A systematic review of the diagnostic test accuracy of brief cognitive tests to detect amnestic mild cognitive impairment.

OBJECTIVE: People with amnestic mild cognitive impairment (aMCI) are at an increased risk of developing dementia. Efficient ways of identifying this 'at risk' population are required for larger-scale research studies. This systematic review describes the diagnostic accuracy of brief cognitive tests for detecting aMCI. METHODS: Fifteen databases were searched from 1999 to July 2013 to identify papers for inclusion. Prospective studies assessing the diagnostic test accuracy of simple and brief cognitive tests for identifying people with aMCI against a reference standard (Petersen criteria) were included. Sensitivity, specificity, positive and negative predictive values and likelihood ratios were calculated. Predictive validity and test-retest reliability were also extracted, when provided. Risk of bias was assessed using the Quality Assessment of Diagnostic Accuracy Studies tool. RESULTS: Thirty-nine studies assessing 42 index tests were included. The Montreal Cognitive Assessment was the most comprehensively assessed test with evidence of high sensitivity for aMCI and good test-retest reliability, but low specificity was reported by the only study judged to be at low risk of bias. Other brief cognitive tests that include an assessment of word recall and multi-task tests that assess several cognitive domains were also found to exhibit high sensitivities and reasonable specificities. However, the confidence of the findings was affected by overall low quality of the contributing studies. CONCLUSION: Several brief cognitive tests have shown promising diagnostic test accuracy results for identifying aMCI. However, concerns over the quality of the constituent studies and lack of evidence on the predictive validity of these tests mean that new validation studies are warranted. Copyright © 2016 John Wiley & Sons, Ltd.

The validity of the Memory Alteration Test and the Test Your Memory test for community-based identification of amnestic mild cognitive impairment.

INTRODUCTION: This study investigated the validity of two brief cognitive tests (Memory Alteration Test [M@T] and Test Your Memory [TYM] test) for identifying people with aMCI in the community. METHODS: Older people were invited to participate by their general practitioner practice. Eligible participants were assessed for aMCI using an operationalized approach to the Petersen criteria and the M@T and TYM. RESULTS: Both tests demonstrated significant ability in discriminating between people with aMCI and controls (AUC = 0.91 for M@T and 0.80 for TYM [P < .001 for both]). M@T performed with higher sensitivity than TYM (85% vs. 63%) and similar specificity (84% vs. 87%). Both tests demonstrated moderate test-retest reliability (κ = ∼0.5) and took <10 minutes to administer. DISCUSSION: M@T and TYM are quick to administer. M@T demonstrated higher diagnostic test accuracy than TYM and could provide an efficient method for identifying aMCI in clinical and research settings.

The effect of physical rehabilitation on activities of daily living in older residents of long-term care facilities: systematic review with meta-analysis.

BACKGROUND: the worldwide population is ageing. One expected consequence of this is an increase in morbidity and an associated increased demand for long-term care. Physical rehabilitation is beneficial in older people, but relatively little is known about effects in residents of long-term care facilities. OBJECTIVE: to examine the effects of physical rehabilitation on activities of daily living (ADL) in elderly residents of long-term care facilities. METHODS: systematic review with meta-analysis of randomised controlled trials. We included studies that compared the effect of a physical rehabilitation intervention on independence in ADL with either no intervention or an alternative intervention in older people (over 60 years) living in long-term care facilities. We searched 19 databases including the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, CINAHL, AMED, Web of Knowledge and Google Scholar. Two researchers independently screened papers and extracted data. Outcomes of included studies were combined in a standardised mean difference random-effects meta-analysis. RESULTS: thirteen of 14 studies identified were included in the meta-analysis. Independence in ADL was improved by 0.24 standard units (95% CI: 0.11-0.38; P = 0.0005). This is equivalent to 1.3 points on the Barthel Index (0-20 scale). No significant differences in effect were found based on participant or intervention characteristics. Larger sample size and low attrition were associated with smaller estimates of effect. All studies were assessed to be at risk of bias. CONCLUSIONS: physical rehabilitation may improve independence for elderly long-term care facility residents, but mean effects are small. It is unclear which interventions are most appropriate.

Physical rehabilitation for older people in long-term care.

BACKGROUND: The worldwide population is progressively ageing, with an expected increase in morbidity and demand for long-term care. Physical rehabilitation is beneficial in older people, but relatively little is known about effects on long-term care residents. This is an update of a Cochrane review first published in 2009. OBJECTIVES: To evaluate the benefits and harms of rehabilitation interventions directed at maintaining, or improving, physical function for older people in long-term care through the review of randomised and cluster randomised controlled trials. SEARCH METHODS: We searched the trials registers of the following Cochrane entities: the Stroke Group (May 2012), the Effective Practice and Organisation of Care Group (April 2012), and the Rehabilitation and Related Therapies Field (April 2012). In addition, we searched 20 relevant electronic databases, including the Cochrane Central Register of Controlled Trials (The Cochrane Library, 2009, Issue 4), MEDLINE (1966 to December 2009), EMBASE (1980 to December 2009), CINAHL (1982 to December 2009), AMED (1985 to December 2009), and PsycINFO (1967 to December 2009). We also searched trials and research registers and conference proceedings; checked reference lists; and contacted authors, researchers, and other relevant Cochrane entities. We updated our searches of electronic databases in 2011 and listed relevant studies as awaiting assessment. SELECTION CRITERIA: Randomised studies comparing a rehabilitation intervention designed to maintain or improve physical function with either no intervention or an alternative intervention in older people (over 60 years) who have permanent long-term care residency. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed risk of bias and extracted data. We contacted study authors for additional information. The primary outcome was function in activities of daily living. Secondary outcomes included exercise tolerance, strength, flexibility, balance, perceived health status, mood, cognitive status, fear of falling, and economic analyses. We investigated adverse effects, including death, morbidity, and other events. We synthesised estimates of the primary outcome with the mean difference; mortality data, with the risk ratio; and secondary outcomes, using vote-counting. MAIN RESULTS: We included 67 trials, involving 6300 participants. Fifty-one trials reported the primary outcome, a measure of activities of daily living. The estimated effects of physical rehabilitation at the end of the intervention were an improvement in Barthel Index (0 to 100) scores of six points (95% confidence interval (CI) 2 to 11, P = 0.008, seven studies), Functional Independence Measure (0 to 126) scores of five points (95% CI -2 to 12, P = 0.1, four studies), Rivermead Mobility Index (0 to 15) scores of 0.7 points (95% CI 0.04 to 1.3, P = 0.04, three studies), Timed Up and Go test of five seconds (95% CI -9 to 0, P = 0.05, seven studies), and walking speed of 0.03 m/s (95% CI -0.01 to 0.07, P = 0.1, nine studies). Synthesis of secondary outcomes suggested there is a beneficial effect on strength, flexibility, and balance, and possibly on mood, although the size of any such effect is unknown. There was insufficient evidence of the effect on other secondary outcomes. Based on 25 studies (3721 participants), rehabilitation does not increase risk of mortality in this population (risk ratio 0.95, 95% CI 0.80 to 1.13). However, it is possible bias has resulted in overestimation of the positive effects of physical rehabilitation. AUTHORS' CONCLUSIONS: Physical rehabilitation for long-term care residents may be effective, reducing disability with few adverse events, but effects appear quite small and may not be applicable to all residents. There is insufficient evidence to reach conclusions about improvement sustainability, cost-effectiveness, or which interventions are most appropriate. Future large-scale trials are justified.

RECREATE: a study protocol for a multicentre pilot cluster randomised controlled trial (cRCT) in UK stroke services evaluating an intervention to reduce sedentary behaviour in stroke survivors (Get Set Go) with embedded process and economic evaluations.

INTRODUCTION: Sedentary behaviour (sitting or lying during waking hours without being otherwise active) is strongly associated with adverse health outcomes, including all-cause, cancer and cardiovascular mortality in adults. Stroke survivors are consistently reported as being more sedentary than healthy age-matched controls, spending more hours sedentary daily and sustaining longer unbroken bouts of sedentary time. An evidence-based and clinically feasible intervention ('Get Set Go') was developed. A pragmatic definitive trial to evaluate Get Set Go was planned; however, due to the unprecedented effects of the COVID-19 pandemic on National Health Service (NHS) services this study was reduced in size and scope to become an external pilot trial. We report the protocol for this external pilot trial, which aims to undertake a preliminary exploration of whether Get Set Go is likely to improve ability to complete extended activities of daily living in the first year post-stroke and inform future trial designs in stroke rehabilitation. METHODS AND ANALYSIS: This study is a pragmatic, multicentre, two-arm, external pilot cluster randomised controlled trial with embedded process and economic evaluations. UK-based stroke services will be randomised 1:1 to the intervention (usual care plus Get Set Go) or control (usual care) arm. Fifteen stroke services will recruit 300-400 stroke inpatient and carer participants, with follow-up at 6, 12 and 24 months. The proposed primary endpoint is stroke survivor self-reported Nottingham Extended Activities of Daily Living scale at 12 months. Endpoint analyses will be exploratory and provide preliminary estimates of intervention effect. The process evaluation will provide valuable information on intervention fidelity, acceptability and how it can be optimised. ETHICS AND DISSEMINATION: The study has been approved by Yorkshire and The Humber - Bradford-Leeds Research Ethics Committee (Ref: 19/YH/0403). Results will be disseminated through journal publications and conference presentations. TRIAL REGISTRATION NUMBER: This trial was registered prospectively on 01 April 2020 (ISRCTN ref: ISRCTN82280581).

Intervention to reduce sedentary behaviour and improve outcomes after stroke (Get Set Go): a study protocol for the process evaluation of a pilot cluster randomised controlled trial (RECREATE).

INTRODUCTION: Stroke survivors spend long periods of time engaging in sedentary behaviour (SB) even when their functional recovery is good. In the RECREATE programme, an intervention aimed at reducing SB ('Get Set Go') will be implemented and evaluated in a pragmatic external pilot cluster randomised controlled trial with embedded process and economic evaluations. We report the protocol for the process evaluation which will address the following objectives: (1) describe and clarify causal assumptions about the intervention, and its mechanisms of impact; (2) assess implementation fidelity; (3) explore views, perceptions and acceptability of the intervention to staff, stroke survivors and their carers; (4) establish the contextual factors that influence implementation, intervention mechanisms and outcomes. METHODS AND ANALYSIS: This pilot trial will be conducted in 15 UK-based National Health Service stroke services. This process evaluation study, underpinned by the Medical Research Council guidance, will be undertaken in six of the randomised services (four intervention, two control). Data collection includes the following: observations of staff training sessions, non-participant observations in inpatient and community settings, semi-structured interviews with staff, patients and carers, and documentary analysis of key intervention components. Additional quantitative implementation data will be collected in all sites. Training observations and documentary analysis data will be summarised, with other observational and interview data analysed using thematic analysis. Relevant theories will be used to interpret the findings, including the theoretical domains framework, normalisation process theory and the theoretical framework of acceptability. Anticipated outputs include the following: recommendations for intervention refinements (both content and implementation); a revised implementation plan and a refined logic model. ETHICS AND DISSEMINATION: The study was approved by Yorkshire & The Humber - Bradford Leeds Research Ethics Committee (REC reference: 19/YH/0403). Findings will be disseminated via peer review publications, and national and international conference presentations. TRIAL REGISTRATION NUMBER: ISRCTN82280581.

An intervention to support stroke survivors and their carers in the longer term: results of a cluster randomised controlled feasibility trial (LoTS2Care).

BACKGROUND: To address the limited provision of longer-term stroke care, we conducted a programme of research (LoTS2Care) to develop and test an intervention to form part of a replicable longer-term care strategy. New Start, a programme of facilitated self-management, was developed to be delivered at 6 months post-stroke by trained facilitators. Here, we report the findings from the final workstream of this programme, which aimed to evaluate the feasibility and acceptability of implementing a future definitive cluster randomised controlled trial of the developed intervention (New Start) to support stroke survivors and their carers in the longer term. METHODS: A feasibility cluster randomised controlled trial was conducted in English and Welsh NHS stroke services. Stroke services (clusters) were randomised on a 1:1 basis to implement New Start or continue with usual care only. Community-dwelling stroke survivors between 4 and 6 months post-stroke were invited to participate in the trial by post. Outcome measures were collected via post at 3, 6 and 9 months after recruitment. Recruitment and follow-up rates, delivery and uptake of the intervention, data collection feasibility (including postal outcome measures of health and disability, mental well-being at 3, 6, and 9 months post-recruitment) and safety were assessed. RESULTS: Ten stroke services were recruited. A total of 1127 stroke survivors were screened for participation, and 269 were registered (New Start, n = 145; usual care, n = 124). Retention was high with 239 (89%) stroke survivors being available for follow-up at 9 months, and high return rates of postal questionnaires were achieved (80.3% at 9 months). Intervention training was successfully delivered, and New Start was offered to 95.2% of trial participants in the intervention arm. Uptake was variable, however, ranging from 11.8 to 75.0%. There were no safety concerns. CONCLUSIONS: Stroke service recruitment and longer-term stroke survivor postal recruitment and outcome data collection are feasible; however, refinement of intervention targeting and delivery is required prior to undertaking a definitive trial. TRIAL REGISTRATION: ISRCTN38920246. Registered 22 June 2016 ( http://www.isrctn.com/ISRCTN38920246 ).

Systematic review of process evaluations of interventions in trials investigating sedentary behaviour in adults.

OBJECTIVES: To systematically review and synthesise findings from process evaluations of interventions in trials which measured sedentary behaviour as an outcome in adults to explore: (1) how intervention content, implementation, mechanisms of impact and context influence outcomes and (2) how these interventions are experienced from different perspectives (participants, carers, staff). DESIGN: Systematic review and narrative synthesis underpinned by the Medical Research Council process evaluation framework. DATA SOURCES: Databases searches were conducted in March 2019 then updated in May 2020 and October 2021 in: CINAHL, SPORTDiscus, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, AMED; EMBASE, PsycINFO, MEDLINE, Web of Science and ProQuest Dissertations & Theses. ELIGIBILITY CRITERIA: We included: Process evaluations of trials including interventions where sedentary behaviour was measured as an outcome in adults aged 16 or over from clinical or non-clinical populations. We excluded studies if interventions were delivered in educational or workplace settings, or if they were laboratory studies focused on immediate effects of breaking sitting. DATA EXTRACTION AND SYNTHESIS: Two independent reviewers extracted and coded data into a framework and assessed the quality of studies using the Mixed Methods Appraisal Tool. We synthesised findings using a narrative approach. RESULTS: 17 process evaluations were included. Five interventions focused on reducing sedentary behaviour or sitting time, 12 aimed to increase physical activity or promote healthier lifestyles. Process evaluations indicated changes in sedentary behaviour outcomes were shaped by numerous factors including: barriers (eg, staffing difficulties and scheduling problems) and facilitators (eg, allowing for flexibility) to intervention delivery; contextual factors (eg, usual lifestyle and religious events) and individual factors (eg, pain, tiredness, illness, age and individual preferences). DISCUSSION: Intervention requires careful consideration of different factors that could influence changes in sedentary behaviour outcomes to ensure that interventions can be tailored to suit different individuals and groups. PROSPERO REGISTRATION NUMBER: CRD42018087403.

An intervention to support stroke survivors and their carers in the longer term (LoTS2Care): study protocol for the process evaluation of a cluster randomised controlled feasibility trial.

BACKGROUND: Whilst pathways relating to the early stages of stroke care have become well established, strategies for longer-term care are less developed and longer-term outcomes remain poor for many stroke survivors. New Start, a complex intervention that includes needs identification, exploration of social networks and components of problem-solving and self-management, was designed to improve stroke survivors' quality of life by addressing unmet needs and increasing participation. It is delivered approximately 6 months post-stroke by trained staff (facilitators). We are currently undertaking a cluster randomised feasibility trial of the New Start intervention with an embedded process evaluation, which is an important component of the design and testing of complex interventions as it provides an understanding of how interventions are delivered and function in different settings. METHODS/DESIGN: This mixed methods process evaluation will explore the degree to which New Start is implemented as intended, the impact of context on intervention delivery and the acceptability of the intervention for stroke survivors, their families and practitioners. It will include non-participant observation of facilitator training and intervention delivery. Interviews with stroke survivors, facilitators and other relevant staff (including administrators and managerial staff) will be undertaken. Qualitative data from interview transcripts, facilitator reflections and observational field notes will be analysed thematically alongside numerical data documenting intervention delivery collected as part of the trial. DISCUSSION: This process evaluation will identify factors that aid and impede implementation of the New Start intervention and improve understanding of this novel approach to longer-term stroke care. TRIAL REGISTRATION: ISRCTN Registry, ISRCTN38920246 . Registered on 22 June 2016.

An intervention to support stroke survivors and their carers in the longer term (LoTS2Care): study protocol for a cluster randomised controlled feasibility trial.

BACKGROUND: Despite the evidence that many stroke survivors report longer term unmet needs, the provision of longer term care is limited. To address this, we are conducting a programme of research to develop an evidence-based and replicable longer term care strategy. The developed complex intervention (named New Start), which includes needs identification, exploration of social networks and components of problem solving and self-management, was designed to improve quality of life by addressing unmet needs and increasing participation. METHODS/DESIGN: A multicentre, cluster randomised controlled feasibility trial designed to inform the design of a possible future definitive cluster randomised controlled trial (cRCT) and explore the potential clinical and cost-effectiveness of New Start. Ten stroke services across the UK will be randomised on a 1:1 basis either to implement New Start or continue with usual care only. New Start will be delivered by trained facilitators and will be offered to all stroke survivors within the services allocated to the intervention arm. Stroke survivors will be eligible for the trial if they are 4-6 months post-stroke and residing in the community. Carers (if available) will also be invited to take part. Invitation to participate will be initiated by post and outcome measures will be collected via postal questionnaires at 3, 6 and 9 months after recruitment. Outcome data relating to perceived health and disability, wellbeing and quality of life as well as unmet needs will be collected. A 'study within a trial' (SWAT) is planned to determine the most acceptable format in which to provide the postal questionnaires. Details of health and social care service usage will also be collected to inform the economic evaluation. The feasibility of recruiting services and stroke survivors to the trial and of collecting postal outcomes will be assessed and the potential for effectiveness will be investigated. An embedded process evaluation (reported separately) will assess implementation fidelity and explore and clarify causal assumptions regarding implementation. DISCUSSION: This feasibility trial with embedded process evaluation will allow us to gather important and detailed data regarding methodological and implementation issues to inform the design of a possible future definitive cRCT of this complex intervention. TRIAL REGISTRATION: ISRCTN38920246 . Registered 22 June 2016.