Objectives To determine whether individual goal‐oriented cognitive rehabilitation (CR) improves everyday functioning for people with mild‐to‐moderate dementia. Design and methods Parallel group multicentre single‐blind randomised controlled trial (RCT) comparing CR added to usual treatment (CR) with usual treatment alone (TAU) for people with an ICD‐10 diagnosis of Alzheimer, vascular or mixed dementia, and mild‐to‐moderate cognitive impairment (Mini‐Mental State Examination [MMSE] score ≥ 18), and with a family member willing to contribute. Participants allocated to CR received 10 weekly sessions over 3 months and four maintenance sessions over 6 months. Participants were followed up 3 and 9 months post randomisation by blinded researchers. The primary outcome was self‐reported goal attainment at 3 months. Secondary outcomes at 3 and 9 months included informant‐reported goal attainment, quality of life, mood, self‐efficacy, and cognition and study partner stress and quality of life. Results We randomised (1:1) 475 people with dementia; 445 (CR = 281) were included in the intention to treat analysis at 3 months and 426 (CR = 208) at 9 months. At 3 months, there were statistically significant large positive effects for participant‐rated goal attainment (d = 0.97; 95% CI, 0.75‐1.19), corroborated by informant ratings (d = 1.11; 95% CI, 0.89‐1.34). These effects were maintained at 9 months for both participant (d = 0.94; 95% CI, 0.71‐1.17) and informant (d = 0.96; 95% CI, 0.73‐1.2) ratings. The observed gains related to goals directly targeted in the therapy. There were no significant differences in secondary outcomes. Conclusions CR enables people with early‐stage dementia to improve their everyday functioning in relation to individual goals targeted in the therapy.

BackgroundCognitive rehabilitation (CR) is an individualised, person-centred intervention for people with mild to moderate dementia that addresses the impact of cognitive impairment on everyday functioning.ObjectivesTo determine whether or not CR is a clinically effective and cost-effective intervention for people with mild to moderate Alzheimer’s disease or vascular or mixed dementia, and their carers.DesignThis multicentre randomised controlled trial compared CR with treatment as usual (TAU). Following a baseline assessment and goal-setting to identify areas of everyday functioning that could be improved or better managed, participants were randomised (1 : 1) via secure web access to an independent randomisation centre to receive either TAU or CR and followed up at 3 and 9 months post randomisation.SettingCommunity.ParticipantsParticipants had anInternational Classification of Diseases, Tenth Edition, diagnosis of Alzheimer’s disease or vascular or mixed dementia, had mild to moderate cognitive impairment (Mini Mental State Examination score of ≥ 18 points), were stable on medication if prescribed, and had a family carer who was willing to contribute. The exclusion criteria were people with a history of brain injury or other neurological disorder and an inability to speak English. To achieve adequate power, we needed 350 people to complete the trial, with 175 people in each trial arm.InterventionCognitive rehabilitation consisted of 10 therapy sessions over 3 months, followed by four maintenance sessions over 6 months, delivered in participants’ homes. The therapists were nine occupational therapists and one nurse.Outcome measuresThe primary outcome was self-reported goal attainment at 3 months. Goal attainment was also assessed at 9 months. Carers provided independent ratings of goal attainment at both time points. The secondary outcomes were participant quality of life, mood, self-efficacy and cognition, and carer stress, health status and quality of life. The assessments at 3 and 9 months were conducted by researchers who were blind to the participants’ group allocation.ResultsA total of 475 participants were randomised (CR arm,n = 239; TAU arm,n = 236), 427 participants (90%) completed the trial and 426 participants were analysed (CR arm,n = 208, TAU arm,n = 218). At 3 months, there were statistically significant large positive effects for participant-rated goal attainment [mean change in the CR arm: 2.57; mean change in the TAU arm: 0.86; Cohen’sd = 0.97, 95% confidence interval (CI) 0.75 to 1.19], corroborated by carer ratings (Cohen’sd = 1.11, 95% CI 0.89 to 1.34). These effects were maintained at 9 months for both the participant ratings (Cohen’sd = 0.94, 95% CI 0.71 to 1.17) and the carer ratings (Cohen’sd = 0.96, 95% CI 0.73 to 1.20). There were no significant differences in the secondary outcomes. In the cost–utility analyses, there was no evidence of cost-effectiveness in terms of gains in the quality-adjusted life-years (QALYs) of the person with dementia (measured using the DEMentia Quality Of Life questionnaire utility score) or the QALYs of the carer (measured using the EuroQol-5 Dimensions, three-level version) from either cost perspective. In the cost-effectiveness analyses, by reference to the primary outcome of participant-rated goal attainment, CR was cost-effective from both the health and social care perspective and the societal perspective at willingness-to-pay values of £2500 and above for improvement in the goal attainment measure. There was no evidence on the cost-effectiveness of the self-efficacy measure (the Generalized Self-Efficacy Scale) from either cost perspective.LimitationsPossible limitations arose from the non-feasibility of using observational outcome measures, the lack of a general measure of functional ability and the exclusion of people without a carer or with rarer forms of dementia.ConclusionsCognitive rehabilitation is clinically effective in enabling people with early-stage dementia to improve their everyday functioning in relation to individual goals targeted in the therapy sessions.Future workNext steps will focus on the implementation of CR into NHS and social care services and on extending the approach to people with rarer forms of dementia.Trial registrationCurrent Controlled Trials ISRCTN21027481.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 23, No. 10. See the NIHR Journals Library website for further project information.

Background: Self-management equips people to manage the symptoms and lifestyle

Cognitive rehabilitation is feasible and potentially effective for dementias associated with Parkinson's disease.

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A simulation was conducted to assess the effect of technical variance on the statistical power of web experiments measuring response times. The results of the simulation showed that technical variance reduced the statistical power and the accuracy of the effect size estimate by a negligible magnitude. This finding therefore suggests that researchers’ preconceptions concerning the unsuitability of web experiments for conducting research using response time as a dependent measure are misguided.

PurposeTo determine the incremental cost‐effectiveness of portable electronic vision enhancement system (p‐EVES) devices compared with optical low vision aids (LVAs), for improving near vision visual function, quality of life and well‐being of people with a visual impairment.MethodsAn AB/BA randomized crossover trial design was used. Eighty‐two participants completed the study. Participants were current users of optical LVAs who had not tried a p‐EVES device before and had a stable visual impairment. The trial intervention was the addition of a p‐EVES device to the participant's existing optical LVA(s) for 2 months, and the control intervention was optical LVA use only, for 2 months. Cost‐effectiveness and cost‐utility analyses were conducted from a societal perspective.ResultsThe mean cost of the p‐EVES intervention was £448. Carer costs were £30 (4.46 hr) less for the p‐EVES intervention compared with the LVA only control. The mean difference in total costs was £417. Bootstrapping gave an incremental cost‐effectiveness ratio (ICER) of £736 (95% CI £481 to £1525) for a 7% improvement in near vision visual function. Cost per quality‐adjusted life year (QALY) ranged from £56 991 (lower 95% CI = £19 801) to £66 490 (lower 95% CI = £23 055). Sensitivity analysis varying the commercial price of the p‐EVES device reduced ICERs by up to 75%, with cost per QALYs falling below £30 000.ConclusionPortable electronic vision enhancement system (p‐EVES) devices are likely to be a cost‐effective use of healthcare resources for improving near vision visual function, but this does not translate into cost‐effective improvements in quality of life, capability or well‐being.

A Monte-Carlo simulation was used to model the biasing of effect sizes in published studies. The findings from the simulation indicate that, when a predominant bias to publish studies with statistically significant results is coupled with inadequate statistical power, there will be an overestimation of effect sizes. The consequences such an effect size overestimation will then have on meta-analyses and power analyses are highlighted and discussed along with measures which can be taken to reduce the problem.