | 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. |
| title_short | 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. |
| title_sort | 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 |
| url | https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0179521&type=printable |
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