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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.

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.

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.

This article describes 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 recognised 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. Keywords: co-design, behaviour change, stroke care, oral-care, person-centred care, EBCD, experience based co-design.

Background and Purpose: The factors associated with recovery of language domains after stroke remain uncertain. We described recovery of overall-language-ability, auditory comprehension, naming, and functional-communication across participants’ age, sex, and aphasia chronicity in a large, multilingual, international aphasia dataset. Methods: Individual participant data meta-analysis of systematically sourced aphasia datasets described overall-language ability using the Western Aphasia Battery Aphasia-Quotient; auditory comprehension by Aachen Aphasia Test (AAT) Token Test; naming by Boston Naming Test and functional-communication by AAT Spontaneous-Speech Communication subscale. Multivariable analyses regressed absolute score-changes from baseline across language domains onto covariates identified a priori in randomized controlled trials and all study types. Change-from-baseline scores were presented as estimates of means and 95% CIs. Heterogeneity was described using relative variance. Risk of bias was considered at dataset and meta-analysis level. Results: Assessments at baseline (median=43.6 weeks poststroke; interquartile range [4–165.1]) and first-follow-up (median=10 weeks from baseline; interquartile range [3–26]) were available for n=943 on overall-language ability, n=1056 on auditory comprehension, n=791 on naming and n=974 on functional-communication. Younger age ( Conclusions: Earlier intervention for poststroke aphasia was crucial to maximize language recovery across a range of language domains, although recovery continued to be observed to a lesser extent beyond 6 months poststroke.

ObjectivesThis 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.SettingRETurn 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 measuresIntervention 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 disseminationApproval 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 numberISRCTN12464275.

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.

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.

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. Published online: 21 Jul 2020

Background: Dental disease is highly prevalent in people with stroke. Stroke survivors regard oral hygiene as an important, yet neglected, area. The aim was to explore experiences of and barriers to oral care, particularly in relation to oral hygiene practice and dental attendance, among stroke survivors in the community. Methods: This was a qualitative study incorporating a critical realist approach. Interviews were conducted with community-dwelling stroke survivors requiring assistance with activities of daily living, and focus groups were held with health and care professionals. Interviews and focus groups were recorded and transcribed verbatim. Thematic analysis was conducted. Results: Twenty-three stroke survivors were interviewed, and 19 professionals took part in 3 focus groups. Professionals included nurses, speech and language therapists, occupational therapists, dieticians, professional carers and dental staff. Interviews revealed difficulties in carrying out oral hygiene self-care due to fatigue, forgetfulness and limb function and dexterity problems. Routine was considered important for oral hygiene self-care and was disrupted by hospitalization resulting from stroke. Professionals highlighted gaps in staff training and confidence in supporting patients with oral care. Access to dental services appeared particularly problematic for those who were not registered with a dentist pre-stroke. Conclusion: Oral hygiene routines may be disrupted by stroke, and resulting disabilities may make regular oral self-care more difficult. This study has identified specific barriers to oral hygiene self-care and dental service access. Findings from this study are feeding into the development of an intervention to support stroke survivors with oral care.

Objectives: To understand why most stroke patients receive little therapy. We investigated the factors associated with the amount of stroke therapy delivered. Methods: Data regarding adults admitted to hospital with stroke for at least 72 hours (July 2013–July 2015) were extracted from the UK’s Sentinel Stroke National Audit Programme. Descriptive statistics and multilevel mixed effects regression models explored the factors that influenced the amount of therapy received while adjusting for confounding. Results: Of the 94,905 patients in the study cohort (mean age: 76 (SD: 13.2) years, 78% had a mild or moderate severity stroke. In all, 92% required physiotherapy, 87% required occupational therapy, 57% required speech therapy but only 5% were considered to need psychology. The average amount of therapy ranged from 2 minutes (psychology) to 14 minutes (physiotherapy) per day of inpatient stay. Unmodifiable characteristics (such as stroke severity) dominated the variation in the amount of therapy. However important, modifiable organizational factors were the day and time of admission, type of stroke team, timely therapy assessments, therapy and nursing staffing levels (qualified and support staff), and presence of weekend or early supported discharge services. Conclusion: The amount of stroke therapy is associated with unmodifiable patient-related characteristics and modifiable organizational factors in that more therapy was associated with higher therapy and nurse staffing levels, specialist stroke rehabilitation services, timely therapy assessments, and the presence of weekend and early discharge services.

Background: Stroke causes communication impairments but we lack the real-world population-level data needed to inform inpatient and community services. Objectives: To establish prevalence of aphasia and dysarthria within inpatient stroke survivors, describe those affected, the amount of therapy they receive and their outcomes. Methods: Secondary analysis of data from the Sentinel Stroke National Audit Programme including inpatient stroke survivors after 72 hours, with completed National Institute of Health Stroke Scale data (communication items), excluding those already discharged, not conscious or with incomplete data. Results: 64% of the 88,974 stroke survivors meeting our criteria were communication impaired: 28% had both aphasia and dysarthria, 24% had dysarthria only and 12% had aphasia only. Those in the older age range and with more severe stroke were more likely to have a communication impairment and had a worse outcome than those without communication impairment. Subgroups with communication impairment received an average of 10 minutes of speech and language therapy for communication and/or dysphagia per day of stay. Conclusions: Communication impairment is common during the inpatient phase of stroke care yet average therapy provision is below the recommended levels and is likely to include dysphagia assessment and intervention. Dysarthria is reported as more prevalent than aphasia at this early stage, although this is not necessarily diagnosed by a speech and language therapist. The most common presentation is to have a combination of aphasia and dysarthria for which there is limited clinical guidance.

Objective: To map and describe how patients pass through stroke services. Methods: Data from 94,905 stroke patients (July 2013–July 2015) who were still inpatients 72 hours after hospital admission were extracted from a national stroke register and were used to identify the routes patients took through hospital and community stroke services. We sought to categorize these routes through iterative consultations with clinical experts and to describe patient characteristics, therapy provision, outcomes and costs within each category. Results: We identified 874 routes defined by the type of admitting stroke team and subsequent transfer history. We consolidated these into nine distinct routes and further summarized these into three overlapping ‘pathways’ that accounted for 99% of the patients. These were direct discharge (44%), community rehabilitation (47%) and inpatient transfer (19%) with 12% of the patients receiving both inpatient transfer and community rehabilitation. Patients with the mildest and most severe strokes were more likely to follow the direct discharge pathway. Those perceived to need most therapy were more likely to follow the inpatient transfer pathway. Costs were lowest and mortality was highest for patients on the direct discharge pathway. Outcomes were best for patients on the community rehabilitation pathway and costs were highest where patients underwent inpatient transfers. Conclusion: Three overarching stroke care pathways were identified which differ according to patient characteristics, therapy needs and outcomes. This pathway mapping provides a benchmark to develop and plan clinical services, and for future research.

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 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.

Stroke 53(3), 956-967 (2022). doi:10.1161/STROKEAHA.121.035216, Published by Lippincott Williams & Wilkins, Philadelphia, Pa.

Background: Acceptance and Commitment Therapy (ACT) interventions may promote wellbeing in neurological populations, but there is a lack of evidence to inform measure selection in research. Purpose: To identify and classify the measures used in ACT with adults with acquired neurological conditions.Methods: PRISMA guided systematic review. MEDLINE, PsycInfo and CINAHL databases searched (27/05/2020) with forward and backward searching. All study types included. Extraction of ACT process-of-change and health-related outcome measures. Outcomes coded using the Core Outcome Measures in Effectiveness Trials (COMET) taxonomy.Results: 204 papers screened. 34 studies included. Conditions included multiple sclerosis (n=17), traumatic brain injury (n=9) and stroke (n=8). 25 process-of-change measures extracted. Psychological flexibility was the most common process measured (AAQ-II most commonly used, n=14 studies). 76 health-related outcome measures extracted. Measures exploring quality of life, health status, anxiety and depression occurred most frequently. The Hospital Anxiety and Depression Scale was the most commonly used measure (n=8 studies). Conclusions: Future studies should follow reporting guidelines and consider the consistent use of measures to support synthesis of results. This could be achieved through the development of a Core Outcome Set – a standardised set of measures to be used across trials of ACT with adults with neurological conditions.

People with spatial neglect have difficulty attending to one side of space, which can affect their ability to carry out many everyday tasks and reduce independence. We examined the evidence for any type of nonpharmacological intervention.1MethodsWe searched for randomized controlled trials of any nonpharmacological intervention versus any control specifically aimed at spatial neglect, searching 6 databases including MEDLINE, Embase, CINAHL, and international trials registers in October 2020. Review authors independently assessed risk of bias of included trials and extracted data and assessed the quality of evidence for each outcome using the Grading of Recommendations, Assessment, Development and Evaluations approach. We categorized interventions into 8 broad types through iterative discussion. Our primary outcome was longer term functional ability in activities of daily living (ADL), that is, ≥1 month after the end of intervention.Main ResultsWe included 65 small randomized controlled trials (1951 participants); 43 provided data for meta-analyses. All included people with stroke, one included 3 participants with nonstroke brain injury, and only 7 included participants with left brain damage. All evidence is very low quality, with very low certainty. There were only 2 low risk of bias trials and no adequately powered definitive trials. None reported patient involvement in design or reporting. Outcome measurement focused on cognitive tests and short-term effects; 58 of 65 trials measured ADL using different methods and 16 measured it longer term. Other meaningful outcomes were rarely reported.Four intervention types measured our primary outcome:Visual interventions (training eye movements or scanning): 17 trials (n=398). No evidence of effect on ADL from visual interventions (2 trials, 55 participants; standardized mean difference, −0.04 [95% CI, −0.57 to 0.49]).Noninvasive brain stimulation: 17 trials (n=467). No evidence of effect on ADL from noninvasive brain stimulation (3 trials, 92 participants; standardized mean difference, 0.35 [95% CI, −0.08 to 0.77]).Body awareness (increasing awareness of affected side): 12 trials (n=447). Very low certainty evidence suggesting possible benefit on ADL from body awareness interventions (5 trials, 125 participants; standardized mean difference, 0.61 [95% CI, 0.24–0.97]).Prism adaptation training: 8 trials (n=257). No evidence of effect on ADL from prism adaptation (2 trials, 39 participants; standardized mean difference, −0.29 [95% CI, −0.93 to 0.35]).Four intervention types did not provide data on longer term ADL: electrical stimulation, 8 trials (n=270); mental function (increasing mental processing skills), 7 trials (n=170); movement (of the arm/body), 6 trials (n=220); and acupuncture, 2 trials (n=104).DiscussionDespite 65 trials (1951 participants), evidence of benefit/risk of nonpharmacological intervention to improve longer term functional ability remains very uncertain due to study quality. No rehabilitation approach can be supported or refuted over any other based on current evidence.Implications for Clinical Practice and Future ResearchNo strategy for neglect rehabilitation has been researched through fully powered randomized controlled trials. One way to improve the quality of research is by involving patients in trial design and management. Clinicians should continue to follow national clinical guidelines and are strongly encouraged to participate in trials.AcknowledgmentsThis article is based on a Cochrane Review published in The Cochrane Library 2021, Issue 7, doi: 10.1002/14651858.CD003586.pub4/full (see www.thecochranelibrary.com for information). Cochrane Reviews are regularly updated as new evidence emerges and in response to feedback, and The Cochrane Library should be consulted for the most recent version of the review. This review was supported by the Cochrane Stroke Review Group.Sources of FundingNational Institute for Health Research (NIHR) Development and Skills Enhancement Award, United Kingdom: funded Verity Longley; The Stroke Association, United Kingdom: part-funded Audrey Bowen and Christine Hazelton; NIHR NETSCC Incentive Award, United Kingdom: awarded to Audrey Bowen for the update.

Coordination of international aphasia research would minimise duplication of effort, support synergistic international activities across languages and multidisciplinary perspectives, and promote high-quality conduct and reporting of aphasia research, thereby increasing the relevance, transparency, and implementation of findings. The Collaboration of Aphasia Trialists (CATs) sought to develop an aphasia research agenda to direct future research activities, based on priorities shared by people with aphasia, family members, and healthcare professionals. Our established international research network spanning 33 countries contributed to this activity. Research literature reporting the priorities of stakeholders was reviewed and synthesized (phase 1). Representatives from Working Groups on Aphasia Assessment & Outcomes, Prognosis & Predictors of Recovery, Effectiveness of Interventions, and Societal Impact & Reintegration participated in a two-day research agenda-setting meeting. The CATs expert panel refined research objectives and identified constituent components of research and methodological developments required to address these research components. The objectives and research components were grouped into overarching themes (phase 2). The resultant list was then circulated to more than 180 CATs members for review, revision, and approval. Consensus on the final aphasia research agenda and roadmap was reached by CATs executive committee (phase 3). The expert panel identified five overarching research themes: (i) evidence-based interventions for people with aphasia, (ii) effective interventions to support those communicating with people with aphasia, (iii) cross-linguistic assessment and core outcomes for aphasia research, (iv) predictors of language recovery, and (v) clinical implementation of research findings. Within these broad themes, 30 research objectives and 91 individual aphasia research components were identified and sequentially ordered. This agenda builds on research priorities identified by people with aphasia and their families, and includes priorities of healthcare professionals and researchers, and will support the rehabilitation and recovery of people with aphasia. Our internationally relevant research agenda promotes rigor in methodology, considers international applicability, synergistic activities, and sharing of resources and expertise. publishedVersion

BackgroundPeople 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.ObjectivesThe 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 methodsWe 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 criteriaWe 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 analysisWe 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 resultsWe 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' conclusionsThe 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.

ObjectiveInvestigated clinical effectiveness and cost-effectiveness of a person-centred intervention for informal carers/caregivers of stroke survivors.DesignPragmatic cluster randomised controlled trial (cRCT) with economic and process evaluation.SettingClusters were services, from a UK voluntary sector specialist provider, delivering support primarily in the homes of stroke survivors and informal carers.ParticipantsAdult carers in participating clusters were referred to the study by cluster staff following initial support contact.InterventionsIntervention 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 measuresParticipants 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 maskingClusters 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.ResultsBetween 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.ConclusionsThe 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 numberISRCTN58414120.

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.

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.DesignA 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.SettingData 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.ResultsThe 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.ConclusionsOur 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.

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: 760 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, 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 hours/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 26th February 2018, http://www.isrctn.com/ISRCTN12464275.

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. Electronic supplementary material The online version of this article (10.1186/s13063-018-3104-7) contains supplementary material, which is available to authorized users.

Background People with aphasia may improve their communication with speech and language therapy many months/years after stroke. However, NHS speech and language therapy reduces in availability over time post stroke. Objective This trial evaluated the clinical effectiveness and cost-effectiveness of self-managed computerised speech and language therapy to provide additional therapy. Design A pragmatic, superiority, single-blind, parallel-group, individually randomised (stratified block randomisation, stratified by word-finding severity and site) adjunct trial. Setting Twenty-one UK NHS speech and language therapy departments. Participants People with post-stroke aphasia (diagnosed by a speech and language therapist) with long-standing (> 4 months) word-finding difficulties. Interventions The groups were (1) usual care; (2) daily self-managed computerised word-finding therapy tailored by speech and language therapists and supported by volunteers/speech and language therapy assistants for 6 months plus usual care (computerised speech and language therapy); and (3) activity/attention control (completion of puzzles and receipt of telephone calls from a researcher for 6 months) plus usual care. Main outcome measures Co-primary outcomes – change in ability to find treated words of personal relevance in a bespoke naming test (impairment) and change in functional communication in conversation rated on the activity scale of the Therapy Outcome Measures (activity) 6 months after randomisation. A key secondary outcome was participant-rated perception of communication and quality of life using the Communication Outcomes After Stroke questionnaire at 6 months. Outcomes were assessed by speech and language therapists using standardised procedures. Cost-effectiveness was estimated using treatment costs and an accessible EuroQol-5 Dimensions, five-level version, measuring quality-adjusted life-years. Results A total of 818 patients were assessed for eligibility and 278 participants were randomised between October 2014 and August 2016. A total of 240 participants (86 usual care, 83 computerised speech and language therapy, 71 attention control) contributed to modified intention-to-treat analysis at 6 months. The mean improvements in word-finding were 1.1% (standard deviation 11.2%) for usual care, 16.4% (standard deviation 15.3%) for computerised speech and language therapy and 2.4% (standard deviation 8.8%) for attention control. Computerised speech and language therapy improved word-finding 16.2% more than usual care did (95% confidence interval 12.7% to 19.6%; p n = 219); the mean differences in change in word-finding score were 12.7% (95% confidence interval 8.7% to 16.7%) higher in the computerised speech and language therapy group (n = 74) than in the usual-care group (n = 84) and 9.3% (95% confidence interval 4.8% to 13.7%) higher in the computerised speech and language therapy group than in the attention control group (n = 61). Computerised speech and language therapy did not show significant improvements on the Therapy Outcome Measures or Communication Outcomes After Stroke scale compared with usual care or attention control. Primary cost-effectiveness analysis estimated an incremental cost per participant of £732.73 (95% credible interval £674.23 to £798.05). The incremental quality-adjusted life-year gain was 0.017 for computerised speech and language therapy compared with usual care, but its direction was uncertain (95% credible interval –0.05 to 0.10), resulting in an incremental cost-effectiveness ratio of £42,686 per quality-adjusted life-year gained. For mild and moderate word-finding difficulty subgroups, incremental cost-effectiveness ratios were £22,371 and £28,898 per quality-adjusted life-year gained, respectively, for computerised speech and language therapy compared with usual care. Limitations This trial excluded non-English-language speakers, the accessible EuroQol-5 Dimensions, five-level version, was not validated and the measurement of attention control fidelity was limited. Conclusions Computerised speech and language therapy enabled additional self-managed speech and language therapy, contributing to significant improvement in finding personally relevant words (as specifically targeted by computerised speech and language therapy) long term post stroke. Gains did not lead to improvements in conversation or quality of life. Cost-effectiveness is uncertain owing to uncertainty around the quality-adjusted life-year gain, but computerised speech and language therapy may be more cost-effective for participants with mild and moderate word-finding difficulties. Exploring ways of helping people with aphasia to use new words in functional communication contexts is a priority. Trial registration Current Controlled Trials ISRCTN68798818. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 19. See the NIHR Journals Library website for further project information. The Tavistock Trust for Aphasia provided additional support to enable people in the control groups to experience the intervention after the trial had ended.

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.

Objective: To assess the clinical and cost-effectiveness of cognitive rehabilitation for attention and memory problems in people with multiple sclerosis. Design: Multicentre, pragmatic, randomized controlled trial. Setting: Community Participants: People with multiple sclerosis aged 18–69 years, who reported cognitive problems in daily life and had cognitive problems on standardized assessment. Interventions: A group cognitive rehabilitation programme delivered in 10 weekly sessions in comparison with usual care. Main measures: The primary outcome was the Multiple Sclerosis Impact Scale Psychological subscale at 12 months after randomization. Secondary outcomes included measures of everyday memory problems, mood, fatigue, cognitive abilities and employment at 6 and 12 months after randomization. Results: In all, 245 participants were allocated to cognitive rehabilitation and 204 to usual care. Mean Multiple Sclerosis Impact Scale Psychological at 12 months was 22.2 (SD = 6.1) for cognitive rehabilitation and 23.4 (SD = 6.0) for usual care group; adjusted difference −0.6, 95% confidence interval (CI) = −1.5 to 0.3, P = 0.20. No differences were observed in cognitive abilities, fatigue or employment. There were small differences in favour of cognitive rehabilitation for the Multiple Sclerosis Impact Scale Psychological at 6 months and everyday memory and mood at 6 and 12 months. There was no evidence of an effect on costs (−£808; 95% CI = −£2248 to £632) or on quality-adjusted life year gain (0.00; 95% CI = −0.01 to 0.02). Conclusion: This rehabilitation programme had no long-term benefits on the impact of multiple sclerosis on quality of life, but there was some evidence of an effect on everyday memory problems and mood.

Objective:To evaluate the feasibility of a multicentre randomized controlled trial of ReaDySpeech, an online speech therapy programme for people with dysarthria.Design:Feasibility randomized controlled trial, 2:1 minimization procedure.Setting:Four UK NHS services across hospital and community.Participants:Forty participants with dysarthria at least one week post-stroke.Interventions/comparator:ReaDySpeech with usual care ( n = 26) versus usual care only ( n = 14).Main outcomes:Feasibility measures included the following: recruitment and retention rate, time taken to carry out assessments, success of outcome assessor blinding, fidelity and adherence. Participant baseline and outcome measures collected before and after 8–10 weeks of intervention were the Frenchay Dysarthria Assessment II, Therapy Outcome Measure, Communication Outcomes After Stroke Scale, EQ-5D-5L and Dysarthria Impact Profile.Results:Recruited 40 participants out of 74 eligible people, 1–13 weeks post stroke and mean age 69 years (37–99). Retention was very high (92%). Assessor blinding was not achieved with intervention allocation correctly guessed for 70% of participants (26/37). Time to carry out assessments was acceptable to participants. ReaDySpeech was delivered to 16 of 26 allocated participants, who completed 55% of prescribed activities, but both interventions were delivered at low intensity (mean 6.6 face-to-face sessions of 40-minute duration).Conclusion:Recruitment and retention in this randomized controlled trial of computerized therapy for dysarthria is feasible for acute stroke. However, further feasibility work is needed to evaluate whether it is possible to recruit chronic stroke; increase intervention delivery, intensity and adherence; achieve outcome assessor blinding by video-recording and to determine sample size for a larger trial of effectiveness.

We established spatial neglect prevalence, disease profile and amount of therapy that inpatient stroke survivors received, and outcomes at discharge using Sentinel Stroke National Audit Programme (SSNAP) data. We used data from 88,664 National Health Service (NHS) admissions in England, Wales and Northern Ireland (July 2013&ndash, July 2015), for stroke survivors still in hospital after 3 days with a completed baseline neglect National Institute for Health Stroke Scale (NIHSS) score. Thirty percent had neglect (NIHSS item 11 &ge, 1) and they were slightly older (78 years) than those without neglect (75 years). Neglect was observed more commonly in women (33 vs. 27%) and in individuals with a premorbid dependency (37 vs. 28%). Survivors of mild stroke were far less likely to present with neglect than those with severe stroke (4% vs. 84%). Those with neglect had a greatly increased length of stay (27 vs. 10 days). They received a comparable amount of average daily occupational and physiotherapy during their longer inpatient stay but on discharge a greater percentage of individuals with neglect were dependent on the modified Rankin scale (76 vs. 57%). Spatial neglect is common and associated with worse clinical outcomes. These results add to our understanding of neglect to inform clinical guidelines, service provision and priorities for future research.

ObjectiveTo identify the main drivers of inpatient stroke care resource use, estimate the influence of stroke teams on the length of stay (LoS) of its patients and analyse the variation in relative performance across teams.DesignFor each of four types of stroke care teams, a two-level count data model describing the variation in LoS and identifying the team influence on LoS purged of patient and treatment characteristics was estimated. Each team effect was interpreted as a measure of stroke care relative performance and its variation was analysed.SettingThis study used data from 145 396 admissions in 256 inpatient stroke care teams between June 2013 and July 2015 included in the national stroke register of England, Wales and Northern Ireland—Sentinel Stroke National Audit Programme.ResultsThe main driver of LoS, and thus resource use, was the need for stroke therapy even after stroke severity was taken into account. Conditional on needing the therapy in question, an increase in the average amount of therapy received per inpatient day was associated with shorter LoS. Important variations in stroke care performance were found within each team category.ConclusionsResource use was strongly associated with stroke severity, the need for therapy and the amount of therapy received. The variations in stroke care performance were not explained by measurable patient or team characteristics. Further operational and financial analyses are needed to unmask the causes of this unexplained variation.

Objective: To examine whether stroke survivors in inpatient rehabilitation with pre-existing cognitive impairment receive less therapy than those without. Design: Prospective observational cohort. Setting: Four UK inpatient stroke rehabilitation units. Participants: A total of 139 stroke patients receiving rehabilitation, able to give informed consent/had an individual available to act as personal consultee. In total, 33 participants were categorized with pre-existing cognitive impairment based on routine documentation by clinicians and 106 without. Measures: Number of inpatient therapy sessions received during the first eight weeks post-stroke, referral to early supported discharge, and length of stay. Results: On average, participants with pre-existing cognitive impairment received 40 total physiotherapy and occupational therapy sessions compared to 56 for those without (mean difference = 16.0, 95% confidence interval (CI) = 2.9, 29.2), which was not fully explained by adjusting for potential confounders (age, sex, National Institutes of Health Stroke Scale (NIHSS), and pre-stroke modified Rankin Scale (mRS)). While those with pre-existing cognitive impairment received nine fewer single-discipline physiotherapy sessions (95% CI = 3.7, 14.8), they received similar amounts of single-discipline occupational therapy, psychology, and speech and language therapy; two more non-patient-facing occupational therapy sessions (95% CI = –4.3, –0.6); and nine fewer patient-facing occupational therapy sessions (95% CI = 3.5, 14.9). There was no evidence to suggest they were discharged earlier, but of the 85 participants discharged within eight weeks, 8 (42%) with pre-existing cognitive impairment were referred to early supported discharge compared to 47 (75%) without. Conclusion: People in stroke rehabilitation with pre-existing cognitive impairments receive less therapy than those without, but it remains unknown whether this affects outcomes.

Summary Background Post-stroke aphasia might improve over many years with speech and language therapy; however speech and language therapy is often less readily available beyond a few months after stroke. We assessed self-managed computerised speech and language therapy (CSLT) as a means of providing more therapy than patients can access through usual care alone. Methods In this pragmatic, superiority, three-arm, individually randomised, single-blind, parallel group trial, patients were recruited from 21 speech and language therapy departments in the UK. Participants were aged 18 years or older and had been diagnosed with aphasia post-stroke at least 4 months before randomisation; they were excluded if they had another premorbid speech and language disorder caused by a neurological deficit other than stroke, required treatment in a language other than English, or if they were currently using computer-based word-finding speech therapy. Participants were randomly assigned (1:1:1) to either 6 months of usual care (usual care group), daily self-managed CSLT plus usual care (CSLT group), or attention control plus usual care (attention control group) with the use of computer-generated stratified blocked randomisation (randomly ordered blocks of sizes three and six, stratified by site and severity of word finding at baseline based on CAT Naming Objects test scores). Only the outcome assessors and trial statistician were masked to the treatment allocation. The speech and language therapists who were doing the outcome assessments were different from those informing participants about which group they were assigned to and from those delivering all interventions. The statistician responsible for generating the randomisation schedule was separate from those doing the analysis. Co-primary outcomes were the change in ability to retrieve personally relevant words in a picture naming test (with 10% mean difference in change considered a priori as clinically meaningful) and the change in functional communication ability measured by masked ratings of video-recorded conversations, with the use of Therapy Outcome Measures (TOMs), between baseline and 6 months after randomisation (with a standardised mean difference in change of 0·45 considered a priori as clinically meaningful). Primary analysis was based on the modified intention-to-treat (mITT) population, which included randomly assigned patients who gave informed consent and excluded those without 6-month outcome measures. Safety analysis included all participants. This trial has been completed and was registered with the ISRCTN, number ISRCTN68798818. Findings From Oct 20, 2014, to Aug 18, 2016, 818 patients were assessed for eligibility, of which 278 (34%) participants were randomly assigned (101 [36%] to the usual care group; 97 [35%] to the CSLT group; 80 [29%] to the attention control group). 86 patients in the usual care group, 83 in the CSLT group, and 71 in the attention control group contributed to the mITT. Mean word finding improvements were 1·1% (SD 11·2) in the usual care group, 16·4% (15·3) in the CSLT group, and 2·4% (8·8) in the attention control group. Word finding improvement was 16·2% (95% CI 12·7 to 19·6; p

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 NCT58414120.

AIM: To explore the use, meaning and value of the term "rehabilitation potential". METHOD: The authors of this commentary met to discuss concerns relating to the pressure on health service staff created by reduced length of stay in acute settings of those who have suffered a stroke and the need to determine the potential of a patient for rehabilitation in order to inform discharge arrangements. Points raised at this meeting were shared with an email group who over a 12-month period contributed to this paper. RESULTS: The group agreed that: (a) Given that there is very limited evidence to guide judgements regarding rehabilitation potential following stroke at an early stage the need for rehabilitation needs to be reviewed on a regular basis over a long period and that this needs to be reflected in clinical guidelines. (b) Rehabilitation needs to be available in a broad range of care settings, in order that discharge from hospital is not equated with a lack of rehabilitation potential. (c) Research related to rehabilitation potential needs to be conducted. This should examine influences of decision-making and the algorithms associated with recovery and local policy on rehabilitation potential. (d) The economic benefits of rehabilitation needs further exploration. (e) Assessment of rehabilitation potential should be made more explicit and supported by appropriate evidence. CONCLUSION: Whilst further research is required to assist in determining the right time for people to benefit from formal rehabilitation this gives the impression that one dose of rehabilitation at a specific time will meet all needs. It is likely that a rehabilitation pathway identifying features required in the early stages following stroke as well as that required over many years in order to prevent readmission, maintain fitness and prevent secondary sequelae such as depression and social isolation would be beneficial. Implications for Rehabilitation The potential of a patient to benefit from rehabilitation may be overlooked due to other pressures. Some patients following a stroke will demonstrate potential to benefit from rehabilitation later than the majority and this is not always easy to predict. Regular reassessment is required in order to identify whether an individual will benefit from rehabilitation at a particular time.