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The effect of treatment dose on recovery of post-stroke aphasia is not well understood. Inconsistent conceptualization, measurement, and reporting of the multiple dimensions of dose hinders efforts to evaluate dose-response relations in aphasia rehabilitation research. We review the state of dose conceptualization in aphasia rehabilitation and compare the applicability of 3 existing dose frameworks to aphasia rehabilitation research-the Frequency, Intensity, Time, and Type (FITT) principle, the Cumulative Intervention Intensity (CII) framework, and the Multidimensional Dose Articulation Framework (MDAF). The MDAF specifies dose in greater detail than the CII framework and the FITT principle. On this basis, we selected the MDAF to be applied to 3 diverse examples of aphasia rehabilitation research. We next critically examined applicability of the MDAF to aphasia rehabilitation research and identified the next steps needed to systematically conceptualize, measure, and report the multiple dimensions of dose, which together can progress understanding of the effect of treatment dose on outcomes for people with aphasia after stroke. Further consideration is required to enable application of this framework to aphasia interventions that focus on participation, personal, and environmental interventions and to understand how the construct of episode difficulty applies across therapeutic activities used in aphasia interventions.

OBJECTIVE: To describe the costs of hospital care for acute stroke for patients with aphasia or dysarthria. DESIGN: Observational study from the Stroke123 project. SETTING: Data from patients admitted with stroke (2009-2013) from 22 hospitals in Queensland participating in the Australian Stroke Clinical Registry (AuSCR) were linked to administrative datasets. PARTICIPANTS: Communication impairments were identified using International Classification of Diseases, 10th Revision, Australian Modification codes. Overall, 1043 of 4195 (25%) patients were identified with aphasia (49% were women; median age 78 years; 83% with ischemic stroke), and 1005 (24%) with dysarthria (42% were women; median age 76 years; 85% with ischemic stroke). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Linked patient-level, hospital clinical costing related to the stroke, were adjusted to 2013/2014 Australian dollars (AU$, US$ conversion x 0.691) using recommended national price indices and multivariable regression analysis with clustering by hospital performed. RESULTS: Compared with patients without aphasia, the median hospital costs/patient were greater for those with aphasia for medical (aphasia AU$2273 vs AU$1727, P<.001), nursing (aphasia AU$3829 vs AU$2748, P<.001) and allied health services (aphasia AU$1138 vs AU$720, P<.001). Similarly, costs were greater for patients with dysarthria compared with those without dysarthria. Adjusted median total costs were AU$2882 greater for patients with aphasia compared with patients without aphasia (95% confidence interval, AU$1880-3884), and AU$843 greater for patients with dysarthria compared with those without dysarthria (95% confidence interval, AU$-301 to 1987). CONCLUSIONS: People with communication impairment after stroke incur greater hospital costs, in particular for medical, allied health, and nursing resources.

BACKGROUND: Aphasia is a common consequence of stroke, and people who live with this condition experience poor outcomes. Adherence to clinical practice guidelines can promote high-quality service delivery and optimize patient outcomes. However, there are currently no high-quality guidelines specific to post-stroke aphasia management. AIMS: To identify and evaluate recommendations from high-quality stroke guidelines that can inform aphasia management. SUMMARY OF REVIEW: We conducted an updated systematic review in accordance with PRISMA guidelines to identify high-quality clinical guidelines published between January 2015 and October 2022. Primary searches were performed using electronic databases: PubMed, EMBASE, CINAHL, and Web of Science. Gray literature searches were conducted using Google Scholar, guideline databases, and stroke websites. Clinical practice guidelines were evaluated using the Appraisal of Guidelines and Research and Evaluation (AGREE II) tool. Recommendations were extracted from high-quality guidelines (scored > 66.7% on Domain 3: "Rigor of Development"), classified as aphasia-specific or aphasia-related, and categorized into clinical practice areas. Evidence ratings and source citations were assessed, and similar recommendations were grouped. Twenty-three stroke clinical practice guidelines were identified and 9 (39%) met our criteria for rigor of development. From these guidelines, 82 recommendations for aphasia management were extracted: 31 were aphasia-specific, 51 aphasia-related, 67 evidence-based, and 15 consensus-based. CONCLUSION: More than half of stroke clinical practice guidelines identified did not meet our criteria for rigorous development. We identified 9 high-quality guidelines and 82 recommendations to inform aphasia management. Most recommendations were aphasia-related; aphasia-specific recommendation gaps were identified in three clinical practice areas: "accessing community supports," "return to work, leisure, driving," and "i

Background: While meta-analyses confirm treatment for chronic post-stroke aphasia is effective, a lack of comparative evidence for different interventions limits prescription accuracy. We investigated whether Constraint-Induced Aphasia Therapy Plus (CIAT-plus) and/or Multimodality Aphasia Therapy (M-MAT) provided greater therapeutic benefit compared with usual community care and were differentially effective according to baseline aphasia severity. Method(s): We conducted a three-arm, multicentre, parallel group, open-label, blinded endpoint, phase III, randomised-controlled trial. We stratified eligible participants by baseline aphasia on the Western Aphasia Battery-Revised Aphasia Quotient (WAB-R-AQ). Groups of three participants were randomly assigned (1:1:1) to 30 hours of CIAT-Plus or M-MAT or to usual care (UC). Primary outcome was change in aphasia severity (WAB-R-AQ) from baseline to therapy completion analysed in the intention-to-treat population. Secondary outcomes included word retrieval, connected speech, functional communication, multimodal communication, quality of life and costs. Result(s): We analysed 201 participants (70 in CIAT-Plus, 70 in M-MAT and 61 in UC). Aphasia severity was not significantly different between groups at postintervention: 1.05 points (95% CI -0.78 to 2.88; p=0.36) UC group vs CIAT-Plus; 1.06 points (95% CI -0.78 to 2.89; p=0.36) UC group vs M-MAT; 0.004 points (95% CI -1.76 to 1.77; p=1.00) CIAT-Plus vs M-MAT. Word retrieval, functional communication and communication-related quality of life were significantly improved following CIAT-Plus and M-MAT. Word retrieval benefits were maintained at 12-week follow-up. Conclusion(s): CIAT-Plus and M-MAT were effective for word retrieval, functional communication, and quality of life, while UC was not. Future studies should explore predictive characteristics of responders and impacts of maintenance doses. Trial registration number: ACTRN 2615000618550. Copyright © Author(s) (or their emp

Background: We require high-quality information on the current burden, the types of therapy and resources available, methods of delivery, care pathways and long-term outcomes for people with aphasia. Aim: To document and inform international delivery of post-stroke aphasia treatment, to optimise recovery and reintegration of people with aphasia. Methods & Procedures: Multi-centre, prospective, non-randomised, open study, employing blinded outcome assessment, where appropriate, including people with post-stroke aphasia, able to attend for 30 minutes during the initial language assessment, at first contact with a speech and language therapist for assessment of aphasia at participating sites. There is no study-mandated intervention. Assessments will occur at baseline (first contact with a speech and language therapist for aphasia assessment), discharge from Speech and Language Therapy (SLT), 6 and 12-months post-stroke. Our primary outcome is changed from baseline in the Amsterdam Nijmegen Everyday Language Test (ANELT/Scenario Test for participants with severe verbal impairments) at 12-months post-stroke. Secondary outcomes at 6 and 12 months include the Therapy Outcome Measure (TOMS), Subjective Index of Physical and Social Outcome (SIPSO), Aphasia Severity Rating Scale (ASRS), Western Aphasia Battery Aphasia Quotient (WAB-AQ), stroke and aphasia quality of life scale (SAQoL-39), European Quality of Life Scale (EQ-5D), lesion description, General Health Questionnaire (GHQ-12), resource use, and satisfaction with therapy provision and success. We will collect demography, clinical data, and therapy content. Routine neuroimaging and medication administration records will be accessed where possible; imaging will be pseudonymised and transferred to a central reading centre. Data will be collected in a central registry. We will describe demography, stroke and aphasia profiles and therapies available. International individual participant data (IPD) meta-analyses will ex

Background Aboriginal Australians are known to suffer high levels of acquired brain injury (stroke and traumatic brain injury) yet experience significant barriers in accessing rehabilitation services. The aim of the Healing Right Way trial is to evaluate a culturally secure intervention for Aboriginal people with newly acquired brain injury to improve their rehabilitation experience and quality of life. Following publication of the trial protocol, this paper outlines the statistical analysis plan prior to locking the database. Methods The trial involves a stepped wedge design with four steps over 3 years. Participants were 108 adult Aboriginal Australians admitted to one of eight hospitals (four rural, four urban) in Western Australia within 6 weeks of onset of a new stroke or traumatic brain injury who consented to follow-up for 26 weeks. All hospital sites started in a control phase, with the intervention assigned to pairs of sites (one metropolitan, one rural) every 26 weeks until all sites received the intervention. The two-component intervention involves training in culturally safe care for hospital sites and enhanced support provided to participants by Aboriginal Brain Injury Coordinators during their hospital stay and after discharge. The primary outcome is quality of life as measured by the Euro QOL–5D-3L VAS. A mixed effects linear regression model will be used to assess the between-group difference at 26 weeks post-injury. The model will control for injury type and severity, age at recruitment and time since commencement of the trial, as fixed effects. Recruitment site and participant will be included as random effects. Secondary outcomes include measurements of function, independence, anxiety and depression, carer strain, allied health occasions of service received and hospital compliance with minimum processes of care based on clinical guidelines and best practice models of care. Discussion The trial will provide the first data surrounding the effectiven

Background: Access to rehabilitation services for Aboriginal people following acquired brain injury (ABI) is frequently hindered by challenges navigating: i) complex medical systems, ii) geographical distances from services and iii) culturally insecure service delivery. Healing Right Way is the first randomised control trial (RCT) to address these issues in partnership with multiple health service providers across Western Australia (WA). Aims: To outline the multicomponent Healing Right Way intervention by providing case studies, and describing challenges, facilitators and implications for rehabilitation services. Method: This stepped-wedge cluster RCT involved four metropolitan and four regional sites across WA. Aboriginal adults hospitalised for ABI were recruited from 2018-2021. Intervention components comprised ABI-related cultural security training (CST) for hospital staff, and employment of Aboriginal Brain Injury Coordinators (ABICs) to support ABI survivors for six months post-injury. The primary outcome was quality of life (measured with Euro QOL–5D-3L VAS) at 26 weeks. Secondary outcomes included participants’ overall function and disability, anxiety and depression, carer strain, and changes to service delivery across the 26-week follow-up period. Detailed process and cost evaluations were also undertaken. Results: 108 participants were recruited from the participating sites. The CST was delivered across all eight participating hospitals with 250 hospital staff trained. ABICs supported 61 participants, 70% residing in regional, rural or remote areas. Challenges to implementation of the intervention included impacts from COVID-19 responses, hospital staff turnover and availability, recruitment of people with traumatic brain injury and methods for maintaining contact with participants and next-of-kin across locations. Collaboration with Aboriginal health providers and community networks were invaluable to maintaining contact with participants during follow-u

BACKGROUND: While meta-analyses confirm treatment for chronic post-stroke aphasia is effective, a lack of comparative evidence for different interventions limits prescription accuracy. We investigated whether Constraint-Induced Aphasia Therapy Plus (CIAT-plus) and/or Multimodality Aphasia Therapy (M-MAT) provided greater therapeutic benefit compared with usual community care and were differentially effective according to baseline aphasia severity. METHODS: We conducted a three-arm, multicentre, parallel group, open-label, blinded endpoint, phase III, randomised-controlled trial. We stratified eligible participants by baseline aphasia on the Western Aphasia Battery-Revised Aphasia Quotient (WAB-R-AQ). Groups of three participants were randomly assigned (1:1:1) to 30 hours of CIAT-Plus or M-MAT or to usual care (UC). Primary outcome was change in aphasia severity (WAB-R-AQ) from baseline to therapy completion analysed in the intention-to-treat population. Secondary outcomes included word retrieval, connected speech, functional communication, multimodal communication, quality of life and costs. RESULTS: We analysed 201 participants (70 in CIAT-Plus, 70 in M-MAT and 61 in UC). Aphasia severity was not significantly different between groups at postintervention: 1.05 points (95% CI -0.78 to 2.88; p=0.36) UC group vs CIAT-Plus; 1.06 points (95% CI -0.78 to 2.89; p=0.36) UC group vs M-MAT; 0.004 points (95% CI -1.76 to 1.77; p=1.00) CIAT-Plus vs M-MAT. Word retrieval, functional communication and communication-related quality of life were significantly improved following CIAT-Plus and M-MAT. Word retrieval benefits were maintained at 12-week follow-up. CONCLUSIONS: CIAT-Plus and M-MAT were effective for word retrieval, functional communication, and quality of life, while UC was not. Future studies should explore predictive characteristics of responders and impacts of maintenance doses. TRIAL REGISTRATION NUMBER: ACTRN 2615000618550.

BACKGROUND: Treatment fidelity is inconsistently reported in aphasia research, contributing to uncertainty about the effectiveness of types of aphasia therapy following stroke. We outline the processes and outcomes of treatment fidelity monitoring in a pre-specified secondary analysis of the VERSE trial. METHODS: VERSE was a 3-arm, single-blinded RCT with a 12-week primary endpoint comparing Usual Care (UC) to two higher intensity treatments: Usual Care-Plus (UC-Plus) and VERSE, a prescribed intervention. Primary outcome results were previously reported. This secondary analysis focused on treatment fidelity. Video-recorded treatment sessions in the higher intensity study arms were evaluated for treatment adherence and treatment differentiation. Treatment components were evaluated using a pre-determined fidelity checklist. PRIMARY OUTCOME: prescribed amount of therapy time (minutes); secondary outcomes: (i) adherence to therapy protocol (%) and (ii) treatment differentiation between control and high intensity groups. RESULTS: Two hundred forty-six participants were randomised to Usual Care (n=81), Usual Care-Plus (n=82), and VERSE (n=83). One hundred thirty-five (82%) participants in higher intensity intervention arms received the minimum prescribed therapy minutes. From 10,805 (UC 7787; UC-Plus 1450; VERSE 1568) service events, 431 treatment protocol deviations were noted in 114 participants. Four hundred thirty-seven videos were evaluated. The VERSE therapists achieved over 84% adherence to key protocol elements. Higher stroke and aphasia severity, older age, and being in the UC-Plus group predicted more treatment deviations. CONCLUSIONS: We found high levels of treatment adherence and differentiation between the intervention arms, providing greater confidence interpreting our results. The comprehensive systems for intervention fidelity monitoring and reporting in this trial make an important contribution to aphasia research and, we argue, should set a new standard

BACKGROUND: Aboriginal Australians are known to suffer high levels of acquired brain injury (stroke and traumatic brain injury) yet experience significant barriers in accessing rehabilitation services. The aim of the Healing Right Way trial is to evaluate a culturally secure intervention for Aboriginal people with newly acquired brain injury to improve their rehabilitation experience and quality of life. Following publication of the trial protocol, this paper outlines the statistical analysis plan prior to locking the database. METHODS: The trial involves a stepped wedge design with four steps over 3 years. Participants were 108 adult Aboriginal Australians admitted to one of eight hospitals (four rural, four urban) in Western Australia within 6 weeks of onset of a new stroke or traumatic brain injury who consented to follow-up for 26 weeks. All hospital sites started in a control phase, with the intervention assigned to pairs of sites (one metropolitan, one rural) every 26 weeks until all sites received the intervention. The two-component intervention involves training in culturally safe care for hospital sites and enhanced support provided to participants by Aboriginal Brain Injury Coordinators during their hospital stay and after discharge. The primary outcome is quality of life as measured by the Euro QOL-5D-3L VAS. A mixed effects linear regression model will be used to assess the between-group difference at 26 weeks post-injury. The model will control for injury type and severity, age at recruitment and time since commencement of the trial, as fixed effects. Recruitment site and participant will be included as random effects. Secondary outcomes include measurements of function, independence, anxiety and depression, carer strain, allied health occasions of service received and hospital compliance with minimum processes of care based on clinical guidelines and best practice models of care. DISCUSSION: The trial will provide the first data surrounding the effect

Background: We require high-quality information on the current burden, the types of therapy and resources available, methods of delivery, care pathways and long-term outcomes for people with aphasia. Aim: To document and inform international delivery of post-stroke aphasia treatment, to optimise recovery and reintegration of people with aphasia. Methods & Procedures: Multi-centre, prospective, non-randomised, open study, employing blinded outcome assessment, where appropriate, including people with post-stroke aphasia, able to attend for 30 minutes during the initial language assessment, at first contact with a speech and language therapist for assessment of aphasia at participating sites. There is no study-mandated intervention. Assessments will occur at baseline (first contact with a speech and language therapist for aphasia assessment), discharge from Speech and Language Therapy (SLT), 6 and 12-months post-stroke. Our primary outcome is changed from baseline in the Amsterdam Nijmegen Everyday Language Test (ANELT/Scenario Test for participants with severe verbal impairments) at 12-months post-stroke. Secondary outcomes at 6 and 12 months include the Therapy Outcome Measure (TOMS), Subjective Index of Physical and Social Outcome (SIPSO), Aphasia Severity Rating Scale (ASRS), Western Aphasia Battery Aphasia Quotient (WAB-AQ), stroke and aphasia quality of life scale (SAQoL-39), European Quality of Life Scale (EQ-5D), lesion description, General Health Questionnaire (GHQ-12), resource use, and satisfaction with therapy provision and success. We will collect demography, clinical data, and therapy content. Routine neuroimaging and medication administration records will be accessed where possible; imaging will be pseudonymised and transferred to a central reading centre. Data will be collected in a central registry. We will describe demography, stroke and aphasia profiles and therapies available. International individual participant data (IPD) meta-analyses will ex

Background: While high-quality meta-analyses have confirmed the effectiveness of aphasia therapy after stroke, there is limited evidence for the comparative effectiveness of different aphasia interventions. Two commonly used interventions, Constraint-induced Aphasia Therapy Plus (CIAT Plus) and Multi-modality Aphasia Therapy (M-MAT), are hypothesised to rely on diverse underlying neural mechanisms for recovery and may be differentially responsive to aphasia severity. COMPARE is a prospective randomised open-blinded end-point trial designed to determine whether, in people with chronic post-stroke aphasia living in the community, CIAT Plus and M-MAT provide greater therapeutic benefit compared to usual care, are differentially effective according to aphasia severity, and are cost-effective. This paper details the statistical analysis plan for the COMPARE trial developed prior to data analysis. Method(s): Participants (n = 216) are randomised to one of three arms, CIAT Plus, M-MAT or usual care, and undertake therapy with a study trained speech pathologist in groups of three participants stratified by aphasia severity. Therapy occurs for 3 h blocks per day for 10 days across 2 weeks. The primary clinical outcome is aphasia severity as measured by the Western Aphasia Battery-Revised Aphasia Quotient (WAB-R-AQ) immediately post intervention. Secondary outcomes include WAB-R-AQ at 12-week follow-up, and functional communication, discourse efficiency, multimodal communication, and health-related quality of life immediately post intervention and at 12-week follow-up. Result(s): Linear mixed models (LMMs) will be used to analyse differences between M-MAT and UC, and CIAT-Plus and UC on each outcome measure immediately and at 12 weeks post-intervention. The LMM for WAB-R-AQ will assess the differences in efficacy between M-MAT and CIAT-Plus. All analyses will control for baseline aphasia severity (fixed effect) and for the clustering effect of treatment groups (random effect)

Background: We require high-quality information on the current burden, the types of therapy and resources available, methods of delivery, care pathways and long-term outcomes for people with aphasia. Aim(s): To document and inform international delivery of post-stroke aphasia treatment, to optimise recovery and reintegration of people with aphasia. Methods & Procedures: Multi-centre, prospective, non-randomised, open study, employing blinded outcome assessment, where appropriate, including people with post-stroke aphasia, able to attend for 30 minutes during the initial language assessment, at first contact with a speech and language therapist for assessment of aphasia at participating sites. There is no study-mandated intervention. Assessments will occur at baseline (first contact with a speech and language therapist for aphasia assessment), discharge from Speech and Language Therapy (SLT), 6 and 12-months post-stroke. Our primary outcome is changed from baseline in the Amsterdam Nijmegen Everyday Language Test (ANELT/Scenario Test for participants with severe verbal impairments) at 12-months post-stroke. Secondary outcomes at 6 and 12 months include the Therapy Outcome Measure (TOMS), Subjective Index of Physical and Social Outcome (SIPSO), Aphasia Severity Rating Scale (ASRS), Western Aphasia Battery Aphasia Quotient (WAB-AQ), stroke and aphasia quality of life scale (SAQoL-39), European Quality of Life Scale (EQ-5D), lesion description, General Health Questionnaire (GHQ-12), resource use, and satisfaction with therapy provision and success. We will collect demography, clinical data, and therapy content. Routine neuroimaging and medication administration records will be accessed where possible; imaging will be pseudonymised and transferred to a central reading centre. Data will be collected in a central registry. We will describe demography, stroke and aphasia profiles and therapies available. International individual participant data (IPD) meta-analyses will exa

Background: Aphasia is associated with increased hospital stays and use of rehabilitation services. Little is known about the hospitalisation costs for patients with aphasia in Australia. Aim(s): To compare the costs of hospitalisation for patients with and without aphasia. Method(s): Data on patients admitted with stroke/TIA to Queensland hospitals (n=22) participating in the Australian Stroke Clinical Registry were linked to administrative datasets. The International Classification of Diseases 10th Revision codes were used to identify patients with aphasia (R470). These codes were selected from emergency department presentations and hospital admissions for linked cases using a 5-year look back period. Clinical costing data were obtained from Queensland Health and were inflated to a 2013/2014 financial year equivalent using the Total Health Price Index. The additional cost associated with aphasia was assessed using median regression analysis, with clustering by hospital. Result(s): There were 1043/4195 (26.5%) patients recorded as having aphasia (49% female; 78 median age; 83% ischaemic stroke). Greater overall costs per person were observed for medical (median cost $2273 vs. $1727, p<0.05), nursing ($3829 vs. $2748, p<0.05), non-clinical ($765 vs. $601, p<0.05), and allied health ($1138 vs. $720, p<0.05) activities. After adjustment for confounding factors, patients with aphasia had $2882 greater total costs of admission on average than patients without aphasia (95% confidence interval $1880 to $3884). Conclusion(s): Greater costs were associated with hospitalisation for patients with aphasia after stroke. This has implications for the economic burden of healthcare provision for patients with post-stroke aphasia in Australia.

Background and Aims: The reasons people with post-stroke aphasia have poor health outcomes are not well understood. We aimed to determine factors associated with aphasia, and compare the frequency of post-stroke hospital readmissions amongst patients with and without aphasia. Method(s): Patient-level data from the Australian Stroke Clinical Registry (years 2009-2013) were linked to national death data, hospital emergency presentations and admissions data from Victoria, Queensland, New South Wales and Western Australia. Multivariable logistic regression was used to assess factors associated with aphasia identified from ICD10 discharge codes for the index stroke event. Cox regression was used for hospital readmissions within 30 days, 90 days, 180 days and 1-year. Comorbidities were identified using ICD-10 coded admission data from 5-years prior to the stroke event. Result(s): 12,690 adults with stroke were included (median age 76; 54% male; 77% ischaemic stroke); 26% identified with aphasia. The factors most strongly associated with aphasia were prior diagnosis of stroke (aOR 7.76, 95%CI 2.44-24.7; p<0.001), paraplegia (aOR 1.57, 95%CI 1.42-1.75; p<0.001), and atrial fibrillation (aOR 1.56, 95%CI 1.41-1.73; p<0.001). Compared to people without aphasia, people with aphasia more often had a hospital readmission within 180 days (HR 1.11, 95%CI 1.02-1.22; p=0.009), and 1-year (HR 1.12, 95%CI 1.03-1.21; p=0.005). Hospital readmissions within 30 days and 90 days were not significantly different. Conclusion(s): Patients with prior stroke are more likely to experience aphasia following a new stroke event. Early aphasia-specific secondary stroke prevention, education and support may help reduce the prevalence of post-stroke aphasia and hospital readmissions.

Background: We require high-quality information on the current burden, the types of therapy and resources available, methods of delivery, care pathways and long-term outcomes for people with aphasia. Aim: To document and inform international delivery of post-stroke aphasia treatment, to optimise recovery and reintegration of people with aphasia. Methods & Procedures: Multi-centre, prospective, non-randomised, open study, employing blinded outcome assessment, where appropriate, including people with post-stroke aphasia, able to attend for 30 minutes during the initial language assessment, at first contact with a speech and language therapist for assessment of aphasia at participating sites. There is no study-mandated intervention. Assessments will occur at baseline (first contact with a speech and language therapist for aphasia assessment), discharge from Speech and Language Therapy (SLT), 6 and 12-months post-stroke. Our primary outcome is changed from baseline in the Amsterdam Nijmegen Everyday Language Test (ANELT/Scenario Test for participants with severe verbal impairments) at 12-months post-stroke. Secondary outcomes at 6 and 12 months include the Therapy Outcome Measure (TOMS), Subjective Index of Physical and Social Outcome (SIPSO), Aphasia Severity Rating Scale (ASRS), Western Aphasia Battery Aphasia Quotient (WAB-AQ), stroke and aphasia quality of life scale (SAQoL-39), European Quality of Life Scale (EQ-5D), lesion description, General Health Questionnaire (GHQ-12), resource use, and satisfaction with therapy provision and success. We will collect demography, clinical data, and therapy content. Routine neuroimaging and medication administration records will be accessed where possible; imaging will be pseudonymised and transferred to a central reading centre. Data will be collected in a central registry. We will describe demography, stroke and aphasia profiles and therapies available. International individual participant data (IPD) meta-analyses will examin

BACKGROUND: While high-quality meta-analyses have confirmed the effectiveness of aphasia therapy after stroke, there is limited evidence for the comparative effectiveness of different aphasia interventions. Two commonly used interventions, Constraint-induced Aphasia Therapy Plus (CIAT Plus) and Multi-modality Aphasia Therapy (M-MAT), are hypothesised to rely on diverse underlying neural mechanisms for recovery and may be differentially responsive to aphasia severity. COMPARE is a prospective randomised open-blinded end-point trial designed to determine whether, in people with chronic post-stroke aphasia living in the community, CIAT Plus and M-MAT provide greater therapeutic benefit compared to usual care, are differentially effective according to aphasia severity, and are cost-effective. This paper details the statistical analysis plan for the COMPARE trial developed prior to data analysis. METHODS: Participants (n = 216) are randomised to one of three arms, CIAT Plus, M-MAT or usual care, and undertake therapy with a study trained speech pathologist in groups of three participants stratified by aphasia severity. Therapy occurs for 3 h blocks per day for 10 days across 2 weeks. The primary clinical outcome is aphasia severity as measured by the Western Aphasia Battery-Revised Aphasia Quotient (WAB-R-AQ) immediately post intervention. Secondary outcomes include WAB-R-AQ at 12-week follow-up, and functional communication, discourse efficiency, multimodal communication, and health-related quality of life immediately post intervention and at 12-week follow-up. RESULTS: Linear mixed models (LMMs) will be used to analyse differences between M-MAT and UC, and CIAT-Plus and UC on each outcome measure immediately and at 12 weeks post-intervention. The LMM for WAB-R-AQ will assess the differences in efficacy between M-MAT and CIAT-Plus. All analyses will control for baseline aphasia severity (fixed effect) and for the clustering effect of treatment groups (random effect). DI

BACKGROUND: Effectiveness of early intensive aphasia rehabilitation after stroke is unknown. The Very Early Rehabilitation for SpEech trial (VERSE) aimed to determine whether intensive aphasia therapy, beginning within 14 days after stroke, improved communication recovery compared to usual care. METHODS: Prospective, randomized, single-blinded trial conducted at 17 acute-care hospitals across Australia/New Zealand from 2014 to 2018. Participants with aphasia following acute stroke were randomized to receive usual care (direct usual care aphasia therapy), or one of two higher intensity regimens (20 sessions of either non-prescribed (usual care-plus or prescribed (VERSE) direct aphasia therapy). The primary outcome was improvement of communication on the Western Aphasia Battery-Revised Aphasia Quotient (AQ) at 12 weeks after stroke. Our pre-planned intention to treat analysis combined high intensity groups for the primary outcome. FINDINGS: Among 13,654 acute stroke patients screened, 25% (3477) had aphasia, of whom 25% (866) were eligible and 246 randomized to usual care (n = 81; 33%), usual care-plus (n = 82; 33%) or VERSE (n = 83; 34%). At 12 weeks after stroke, the primary outcome was assessed in 217 participants (88%); 14 had died, 9 had withdrawn, and 6 were too unwell for assessment. Communication recovery was 50.3% (95% CI 45.7-54.8) in the high intensity group (n = 147) and 52.1% (95% CI 46.1-58.1) in the usual care group (n = 70; difference -1.8, 95% CI -8.7-5.0). There was no difference between groups in non-fatal or fatal adverse events (p = 0.72). INTERPRETATION: Early, intensive aphasia therapy did not improve communication recovery within 12 weeks post stroke compared to usual care.

INTRODUCTION: People with communication disability after stroke need interventions to optimise healthcare communication and rehabilitation outcomes. Current evidence syntheses do not adequately inform the management of communication disability during the first 90 days post-stroke. PURPOSE: To explore the scope of literature for the management of communication disability in the first 90 days after stroke. MATERIALS AND METHODS: A scoping review was conducted using a systematic keyword search of six databases. A descriptive synthesis was generated using communication-related domains related to the biopsychosocial framework of the International Classification of Functioning, Disability, and Health (ICF). RESULTS: A total of 129 studies met eligibility criteria. Aphasia was the most frequently addressed communication disability after stroke (76/129 studies) with a paucity of evidence investigating other acquired neurogenic communication impairments. Management predominantly focused on communication-related: body functions and structures (62 studies) (e.g., linguistic-behavioural therapies), followed by environmental factors (39 studies) (e.g., communication partner training/support); activities and participation (15 studies) (e.g., augmentative and alternative communication); and personal factors (13 studies) (e.g., assessment of depression after aphasia). CONCLUSION: A coordinated, integrated approach to developing and testing acute and subacute interventions for all communication disabilities across all communication-related domains is required.IMPLICATIONS FOR REHABILITATIONInterdisciplinary stroke clinicians need to manage communication disabilities in the first 90 days after stroke to optimise healthcare communication and rehabilitation outcomes.There is some evidence to guide clinicians in aphasia management but less in other disabilities of speech and cognitive functioning.Most interventions to inform clinical practice address communication-related body functions

Introduction

Rationale: The comparative efficacy and cost-effectiveness of constraint-induced and multi-modality aphasia therapy in chronic stroke are unknown. Aims and hypotheses: In the COMPARE trial, we aim to determine whether Multi-Modal Aphasia Treatment (M-MAT) and Constraint-Induced Aphasia Therapy Plus (CIAT-Plus) are superior to usual care (UC) for chronic post-stroke aphasia. Primary hypothesis: CIAT-Plus and M-MAT will reduce aphasia severity (Western Aphasia Battery-Revised Aphasia Quotient (WAB-R-AQ)) compared with UC: CIAT-Plus superior for moderate aphasia; M-MAT superior for mild and severe aphasia. Sample size estimates: A total of 216 participants (72 per arm) will provide 90% power to detect a 5-point difference on the WAB-R-AQ between CIAT-Plus or M-MAT and UC at alpha = 0.05. Methods and design: Prospective, randomized, parallel group, open-label, assessor blinded trial. Participant(s): Stroke >6 months; aphasia severity categorized using WAB-R-AQ. Computer-generated blocked and stratified randomization by aphasia severity (mild, moderate, and severe), to 3 arms: CIAT-Plus, M-MAT (both 30 h therapy over two weeks); UC (self-reported usual community care). Study outcomes: WAB-R-AQ immediately post-intervention. Secondary Outcomes: WAB-R-AQ at 12-week follow-up; naming scores, discourse measures, Communicative Effectiveness Index, Scenario Test, and Stroke and Aphasia Quality of Life Scale-39 g immediately and at 12 weeks post-intervention; incremental cost-effectiveness ratios compared with UC at 12 weeks. Discussion(s): This trial will determine whether CIAT-Plus and M-MAT are superior and more cost-effective than UC in chronic aphasia. Participant subgroups with the greatest response to CIAT-Plus and M-MAT will be described.Copyright © 2019 World Stroke Organization.

Background: Effectiveness of early intensive aphasia rehabilitation after stroke is unknown. The Very Early Rehabilitation for SpEech trial (VERSE) aimed to determine whether intensive aphasia therapy, beginning within 14 days after stroke, improved communication recovery compared to usual care. Method(s): Prospective, randomized, single-blinded trial conducted at 17 acute-care hospitals across Australia/New Zealand from 2014 to 2018. Participants with aphasia following acute stroke were randomized to receive usual care (direct usual care aphasia therapy), or one of two higher intensity regimens (20 sessions of either non-prescribed (usual care-plus or prescribed (VERSE) direct aphasia therapy). The primary outcome was improvement of communication on the Western Aphasia Battery-Revised Aphasia Quotient (AQ) at 12 weeks after stroke. Our pre-planned intention to treat analysis combined high intensity groups for the primary outcome. Finding(s): Among 13,654 acute stroke patients screened, 25% (3477) had aphasia, of whom 25% (866) were eligible and 246 randomized to usual care (n = 81; 33%), usual care-plus (n = 82; 33%) or VERSE (n = 83; 34%). At 12 weeks after stroke, the primary outcome was assessed in 217 participants (88%); 14 had died, 9 had withdrawn, and 6 were too unwell for assessment. Communication recovery was 50.3% (95% CI 45.7-54.8) in the high intensity group (n = 147) and 52.1% (95% CI 46.1-58.1) in the usual care group (n = 70; difference -1.8, 95% CI -8.7-5.0). There was no difference between groups in non-fatal or fatal adverse events (p = 0.72). Interpretation(s): Early, intensive aphasia therapy did not improve communication recovery within 12 weeks post stroke compared to usual care.Copyright © 2020 World Stroke Organization.

Inclusion Body Myositis (IBM) is the most common acquired myopathy in older individuals with more than two thirds of patients experiencing impaired swallowing. There are currently no standardized exercise therapies to improve or sustain swallowing despite good evidence for exercise therapy in limb muscles. Reduced upper esophageal sphincter opening is a common abnormality associated with dysphagia in IBM. This pilot study recruited IBM patients with abnormal upper esophageal sphincter function and dysphagia into an exercise program. It was hypothesized that regular practice using the Expiratory Muscle Strength Trainer (EMST) device would improve hyolaryngeal movement by strengthening suprahyoid musculature and facilitate opening of the upper esophageal sphincter thereby improving swallowing and quality of life. Overall, IBM patients who used the EMST device demonstrated no improvement in swallowing function. Consistent with that result, there was also no change in measures of quality of life. However, further studies are needed to elucidate whether it has a preventative role in the development or progression of dysphagia in IBM as there is a suggestion that patients with a shorter duration of disease may have had some benefit. This research provides pilot data and recommendations that will guide future studies on exercise therapy and swallowing in this area.

BACKGROUND:Effectiveness of early intensive aphasia rehabilitation after stroke is unknown. The Very Early Rehabilitation for SpEech trial (VERSE) aimed to determine whether intensive aphasia therapy, beginning within 14 days after stroke, improved communication recovery compared to usual care. METHODS:Prospective, randomized, single-blinded trial conducted at 17 acute-care hospitals across Australia/New Zealand from 2014 to 2018. Participants with aphasia following acute stroke were randomized to receive usual care (direct usual care aphasia therapy), or one of two higher intensity regimens (20 sessions of either non-prescribed (usual care-plus or prescribed (VERSE) direct aphasia therapy). The primary outcome was improvement of communication on the Western Aphasia Battery-Revised Aphasia Quotient (AQ) at 12 weeks after stroke. Our pre-planned intention to treat analysis combined high intensity groups for the primary outcome. FINDINGS:Among 13,654 acute stroke patients screened, 25% (3477) had aphasia, of whom 25% (866) were eligible and 246 randomized to usual care (n = 81; 33%), usual care-plus (n = 82; 33%) or VERSE (n = 83; 34%). At 12 weeks after stroke, the primary outcome was assessed in 217 participants (88%); 14 had died, 9 had withdrawn, and 6 were too unwell for assessment. Communication recovery was 50.3% (95% CI 45.7-54.8) in the high intensity group (n = 147) and 52.1% (95% CI 46.1-58.1) in the usual care group (n = 70; difference -1.8, 95% CI -8.7-5.0). There was no difference between groups in non-fatal or fatal adverse events (p = 0.72). INTERPRETATION:Early, intensive aphasia therapy did not improve communication recovery within 12 weeks post stroke compared to usual care.

Background and objectives: Treatment fidelity is a complex evaluative process that forms a critical aspect of all health-related intervention studies. Its objective is to determine whether an intervention was delivered as intended and report how this was monitored. Evidence of a high level of treatment fidelity is an important benchmark of quality, signalling confidence in the findings of the study and potential for implementation. Despite its benefits, treatment fidelity has been inconsistently monitored and reported in behavioural intervention studies. Method(s): The COMPARE study is an Australian-based three-arm randomised controlled trial (planned sample size n=216) which aims to determine whether two novel, intensive and contrasting treatments for chronic post-stroke aphasia are superior to usual care. Based on the theoretical models underlying the trial interventions, we developed a fidelity protocol to monitor and enhance treatment delivery by multiple clinicians across Australia. The fidelity protocol adheres to the recommended standards outlined in the TiDIER statement (a template for reporting interventions stemming from the CONSORT 2010 and SPIRIT 2013 statements). Result(s): The COMPARE fidelity protocol is currently being implemented. An overview of the protocol will be presented, including the theoretical rationale, methods, challenges and results to date. Data will be presented on the assessment measures, including (a) standardised clinician training, (b) video recording all assessment and treatment sessions, (c) providing feedback in real-time to clinicians and (d) monitoring for therapist drift. Conclusion(s): The COMPARE fidelity protocol offers one solution to the challenge of monitoring and enhancing treatment fidelity within a behavioural change intervention.

Background: Patients with communication impairment are often excluded from collaborative goal setting, despite recommendations in the Australian Clinical Guidelines for Stroke Management. Aim(s): To develop and field test a modified goal setting package to meet the needs of stroke patients with communication impairment. Method(s): A 34-item goal setting menu was formatted into a layout suitable for patients with communication impairment with input from clinician researchers (n=5). Feedback from a consumer focus group (n=5) was also sought. A thematic analysis of consumer group data was performed using NVivo software. Post the development phase eight inpatients with communication impairment (2 mild, 3 moderate, 3 severe) and their treating clinicians (occupational therapy (n=2), physiotherapy (n=1) and speech pathology (n=3)) were observed using the goal setting package. Descriptive statistics were used to explain the goal setting outcomes. Result(s): Themes from the consumer focus group indicated previous experiences of goal setting had been therapist-controlled or led, and that the new layout and process was helpful. The package itself was modified to include 43 subheadings supported by pictorial representations rather than the original 34-item menu. During field testing 17 person-centred goals were set (median 2 per patient). Goal areas included functional recovery (n=6), community participation (n=5), and everyday activities (n=5). Both clinicians and patients reported the menu useful. Conclusion(s): The modified goal setting menu was considered appropriate to the needs of stroke patients with communication impairment and encouraged goal setting across multiple areas. Structured clinician focus groups, patient interviews and additional refinements are planned.

Background and Aims: The Very Early Rehabilitation of SpEech after stroke (VERSE) trial recently showed no benefit of more therapy (26 hours) compared to usual care (13 hours) delivered in the first 12 weeks of stroke recovery. This paper examines the question: What therapy frequency and session length is associated with recovery in individual aphasia therapy regimens in the first 12 weeks after stroke? Methods: Participants with aphasia, recruited from 17 Australia/New Zealand acute-stroke units were randomised to one of three treatment arms. This secondary analysis used linear mixed models to investigate the effects of therapy frequency and session length on the Western Aphasia Battery-Aphasia Quotient (AQ) at 12 weeks, after controlling for therapy amount. Result(s): Participants (n=214) received aphasia therapy (mean=1377 minutes; sd=735) in 36 sessions (sd=19) with mean session length: 39 minutes (sd=11) in the first 12 weeks. The mean AQ was 41.2 (sd=28.0) at baseline and 67.7 (sd=29.5) at 12 weeks. After controlling for baseline stroke and aphasia severity, site and therapy amount, the session length had a significant effect (b=0.33, p=0.024) of increasing AQ at 12 weeks by 0.33 points per minute increase in session length. On average, 1350 minutes of therapy provided in 30 sessions of 45 minutes each, can be expected to achieve 5 points more on AQ at 12 weeks, than if 45 sessions of 30 minutes each was provided. Conclusion(s): Sessions of longer duration were associated with better recovery than a larger number of shorter sessions which achieved the same total amount of therapy.