An International and Multidisciplinary Consensus on the Labeling of Spatial Neglect Using a Modified Delphi Method.

Survivors of neurologic injury (most commonly stroke or traumatic brain injury) frequently experience a disorder in which contralesionally positioned objects or the contralesional features of individual objects are often left unattended or underappreciated. The disorder is known by >200 unique labels in the literature, which potentially causes confusion for patients and their families, complicates literature searches for researchers and clinicians, and promotes a fractionated conceptualization of the disorder. The objective of this Delphi was to determine if consensus (≥75% agreement) could be reached by an international and multidisciplinary panel of researchers and clinicians with expertise on the topic. To accomplish this aim, we used a modified Delphi method in which 66 researchers and/or clinicians with expertise on the topic completed at least 1 of 4 iterative rounds of surveys. Per the Delphi method, panelists were provided with results from each round prior to responding to the survey in the subsequent round with the explicit intention of achieving consensus. The panel ultimately reached consensus that the disorder should be consistently labeled spatial neglect. Based on the consensus reached by our expert panel, we recommend that researchers and clinicians use the label spatial neglect when describing the disorder in general and more specific labels pertaining to subtypes of the disorder when appropriate.

Identifying spatial neglect - an updated systematic review of the psychometric properties of assessment tools in adults post-stroke.

Spatial neglect commonly occurs after a stroke, resulting in diverse impacts depending on the type and severity. There are almost 300 tools for assessing neglect, yet there is a lack of knowledge on the psychometric properties of these tools. The objective of this systematic review, registered on Prospero (CRD42021271779), was to determine the quality of the evidence for assessing spatial neglect, categorized by neglect subtype. The following databases were searched on 3rd May 2022 from database inception: Ovid Emcare, Embase, Ovid MEDLINE, APA PsycINFO, Web of Science (SCI-EXPANDED; SSCI; A&HCI; ESCI) and Scopus. All primary peer-reviewed studies (>5 participants) of adults post stroke, reporting any psychometric property of 33 commonly used neglect assessment tools were included. The COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) risk of bias tool was used to assess the methodological quality of the studies and summarize the psychometric properties of each tool. 164 articles were included, with a total of 12,463 people with stroke. The general quality of the evidence was poor and no one tool had high-quality evidence of both validity and reliability. Eleven tools show some promise as they meet the minimum criteria for good measurement properties for both validity and reliability.

Wellbeing After Stroke (WAterS): Feasibility Testing of a Co-developed Acceptance and Commitment Therapy Intervention to Support Psychological Adjustment After Stroke.

OBJECTIVE: Feasibility test a co-developed intervention based on Acceptance and Commitment Therapy to support psychological adjustment post-stroke, delivered by a workforce with community in-reach. DESIGN: Observational feasibility study utilising patient, carer, public involvement. SETTING: Online. UK. PARTICIPANTS: Stroke survivors with self-reported psychological distress 4 + months post-stroke. INTERVENTIONS: The co-developed Wellbeing After Stroke (WAterS) intervention includes: 9-weekly, structured, online, group sessions for stroke survivors, delivered via a training programme to upskill staff without Acceptance and Commitment Therapy experience, under Clinical Psychology supervision. MAIN MEASURES: Feasibility of recruitment and retention; data quality from candidate measures; safety. Clinical and demographic information at baseline; patient-reported outcome measures (PROMs) via online surveys (baseline, pre- and post-intervention, 3 and 6 months after intervention end) including Mood (hospital anxiety and depression scale (HADS)), Wellbeing (ONS4), Health-Related Quality of Life (EQ5D5L), Psychological Flexibility (AAQ-ABI) and Values-Based Living (VQ). RESULTS: We trained eight staff and recruited 17 stroke survivors with mild-to-moderate cognitive and communication difficulties. 12/17 (71%) joined three intervention groups with 98% attendance and no related adverse events. PROMS data were well-completed. The HADS is a possible future primary outcome (self-reported depression lower on average by 1.3 points: 8.5 pre-group to 7.1 at 3-month follow-up; 95% CI 0.4 to 3.2). CONCLUSION: The WAterS intervention warrants further research evaluation. Staff can be trained and upskilled to deliver. It appears safe and feasible to deliver online to groups, and study recruitment and data collection are feasible. Funding has been secured to further develop the intervention, considering implementation and health equality.

Towards a core outcome set for dysarthria after stroke: What should we measure?

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.

A Case Report and a Review of Pediatric Hepatoblastoma.

Introduction: Hepatoblastoma is a rare pediatric cancer. Approximately 100 cases of hepatoblastoma are reported per year. Due to the limited incidence of this disorder an internationally agreed-upon criteria was developed to classify patients as standard or high-risk. Studies involving chemotherapeutic agents, surgery, and liver transplants have been demonstrated to improve the disease-free survival rate. The combination of chemotherapeutic agents and surgery demonstrated the ability of these regimens to downgrade the initial diagnostic staging of tumors and transform previously unresectable tumors into resectable tumors. Case Presentation: The following case of hepatoblastoma presents a 4-year-old male who presented to the emergency department with an upper respiratory infection symptom and was found to have hepatomegaly. The patient was later classified as high-risk, unresectable hepatoblastoma. Conclusion: Hepatoblastoma is a rare liver cancer in children with an annual incidence of 1.5 cases per million. With PRETEXT staging criterion, therapeutic options such as cisplatin/doxorubicin combination, radiotherapy, and lobectomy, have become the standard of care for this condition. Many trials have demonstrated these therapeutic options to successfully improve the survivability rate of patients affected by hepatoblastoma, downgrading tumors from advanced PRETEXT stages and enabling previously unresectable tumors to be considered resectable.

A scoping review to identify process and outcome measures used in acceptance and commitment therapy research, with adults with acquired neurological conditions.

BACKGROUND: Acceptance and Commitment Therapy interventions are increasing in use in neurological populations. There is a lack of information on the measures available. PURPOSE: To identify and classify the measures used in Acceptance and Commitment Therapy research studies with adults with acquired neurological conditions. METHODS: PRISMA-ScR guided scoping review. MEDLINE, PsycInfo and CINAHL databases searched (up to date 29/06/2022) with forward and backward searching. All study types included. Extraction of Acceptance and Commitment Therapy process-of-change and health-related outcome measures. Outcomes coded using the Core Outcome Measures in Effectiveness Trials (COMET) taxonomy. RESULTS: Three hundred and thirty three papers found on searching. Fifty four studies included and 136 measurement tools extracted. Conditions included multiple sclerosis, traumatic brain injury and stroke. Thirty-eight studies measured processes of change, with 32 measures extracted. The process measure most often used was the Acceptance and Action Questionnaire (n = 21 studies). One hundred and four health-related outcome measures extracted. Measures exploring quality of life, health status, anxiety and depression occurred most frequently, and were used in all included neurological conditions. COMET domains most frequently coded were emotional functioning/well-being (n = 50), physical functioning (n = 32), role functioning (n = 22) and psychiatric (n = 22). CONCLUSIONS: This study provides a resource to support future identification of candidate measures. This could aid development of a Core Outcome Set to support both research and clinical practice. Further research to identify the most appropriate and relevant targets and tools for use in these populations should include expert consensus, patient, carer and public involvement and psychometric examination of measures.

Measuring communication as a core outcome in aphasia trials: Results of the ROMA-2 international core outcome set development meeting.

BACKGROUND: Evidence-based recommendations for a core outcome set (COS; minimum set of outcomes) for aphasia treatment research have been developed (the Research Outcome Measurement in Aphasia-ROMA, COS). Five recommended core outcome constructs: communication, language, quality of life, emotional well-being and patient-reported satisfaction/impact of treatment, were identified through three international consensus studies. Constructs were paired with outcome measurement instruments (OMIs) during an international consensus meeting (ROMA-1). Before the current study (ROMA-2), agreement had not been reached on OMIs for the constructs of communication or patient-reported satisfaction/impact of treatment. AIM: To establish consensus on a communication OMI for inclusion in the ROMA COS. METHODS & PROCEDURES: Research methods were based on recommendations from the Core Outcome Measures in Effectiveness Trials (COMET) Initiative. Participants with expertise in design and conduct of aphasia trials, measurement instrument development/testing and/or communication outcome measurement were recruited through an open call. Before the consensus meeting, participants agreed on a definition of communication, identified appropriate OMIs, extracted their measurement properties and established criteria for their quality assessment. During the consensus meeting they short-listed OMIs and participants without conflicts of interest voted on the two most highly ranked instruments. Consensus was defined a priori as agreement by ≥ 70% of participants. OUTCOMES & RESULTS: In total, 40 researchers from nine countries participated in ROMA-2 (including four facilitators and three-panel members who participated in pre-meeting activities only). A total of 20 OMIs were identified and evaluated. Eight short-listed communication measures were further evaluated for their measurement properties and ranked. Participants in the consensus meeting (n = 33) who did not have conflicts of interest (n = 29) voted on the top two ranked OMIs: The Scenario Test (TST) and the Communication Activities of Daily Living-3 (CADL-3). TST received 72% (n = 21) of 'yes' votes and the CADL-3 received 28% (n = 8) of 'yes' votes. CONCLUSIONS & IMPLICATIONS: Consensus was achieved that TST was the preferred communication OMI for inclusion in the ROMA COS. It is currently available in the original Dutch version and has been adapted into English, German and Greek. Further consideration must be given to the best way to measure communication in people with mild aphasia. Development of a patient-reported measure for satisfaction with/impact of treatment and multilingual versions of all OMIs of the COS is still required. Implementation of the ROMA COS would improve research outcome measurement and the quality, relevance, transparency, replicability and efficiency of aphasia treatment research. WHAT THIS PAPER ADDS: What is already known on this subject International consensus has been reached on five core constructs to be routinely measured in aphasia treatment studies. International consensus has also been established for OMIs for the three constructs of language, quality of life and emotional well-being. Before this study, OMIs for the constructs of communication and patient-reported satisfaction/impact of treatment were not established. What this paper adds to existing knowledge We gained international consensus on an OMI for the construct of communication. TST is recommended for inclusion in the ROMA COS for routine use in aphasia treatment research. What are the potential or actual clinical implications of this work? The ROMA COS recommends OMIs for a minimum set of outcomes for adults with post-stroke aphasia within phases I-IV aphasia treatment research. Although not intended for clinical use, clinicians may employ the instruments of the ROMA COS, considering the quality of their measurement properties. The systematic inclusion of a measure of communication, such as TST, in clinical practice could ultimately support the implementation of research evidence and best practices.

A study of prisms and therapy in attention loss after stroke (SPATIAL): A feasibility randomised controlled trial.

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.

Co-designing for behaviour change: The development of a theory-informed oral-care intervention for stroke survivors.

This article discusses how research to understand the oral care needs and experiences of stroke survivors was translated into a prototypical intervention. It addresses the challenge of how to develop service improvements in healthcare settings that are both person-centred, through the use of co-design, and also based on theory and evidence. A sequence of co-design workshops with stroke survivors, family carers, and with health and social care professionals, ran in parallel with an analysis of behavioural factors. This determined key actions which could improve mouthcare for this community and identified opportunities to integrate recognized behaviour-change techniques into the intervention. In this way, behaviour change theory, evidence from qualitative research, and experience-based co-design were effectively combined. The intervention proposed is predominantly a patient-facing resource, intended to support stroke survivors and their carers with mouth care, as they transition from hospital care to living at home. This addresses a gap in existing provision, as other published oral-care protocols for stroke are clinician-facing and concerned primarily with acute care (in the first days after a stroke). Although it draws on the experiences of a single design project, this study articulates a 'working relationship' between design practice methods and the application of behaviour change theory.

Rapid screening for neglect following stroke: A systematic search and European Academy of Neurology recommendations.

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.

Investigating the association between inpatient stroke therapy and disability, destination on discharge, length of stay and mortality: a prospective cohort study using the Sentinel Stroke National Audit Programme.

OBJECTIVE: 'More is better' is a recognised mantra within stroke therapy, however, this has been developed in patients receiving long term rehabilitation. We investigated the relationship between amount of therapy received (from therapists and psychologists) and key patient outcomes during inpatient care. DESIGN: A secondary analysis of data from a prospective cohort study was performed. Multilevel mixed models adjusting for measured confounders (eg, severity), explored the relationship between therapy dose (average minutes per day of stay) and outcomes (disability, length of stay, home at discharge and mortality). Therapy was explored using simple linear terms and flexible natural cubic splines to allow for more complex relationships. SETTING: Data from the Sentinel Stroke National Audit Programme, covering England, Wales and Northern Ireland between July 2013 and July 2015 contained 94 905 adults with a stroke and still an inpatient after 72 hours. These patients received 92% (physiotherapy), 88% (occupational therapy), 57% (speech and language therapy) and 5% (clinical psychology), respectively. RESULTS: The average amount of therapy, for individual and 'any' therapy combined per day of stay was low. Overall, 41% were discharged with an 'independent' modified Rankin Scale (≤2), 14% died, 44% were discharged home, and the median length of stay was 16 days. We observed complex relationships between amount of therapy received and outcomes. An additional minute of 'any' therapy, occupational therapy, speech and language therapy and clinical psychology was associated with improved outcomes. Conversely, more physiotherapy was also associated with lower mortality and shorter length of stay, but also lower independence and discharge home. CONCLUSIONS: Our findings suggest for stroke inpatients requiring therapy, 'More is better' may be overly simplistic. Strong limitations associated with analysis of routine data restrict further robust investigation of the therapy-response relationship. Robust prospective work is urgently needed to further investigate the relationships observed here.

Precision rehabilitation for aphasia by patient age, sex, aphasia severity, and time since stroke? A prespecified, systematic review-based, individual participant data, network, subgroup meta-analysis.

BACKGROUND: Stroke rehabilitation interventions are routinely personalized to address individuals' needs, goals, and challenges based on evidence from aggregated randomized controlled trials (RCT) data and meta-syntheses. Individual participant data (IPD) meta-analyses may better inform the development of precision rehabilitation approaches, quantifying treatment responses while adjusting for confounders and reducing ecological bias. AIM: We explored associations between speech and language therapy (SLT) interventions frequency (days/week), intensity (h/week), and dosage (total SLT-hours) and language outcomes for different age, sex, aphasia severity, and chronicity subgroups by undertaking prespecified subgroup network meta-analyses of the RELEASE database. METHODS: MEDLINE, EMBASE, and trial registrations were systematically searched (inception-Sept2015) for RCTs, including ⩾ 10 IPD on stroke-related aphasia. We extracted demographic, stroke, aphasia, SLT, and risk of bias data. Overall-language ability, auditory comprehension, and functional communication outcomes were standardized. A one-stage, random effects, network meta-analysis approach filtered IPD into a single optimal model, examining SLT regimen and language recovery from baseline to first post-intervention follow-up, adjusting for covariates identified a-priori. Data were dichotomized by age (⩽/> 65 years), aphasia severity (mild-moderate/ moderate-severe based on language outcomes' median value), chronicity (⩽/> 3 months), and sex subgroups. We reported estimates of means and 95% confidence intervals. Where relative variance was high (> 50%), results were reported for completeness. RESULTS: 959 IPD (25 RCTs) were analyzed. For working-age participants, greatest language gains from baseline occurred alongside moderate to high-intensity SLT (functional communication 3-to-4 h/week; overall-language and comprehension > 9 h/week); older participants' greatest gains occurred alongside low-intensity SLT (⩽ 2 h/week) except for auditory comprehension (> 9 h/week). For both age-groups, SLT-frequency and dosage associated with best language gains were similar. Participants ⩽ 3 months post-onset demonstrated greatest overall-language gains for SLT at low intensity/moderate dosage (⩽ 2 SLT-h/week; 20-to-50 h); for those > 3 months, post-stroke greatest gains were associated with moderate-intensity/high-dosage SLT (3-4 SLT-h/week; ⩾ 50 hours). For moderate-severe participants, 4 SLT-days/week conferred the greatest language gains across outcomes, with auditory comprehension gains only observed for ⩾ 4 SLT-days/week; mild-moderate participants' greatest functional communication gains were associated with similar frequency (⩾ 4 SLT-days/week) and greatest overall-language gains with higher frequency SLT (⩾ 6 days/weekly). Males' greatest gains were associated with SLT of moderate (functional communication; 3-to-4 h/weekly) or high intensity (overall-language and auditory comprehension; (> 9 h/weekly) compared to females for whom the greatest gains were associated with lower-intensity SLT (< 2 SLT-h/weekly). Consistencies across subgroups were also evident; greatest overall-language gains were associated with 20-to-50 SLT-h in total; auditory comprehension gains were generally observed when SLT > 9 h over ⩾ 4 days/week. CONCLUSIONS: We observed a treatment response in most subgroups' overall-language, auditory comprehension, and functional communication language gains. For some, the maximum treatment response varied in association with different SLT-frequency, intensity, and dosage. Where differences were observed, working-aged, chronic, mild-moderate, and male subgroups experienced their greatest language gains alongside high-frequency/intensity SLT. In contrast, older, moderate-severely impaired, and female subgroups within 3 months of aphasia onset made their greatest gains for lower-intensity SLT. The acceptability, clinical, and cost effectiveness of precision aphasia rehabilitation approaches based on age, sex, aphasia severity, and chronicity should be evaluated in future clinical RCTs.

RETurn to work After stroKE (RETAKE) Trial: protocol for a mixed-methods process evaluation using normalisation process theory.

OBJECTIVES: This mixed-method process evaluation underpinned by normalisation process theory aims to measure fidelity to the intervention, understand the social and structural context in which the intervention is delivered and identify barriers and facilitators to intervention implementation. SETTING: RETurn to work After stroKE (RETAKE) is a multicentre individual patient randomised controlled trial to determine whether Early Stroke Specialist Vocational Rehabilitation (ESSVR) plus usual care is a clinically and cost-effective therapy to facilitate return to work after stroke, compared with usual care alone. This protocol paper describes the embedded process evaluation. PARTICIPANTS AND OUTCOME MEASURES: Intervention training for therapists will be observed and use of remote mentor support reviewed through documentary analysis. Fidelity will be assessed through participant questionnaires and analysis of therapy records, examining frequency, duration and content of ESSVR sessions. To understand the influence of social and structural contexts, the process evaluation will explore therapists' attitudes towards evidence-based practice, competency to deliver the intervention and evaluate potential sources of contamination. Longitudinal case studies incorporating non-participant observations will be conducted with a proportion of intervention and usual care participants. Semistructured interviews with stroke survivors, carers, occupational therapists, mentors, service managers and employers will explore their experiences as RETAKE participants. Analysis of qualitative data will draw on thematic and framework approaches. Quantitative data analysis will include regression models and descriptive statistics. Qualitative and quantitative data will be independently analysed by process evaluation and Clinical Trials Research Unit teams, respectively. Linked data, for example, fidelity and describing usual care will be synthesised by comparing and integrating quantitative descriptive data with the qualitative findings. ETHICS AND DISSEMINATION: Approval obtained through the East Midlands-Nottingham 2 Research Ethics Committee (Ref: 18/EM/0019) and the National Health ServiceResearch Authority. Dissemination via journal publications, stroke conferences, social media and meetings with national Stroke clinical leads. TRIAL REGISTRATION NUMBER: ISRCTN12464275.

Non-pharmacological interventions for spatial neglect or inattention following stroke and other non-progressive brain injury.

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.

Challenges implementing a carer support intervention within a national stroke organisation: findings from the process evaluation of the OSCARSS trial.

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.

Organising Support for Carers of Stroke Survivors (OSCARSS): a cluster randomised controlled trial with economic evaluation.

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.

Self-managed, computerised word finding therapy as an add-on to usual care for chronic aphasia post-stroke: An economic evaluation.

OBJECTIVE: To examine the cost-effectiveness of self-managed computerised word finding therapy as an add-on to usual care for people with aphasia post-stroke. DESIGN: Cost-effectiveness modelling over a life-time period, taking a UK National Health Service (NHS) and personal social service perspective. SETTING: Based on the Big CACTUS randomised controlled trial, conducted in 21 UK NHS speech and language therapy departments. PARTICIPANTS: Big CACTUS included 278 people with long-standing aphasia post-stroke. INTERVENTIONS: Computerised word finding therapy plus usual care; usual care alone; usual care plus attention control. MAIN MEASURES: Incremental cost-effectiveness ratios (ICER) were calculated, comparing the cost per quality adjusted life year (QALY) gained for each intervention. Credible intervals (CrI) for costs and QALYs, and probabilities of cost-effectiveness, were obtained using probabilistic sensitivity analysis. Subgroup and scenario analyses investigated cost-effectiveness in different subsets of the population, and the sensitivity of results to key model inputs. RESULTS: Adding computerised word finding therapy to usual care had an ICER of £42,686 per QALY gained compared with usual care alone (incremental QALY gain: 0.02 per patient (95% CrI: -0.05 to 0.10); incremental costs: £732.73 per patient (95% CrI: £674.23 to £798.05)). ICERs for subgroups with mild or moderate word finding difficulties were £22,371 and £21,262 per QALY gained respectively. CONCLUSION: Computerised word finding therapy represents a low cost add-on to usual care, but QALY gains and estimates of cost-effectiveness are uncertain. Computerised therapy is more likely to be cost-effective for people with mild or moderate, as opposed to severe, word finding difficulties.

Current clinical practice in the screening and diagnosis of spatial neglect post-stroke: Findings from a multidisciplinary international survey.

Spatial neglect has profound implications for quality of life after stroke, yet we lack consensus for screening/diagnosing this heterogeneous syndrome. Our first step in a multi-stage research programme aimed to determine which neglect tests are used (within four categories: cognitive, functional, neurological and neuroimaging/neuromodulation), by which stroke clinicians, in which countries, and whether choice is by professional autonomy or institutional policy. 454 clinicians responded to an online survey: 12 professions (e.g., 39% were occupational therapists) from 33 countries (e.g., 38% from the UK). Multifactorial logistic regression suggested inter-professional differences but fewer differences between countries (Italy was an outlier). Cognitive tests were used by 82% (particularly by psychologists, cancellation and drawing were most popular); 80% used functional assessments (physiotherapists were most likely). 20% (mainly physicians, from Italy) used neuroimaging/ neuromodulation. Professionals largely reported clinical autonomy in their choices. Respondents agreed on the need for a combined approach to screening and further training. This study raises awareness of the translation gap between theory and practice. These findings lay an important foundation to subsequent collaborative action between clinicians, researchers and stroke survivors to reach consensus on screening and diagnostic measures. The immediate next step is a review of the measures' psychometric properties.

Stroke impairment categories: A new way to classify the effects of stroke based on stroke-related impairments.

OBJECTIVE: To create a classification system based on stroke-related impairments. DATA SOURCE: All adults with stroke admitted for at least 72 hours in England, Wales and Northern Ireland from July 2013 to July 2015 extracted from the Sentinel Stroke National Audit Programme. ANALYSIS: Impairments were defined using the National Institute of Health Stroke Scale scores at admission. Common combinations of impairments were identified based on geometric coding and expert knowledge. Validity of the classification was assessed using standard descriptive statistics to report and compare patients' characteristics, therapy received and outcomes in each group. RESULTS: Data from 94,905 patients were extracted. The items of the National Institute of Health Stroke Scale (on admission) were initially grouped into four body systems: Cognitive, Motor, Sensory and Consciousness. Seven common combinations of these impairments were identified (in order of stroke severity); Patients with Loss of Consciousness (n = 6034, 6.4%); those with Motor + Cognitive + Sensory impairments (n = 28,226, 29.7%); Motor + Cognitive impairments (n = 16,967, 17.9%); Motor + Sensory impairments (n = 9882, 10.4%); Motor Only impairments (n = 20,471, 21.6%); Any Non-Motor impairments (n = 7498, 7.9%); and No Impairments (n = 5827, 6.1%). There was a gradation of age, premorbid disability, mortality and disability on discharge. People with the most and least severe categories were least likely to receive therapy, and received least therapy (-20 minutes/day of stay) compared to -35 minutes/day of stay for the moderately severe categories. CONCLUSIONS: A classification system of seven Stroke Impairment Categories has been presented.

An individually randomised controlled multi-centre pragmatic trial with embedded economic and process evaluations of early vocational rehabilitation compared with usual care for stroke survivors: study protocol for the RETurn to work After stroKE (RETAKE) trial.

BACKGROUND: Return to work (RTW) is achieved by less than 50% of stroke survivors. The rising incidence of stroke among younger people, the UK economic forecast, and clinical drivers highlight the need for stroke survivors to receive support with RTW. However, evidence for this type of support is lacking. This randomised controlled trial (RCT) will investigate whether Early Stroke Specialist Vocational Rehabilitation (ESSVR) plus usual care (UC) (i.e. usual NHS rehabilitation) is more clinically and cost-effective for supporting post-stroke RTW, than UC alone. METHODS: Seven hundred sixty stroke survivors and their carers will be recruited from approximately 20 NHS stroke services. A 5:4 allocation ratio will be employed to randomise participants to receive ESSVR plus UC, or UC alone. The individually tailored ESSVR intervention will commence within 12 weeks of stroke onset and be delivered for up to 12 months as necessary by trained RETAKE occupational therapists in the community, participants' homes or workplaces, and outpatient/inpatient therapy settings, via telephone, email, or SMS text message. Outcome data will be collected via self-report questionnaires administered by post or online at 3, 6, and 12 months follow-up. The primary outcome will be self-reported RTW and job retention at 12 months (minimum 2 h/week). Secondary outcomes will include mood, function, participation, health-related quality of life, confidence, intervention compliance, health and social care resource use, and mortality. An embedded economic evaluation will estimate cost-effectiveness and cost-utility analyses from National Health Service (NHS) and Personal Social Services (PSS) perspectives. An embedded process evaluation will employ a mixed methods approach to explore ESSVR implementation, contextual factors linked to outcome variation, and factors affecting NHS roll-out. DISCUSSION: This article describes the protocol for a multi-centre RCT evaluating the clinical- and cost-effectiveness of an early vocational rehabilitation intervention aimed at supporting adults to return to work following a stroke. Evidence favouring the ESSVR intervention would support its roll-out in NHS settings. TRIAL REGISTRATION: ISRCTN, ISRCTN12464275 . Registered on 26 February 2018.