TY - JOUR
T1 - Core outcome measures for interventions to prevent or slow the progress of dementia for people living with mild to moderate dementia
T2 - systematic review and consensus recommendations
AU - Webster, Lucy
AU - Groskreutz, Derek
AU - Grinbergs-Saull, Anna
AU - Howard, Rob
AU - O'Brien, John T.
AU - Mountain, Gail
AU - Banerjee, Sube
AU - Woods, Bob
AU - Perneczky, Robert
AU - Lafortune, Louise
AU - Roberts, Charlotte
AU - McCleery, Jenny
AU - Pickett, James
AU - Bunn, Frances
AU - Challis, David
AU - Charlesworth, Georgina
AU - Featherstone, Katie
AU - Fox, Chris
AU - Goodman, Claire
AU - Jones, Roy
AU - Lamb, Sarah
AU - Moniz-Cook, Esme
AU - Schneider, Justine
AU - Shepperd, Sasha
AU - Surr, Claire
AU - Thompson-Coon, Jo
AU - Ballard, Clive
AU - Brayne, Carol
AU - Burns, Alistair
AU - Clare, Linda
AU - Garrard, Peter
AU - Kehoe, Patrick
AU - Passmore, Peter
AU - Holmes, Clive
AU - Maidment, Ian
AU - Robinson, Louise
AU - Livingston, Gill
N1 - © 2017 Webster et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
All data available UCL Discovery: http://discovery.ucl.ac.uk/1543119.
PY - 2017/6/29
Y1 - 2017/6/29
N2 - 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.
AB - 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.
KW - Journal Article
UR - http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0179521
UR - http://www.scopus.com/inward/record.url?scp=85021661906&partnerID=8YFLogxK
U2 - 10.1371/journal.pone.0179521
DO - 10.1371/journal.pone.0179521
M3 - Article
C2 - 28662127
SN - 1932-6203
VL - 12
JO - PLoS ONE
JF - PLoS ONE
IS - 6
M1 - e0179521
ER -