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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.
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Afasia , Benchmarking , Grupos Focales , Rehabilitación de Accidente Cerebrovascular , Humanos , Afasia/rehabilitación , Afasia/psicología , Masculino , Femenino , Persona de Mediana Edad , Anciano , Calidad de Vida , Evaluación de Resultado en la Atención de Salud , Adulto , Accidente Cerebrovascular/complicaciones , Accidente Cerebrovascular/psicología , Investigación Cualitativa , Encuestas y CuestionariosRESUMEN
BACKGROUND: Few individuals (<2%) who experience a stroke or transient ischemic attack (TIA) participate in secondary prevention lifestyle programs. Novel approaches that leverage digital health technology may provide a viable alternative to traditional interventions that support secondary prevention in people living with stroke or TIA. To be successful, these strategies should focus on user needs and preferences and be acceptable to clinicians and people living with stroke or TIA. OBJECTIVE: This study aims to co-design, with people with lived experience of stroke or TIA (referred to as consumers) and clinicians, a multicomponent digital technology support program for secondary prevention of stroke. METHODS: A consumer user needs survey (108 items) was distributed through the Australian Stroke Clinical Registry and the Stroke Association of Victoria. An invitation to a user needs survey (135 items) for clinicians was circulated via web-based professional forums and national organizations (eg, the Stroke Telehealth Community of Practice Microsoft Teams Channel) and the authors' research networks using Twitter (subsequently rebranded X, X Corp) and LinkedIn (LinkedIn Corp). Following the surveys, 2 rounds of user experience workshops (design and usability testing workshops) were completed with representatives from each end user group (consumers and clinicians). Feedback gathered after each round informed the final design of the digital health program. RESULTS: Overall, 112 consumers (male individuals: n=63, 56.3%) and 54 clinicians (female individuals: n=43, 80%) responded to the survey; all items were completed by 75.8% (n=85) of consumers and 78% (n=42) of clinicians. Most clinicians (46/49, 94%) indicated the importance of monitoring health and lifestyle measures more frequently than current practice, particularly physical activity, weight, and sleep. Most consumers (87/96, 90%) and clinicians (41/49, 84%) agreed that providing alerts about potential deterioration in an individual's condition were important functions for a digital program. Intention to use a digital program for stroke prevention and discussing the data collected during face-to-face consultations was high (consumers: 79/99, 80%; clinicians 36/42, 86%). In addition, 7 consumers (male individuals: n=5, 71%) and 9 clinicians (female individuals: n=6, 67%) took part in the user experience workshops. Participants endorsed using a digital health program to help consumers manage stroke or TIA and discussed preferred functions and health measures in a digital solution for secondary prevention of stroke. They also noted the need for a mobile app that is easy to use. Clinician feedback highlighted the need for a customizable clinician portal that captures individual consumer goals. CONCLUSIONS: Following an iterative co-design process, supported by evidence from user needs surveys and user experience workshops, a consumer-facing app that integrates wearable activity trackers and a clinician web portal were designed and developed to support secondary prevention of stroke. Feasibility testing is currently in progress to assess acceptability and use.
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Ataque Isquémico Transitorio , Prevención Secundaria , Accidente Cerebrovascular , Humanos , Ataque Isquémico Transitorio/prevención & control , Prevención Secundaria/métodos , Accidente Cerebrovascular/prevención & control , Femenino , Masculino , Tecnología Digital , Telemedicina , Persona de Mediana Edad , Anciano , Encuestas y Cuestionarios , Australia , Tecnología Biomédica/métodos , Salud DigitalRESUMEN
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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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.
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Afasia , Fatiga , Humanos , Afasia/etiología , Afasia/rehabilitación , Afasia/terapia , Femenino , Masculino , Persona de Mediana Edad , Anciano , Fatiga/etiología , Fatiga/terapia , Adulto , Anciano de 80 o más Años , Estudios Retrospectivos , Enfermedad Crónica , Accidente Cerebrovascular/complicaciones , Adolescente , Adulto Joven , Rehabilitación de Accidente Cerebrovascular/métodos , AutoinformeRESUMEN
BACKGROUND: In the context of expanding digital health tools, the health system is ready for Learning Health System (LHS) models. These models, with proper governance and stakeholder engagement, enable the integration of digital infrastructure to provide feedback to all relevant parties including clinicians and consumers on performance against best practice standards, as well as fostering innovation and aligning healthcare with patient needs. The LHS literature primarily includes opinion or consensus-based frameworks and lacks validation or evidence of benefit. Our aim was to outline a rigorously codesigned, evidence-based LHS framework and present a national case study of an LHS-aligned national stroke program that has delivered clinical benefit. MAIN TEXT: Current core components of a LHS involve capturing evidence from communities and stakeholders (quadrant 1), integrating evidence from research findings (quadrant 2), leveraging evidence from data and practice (quadrant 3), and generating evidence from implementation (quadrant 4) for iterative system-level improvement. The Australian Stroke program was selected as the case study as it provides an exemplar of how an iterative LHS works in practice at a national level encompassing and integrating evidence from all four LHS quadrants. Using this case study, we demonstrate how to apply evidence-based processes to healthcare improvement and embed real-world research for optimising healthcare improvement. We emphasize the transition from research as an endpoint, to research as an enabler and a solution for impact in healthcare improvement. CONCLUSIONS: The Australian Stroke program has nationally improved stroke care since 2007, showcasing the value of integrated LHS-aligned approaches for tangible impact on outcomes. This LHS case study is a practical example for other health conditions and settings to follow suit.
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Aprendizaje del Sistema de Salud , Accidente Cerebrovascular , Humanos , Accidente Cerebrovascular/terapia , Australia , Medicina Basada en la Evidencia , Práctica Clínica Basada en la Evidencia/métodosRESUMEN
INTRODUCTION: Dysphagia (i.e., disordered swallowing) is a consequence of stroke. Existing literature on the marginal cost of dysphagia after stroke is limited and ignores long-term impacts. Our aim was to determine the marginal 12-month cost attributable to dysphagia, including health-related quality of life (HRQoL) impacts, among patients hospitalised with stroke in New Zealand. METHODS: Secondary analysis of observational data from the REGIONS Care study, a national study from New Zealand of consecutively hospitalised patients with acute stroke between May 1, 2018, and October 30, 2018, including an outcome survey at 12 months among those who provided consent. Patients were identified as dysphagic if they received a swallow screen in hospital resulting in a speech language therapist review. Patients that required a nasogastric feeding tube in hospital were classified as "severe." Optimal linear propensity score matching was utilised to provide a group of patients to compare with stroke and dysphagia. All costs were converted to 2021NZD. RESULTS: Overall, of the 2,379 patients in the REGIONS cohort (51% male, median age: 78), 40% (944/2,379) were dysphagic (52% male, median age: 78), and 5% (111/2,379) were classified as severely dysphagic. Within 12 months of hospital discharge, dysphagia reduced HRQoL overall by 0.06 index points (95% CI: 0.028-0.100), and severe dysphagia by 0.12 index points (95% CI: 0.03-0.20). The estimated marginal 12-month cost attributable to stroke-related dysphagia was NZD 24,200 on average per patient. This estimate includes the additional hospitalisation costs (NZD 16,100), community rehabilitation services (NZD 570), hospital level aged residential care (NZD 4,030), and reduced HRQoL (NZD 3,470) over a 12-month period post-hospital discharge. The overall total marginal cost for those with severe dysphagia was NZD 34,000 per patient. CONCLUSION: We report cost estimates to 12 months from a national perspective on the additional costs and HRQoL outcomes of dysphagia for people hospitalised with stroke in New Zealand. Findings provide a novel contribution internationally since few prior studies have extended beyond the acute hospital phase of care. By quantifying the economic burden, we provide information to decision makers to improve dysphagia management strategies and ultimately enhance the overall HRQoL for people with stroke and dysphagia.
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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.
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Afasia , Rehabilitación de Accidente Cerebrovascular , Accidente Cerebrovascular , Femenino , Humanos , Proyectos Piloto , Calidad de Vida , Australia , Accidente Cerebrovascular/complicaciones , Accidente Cerebrovascular/terapia , Afasia/rehabilitación , Estudios Multicéntricos como AsuntoRESUMEN
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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OBJECTIVE: Post-stroke mental health impairments are common, but under-assessed and under-treated. We aim to describe trends in the provision of mood management to patients with stroke, and describe factors associated with adoption of national mood management recommendations for stroke within Australian hospitals. DESIGN: Secondary analysis of cross-sectional data from the biennial Stroke Foundation Audit Program. SETTING: Participating acute (2011-2021) and rehabilitation hospitals (2012-2020) in Australia. PARTICIPANTS: In the acute audit, 22,937 stroke cases were included from 133 hospitals. In the rehabilitation audit, 15,891 stroke cases were included from 127 hospitals. MAIN MEASURES: Hospital- and patient-level mood management processes. RESULTS: Among 133 acute hospitals (22,937 stroke episodes), improvements were made between 2011 and 2021 in utilization of mood screening (17% [2011], 33% [2021]; p < 0.001) and access to psychologists during hospital stay (18% [2011], 45% [2021]; p < 0.001). There was no change in access to a psychologist among those with a mood impairment (p = 0.34). Among 127 rehabilitation hospitals (15,891 stroke episodes) improvements were observed for mood screening (35% [2012], 61% [2020]; p < 0.001), and access to a psychologist during hospital stay (38% [2012], 68% [2020]; p < 0.001) and among those with a mood-impairment (30% [2012], 50% [2020]; p < 0.001). Factors associated with receiving mood management processes included: younger age, not requiring an interpreter and longer length of stay. CONCLUSIONS: Adherence to mood management recommendations has improved over 10 years within Australian hospitals. Those aged over 65, requiring an interpreter, or with shorter hospital stays are at risk of missing out on appropriate mood management.
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Hospitales de Rehabilitación , Trastornos del Humor , Rehabilitación de Accidente Cerebrovascular , Accidente Cerebrovascular , Humanos , Australia , Masculino , Femenino , Estudios Transversales , Accidente Cerebrovascular/complicaciones , Anciano , Persona de Mediana Edad , Trastornos del Humor/etiología , Trastornos del Humor/rehabilitación , Trastornos del Humor/terapia , Accesibilidad a los Servicios de Salud , Pacientes Internos , Anciano de 80 o más AñosRESUMEN
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.
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Afasia , Rehabilitación de Accidente Cerebrovascular , Accidente Cerebrovascular , Humanos , Persona de Mediana Edad , Análisis Costo-Beneficio , Calidad de Vida , Resultado del Tratamiento , Australia , Afasia/etiología , Afasia/terapia , Accidente Cerebrovascular/complicaciones , Accidente Cerebrovascular/terapia , Terapia del LenguajeRESUMEN
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.
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Análisis Costo-Beneficio , Años de Vida Ajustados por Calidad de Vida , Accidente Cerebrovascular , Humanos , Masculino , Femenino , Anciano , Accidente Cerebrovascular/economía , Accidente Cerebrovascular/terapia , Persona de Mediana Edad , Australia , Ataque Isquémico Transitorio/economía , Ataque Isquémico Transitorio/terapia , Anciano de 80 o más AñosRESUMEN
BACKGROUND: Variation in hospital stroke care is problematic. The Quality in Acute Stroke (QASC) Australia trial demonstrated reductions in death and disability through supported implementation of nurse-led, evidence-based protocols to manage fever, hyperglycaemia (sugar) and swallowing (FeSS Protocols) following stroke. Subsequently, a pre-test/post-test study was conducted in acute stroke wards in 64 hospitals in 17 European countries to evaluate upscale of the FeSS Protocols. Implementation across countries was underpinned by a cascading facilitation framework of multi-stakeholder support involving academic partners and a not-for-profit health organisation, the Angels Initiative (the industry partner), that operates to promote evidence-based treatments in stroke centres. .We report here an a priori qualitative process evaluation undertaken to identify factors that influenced international implementation of the FeSS Protocols using a cascading facilitation framework. METHODS: The sampling frame for interviews was: (1) Executives/Steering Committee members, consisting of academics, the Angels Initiative and senior project team, (2) Angel Team leaders (managers of Angel Consultants), (3) Angel Consultants (responsible for assisting facilitation of FeSS Protocols into multiple hospitals) and (4) Country Co-ordinators (senior stroke nurses with country and hospital-level responsibilities for facilitating the introduction of the FeSS Protocols). A semi-structured interview elicited participant views on the factorsthat influenced engagement of stakeholders with the project and preparation for and implementation of the FeSS Protocol upscale. Interviews were recorded, transcribed verbatim and analysed inductively within NVivo. RESULTS: Individual (n = 13) and three group interviews (3 participants in each group) were undertaken. Three main themes with sub-themes were identified that represented key factors influencing upscale: (1) readiness for change (sub-themes: negotiating expectations; intervention feasible and acceptable; shared goal of evidence-based stroke management); (2) roles and relationships (sub-themes: defining and establishing roles; harnessing nurse champions) and (3) managing multiple changes (sub-themes: accommodating and responding to variation; more than clinical change; multi-layered communication framework). CONCLUSION: A cascading facilitation model involving a partnership between evidence producers (academic partners), knowledge brokers (industry partner, Angels Initiative) and evidence adopters (stroke clinicians) overcame multiple challenges involved in international evidence translation. Capacity to manage, negotiate and adapt to multi-level changes and strategic engagement of different stakeholders supported adoption of nurse-initiated stroke protocols within Europe. This model has promise for other large-scale evidence translation programs.
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Trastornos de Deglución , Accidente Cerebrovascular , Humanos , Calidad de la Atención de Salud , Australia , Hospitales , Accidente Cerebrovascular/terapiaRESUMEN
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.
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Apoyo Comunitario , Accidente Cerebrovascular , Humanos , Readmisión del Paciente , Salud Digital , Escolaridad , ElectrónicaRESUMEN
PURPOSE: To map and summarise available literature on the effectiveness or other benefits of group- and individual-based interventions provided for adults living with stroke or ischaemic heart disease (IHD) in the community. MATERIAL AND METHODS: The review was conducted based on JBI methodology and reported using Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews. Articles were retrieved from: Medline, PsychInfo, Embase, Scopus, and CINAHL from 2002-2022. Extracted data from eligible studies included type of health outcomes (e.g., impairments), retention and adherence, social connectedness, and the costs associated with group- and individual-based interventions. RESULTS: After screening, five articles (representing 4 unique studies) comparing a group- and individual-based intervention were included (total sample size n = 87). Three types of interventions were assessed: exercise (3/5), communication (1/5), and occupational therapy (1/5). Effectiveness of group- and individual-based interventions at improving health outcomes (i.e. physical ability, communication, motivation, and quality of life) is unclear. Currently there is insufficient evidence to guide clinical practice. CONCLUSIONS: There is limited evidence comparing interventions delivered in a group and individual modality for adults living with stroke or IHD. Adequately powered studies are needed to determine if mode of delivery is equivalent or more cost effective.
Rehabilitation interventions can be offered individually or in group settings with clinicians choosing the most appropriate modality.Both group- and individual-based interventions have advantages and disadvantages, with clinical, practical, and economic factors as important considerations when deciding between the two modalities.Based on this scoping review, the authors conclude that there is currently insufficient evidence to guide clinical practice in deciding which mode of delivery (group or individual) is optimal.There is insufficient research evidence to guide clinicians in their choice between offering rehabilitation interventions for stroke or IHD in groups or individually.
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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.
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Análisis Costo-Beneficio , Años de Vida Ajustados por Calidad de Vida , Accidente Cerebrovascular , Humanos , Femenino , Masculino , Accidente Cerebrovascular/economía , Accidente Cerebrovascular/terapia , Anciano , Australia , Enfermedad Crónica , Manejo de la Enfermedad , Persona de Mediana Edad , Cadenas de Markov , Política de Salud , Anciano de 80 o más AñosRESUMEN
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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Afasia , Rehabilitación de Accidente Cerebrovascular , Accidente Cerebrovascular , Humanos , Accidente Cerebrovascular/complicaciones , Accidente Cerebrovascular/terapia , Rehabilitación de Accidente Cerebrovascular/métodos , Estudios de Factibilidad , Calidad de Vida , Terapia del Lenguaje/métodos , Resultado del Tratamiento , Afasia/etiología , Afasia/terapia , LogopediaRESUMEN
RATIONALE: Delivering optimal patient health care requires interdisciplinary clinician communication. A single communication tool across multiple pre-hospital and hospital settings, and between hospital departments is a novel solution to current systems. Fit-for-purpose, secure smartphone applications allow clinical information to be shared quickly between health providers. Little is known as to what underpins their successful implementation in an emergency care context. AIMS: To identify (a) whether implementing a single, digital health communication application across multiple health care organisations and hospital departments is feasible; (b) the barriers and facilitators to implementation; and (c) which factors are associated with clinicians' intentions to use the technology. METHODS: We used a multimethod design, evaluating the implementation of a secure, digital communication application (Pulsara™). The technology was trialled in two Australian regional hospitals and 25 Ambulance Victoria branches (AV). Post-training, clinicians involved in treating patients with suspected stroke or cardiac events were administered surveys measuring perceived organisational readiness (Organisational Readiness for Implementing Change), clinicians' intentions (Unified Theory of Acceptance and Use of Technology) and internal motivations (Self-Determination Theory) to use Pulsara™, and the perceived benefits and barriers of use. Quantitative data were descriptively summarised with multivariable associations between factors and intentions to use Pulsara™ examined with linear regression. Qualitative data responses were subjected to directed content analysis (two coders). RESULTS: Participants were paramedics (n = 82, median 44 years) or hospital-based clinicians (n = 90, median 37 years), with organisations perceived to be similarly ready. Regression results (F(11, 136) = 21.28, p = <0.001, Adj R2 = 0.60) indicated Habit, Effort Expectancy, Perceived Organisational Readiness, Performance Expectancy and Organisation membership (AV) as predictors of intending to use Pulsara™. Themes relating to benefits (95% coder agreement) included improved communication, procedural efficiencies and faster patient care. Barriers (92% coder agreement) included network accessibility and remembering passwords. PulsaraTM was initiated 562 times. CONCLUSION: Implementing multiorganisational, digital health communication applications is feasible, and facilitated when organisations are change-ready for an easy-to-use, effective solution. Developing habitual use is key, supported through implementation strategies (e.g., hands-on training). Benefits should be emphasised (e.g., during education sessions), including streamlining communication and patient flow, and barriers addressed (e.g., identify champions and local technical support) at project commencement.
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Servicios Médicos de Urgencia , Comunicación Interdisciplinaria , Humanos , Salud Digital , Australia , Atención a la SaludRESUMEN
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.