What influences provision of information about recovery on stroke units? A focused ethnographic case study.

OBJECTIVE: Patients and carers frequently report dissatisfaction with post-stroke information provision. This study aimed to develop an in-depth understanding of the factors influencing provision of information about recovery in stroke units. METHODS: Focused ethnographic case-studies in two UK stroke units, including non-participant observations and semi-structured interviews with professionals, patients and carers, and documentary analysis. A Framework approach to analysis was undertaken. RESULTS: Twenty patients, 17 carers and 47 professionals participated. The unpredictable recovery trajectory led professionals to present prognostic estimates as uncertain possibilities. The need to maintain patients' motivation limited sharing of negative predictions, and generic information over-emphasised the importance of therapy in recovery. A structured multidisciplinary team approach to delivering information improved consistency. Complex clinical reasoning was required to identify and meet patients' needs. Hospital environments and routines restricted opportunities for dialogue, particularly with carers. CONCLUSIONS: The process of providing information about post-stroke recovery is complex, requiring enhanced clinical reasoning and communication. The challenges faced by professionals are numerous and if not addressed can result in suboptimal provision. PRACTICE IMPLICATIONS: Professionals should develop a co-ordinated multidisciplinary approach to information provision; and engage in dialogue to ensure a tailored approach to identifying and meeting patients' and carers' information needs.

Development of the Community-based complex Interventions to sustain Independence in Older People (CII-OP) typology: a qualitative synthesis of interventions in randomised controlled trials.

INTRODUCTION: Community-based services to sustain independence for older people have varying configurations. A typology of these interventions would improve service provision and research by providing conceptual clarity and enabling the identification of effective configurations. We aimed to produce such a typology. METHOD: We developed our typology by qualitatively synthesising community-based complex interventions to sustain independence in older people, evaluated in randomised controlled trials (RCTs), in four stages: (i) systematically identifying relevant RCTs; (ii) extracting descriptions of interventions (including control) using the Template for Intervention Description and Replication; (iii) generating categories of key intervention features and (iv) grouping the interventions based on these categories. PROSPERO registration: CRD42019162195. RESULTS: Our search identified 129 RCTs involving 266 intervention arms. The Community-based complex Interventions to sustain Independence in Older People (CII-OP) typology comprises 14 action components and 5 tailoring components. Action components include procedures for treating patients or otherwise intended to directly improve their outcomes; regular examples include formal homecare; physical exercise; health education; activities of daily living training; providing aids and adaptations and nutritional support. Tailoring components involve a process that may result in care planning, with multiple action components being planned, recommended or prescribed. Multifactorial action from care planning was the most common tailoring component. It involves individualised, multidomain assessment and management, as in comprehensive geriatric assessment. Sixty-three different intervention types (combinations) were identified. CONCLUSIONS: Our typology provides an empirical basis for service planning and evidence synthesis. We recommend better reporting about organisational aspects of interventions and usual care.

Community based complex interventions to sustain independence in older people: systematic review and network meta-analysis.

OBJECTIVE: To synthesise evidence of the effectiveness of community based complex interventions, grouped according to their intervention components, to sustain independence for older people. DESIGN: Systematic review and network meta-analysis. DATA SOURCES: Medline, Embase, CINAHL, PsycINFO, CENTRAL, clinicaltrials.gov, and International Clinical Trials Registry Platform from inception to 9 August 2021 and reference lists of included studies. ELIGIBILITY CRITERIA: Randomised controlled trials or cluster randomised controlled trials with ≥24 weeks' follow-up studying community based complex interventions for sustaining independence in older people (mean age ≥65 years) living at home, with usual care, placebo, or another complex intervention as comparators. MAIN OUTCOMES: Living at home, activities of daily living (personal/instrumental), care home placement, and service/economic outcomes at 12 months. DATA SYNTHESIS: Interventions were grouped according to a specifically developed typology. Random effects network meta-analysis estimated comparative effects; Cochrane's revised tool (RoB 2) structured risk of bias assessment. Grading of recommendations assessment, development and evaluation (GRADE) network meta-analysis structured certainty assessment. RESULTS: The review included 129 studies (74 946 participants). Nineteen intervention components, including "multifactorial action from individualised care planning" (a process of multidomain assessment and management leading to tailored actions), were identified in 63 combinations. For living at home, compared with no intervention/placebo, evidence favoured multifactorial action from individualised care planning including medication review and regular follow-ups (routine review) (odds ratio 1.22, 95% confidence interval 0.93 to 1.59; moderate certainty); multifactorial action from individualised care planning including medication review without regular follow-ups (2.55, 0.61 to 10.60; low certainty); combined cognitive training, medication review, nutritional support, and exercise (1.93, 0.79 to 4.77; low certainty); and combined activities of daily living training, nutritional support, and exercise (1.79, 0.67 to 4.76; low certainty). Risk screening or the addition of education and self-management strategies to multifactorial action from individualised care planning and routine review with medication review may reduce odds of living at home. For instrumental activities of daily living, evidence favoured multifactorial action from individualised care planning and routine review with medication review (standardised mean difference 0.11, 95% confidence interval 0.00 to 0.21; moderate certainty). Two interventions may reduce instrumental activities of daily living: combined activities of daily living training, aids, and exercise; and combined activities of daily living training, aids, education, exercise, and multifactorial action from individualised care planning and routine review with medication review and self-management strategies. For personal activities of daily living, evidence favoured combined exercise, multifactorial action from individualised care planning, and routine review with medication review and self-management strategies (0.16, -0.51 to 0.82; low certainty). For homecare recipients, evidence favoured addition of multifactorial action from individualised care planning and routine review with medication review (0.60, 0.32 to 0.88; low certainty). High risk of bias and imprecise estimates meant that most evidence was low or very low certainty. Few studies contributed to each comparison, impeding evaluation of inconsistency and frailty. CONCLUSIONS: The intervention most likely to sustain independence is individualised care planning including medicines optimisation and regular follow-up reviews resulting in multifactorial action. Homecare recipients may particularly benefit from this intervention. Unexpectedly, some combinations may reduce independence. Further research is needed to investigate which combinations of interventions work best for different participants and contexts. REGISTRATION: PROSPERO CRD42019162195.

Apathy After Stroke: Incidence, Symptom Trajectory, and Impact on Quality of Life and Disability

BACKGROUND AND OBJECTIVES: Apathy is one of the most common symptoms following stroke and is often associated with worse functional outcome and poor quality of life (QoL). The trajectory of apathy symptoms has been previously described, and different trajectories have been identified. We determined group and individual changes in apathy symptomatology from the acute phase until 1 year after stroke. We also examined the association of apathy and depression with disability and QoL 1 year after stroke. METHODS: We measured apathy in a cohort of ischemic stroke survivors at 4 time points from 0 to 12 months after stroke. The Apathy Evaluation Scale (AES) and Dimensional Apathy Scale (DAS) were administered at each time point. Where possible we obtained apathy measured from carers. Depression was assessed with the Geriatric Depression Scale (GDS). Disability and QoL were assessed with the modified Rankin Scale (mRS) and 36-Item Short Form Survey (SF-36). We examined the cross-sectional and individual trajectory of apathy symptoms in each dimension and looked at associations of apathy and depression soon after stroke with mRS and SF-36 at 1 year. RESULTS: Of 200 participants enrolled, 165 completed apathy measures at 12 months. Patient-rated apathy scores increased in both tests at the group level (AES: χ2(3) = 9.86, p = 0.019; DAS: χ2(3) = 8.49, p = 0.037) and individual level (AES: ß = 0.13, p = 0.002; DAS ß = 0.13, p = 0.005; DAS: executive ß = 0.08, p < 0.001). By contrast, carer-rated apathy did not significantly increase (AES: χ2(3) = 0.75, p = 0.862; DAS: χ2(3) = 2.45, p = 0.484). Apathy scores were associated with worse mRS and SF-36, although most associations were no longer significant when controlling for depression. GDS was associated with worse mRS and SF-36 after controlling for covariates and apathy (mRS: ß = 0.08, p = 0.006; SF-36 Mental Component Summary: ß = -1.53, p < 0.001; SF-36 Physical Component Summary: ß = -0.57, p = 0.016). DISCUSSION: Self-reported apathy progressively increases after stroke, especially in the executive dimension. Apathy is associated with worse QoL and greater disability, although some of these associations might be mediated by depression.

What are the priorities for research of older people living in their own home, including those living with frailty? A systematic review and content analysis of studies reporting older people's priorities and unmet needs.

BACKGROUND: There is limited evidence regarding the needs of older people, including those living with frailty, to inform research priority setting. OBJECTIVES: This systematic review aimed to identify the range of research priorities of community-dwelling older people living in their own home, including those living with frailty. METHODS: Included studies were from economically developed countries and designed to identify the priorities for research or unmet needs of community-dwelling older people. Studies were excluded if they described priorities relating to specific health conditions. Medline, Embase, PsycInfo and CINAHL were searched (January 2010-June 2022), alongside grey literature. Study quality was assessed, but studies were not excluded on the basis of quality. A bespoke data extraction form was used and content analysis undertaken to synthesise findings. RESULTS: Seventy-five reports were included. Seven explicitly aimed to identify the priorities or unmet needs of frail older people; 68 did not specify frailty as a characteristic. Study designs varied, including priority setting exercises, surveys, interviews, focus groups and literature reviews. Identified priorities and unmet needs were organised into themes: prevention and management, improving health and care service provision, improving daily life, meeting carers' needs and planning ahead. DISCUSSION: Many priority areas were raised by older people, carers and health/care professionals, but few were identified explicitly by/for frail older people. An overarching need was identified for tailored, collaborative provision of care and support. CONCLUSION: Review findings provide a valuable resource for researchers and health/care staff wishing to focus their research or service provision on areas of importance for older people.

Mapping review of pain management programmes and psychological therapies for community-dwelling older people living with pain.

PURPOSE: Persistent pain is common in older people and people living with frailty. Pain or the impact of pain on everyday life is potentially modifiable. We sought to map research evidence and information from randomised controlled trials (RCTs) of pain management programmes and psychological therapies targeting community-dwelling older people, and explore appropriate strategies and interventions for managing or reducing the negative impact of pain for older people, particularly those with frailty. METHOD: A mapping review of pain management programmes and psychological therapies for community-dwelling older people living with chronic pain. We searched for systematic reviews of randomised controlled trials and for individual randomised controlled trials and extracted data from eligible studies. RESULTS: Searches resulted in 3419 systematic review records and 746 RCT records from which there were 33 eligible interventions identified in 31 eligible RCTs (48 reports). Broad aims of the interventions were to: improve physical, psychological, or social functioning; adjust the effects or sensation of pain psychologically; enhance self-care with self-management skills or knowledge. Common mechanisms of change proposed were self-efficacy enhanced by self-management tasks and skills, using positive psychological skills or refocusing attention to improve responses to pain, and practising physical exercises to improve physiological well-being and reduce restrictions from pain. Content of interventions included: skills training and activity management, education, and physical exercise. Interventions were delivered in person or remotely to individuals or in groups, typically in 1-2 sessions weekly over 5-12 weeks. CONCLUSION: All the evaluated interventions appeared to show potential to provide some benefits to older people. None of the included studies assessed frailty. However, some of the included interventions appear appropriate for community-dwelling older people living with both frailty and pain.

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.

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).

Risk-of-bias assessment using Cochrane's revised tool for randomized trials (RoB 2) was useful but challenging and resource-intensive: observations from a systematic review.

OBJECTIVES: To report our experience using version 2 of the Cochrane risk-of-bias tool for randomized trials (RoB 2). STUDY DESIGN AND SETTING: Two reviewers independently applied RoB 2 to results of interest in a large systematic review of complex interventions and reached consensus. We recorded the time taken, and noted and discussed our difficulties using the tool, and the resolutions we adopted. We explored the time taken with regression analysis and summarized our experience of implementing the tool. RESULTS: We assessed risk of bias in 860 results of interest in 113 studies. Staff resource averaged 358 minutes per study (SD 183). Number of results (ß = 22) and reports (ß = 14) per study and experience of the team (ß = -6) significantly affected assessment time. To implement the tool consistently, we developed cut points for missingness and considerations of balance regarding missingness, assumed some concerns with intervention deviations unless otherwise prevented or investigated, some concerns with measurements from unblinded self-reporting participants, and judged low risk of selection for certain dichotomous outcomes despite the absence of an analysis plan. CONCLUSION: The RoB 2 tool and guidance are useful but resource-intensive and challenging to implement. Critical appraisal tools and reporting guidelines should detail risk of bias implementation. Improved guidance focusing on implementation could assist reviewers.

Developing the evidence and associated service models to support older adults living with frailty to manage their pain and to reduce its impact on their lives: protocol for a mixed-method, co-design study (The POPPY Study).

INTRODUCTION: The Pain in Older People with Frailty Study is a mixed-method, co-design study, which aims to develop the content, implementation strategies, service and professional guidance to support older adults with frailty to manage their pain. METHODS AND ANALYSIS: The study has four phases: Phase 1, research evidence and information synthesis from randomised controlled trials of multicomponent pain management programmes and psychological therapies for community-dwelling older adults. Phase 2, qualitative interviews with 30 community-dwelling older adults (≥75 years) living with frailty and persistent pain, including dyadic interviews with a spouse or unpaid carer. Phase 3, qualitative interviews with healthcare professionals (HCPs) working within various pain service types; 5-8 HCPs per service and up to 12 services including primary care, secondary care, tertiary centres and services with voluntary sector input. Phase 4, co-design workshops with older adults, HCPs and commissioners. Inclusion criteria (Phase 2): community-dwelling older adults (≥75 years) living with frailty and persistent pain. Exclusion criteria (Phase 2): care home residents, a dementia or cancer diagnosis. Cancer survivors, ≥5 years cancer free, and not undergoing active cancer treatment can participate. Analysis for Phase 1 will use narrative synthesis, Phase 2 will use grounded theory analysis and Phase 3 will use thematic analysis. Oversight is provided from a patient and public involvement group and an independent steering committee. ETHICS AND DISSEMINATION: The protocol was approved by Leeds-East Research Ethics Committee on 28 April 2022 (22/YH/0080). Consent is sought if an individual is willing to participate (Phases 2-4) and has capacity. Findings will be disseminated at conferences, in newsletters and journals and to local authorities and charities.

The role of the healthcare assistant on a stroke unit: A scoping review.

OBJECTIVE: This scoping review explores the role of a healthcare assistant on a stroke unit, potential barriers to role fulfilment and whether stroke-specific training could enhance rehabilitative practice. DATA SOURCES: Searches were conducted on CINAHL, MEDLINE and APA PsycInfo in May 2021 and repeated in September 2022. METHODS: This scoping review was guided by Arksey and O'Malley's framework. Article selection and data extraction were conducted by one researcher using a structured proforma. A narrative approach to data synthesis was undertaken following the research questions. RESULTS: From a combined total of 533 articles, sixty-six full-text articles were assessed for eligibility. Sixteen full articles were included in this review. A healthcare assistants' role was viewed as caring directly for patients - some individuals felt they contributed to rehabilitation during these tasks, and that they could be undervalued by multidisciplinary team members, patients and their families. The barriers identified to healthcare assistants' role fulfilment were lack of time, training and staffing shortages. Training was perceived to improve healthcare assistants' communication, confidence and knowledge but training needed to be flexible, ward based and accommodate staffing shortages. However, it is unclear whether training has any clinical benefit for patients. CONCLUSION: Healthcare assistants are well placed to enhance rehabilitative practice with patients; however, there are clear perceived barriers to this occurring. Future research should aim to define the role of healthcare assistants and explore whether further stroke-specific training could cause clinical benefits for patients.

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 ).

Using consensus methods to prioritize modifiable risk factors for development of manifestations of frailty in hospitalized older adults.

AIM: The aim of the study was to reach consensus on modifiable risk factors for a novel system of care to address Manifestations of Frailty in hospitalized older adults. DESIGN: Consensus study. METHOD: A modified nominal group technique, incorporating expert group face-to-face interaction, review of existing evidence and pre/post-meeting questionnaire completion was undertaken November 2019-February 2020. RESULTS: Seventy-one risk factors, within seven risk factor domains (pain, medication, fluid and nutrition intake, mobility, elimination, infection, additional patient factors) were considered. It was agreed that 44 risk factors incorporating patient, organizational and environmental risk factors were modifiable and should be included in a novel system of care.

New horizons in evidence-based care for older people: individual participant data meta-analysis.

Evidence-based decisions on clinical and cost-effectiveness of interventions are ideally informed by meta-analyses of intervention trial data. However, when undertaken, such meta-analyses in ageing research have typically been conducted using standard methods whereby summary (aggregate) data are extracted from published trial reports. Although meta-analysis of aggregate data can provide useful insights into the average effect of interventions within a selected trial population, it has limitations regarding robust conclusions on which subgroups of people stand to gain the greatest benefit from an intervention or are at risk of experiencing harm. Future evidence synthesis using individual participant data from ageing research trials for meta-analysis could transform understanding of the effectiveness of interventions for older people, supporting evidence-based and sustainable commissioning. A major advantage of individual participant data meta-analysis (IPDMA) is that it enables examination of characteristics that predict treatment effects, such as frailty, disability, cognitive impairment, ethnicity, gender and other wider determinants of health. Key challenges of IPDMA relate to the complexity and resources needed for obtaining, managing and preparing datasets, requiring a meticulous approach involving experienced researchers, frequently with expertise in designing and analysing clinical trials. In anticipation of future IPDMA work in ageing research, we are establishing an international Ageing Research Trialists collective, to bring together trialists with a common focus on transforming care for older people as a shared ambition across nations.

An investigation into the optimal wear time criteria necessary to reliably estimate physical activity and sedentary behaviour from ActiGraph wGT3X+ accelerometer data in older care home residents.

BACKGROUND: Research protocols regarding the use of ActiGraph wGT3X+ accelerometers in care home residents are yet to be established. The purpose of this study was to identify the minimal wear time criteria required to achieve reliable estimates of physical activity (PA) and sedentary behaviour (SB) in older care home residents. METHODS: Ninety-four older adults from 14 care homes wore an ActiGraph wGT3X+ accelerometer on the right hip for 7 consecutive days. A pragmatic, staged approach was adopted in order to explore the effect of: monitoring day; minimum daily wear time and number of wear days on estimates of four outcomes derived from the accelerometer data: counts.day- 1, counts.minute- 1, PA time and SB time. RESULTS: Data from 91 participants (mean age: 84 ± 9 years, 34% male) was included in the analysis. No effect of monitoring day was observed. Lowering the daily wear time to ≥ 8 h (compared to ≥10 h) had no effect on the outcomes of interest. Four days of monitoring was sufficient to provide reliable estimates of all four outcomes. CONCLUSION: In this study, a minimum wear time criterion of ≥ 8 h on any 4 days was required to derive reliable estimates of PA and SB from ActiGraph wGT3X+ accelerometer data in older care home residents.

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.

Risk factors for manifestations of frailty in hospitalized older adults: A qualitative study.

AIMS: To explore the experiences of older people and ward staff to identify modifiable factors (risk factors) which have the potential to reduce development or exacerbation of manifestations of frailty during hospitalization. To develop a theoretical framework of modifiable risk factors. DESIGN: Qualitative descriptive study. METHODS: Qualitative interviews with recently discharged older people (n = 18) and focus groups with ward staff (n = 22) were undertaken between July and October 2019. Data were analysed using directed content analysis. RESULTS: Themes identified related to attitude to risk, communication and, loss of routine, stimulation and confidence. Using findings from this study and previously identified literature, we developed a theoretical framework including 67 modifiable risk factors. Risk factors are grouped by patient risk factor domains (pain, medication, nutritional/fluid intake, mobility, elimination, infection, additional patient risk factors) and linked care management sub-domains (including risk factors relating to the ward environment, process of care, ward culture or broader organizational set up). Many of the additional 36 risk factors identified by this study were related to care management sub-domains. CONCLUSION: A co-ordinated approach is needed to address modifiable risk factors which lead to the development or exacerbation of manifestations of frailty in hospitalized older people. Risk assessment and management practices should not be duplicative and, should recognize and address modifiable risk factors which occur at the ward and organizational level. IMPACT: Some older people leave hospital more dependent than when they come in and this is, in part, due to the environment and process of care and not just the severity of their presenting illness. Many of the risk factors identified need to be addressed at an organizational rather than individual level. Findings will inform a programme of research to develop and test a novel system of care aimed at preventing loss of independence in hospitalized older people.

A qualitative study of sedentary behaviours in stroke survivors: non-participant observations and interviews with stroke service staff in stroke units and community services.

PURPOSE: Sedentary behaviour (SB) is associated with negative health outcomes and is prevalent post-stroke. This study explored SB after stroke from the perspective of stroke service staff. METHODS: Qualitative mixed-methods study. Non-participant observations in two stroke services (England/Scotland) and semi-structured interviews with staff underpinned by the COM-B model of behaviour change. Observations were analysed thematically; interviews were analysed using the Framework approach. RESULTS: One hundred and thirty-two observation hours (October - December 2017), and 31 staff interviewed (January -June 2018). Four themes were identified: (1) Opportunities for staff to support stroke survivors to reduce SB; (2) Physical and psychological capability of staff to support stroke survivors to reduce SB; (3) Motivating factors influencing staff behaviour to support stroke survivors to reduce SB; (4) Staff suggestions for a future intervention to support stroke survivors to reduce SB. CONCLUSIONS: Staff are aware of the consequences of prolonged sitting but did not relate to SB. Explicit knowledge of SB was limited. Staff need training to support stroke survivors to reduce SB. Sedentary behaviour in the community was not reported to change markedly, highlighting the need to engage stroke survivors in movement from when capable in hospital, following through to home.Implications for rehabilitationStroke survivor sedentary behaviour is influenced, directly and indirectly, by the actions and instructions of stroke service staff in the inpatient and community setting.The built and social environment, both in the inpatient and community settings, may limit opportunities for safe movement and can result in stroke survivors spending more time sedentary.Stroke service staff appreciate the benefit of encouraging stroke survivors to stand and move more, if it is safe for them to do so.Staff would be amenable to encourage stroke survivors to reduce sedentary behaviour, provided they have the knowledge and resources to equip them to support this.

Home-based Extended Rehabilitation for Older people (HERO): study protocol for an individually randomised controlled multi-centre trial to determine the clinical and cost-effectiveness of a home-based exercise intervention for older people with frailty as extended rehabilitation following acute illness or injury, including embedded process evaluation.

BACKGROUND: The majority of older people (> 65 years) in hospital have frailty and are at increased risk of readmission or death following discharge home. In the UK, following acute hospitalisation, around one third of older people with frailty are referred on for rehabilitation, termed 'intermediate care' services. Although this rehabilitation can reduce early readmission to hospital (< 30 days), recipients often do not feel ready to leave the service on discharge, suggesting possible incomplete recovery. Limited evidence suggests extended rehabilitation is of benefit in several conditions and there is preliminary evidence that progressive physical exercise can improve mobility and function for older people with frailty, and slow progression to disability. Our aim is to evaluate the effectiveness of the Home-based Older People's Exercise (HOPE) programme as extended rehabilitation for older people with frailty discharged home from hospital or intermediate care services after acute illness or injury. METHODS: A multi-centre individually randomised controlled trial, to evaluate the clinical and cost-effectiveness of the HOPE programme. This individualised, graded and progressive 24-week exercise programme is delivered by NHS physiotherapy teams to people aged 65 and older with frailty, identified using the Clinical Frailty Scale, following discharge from acute hospitalisation and linked intermediate care rehabilitation pathways. The primary outcome is physical health-related quality of life, measured using the physical component summary score of the modified Short Form 36- item health questionnaire (SF36) at 12 months. Secondary outcomes include self-reported physical and mental health, functional independence, death, hospitalisations, care home admissions. Plans include health economic analyses and an embedded process evaluation. DISCUSSION: This trial seeks to determine if extended rehabilitation, via the HOPE programme, can improve physical health-related quality of life for older people with frailty following acute hospitalisation. Results will improve awareness of the rehabilitation needs of older people with frailty, and provide evidence on the clinical and cost-effectiveness of the targeted exercise intervention. There is potential for considerable benefit for health and social care services through widespread implementation of trial findings if clinical and cost-effectiveness is demonstrated. TRIAL REGISTRATION: ISRCTN 13927531 . Registered on April 19, 2017.

Information provision for stroke survivors and their carers.

BACKGROUND: A stroke is a sudden loss of brain function caused by lack of blood supply. Stroke can lead to death or physical and cognitive impairment and can have long lasting psychological and social implications. Research shows that stroke survivors and their families are dissatisfied with the information provided and have a poor understanding of stroke and associated issues. OBJECTIVES: The primary objective is to assess the effects of active or passive information provision for stroke survivors (people with a clinical diagnosis of stroke or transient ischaemic attack (TIA)) or their identified carers. The primary outcomes are knowledge about stroke and stroke services, and anxiety. SEARCH METHODS: We updated our searches of the Cochrane Stroke Group Specialised Register on 28 September 2020 and for the following databases to May/June 2019: the Cochrane Central Register of Controlled Trials (CENTRAL; 2019, Issue 5) and the Cochrane Database of Systematic Reviews (CDSR; 2019, Issue 5) in the Cochrane Library (searched 31 May 2019), MEDLINE Ovid (searched 2005 to May week 4, 2019), Embase Ovid (searched 2005 to 29 May 2019), CINAHL EBSCO (searched 2005 to 6 June 2019), and five others. We searched seven study registers and checked reference lists of reviews. SELECTION CRITERIA: Randomised trials involving stroke survivors, their identified carers or both, where an information intervention was compared with standard care, or where information and another therapy were compared with the other therapy alone, or where the comparison was between active and passive information provision without other differences in treatment. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trial eligibility and risk of bias, and extracted data. We categorised interventions as either active information provision or passive information provision: active information provision included active participation with subsequent opportunities for clarification and reinforcement; passive information provision provided no systematic follow-up or reinforcement procedure. We stratified analyses by this categorisation. We used GRADE methods to assess the overall certainty of the evidence. MAIN RESULTS: We have added 12 new studies in this update. This review now includes 33 studies involving 5255 stroke-survivor and 3134 carer participants. Twenty-two trials evaluated active information provision interventions and 11 trials evaluated passive information provision interventions. Most trials were at high risk of bias due to lack of blinding of participants, personnel, and outcome assessors where outcomes were self-reported. Fewer than half of studies were at low risk of bias regarding random sequence generation, concealment of allocation, incomplete outcome data or selective reporting. The following estimates have low certainty, based on the quality of evidence, unless stated otherwise. Accounting for certainty and size of effect, analyses suggested that for stroke survivors, active information provision may improve stroke-related knowledge (standardised mean difference (SMD) 0.41, 95% confidence interval (CI) 0.17 to 0.65; 3 studies, 275 participants), may reduce cases of anxiety and depression slightly (anxiety risk ratio (RR) 0.85, 95% CI 0.68 to 1.06; 5 studies, 1132 participants; depression RR 0.83, 95% CI 0.68 to 1.01; 6 studies, 1315 participants), may reduce Hospital Anxiety and Depression Scale (HADS) anxiety score slightly, (mean difference (MD) -0.73, 95% CI -1.10 to -0.36; 6 studies, 1171 participants), probably reduces HADS depression score slightly (MD (rescaled from SMD) -0.8, 95% CI -1.27 to -0.34; 8 studies, 1405 participants; moderate-certainty evidence), and may improve each domain of the World Health Organization Quality of Life assessment short-form (WHOQOL-BREF) (physical, MD 11.5, 95% CI 7.81 to 15.27; psychological, MD 11.8, 95% CI 7.29 to 16.29; social, MD 5.8, 95% CI 0.84 to 10.84; environment, MD 7.0, 95% CI 3.00 to 10.94; 1 study, 60 participants). No studies evaluated positive mental well-being. For carers, active information provision may reduce HADS anxiety and depression scores slightly (MD for anxiety -0.40, 95% CI -1.51 to 0.70; 3 studies, 921 participants; MD for depression -0.30, 95% CI -1.53 to 0.92; 3 studies, 924 participants), may result in little to no difference in positive mental well-being assessed with Bradley's well-being questionnaire (MD -0.18, 95% CI -1.34 to 0.98; 1 study, 91 participants) and may result in little to no difference in quality of life assessed with a 0 to 100 visual analogue scale (MD 1.22, 95% CI -7.65 to 10.09; 1 study, 91 participants). The evidence is very uncertain (very low certainty) for the effects of active information provision on carers' stroke-related knowledge, and cases of anxiety and depression. For stroke survivors, passive information provision may slightly increase HADS anxiety and depression scores (MD for anxiety 0.67, 95% CI -0.37 to 1.71; MD for depression 0.39, 95% CI -0.61 to 1.38; 3 studies, 227 participants) and the evidence is very uncertain for the effects on stroke-related knowledge, quality of life, and cases of anxiety and depression. For carers, the evidence is very uncertain for the effects of passive information provision on stroke-related knowledge, and HADS anxiety and depression scores. No studies of passive information provision measured carer quality of life, or stroke-survivor or carer positive mental well-being. AUTHORS' CONCLUSIONS: Active information provision may improve stroke-survivor knowledge and quality of life, and may reduce anxiety and depression. However, the reductions in anxiety and depression scores were small and may not be important. In contrast, providing information passively may slightly worsen stroke-survivor anxiety and depression scores, although again the importance of this is unclear. Evidence relating to carers and to other outcomes of passive information provision is generally very uncertain. Although the best way to provide information is still unclear, the evidence is better for strategies that actively involve stroke survivors and carers and include planned follow-up for clarification and reinforcement.