BackgroundThere 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 findingsWe 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.LimitationsMost trials were about AD. Specific instruments may be superseded. We searched one database for psychometric properties.InterpretationThis 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 registrationPROSPERO no. CRD42015027346.
Background: There is currently no disease-modifying treatment available to halt or delay the progression of the disease pathology in dementia. An agreed core set of the best-available and most appropriate outcomes for disease modification would facilitate the design of trials and ensure consistency across disease modification trials, as well as making results comparable and meta-analysable in future trials. Objectives: To agree a set of core outcomes for disease modification trials for mild to moderate dementia with the UK dementia research community and patient and public involvement (PPI). Data sources: We included disease modification trials with quantitative outcomes of efficacy from (1) references from related systematic reviews in workstream 1; (2) searches of the Cochrane Dementia and Cognitive Improvement Group study register, Cochrane Central Register of Controlled Trials, Cumulative Index to Nursing and Allied Health Literature, EMBASE, Latin American and Caribbean Health Sciences Literature and PsycINFO on 11 December 2015, and clinical trial registries [International Standard Randomised Controlled Trial Number (ISRCTN) and clinicaltrials.gov] on 22 and 29 January 2016; and (3) hand-searches of reference lists of relevant systematic reviews from database searches. Review methods: The project consisted of four workstreams. (1) We obtained related core outcome sets and work from co-applicants. (2) We systematically reviewed published and ongoing disease modification trials to identify the outcomes used in different domains. We extracted outcomes used in each trial, recording how many used each outcome and with how many participants. We divided outcomes into the domains measured and searched for validation data. (3) We consulted with PPI participants about recommended outcomes. (4) We presented all the synthesised information at a conference attended by the wider body of National Institute for Health Research (NIHR) dementia researchers to reach consensus on a core set of outcomes. Results: We included 149 papers from the 22,918 papers screened, referring to 125 individual trials. Eighty-one outcomes were used across trials, including 72 scales [31 cognitive, 12 activities of daily living (ADLs), 10 global, 16 neuropsychiatric and three quality of life] and nine biological techniques. We consulted with 18 people for PPI. The conference decided that only cognition and biological markers are core measures of disease modification. Cognition should be measured by the Mini Mental State Examination (MMSE) or the Alzheimer’s Disease Assessment Scale – Cognitive subscale (ADAS-Cog), and brain changes through structural magnetic resonance imaging (MRI) in a subset of participants. All other domains are important but not core. We recommend using the Neuropsychiatric Inventory for neuropsychiatric symptoms: the Disability Assessment for Dementia for ADLs, the Dementia Quality of Life Measure for quality of life and the Clinical Dementia Rating scale to measure dementia globally. Limitations: Most of the trials inclu...
Study Objectives Sleep disturbances are a feature in people living with dementia, including getting up during the night, difficulty falling asleep, and excessive daytime sleepiness and may precipitate a person with dementia moving into residential care. There are varying estimates of the frequency of sleep disturbances, and it is unknown whether they are a problem for the individual. We conducted the first systematic review and meta-analysis on the prevalence and associated factors of sleep disturbances in the care home population with dementia. Methods We searched Embase, MEDLINE, and PsycINFO (29/04/2019) for studies of the prevalence or associated factors of sleep disturbances in people with dementia living in care homes. We computed meta-analytical estimates of the prevalence of sleep disturbances and used meta-regression to investigate the effects of measurement methods, demographics, and study characteristics. Results We included 55 studies of 22,780 participants. The pooled prevalence on validated questionnaires of clinically significant sleep disturbances was 20% (95% confidence interval, CI 16% to 24%) and of any symptom of sleep disturbance was 38% (95% CI 33% to 44%). On actigraphy using a cutoff sleep efficiency of <85% prevalence was 70% (95% CI 55% to 85%). Staff distress, resident agitation, and prescription of psychotropic medications were associated with sleep disturbances. Studies with a higher percentage of males had a higher prevalence of sleep disturbance. Conclusions Clinically significant sleep disturbances are less common than those measured on actigraphy and are associated with residents and staff distress and the increased prescription of psychotropics. Actigraphy appears to offer no benefit over proxy reports in this population.
DREAM-START for sleep disorders in dementia is feasible and acceptable.
Many people living with dementia experience sleep disturbances yet there are currently no known effective, safe and acceptable treatments. Working with those affected by dementia to co-produce interventions is increasingly promoted to ensure that approaches are fit for purpose and meet the specific needs of target groups. Our aim here is to outline and reflect upon the co-production of Dementia RElAted Manual for Sleep; STrAtegies for RelaTives (DREAMS:START), an intervention to improve sleep for people living with dementia. Our co-production team brought together experts in the development and testing of manualised interventions in dementia care and cognitive behavioural interventions for sleep disorders, with Alzheimer’s Society research network volunteers (ASRNVs) whose lives had been affected by dementia. Here we present the process of intervention development. We worked with (ASRNVs) at each stage of the process bringing together ‘experts by training’ and ‘experts by experience’. (ASRNVs)shared their experiences of sleep disturbances in dementia and how they had managed these difficulties, as well as suggestions for how to overcome barriers to putting the intervention into practice; making (DREAMS:START) more accessible and usable for those in need. In this paper we discuss both the benefits and challenges to this process and what we can learn for future work. Collaborating with ‘experts by experience’ caring for a relative with sleep difficulties helped us to develop a complex intervention in an accessible and engaging way which we have tested and found to be feasible and acceptable in a randomised controlled trial.
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