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INTRODUCTION: Outcome measurement instruments (OMIs) are used to gauge the effects of treatment. In post-stroke aphasia rehabilitation, benchmarks for meaningful change are needed to support the interpretation of patient outcomes. This study is part of a research programme to establish minimal important change (MIC) values (the smallest change above which patients perceive themselves as importantly changed) for core OMIs. As a first step in this process, the views of people with aphasia and clinicians were explored, and consensus was sought on a threshold for clinically meaningful change. METHODS: Sequential mixed-methods design was employed. Participants included people with post-stroke aphasia and speech pathologists. People with aphasia were purposively sampled based on time post-stroke, age and gender, whereas speech pathologists were sampled according to their work setting (hospital or community). Each participant attended a focus group followed by a consensus workshop with a survey component. Within the focus groups, experiences and methods for measuring meaningful change during aphasia recovery were explored. Qualitative data were transcribed and analysed using reflexive thematic analysis. In the consensus workshop, participants voted on thresholds for meaningful change in core outcome constructs of language, communication, emotional well-being and quality of life, using a six-point rating scale (much worse, slightly worse, no change, slightly improved, much improved and completely recovered). Consensus was defined a priori as 70% agreement. Voting results were reported using descriptive statistics. RESULTS: Five people with aphasia (n = 4, > 6 months after stroke; n = 5, < 65 years; n = 3, males) and eight speech pathologists (n = 4, hospital setting; n = 4, community setting) participated in one of four focus groups (duration: 92-112 min). Four themes were identified describing meaningful change as follows: (1) different for every single person; (2) small continuous improvements; (3) measured by progress towards personally relevant goals; and (4) influenced by personal factors. 'Slightly improved' was agreed as the threshold of MIC on the anchor-rating scale (75%-92%) within 6 months of stroke, whereas after 6 months there was a trend towards supporting 'much improved' (36%-66%). CONCLUSION: Our mixed-methods research with people with aphasia and speech pathologists provides novel evidence to inform the definition of MIC in aphasia rehabilitation. Future research will aim to establish MIC values for core OMIs. PATIENT OR PUBLIC CONTRIBUTION: This work is the result of engagement between people with lived experience of post-stroke aphasia, including people with aphasia, family members, clinicians and researchers. Engagement across the research cycle was sought to ensure that the research tasks were acceptable and easily understood by participants and that the outcomes of the study were relevant to the aphasia community. This engagement included the co-development of a plain English summary of the results. Advisors were remunerated in accordance with Health Consumers Queensland guidelines. Interview guides for clinicians were piloted by speech pathologists working in aphasia rehabilitation.
Subject(s)
Aphasia , Benchmarking , Focus Groups , Stroke Rehabilitation , Humans , Aphasia/rehabilitation , Aphasia/psychology , Male , Female , Middle Aged , Aged , Quality of Life , Outcome Assessment, Health Care , Adult , Stroke/complications , Stroke/psychology , Qualitative Research , Surveys and QuestionnairesABSTRACT
BACKGROUND: Stroke affects long-term physical and cognitive function; many survivors report unmet health needs, such as pain or depression. A hospital-led follow-up service designed to address ongoing health problems may avoid unplanned readmissions and improve quality of life. METHODS: This paper outlines the protocol for a registry-based, randomised controlled trial with allocation concealment of participants and outcome assessors. Based on an intention-to-treat analysis, we will evaluate the feasibility, acceptability, potential effectiveness and cost implications of a new tailored, codesigned, hospital-led follow-up service for people within 6-12 months of stroke. Participants (n = 100) from the Australian Stroke Clinical Registry who report extreme health problems on the EuroQol EQ-5D-3L survey between 90 and 180 days after stroke will be randomly assigned (1:1) to intervention (follow-up service) or control (usual care) groups. All participants will be independently assessed at baseline and 12-14-week post-randomisation. Primary outcomes for feasibility are the proportion of participants completing the trial and for intervention participants the proportion that received follow-up services. Acceptability is satisfaction of clinicians and participants involved in the intervention. Secondary outcomes include effectiveness: change in extreme health problems (EQ-5D-3L), unmet needs (Longer-term Unmet Needs questionnaire), unplanned presentations and hospital readmission, functional independence (modified Rankin Scale) and cost implications estimated from self-reported health service utilisation and productivity (e.g. workforce participation). To inform future research or implementation, the design contains a process evaluation including clinical protocol fidelity and an economic evaluation. DISCUSSION: The results of this study will provide improved knowledge of service design and implementation barriers and facilitators and associated costs and resource implications to inform a future fully powered effectiveness trial of the intervention. TRIAL REGISTRATION: ACTRN12622001015730pr. TRIAL SPONSOR: Florey Institute of Neuroscience and Mental Health, 245 Burgundy Street, Heidelberg, VIC, 3084, PH: +61 3 9035 7032.
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OBJECTIVES: To estimate the long term cost savings, return on investment, and gain in quality-adjusted life years (QALYs) that could be achieved by a national anterior cruciate ligament (ACL) injury prevention program for amateur football (soccer) players in Australia. STUDY DESIGN: Markov model decision analysis. SETTING, PARTICIPANTS: Two hypothetical scenarios including all amateur football players in Australia (340 253 players): no intervention, and a national ACL injury prevention program. Transitions between health states, including ACL rupture, meniscal injury, knee osteoarthritis, and total knee replacement were made in one-year cycles over 35 years from a societal perspective. MAIN OUTCOME MEASURES: Cost savings, return on investment, and QALY gain achieved in the prevention program scenario relative to control scenario, by age group (10-17, 18-34, 35 years or older) and gender. SECONDARY OUTCOMES: incidence of ACL rupture, knee osteoarthritis, total knee replacement, and total knee replacement revision. RESULTS: The total mean cost of an ACL injury was estimated to be $30 665. The national injury prevention program was projected to save $52 539 751 in medical and societal costs caused by ACL ruptures in amateur footballers over 35 years; the estimated return on each dollar invested in the program was $3.51. Over this period, the number of players with ruptured ACLs could be reduced by 4385 (9%), the number of knee osteoarthritis cases by 780 (8.1%), and the number of total knee replacements by 121 (8.1%); 445 QALYs were gained. CONCLUSION: Our findings support investing in a national, evidence-based program for the primary prevention of ACL injuries in amateur football players.
Subject(s)
Anterior Cruciate Ligament Injuries , Markov Chains , Quality-Adjusted Life Years , Soccer , Humans , Anterior Cruciate Ligament Injuries/prevention & control , Australia/epidemiology , Soccer/injuries , Male , Adolescent , Adult , Female , Young Adult , Cost-Benefit Analysis , Child , Knee Injuries/prevention & control , Knee Injuries/economics , Osteoarthritis, Knee/prevention & control , Osteoarthritis, Knee/economicsABSTRACT
BACKGROUND: High-intensity therapy is recommended in current treatment guidelines for chronic poststroke aphasia. Yet, little is known about fatigue levels induced by treatment, which could interfere with rehabilitation outcomes. We analyzed fatigue experienced by people with chronic aphasia (>6 months) during high-dose interventions at 2 intensities. METHODS: A retrospective observational analysis was conducted on self-rated fatigue levels of people with chronic aphasia (N=173) collected during a previously published large randomized controlled trial of 2 treatments: constraint-induced aphasia therapy plus and multi-modality aphasia therapy. Interventions were administered at a higher intensity (30 hours over 2 weeks) or lower intensity (30 hours over 5 weeks). Participants rated their fatigue on an 11-point scale before and after each day of therapy. Data were analyzed using Bayesian ordinal multilevel models. Specifically, we considered changes in self-rated participant fatigue across a therapy day and over the intervention period. RESULTS: Data from 144 participants was analyzed. Participants were English speakers from Australia or New Zealand (mean age, 62 [range, 18-88] years) with 102 men and 42 women. Most had mild (n=115) or moderate (n=52) poststroke aphasia. Median ratings of the level of fatigue by people with aphasia were low (1 on a 0-10-point scale) at the beginning of the day. Ratings increased slightly (+1.0) each day after intervention, with marginally lower increases in the lower intensity schedule. There was no evidence of accumulating fatigue over the 2- or 5-week interventions. CONCLUSIONS: Findings suggest that intensive intervention was not associated with large increases in fatigue for people with chronic aphasia enrolled in the COMPARE trial (Constraint-Induced or Multimodality Personalised Aphasia Rehabilitation). Fatigue did not change across the course of the intervention. This study provides evidence that intensive treatment was minimally fatiguing for stroke survivors with chronic aphasia, suggesting that fatigue is not a barrier to high-intensity treatment.
Subject(s)
Aphasia , Fatigue , Humans , Aphasia/etiology , Aphasia/rehabilitation , Aphasia/therapy , Female , Male , Middle Aged , Aged , Fatigue/etiology , Fatigue/therapy , Adult , Aged, 80 and over , Retrospective Studies , Chronic Disease , Stroke/complications , Adolescent , Young Adult , Stroke Rehabilitation/methods , Self ReportSubject(s)
Hypertension , Social Media , Humans , Hypertension/diagnosis , Health Knowledge, Attitudes, Practice , Male , Female , Awareness , Middle AgedABSTRACT
INTRODUCTION: There is limited evidence about the management of cardiovascular risk factors within 12 months before stroke/transient ischaemic attack (TIA) in Australian general practices. We evaluated whether age and sex disparities in cardiovascular risk factor management for primary prevention exist in general practice. METHODS: A retrospective cohort study using data from the Australian Stroke Clinical Registry (2014-2018) linked with general practice data from three primary health networks in Victoria, Australia. We included adults who had ≥2 encounters with a general practitioner within 12 months immediately before the first stroke/TIA. Cardiovascular risk factor management within 12 months before stroke/TIA was evaluated in terms of: assessment of risk factors (blood pressure [BP], serum lipids, blood glucose, body weight); prescription of prevention medications (BP, lipid-, glucose-lowering, antithrombotic agents); and attainment of risk factor targets. RESULTS: Of 2,880 patients included (median age 76.5 years, 48.4% women), 80.9% were assessed for BP, 49.9% serum lipids, 46.8% blood glucose, and 39.3% body weight. Compared to patients aged 65-84 years, those aged <65 or ≥85 years were less often assessed for risk factors, with women aged ≥85 years assessed for significantly fewer risk factors than their male counterparts. The most prescribed prevention medications were BP-lowering (64.9%) and lipid-lowering agents (42.0%). There were significant sex differences among those aged <65 years (34.7% women vs. 40.2% men) and ≥85 years (34.0% women vs. 44.3% men) for lipid-lowering agents. Risk factor target attainment was generally poorer in men than women, especially among those aged <65 years. CONCLUSION: Age-sex disparity exists in risk factor management for primary prevention in general practice, and this was more pronounced among younger patients and older women.
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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.
Subject(s)
Aphasia , Stroke Rehabilitation , Stroke , Female , Humans , Pilot Projects , Quality of Life , Australia , Stroke/complications , Stroke/therapy , Aphasia/rehabilitation , Multicenter Studies as TopicABSTRACT
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 ($13â 797 usual care, $17â 478 CIAT-Plus, $11â 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.
Subject(s)
Aphasia , Stroke Rehabilitation , Stroke , Humans , Middle Aged , Cost-Benefit Analysis , Quality of Life , Treatment Outcome , Australia , Aphasia/etiology , Aphasia/therapy , Stroke/complications , Stroke/therapy , Language TherapyABSTRACT
INTRODUCTION: Evidence on the cost-effectiveness of comprehensive post-stroke programs is limited. We assessed the cost-effectiveness of an individualised management program (IMP) for stroke or transient ischaemic attack (TIA). METHODS: A cost-utility analysis alongside a randomised controlled trial with a 24-month follow-up, from both societal and health system perspectives, was conducted. Adults with stroke/TIA discharged from hospitals were randomised by primary care practice to receive either usual care (UC) or an IMP in addition to UC (intervention). An IMP included stroke-specific nurse-led education and a specialist review of care plans at baseline, 3 months, and 12 months, and telephone reviews by nurses at 6 months and 18 months. Costs were expressed in 2021 Australian dollars (AUD). Costs and quality-adjusted life years (QALYs) beyond 12 months were discounted by 5%. The probability of cost-effectiveness of the intervention was determined by quantifying 10,000 bootstrapped iterations of incremental costs and QALYs below the threshold of AUD 50,000/QALY. RESULTS: Among the 502 participants (65% male, median age 69 years), 251 (50%) were in the intervention group. From a health system perspective, the incremental cost per QALY gained was AUD 53,175 in the intervention compared to the UC group, and the intervention was cost-effective in 46.7% of iterations. From a societal perspective, the intervention was dominant in 52.7% of iterations, with mean per-person costs of AUD 49,045 and 1.352 QALYs compared to mean per-person costs of AUD 51,394 and 1.324 QALYs in the UC group. The probability of the cost-effectiveness of the intervention, from a societal perspective, was 60.5%. CONCLUSIONS: Care for people with stroke/TIA using an IMP was cost-effective from a societal perspective over 24 months. Economic evaluations of prevention programs need sufficient time horizons and consideration of costs beyond direct healthcare utilisation to demonstrate their value to society.
Subject(s)
Cost-Benefit Analysis , Quality-Adjusted Life Years , Stroke , Humans , Male , Female , Aged , Stroke/economics , Stroke/therapy , Middle Aged , Australia , Ischemic Attack, Transient/economics , Ischemic Attack, Transient/therapy , Aged, 80 and overABSTRACT
INTRODUCTION: Little is known about the cost-effectiveness of government policies that support primary care physicians to provide comprehensive chronic disease management (CDM). This paper aimed to estimate the potential cost-effectiveness of CDM policies over a lifetime for long-time survivors of stroke. METHODS: A Markov model, using three health states (stable, hospitalised, dead), was developed to simulate the costs and benefits of CDM policies over 30 years (with 1-year cycles). Transition probabilities and costs from a health system perspective were obtained from the linkage of data between the Australian Stroke Clinical Registry (cohort n = 12,368, 42% female, median age 70 years, 45% had CDM claims) and government-held hospital, Medicare, and pharmaceutical claims datasets. Quality-adjusted life years (QALYs) were obtained from a comparable cohort (n = 512, 34% female, median age 69.6 years, 52% had CDM claims) linked with Medicare claims and death data. A 3% discount rate was applied to costs in Australian dollars (AUD, 2016) and QALYs beyond 12 months. Probabilistic sensitivity analyses were used to understand uncertainty. RESULTS: Per-person average total lifetime costs were AUD 142,939 and 8.97 QALYs for those with a claim, and AUD 103,889 and 8.98 QALYs for those without a claim. This indicates that these CDM policies were costlier without improving QALYs. The probability of cost-effectiveness of CDM policies was 26.1%, at a willingness-to-pay threshold of AUD 50,000/QALY. CONCLUSION: CDM policies, designed to encourage comprehensive care, are unlikely to be cost-effective for stroke compared to care without CDM. Further research to understand how to deliver such care cost-effectively is needed.
Subject(s)
Cost-Benefit Analysis , Quality-Adjusted Life Years , Stroke , Humans , Female , Male , Stroke/economics , Stroke/therapy , Aged , Australia , Chronic Disease , Disease Management , Middle Aged , Markov Chains , Health Policy , Aged, 80 and overABSTRACT
BACKGROUND: Unplanned hospital presentations may occur post-stroke due to inadequate preparation for transitioning from hospital to home. The Recovery-focused Community support to Avoid readmissions and improve Participation after Stroke (ReCAPS) trial was designed to test the effectiveness of receiving a 12-week, self-management intervention, comprising personalised goal setting with a clinician and aligned educational/motivational electronic messages. Primary outcome is as follows: self-reported unplanned hospital presentations (emergency department/admission) within 90-day post-randomisation. We present the statistical analysis plan for this trial. METHODS/DESIGN: Participants are randomised 1:1 in variable block sizes, with stratification balancing by age and level of baseline disability. The sample size was 890 participants, calculated to detect a 10% absolute reduction in the proportion of participants reporting unplanned hospital presentations/admissions, with 80% power and 5% significance level (two sided). Recruitment will end in December 2023 when funding is expended, and the sample size achieved will be used. Logistic regression, adjusted for the stratification variables, will be used to determine the effectiveness of the intervention on the primary outcome. Secondary outcomes will be evaluated using appropriate regression models. The primary outcome analysis will be based on intention to treat. A p-value ≤ 0.05 will indicate statistical significance. An independent Data Safety and Monitoring Committee has routinely reviewed the progress and safety of the trial. CONCLUSIONS: This statistical analysis plan ensures transparency in reporting the trial outcomes. ReCAPS trial will provide novel evidence on the effectiveness of a digital health support package post-stroke. TRIAL REGISTRATION: ClinicalTrials.gov ACTRN12618001468213. Registered on August 31, 2018. SAP version 1.13 (October 12 2023) Protocol version 1.12 (October 12, 2022) SAP revisions Nil.
Subject(s)
Community Support , Stroke , Humans , Patient Readmission , Digital Health , Educational Status , ElectronicsABSTRACT
BACKGROUND: High-intensity Constraint-Induced Aphasia Therapy Plus (CIAT-Plus) and Multi-Modality Aphasia Therapy (M-MAT) are effective interventions for chronic post-stroke aphasia but challenging to provide in clinical practice. Providing these interventions may be more feasible at lower intensities, but comparative evidence is lacking. We therefore explored feasibility, acceptability, and preliminary efficacy of the treatments at a lower intensity. METHODS: A multisite, single-blinded, randomized Phase II trial was conducted within the Phase III COMPARE trial. Groups of participants with chronic aphasia from the usual care arm of the COMPARE trial were randomized to M-MAT or CIAT-Plus, delivered at the same dose as the COMPARE trial but at lower intensity (6 hours/week × 5 weeks rather than 15 hours/week × 2 weeks). Blinded assessors measured aphasia severity (Western Aphasia Battery-Revised Aphasia Quotient), word retrieval, connected speech, multimodal communication, functional communication, and quality of life immediately post interventions and after 12 weeks. Feasibility and acceptability were explored. RESULTS: Of 70 eligible participants, 77% consented to the trial; 78% of randomized participants completed intervention and 98% of assessment visits were conducted. Fatigue and distress ratings were low with no related withdrawals. Adverse events related to the trial (n = 4) were mild in severity. Statistically significant treatment effects were demonstrated on word retrieval and functional communication and both interventions were equally effective. CONCLUSIONS: Low-moderateintensity CIAT-Plus and M-MAT were feasible and acceptable. Both interventions show preliminary efficacy at a low-moderate intensity. These results support a powered trial investigating these interventions at a low-moderate intensity.
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Aphasia , Stroke Rehabilitation , Stroke , Humans , Stroke/complications , Stroke/therapy , Stroke Rehabilitation/methods , Feasibility Studies , Quality of Life , Language Therapy/methods , Treatment Outcome , Aphasia/etiology , Aphasia/therapy , Speech TherapyABSTRACT
BACKGROUND: Disparities in the availability of reperfusion services for acute ischemic stroke are considerable globally and require urgent attention. Contemporary data on the availability of reperfusion services in different countries are used to provide the necessary evidence to prioritize where access to acute stroke treatment is needed. AIMS: To provide a snapshot of published literature on the provision of reperfusion services globally, including when facilitated by telemedicine or mobile stroke unit services. METHODS: We searched PubMed to identify original articles, published up to January 2023 for the most recent, representative, and relevant patient-level data for each country. Keywords included thrombolysis, endovascular thrombectomy and telemedicine. We also screened reference lists of review articles, citation history of articles, and the gray literature. The information is provided as a narrative summary. RESULTS: Of 11,222 potentially eligible articles retrieved, 148 were included for review following de-duplications and full-text review. Data were also obtained from national stroke clinical registry reports, Registry of Stroke Care Quality (RES-Q) and PRE-hospital Stroke Treatment Organization (PRESTO) repositories, and other national sources. Overall, we found evidence of the provision of intravenous thrombolysis services in 70 countries (63% high-income countries (HICs)) and endovascular thrombectomy services in 33 countries (68% HICs), corresponding to far less than half of the countries in the world. Recent data (from 2019 or later) were lacking for 35 of 67 countries with known year of data (52%). We found published data on 74 different stroke telemedicine programs (93% in HICs) and 14 active mobile stroke unit pre-hospital ambulance services (80% in HICs) around the world. CONCLUSION: Despite remarkable advancements in reperfusion therapies for stroke, it is evident from available patient-level data that their availability remains unevenly distributed globally. Contemporary published data on availability of reperfusion services remain scarce, even in HICs, thereby making it difficult to reliably ascertain current gaps in the provision of this vital acute stroke treatment around the world.
Subject(s)
Ischemic Stroke , Stroke , Humans , Stroke/epidemiology , Stroke/therapy , Thrombectomy , Ambulances , ReperfusionABSTRACT
BACKGROUND: Information on the characteristics or long-term outcomes of people with communication support needs post-stroke is limited. We investigated associations between communication gains in rehabilitation and long-term outcomes (quality-of-life [EuroQOL-ED-3 L], mortality) by post-stroke communication support need status. METHODS: Retrospective cohort study using person-level linked data from the Australian Stroke Clinical Registry and the Australasian Rehabilitation Outcomes Centre (2014-2017). Communication support needs were assessed using the Functional Independence Measure™ comprehension and expression items recorded on admission indicated by scores one (total assistance) to five (standby prompting). Multivariable multilevel and Cox regression models were used to determine associations with long-term outcomes. RESULTS: Of 8,394 patients who received in-patient rehabilitation after stroke (42% female, median age 75.6 years), two-thirds had post-stroke communication support needs. Having aphasia (odds ratio [OR] 4.34, 95% CI 3.67-5.14), being aged ≥65 years (OR 1.21, 95% CI 1.08-1.36), greater stroke severity (unable to walk on admission; OR 1.48, 95% CI 1.32-1.68) and previous stroke (OR 1.25, 95% CI 1.11-1.41) were associated with increased likelihoods of having communication support needs. One-point improvement in FIM™ expression was associated with reduced likelihood of self-reporting problems related to mobility (OR 0.85, 95% CI: 0.80-0.90), self-care (OR 0.79, 95% CI: 0.74-0.86) or usual activities (OR 0.84, 95% CI: 0.75-0.94) at 90-180 days. Patients with communication support needs had greater mortality rates within one-year post-stroke (adjusted hazard ratio 1.99, 95% CI: 1.65-2.39). CONCLUSIONS: Two-thirds of patients with stroke require communication support to participate in healthcare activities. Establishing communication-accessible stroke care environments is a priority.
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Stroke Rehabilitation , Stroke , Humans , Female , Aged , Male , Stroke/complications , Stroke/therapy , Retrospective Studies , Semantic Web , Australia , CommunicationABSTRACT
INTRODUCTION: Survivors of stroke are at risk of experiencing subsequent major adverse cardiovascular events (MACE). We aimed to determine the incidence of, and risk factors for, MACE after first-ever ischemic stroke, by age group (18-64 years vs. ≥65 years). METHODS: Observational cohort study using patient-level data from the Australian Stroke Clinical Registry (2009-2013), linked with hospital administrative data. We included adults with first-ever ischemic stroke who had no previous acute cardiovascular admissions and followed these patients for 2 years post-discharge, or until the first post-stroke MACE event. A Fine-Gray sub-distribution hazard model, accounting for the competing risk of non-cardiovascular death, was used to determine factors for incident post-stroke MACE. RESULTS: Among 5,994 patients with a first-ever ischemic stroke (median age 73 years, 45% female), 17% were admitted for MACE within 2 years (129 events per 1,000 person-years). The median time to first post-stroke MACE was 117 days (89 days if aged <65 years vs. 126 days if aged ≥65 years; p = 0.025). Among patients aged 18-64 years, receiving intravenous thrombolysis (sub-distribution hazard ratio [SHR] 0.51 [95% CI, 0.28-0.92]) or being discharged to inpatient rehabilitation (SHR 0.65 [95% CI, 0.46-0.92]) were associated with a reduced incidence of post-stroke MACE. In those aged ≥65 years, being unable to walk on admission (SHR 1.33 [95% CI 1.15-1.54]), and history of smoking (SHR 1.40 [95% CI 1.14-1.71]) or atrial fibrillation (SHR 1.31 [95% CI 1.14-1.51]) were associated with an increased incidence of post-stroke MACE. Acute management in a large hospital (>300 beds) for the initial stroke event was associated with reduced incidence of post-stroke MACE, irrespective of age group. CONCLUSIONS: MACE is common within 2 years of stroke, with most events occurring within the first year. We have identified important factors to consider when designing interventions to prevent MACE after stroke, particularly among those aged <65 years.
Subject(s)
Ischemic Stroke , Stroke , Aged , Female , Humans , Male , Aftercare , Australia/epidemiology , Ischemic Stroke/epidemiology , Patient Discharge , Registries , Risk Factors , Stroke/complicationsABSTRACT
Implementation of evidence-informed rehabilitation of the upper limb is variable, and outcomes for stroke survivors are often suboptimal. We established a national partnership of clinicians, survivors of stroke, researchers, healthcare organizations, and policy makers to facilitate change. The objectives of this study are to increase access to best-evidence rehabilitation of the upper limb and improve outcomes for stroke survivors. This prospective pragmatic, knowledge translation study involves four new specialist therapy centers to deliver best-evidence upper-limb sensory rehabilitation (known as SENSe therapy) for survivors of stroke in the community. A knowledge-transfer intervention will be used to upskill therapists and guide implementation. Specialist centers will deliver SENSe therapy, an effective and recommended therapy, to stroke survivors in the community. Outcomes include number of successful deliveries of SENSe therapy by credentialled therapists; improved somatosensory function for stroke survivors; improved performance in self-selected activities, arm use, and quality of life; treatment fidelity and confidence to deliver therapy; and for future implementation, expert therapist effect and cost-effectiveness. In summary, we will determine the effect of a national partnership to increase access to evidence-based upper-limb sensory rehabilitation following stroke. If effective, this knowledge-transfer intervention could be used to optimize the delivery of other complex, evidence-based rehabilitation interventions.
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Aim: To describe the Heart Matters (HM) trial which aims to evaluate the effectiveness of a community heart attack education intervention in high-risk areas in Victoria, Australia. These local government areas (LGAs) have high rates of acute coronary syndrome (ACS), out-of-hospital cardiac arrest (OHCA), cardiovascular risk factors, and low rates of emergency medical service (EMS) use for ACS. Methods: The trial follows a stepped-wedge cluster randomised design, with eight clusters (high-risk LGAs) randomly assigned to transition from control to intervention every four months. Two pairs of LGAs will transition simultaneously due to their proximity. The intervention consists of a heart attack education program delivered by trained HM Coordinators, with additional support from opportunistic media and a geo-targeted social media campaign. The primary outcome measure is the proportion of residents from the eight LGAs who present to emergency departments by EMS during an ACS event. Secondary outcomes include prehospital delay time, rates of OHCA and heart attack awareness. The primary and secondary outcomes will be analysed at the patient/participant level using mixed-effects logistic regression models. A detailed program evaluation is also being conducted. The trial was registered on August 9, 2021 (NCT04995900). Results: The intervention was implemented between February 2022 and March 2023, and outcome data will be collected from administrative databases, registries, and surveys. Primary trial data is expected to be locked for analysis by October 31st 2023, with a follow-up planned until March 31st 2024. Conclusion: The results from this trial will provide high-level evidence the effectiveness of a community education intervention targeting regions at highest-risk of ACS and low EMS use.
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Background: Governments are investing in primary care policies that support chronic disease management. Large scale population-based evaluations are lacking. We aim to determine the effectiveness of government-funded chronic disease management policies to improve long-term outcomes (survival, hospital presentations, and preventive medication adherence) following stroke/Transient Ischemic Attack (TIA). Methods: Using a population-based cohort we utilized the target trial methodology. Participants were identified through the Australian Stroke Clinical Registry (January 2012-December 2016) from 42 hospitals in the states of Victoria and Queensland and linked with state and national hospital, primary care, pharmaceutical, aged care, and death datasets. Registrants living in the community, not receiving palliative care and who survived to 18 months following stroke/TIA were included. The comparison was a Medicare claim for policy-supported chronic disease management, 7-18 months following stroke/TIA versus usual care. Outcomes were modelled using multi-level, mixed-effects inverse probability of treatment weighted regression. Findings: 12,368 registrants were eligible (42% female, median age 70 years, 26% TIA), 45% had a chronic disease management claim. The difference in mean outcomes for participants with a claim, compared to those without, showed a 26% lesser mortality rate (adjusted hazard ratio [aHR]: 0.74, 95% confidence interval [CI]: 0.62, 0.87) and a greater adjusted Odds Ratio [aOR] of being adherent with preventive medications: antithrombotics (aOR: 1.16, 95% CI: 1.07, 1.26); lipid-lowering (aOR: 1.23, 95% CI: 1.13, 1.33). Impacts on hospital presentations were variable. Interpretation: Government policies that financially support primary care physicians to provide structured chronic disease management improve survival in the long-term following stroke/TIA. Funding: National Health and Medical Research Council Australia.
ABSTRACT
Importance: Symptomatic intracranial hemorrhage (sICH) is a serious complication of stroke thrombolytic therapy. Many stroke centers have adopted 0.25-mg/kg tenecteplase instead of alteplase for stroke thrombolysis based on evidence from randomized comparisons to alteplase as well as for its practical advantages. There have been no significant differences in symptomatic intracranial hemorrhage (sICH) reported from randomized clinical trials or published case series for the 0.25-mg/Kg dose. Objective: To assess the risk of sICH following ischemic stroke in patients treated with tenecteplase compared to those treated with alteplase. Design, Setting, and Participants: This was a retrospective observational study using data from the large multicenter international Comparative Effectiveness of Routine Tenecteplase vs Alteplase in Acute Ischemic Stroke (CERTAIN) collaboration comprising deidentified data on patients with ischemic stroke treated with intravenous thrombolysis. Data from more than 100 hospitals in New Zealand, Australia, and the US that used alteplase or tenecteplase for patients treated between July 1, 2018, and June 30, 2021, were included for analysis. Participating centers included a mix of nonthrombectomy- and thrombectomy-capacity comprehensive stroke centers. Standardized data were abstracted and harmonized from local or regional clinical registries. Consecutive patients with acute ischemic stroke who were considered eligible and received thrombolysis at the participating stroke registries during the study period were included. All 9238 patients who received thrombolysis were included in this retrospective analysis. Main Outcomes and Measures: sICH was defined as clinical worsening of at least 4 points on the National Institutes of Health Stroke Scale (NIHSS), attributed to parenchymal hematoma, subarachnoid, or intraventricular hemorrhage. Differences between tenecteplase and alteplase in the risk of sICH were assessed using logistic regression, adjusted for age, sex, NIHSS score, and thrombectomy. Results: Of the 9238 patients included in the analysis, the median (IQR) age was 71 (59-80) years, and 4449 patients (48%) were female. Tenecteplase was administered to 1925 patients. The tenecteplase group was older (median [IQR], 73 [61-81] years vs 70 [58-80] years; P < .001), more likely to be male (1034 of 7313 [54%] vs 3755 of 1925 [51%]; P < .01), had higher NIHSS scores (median [IQR], 9 [5-17] vs 7 [4-14]; P < .001), and more frequently underwent endovascular thrombectomy (38% vs 20%; P < .001). The proportion of patients with sICH was 1.8% for tenecteplase and 3.6% for alteplase (P < .001), with an adjusted odds ratio (aOR) of 0.42 (95% CI, 0.30-0.58; P < .01). Similar results were observed in both thrombectomy and nonthrombectomy subgroups. Conclusions and Relevance: In this large study, ischemic stroke treatment with 0.25-mg/kg tenecteplase was associated with lower odds of sICH than treatment with alteplase. The results provide evidence supporting the safety of tenecteplase for stroke thrombolysis in real-world clinical practice.
Subject(s)
Brain Ischemia , Ischemic Stroke , Stroke , Humans , Male , Female , Aged , Aged, 80 and over , Tissue Plasminogen Activator/therapeutic use , Tenecteplase/therapeutic use , Ischemic Stroke/drug therapy , Retrospective Studies , Brain Ischemia/drug therapy , Brain Ischemia/complications , Fibrinolytic Agents , Stroke/drug therapy , Stroke/complications , Intracranial Hemorrhages/etiology , Intracranial Hemorrhages/chemically induced , Treatment OutcomeABSTRACT
BACKGROUND: National organisational surveys and clinical audits to monitor and guide improvements to the delivery of evidence-based acute stroke care have been undertaken in Australia since 1999. This study aimed to determine the association between repeated national audit cycles on stroke service provision and care delivery from 1999 to 2019. METHODS: Cross-sectional study using data from organisational surveys (1999, 2004, 2007-2019) and clinical data from the biennial National Stroke Acute Audit (2007-2019). Age-, sex-, and stroke severity-adjusted proportions were reported for adherence to guideline-recommended care processes. Multivariable, logistic regression models were performed to determine the association between repeated audit cycles and service provision (organisational) and care delivery (clinical). RESULTS: Overall, 197 hospitals provided organisational survey data (1999-2019), with 24,996 clinical cases from 136 hospitals (around 40 cases per audit) (2007-2019). We found significant improvements in service organisation between 1999 and 2019 for access to stroke units (1999: 42%, 2019: 81%), thrombolysis services (1999: 6%, 2019: 85%), and rapid assessment/management for patients with transient ischaemic attack (1999: 11%, 2019: 61%). Analyses of patient-level audits for 2007 to 2019 found the odds of receiving care processes per audit cycle to have significantly increased for thrombolysis (2007: 3%, 2019: 11%; OR 1.15, 95% CI 1.13, 1.17), stroke unit access (2007: 52%, 2019: 69%; OR 1.15, 95% CI 1.14, 1.17), risk factor advice (2007: 40%, 2019: 63%; OR 1.10, 95% CI 1.09, 1.12), and carer training (2007: 24%, 2019: 51%; OR 1.12, 95% CI 1.10, 1.15). CONCLUSIONS: Between 1999 and 2019, the quality of acute stroke care in Australia has improved in line with best practice evidence. Standardised monitoring of stroke care can inform targeted efforts to reduce identified gaps in best practice, and illustrate the evolution of the health system for stroke.