Protocol for a feasibility registry-based randomised controlled trial investigating a tailored follow-up service for stroke (A-LISTS).

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.

Adelaide stroke incidence study: declining stroke rates but many preventable cardioembolic strokes.

BACKGROUND AND PURPOSE: Stroke incidence rates are in flux worldwide because of evolving risk factor prevalence, risk factor control, and population aging. Adelaide Stroke Incidence Study was performed to determine the incidence of strokes and stroke subtypes in a relatively elderly population of 148 000 people in the Western suburbs of Adelaide. METHODS: All suspected strokes were identified and assessed in a 12-month period from 2009 to 2010. Standard definitions for stroke and stroke fatality were used. Ischemic stroke pathogenesis was classified by the Trial of ORG 10172 in Acute Stroke Treatment criteria. RESULTS: There were 318 stroke events recorded in 301 individuals; 238 (75%) were first-in-lifetime events. Crude incidence rates for first-ever strokes were 161 per 100 000 per year overall (95% confidence interval [CI], 141-183), 176 for men (95% CI, 147-201), and 146 for women (95% CI, 120-176). Adjusted to the world population rates were 76 overall (95% CI, 59-94), 91 for men (95% CI, 73-112), and 61 for women (95% CI, 47-78). The 28-day case fatality rate for first-ever stroke was 19% (95% CI, 14-24); the majority were ischemic (84% [95% CI, 78-88]). Intracerebral hemorrhage comprised 11% (8-16), subarachnoid hemorrhage 3% (1-6), and 3% (1-6) were undetermined. Of the 258 ischemic strokes, 42% (95% CI, 36-49) were of cardioembolic pathogenesis. Atrial fibrillation accounted for 36% of all ischemic strokes, of which 85% were inadequately anticoagulated. CONCLUSIONS: Stroke incidence in Adelaide has not increased compared with previous Australian studies, despite the aging population. Cardioembolic strokes are becoming a higher proportion of all ischemic strokes.

Early minimally invasive intracerebral hemorrhage evacuation: a phase 2a feasibility, safety, and promise of surgical efficacy study.

BACKGROUND: Surgical 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. METHODS: We 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. RESULTS: From 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. CONCLUSION: In this study, early ICH MIS using the Aurora Surgiscope and Evacuator appeared to be feasible and safe, warranting further exploration. TRIAL REGISTRATION NUMBER: ACTRN12619001748101.

Excess stroke incidence in young Aboriginal people in South Australia: Pooled results from two population-based studies.

Background Retrospective data indicate increased stroke incidence in Aboriginal/Torres Strait Islander (Indigenous) Australians, possibly with poorer outcomes. We present the first prospective population-based stroke incidence study in Indigenous Australians. Methods We pooled data from ASCEND and SEARCH, two prospective "ideal" South Australian stroke incidence studies, ASCEND conducted in urban Northwestern Adelaide (2009-2010) and SEARCH in five South Australian rural centers (2009-2011). We calculated age-standardized incidence for Aboriginal and non-Aboriginal people. Results The study population comprised 261,403 inhabitants. Among 432 first-ever strokes, 13 were in Aboriginal people (median age 51 vs. 78 years for non-Aboriginal people, p < 0.001). Age-standardized stroke incidence per 100,000 in Aboriginal patients (116, 95% CI: 95-137) was nearly two-fold that of non-Aboriginal patients (67, 95% CI: 51-84). Age-stratified excess incidence in Aboriginal people was restricted to those aged < 55 years (incidence rate ratio (IRR) 3.5, 95% CI: 2-7), particularly for intracerebral hemorrhage (IRR: 16, 95% CI: 4-61). Conclusion The excess stroke incidence in Aboriginal South Australians appears substantial, especially in those aged <55 years. Further work is required to delineate and address disparities.

Stroke Epidemiology in an Australian Rural Cohort (SEARCH).

Background Stroke rates in Australia and New Zealand have been declining since 1990 but all studies have been completed in large urban centers. Aim We report the first Australasian stroke incidence study in a rural population. Methods The authors applied the principle of complete ascertainment, used the WHO standard definition of stroke and classified ischemic stroke by the TOAST criteria. Data were collected from five rural centers defined by postcode of residence, over a 2-year period with 12 months of follow up of all cases. Results There were 217 strokes in 215 individuals in a population of 96,036 people, over 2 years, giving a crude attack rate of 113 per 100,000 per year. The 181 first-ever strokes (83% of total), standardized to the WHO world population, occurred at a rate of 50/100,000 (95% CI: 43-58). The 28-day fatality for first-ever strokes was 24% (95% CI: 18-31) and 77% (95% CI: 71-83) were classified as ischemic (140/181), 15% (95% CI: 10-21) intracerebral hemorrhage, 3% (95% CI: 1-6) due to subarachnoid hemorrhage and 5% (95% CI: 2-9) were unknown. A high proportion of first-ever ischemic strokes (44%) were cardioembolic, mostly (77%) due to atrial arrhythmias. Of the 38 with known atrial arrhythmias prior to stroke, only six (16%) were therapeutically anticoagulated. Conclusions This rural companion study of a recent Australian urban stroke incidence study confirms the downward trend of stroke incidence in Australia, and reiterates that inadequate anticoagulation of atrial arrhythmia remains a preventable cause of ischemic stroke.