Criteria and Indicators for Centers of Clinical Excellence in Stroke Recovery and Rehabilitation: A Global Consensus Facilitated by ISRRA.

BACKGROUND: The aim of the International Stroke Recovery and Rehabilitation Alliance is to create a world where worldwide collaboration brings major breakthroughs for the millions of people living with stroke. A key pillar of this work is to define globally relevant criteria for centers that aspire to deliver excellent clinical rehabilitation and generate exceptional outcomes for patients. OBJECTIVES: This paper presents consensus work conducted with an international group of expert stroke recovery and rehabilitation researchers, clinicians, and people living with stroke to identify and define criteria and measurable indicators for Centers of Clinical Excellence (CoCE) in stroke recovery and rehabilitation. These were intentionally developed to be ambitious and internationally relevant, regardless of a country's development or income status, to drive global improvement in stroke services. METHODS: Criteria and specific measurable indicators for CoCE were collaboratively developed by an international panel of stroke recovery and rehabilitation experts from 10 countries and consumer groups from 5 countries. RESULTS: The criteria and associated indicators, ranked in order of importance, focused upon (i) optimal outcome, (ii) research culture, (iii) working collaboratively with people living with stroke, (iv) knowledge exchange, (v) leadership, (vi) education, and (vii) advocacy. Work is currently underway to user-test the criteria and indicators in 14 rehabilitation centers in 10 different countries. CONCLUSIONS: We anticipate that use of the criteria and indicators could support individual organizations to further develop their services and, more widely, provide a mechanism by which clinical excellence can be articulated and shared to generate global improvements in stroke care.

The Unmet Needs of Caregiving Skills, Support, Emotions, and Finances of Stroke Caregivers: A Multicenter Study.

​​​​​​Background Informal stroke caregivers in Malaysia play an important role in supporting stroke survivors following acute care. Nevertheless, there is a lack of available data to inform the sufficiency of help and resources available to address the needs of local stroke caregivers. This study aimed to determine the unmet needs in caregiving skills, support, emotions, and finances as well as the associated factors of stroke caregivers in Malaysia. Methodology This multicenter, cross-sectional study used a self-administered survey developed and validated for the Malaysian population. It was prepared in paper-based and web-based formats, and it was distributed via direct contact with the respondents, post, and email. Respondents were recruited from different sites in Malaysia. In this study, unmet needs were defined as "help that was needed more or was not provided to assist caregivers and address their specific needs." This article only presents the quantitative data of this study. Data were analyzed using descriptive analysis and logistic regression to determine factors associated with unmet needs. Results Almost all study respondents (91%) reported having unmet needs. Unmet needs ranged from 1 to 10, while the mean unmet needs was 5. The highest unmet need was related to financial support (72.5%), followed by support from professionals to address their own needs (59.2%), skills to care for stroke survivors, i.e., skills in caring for stroke survivors with their daily activities (57.9%), and skills in supporting stroke survivors to perform rehabilitation at home (53.1%). The lowest unmet need was related to support in transporting stroke survivors from place to place (45.3%). Additionally, this study did not identify an association between the reported unmet needs and gender, age, ethnicity, duration of caregiving, and site of participation. Conclusions This study reported a range of unmet needs perceived by stroke caregivers in Malaysia. Further research is warranted to understand the gaps in supporting local stroke caregivers to inform future post-stroke support and services in the country.

Development of the stroke patient concerns inventory: A modified Delphi study.

OBJECTIVES: Stroke survivors often have unmet physical, psychological and/or social concerns. Patient Concerns Inventories (PCIs) have been developed for other health conditions to address concerns. Our objective was to develop a PCI for stroke care. METHODS: This was a development study, including Modified Delphi study design, with academic and healthcare professionals with stroke care expertise. In Stage 1, a draft Stroke PCI (Version 1a) was created through identifying patient-reported concerns post-stroke from three previous studies and through expert panel discussions using Nominal Group Technique. In Stage 2, Version 1a was sent to 92 academic and healthcare professionals with stroke care expertise. Participants ranked their top 20 Stroke PCI items in order of importance and provided feedback. Rankings were converted into scores, and, with the feedback, used to amend the Stroke PCI. Two further rounds of feedback followed until consensus was reached between participants. A final draft of the Stroke PCI was created. RESULTS: In stage 1, 64 potential Stroke PCI items were generated. In Stage 2, 38 participants (41.3%) responded to the request to rank Stroke PCI items. The three highest ranked items were 'Risk of another stroke', 'Walking', 'Recovery'. After three rounds of feedback and amendments, the final draft of the Stroke PCI consisted of 53 items. CONCLUSIONS: A Stroke PCI has been developed using patient-reported concerns in previous studies and input from academic and healthcare professionals. Future work will involve gathering further feedback on the tool and exploring its acceptability and usability in a pilot study.

A Qualitative Study Exploring the Lives and Caring Practices of Young Carers of Stroke Survivors.

This study investigated the life transformation of children when a parent returned home from hospital after a stroke. The study explored children's experiences of taking on caring roles in partnership with their well parent and stroke survivors' perceptions of the young carer roles. The study aimed to identify unmet support needs in order to inform future service provision. Semi-structured interviews were conducted separately with stroke survivors (n = 7) (age range 41-60 years, mean 50.6) and their young carers (n = 11) (age range 11-20 years, mean 16). Interviews were audio recorded, transcribed and analysed using reflexive thematic analysis. Three overarching themes were identified: the lives of young carers, impact of stroke, and insulating the family. All the children were providing some level of care. None were in receipt of any formal support. Children moved in and out of the caring role in the absence of an adult, to act as primary carer. Young carers valued the life skills they were gaining but reported gaps in their knowledge and understanding of stroke. The well parent and young carers worked together in a bi-directional partnership to ameliorate the impact of stroke on the family. The study concluded that age appropriate and stroke specific information for children of stroke survivors could enhance agency and optimise positive outcomes of caring.

A Biopsychosocial Intervention for Stroke Carers (BISC): development and description of the intervention.

OBJECTIVE: Family members of stroke survivors are often not supported for their caring role, with many reporting adjustment difficulties. This paper describes the development and content of a group-based intervention for informal carers of stroke survivors. METHOD: The intervention is based on the theoretical foundation of the biopsychosocial model with the aim to understand and address the physical, psychological and social factors of caring for stroke survivors. Findings from a comprehensive literature review and a qualitative study with carers and stroke professionals were synthesized to guide the intervention development. The Template for Intervention Description and Replication (TIDieR) checklist was used as a framework to describe the intervention. RESULTS: The intervention integrates cognitive-behavioural approaches via the identification of the biopsychosocial (physical, emotional, social) factors that can have an impact on the well-being of carers. It includes education on stroke-specific topics and advice on coping strategies. It consists of six structured two-hour group sessions facilitated in a community setting. It provides information and support on adjusting to the caring role in the first year post-stroke. Intervention materials were designed for addressing carers' specific needs using psychological techniques, such as problem-solving, goal setting and relaxation exercises. CONCLUSION: We have underlined the importance for describing and reporting the process of intervention development for complex interventions in the context of stroke rehabilitation. An intervention addressing the needs of informal stroke carers (Biopsychosocial Intervention for Stroke Carers; BISC) has been developed and described. BISC was further evaluated in a single-centre feasibility randomized controlled trial.

Evaluating stroke early supported discharge using cost-consequence analysis.

PURPOSE: To evaluate different stroke early supported discharge (ESD) services in different geographical settings using cost-consequence analysis (CCA), which presents information about costs and outcomes in the form of a balance sheet. ESD is a multidisciplinary service intervention that facilitates discharge from hospital and includes delivery of stroke specialist rehabilitation at home. MATERIALS AND METHODS: Data were collected from six purposively sampled services across the Midlands, East and North of England. All services, rural and urban, provided stroke rehabilitation to patients in their own homes. Cost data included direct and overhead costs of service provision and staff travel. Consequence data included service level adherence to an expert consensus regarding the specification of ESD service provision. RESULTS: We observed that the most rural services had the highest service cost per patient. The main costs associated with running each ESD service were staff costs. In terms of the consequences, there was a positive association between service costs per patient and greater adherence to meeting the evidence-based ESD service specification agreed by an expert panel. CONCLUSIONS: This study found that rural services were associated with higher costs per patient, which in turn were associated with greater adherence to the expert consensus regarding ESD service specification. We suggest additional resources and costs are required in order for rural services to meet evidence-based criteria.Implications for rehabilitationThe main costs of an early supported discharge (ESD) service for stroke survivors were staff costs and these were positively associated with greater levels of rurality.Greater costs were associated with greater adherence to ESD core components, which has been previously found to enhance the effectiveness of ESD service provision.The cost-consequence analysis provides a descriptive summary for decision-makers about the costs of delivering ESD, suggesting additional resources and costs are required in order for rural services to meet evidence-based criteria.

Evidence-based stroke rehabilitation: do priorities for practice change and feasibility of implementation vary across high income, upper and lower-middle income countries?

PURPOSE: The context of implementation plays an important role in the delivery of optimal treatments in stroke recovery and rehabilitation. Considering that stroke systems of care vary widely across the globe, the goal of the present paper is to compare healthcare providers' priority of key areas in translating stroke research to clinical practice among High Income Countries, Upper Middle- and Lower Middle-Income Countries (HICs, UMICs, LMICs). We also aimed to compare perceptions regarding the key areas' feasibility of implementation, and formulate recommendations specific to each socioeconomic region. METHODS: Data related to recommendations for knowledge translation in stroke, from a primary survey from the second Stroke Recovery and Rehabilitation Roundtable were segregated based on socioeconomic region. Frequency distribution was used to compare the key areas for practice change and examine the perceived feasibility of implementation of the same across HIC, UMIC and LMICs. RESULTS: A total of 632 responses from healthcare providers across 28 countries were received. Interdisciplinary care and access to services were high priorities across the three groups. Transitions in Care and Intensity of Practice were high priority areas in HICs, whereas Clinical Practice Guidelines were a high priority in LMICs. Interventions specific to clinical discipline, screening and assessment were among the most feasible areas in HICs, whereas Intensity of practice and Clinical Practice Guidelines were perceived as most feasible to implement in LMICs. CONCLUSION: We have identified healthcare providers' priorities for addressing international practice change across socioeconomic regions. By focusing on the most feasible key areas, we can aid the channeling of appropriate resources to bridge the disparities in stroke outcomes across HICs, UMICs and LMICs.IMPLICATIONS FOR REHABILITATIONIt is pertinent to examine the differences in priorities of stroke rehabilitation professionals and the feasibility of implementing evidence-based practice across socioeconomic regions.There is an urgent necessity for the development of clinical practice guidelines for stroke rehabilitation in Low-Middle Income Countries, taking into consideration the cultural, economic and geographical constraints.In upper-middle income countries, encouraging family support and timely screening and assessment for aphasia, cognition and depression appear to be the low hanging fruits to enhance quality of life after stroke.Innovative ways to increase intensity of practice and channelling of resources to improve transitions in care may prove to be the most beneficial in advancing stroke rehabilitation in high income countries.

A scoping review of psychoeducational interventions for people after transient ischemic attack and minor stroke.

BACKGROUND: Psychoeducation can provide information and support to cope with the physical and emotional effects of a health condition. This scoping review aimed to identify the evidence regarding psychoeducational interventions for people after a Transient Ischemic Attack (TIA) and minor stroke. METHODS: This review was conducted in accordance with the PRISMA Extension for Scoping Reviews. Three electronic databases (MEDLINE, Embase, PsycINFO) were searched for articles on interventions related to psychoeducational support post-TIA and minor/mild stroke. Search retrieved 3722 articles. Three reviewers independently screened titles, abstracts, full-texts, and extracted data for included studies. Study quality was assessed using the JADAD scale. TIDieR checklist was used to describe interventions. RESULTS: Fifteen RCTs were included. Twelve studies were of high quality (JADAD score ≥2), two were of low quality. A total of 1500 participants were recruited across studies. Definition of TIA and minor stroke was unclear, leading to the exclusion of several studies. Various interventions were included, including education/psychoeducation (n = 4); exercise and lifestyle advice (n = 3); telephone-based education/counseling (n = 3); secondary prevention education (n = 1); motivational interviewing (n = 2); self-management (n = 2). Interventions were inconsistently described, with information missing about who delivered it and tailoring. CONCLUSIONS: Definitions of stroke severity are not adequately reported. There are a variety of interventions including education about a range of stroke-specific topics. Many interventions are not adequately described, thus making it difficult to determine if the aim was to provide information or support post-TIA/minor stroke. There is a need for an in-depth systematic review to develop a clear definition of psychoeducation.

Effectiveness of Stroke Early Supported Discharge: Analysis From a National Stroke Registry.

BACKGROUND: Implementation of stroke early supported discharge (ESD) services has been recommended in many countries' clinical guidelines, based on clinical trial evidence. This is the first observational study to investigate the effectiveness of ESD service models operating in real-world conditions, at scale. METHODS AND RESULTS: Using historical prospective data from the United Kingdom Sentinel Stroke National Audit Programme (January 1, 2016-December 31, 2016), measures of ESD effectiveness were "days to ESD" (number of days from hospital discharge to first ESD contact; n=6222), "rehabilitation intensity" (total number of treatment days/total days with ESD; n=5891), and stroke survivor outcome (modified Rankin scale at ESD discharge; n=6222). ESD service models (derived from Sentinel Stroke National Audit Programme postacute organizational audit data) were categorized with a 17-item score, reflecting adoption of ESD consensus core components (evidence-based criteria). Multilevel modeling analysis was undertaken as patients were clustered within ESD teams across the Midlands, East, and North of England (n=31). A variety of ESD service models had been adopted, as reflected by variability in the ESD consensus score. Controlling for patient characteristics and Sentinel Stroke National Audit Programme hospital score, a 1-unit increase in ESD consensus score was significantly associated with a more responsive ESD service (reduced odds of patient being seen after ≥1 day of 29% [95% CI, 1%-49%] and increased treatment intensity by 2% [95% CI, 0.3%-4%]). There was no association with stroke survivor outcome measured by the modified Rankin Scale. CONCLUSIONS: This study has shown that adopting defined core components of ESD is associated with providing a more responsive and intensive ESD service. This shows that adherence to evidence-based criteria is likely to result in a more effective ESD service as defined by process measures. Registration: URL: http://www.isrctn.com/; Unique identifier: ISRCTN15568163.

Biopsychosocial intervention for stroke carers (BISC): results of a feasibility randomised controlled trial and nested qualitative interview study.

OBJECTIVE: To determine the feasibility of recruiting to and delivering a biopsychosocial intervention for carers of stroke survivors. DESIGN: Feasibility randomised controlled study with nested qualitative interview study. SETTING: The intervention was delivered in the community in either a group or one-to-one format. SUBJECTS: Carers and stroke survivors within one year of stroke onset. INTERVENTIONS: A carer targeted intervention delivered by a research psychologist in six structured two-hour sessions or usual care control. The intervention combined education about the biological, psychological and social effects of stroke with strategies and techniques focussing on adjustment to stroke and caregiving. Stroke survivors in both groups received baseline and follow-up assessment but no intervention. MAIN OUTCOME: Recruitment rate, study attrition, fidelity of intervention delivery, acceptability and sensitivity of outcome measures used (health related quality of life, anxiety and depression and carer burden six months after randomisation). RESULTS: Of the 257 carers approached, 41 consented. Six withdrew before randomisation. Eighteen participants were randomised to receive the intervention and 17 to usual care. Attendance at sessions was greater when treated one-to-one. Feedback interviews suggested that participants found the intervention acceptable and peer support particularly helpful in normalising their feelings. Thirty participants were assessed at follow-up with improvements from baseline on all health measures for both groups. CONCLUSIONS: Our results suggest that a biopsychosocial intervention was acceptable to carers and can be delivered in group and one-to-one formats. Timing of approach and mode of intervention delivery is critical and requires tailoring to the carers individual needs.

Moving stroke rehabilitation research evidence into clinical practice: Consensus-based core recommendations from the Stroke Recovery and Rehabilitation Roundtable.

Moving research evidence to practice can take years, if not decades, which denies stroke patients and families from receiving the best care. We present the results of an international consensus process prioritizing what research evidence to implement into stroke rehabilitation practice to have maximal impact. An international 10-member Knowledge Translation Working Group collaborated over a six-month period via videoconferences and a two-day face-to-face meeting. The process was informed from surveys received from 112 consumers/family members and 502 health care providers in over 28 countries, as well as from an international advisory of 20 representatives from 13 countries. From this consensus process, five of the nine identified priorities relate to service delivery (interdisciplinary care, screening and assessment, clinical practice guidelines, intensity, family support) and are generally feasible to implement or improve upon today. Readily available website resources are identified to help health care providers harness the necessary means to implement existing knowledge and solutions to improve service delivery. The remaining four priorities relate to system issues (access to services, transitions in care) and resources (equipment/technology, staffing) and are acknowledged to be more difficult to implement. We recommend that health care providers, managers, and organizations determine whether the priorities we identified are gaps in their local practice, and if so, consider implementation solutions to address them to improve the quality of lives of people living with stroke.

Moving Stroke Rehabilitation Research Evidence into Clinical Practice: Consensus-Based Core Recommendations From the Stroke Recovery and Rehabilitation Roundtable.

Moving research evidence to practice can take years, if not decades, which denies stroke patients and families from receiving the best care. We present the results of an international consensus process prioritizing what research evidence to implement into stroke rehabilitation practice to have maximal impact. An international 10-member Knowledge Translation Working Group collaborated over a six-month period via videoconferences and a two-day face-to-face meeting. The process was informed from surveys received from 112 consumers/family members and 502 health care providers in over 28 countries, as well as from an international advisory of 20 representatives from 13 countries. From this consensus process, five of the nine identified priorities relate to service delivery (interdisciplinary care, screening and assessment, clinical practice guidelines, intensity, family support) and are generally feasible to implement or improve upon today. Readily available website resources are identified to help health care providers harness the necessary means to implement existing knowledge and solutions to improve service delivery. The remaining four priorities relate to system issues (access to services, transitions in care) and resources (equipment/technology, staffing) and are acknowledged to be more difficult to implement. We recommend that health care providers, managers, and organizations determine whether the priorities we identified are gaps in their local practice, and if so, consider implementation solutions to address them to improve the quality of lives of people living with stroke.

Safety and efficacy of co-careldopa as an add-on therapy to occupational and physical therapy in patients after stroke (DARS): a randomised, double-blind, placebo-controlled trial.

BACKGROUND: Dopamine is a key modulator of striatal function and learning and might improve motor recovery after stroke. Previous small trials of dopamine agonists after stroke provide equivocal evidence of effectiveness on improving motor recovery. We aimed to assess the safety and efficacy of co-careldopa plus routine occupational and physical therapy during early rehabilitation after stroke. METHODS: This double-blind, multicentre, randomised controlled trial of co-careldopa versus placebo in addition to routine NHS occupational and physical therapy was done at 51 UK NHS acute inpatient stroke rehabilitation services. We recruited patients with new or recurrent clinically diagnosed ischaemic or haemorrhagic (excluding subarachnoid haemorrhage) stroke 5-42 days before randomisation, who were unable to walk 10 m or more, had a score of less than 7 points on the Rivermead Mobility Index, were expected to need rehabilitation, and were able to access rehabilitation after discharge from hospital. Participants were assigned (1:1) using stratified random blocks to receive 6 weeks of oral co-careldopa or matched placebo in addition to routine NHS physiotherapy and occupational therapy. The initial two doses of co-careldopa were 62·5 mg (50 mg of levodopa and 12·5 mg of carbidopa) and the remaining doses were 125 mg (100 mg of levodopa and 25 mg of carbidopa). Participants were required to take a single oral tablet 45-60 min before physiotherapy or occupational therapy session. The primary outcome was ability to walk independently, defined as a Rivermead Mobility Index score of 7 or more, at 8 weeks. Primary and safety analyses were done in the intention-to-treat population. The trial is registered on the ISRCTN registry, number ISRCTN99643613. FINDINGS: Between May 30, 2011, and March 28, 2014, of 1574 patients found eligible, 593 (mean age 68·5 years) were randomly assigned to either the co-careldopa group (n=308) or to the placebo group (n=285), on an average 18 days after stroke onset. Primary outcome data were available for all 593 patients. We found no evidence that the ability to walk independently improved with co-careldopa (125 [41%] of 308 patients) compared with placebo (127 [45%] of 285 patients; odds ratio 0·78 [95% CI 0·53-1·15]) at 8 weeks. Mortality at 12 months did not differ between the two groups (22 [7%] vs 17 [6%]). Serious adverse events were largely similar between groups. Vomiting during therapy sessions, after taking the study drug, was the most frequent adverse event and was more frequent in the co-careldopa group than the placebo group (19 [6·2%] vs 9 [3·2%]). INTERPRETATION: Co-careldopa in addition to routine occupational and physical therapy does not seem to improve walking after stroke. Further research might identify subgroups of patients with stroke who could benefit from dopaminergic therapy at different doses or times after stroke with more intensive motor therapy. FUNDING: Medical Research Council.

Setting the scene for the Second Stroke Recovery and Rehabilitation Roundtable.

The Stroke Recovery and Rehabilitation Roundtable (SRRR) meetings bring together an international group of preclinical and clinical researchers along with statisticians, methodologists, funders and consumers, working to accelerate the development of effective treatments for stroke recovery and to support best-evidence uptake in rehabilitation practice. The first meeting (2016) focused on four recommendation areas: translation of preclinical evidence into human discovery trials; recovery biomarkers to provide knowledge of therapeutic targets and prognosis in human stroke; intervention development, monitoring, and reporting standards; and standardized measurement in motor recovery trials. The impact of SRRR is growing, with uptake of recommendations emerging, and funders exploring ways to incorporate research targets and recommendations. At our second meeting (SRRR2, 2018), we worked on new priority areas: (1) cognitive impairment, (2) standardizing metrics for measuring quality of movement, (3) improving development of recovery trials, and (4) moving evidence-based treatments into practice. To accelerate progress towards breakthrough treatments, formation of an International Stroke Recovery and Rehabilitation Alliance is our next step, where working groups will take recommendations and build partnerships needed to achieve our goals.

Bathing adaptations in the homes of older adults (BATH-OUT): results of a feasibility randomised controlled trial (RCT).

BACKGROUND: Housing adaptations have been identified as an important environmental and prevention intervention for older adults, which may improve health and quality of life. The onset of disability in bathing can act as a warning for further disability in other activities and may therefore be a judicious time-point for intervention. The aim of this study was to determine the feasibility of conducting a Randomised Controlled Trial (RCT) of bathing adaptations, to evaluate whether they improve older adults' perceived health status and quality of life, prevent further functional deterioration, and reduce the use of other health and social care resources. This study was conducted in preparation for a powered RCT. METHOD: Eligibility criteria were aged > 65 and referred to local authority housing adaptations service for an accessible flush-floor shower. Participants were randomised to either usual adaptations (3-4 month wait) or immediate adaptations (no wait). Outcomes were assessed at 3, 6 and 9 months and included perceived physical and mental health status, health and social care related quality of life, independence in activities of daily living (ADL) and bathing, and falls. Data on costs and the use of health and social care resources were collected during follow-up in order to inform a definitive health economic evaluation. RESULTS: Sixty participants were recruited and randomised, 31 to immediate adaptations and 29 to waiting list control. Mean age was 77(SD8), 58% women and 58% living alone. Follow-ups were completed with 90, 85 and 72% at 3, 6 and 9 months respectively. Adaptations were delivered to 65% of participants within the requisite timescales as there were delays with some privately owned properties. There were improvements from baseline in both groups on all outcome measures following the completion of the adaptations. CONCLUSIONS: This is the first RCT of housing adaptations in the UK. We demonstrated the feasibility of using a waiting list control, subject to minor alterations to the timescales for privately owned properties. A powered trial would evaluate the impact on older adults' quality of life and investigate the impact of waiting times on functional outcomes and health and care resource use. TRIAL REGISTRATION: ISRCTN14876332 Registered 12 July 2016.

Improving the Development, Monitoring and Reporting of Stroke Rehabilitation Research: Consensus-Based Core Recommendations from the Stroke Recovery and Rehabilitation Roundtable.

Recent reviews have demonstrated that the quality of stroke rehabilitation research has continued to improve over the last four decades but despite this progress, there are still many barriers in moving the field forward. Rigorous development, monitoring and complete reporting of interventions in stroke trials are essential in providing rehabilitation evidence that is robust, meaningful and implementable. An international partnership of stroke rehabilitation experts committed to develop consensus-based core recommendations with a remit of addressing the issues identified as limiting stroke rehabilitation research in the areas of developing, monitoring and reporting stroke rehabilitation interventions. Work exploring each of the three areas took place via multiple teleconferences and a two-day meeting in Philadelphia in May 2016. A total of 15 recommendations were made. To validate the need for the recommendations, the group reviewed all stroke rehabilitation trials published in 2015 (n=182 papers). Our review highlighted that the majority of publications did not clearly describe how interventions were developed or monitored during the trial. In particular, under-reporting of the theoretical rationale for the intervention and the components of the intervention call into question many interventions that have been evaluated for efficacy. More trials were found to have addressed the reporting of interventions recommendations than those related to development or monitoring. Nonetheless, the majority of reporting recommendations were still not adequately described. To progress the field of stroke rehabilitation research and to ensure stroke patients receive optimal evidence-based clinical care, we urge the research community to endorse and adopt our recommendations.

Biopsychosocial Intervention for Stroke Carers (BISC): protocol for a feasibility randomised controlled trial (RCT).

INTRODUCTION: Reducing length of hospital stay for stroke survivors often creates a shift in the responsibility of care towards informal carers. Adjustment to the caregiving process is experienced by many carers as overwhelming, complex and demanding and can have a detrimental impact on mental and physical health and well-being. National policy guidelines recommend that carers' needs are considered and addressed; despite this, few interventions have been developed and empirically evaluated. We developed a biopsychosocial intervention in collaboration with carers of stroke survivors. Our aim is to determine whether the intervention can be delivered in a group setting and evaluated using a randomised controlled trial (RCT). METHODS AND ANALYSIS: Feasibility RCT and nested qualitative interview study. We aim to recruit up to 40 stroke carers within 1 year of the stroke onset. Carers are randomised to usual care or usual care plus biopsychosocial intervention. Each intervention group will consist of five stroke carers. The intervention will focus on: psychoeducation, psychological adjustment to stroke, strategies for reducing unwanted negative thoughts and emotions and problem-solving strategies. The main outcome is the feasibility of conducting an RCT. Carer outcomes at 6 months include: anxiety and depression, quality of life and carer strain. Data are also collected from stroke survivors at baseline and 6 months including: level of disability, anxiety and depression, and quality of life. ETHICS AND DISSEMINATION: Favourable ethical opinion was provided by East Midlands - Nottingham2 Research Ethics Committee (14/EMI/1264). This study will determine whether delivery of the biopsychosocial intervention is feasible and acceptable to stroke carers within a group format. It will also determine whether it is feasible to evaluate the effects of the biopsychosocial intervention in an RCT. We will disseminate our findings through peer-reviewed publications and presentations at national and international conferences. TRIAL REGISTRATION NUMBER: ISRCTN15643456; Pre-results.

Improving the development, monitoring and reporting of stroke rehabilitation research: Consensus-based core recommendations from the Stroke Recovery and Rehabilitation Roundtable.

Recent reviews have demonstrated that the quality of stroke rehabilitation research has continued to improve over the last four decades but despite this progress, there are still many barriers in moving the field forward. Rigorous development, monitoring and complete reporting of interventions in stroke trials are essential in providing rehabilitation evidence that is robust, meaningful and implementable. An international partnership of stroke rehabilitation experts committed to develop consensus-based core recommendations with a remit of addressing the issues identified as limiting stroke rehabilitation research in the areas of developing, monitoring and reporting stroke rehabilitation interventions. Work exploring each of the three areas took place via multiple teleconferences and a two-day meeting in Philadelphia in May 2016. A total of 15 recommendations were made. To validate the need for the recommendations, the group reviewed all stroke rehabilitation trials published in 2015 (n = 182 papers). Our review highlighted that the majority of publications did not clearly describe how interventions were developed or monitored during the trial. In particular, under-reporting of the theoretical rationale for the intervention and the components of the intervention call into question many interventions that have been evaluated for efficacy. More trials were found to have addressed the reporting of interventions recommendations than those related to development or monitoring. Nonetheless, the majority of reporting recommendations were still not adequately described. To progress the field of stroke rehabilitation research and to ensure stroke patients receive optimal evidence-based clinical care, we urge the research community to endorse and adopt our recommendations.

Bathing adaptations in the homes of older adults (BATH-OUT): protocol for a feasibility randomised controlled trial (RCT).

INTRODUCTION: The Care Act 2014 has placed a responsibility on local authorities in England to provide services that prevent deterioration and minimise the use of other health and social care services. Housing adaptations have been identified as 1 of the 10 most promising prevention services for older adults, with bathing adaptations being the most requested. However, many local authorities have lengthy waiting times which may increase costs, reduce effectiveness and reduce the preventive effect. There is no robust evidence of the effect of these adaptations on: health, well-being and functional ability. METHODS AND ANALYSIS: This is a feasibility randomised controlled trial (RCT) with nested qualitative interview study. The RCT will recruit between 40 and 60 people who have been referred for an accessible showering facility, and their carers, from 1 local authority in England. They will be randomised to either usual adaptations (∼3-month wait) or immediate adaptations (no wait). The primary outcome is the feasibility of conducting a powered study. The outcomes assessed will be: health and social care-related quality of life, independence in activities of daily living and bathing, falls and use of health and social care services. Outcomes will be assessed at 3 and 6 months. Preliminary health economic feasibility will be established. ETHICS AND DISSEMINATION: Favourable ethical opinion was provided by the Social Care Research Ethics Committee (reference number 16/IEC08/0017). The results of this study will lay the foundations for a further powered study. This would investigate the effect of bathing adaptations on quality of life and whether increased waiting times are associated with poorer outcomes and increased costs. The results have further potential to inform trials of other housing or social care interventions using the novel waiting list control method. Dissemination will include peer-reviewed publications and presentations at national and international conferences. TRIAL REGISTRATION NUMBER: ISRCTN14876332; Pre-results.