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dc.contributor.authorWebster, Len
dc.contributor.authorGroskreutz, Den
dc.contributor.authorGrinbergs-Saull, Aen
dc.contributor.authorHoward, Ren
dc.contributor.authorO'Brien, Johnen
dc.contributor.authorMountain, Gen
dc.contributor.authorBanerjee, Sen
dc.contributor.authorWoods, Ben
dc.contributor.authorPerneczky, Ren
dc.contributor.authorLafortune, Louiseen
dc.contributor.authorRoberts, Cen
dc.contributor.authorMcCleery, Jen
dc.contributor.authorPickett, Jen
dc.contributor.authorBunn, Fen
dc.contributor.authorChallis, Den
dc.contributor.authorCharlesworth, Gen
dc.contributor.authorFeatherstone, Ken
dc.contributor.authorFox, Cen
dc.contributor.authorGoodman, Cen
dc.contributor.authorJones, Ren
dc.contributor.authorLamb, Sen
dc.contributor.authorMoniz-Cook, Een
dc.contributor.authorSchneider, Jen
dc.contributor.authorShepperd, Sen
dc.contributor.authorSurr, Cen
dc.contributor.authorThompson-Coon, Jen
dc.contributor.authorBallard, Cen
dc.contributor.authorBrayne, Carolen
dc.contributor.authorBurns, Aen
dc.contributor.authorClare, Len
dc.contributor.authorGarrard, Pen
dc.contributor.authorKehoe, Pen
dc.contributor.authorPassmore, Pen
dc.contributor.authorHolmes, Cen
dc.contributor.authorMaidment, Ien
dc.contributor.authorRobinson, Len
dc.contributor.authorLivingston, Gen
dc.date.accessioned2017-08-22T15:13:15Z
dc.date.available2017-08-22T15:13:15Z
dc.date.issued2017-06-29en
dc.identifier.issn1932-6203
dc.identifier.urihttps://www.repository.cam.ac.uk/handle/1810/266731
dc.description.abstractBACKGROUND: 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.
dc.description.sponsorshipGL was (in part) supported by the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care (CLAHRC) North Thames at Bart’s Health NHS Trust. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health. JTC is funded by the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care South West Peninsula. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health.
dc.languageengen
dc.language.isoenen
dc.publisherPloS
dc.rightsAttribution 4.0 Internationalen
dc.rightsAttribution 4.0 Internationalen
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/en
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/en
dc.titleCore 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.en
dc.typeArticle
prism.issueIdentifier6en
prism.numbere0179521en
prism.publicationDate2017en
prism.publicationNamePLoS Oneen
prism.volume12en
dc.identifier.doi10.17863/CAM.12805
dcterms.dateAccepted2017-05-31en
rioxxterms.versionofrecord10.1371/journal.pone.0179521en
rioxxterms.versionVoRen
rioxxterms.licenseref.urihttp://creativecommons.org/licenses/by/4.0/en
rioxxterms.licenseref.startdate2017-06-29en
dc.contributor.orcidO'Brien, John [0000-0002-0837-5080]
dc.contributor.orcidLafortune, Louise [0000-0002-9018-1217]
dc.contributor.orcidBrayne, Carol [0000-0001-5307-663X]
dc.identifier.eissn1932-6203
rioxxterms.typeJournal Article/Reviewen
cam.issuedOnline2017-06-29en


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Attribution 4.0 International
Except where otherwise noted, this item's licence is described as Attribution 4.0 International