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Introduction: There is limited evidence on the costs and outcomes of patients with aphasia after stroke. The aim of this study was to estimate costs in patients with aphasia after stroke according to the aphasia therapies provided. Methods: A three-arm, prospective, randomized, parallel group, open-label, blinded endpoint assessment trial conducted in Australia and New Zealand. Usual ward-based care (Usual Care) was compared to additional usual ward-based therapy (Usual Care Plus) and a prescribed and structured aphasia therapy program in addition to Usual Care (the VERSE intervention). Information about healthcare utilization and productivity were collected to estimate costs in Australian dollars for 2017–18. Multivariable regression models with bootstrapping were used to estimate differences in costs and outcomes (clinically meaningful change in aphasia severity measured by the WAB-R-AQ). Results: Overall, 202/246 (82%) participants completed follow-up at 26 weeks. Median costs per person were $23,322 (Q1 5,367, Q3 52,669, n = 63) for Usual Care, $26,923 (Q1 7,303, Q3 76,174, n = 70) for Usual Care Plus and $31,143 (Q1 7,001. Q3 62,390, n = 69) for VERSE. No differences in costs and outcomes were detected between groups. Usual Care Plus was inferior (i.e. more costly and less effective) in 64% of iterations, and in 18% was less costly and less effective compared to Usual Care. VERSE was inferior in 65% of samples and less costly and less effective in 12% compared to Usual Care. Conclusion: There was limited evidence that additional intensively delivered aphasia therapy within the context of usual acute care provided was worthwhile in terms of costs for the outcomes gained.

India has the highest burden of both tuberculosis (TB) and multidrug-resistant TB (MDR-TB) based on the WHO Global TB Report 2019. Although the available data suggest that the total TB incidence has declined, the absolute number of new cases is still increasing. The number of reported TB cases in India in 2018 was 2.2 million, which was 1.5 million in 2009. About 47% increment in TB case notification in India within a decade shows a persistent public health problem. India contributes about 22% of the World's TB burden. Indian National Strategic Plan 2017-2025, sets out the government plans to eliminate TB by 2025. However, the milestone seems unrealistic to achieve the TB eradication goal by 2025. We developed a five-dimensional mathematical model to understand the TB dynamics in India and investigate the possibility of the earliest TB eradication time frame. The model stratifies the entire TB class into three different classes as drug-sensitive (DS), MDR, and isolated classes. The effective reproduction number, equilibrium points, and stability analysis of the model were carried out. This model predicts the total estimated cases of DS-TB and MDR-TB from 2018 to 2035 through numerical simulation and suggests that TB may be eliminated by 2035 in India if the treatment success rate could be achieved to 95%, by contact tracing and isolating at least 50% of MDR-TB.

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 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: 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: 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

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.

This paper is a detailed case study of the southerly buster of October 6-7, 2015, along the New South Wales coast. It takes advantage of recently available Himawari-8 high temporal- and spatial-resolution satellite data, and other observational data. The data analyses support the widespread view that the southerly buster is a density current, coastally trapped by the Great Dividing Range. In addition, it appears that solitary waves develop in this event because the prefrontal boundary layer is shallow and stable. A simplified density current model produced speeds matching well with observational southerly buster data, at both Nowra and Sydney airports. Extending the density current theory, to include inertia-gravity effects, suggests that the solitary waves travel at speeds approximately 20% faster than the density current. This speed difference is consistent with the high-resolution satellite data, which shows the solitary waves moving increasingly ahead of the leading edge of the density current.

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 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.

© 2019 National Institute of Occupational Safety and Health. Law enforcement is inherently stressful, and police officers are particularly vulnerable to mental and physical disorders. As such, researchers are currently assessing intervention strategies that may combat or manage these psychological, physical and mental issues. To review most recent information regarding anxiety, PTSD, and sleepiness and fatigue and identify the interventions and treatments proposed to overcome work related stressors and associated mental illnesses inflicting law enforcement officers. The EMBASE, OVID MEDLINE and PsycINFO databases were canvassed for articles investigating anxiety, post-traumatic stress disorder, sleepiness, and fatigue. Initial article selections were made based on title, whilst final inclusion was informed by a full critical appraisal with respect to the primary and secondary effects. The systematic search returned 363 records, of which 183 were unique. Following screening, 43 records were included in the final review. The included literature assessed the efficacy of several interventions, and provided a number of recommendations regarding interventions, and policy. Moreover, literature indicates that police officers benefit from interventions targeting work-related stress and potential psychological disorders, if these interventions are continuous. Furthermore, larger controlled studies are required to further elucidate the benefits of psychosocial intervention in law enforcement.

Background: Limited evidence exists to support very early intensive aphasia rehabilitation. VERSE is a PROBE trial designed to determine whether two types of intensive aphasia therapy, beginning within 14 days of acute stroke, provide greater therapeutic and cost-effectiveness than usual care. Method(s): Participants with aphasia following acute stroke were recruited from 17 acute-care hospitals across Australia/New Zealand and randomised (stratified by aphasia severity) using a centralised computer-generated system to receive Usual Care (UC), Usual Care-Plus (UC+) (usual care plus 20 sessions of direct aphasia therapy) or VERSE therapy (usual care plus 20 sessions of a prescribed direct aphasia therapy). The sample size required for the primary outcome (20% greater score on the Aphasia Quotient (AQ) of the Western Aphasia Battery) at 12 weeks was 246 patients. Secondary outcomes included AQ, discourse, quality of life, and depression measures at 12 and 26 weeks. Cost evaluation will be reported separately. Result(s): 13,654 patients were screened; 25% had aphasia and of these 25% were trial eligible. 246 patients were recruited. Median scores were: NIHSS 9, mRS 4; 92% had an ischaemic stroke. Median age was 75 years, 50% were female. Baseline characteristics were equivalent for stroke and aphasia severity, age, gender and aetiology for UC (n=81), UC+(n=82) and VERSE (n=83). Eighty three percent of participants completed the trial and 'data-lock' occurred on 30/7/2018. Discussion(s): The VERSE trial was completed with high fidelity data. The overall results, to be reported in this paper, will influence future aphasia rehabilitation practice after acute stroke.

Background and Aims: Treatment fidelity is a complex evaluative process critical for achieving quality in intervention studies. Its objective is to determine whether an intervention was delivered as intended. Despite its benefits, treatment fidelity has been inconsistently reported in behavioural intervention studies with only 14% of aphasia treatment studies explicitly reporting on treatment fidelity. Complex interventions, such as those for post-stroke aphasia, pose particular challenges to fidelity monitoring. Method(s): The COMPARE study is an Australian-based 3-arm randomised controlled trial (planned sample size n=216) which aims to determine whether two intensive and contrasting treatments (constraint induced aphasia therapy; multi-modality aphasia therapy) 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 delivered 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): 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, which include (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 challenges of monitoring and enhancing treatment fidelity within behavioural change interventions. Our solution may be of utility to a wide range of trials of complex interventions.

Background: Limited evidence exists to support very early intensive aphasia rehabilitation after stroke. VERSE is a PROBE trial designed to determine whether two types of intensive aphasia therapy, beginning within 14 days of acute stroke, provide greater therapeutic and cost-effectiveness than usual care. Objective(s): To publish the detailed statistical analysis plan for the VERSE trial prior to unblinding. This statistical analysis plan was based on the published and registered VERSE trial protocol and was developed by the blinded steering committee and management team, led by the trial statistician. This plan was developed using outcome measures and trial data collection forms. Result(s): The VERSE statistical analysis plan is consistent with reporting standards for clinical trials and provides for clear and open reporting. Conclusion(s): Publication of a statistical analysis plan serves to reduce potential trial reporting bias and outlines transparent pre-specified analyses. Australian New Zealand Clinical Trials Registry (ANZCTR) Registration number: ACTRN12613000776707; Universal Trial Number (UTN) is U1111-1145-4130.Copyright © 2018 World Stroke Organization.