Publications by authors named "Christopher F Bladin"

58 Publications

Factors associated with arrival by ambulance for patients with stroke: a multicentre, national data linkage study.

Australas Emerg Care 2021 Feb 25. Epub 2021 Feb 25.

Stroke and Ageing Research, School of Clinical Sciences at Monash Health, Monash University, Clayton, Victoria, Australia; Florey Institute of Neuroscience and Mental Health, Heidelberg, Victoria, Australia. Electronic address:

Background: Hospital arrival via ambulance influences treatment of acute stroke. We aimed to determine the factors associated with use of ambulance and access to evidence-based care among patients with stroke.

Methods: Patients with first-ever strokes from the Australian Stroke Clinical Registry (2010-2013) were linked with administrative data (emergency, hospital admissions). Multilevel, multivariable regression models were used to determine patient, clinical and system factors associated with arrival by ambulance.

Results: Among the 6,262 patients with first-ever stroke, 4,737 (76%) arrived by ambulance (52% male; 80% ischaemic). Patients who were older, frailer, with comorbidities or were unable to walk on admission (stroke severity) were more likely to arrive by ambulance to hospital. Compared to those using other means of transport, those who used ambulances arrived to hospital sooner after stroke onset (minutes, 124 vs 397) and were more likely to receive reperfusion therapy (adjusted odds ratio, 1.57, 95% CI: 1.09, 2.27).

Conclusion: Patients with stroke who use ambulances arrived faster and were more likely to receive reperfusion therapy compared to those using personal transport. Further public education about using ambulance services at all times, instead of personal transport when stroke is suspected is needed to optimise access to time critical care.
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http://dx.doi.org/10.1016/j.auec.2021.01.002DOI Listing
February 2021

Economic Evaluation Protocol and Statistical Analysis Plan for the Cost-Effectiveness of a Novel Australian Stroke Telemedicine Program; the Victorian Stroke Telemedicine (VST) program.

Front Neurol 2020 21;11:602044. Epub 2021 Jan 21.

Deakin Health Economics, Institute for Health Transformation, Deakin University, Geelong, VIC, Australia.

Telemedicine can address limited access to medical specialists in rural hospitals. Stroke provides an important case study because: it is a major cause of disease burden; effective treatments to reduce disability (e.g., thrombolysis) can be provided within the initial hours of stroke onset; careful selection of patients is needed by skilled doctors to minimize adverse events from thrombolysis; and there are major treatment gaps (only about half of regional hospitals in Australia provide thrombolysis for stroke). Few economic analyses have been undertaken on telestroke and the majority have been simulation models. The aim of this protocol and statistical analysis plan is to outline the methods for the cost-effectiveness evaluation of a large, multicentre acute stroke telemedicine program being conducted in Victoria, Australia. Using a historical- and prospective-controlled design, we will compare patient-level data obtained in the 12 months prior to the Victorian Stroke Telemedicine (VST) program implementation and during the first 12 months of VST to determine the incremental difference in costs and patient outcomes at 3 and 12 months. Secondary aims include assessing the cost per additional patient receiving intravenous thrombolysis and the cost per additional patient receiving intravenous thrombolysis within 60 min. Tertiary aims include assessing the potential longer-term cost-effectiveness in the second year of the program at the hospitals to determine whether any program benefits are sustained once site coordinators are no longer employed; and modeling the potential net life-time costs and benefits from a societal perspective. Multivariable uncertainty and one-way sensitivity analyses will be performed to assess the robustness of results. Sixteen hospitals participated. Patient-level data collection including 12-month outcomes for the cohorts obtained in the first and second year of the program for each hospital was completed in January 2020. The results from this real-world study with patient-level data will provide high quality evidence of the costs, health benefits and policy implications of telestroke programs, including the potential for application in other locations within Australia or other countries with similar health system delivery and financing.
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http://dx.doi.org/10.3389/fneur.2020.602044DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7873861PMC
January 2021

Utility of Severity-Based Prehospital Triage for Endovascular Thrombectomy: ACT-FAST Validation Study.

Stroke 2021 01 22;52(1):70-79. Epub 2020 Dec 22.

Departments of Medicine and Neurology, Melbourne Brain Centre at The Royal Melbourne Hospital (H.Z., L.C., J.L.N., C.W., F.A., F.N., P.J.M., M.W.P., N.Y., S.M.D., B.C.V.C.), University of Melbourne, Australia.

Background And Purpose: Severity-based assessment tools may assist in prehospital triage of patients to comprehensive stroke centers (CSCs) for endovascular thrombectomy (EVT), but criticisms regarding diagnostic inaccuracy have not been adequately addressed. This study aimed to quantify the benefits and disadvantages of severity-based triage in a large real-world paramedic validation of the Ambulance Clinical Triage for Acute Stroke Treatment (ACT-FAST) algorithm.

Methods: Ambulance Victoria paramedics assessed the prehospital ACT-FAST algorithm in patients with suspected stroke from November 2017 to July 2019 following an 8-minute training video. All patients were transported to the nearest stroke center as per current guidelines. ACT-FAST diagnostic accuracy was compared with hospital imaging for the presence of large vessel occlusion (LVO) and need for CSC-level care (LVO, intracranial hemorrhage, and tumor). Patient-level time saving to EVT was modeled using a validated Google Maps algorithm. Disadvantages of CSC bypass examined potential thrombolysis delays in non-LVO infarcts, proportion of patients with false-negative EVT, and CSC overburdening.

Results: Of 517 prehospital assessments, 168/517 (32.5%) were ACT-FAST positive and 132/517 (25.5%) had LVO. ACT-FAST sensitivity and specificity for LVO was 75.8% and 81.8%, respectively. Positive predictive value was 58.8% for LVO and 80.0% when intracranial hemorrhage and tumor (CSC-level care) were included. Within the metropolitan region, 29/55 (52.7%) of ACT-FAST-positive patients requiring EVT underwent a secondary interhospital transfer. Prehospital bypass with avoidance of secondary transfers was modeled to save 52 minutes (95% CI, 40.0-61.5) to EVT commencement. ACT-FAST was false-positive in 8 patients receiving thrombolysis (8.1% of 99 non-LVO infarcts) and false-negative in 4 patients with EVT requiring secondary transfer (5.4% of 74 EVT cases). CSC bypass was estimated to over-triage 1.1 patients-per-CSC-per-week in our region.

Conclusions: The overall benefits of an ACT-FAST algorithm bypass strategy in expediting EVT and avoiding secondary transfers are estimated to substantially outweigh the disadvantages of potentially delayed thrombolysis and over-triage, with only a small proportion of EVT patients missed.
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http://dx.doi.org/10.1161/STROKEAHA.120.031467DOI Listing
January 2021

Intravenous alteplase for stroke with unknown time of onset guided by advanced imaging: systematic review and meta-analysis of individual patient data.

Lancet 2020 11 8;396(10262):1574-1584. Epub 2020 Nov 8.

Department of Neurology, University of Erlangen-Nuremberg, Erlangen, Germany.

Background: Patients who have had a stroke with unknown time of onset have been previously excluded from thrombolysis. We aimed to establish whether intravenous alteplase is safe and effective in such patients when salvageable tissue has been identified with imaging biomarkers.

Methods: We did a systematic review and meta-analysis of individual patient data for trials published before Sept 21, 2020. Randomised trials of intravenous alteplase versus standard of care or placebo in adults with stroke with unknown time of onset with perfusion-diffusion MRI, perfusion CT, or MRI with diffusion weighted imaging-fluid attenuated inversion recovery (DWI-FLAIR) mismatch were eligible. The primary outcome was favourable functional outcome (score of 0-1 on the modified Rankin Scale [mRS]) at 90 days indicating no disability using an unconditional mixed-effect logistic-regression model fitted to estimate the treatment effect. Secondary outcomes were mRS shift towards a better functional outcome and independent outcome (mRS 0-2) at 90 days. Safety outcomes included death, severe disability or death (mRS score 4-6), and symptomatic intracranial haemorrhage. This study is registered with PROSPERO, CRD42020166903.

Findings: Of 249 identified abstracts, four trials met our eligibility criteria for inclusion: WAKE-UP, EXTEND, THAWS, and ECASS-4. The four trials provided individual patient data for 843 individuals, of whom 429 (51%) were assigned to alteplase and 414 (49%) to placebo or standard care. A favourable outcome occurred in 199 (47%) of 420 patients with alteplase and in 160 (39%) of 409 patients among controls (adjusted odds ratio [OR] 1·49 [95% CI 1·10-2·03]; p=0·011), with low heterogeneity across studies (I=27%). Alteplase was associated with a significant shift towards better functional outcome (adjusted common OR 1·38 [95% CI 1·05-1·80]; p=0·019), and a higher odds of independent outcome (adjusted OR 1·50 [1·06-2·12]; p=0·022). In the alteplase group, 90 (21%) patients were severely disabled or died (mRS score 4-6), compared with 102 (25%) patients in the control group (adjusted OR 0·76 [0·52-1·11]; p=0·15). 27 (6%) patients died in the alteplase group and 14 (3%) patients died among controls (adjusted OR 2·06 [1·03-4·09]; p=0·040). The prevalence of symptomatic intracranial haemorrhage was higher in the alteplase group than among controls (11 [3%] vs two [<1%], adjusted OR 5·58 [1·22-25·50]; p=0·024).

Interpretation: In patients who have had a stroke with unknown time of onset with a DWI-FLAIR or perfusion mismatch, intravenous alteplase resulted in better functional outcome at 90 days than placebo or standard care. A net benefit was observed for all functional outcomes despite an increased risk of symptomatic intracranial haemorrhage. Although there were more deaths with alteplase than placebo, there were fewer cases of severe disability or death.

Funding: None.
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http://dx.doi.org/10.1016/S0140-6736(20)32163-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7734592PMC
November 2020

Association of Reperfusion After Thrombolysis With Clinical Outcome Across the 4.5- to 9-Hours and Wake-up Stroke Time Window: A Meta-Analysis of the EXTEND and EPITHET Randomized Clinical Trials.

JAMA Neurol 2021 Feb;78(2):236-240

Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.

Importance: Intravenous alteplase reduces disability after ischemic stroke in patients 4.5 to 9 hours after onset and with wake-up onset stroke selected using perfusion imaging mismatch. However, whether the benefit is consistent across the 4.5- to 6-hours, 6- to 9-hours, and wake-up stroke epochs is uncertain.

Objective: To examine the association of reperfusion with reduced disability, including by onset-to-randomization time strata in the Extending the Time for Thrombolysis in Emergency Neurological Deficits (EXTEND) and Echoplanar Imaging Thrombolytic Evaluation Trial (EPITHET) randomized clinical trials.

Design, Setting, And Participants: Individual patient meta-analysis of randomized clinical trials performed from August 2001 to June 2018 with 3-month follow-up. Patients had acute ischemic stroke with 4.5-to 9-hours poststroke onset or with wake-up stroke were randomized to alteplase or placebo after perfusion mismatch imaging. Analysis began July 2019 and ended May 2020.

Exposures: Reperfusion was defined as more than 90% reduction in time to maximum of more than 6 seconds' lesion volume at 24- to 72-hour follow-up.

Main Outcomes And Measures: Ordinal logistic regression adjusted for baseline age and National Institutes of Health Stroke Scale score was used to analyze functional improvement in day 90 modified Rankin Scale score overall, including a reperfusion × time-to-randomization multiplicative interaction term, and in the 4.5- to 6-hours, 6- to 9-hours, and wake-up time strata. Symptomatic hemorrhage was defined as large parenchymal hematoma with a National Institutes of Health Stroke Scale score increase of 4 points or more.

Results: Reperfusion was assessable in 270 of 295 patients (92%), 68 of 133 (51%) in the alteplase group, and 38 of 137 (28%) in the placebo reperfused group (P < .001). The median (interquartile range) age was 76 (66-81) years in the reperfusion group vs 74 (64.5-81.0) years in the group with no reperfusion. The median (interquartile range) baseline National Institutes of Health Stroke Scale score was 10 (7-15) in the reperfusion group vs 12 (8.0-17.5) in the no reperfusion group. Overall, reperfusion was associated with improved functional outcome (common odds ratio, 7.7; 95% CI, 4.6-12.8; P < .001). Reperfusion was associated with significantly improved functional outcome in each of the 4.5- to 6-hours, 6- to 9-hours, and wake-up time strata, with no evidence of association between time to randomization and beneficial effect of reperfusion (P = .63). Symptomatic hemorrhage, assessed in all 294 patients, occurred in 3 of 51 (5.9%) in the 4.5- to 6-hours group, 2 of 28 (7.1%) in the 6- to 9-hours group, and 4 of 73 (5.5%) in the wake-up stroke in patients treated with alteplase (Fisher P = .91).

Conclusions And Relevance: Strong benefits of reperfusion in all time strata without differential risk in symptomatic hemorrhage support the consistent treatment effect of alteplase in perfusion mismatch-selected patients throughout the 4.5- to 9-hours and wake-up stroke time window.
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http://dx.doi.org/10.1001/jamaneurol.2020.4123DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7607491PMC
February 2021

Effect of Intravenous Tenecteplase Dose on Cerebral Reperfusion Before Thrombectomy in Patients With Large Vessel Occlusion Ischemic Stroke: The EXTEND-IA TNK Part 2 Randomized Clinical Trial.

JAMA 2020 04;323(13):1257-1265

Department of Medicine, Ballarat Base Hospital, Ballarat, Victoria, Australia.

Importance: Intravenous thrombolysis with tenecteplase improves reperfusion prior to endovascular thrombectomy for ischemic stroke compared with alteplase.

Objective: To determine whether 0.40 mg/kg of tenecteplase safely improves reperfusion before endovascular thrombectomy vs 0.25 mg/kg of tenecteplase in patients with large vessel occlusion ischemic stroke.

Design, Setting, And Participants: Randomized clinical trial at 27 hospitals in Australia and 1 in New Zealand using open-label treatment and blinded assessment of radiological and clinical outcomes. Patients were enrolled from December 2017 to July 2019 with follow-up until October 2019. Adult patients (N = 300) with ischemic stroke due to occlusion of the intracranial internal carotid, \basilar, or middle cerebral artery were included less than 4.5 hours after symptom onset using standard intravenous thrombolysis eligibility criteria.

Interventions: Open-label tenecteplase at 0.40 mg/kg (maximum, 40 mg; n = 150) or 0.25 mg/kg (maximum, 25 mg; n = 150) given as a bolus before endovascular thrombectomy.

Main Outcomes And Measures: The primary outcome was reperfusion of greater than 50% of the involved ischemic territory prior to thrombectomy, assessed by consensus of 2 blinded neuroradiologists. Prespecified secondary outcomes were level of disability at day 90 (modified Rankin Scale [mRS] score; range, 0-6); mRS score of 0 to 1 (freedom from disability) or no change from baseline at 90 days; mRS score of 0 to 2 (functional independence) or no change from baseline at 90 days; substantial neurological improvement at 3 days; symptomatic intracranial hemorrhage within 36 hours; and all-cause death.

Results: All 300 patients who were randomized (mean age, 72.7 years; 141 [47%] women) completed the trial. The number of participants with greater than 50% reperfusion of the previously occluded vascular territory was 29 of 150 (19.3%) in the 0.40 mg/kg group vs 29 of 150 (19.3%) in the 0.25 mg/kg group (unadjusted risk difference, 0.0% [95% CI, -8.9% to -8.9%]; adjusted risk ratio, 1.03 [95% CI, 0.66-1.61]; P = .89). Among the 6 secondary outcomes, there were no significant differences in any of the 4 functional outcomes between the 0.40 mg/kg and 0.25 mg/kg groups nor in all-cause deaths (26 [17%] vs 22 [15%]; unadjusted risk difference, 2.7% [95% CI, -5.6% to 11.0%]) or symptomatic intracranial hemorrhage (7 [4.7%] vs 2 [1.3%]; unadjusted risk difference, 3.3% [95% CI, -0.5% to 7.2%]).

Conclusions And Relevance: Among patients with large vessel occlusion ischemic stroke, a dose of 0.40 mg/kg, compared with 0.25 mg/kg, of tenecteplase did not significantly improve cerebral reperfusion prior to endovascular thrombectomy. The findings suggest that the 0.40-mg/kg dose of tenecteplase does not confer an advantage over the 0.25-mg/kg dose in patients with large vessel occlusion ischemic stroke in whom endovascular thrombectomy is planned.

Trial Registration: ClinicalTrials.gov Identifier: NCT03340493.
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http://dx.doi.org/10.1001/jama.2020.1511DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7139271PMC
April 2020

Melbourne Mobile Stroke Unit and Reperfusion Therapy: Greater Clinical Impact of Thrombectomy Than Thrombolysis.

Stroke 2020 03 12;51(3):922-930. Epub 2020 Feb 12.

From the Department of Neurology, Melbourne Brain Centre (H.Z., S.C., D.E., L.C., N.Y., B.Y., B.C.V.C., M.W.P., G.A.D., S.M.D.), Royal Melbourne Hospital, Victoria, Australia.

Background and Purpose- Mobile stroke units (MSUs) are increasingly used worldwide to provide prehospital triage and treatment. The benefits of MSUs in giving earlier thrombolysis have been well established, but the impacts of MSUs on endovascular thrombectomy (EVT) and effect on disability avoidance are largely unknown. We aimed to determine the clinical impact and disability reduction for reperfusion therapies in the first operational year of the Melbourne MSU. Methods- Treatment time metrics for MSU patients receiving reperfusion therapy were compared with control patients presenting to metropolitan Melbourne stroke units via standard ambulance within MSU operating hours. The primary outcome was median time difference in first ambulance dispatch to treatment modeled using quantile regression analysis. Time savings were subsequently converted to disability-adjusted life years avoided using published estimates. Results- In the first 365-day operation of the Melbourne MSU, prehospital thrombolysis was administered to 100 patients (mean age, 73.8 years; 62% men). The median time savings per MSU patient, compared with the control cohort, was 26 minutes (<0.001) for dispatch to hospital arrival and 15 minutes (<0.001) for hospital arrival to thrombolysis. The calculated overall time saving from dispatch to thrombolysis was 42.5 minutes (95% CI, 36.0-49.0). In the same period, 41 MSU patients received EVT (mean age, 76 years; 61% men) with median dispatch-to-treatment time saving of 51 minutes ([95% CI, 30.1-71.9], <0.001). This included a median time saving of 17 minutes ([95% CI, 7.6-26.4], =0.001) for EVT hospital arrival to arterial puncture for MSU patients. Estimated median disability-adjusted life years saved through earlier provision of reperfusion therapies were 20.9 for thrombolysis and 24.6 for EVT. Conclusions- The Melbourne MSU substantially reduced time to reperfusion therapies, with the greatest estimated disability avoidance driven by the more powerful impact of earlier EVT. These findings highlight the benefits of prehospital notification and direct triage to EVT centers with facilitated workflow on arrival by the MSU.
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http://dx.doi.org/10.1161/STROKEAHA.119.027843DOI Listing
March 2020

Cluster-Randomized Trial of Thrombolysis Implementation Support in Metropolitan and Regional Australian Stroke Centers: Lessons for Individual and Systems Behavior Change.

J Am Heart Assoc 2020 02 24;9(3):e012732. Epub 2020 Jan 24.

The University of Newcastle, School of Medicine and Public Health Callaghan Australia.

Background Intravenous thrombolytic therapy (IVT) with tissue plasminogen activator for acute ischemic stroke is underutilized in many parts of the world. Randomized trials to test the effectiveness of thrombolysis implementation strategies are limited. Methods and Results This study aimed to test the effectiveness of a multicomponent, multidisciplinary tissue plasminogen activator implementation package in increasing the proportion of thrombolyzed cases while maintaining accepted benchmarks for low rates of intracranial hemorrhage and high rates of functional outcomes at 3 months. A cluster randomized controlled trial of 20 hospitals in the early stages of thrombolysis implementation across 3 Australian states was undertaken. Monitoring of IVT rates during the baseline period allowed hospitals (the unit of randomization) to be grouped into 3 baseline IVT strata-very low rates (0% to ≤4.0%); low rates (>4.0% to ≤10.0%); and moderate rates (>10.0%). Hospitals were randomized to an implementation package (experimental group) or usual care (control group) using a 1:1 ratio. The 16-month intervention was based on behavioral theory and analysis of the steps, roles, and barriers to rapid assessment for thrombolysis eligibility and involved comprehensive strategies addressing individual and system-level change. The primary outcome was the difference in tissue plasminogen activator proportions between the 2 groups postintervention. The absolute difference in postintervention IVT rates between intervention and control hospitals adjusted for baseline IVT rate and stratum was not significant (primary outcome rate difference=1.1% (95% CI -1.5% to 3.7%; =0.38). Rates of intracranial hemorrhage remained below international benchmarks. Conclusions The implementation package resulted in no significant change in tissue plasminogen activator implementation, suggesting that ongoing support is needed to sustain initial modifications in behavior. Clinical Trial Registration URL: www.anzctr.org.au Unique identifiers: ACTRN12613000939796 and U1111-1145-6762.
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http://dx.doi.org/10.1161/JAHA.119.012732DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7033885PMC
February 2020

Establishment of an internationally agreed minimum data set for acute telestroke.

J Telemed Telecare 2020 Jan 14:1357633X19899262. Epub 2020 Jan 14.

Public Health Group, Stroke Division, Florey Institute of Neuroscience and Mental Health, the University of Melbourne, Australia.

Introduction: Globally, the use of telestroke programmes for acute care is expanding. Currently, a standardised set of variables for enabling reliable international comparisons of telestroke programmes does not exist. The aim of the study was to establish a consensus-based, minimum dataset for acute telestroke to enable the reliable comparison of programmes, clinical management and patient outcomes.

Methods: An initial scoping review of variables was conducted, supplemented by reaching out to colleagues leading some of these programmes in different countries. An international expert panel of clinicians, researchers and managers ( = 20) from the Australasia Pacific region, USA, UK and Europe was convened. A modified-Delphi technique was used to achieve consensus via online questionnaires, teleconferences and email.

Results: Overall, 533 variables were initially identified and harmonised into 159 variables for the expert panel to review. The final dataset included 110 variables covering three themes (service configuration, consultations, patient information) and 12 categories: (1) details about telestroke network/programme ( = 12), (2) details about initiating hospital ( = 10), (3) telestroke consultation ( = 17), (4) patient characteristics ( = 7), (5) presentation to hospital ( = 5), (6) general clinical care within first 24 hours ( = 10), (7) thrombolysis treatment ( = 10), (8) endovascular treatment ( = 13), (9) neurosurgery treatment ( = 8), (10) processes of care beyond 24 hours ( = 7), (11) discharge information ( = 5), (12) post-discharge and follow-up data ( = 6).

Discussion: The acute telestroke minimum dataset provides a recommended set of variables to systematically evaluate acute telestroke programmes in different countries. Adoption is recommended for new and existing services.
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http://dx.doi.org/10.1177/1357633X19899262DOI Listing
January 2020

Nurses' Role in Implementing and Sustaining Acute Telemedicine: A Mixed-Methods, Pre-Post Design Using an Extended Technology Acceptance Model.

J Nurs Scholarsh 2020 01 11;52(1):34-46. Epub 2019 Sep 11.

Head, Translational Public Health and Evaluation Division, Stroke and Ageing Research, School of Clinical Sciences at Monash Health, Monash University, Clayton, VIC, Australia.

Purpose: Technology-based systems like telemedicine are frequently being implemented into healthcare settings, impacting clinician practices. Little is known about factors influencing acute telemedicine uptake, if factors differ across time, or between nurses and non-nurses.

Design: A mixed-methods, pre-post design with implementation of a new acute stroke telemedicine service.

Methods: A survey based on an extended Technology Acceptance Model (TAM) was administered to clinicians involved in acute stroke care at 16 regional hospitals (2014-2017). Open-ended questions postimplementation (at 6 months) included strengths of the program and areas to improve. Subsequently, a secondary analysis of nurses' semistructured interviews at the first telemedicine site (2010-2011) was completed to provide greater explanatory detail.

Findings: Surveys were completed by nurses (preimplementation n = 77, postimplementation n = 92) and non-nurses (pre n = 90, post n = 44). Preimplementation, perceived usefulness was the only significant predictor of intending to use telemedicine for nurses, while perceived ease of use and social influence were significant for non-nurses. Postimplementation, perceived usefulness was significant for both groups, as was facilitating conditions for nurses. Specific examples aligned to TAM categories from our detailed interviews (n = 11 nurses) included perceived usefulness (improved clinical support and patient care), perceived ease of use (technical, clinical aspects), facilitating conditions (setting, education, confidence), and social influence (working relationships).

Conclusions: Important factors for acute stroke telemedicine varied between nurses and non-nurses, and changed after implementation. The benefits of telemedicine should be emphasized to nurses. Preimplementation, more non-nurses wanted systems to be easy. Support in clinical, technical, and relationship aspects of telemedicine consultations is required.

Clinical Relevance: Nurses are influential in implementing acute telemedicine, which is complex, with clinical and technical aspects entwined. Evidence-based implementation strategies must be tailored over time, and between nurses and non-nurses, to ensure initial uptake and ongoing use.
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http://dx.doi.org/10.1111/jnu.12509DOI Listing
January 2020

Extending thrombolysis to 4·5-9 h and wake-up stroke using perfusion imaging: a systematic review and meta-analysis of individual patient data.

Lancet 2019 07 22;394(10193):139-147. Epub 2019 May 22.

Department of Neurology, Sapienza University of Roma, Rome, Italy.

Background: Stroke thrombolysis with alteplase is currently recommended 0-4·5 h after stroke onset. We aimed to determine whether perfusion imaging can identify patients with salvageable brain tissue with symptoms 4·5 h or more from stroke onset or with symptoms on waking who might benefit from thrombolysis.

Methods: In this systematic review and meta-analysis of individual patient data, we searched PubMed for randomised trials published in English between Jan 1, 2006, and March 1, 2019. We also reviewed the reference list of a previous systematic review of thrombolysis and searched ClinicalTrials.gov for interventional studies of ischaemic stroke. Studies of alteplase versus placebo in patients (aged ≥18 years) with ischaemic stroke treated more than 4·5 h after onset, or with wake-up stroke, who were imaged with perfusion-diffusion MRI or CT perfusion were eligible for inclusion. The primary outcome was excellent functional outcome (modified Rankin Scale [mRS] score 0-1) at 3 months, adjusted for baseline age and clinical severity. Safety outcomes were death and symptomatic intracerebral haemorrhage. We calculated odds ratios, adjusted for baseline age and National Institutes of Health Stroke Scale score, using mixed-effects logistic regression models. This study is registered with PROSPERO, number CRD42019128036.

Findings: We identified three trials that met eligibility criteria: EXTEND, ECASS4-EXTEND, and EPITHET. Of the 414 patients included in the three trials, 213 (51%) were assigned to receive alteplase and 201 (49%) were assigned to receive placebo. Overall, 211 patients in the alteplase group and 199 patients in the placebo group had mRS assessment data at 3 months and thus were included in the analysis of the primary outcome. 76 (36%) of 211 patients in the alteplase group and 58 (29%) of 199 patients in the placebo group had achieved excellent functional outcome at 3 months (adjusted odds ratio [OR] 1·86, 95% CI 1·15-2·99, p=0·011). Symptomatic intracerebral haemorrhage was more common in the alteplase group than the placebo group (ten [5%] of 213 patients vs one [<1%] of 201 patients in the placebo group; adjusted OR 9·7, 95% CI 1·23-76·55, p=0·031). 29 (14%) of 213 patients in the alteplase group and 18 (9%) of 201 patients in the placebo group died (adjusted OR 1·55, 0·81-2·96, p=0·66).

Interpretation: Patients with ischaemic stroke 4·5-9 h from stroke onset or wake-up stroke with salvageable brain tissue who were treated with alteplase achieved better functional outcomes than did patients given placebo. The rate of symptomatic intracerebral haemorrhage was higher with alteplase, but this increase did not negate the overall net benefit of thrombolysis.

Funding: None.
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http://dx.doi.org/10.1016/S0140-6736(19)31053-0DOI Listing
July 2019

Thrombolysis Guided by Perfusion Imaging up to 9 Hours after Onset of Stroke.

N Engl J Med 2019 05;380(19):1795-1803

From Florey Institute of Neuroscience and Mental Health (H.M., L. Churilov, N.Y., V.T., L. Carey, A.M., G.A.D.), the Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital (B.C.V.C., M.W.P., L. Churilov, S. Christensen, N.Y., G.S., A.B., B.Y., A.M., S.M.D., G.A.D.), and the Department of Radiology, Royal Melbourne Hospital (P.M.D., B.Y., P.J.M.), University of Melbourne, Parkville, the Department of Medicine, School of Clinical Science, Monash University, Clayton (H.M., T.G.P.), the Departments of Medicine and Neurology, Melbourne Medical School, University of Melbourne and Western Health, Sunshine Hospital, St. Albans (T.W.), the Department of Neurosciences, Eastern Health and Eastern Health Clinical School, Monash University, Box Hill (H.M.D., C.F.B.), the Department of Neurology, University Hospital Geelong, Deakin University, Geelong (B.C.), the Department of Neurology, Austin Hospital, Austin Health, Heidelberg (V.T.), and Occupational Therapy, School of Allied Health, College of Science, Health and Engineering, La Trobe University, Bundoora (L. Carey), VIC, the Department of Neurology, Priority Research Centre for Brain and Mental Health Research, John Hunter Hospital (C.R.L., F.M.), University of Newcastle (J.S.), Newcastle, the Department of Neurology, Westmead Hospital (N.M.), the Department of Neurology, Royal North Shore Hospital and Kolling Institute, University of Sydney (M.K.), and the Department of Neurology, St. Vincent's Hospital Sydney (R.M.), Sydney, and the Department of Neurology, Gosford Hospital, Gosford (J.S.), NSW, the Department of Neurology, Royal Adelaide Hospital (T.J.K., J.J.), the Department of Neurology, Lyell McEwin Hospital (D.F.), and the Department of Neurology, Queen Elizabeth Hospital (J.J.), Adelaide, SA, the Department of Medicine, Sunshine Coast University Hospital, Nambour (R.G.), the Department of Neurology, Royal Brisbane and Women's Hospital and the University of Queensland, Brisbane (A.A.W.), and the Department of Neurology, Gold Coast University Hospital, Southport (A.S.), and Australia and Griffith University, Gold Coast (A.S.), QLD - all in Australia; the Graduate Institute of Clinical Medical Science (C.H.) and the School of Medicine (C.-H.T.), China Medical University, and the Department of Neurology, China Medical University Hospital (C.-H.T.), Taichung, the Department of Neurology, Tri-Service General Hospital, National Defense Medical Center (J.-T.L.), the Department of Neurology, Shuang Ho Hospital (C.-J.H.), the Department of Neurology, En Chu Kong Hospital (Y.S.), the Stroke Center and Department of Neurology, National Taiwan University Hospital (J.-S.J.), and the Department of Neurology, Shin Kong Wu Ho-Su Memorial Hospital, Taipei Medical University College of Medicine (L.-M.L.), Taipei, the Stroke Center and Department of Neurology, Changhua Christian Hospital, Changhua (M.-C.S.), the Department of Neurology, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan (C.-H.C.), and the Department of Neurology, Kaohsiung Veterans General Hospital, Kaohsiung (C.-H.L.) - all in Taiwan; the Department of Neurology, Helsinki University Hospital, Helsinki (S. Curtze, A.M.); the Department of Neurology, Auckland City Hospital, University of Auckland, Auckland, New Zealand (P.A.B.); and the Stanford Stroke Center, Stanford University, Stanford, CA (S. Christensen).

Background: The time to initiate intravenous thrombolysis for acute ischemic stroke is generally limited to within 4.5 hours after the onset of symptoms. Some trials have suggested that the treatment window may be extended in patients who are shown to have ischemic but not yet infarcted brain tissue on imaging.

Methods: We conducted a multicenter, randomized, placebo-controlled trial involving patients with ischemic stroke who had hypoperfused but salvageable regions of brain detected on automated perfusion imaging. The patients were randomly assigned to receive intravenous alteplase or placebo between 4.5 and 9.0 hours after the onset of stroke or on awakening with stroke (if within 9 hours from the midpoint of sleep). The primary outcome was a score of 0 or 1 on the modified Rankin scale, on which scores range from 0 (no symptoms) to 6 (death), at 90 days. The risk ratio for the primary outcome was adjusted for age and clinical severity at baseline.

Results: After 225 of the planned 310 patients had been enrolled, the trial was terminated because of a loss of equipoise after the publication of positive results from a previous trial. A total of 113 patients were randomly assigned to the alteplase group and 112 to the placebo group. The primary outcome occurred in 40 patients (35.4%) in the alteplase group and in 33 patients (29.5%) in the placebo group (adjusted risk ratio, 1.44; 95% confidence interval [CI], 1.01 to 2.06; P = 0.04). Symptomatic intracerebral hemorrhage occurred in 7 patients (6.2%) in the alteplase group and in 1 patient (0.9%) in the placebo group (adjusted risk ratio, 7.22; 95% CI, 0.97 to 53.5; P = 0.05). A secondary ordinal analysis of the distribution of scores on the modified Rankin scale did not show a significant between-group difference in functional improvement at 90 days.

Conclusions: Among the patients in this trial who had ischemic stroke and salvageable brain tissue, the use of alteplase between 4.5 and 9.0 hours after stroke onset or at the time the patient awoke with stroke symptoms resulted in a higher percentage of patients with no or minor neurologic deficits than the use of placebo. There were more cases of symptomatic cerebral hemorrhage in the alteplase group than in the placebo group. (Funded by the Australian National Health and Medical Research Council and others; EXTEND ClinicalTrials.gov numbers, NCT00887328 and NCT01580839.).
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http://dx.doi.org/10.1056/NEJMoa1813046DOI Listing
May 2019

Changes in acute hospital costs after employing clinical facilitators to improve stroke care in Victoria, Australia.

BMC Health Serv Res 2019 Jan 18;19(1):41. Epub 2019 Jan 18.

Stroke Division, Florey Institute of Neuroscience and Mental Health, University of Melbourne, Heidelberg, Australia.

Background: Hospital costs for stroke are increasing and variability in care quality creates inefficiencies. In 2007, the Victorian Government (Australia) employed clinical facilitators for three years in eight public hospitals to improve stroke care. Literature on the cost implications of such roles is rare. We report changes in the costs of acute stroke care following implementation of this program.

Methods: Observational controlled before-and-after cohort design. Standardised hospital costing data were compared pre-program (financial year 2006-07) and post-program (2010-11) for all admitted episodes of stroke or transient ischaemic attack (TIA) using ICD-10 discharge codes. Costs in Australian dollars (AUD) were adjusted to a common year 2010. Generalised linear regression models were used for adjusted comparisons.

Results: A 20% increase in stroke and TIA episodes was observed: 2624 pre-program (age > 75 years: 53%) and 3142 post-program (age > 75 years: 51%); largely explained by more TIA admissions (up from 785 to 1072). Average length of stay reduced by 22% (pre-program 7.3 days to post-program 5.7 days, p < 0.001). Six hospitals provided cost data. Average per-episode costs decreased by 10% (pre-program AUD7888 to post-program AUD7115). After adjusting for age, sex, stroke type, and hospital, average per-episode costs decreased by 6.1% from pre to post program (p = 0.025). When length of stay was additionally adjusted for, these costs increased by 10.8%, indicating a greater mean cost per day (p < 0.001).

Conclusion: Cost containment of acute inpatient episodes was observed after the implementation of stroke clinical facilitators, likely associated with the shorter lengths of stay.
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http://dx.doi.org/10.1186/s12913-018-3836-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6337854PMC
January 2019

Recommendation for an internationally agreed minimum data set for teleneurology.

Nat Rev Neurol 2018 11;14(11):687

Public Health & Health Services Research Group, Stroke Division, The Florey Institute of Neuroscience and Mental Health, University of Melbourne, Heidelberg, Victoria, Australia.

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http://dx.doi.org/10.1038/s41582-018-0081-0DOI Listing
November 2018

Sustainable implementation of innovative, technology-based health care practices: A qualitative case study from stroke telemedicine.

J Telemed Telecare 2020 Jan-Feb;26(1-2):79-91. Epub 2018 Sep 7.

The Florey Institute of Neuroscience and Mental Health, University of Melbourne, Australia.

Introduction: Technology-based innovation requires long-term changes to workforce routines, otherwise practices will not be sustained. The aim of this study was to identify influential factors in the ongoing use of an acute stroke telemedicine programme.

Methods: A new acute stroke telemedicine programme in a regional hospital receiving 375 patients with stroke or transient ischaemic attack per year was used as an exploratory case study. Semi-structured interviews with acute care and emergency department clinicians ( = 25) were conducted at two time-points: after a six-month pilot and then after a further 12-month implementation phase. Interviews (between 12-60 min) were recorded, transcribed and analysed inductively using descriptive thematic analysis. Reported barriers and facilitators were compared with those previously reported pre-implementation (deductive analysis) to identify changes over time. Using an implementation framework and a behaviour change taxonomy, strategies were developed to address influential factors on sustainability.

Results: New facilitators were identified including hospital system changes, benefits to clinicians and telemedicine becoming standard practice. New and ongoing barriers included infrequent use, competing demands and the continued resistance to a specific treatment.

Discussion: Understanding the factors supporting a health service in successfully implementing change can accelerate population benefits. The innovation itself may include barriers to be addressed, and barriers and facilitators can change over time. Individual attitudes remain critical to initial and ongoing success. Strategies proposed included promoting benefits across the organisation and allaying uncertainties with site-specific evidence. The effectiveness of these strategies, however, needs to be evaluated. Strategies sustaining change post-implementation should be considered.
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http://dx.doi.org/10.1177/1357633X18792380DOI Listing
June 2020

Tenecteplase versus Alteplase before Thrombectomy for Ischemic Stroke.

N Engl J Med 2018 04;378(17):1573-1582

From the Departments of Medicine and Neurology, Melbourne Brain Centre (B.C.V.C., N.Y., B.Y., T.Y.W., D.G.S., E.R., H.Z., P.S., G.S., M.W.P., S.M.D.), and the Department of Radiology (P.J.M., R.J.D., S.J.B., P.M.D.), Royal Melbourne Hospital, and the Florey Institute of Neuroscience and Mental Health (L.C., N.Y., V.T., H.A., H.M., C.F.B., G.A.D.), University of Melbourne, Parkville, VIC, the Departments of Neurology (T.J.K.) and Radiology (R.S.), Royal Adelaide Hospital, and the Department of Neurology, Lyell McEwin Hospital (D.F.), Adelaide, SA, the Department of Neurosciences, Eastern Health and Eastern Health Clinical School (H.M.D., C.F.B.), and the Departments of Neurology (H.M., T.G.P.) and Radiology (W. Chong, R.V.C., L.-A.S.), Monash Medical Centre, Monash University, Clayton, VIC, the Departments of Neurology (V.T., M.S.) and Radiology (M.B., H.A.), Austin Hospital, Austin Health, Heidelberg, VIC, School of Medicine, Faculty of Health, Deakin University, Melbourne, VIC (H.A.), and the Departments of Medicine and Neurology, Melbourne Medical School, University of Melbourne and Western Health, Sunshine Hospital, St. Albans, VIC (T.W.), the Departments of Neurology (D.G.S., H.B.) and Radiology (K.R., D.L.), Princess Alexandra Hospital, and the Departments of Neurology (A.A.W., C.M.) and Radiology (A.C., K. Mitchell, J.C., K. Mahady), Royal Brisbane and Women's Hospital and the University of Queensland, Brisbane, the Departments of Neurology (P.B.) and Radiology (H.R., L.V.), Gold Coast University Hospital, Southport, QLD, and the Department of Neurology, Priority Research Centre for Brain and Mental Health Research, John Hunter Hospital, University of Newcastle, Newcastle, NSW (T.A., F.M., C.R.L., C.G.-E., M.W.P.), the Department of Neurology, Royal North Shore Hospital and Kolling Institute, University of Sydney (M.K.), and the Department of Radiology, Royal North Shore Hospital (T.J.H., K.C.F., B.S.S.), St. Leonards, and the Department of Radiology, Westmead Hospital, Sydney (T.J.H., K.C.F., B.S.S.) - all in Australia; and the Departments of Neurology (T.Y.W., J.N.F.) and Radiology (W. Collecutt), Christchurch Hospital, Christchurch, New Zealand.

Background: Intravenous infusion of alteplase is used for thrombolysis before endovascular thrombectomy for ischemic stroke. Tenecteplase, which is more fibrin-specific and has longer activity than alteplase, is given as a bolus and may increase the incidence of vascular reperfusion.

Methods: We randomly assigned patients with ischemic stroke who had occlusion of the internal carotid, basilar, or middle cerebral artery and who were eligible to undergo thrombectomy to receive tenecteplase (at a dose of 0.25 mg per kilogram of body weight; maximum dose, 25 mg) or alteplase (at a dose of 0.9 mg per kilogram; maximum dose, 90 mg) within 4.5 hours after symptom onset. The primary outcome was reperfusion of greater than 50% of the involved ischemic territory or an absence of retrievable thrombus at the time of the initial angiographic assessment. Noninferiority of tenecteplase was tested, followed by superiority. Secondary outcomes included the modified Rankin scale score (on a scale from 0 [no neurologic deficit] to 6 [death]) at 90 days. Safety outcomes were death and symptomatic intracerebral hemorrhage.

Results: Of 202 patients enrolled, 101 were assigned to receive tenecteplase and 101 to receive alteplase. The primary outcome occurred in 22% of the patients treated with tenecteplase versus 10% of those treated with alteplase (incidence difference, 12 percentage points; 95% confidence interval [CI], 2 to 21; incidence ratio, 2.2; 95% CI, 1.1 to 4.4; P=0.002 for noninferiority; P=0.03 for superiority). Tenecteplase resulted in a better 90-day functional outcome than alteplase (median modified Rankin scale score, 2 vs. 3; common odds ratio, 1.7; 95% CI, 1.0 to 2.8; P=0.04). Symptomatic intracerebral hemorrhage occurred in 1% of the patients in each group.

Conclusions: Tenecteplase before thrombectomy was associated with a higher incidence of reperfusion and better functional outcome than alteplase among patients with ischemic stroke treated within 4.5 hours after symptom onset. (Funded by the National Health and Medical Research Council of Australia and others; EXTEND-IA TNK ClinicalTrials.gov number, NCT02388061 .).
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http://dx.doi.org/10.1056/NEJMoa1716405DOI Listing
April 2018

Endovascular Thrombectomy for Ischemic Stroke Increases Disability-Free Survival, Quality of Life, and Life Expectancy and Reduces Cost.

Front Neurol 2017 14;8:657. Epub 2017 Dec 14.

Gold Coast University Hospital, Southport, QLD, Australia.

Background: Endovascular thrombectomy improves functional outcome in large vessel occlusion ischemic stroke. We examined disability, quality of life, survival and acute care costs in the EXTEND-IA trial, which used CT-perfusion imaging selection.

Methods: Large vessel ischemic stroke patients with favorable CT-perfusion were randomized to endovascular thrombectomy after alteplase versus alteplase-only. Clinical outcome was prospectively measured using 90-day modified Rankin scale (mRS). Individual patient expected survival and net difference in Disability/Quality-adjusted life years (DALY/QALY) up to 15 years from stroke were modeled using age, sex, 90-day mRS, and utility scores. Level of care within the first 90 days was prospectively measured and used to estimate procedure and inpatient care costs (US$ reference year 2014).

Results: There were 70 patients, 35 in each arm, mean age 69, median NIHSS 15 (IQR 12-19). The median (IQR) disability-weighted utility score at 90 days was 0.65 (0.00-0.91) in the alteplase-only versus 0.91 (0.65-1.00) in the endovascular group ( = 0.005). Modeled life expectancy was greater in the endovascular versus alteplase-only group (median 15.6 versus 11.2 years,  = 0.02). The endovascular thrombectomy group had fewer simulated DALYs lost over 15 years [median (IQR) 5.5 (3.2-8.7) versus 8.9 (4.7-13.8),  = 0.02] and more QALY gained [median (IQR) 9.3 (4.2-13.1) versus 4.9 (0.3-8.5),  = 0.03]. Endovascular patients spent less time in hospital [median (IQR) 5 (3-11) days versus 8 (5-14) days,  = 0.04] and rehabilitation [median (IQR) 0 (0-28) versus 27 (0-65) days,  = 0.03]. The estimated inpatient costs in the first 90 days were less in the thrombectomy group (average US$15,689 versus US$30,569,  = 0.008) offsetting the costs of interhospital transport and the thrombectomy procedure (average US$10,515). The average saving per patient treated with thrombectomy was US$4,365.

Conclusion: Thrombectomy patients with large vessel occlusion and salvageable tissue on CT-perfusion had reduced length of stay and overall costs to 90 days. There was evidence of clinically relevant improvement in long-term survival and quality of life.

Clinical Trial Registration: http://www.ClinicalTrials.gov NCT01492725 (registered 20/11/2011).
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http://dx.doi.org/10.3389/fneur.2017.00657DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5735082PMC
December 2017

Integrating acute stroke telemedicine consultations into specialists' usual practice: a qualitative analysis comparing the experience of Australia and the United Kingdom.

BMC Health Serv Res 2017 Nov 21;17(1):751. Epub 2017 Nov 21.

University of Central Lancashire, Preston, UK.

Background: Stroke telemedicine can reduce healthcare inequities by increasing access to specialists. Successful telemedicine networks require specialists adapting clinical practice to provide remote consultations. Variation in experiences of specialists between different countries is unknown. To support future implementation, we compared perceptions of Australian and United Kingdom specialists providing remote acute stroke consultations.

Methods: Specialist participants were identified using purposive sampling from two new services: Australia's Victorian Stroke Telemedicine Program (n = 6; 2010-13) and the United Kingdom's Cumbria and Lancashire telestroke network (n = 5; 2010-2012). Semi-structured interviews were conducted pre- and post-implementation, recorded and transcribed verbatim. Deductive thematic and content analysis (NVivo) was undertaken by two independent coders using Normalisation Process Theory to explore integration of telemedicine into practice. Agreement between coders was M = 91%, SD = 9 and weighted average κ = 0.70.

Results: Cross-cultural similarities and differences were found. In both countries, specialists described old and new consulting practices, the purpose and value of telemedicine systems, and concerns regarding confidence in the assessment and diagnostic skills of unknown colleagues requesting telemedicine support. Australian specialists discussed how remote consultations impacted on usual roles and suggested future improvements, while United Kingdom specialists discussed system governance, policy and procedures.

Conclusion: Australian and United Kingdom specialists reported telemedicine required changes in work practice and development of new skills. Both groups described potential for improvements in stroke telemedicine systems with Australian specialists more focused on role change and the United Kingdom on system governance issues. Future research should examine if cross-cultural variation reflects different models of care and extends to other networks.
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http://dx.doi.org/10.1186/s12913-017-2694-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5697163PMC
November 2017

Transitioning from a single-site pilot project to a state-wide regional telehealth service: The experience from the Victorian Stroke Telemedicine programme.

J Telemed Telecare 2017 Dec;23(10):850-855

1 Stroke Division, the Florey Institute of Neuroscience and Mental Health, University of Melbourne, Australia.

Scaling of projects from inception to establishment within the healthcare system is rarely formally reported. The Victorian Stroke Telemedicine (VST) programme provided a very useful opportunity to describe how rural hospitals in Victoria were able to access a network of Melbourne-based neurologists via telemedicine. The VST programme was initially piloted at one site in 2010 and has gradually expanded as a state-wide regional service operating with 16 hospitals in 2017. The aim of this paper is to summarise the factors that facilitated the state-wide transition of the VST programme. A naturalistic case-study was used and data were obtained from programme documents, e.g. minutes of governance committees, including the steering committee, the management committee and six working groups; operational and evaluation documentation, interviews and research field-notes taken by project staff. Thematic analysis was undertaken, with results presented in narrative form to provide a summary of the lived experience of developing and scaling the VST programme. The main success factors were attaining funding from various sources, identifying a clinical need and evidence-based solution, engaging stakeholders and facilitating co-design, including embedding the programme within policy, iterative evaluation including performing financial sustainability modelling, and conducting dissemination activities of the interim results, including promotion of early successes.
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http://dx.doi.org/10.1177/1357633X17734004DOI Listing
December 2017

Tenecteplase versus alteplase before endovascular thrombectomy (EXTEND-IA TNK): A multicenter, randomized, controlled study.

Int J Stroke 2018 04 27;13(3):328-334. Epub 2017 Sep 27.

16 Royal Brisbane & Women's Hospital, University of Queensland, Brisbane, Queensland, Australia.

Background and hypothesis Intravenous thrombolysis with alteplase remains standard care prior to thrombectomy for eligible patients within 4.5 h of ischemic stroke onset. However, alteplase only succeeds in reperfusing large vessel arterial occlusion prior to thrombectomy in a minority of patients. We hypothesized that tenecteplase is non-inferior to alteplase in achieving reperfusion at initial angiogram, when administered within 4.5 h of ischemic stroke onset, in patients planned to undergo endovascular therapy. Study design EXTEND-IA TNK is an investigator-initiated, phase II, multicenter, prospective, randomized, open-label, blinded-endpoint non-inferiority study. Eligibility requires a diagnosis of ischemic stroke within 4.5 h of stroke onset, pre-stroke modified Rankin Scale≤3 (no upper age limit), large vessel occlusion (internal carotid, basilar, or middle cerebral artery) on multimodal computed tomography and absence of contraindications to intravenous thrombolysis. Patients are randomized to either IV alteplase (0.9 mg/kg, max 90 mg) or tenecteplase (0.25 mg/kg, max 25 mg) prior to thrombectomy. Study outcomes The primary outcome measure is reperfusion on the initial catheter angiogram, assessed as modified treatment in cerebral infarction 2 b/3 or the absence of retrievable thrombus. Secondary outcomes include modified Rankin Scale at day 90 and favorable clinical response (reduction in National Institutes of Health Stroke Scale by ≥8 points or reaching 0-1) at day 3. Safety outcomes are death and symptomatic intracerebral hemorrhage. Trial registration ClinicalTrials.gov NCT02388061.
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http://dx.doi.org/10.1177/1747493017733935DOI Listing
April 2018

Route of Feeding as a Proxy for Dysphagia After Stroke and the Effect of Transdermal Glyceryl Trinitrate: Data from the Efficacy of Nitric Oxide in Stroke Randomised Controlled Trial.

Transl Stroke Res 2018 04 2;9(2):120-129. Epub 2017 Aug 2.

Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, City Hospital Campus, Hucknall Road, Nottingham, NG5 1PB, UK.

Post-stroke dysphagia is common, associated with poor outcome and often requires non-oral feeding/fluids. The relationship between route of feeding and outcome, as well as treatment with glyceryl trinitrate (GTN), was studied prospectively. The Efficacy of Nitric Oxide in Stroke (ENOS) trial assessed transdermal GTN (5 mg versus none for 7 days) in 4011 patients with acute stroke and high blood pressure. Feeding route (oral = normal or soft diet; non-oral = nasogastric tube, percutaneous endoscopic gastrostomy tube, parenteral fluids, no fluids) was assessed at baseline and day 7. The primary outcome was the modified Rankin Scale (mRS) measured at day 90. At baseline, 1331 (33.2%) patients had non-oral feeding, were older, had more severe stroke and more were female, than 2680 (66.8%) patients with oral feeding. By day 7, 756 patients had improved from non-oral to oral feeding, and 119 had deteriorated. Non-oral feeding at baseline was associated with more impairment at day 7 (Scandinavian Stroke Scale 29.0 versus 43.7; 2p < 0.001), and worse mRS (4.0 versus 2.7; 2p < 0.001) and death (23.6 versus 6.8%; 2p = 0.014) at day 90. Although GTN did not modify route of feeding overall, randomisation ≤6 h of stroke was associated with a move to more oral feeding at day 7 (odds ratio = 0.61, 95% confidence intervals 0.38, 0.98; 2p = 0.040). As a proxy for dysphagia, non-oral feeding is present in 33% of patients with acute stroke and associated with more impairment, dependency and death. GTN moved feeding route towards oral intake if given very early after stroke. Clinical Trial Registration Clinical Trial Registration-URL: http://www.controlled-trials.com . Unique identifier: ISRCTN99414122.
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http://dx.doi.org/10.1007/s12975-017-0548-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5849635PMC
April 2018

Community-Based Intervention to Improve Cardiometabolic Targets in Patients With Stroke: A Randomized Controlled Trial.

Stroke 2017 09 28;48(9):2504-2510. Epub 2017 Jul 28.

From the Stroke and Ageing Research, Department of Medicine, School of Clinical Sciences at Monash Health (M.T.O., D.A.C., J.K., V.K.S., T.P., A.G.T.) and Department of Epidemiology and Preventive Medicine (M.R.N., S.M.F.), Monash University, Clayton, Victoria, Australia; Stroke Division, Florey Institute of Neuroscience and Mental Health, Heidelberg, Victoria, Australia (D.A.C., J.K.); Menzies Institute for Medical Research, Hobart, Tasmania, Australia (M.R.N., V.K.S.); Department of Medicine, Epworth Healthcare, Richmond, Victoria, Australia (R.P.G.); Department of Neurosciences, Box Hill Hospital, Victoria, Australia (C.F.B.); and Department of Neurology, Alfred Hospital, Melbourne, Victoria, Australia (J.F.).

Background And Purpose: Many guidelines for secondary prevention of stroke focus on controlling cardiometabolic risk factors. We investigated the effectiveness of a management program for attaining cardiometabolic targets in survivors of stroke/transient ischemic attack.

Methods: Randomized controlled trial of survivors of stroke/transient ischemic attack aged ≥18 years. General practices were randomized to usual care (control) or an intervention comprising specialist review of care plans and nurse education in addition to usual care. The outcome is attainment of pre-defined cardiometabolic targets based on Australian guidelines. Multivariable regression was undertaken to determine efficacy and identify factors associated with attaining targets.

Results: Overall, 283 subjects were randomized to the intervention and 280 to controls. Although we found no between-group difference in overall cardiometabolic targets achieved at 12 months, the intervention group more often achieved control of low-density lipoprotein cholesterol (odds ratio, 1.97; 95% confidence interval, 1.18-3.29) than controls. At 24 months, no between-group differences were observed. Medication adherence was ≥80% at follow-up, but uptake of lifestyle/behavioral habits was poor. Older age, being male, being married/living with partner, and having greater functional ability or a history of diabetes mellitus were associated with attaining targets.

Conclusions: The intervention in this largely negative trial only had a detectable effect on attaining target for lipids but not for other factors at 12 months or any factor at 24 months. This limited effect may be attributable to inadequate uptake of behavioral/lifestyle interventions, highlighting the need for new or better approaches to achieve meaningful behavioral change.

Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: ACTRN12608000166370.
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http://dx.doi.org/10.1161/STROKEAHA.117.017499DOI Listing
September 2017

Tenecteplase in ischemic stroke offers improved recanalization: Analysis of 2 trials.

Neurology 2017 Jul 2;89(1):62-67. Epub 2017 Jun 2.

From the Department of Neurology (A.B., C.R.L., N.S., M.W.P.), John Hunter Hospital, University of Newcastle, Australia; Institute of Neuroscience and Psychology, Queen Elizabeth University Hospital (X.H., B.K.C., D.K., F.C.M., I.F., K.W.M.), and Robertson Centre for Biostatistics (I.F.), University of Glasgow, UK; Department of Medicine and Neurology, Royal Melbourne Hospital (B.C.V.C., S.M.D.), and The Florey Institute of Neuroscience & Mental Health (C.F.B., G.A.D.), University of Melbourne, Parkville; and the Department of Neurology (C.F.B.), Eastern Health Clinical School, Monash University, Clayton, Australia.

Objective: To test whether patients with complete vessel occlusion show greater recanalization at 24 hours and have improved clinical outcomes at 24 hours and 90 days when treated with tenecteplase compared to alteplase.

Methods: Pooled clinical and imaging data from 2 phase 2 randomized trials comparing tenecteplase with alteplase allowed CT angiography (CTA) scans to be assessed centrally for occlusion status at baseline and at 24 hours post thrombolysis using the modified thrombolysis in cerebral infarction (TICI) scale. Twenty-four-hour poststroke NIH Stroke Scale (NIHSS) and 90-day modified Rankin Scale (mRS) scores were also compared between treatment groups using linear regression to generate odds ratios (ORs).

Results: From 146 pooled patients, 69 had a TICI 0/1 occlusion overall at baseline. Tenecteplase-treated patients with a complete vessel occlusion had greater complete recanalization rates at 24 hours (71% for tenecteplase vs 43% for alteplase, < 0.001). Patients with a TICI 0/1 occlusion who were treated with tenecteplase also showed greater early clinical improvement (median NIHSS change with tenecteplase was 9, interquartile range [IQR] 6, alteplase 1, IQR 1, = 0.001) and higher rates of favorable 90-day outcomes (mRS 0-1 of tenecteplase compared with alteplase, OR 4.82, 95% confidence interval 1.02-7.84, = 0.05).

Conclusions: Tenecteplase may offer greater recanalization efficacy compared to alteplase, possibly exaggerated in patients with complete vessel occlusions on baseline CTA.
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http://dx.doi.org/10.1212/WNL.0000000000004062DOI Listing
July 2017

Long-term unmet needs and associated factors in stroke or TIA survivors: An observational study.

Neurology 2017 Jul 31;89(1):68-75. Epub 2017 May 31.

From Stroke and Ageing Research (M.T.O., D.A.C., J.K., V.K.S., N.E.A., T.P., A.G.T.), Department of Medicine, School of Clinical Sciences at Monash Health, Monash University, Clayton; Stroke Division (D.A.C., J.K., N.E.A.), Florey Institute of Neuroscience and Mental Health, Heidelberg; Menzies Institute for Medical Research (M.R.N., V.K.S.), Hobart; Department of Epidemiology and Preventive Medicine (M.R.N., S.M.F.), Monash University, Melbourne; School of Medicine (M.R.N.), University of Tasmania, Hobart; Department of Neurosciences (C.F.B.), Box Hill Hospital; Department of Medicine (R.P.G.), Epworth Healthcare, Monash University, Richmond; and Department of Neurology (J.F.), Alfred Hospital, Melbourne, Australia.

Objective: To extensively investigate long-term unmet needs in survivors of stroke or TIA and to identify factors associated with these unmet needs.

Methods: Community-dwelling adults were invited to participate in a survey ≥2 years after discharge for stroke/TIA. Unmet needs were assessed across 5 domains: activities and participation, environmental factors, body functions, post-acute care, and secondary prevention. Factors associated with unmet needs were determined with multivariable negative binomial regression.

Results: Of 485 participants invited to complete the survey, 391 (81%) responded (median age 73 years, 67% male). Most responders (87%) reported unmet needs in ≥1 of the measured domains, particularly in secondary prevention (71%). Factors associated with fewer unmet needs included older age (incident rate ratio [IRR] 0.62, 95% confidence interval [CI] 0.50-0.77), greater functional ability (IRR 0.33, 95% CI 0.17-0.67), and reporting that the general practitioner was the most important in care (IRR 0.69, 95% CI 0.57-0.84). Being depressed (IRR 1.61, 95% CI 1.23-2.10) and receiving community services after stroke (IRR 1.45, 95% CI 1.16-1.82) were associated with more unmet needs.

Conclusions: Survivors of stroke/TIA reported considerable unmet needs ≥2 years after discharge, particularly in secondary prevention. The factors associated with unmet needs could help guide policy decisions, particularly for tailoring care and support services provided after discharge.
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http://dx.doi.org/10.1212/WNL.0000000000004063DOI Listing
July 2017

Strategic framework improves access to stroke reperfusion across the state of Victoria Australia.

Intern Med J 2017 Aug;47(8):923-928

The Florey Institute of Neuroscience and Mental Health, Melbourne, Victoria, Australia.

Background: In 2010, rapid access to stroke thrombolysis centres was limited in some regional areas in the Australian state of Victoria. These results, and planning for endovascular clot retrieval (ECR), have led to the implementation of strategies by the Victorian Stroke Clinical Network, the Victorian Stroke Telemedicine Program and local health services to improve state-wide access.

Aims: To examine whether access to stroke reperfusion services (thrombolysis and ECR) in regional Victoria have subsequently improved.

Methods: The locations of suspected stroke patients attended by ambulance in 2015 were mapped, and drive times to the nearest reperfusion services were calculated. We then calculated the proportion of cases with transport times within: (i) 60 min to thrombolysis centres; and (ii) 180 min to two ECR centres designated to receive regional patients. Statistical comparisons to existing 2010 data were made.

Results: In 2015, Ambulance Victoria attended 16 418 cases of suspected stroke (2.9% of all emergency calls), of whom 4597 (28%) were located in regional Victoria. Compared to 2010, a greater proportion of regional suspected stroke patients in 2015 were located within 60 min of a thrombolysis centre by road (77-95%, P < 0.001). A 3-h road travel time to the two ECR centres is currently possible for 88% of regional patients.

Conclusion: A strategic and region-specific approach has resulted in improved access by road transport to reperfusion therapies for stroke patients across Victoria.
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http://dx.doi.org/10.1111/imj.13494DOI Listing
August 2017

Benefits of clinical facilitators on improving stroke care in acute hospitals: a new programme for Australia.

Intern Med J 2017 Jul;47(7):775-784

Department of Medicine, School of Clinical Sciences at Monash Health, Monash University, Melbourne, Australia.

Background: Care gaps for stroke lead to preventable disability and deaths. The Victorian State Government implemented a programme of employing clinical Facilitators on a fixed-term basis for up to 3 years (2008-2011) in eight hospitals to improve stroke care. The Facilitators were to establish stroke units where absent, implement evidence-based management protocols and provide staff education within an agreed work plan.

Aim: To determine if the Facilitator role was associated with improved stroke care and to describe factors supporting or mitigating enhancements to care.

Methods: A mixed methods design was employed with historical control using patient-level audit data (pre-Facilitator: n = 600; post-Facilitator: n = 387) and qualitative data from independently conducted semistructured interviews with hospital staff, including clinicians, executives and facilitators (n = 10 focus groups; 75 respondents).

Results: Stroke units, clinical pathways and outpatient clinics for managing transient ischaemic attacks (TIA) were established. Compared with the pre-Facilitator period, significant increases in patient access to stroke unit care (53% vs 86%, P < 0.001) and intravenous thrombolysis (2% vs 9%, P < 0.001) were achieved. Hospital staff reported that the Facilitator was integral to system improvements by fostering communication, encouraging team motivation and cohesiveness and increasing interest in stroke care. Ongoing barriers included limited resources to operate TIA clinics effectively, staff turnover requiring ongoing education, inconsistency in compliance with protocols and, in some hospitals, the need for formalised medical leadership.

Conclusion: Fixed-term employment of Facilitators was effective in positively influencing stroke care in hospitals through a range of change management strategies where stroke-specific expertise had been previously limited.
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http://dx.doi.org/10.1111/imj.13458DOI Listing
July 2017

Quality of Acute Care and Long-Term Quality of Life and Survival: The Australian Stroke Clinical Registry.

Stroke 2017 04 3;48(4):1026-1032. Epub 2017 Mar 3.

From the Stroke and Ageing Research, School of Clinical Sciences at Monash Health, Monash University, Clayton, Victoria, Australia (D.A.C., N.E.A.); Florey Institute Neuroscience and Mental Health, Heidelberg, University of Melbourne, Victoria, Australia (D.A.C., B.G., C.F.B., G.A.D.); College of Science, Health and Engineering, School of Allied Health, La Trobe University, Bundoora, Victoria, Australia (N.A.L.); Occupational Therapy Department, Alfred Health, Prahran, Victoria, Australia (N.A.L.); Nursing Research Institute, St Vincent's Health Australia (Sydney) and Australian Catholic University, New South Wales (S.M.); Priority Research Centre for Translational Neurosciences Mental Health Research, University of Newcastle and Hunter Research Institute, New South Wales, Australia (C.R.L.); Eastern Health Clinical School, Monash University, Box Hill, Victoria, Australia (H.M.D., C.F.B.); Faculty of Medicine, The University of New South Wales, Sydney and St Vincent's Hospital, Darlinghurst, Australia (S.F.); National Stroke Foundation, Melbourne, Victoria, Australia (K.H.); University of Queensland, Brisbane, Australia (R.G., A.W.); Neurology Department, Royal Brisbane and Women's Hospital, Queensland, Australia (A.W.); Neurology Department, Gold Coast Hospital, Queensland, Australia (A.S.); Neurology Department, Peninsula Health, Frankston, Victoria, Australia (E.B.); Swan District Hospital and University of Western Australia, Perth, Australia (T.R.B.); South West Healthcare, Warrnambool, Victoria, Australia (P.G.); Neurology Department, Royal Hobart Hospital, Hobart, Tasmania, Australia (H.C.); The George Institute for Global Health, The University of Sydney, New South Wales, Australia (C.S.A.); and Neurology Department, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia (C.S.A.).

Background And Purpose: Uncertainty exists over whether quality improvement strategies translate into better health-related quality of life (HRQoL) and survival after acute stroke. We aimed to determine the association of best practice recommended interventions and outcomes after stroke.

Methods: Data are from the Australian Stroke Clinical Registry during 2010 to 2014. Multivariable regression was used to determine associations between 3 interventions: received acute stroke unit (ASU) care and in various combinations with prescribed antihypertensive medication at discharge, provision of a discharge care plan, and outcomes of survival and HRQoL (EuroQoL 5-dimensional questionnaire visual analogue scale) at 180 days, by stroke type. An assessment was also made of outcomes related to the number of processes patients received.

Results: There were 17 585 stroke admissions (median age 77 years, 47% female; 81% managed in ASUs; 80% ischemic stroke) from 42 hospitals (77% metropolitan) assessed. Cumulative benefits on outcomes related to the number of care processes received by patients. ASU care was associated with a reduced likelihood of death (hazard ratio, 0.49; 95% confidence interval, 0.43-0.56) and better HRQoL (coefficient, 21.34; 95% confidence interval, 15.50-27.18) within 180 days. For those discharged from hospital, receiving ASU+antihypertensive medication provided greater 180-day survival (hazard ratio, 0.45; 95% confidence interval, 0.38-0.52) compared with ASU care alone (hazard ratio, 0.64; 95% confidence interval, 0.54-0.76). HRQoL gains were greatest for patients with intracerebral hemorrhage who received care bundles involving discharge processes (range of increase, 11%-19%).

Conclusions: Patients with stroke who receive best practice recommended hospital care have improved long-term survival and HRQoL.
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http://dx.doi.org/10.1161/STROKEAHA.116.015714DOI Listing
April 2017

Effectiveness of an Intervention to Improve Risk Factor Knowledge in Patients With Stroke: A Randomized Controlled Trial.

Stroke 2017 04 1;48(4):1101-1103. Epub 2017 Mar 1.

From the Departments of Medicine (M.T.O., D.A.C., J.K., D.U., V.K.S., T.P., A.G.T.) and Epidemiology and Preventive Medicine (M.R.N., S.M.F.), Monash University, Melbourne, VIC, Australia; Stroke Division, Florey Institute of Neuroscience and Mental Health, Parkville, VIC, Australia (D.A.C., J.K.); Menzies Institute for Medical Research, Hobart, TAS, Australia (M.R.N., V.K.S.); Department of Neurosciences, Box Hill Hospital, VIC, Australia (C.F.B.); Department of Medicine, Epworth Healthcare, Richmond, VIC, Australia (R.P.G.); and Department of Neurology, Alfred Hospital, Melbourne, VIC, Australia (J.F.).

Background And Purpose: Despite the benefit of risk awareness in secondary prevention, survivors of stroke are often unaware of their risk factors. We determined whether a nurse-led intervention improved knowledge of risk factors in people with stroke or transient ischemic attack.

Methods: Prospective study nested within a randomized controlled trial of risk factor management in survivors of stroke or transient ischemic attack.

Intervention: 3 nurse education visits and specialist review of care plans.

Outcome: unprompted knowledge of risk factors of stroke or transient ischemic attack at 24 months. Effect of intervention on knowledge and factors associated with knowledge were determined using multivariable regression models.

Results: Knowledge was assessed in 268 consecutive participants from the main trial, 128 in usual care and 140 in the intervention. Overall, 34% of participants were unable to name any risk factor. In adjusted analyses, the intervention group had better overall knowledge than controls (incidence risk ratio, 1.26; 95% confidence interval, 1.00-1.58). Greater functional ability and polypharmacy were associated with better knowledge and older age and having more comorbidities associated with poorer knowledge.

Conclusions: Overall knowledge of risk factors of stroke or transient ischemic attack was better in the intervention group than controls. However, knowledge was generally poor. New and more effective strategies are required, especially in subgroups identified as having poor knowledge.

Clinical Trial Registration: URL: http://www.anzctr.org.au. Unique identifier: ACTRN12608000166370.
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http://dx.doi.org/10.1161/STROKEAHA.116.016229DOI Listing
April 2017

A cautionary note to authors on the selection and use of keywords.

J Telemed Telecare 2017 09 23;23(8):752-753. Epub 2016 Dec 23.

1 The Florey Institute of Neuroscience and Mental Health, Heidelberg, University of Melbourne, Victoria, Australia.

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http://dx.doi.org/10.1177/1357633X16686549DOI Listing
September 2017