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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: 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.

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.)