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Objective: To identify and agree on what outcome domains should be measured in research and clinical practice when working with stroke survivors who have dysarthria., Design: Delphi process, two rounds of an online survey followed by two online consensus meetings., Setting: UK and Australia., Participants: Stroke survivors with experience of dysarthria, speech and language therapists/pathologists working in stroke and communication researchers., Methods: Initial list of outcome domains generated from existing literature and with our patient and public involvement group to develop the survey. Participants completed two rounds of this survey to rate importance. Outcomes were identified as 'in', 'unclear' or 'out' from the second survey. All participants were invited to two consensus meetings to discuss these results followed by voting to identify critically important outcome domains for a future Core Outcome Set. All outcomes were voted on in the consensus meetings and included if 70% of meeting participants voted 'yes' for critically important., Results: In total, 148 surveys were fully completed, and 28 participants attended the consensus meetings. A core outcome set for dysarthria after stroke should include four outcome domains: (a) intelligibility of speech, (b) ability to participate in conversations, (c) living well with dysarthria, (d) skills and knowledge of communication partners (where relevant)., Conclusions: We describe the consensus of 'what' speech outcomes after stroke are valued by all stakeholders including those with lived experience. We share these findings to encourage the measurement of these domains in clinical practice and research and for future research to identify 'how' best to measure these outcomes., Competing Interests: Declaration of conflicting interestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Objective: Investigate feasibility and acceptability of prism adaptation training for people with inattention (spatial neglect), early after stroke, during usual care., Design: Phase II feasibility randomised controlled trial with 3:1 stratified allocation to standard occupational therapy with or without intervention, and nested process evaluation., Setting: Ten hospital sites providing in-patient stroke services., Participants: Screened positive for inattention more than one-week post-stroke; informal carers. Occupational therapists participated in qualitative interviews., Intervention: Adjunctive prism adaptation training at the start of standard occupational therapy sessions for three weeks., Main Measures: Feasibility measures included recruitment and retention rates, intervention fidelity and attrition. Outcomes collected at baseline, 3 weeks and 12 weeks tested measures including Nottingham Extended Activities of Daily Living Scale. Acceptability was explored through qualitative interviews and structured questions., Results: Eighty (31%) patients were eligible, 57 (71%) consented, 54 randomised (40:13, +1 exclusion) and 39 (74%) completed 12-week outcomes. Treatment fidelity was good: participants received median eight intervention sessions (IQR: 5, 12) lasting 4.7 min (IQR: 4.1, 5.0). All six serious adverse events were unrelated. There was no signal that patients allocated to intervention did better than controls. Twenty five of 35 recruited carers provided outcomes with excellent data completeness. Therapists, patients and carers found prism adaptation training acceptable., Conclusions: It is feasible and acceptable to conduct a high-quality definitive trial of prism adaptation training within occupational therapy early after stroke in usual care setting, but difficult to justify given no sign of benefit over standard occupational therapy., Clinical Trial Registration: https://www.isrctn.com/ Ref ISRCTN88395268.

Background: Dysarthria after stroke is when speech intelligibility is impaired, and this occurs in half of all stroke survivors. Dysarthria often leads to social isolation, poor psychological well-being and can prevent return to work and social lives. Currently, a variety of outcome measures are used in clinical research and practice when monitoring recovery for people who have dysarthria. When research studies use different measures, it is impossible to compare results from trials and delays our understanding of effective clinical treatments. The aim of this study is to develop a core outcome set (COS) to agree what aspects of speech recovery should be measured for dysarthria after stroke (COS-Speech) in research and clinical practice., Methods: The COS-Speech study will include five steps: (1) development of a long list of possible outcome domains of speech that should be measured to guide the survey; (2) recruitment to the COS-Speech study of three key stakeholder groups in the UK and Australia: stroke survivors, communication researchers and speech and language therapists/pathologists; (3) two rounds of the Delphi survey process; (4) a consensus meeting to agree the speech outcomes to be measured and a follow-up consensus meeting to match existing instruments/measures (from parallel systematic review) to the agreed COS-Speech; (5) dissemination of COS-Speech., Discussion: There is currently no COS for dysarthria after stroke for research trials or clinical practice. The findings from this research study will be a minimum COS, for use in all dysarthria research studies and clinical practice looking at post-stroke recovery of speech. These findings will be widely disseminated using professional and patient networks, research and clinical forums as well as using a variety of academic papers, videos, accessible writing such as blogs and links on social media., Trial Registration: COS-Speech is registered with the Core Outcome Measures in Effectiveness Trials (COMET) database, October 2021 https://www.comet-initiative.org/Studies/Details/1959 . In addition, "A systematic review of the psychometric properties and clinical utility of instruments measuring dysarthria after stroke" will inform the consensus meeting to match measures to COS-Speech. The protocol for the systematic reviews registered with the International Prospective Register of Systematic Reviews. PROSPERO registration number: CRD42022302998 ., (© 2023. The Author(s).)

Background and Purpose: Unilateral neglect is a common cognitive disorder following stroke. Neglect has a significant impact on functional outcomes, so it is important to detect. However, there is no consensus on which are the best screening tests to administer to detect neglect in time-limited clinical environments., Methods: Members of the European Academy of Neurology Scientific Panel on Higher Cortical Functions, neuropsychologists, occupational therapists, and researchers produced recommendations for primary and secondary tests for bedside neglect testing based on a rigorous literature review, data extraction, online consensus meeting, and subsequent iterations., Results: A total of 512 articles were screened, and 42 were included. These reported data from 3367 stroke survivors assessed using 62 neglect screens. Tests were grouped into cancellation, line bisection, copying, reading/writing, and behavioral. Cancellation tasks were most frequently used (97.6% of studies), followed by bisection, copying, behavioral, and reading/writing assessments. The panel recommended a cancellation test as the primary screening test if there is time to administer only one test. One of several cancellation tests might be used, depending on availability. If time permits, one or more of line bisection, figure copying, and baking tray task were recommended as secondary tests. Finally, if a functional and ecological test is feasible, the Catherine Bergego Scale was recommended. Overall, the literature suggests that no single test on its own is sufficient to exclude a diagnosis of neglect. Therefore, the panel recommended that multiple neglect tests should be used whenever possible., Conclusions: This study provides consensus recommendations for rapid bedside detection of neglect in real-world, clinical environments., (© 2022 The Authors. European Journal of Neurology published by John Wiley & Sons Ltd on behalf of European Academy of Neurology.)

Background: People with spatial neglect after stroke or other brain injury have difficulty attending to one side of space. Various rehabilitation interventions have been used, but evidence of their benefit is unclear., Objectives: The main objective was to determine the effects of non-pharmacological interventions for people with spatial neglect after stroke and other adult-acquired non-progressive brain injury., Search Methods: We searched the Cochrane Stroke Group Trials Register (last searched October 2020), the Cochrane Central Register of Controlled Trials (CENTRAL; last searched October 2020), MEDLINE (1966 to October 2020), Embase (1980 to October 2020), the Cumulative Index to Nursing and Allied Health Literature (CINAHL; 1983 to October 2020), and PsycINFO (1974 to October 2020). We also searched ongoing trials registers and screened reference lists., Selection Criteria: We included randomised controlled trials (RCTs) of any non-pharmacological intervention specifically aimed at spatial neglect. We excluded studies of general rehabilitation and studies with mixed participant groups, unless separate neglect data were available., Data Collection and Analysis: We used standard Cochrane methods. Review authors categorised the interventions into eight broad types deemed to be applicable to clinical practice through iterative discussion: visual interventions, prism adaptation, body awareness interventions, mental function interventions, movement interventions, non-invasive brain stimulation, electrical stimulation, and acupuncture. We assessed the quality of evidence for each outcome using the GRADE approach., Main Results: We included 65 RCTs with 1951 participants, all of which included people with spatial neglect following stroke. Most studies measured outcomes using standardised neglect assessments. Fifty-one studies measured effects on ADL immediately after completion of the intervention period; only 16 reported persisting effects on ADL (our primary outcome). One study (30 participants) reported discharge destination, and one (24 participants) reported depression. No studies reported falls, balance, or quality of life. Only two studies were judged to be entirely at low risk of bias, and all were small, with fewer than 50 participants per group. We found no definitive (phase 3) clinical trials. None of the studies reported any patient or public involvement. Visual interventions versus any control: evidence is very uncertain about the effects of visual interventions for spatial neglect based on measures of persisting functional ability in ADL (2 studies, 55 participants) (standardised mean difference (SMD) -0.04, 95% confidence interval (CI) -0.57 to 0.49); measures of immediate functional ability in ADL; persisting standardised neglect assessments; and immediate neglect assessments. Prism adaptation versus any control: evidence is very uncertain about the effects of prism adaptation for spatial neglect based on measures of persisting functional ability in ADL (2 studies, 39 participants) (SMD -0.29, 95% CI -0.93 to 0.35); measures of immediate functional ability in ADL; persisting standardised neglect assessments; and immediate neglect assessments. Body awareness interventions versus any control: evidence is very uncertain about the effects of body awareness interventions for spatial neglect based on measures of persisting functional ability in ADL (5 studies, 125 participants) (SMD 0.61, 95% CI 0.24 to 0.97); measures of immediate functional ability in ADL; persisting standardised neglect assessments; immediate neglect assessments; and adverse events. Mental function interventions versus any control: we found no trials of mental function interventions for spatial neglect reporting on measures of persisting functional ability in ADL. Evidence is very uncertain about the effects of mental function interventions on spatial neglect based on measures of immediate functional ability in ADL and immediate neglect assessments. Movement interventions versus any control: we found no trials of movement interventions for spatial neglect reporting on measures of persisting functional ability in ADL. Evidence is very uncertain about the effects of body awareness interventions on spatial neglect based on measures of immediate functional ability in ADL and immediate neglect assessments. Non-invasive brain stimulation (NIBS) versus any control: evidence is very uncertain about the effects of NIBS on spatial neglect based on measures of persisting functional ability in ADL (3 studies, 92 participants) (SMD 0.35, 95% CI -0.08 to 0.77); measures of immediate functional ability in ADL; persisting standardised neglect assessments; immediate neglect assessments; and adverse events. Electrical stimulation versus any control: we found no trials of electrical stimulation for spatial neglect reporting on measures of persisting functional ability in ADL. Evidence is very uncertain about the effects of electrical stimulation on spatial neglect based on immediate neglect assessments. Acupuncture versus any control: we found no trials of acupuncture for spatial neglect reporting on measures of persisting functional ability in ADL. Evidence is very uncertain about the effects of acupuncture on spatial neglect based on measures of immediate functional ability in ADL and immediate neglect assessments., Authors' Conclusions: The effectiveness of non-pharmacological interventions for spatial neglect in improving functional ability in ADL and increasing independence remains unproven. Many strategies have been proposed to aid rehabilitation of spatial neglect, but none has yet been sufficiently researched through high-quality fully powered randomised trials to establish potential or adverse effects. As a consequence, no rehabilitation approach can be supported or refuted based on current evidence from RCTs. As recommended by a number of national clinical guidelines, clinicians should continue to provide rehabilitation for neglect that enables people to meet their rehabilitation goals. Clinicians and stroke survivors should have the opportunity, and are strongly encouraged, to participate in research. Future studies need to have appropriate high-quality methodological design, delivery, and reporting to enable appraisal and interpretation of results. Future studies also must evaluate outcomes of importance to patients, such as persisting functional ability in ADL. One way to improve the quality of research is to involve people with experience with the condition in designing and running trials., (Copyright © 2021 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Objective: Investigated clinical effectiveness and cost-effectiveness of a person-centred intervention for informal carers/caregivers of stroke survivors., Design: Pragmatic cluster randomised controlled trial (cRCT) with economic and process evaluation., Setting: Clusters were services, from a UK voluntary sector specialist provider, delivering support primarily in the homes of stroke survivors and informal carers., Participants: Adult carers in participating clusters were referred to the study by cluster staff following initial support contact., Interventions: Intervention was the Carer Support Needs Assessment Tool for Stroke: a staff-facilitated, carer-led approach to help identify, prioritise and address the specific support needs of carers. It required at least one face-to-face support contact dedicated to carers, with reviews as required. Control was usual care, which included carer support (unstructured and variable)., Outcome Measures: Participants provided study entry and self-reported outcome data by postal questionnaires, 3 and 6 months after first contact by cluster staff., Primary Outcome: 3-month caregiver strain (Family Appraisal of Caregiving Questionnaire, FACQ)., Secondary Outcomes: FACQ subscales of caregiver distress and positive appraisals of caregiving, mood (Hospital Anxiety and Depression Scale) and satisfaction with stroke services (Pound). The economic evaluation included self-reported healthcare utilisation, intervention costs and EQ-5D-5L., Randomisation and Masking: Clusters were recruited before randomisation to intervention or control, with stratification for size of service. Cluster staff could not be masked as training was required for participation. Carer research participants provided self-reported outcome data unaware of allocation; they consented to follow-up data collection only., Results: Between 1 February 2017 and 31 July 2018, 35 randomised clusters (18 intervention; 17 control) recruited 414 cRCT carers (208 intervention; 206 control). Study entry characteristics were well balanced., Primary Outcome Measure: intention-to-treat analysis for 84% retained participants (175 intervention; 174 control) found mean (SD) FACQ carer strain at 3 months to be 3.11 (0.87) in the control group compared with 3.03 (0.90) in the intervention group, adjusted mean difference of -0.04 (95% CI -0.20 to 0.13). Secondary outcomes had similarly small differences and tight CIs. Sensitivity analyses suggested robust findings. Intervention fidelity was not achieved. Intervention-related group costs were marginally higher with no additional health benefit observed on EQ-5D-5L. No adverse events were related to the intervention., Conclusions: The intervention was not fully implemented in this pragmatic trial. As delivered, it conferred no clinical benefits and is unlikely to be cost-effective compared with usual care from a stroke specialist provider organisation. It remains unclear how best to support carers of stroke survivors. To overcome the implementation challenges of person-centred care in carers' research and service development, staff training and organisational support would need to be enhanced., Trial Registration Number: ISRCTN58414120., Competing Interests: Competing interests: AB, GG, SAR, EB and GE held grants with NIHR during the course of the OSCARSS Study. AB and EP additionally hold grants with Stroke Association outside of this work. There are no other relationships or activities that could appear to have influenced the submitted work., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: To examine the implementation of an intervention to support informal caregivers and to help understand findings from the Organising Support for Carers of Stroke Survivors (OSCARSS) cluster randomised controlled trial (cRCT)., Design: Longitudinal process evaluation using mixed methods. Normalisation process theory informed data collection and provided a sensitising framework for analysis., Setting: Specialist stroke support services delivered primarily in the homes of informal carers of stroke survivors., Participants: OSCARSS cRCT participants including carers, staff, managers and senior leaders., Intervention: The Carer Support Needs Assessment Tool for Stroke (CSNAT-Stroke) intervention is a staff-facilitated, carer-led approach to help identify, prioritise and address support needs., Results: We conducted qualitative interviews with: OSCARSS cRCT carer participants (11 intervention, 10 control), staff (12 intervention, 8 control) and managers and senior leaders (11); and obtained 140 responses to an online staff survey over three separate time points. Both individual (carer/staff) and organisational factors impacted implementation of the CSNAT-Stroke intervention and how it was received by carers. We identified four themes: staff understanding, carer participation, implementation, and learning and support. Staff valued the idea of a structured approach to supporting carers, but key elements of the intervention were not routinely delivered. Carers did not necessarily identify as 'carers', which made it difficult for staff to engage them in the intervention. Despite organisational enthusiasm for OSCARSS, staff in the intervention arm perceived support and training for implementation of CSNAT-Stroke as delivered primarily by the research team, with few opportunities for shared learning across the organisation., Conclusions: We identified challenges across carer, staff and organisation levels that help explain the OSCARSS cRCT outcome. Ensuring training is translated into practice and ongoing organisational support would be required for full implementation of this type of intervention, with emphasis on the carer-led aspects, including supporting carer self-identification., Trial Registration Number: ISRCTN58414120., Competing Interests: Competing interests: GG reports grants from NIHR CLAHRC, during the conduct of the study; In addition, GG has a patent Copyright issued. GE reports grants from NIHR, during the conduct of the study; In addition, GE has a patent Copyright issued. SR reports grants from NIHR, during the conduct of the study. AB reports grants from NIHR, grants from Stroke Association, during the conduct of the study; grants from Stroke Association, grants from NIHR, outside the submitted work. EP reports grants from Stroke Association, outside the submitted work. SD, SK, KW-N and CM have nothing to disclose., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.)

Background: Patient, Carer and Public Involvement (PCPI) should be embedded in health care research. Delivering PCPI can be challenging, but even when PCPI is carried out it is rarely reported resulting in lost opportunities for learning. This paper aims to describe PCPI in the OSCARSS study, a pragmatic-cluster randomised controlled trial with an embedded economic and process evaluation., Methods: A carer research user group (RUG) co-developed OSCARSS to evaluate how to best deliver support to caregivers of stroke survivors. The PCPI activity involved regular meetings and preparatory work, from the initial conceptualisation of the study through to dissemination. Written reports, structured group discussions and individual interviews were carried out with the RUG and researchers to capture the added value and learning. This paper was co-authored by two of the RUG members with contributions from the wider RUG and researchers., Results: The core six members of the caregiver RUG attended the majority of the meetings alongside three researchers, one of whom was the co-chief investigator. PCPI was instrumental in changing many aspects of the research protocol, design and delivery and contributed to dissemination and sharing of good practice. There were challenges due to the emotional toll when PCPI members shared their stories and the extensive time commitment. Positive experiences of learning and fulfilment were reported by the individual researchers and PCPI members. Wider organisational administrative and financial support facilitated the PCPI. The researchers' existing positive regard for PCPI and the clear focus of the group were key to the successful co-design of this research., Conclusions: The value and learning from the PCPI collaborative work with the researchers was of benefit to the study and the individuals involved. Specific PCPI influences were a challenge to pinpoint as successful co-design meant the researchers' and carers' contributions were intertwined and decision-making shared., Competing Interests: Competing interestsThe authors declare that they have no competing interests., (© The Author(s) 2020.)

Objectives: To explore the feasibility of using a stroke-specific toolkit for six-month post-stroke reviews in care homes to identify unmet needs and actions., Design: An observational study including qualitative interviews to explore the process and outcome of reviews., Setting: UK care homes., Participants: Stroke survivors, family members, care home staff (review participants) and external staff involved in conducting reviews (assessors)., Interventions: Modified Greater Manchester Stroke Assessment Tool (GM-SAT)., Results: The observational study provided data on 74 stroke survivors across 51 care homes. In total, out of 74, 45 (61%) had unmet needs identified. Common unmet needs related to blood pressure, mobility, medicine management and mood. We conducted 25 qualitative interviews, including 13 review participants and 12 assessors. Three overarching qualitative themes covered acceptability of conducting reviews in care homes, process and outcomes of reviews, and acceptability of modified GM-SAT review toolkit. The modified GM-SAT review was positively valued, but stroke survivors had poor recall of the review event including the actions agreed. Care home staff sometimes assisted with reviews and highlighted their need for training to support day-to-day needs of stroke survivors. Assessors highlighted a need for clearer guidance on the use of the toolkit and suggested further modifications to enhance it. They also identified organizational barriers and facilitators to implementing reviews and communicating planned actions to GPs and other agencies., Conclusion: The modified GM-SAT provides a feasible means of conducting six-month reviews for stroke survivors in care homes and helps identify important needs. Further modifications have enhanced acceptability. Full implementation into practice requires staff training and organizational changes.

Background: Stroke often results in chronic disability, with partners and family members taking on the role of informal caregiver. There is considerable uncertainty regarding how best to identify and address carers' needs. The Carer Support Needs Assessment Tool (CSNAT) is a carer-led approach to individualised assessment and support for caregiving that may be beneficial in palliative care contexts. CSNAT includes an implementation toolkit. Through collaboration, including with service users, we adapted CSNAT for stroke and for use in a UK stroke specialist organisation providing long-term support. The main aims of OSCARSS are to investigate the clinical and cost-effectiveness of CSNAT-Stroke relative to current practice. This paper focuses on the trial protocol, with the embedded process evaluation reported separately., Methods: Longitudinal, multi-site, pragmatic, cluster randomised controlled trial with a health economic analysis. Clusters are UK services randomised to CSNAT-Stroke intervention or usual care, stratified by size of service. Eligible carer participants are: adults aged > 18 years; able to communicate in English; referred to participating clusters; and seen face-to-face at least once by the provider, for support. The 'date seen' for initial support denotes the start of intervention (or control) and carers are referred to the research team after this for study recruitment. Primary outcome is caregiver strain (FACQ - Strain) at three months after 'date seen'. Secondary outcomes include: caregiver distress; positive caregiving appraisals (both FACQ subscales); Pound Carer Satisfaction with Services; mood (HADs); and health (EQ-5D5L) at three months. All outcomes are followed up at six months. Health economic analyses will use additional data on caregiver health service utilisation and informal care provision., Discussion: OSCARSS is open to recruitment at the time of article submission. Study findings will allow us to evaluate the clinical and cost-effectiveness of the CSNAT-Stroke intervention, directed at improving outcomes for informal carers of stroke survivors. Trial findings will be interpreted in the context of our embedded process evaluation including qualitative interviews with those who received and provided services as well as data on treatment fidelity. OSCARSS will contribute to knowledge of the unmet needs of informal stroke caregivers and inform future stroke service development., Trial Registration: ISRCTN Registry, ISRCTN58414120 . Registered on 26 July 2016.

Background: Chronic widespread pain (CWP) is a major public health problem. Many people experiencing CWP experience mental health problems such as anxiety or depression. Complete relief of skeletal and body pain symptoms is unlikely but with appropriate treatment the impact upon quality of life, functioning and mental health symptoms can be reduced. Cognitive behavioural therapy (CBT) is widely used for a range of health conditions and can have short and long-term improvements in patients with CWP. This research aimed to explore, from a professional stakeholder perspective, the implementation of a local Pain Platform offering a stepped care approach for interventions including telephone delivered CBT (T-CBT)., Methods: Fourteen professional stakeholders holding various roles across primary and secondary care services within the Pain Platform took part in semi-structured interviews. Their views and experiences of the implementation of the Pain Platform were explored. Interviews were recorded, transcribed verbatim and analysed according to Normalisation Process Theory (NPT)., Results: Professional stakeholders were positive about the Pain Platform and its potential to overcome previously identified existing access issues to psychological interventions for CWP patients. It was considered a valuable part of ensuring that patients' preferences and needs are more readily addressed. In some circumstances, however, introducing psychological interventions to patients was considered challenging and the introduction of new referral processes was raised concerns. To ensure sustainability more work is required to reduce professional isolation and ensure efficient referral procedures between primary and secondary care services are established to reduce concerns over issues related to clinical governance and potential risk to patient., Conclusions: The findings provide professional insight into the key challenges of introducing a Pain Platform incorporating psychological support across primary and secondary care services within a local service. These included development of sustainable procedures and closer working relationships. Areas requiring future development are identified.

Objective: To describe the dose, intensity and context of physiotherapy for balance and mobility problems after stroke., Design: Process mapping to describe the context and non-participant observation of therapy sessions to describe the dose and content of therapy., Setting: Four inpatient stroke units in North-West England., Participants: Therapy staff and previously mobile stroke survivors who were treating, or receiving treatment for balance and mobility problems in the participating units., Results: Two units were stand-alone rehabilitation units; two offered a service at the weekends. One had no access to community-based rehabilitation. All had dedicated treatment facilities but often did not use them because of lack of space and difficulty transporting patients. Twenty-two patients participated and 100 treatment sessions were observed. Practicing walking, sit-to-stand and transfers were the most frequent objectives and interventions usually with the therapist(s) physically facilitating the patient's movements. The dose of practise was low; mean repetitions of sit-to-stand per session was 5 (SD 6.4); mean time spent upright per session was 11.24 (SD = 7) minutes, and mean number of steps per session was 202 (SD 118). The mean number of staff per patient was 2.1 (SD = 0.6, mode = 2), usually involving two qualified therapists. Falls prevention or management, wheelchair skills and bed mobility were not practised., Conclusion: Stroke physiotherapy for balance and mobility problems features low-dose, low-intensity therapist-led practice, mainly of walking and sit-to-stand. Staff:patient ratios were high. Therapists need to organize treatment sessions to maximize the intensity of functional task practice.

Objective: The aim of the study was to compare the effect of two designs of ankle-foot orthosis on people with stroke., Design: The study design was an assessor-blind, multicentre randomized controlled trial., Setting: The setting was community stroke services., Participants: A total of 139 community-dwelling stroke survivors with limited mobility were recruited., Interventions: The two most commonly used types of ankle-foot orthosis (bespoke and off-the-shelf) were chosen., Main Measures: The main measures of the study were as follows: short- (6 weeks) and long-term (12 weeks) effects on stroke survivors' satisfaction; adverse events; mobility (Walking Handicap Scale); fear of falling (Falls Efficacy Scale-International (FES-I)) and walking impairments (gait speed and step length using the 5-m walk test)., Results: Long-term satisfaction was non-significantly higher in the off-the-shelf group: 72% versus 64%; OR (95% CI) = 0.64 (0.31 to 1.3); P = 0.21. No statistically significant differences were found between the orthoses except that the off-the-shelf group had less fear of falling at short-term follow-up than the bespoke group: mean difference (95% CI) = -4.6 (-7.6 to -1.6) points on the FES-I; P = 0.003., Conclusion: No differences between off-the-shelf and bespoke ankle-foot orthoses were found except that participants in the off-the-shelf orthosis group had less fear of falling at short-term follow-up.

Background: Effective recruitment is an essential element of successful research but notoriously difficult to achieve. This article examines health care professionals' views on the factors influencing decision-making regarding referral to a stroke rehabilitation trial., Methods: Semi-structured interviews and a card-sorting task were undertaken with stroke service staff in acute and community hospital trusts. Data analysis used a thematic framework approach., Results: Twenty-seven qualified health care professionals from 12 (6 acute and 6 community) hospital trusts and one charity participated. Four main factors emerged: patient-related, professional views, the organisation and research logistics, which all contributed to staff's decision about whether to refer patients to a trial. Clinicians identified patient-related factors as the most frequent influence and considered themselves the patients' advocate. They used their knowledge of the patient to anticipate the patients' reaction to possible participation and tended to only refer those whom they perceived would respond positively. Participants also identified experience of research, a sense of ownership of the project and a positive view of the intervention being evaluated as factors influencing referral. The need to prioritise clinical matters, meet managerial demands and cope with constant change were organisational factors impacting negatively on referral. Staff often simply forgot about recruitment in the face of other higher priorities. Quick, simple, flexible research processes that were closely aligned with existing ways of working were felt to facilitate recruitment., Conclusions: Patient- and professional-related factors were the most frequent influence on clinicians' recruitment decisions, which often had a 'gate-keeping' effect. Managerial and clinical responsibility to juggle multiple (often higher) priorities was also an important factor. To facilitate recruitment, researchers need to develop strategies to approach potential participants as directly as possible to enable them to make their own decisions about participation; ensure that research processes are as quick and simple as possible; align with existing clinical pathways and systems; and give regular reminders and ongoing support to promote recruitment., Trial Registration: ISRCTN, 98287938 . Registered 6 May 2015.

Background: Improving cognition is service users' top research priority for life after stroke, and future research should include outcomes that they deem important. Patient perspectives on outcomes are collected using patient-reported outcome measures (PROMs). There is currently no patient-centred PROM specific for cognitive rehabilitation trials., Objective: Inform PROM development by exploring stroke survivor perspectives on the important, measurable impacts of persisting post-stroke cognitive problems., Design: Qualitative semi-structured interviews in participants' homes., Participants: Purposive sample of 16 cognitively impaired stroke survivors at least six months post-stroke., Methods: Interviews used a schedule and communication aids developed through patient consultation. Interviews were transcribed verbatim with non-verbal communication recorded using field notes. Data were analysed using a framework approach to find commonalities to shape the focus and content of an outcome measure., Results: Participants identified important impacts of their 'invisible' cognitive problems, outside of other stroke-related impairments. Cognitive problems exacerbated emotional issues and vice versa. Changes in self-identity and social participation were prominent. Impact was not spoken about in terms of frequency but rather in terms of the negative affect associated with problems; terms like 'bothered' and 'frustration' were often used., Conclusions: The results support the development of a PROM specifically designed to address the impact of cognitive problems. It should: include items addressing a comprehensive range of cognitive skills; ask questions about mood, self-identity and social participation; use accessible wording that respondents understand and endorse; measure impact rather than frequency; and explore perceived impact on carers., (© 2014 John Wiley & Sons Ltd.)

Introduction: Multi-disciplinary team members predict each patient's rehabilitation potential to maximise best use of resources. A lack of underpinning theory about rehabilitation potential makes it difficult to apply this concept in clinical practice. This study theorises about rehabilitation potential drawing on everyday decision-making by Health Care Professionals (HCPs) working in stroke rehabilitation services., Methods: A clinical scenario, checked for face validity, was used in two focus groups to explore meaning and practice around rehabilitation potential. Participants were 12 HCPs working across the stroke pathway. Groups were co-facilitated, audio-recorded and fully transcribed. Analysis paid attention to data grounded in first-hand experience, convergence within and across groups and constructed a conceptual overview of HCPs' judgements about rehabilitation potential., Results: Rehabilitation potential is predicted by observations of "carry-over" and functional gain and managed differently across recovery trajectories. HCPs' responses to rehabilitation potential judgements include prioritising workload, working around the system and balancing optimism and realism. Impacts for patients are streaming of rehabilitation intensity, rationing access to rehabilitation and a shifting emphasis between management and active rehabilitation. For staff, the emotional burden of judging rehabilitation potential is significant. Current service organisation restricts opportunities for feedback on the accuracy of previous judgements., Conclusion: Patients should have the opportunity to demonstrate rehabilitation potential by participation in therapy. As therapy resources are limited and responses to therapy may be context-dependent, early decisions about a lack of potential should not limit longer-term opportunities for rehabilitation. Services should develop strategies to enhance the quality of judgements through feedback to HCPs of longer-term patient outcomes. Implications for Rehabilitation Rehabilitation potential is judged at the level of individual patients (rather than population-based predictive models of rehabilitation outcome), draws on different sources of often experiential knowledge, and may be less than reliable. Decisions about rehabilitation potential may have far reaching consequences for individual patients, including the withdrawal of active rehabilitation in hospital or in the community and eventual care placement. A better understanding of what people mean by rehabilitation potential by all team members, and by patients and carers, may improve the quality of joint decision making and communication.