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Abstract 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

Background: The Quality in Acute Stroke Care (QASC) Trial demonstrated that assistance to implement protocols to manage Fever, hyperglycaemia (Sugar) and Swallowing (FeSS) post-stroke reduced death and disability. In 2017, a ‘Strong Recommendation’ for use of FeSS Protocols was included in the Australian Clinical Guidelines for Stroke Management. We aimed to: i) compare adherence to FeSS Protocols pre- and post-guideline inclusion; ii) determine if adherence varied with prior participation in a treatment arm of a FeSS Intervention study, or receiving treatment in a stroke unit; and compare findings with our previous studies. Methods: Pre-test post-test study using Australian acute stroke service audit data comparing 2015/2017 (pre-guideline) versus 2019/2021 (post-guideline) adherence. Primary outcome was adherence to all six FeSS indicators (composite), with mixed-effects logistic regression adjusting for age, sex, stroke type and severity (ability to walk on admission), stroke unit care, hospital prior participation in a FeSS Intervention study, and correlation of outcomes within hospital. Additional analysis examined interaction effects. Results: Overall, 112 hospitals contributed data to ≥1 one Audit cycle for both periods (pre=7011, post=7195 cases); 42 hospitals had participated in any treatment arm of a FeSS Intervention study. Adherence to FeSS Protocols post-guideline increased (pre: composite measure 35% vs post: composite measure 40 %, aOR:1.2 95 %CI: 1.2, 1.3). Prior participation in a FeSS Intervention study (aOR:1.6, 95 %CI: 1.2, 2.0) and stroke unit care (aOR 2.3, 95 %CI: 2.0, 2.5) were independently associated with greater adherence to FeSS Protocols. There was no change in adherence over time based on prior participation in a FeSS Intervention study (p = 0.93 interaction), or stroke unit care (p = 0.07 interaction). Conclusions: There is evidence of improved adherence to FeSS Protocols following a ‘strong recommendation’ for their use in the Australian stroke guidelines. Change in adherence was similar independent of hospital prior participation in a FeSS Intervention study, or stroke unit care. However, maintenance of higher pre-guideline adherence for hospitals prior participation in a FeSS Intervention study suggests that research participation can facilitate greater guideline adherence; and confirms superior care received in stroke units. Nevertheless, less than half of Australian patients are being cared for according to the FeSS Protocols, providing impetus for additional strategies to increase uptake.

ABSTRACT Background Currently, there are no agreed quality standards for post‐stroke aphasia services. Therefore, it is unknown if care reflects best practices or meets the expectations of people living with aphasia. We aimed to (1) shortlist, (2) operationalise and (3) prioritise best practice recommendations for post‐stroke aphasia care. Methods Three phases of research were conducted. In Phase 1, recommendations with strong evidence and/or known to be important to people with lived experience of aphasia were identified. People with lived experience and health professionals rated the importance of each recommendation through a two‐round e‐Delphi exercise. Recommendations were then ranked for importance and feasibility and analysed using a graph theory–based voting system. In Phase 2, shortlisted recommendations from Phase 1 were converted into quality indicators for appraisal and voting in consensus meetings. In Phase 3, priorities for implementation were established by people with lived experience and health professionals following discussion and anonymous voting. Findings In Phase 1, 23 best practice recommendations were identified and rated by people with lived experience (n = 26) and health professionals (n = 81). Ten recommendations were shortlisted. In Phase 2, people with lived experience (n = 4) and health professionals (n = 17) reached a consensus on 11 quality indicators, relating to assessment (n = 2), information provision (n = 3), communication partner training (n = 3), goal setting (n = 1), person and family‐centred care (n = 1) and provision of treatment (n = 1). In Phase 3, people with lived experience (n = 5) and health professionals (n = 7) identified three implementation priorities: assessment of aphasia, provision of aphasia‐friendly information and provision of therapy. Interpretation Our 11 quality indicators and 3 implementation priorities are the first step to enabling systematic, efficient and person‐centred measurement and quality improvement in post‐stroke aphasia services. Quality indicators will be embedded in routine data collection systems, and strategies will be developed to address implementation priorities. Patient and Public Contribution Protocol development was informed by our previous research, which explored the perspectives of 23 people living with aphasia about best practice aphasia services. Individuals with lived experience of aphasia participated as expert panel members in our three consensus meetings. We received support from consumer advisory networks associated with the Centre for Research Excellence in Aphasia Rehabilitation and Recovery and the Queensland Aphasia Research Centre.

Abstract 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.

Abstract 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

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.

BackgroundPrimary care is usually the entry point for preventing cardiovascular disease (CVD). Quality indicators can be used to assess and monitor the quality of care provided in a primary care setting. In this systematic review, we aimed to identify, summarise, and assess the methodological quality of indicators reported in the articles for the primary prevention of CVD in primary care.MethodsWe searched Ovid MEDLINE, Ovid EMBASE, CINAHL Plus, SCOPUS, and grey literature for articles containing quality indicators published in English language. Quality indicators were categorised using the Donabedian framework: Structure (organisation of care), Process (assessment of metabolic risk factors, global risk assessment, lifestyle management, prescription of medications, risk communication/advice, referral), and Outcome (attainment of risk factor targets). Articles were reviewed by two authors, using the Appraisal of Indicators through Research and Evaluation (AIRE) instrument, where a score of ≥50% for each domain indicated strong methodological quality (e.g., stakeholder involvement).ResultsWe identified 282 articles for full-text review; 57 articles were included for extraction. A total of 726 (681 unique) quality indicators were extracted. Three out of four (76%) were process indicators (56 articles), followed by 15% outcome indicators (40 articles), and 9% structure indicators (12 articles). One-third of process indicators were related to the assessment of metabolic risk factors (222/726 indicators, 41 articles), followed by lifestyle management (153/726 indicators, 39 articles), prescription of medications (122/726 indicators, 37 articles), and global risk assessment (27/726, 14 articles). Few indicators were related to risk communication/advice (20/726 indicators, 7 articles) and referral (9/726 indicators, 6 articles). Only 26/57 (46%) articles were found to have strong methodological quality.ConclusionWe summarised and appraised the methodological quality of indicators for the primary prevention of CVD. The next step requires prioritising a minimum set of quality indicators to encourage standardised collection and monitoring across countries.

BackgroundUsing government health datasets for secondary purposes is widespread; however, little is known on researchers' knowledge and reuse practices within Australia.ObjectivesTo explore researchers' knowledge and experience of governance processes, and their data reuse practices, when using Victorian government health datasets for research between 2008-2020.MethodA cross-sectional quantitative survey was conducted with authors who utilised selected Victorian, Australia, government health datasets for peer-reviewed research published between 2008-2020. Information was collected on researchers': data reuse practices; knowledge of government health information assets; perceptions of data trustworthiness for reuse; and demographic characteristics.ResultsWhen researchers used government health datasets, 45% linked their data, 45% found the data access process easy and 27% found it difficult. Government-curated datasets were significantly more difficult to access compared to other-agency curated datasets (p = 0.009). Many respondents received their data in less than six months (58%), in aggregated or de-identified form (76%). Most reported performing their own data validation checks (70%). To assist in data reuse, almost 71% of researchers utilised (or created) contextual documentation, 69% a data dictionary, and 62% limitations documentation. Almost 20% of respondents were not aware if data quality information existed for the dataset they had accessed. Researchers reported data was managed by custodians with rigorous confidentiality/privacy processes (94%) and good data quality processes (76%), yet half lacked knowledge of what these processes entailed. Many respondents (78%) were unaware if dataset owners had obtained consent from the dataset subjects for research applications of the data.ConclusionConfidentiality/privacy processes and quality control activities undertaken by data custodians were well-regarded. Many respondents included data linkage to additional government datasets in their research. Ease of data access was variable. Some documentation types were well provided and used, but improvement is required for the provision of data quality statements and limitations documentation. Provision of information on participants' informed consent in a dataset is required.