Comprehensive quality assessment for aphasia rehabilitation after stroke: protocol for a multicentre, mixed-methods study.

INTRODUCTION: People with aphasia following stroke experience disproportionally poor outcomes, yet there is no comprehensive approach to measuring the quality of aphasia services. The Meaningful Evaluation of Aphasia SeRvicES (MEASuRES) minimum dataset was developed in partnership with people with lived experience of aphasia, clinicians and researchers to address this gap. It comprises sociodemographic characteristics, quality indicators, treatment descriptors and outcome measurement instruments. We present a protocol to pilot the MEASuRES minimum dataset in clinical practice, describe the factors that hinder or support implementation and determine meaningful thresholds of clinical change for core outcome measurement instruments. METHODS AND ANALYSIS: This research aims to deliver a comprehensive quality assessment toolkit for poststroke aphasia services in four studies. A multicentre pilot study (study 1) will test the administration of the MEASuRES minimum dataset within five Australian health services. An embedded mixed-methods process evaluation (study 2) will evaluate the performance of the minimum dataset and explore its clinical applicability. A consensus study (study 3) will establish consumer-informed thresholds of meaningful change on core aphasia outcome constructs, which will then be used to establish minimal important change values for corresponding core outcome measurement instruments (study 4). ETHICS AND DISSEMINATION: Studies 1 and 2 have been registered with the Australian and New Zealand Clinical Trial Registry (ACTRN12623001313628). Ethics approval has been obtained from the Royal Brisbane and Women's Hospital (HREC/2023/MNHB/95293) and The University of Queensland (2022/HE001946 and 2023/HE001175). Study findings will be disseminated through peer-reviewed publications, conference presentations and engagement with relevant stakeholders including healthcare providers, policy-makers, stroke and rehabilitation audit and clinical quality registry custodians, consumer support organisations, and individuals with aphasia and their families.

High-Intensity Aphasia Therapy Is Cost-Effective in People With Poststroke Aphasia: Evidence From the COMPARE Trial.

BACKGROUND: Evidence from systematic reviews confirms that speech and language interventions for people with aphasia during the chronic phase after stroke (>6 months) improve word retrieval, functional communication, and communication-related quality of life. However, there is limited evidence of their cost-effectiveness. We aimed to estimate the cost per quality-adjusted life year gained from 2 speech and language therapies compared with usual care in people with aphasia during the chronic phase (median, 2.9 years) after stroke. METHODS: A 3-arm, randomized controlled trial compared constraint-induced aphasia therapy plus (CIAT-Plus) and multimodality aphasia therapy (M-MAT) with usual care in 216 people with chronic aphasia. Participants were administered a standardized questionnaire before intervention and at 12 weeks after the 2-week intervention/control period to ascertain health service utilization, employment changes, and informal caregiver burden. Unit prices from Australian sources were used to estimate costs in 2020. Quality-adjusted life years were estimated using responses to the EuroQol-5 Dimension-3 Level questionnaire. To test uncertainty around the differences in costs and outcomes between groups, bootstrapping was used with the cohorts resampled 1000 times. RESULTS: Overall 201/216 participants were included (mean age, 63 years, 29% moderate or severe aphasia, 61 usual care, 70 CIAT-Plus, 70 M-MAT). There were no statistically significant differences in mean total costs ($13 797 usual care, $17 478 CIAT-Plus, $11 113 M-MAT) and quality-adjusted life years (0.19 usual care, 0.20 CIAT-Plus, 0.20 M-MAT) between groups. In bootstrapped analysis of CIAT-Plus, 21.5% of iterations were likely to result in better outcomes and be cost saving (dominant) compared with usual care. In contrast, 72.4% of iterations were more favorable for M-MAT than usual care. CONCLUSIONS: We observed that both treatments, but especially M-MAT, may result in better outcomes at an acceptable additional cost, or potentially with cost savings. These findings are relevant in advocating for the use of these therapies for chronic aphasia after stroke.

The Excess Costs of Hospitalization for Acute Stroke in People With Communication Impairment: A Stroke123 Data Linkage Substudy.

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.

Healing Right Way: study protocol for a stepped wedge cluster randomised controlled trial to enhance rehabilitation services and improve quality of life in Aboriginal Australians after brain injury.

INTRODUCTION: Despite higher incidence of brain injury among Aboriginal compared with non-Aboriginal Australians, suboptimal engagement exists between rehabilitation services and Aboriginal brain injury survivors. Aboriginal patients often feel culturally insecure in hospital and navigation of services post discharge is complex. Health professionals report feeling ill-equipped working with Aboriginal patients. This study will test the impact of a research-informed culturally secure intervention model for Aboriginal people with brain injury. METHODS AND ANALYSIS: Design: Stepped wedge cluster randomised control trial design; intervention sequentially introduced at four pairs of healthcare sites across Western Australia at 26-week intervals.Recruitment: Aboriginal participants aged ≥18 years within 4 weeks of an acute stroke or traumatic brain injury.Intervention: (1) Cultural security training for hospital staff and (2) local, trial-specific, Aboriginal Brain Injury Coordinators supporting participants.Primary outcome: Quality-of-life using EuroQOL-5D-3L (European Quality of Life scale, five dimensions, three severity levels) Visual Analogue Scale score at 26 weeks post injury. Recruitment of 312 participants is estimated to detect a difference of 15 points with 80% power at the 5% significance level. A linear mixed model will be used to assess the between-condition difference.Secondary outcome measures: Modified Rankin Scale, Functional Independence Measure, Modified Caregiver Strain Index, Hospital Anxiety and Depression Scale at 12 and 26 weeks post injury, rehabilitation occasions of service received, hospital compliance with minimum care processes by 26 weeks post injury, acceptability of Intervention Package, feasibility of Aboriginal Brain Injury Coordinator role.Evaluations: An economic evaluation will determine the potential cost-effectiveness of the intervention. Process evaluation will document fidelity to study processes and capture changing contexts including barriers to intervention implementation and acceptability/feasibility of the intervention through participant questionnaires at 12 and 26 weeks. ETHICS AND DISSEMINATION: The study has approvals from Aboriginal, university and health services human research ethics committees. Findings will be disseminated through stakeholder reports, participant workshops, peer-reviewed journal articles and conference papers. TRIAL REGISTRATION NUMBER: ACTRN12618000139279.

Awareness and knowledge of developmental coordination disorder: A survey of caregivers, teachers, allied health professionals and medical professionals in Australia.

BACKGROUND: To allow for accurate and timely diagnosis of developmental coordination disorder (DCD) key stakeholders must be familiar with and be able to identify features of this disorder. No studies to date have investigated the awareness of DCD among key stakeholders in Australia. METHODS: An online survey was complete by 494 Australian participants: primary caregivers (n = 153), teachers (n = 149), allied health professionals (n = 165) and medical professionals (n = 27). RESULTS: DCD and related terms were among the least known childhood disorders. Approximately half of the sample were familiar with the term DCD but every stakeholder group were more familiar with the term dyspraxia. Allied health professionals demonstrated greater knowledge of the features of DCD, particularly motor features. Every stakeholder group showed poor recognition of the social and psychological effects of DCD. A relatively low percentage of allied health (53%) and medical (33%) professionals reported they had identified or diagnosed DCD and less than 20% of these felt that the DSM-5 contained adequate information to make a DCD diagnosis. Most teachers (82%) believed they should play a role in identifying early warning signs of this disorder, and 80% believed there are children in the school system who were labelled as lazy or defiant when they have motor skills impairments. Primary caregivers were supportive of a diagnosis of DCD being provided; however, only 16% were confident that a physician would provide an accurate and timely diagnosis. CONCLUSION: Key stakeholders play a unique and important role in the identification of children with DCD. Though most participants acknowledge the role that they play, all stakeholder groups demonstrated poor familiarity with the term DCD and low levels of knowledge about the features of this disorder. Improved familiarity and knowledge of the disorder is needed for access to appropriate services and improved long-term outcomes for this condition.

Constraint-induced or multi-modal personalized aphasia rehabilitation (COMPARE): A randomized controlled trial for stroke-related chronic aphasia.

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 α = 0.05. METHODS AND DESIGN: Prospective, randomized, parallel group, open-label, assessor blinded trial. Participants: 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: 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.

Statistical analysis plan (SAP) for the Very Early Rehabilitation in Speech (VERSE) after stroke trial: an international 3-arm clinical trial to determine the effectiveness of early, intensive, prescribed, direct aphasia therapy.

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 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. Results The VERSE statistical analysis plan is consistent with reporting standards for clinical trials and provides for clear and open reporting. Conclusions 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.

A randomized controlled trial of very early rehabilitation in speech after stroke.

RATIONALE: The efficacy of rehabilitation therapy for aphasia caused by stroke is uncertain. AIMS AND HYPOTHESIS: The Very Early Rehabilitation of Speech (VERSE) trial aims to determine if intensive prescribed aphasia therapy (VERSE) is more effective and cost saving than non-prescribed, intensive (usual care-plus) and non-intensive usual care (UC) therapy when started within 15 days of stroke onset and continued daily over four weeks. We hypothesize that aphasia therapy when started very early after stroke and delivered daily could enhance recovery of communication compared with UC. SAMPLE SIZE ESTIMATES: A total of 246 participants (82 per arm) will provide 80% power to detect a 4.4% improvement on aphasia quotient between VERSE and UC plus at a significance level of α = 0.05. SETTING: Acute-care hospitals and accompanying rehabilitation services throughout Australia, 2014-2017. DESIGN: Three-arm, prospective, randomized, parallel group, open-label, blinded endpoint assessment (PROBE) trial. PARTICIPANTS: Acute stroke in previous 14 days and aphasia diagnosed by aphasia quotient (AQ) of the Western Aphasia Battery (WAB). RANDOMIZATION: Computer-generated blocked randomization procedure stratified by aphasia severity according to Western Aphasia Battery, to one of three arms. INTERVENTION: All participants receive UC-usual ward-based aphasia therapy. Arm 1: UC-no additional therapy; Arm 2: UC-plus usual ward-based therapy; Arm 3: VERSE therapy-a prescribed and structured aphasia therapy program. Arms 2 and 3 receive a total of 20 additional sessions (45-60 min, provided daily) of aphasia therapy. The additional intervention must be provided before day 50 post stroke. STUDY OUTCOME MEASURES: The aphasia quotient of Western Aphasia Battery at 12 weeks post stroke. Secondary outcomes include discourse measures, the Stroke and Aphasia Quality of Life Scale-39 and the Aphasia Depression Rating Scale at 12 and 26 weeks. ECONOMIC EVALUATION: Incremental cost-effectiveness ratios at 26 weeks will be reported. DISCUSSION: This trial is designed to test whether the intensive and prescribed VERSE intervention is effective in promoting maximum recovery and preventing costly health complications in a vulnerable population of survivors of stroke. It will also provide novel, prospective, aphasia specific cost-effectiveness data to guide future policy development for this population.