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Background Often people experience ongoing health challenges after stroke. The Australian Stroke Clinical Registry collects patient‐reported outcomes after stroke. Many patients report challenges that are potentially addressable through additional support. Aims To co‐design a registry‐based, hospital‐initiated, follow‐up service for people who report major health‐related challenges between 90 and 180 days after their stroke. Methods Iterative, consensus‐based methods were used to co‐design a follow‐up service intervention including eligibility criteria, clinical protocol (consultation/communication forms and pathways) and implementation requirements (e.g., training manual) (May 2022–March 2023). Stakeholders, including Australian‐based clinicians providing stroke care, researchers and people with lived experience of stroke, were involved in each stage. Data collection: Stage 1 (development), (i) scoping survey; (ii) two consensus meetings; (iii) interviews with key informants (n = 3); (iv) online modified Delphi survey; Stage 2 (testing and finalisation), (v) piloting of the follow‐up service intervention at one hospital, with service coordinator/study team interview and participant satisfaction surveys and; (vi) final review (modified Delphi survey). Consensus was defined in the modified Delphi surveys as ≥ 80% ‘agreement’ or verbal consensus via open voting during meetings. Additional recommendations from each step were iteratively incorporated to refine the intervention. Results Scoping survey results (n = 41/108 respondents, 38% response rate) highlighted the need for broad inclusion criteria and the involvement of carers/support person and general practitioners. During the consensus meetings (16/18, 89% stakeholders attended at least one), verbal consensus was achieved for the eligibility criteria, and additional recommendations were made for the referral report and components within the clinical protocol and training manual. After the final Stage 1 modified Delphi survey (n = 10, two cohorts), 70%–100% consensus was achieved for the referral report, clinical protocol components and training manual, which were then piloted with six eligible participants. Feedback from the pilot testing (n = 3 coordinator/staff interviews; n = 5 satisfaction surveys) led to further clinical protocol modifications. Agreement was reached for all additional recommendations during the final modified Delphi survey round (16/29 respondents, 55%). Conclusion We describe an iterative, consensus‐based co‐design process which resulted in a novel, registry‐based follow‐up service intervention for people living with stroke reporting major health challenges. A feasibility randomised controlled trial is the next stage. Patient or Public Contribution People with lived experience of stroke, including their family/caregivers, actively participated throughout the co‐design process to develop and test the follow‐up service intervention. There was lived experience representation with scoping survey responses, as well as within the working group and independent review group who were involved with the consensus meetings and modified Delphi process. Survey feedback from people with stroke who piloted the developed service intervention was also integral to informing the final service intervention.

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

BackgroundSurgical treatment of intracerebral hemorrhage (ICH) is unproven, although meta-analyses suggest that both early conventional surgery with craniotomy and minimally invasive surgery (MIS) may be beneficial. We aimed to demonstrate the safety, feasibility, and promise of efficacy of early MIS for ICH using the Aurora Surgiscope and Evacuator.MethodsWe performed a prospective, single arm, phase IIa Simon’s two stage design study at two stroke centers (10 patients with supratentorial ICH volumes ≥20 mL and National Institutes of Health Stroke Scale (NIHSS) score of ≥6, and surgery commencing <12 hours after onset). Positive outcome was defined as ≥50% 24 hour ICH volume reduction, with the safety outcome lack of significant ICH reaccumulation.ResultsFrom December 2019 to July 2020, we enrolled 10 patients at two Australian Comprehensive Stroke Centers, median age 70 years (IQR 65–74), NIHSS score 19 (IQR 19–29), ICH volume 59 mL (IQR 25–77), at a median of 227 min (IQR 175–377) post-onset. MIS was commenced at a median time of 531 min (IQR 437–628) post-onset, had a median duration of 98 min (IQR 77–110), with a median immediate postoperative hematoma evacuation of 70% (IQR 67–80%). A positive outcome was achieved in 5/5 first stage patients and in 4/5 second stage patients. One patient developed significant 24 hour ICH reaccumulation; otherwise, 24 hour stability was observed (median reduction 71% (IQR 61–80), 5/9 patients <15 mL residual). Three patients died, unrelated to surgery. There were no surgical safety concerns. At 6 months, the median modified Rankin Scale score was 4 (IQR 3–6) with 30% achieving a score of 0–3.ConclusionIn this study, early ICH MIS using the Aurora Surgiscope and Evacuator appeared to be feasible and safe, warranting further exploration.Trial registration numberACTRN12619001748101.

Background Unplanned hospital presentations may occur post-stroke due to inadequate preparation for transitioning from hospital to home. The Re covery-focused C ommunity support to A void readmissions and improve P articipation after S troke (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