ORCID Profile
0000-0003-3750-765X
Current Organisations
Hawke's Bay Hospital
,
Royal Australasian College of Physicians
,
The University of Auckland
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Publications
Geographic Disparities in Stroke Outcomes and Service Access
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 26-07-2022
DOI: 10.1212/WNL.0000000000200526
Abstract: International evidence shows that patients treated at nonurban hospitals experience poorer access to key stroke interventions. Evidence for whether this results in poorer outcomes is conflicting and generally based on administrative or voluntary registry data. The aim of this study was to use prospective high-quality comprehensive nationwide patient-level data to investigate the association between hospital geography and outcomes of patients with stroke and access to best-practice stroke care in New Zealand. This is a prospective, multicenter, nationally representative observational study involving all 28 New Zealand acute stroke hospitals (18 nonurban) and affiliated rehabilitation and community services. Consecutive adults admitted to the hospital with acute stroke between May 1 and October 31, 2018, were captured. Outcomes included functional outcome (modified Rankin Scale [mRS] score shift analysis), functional independence (mRS score 0–2), quality of life (EuroQol 5-dimension, 3-level health-related quality of life questionnaire), stroke/vascular events, and death at 3, 6, and 12 months and proportion accessing thrombolysis, thrombectomy, stroke units, key investigations, secondary prevention, and inpatient/community rehabilitation. Results were adjusted for age, sex, ethnicity, stroke severity/type, comorbid conditions, baseline function, and differences in baseline characteristics. Overall, 2,379 patients were eligible (mean [SD] age 75 [13.7] years 51.2% male 1,430 urban, 949 nonurban). Patients treated at nonurban hospitals were more likely to score in a higher mRS score category (greater disability) at 3 (adjusted odds ratio [aOR] 1.28, 95% CI 1.07–1.53), 6 (aOR 1.33, 95% CI 1.07–1.65), and 12 (aOR 1.31, 95% CI 1.06–1.62) months and were more likely to have died (aOR 1.57, 95% CI 1.17–2.12) or experienced recurrent stroke and vascular events at 12 months (aOR 1.94, 95% CI 1.14–3.29 and aOR 1.65, 95% CI 1.09–2.52). Fewer nonurban patients received recommended stroke interventions, including endovascular thrombectomy (aOR 0.25, 95% CI 0.13–0.49), acute stroke unit care (aOR 0.60, 95% CI 0.49–0.73), antiplatelet prescriptions (aOR 0.72, 95% CI 0.58–0.88), ≥60 minutes of daily physical therapy (aOR 0.55, 95% CI 0.40–0.77), and community rehabilitation (aOR 0.69, 95% CI 0.56–0.84). Patients managed at nonurban hospitals experience poorer stroke outcomes and reduced access to key stroke interventions across the entire care continuum. Efforts to improve access to high quality stroke care in nonurban hospitals should be a priority.
Safety and efficacy of fluoxetine on functional outcome after acute stroke (AFFINITY): a randomised, double-blind, placebo-controlled trial
Publisher: Elsevier BV
Date: 08-2020
Taking charge after stroke: promoting self-directed rehabilitation to improve quality of life – a randomized controlled trial
Publisher: SAGE Publications
Date: 15-11-2011
Abstract: Objective: Few community interventions following stroke enhance activity, participation or quality of life. We tested two novel community interventions designed to promote self-directed rehabilitation following stroke. Design: This was a randomized, controlled parallel group 2×2 trial. Setting: Community. Participants: Maori and Pacific New Zealanders, years old, randomized within three months of a new stroke. Interventions: A DVD of four inspirational stories by Maori and Pacific people with stroke and a ‘Take Charge Session’ – a single structured risk factor and activities of daily living assessment, designed to facilitate self-directed rehabilitation. Main measures: Primary outcomes were Health-related Quality of Life (Physical Component Summary (PCS) and Mental Component Summary (MCS) scores of the Short Form 36 (SF-36)) 12 months from randomization. Secondary outcomes were Barthel Index, Frenchay Activities Index, Carer Strain Index and modified Rankin score. Results: One hundred and seventy-two people were randomized with 139 (80.8%) followed up at 12 months post randomization. The effect of the Take Charge Session on SF-36 PCS at 12 months was 6.0 (95% confidence interval (CI) 2.0 to 10.0) and of the DVD was 0.9 (95% CI −3.1 to 4.9). Participants allocated to the Take Charge Session were less likely to have a modified Rankin score of (odds ratio (OR) 0.42, 95% CI 0.2 to 0.89) and their carers had lower (better) Carer Strain Index scores (−1.5, 95% CI −2.8 to −0.1). Conclusion: A simple, low-cost intervention in the community phase of stroke recovery aiming to promote self-directed rehabilitation improved outcomes.
Reducing Ethnic and Geographic Inequities to Optimise New Zealand Stroke Care (REGIONS Care): Protocol for a Nationwide Observational Study
Publisher: JMIR Publications Inc.
Date: 12-01-2021
DOI: 10.2196/25374
Abstract: Stroke systems of care differ between larger urban and smaller rural settings and it is unclear to what extent this may impact on patient outcomes. Ethnicity influences stroke risk factors and care delivery as well as patient outcomes in nonstroke settings. Little is known about the impact of ethnicity on poststroke care, especially in Māori and Pacific populations. Our goal is to describe the protocol for the Reducing Ethnic and Geographic Inequities to Optimise New Zealand Stroke Care (REGIONS Care) study. This large, nationwide observational study assesses the impact of rurality and ethnicity on best practice stroke care access and outcomes involving all 28 New Zealand hospitals caring for stroke patients, by capturing every stroke patient admitted to hospital during the 2017-2018 study period. In addition, it explores current access barriers through consumer focus groups and consumer, carer, clinician, manager, and policy-maker surveys. It also assesses the economic impact of care provided at different types of hospitals and to patients of different ethnicities and explores the cost-efficacy of in idual interventions and care bundles. Finally, it compares manual data collection to routine health administrative data and explores the feasibility of developing outcome models using only administrative data and the cost-efficacy of using additional manually collected registry data. Regarding s le size estimates, in Part 1, Study A, 2400 participants are needed to identify a 10% difference between up to four geographic subgroups at 90% power with an α value of .05 and 10% to 20% loss to follow-up. In Part 1, Study B, a s le of 7645 participants was expected to include an estimated 850 Māori and 419 Pacific patients and to provide over 90% and over 80% power, respectively. Regarding Part 2, 50% of the patient or carer surveys, 40 provider surveys, and 10 focus groups were needed to achieve saturation of themes. The main outcome is the modified Rankin Scale (mRS) score at 3 months. Secondary outcomes include mRS scores EQ-5D-3L (5-dimension, 3-level EuroQol questionnaire) scores stroke recurrence vascular events death readmission at 3, 6, and 12 months cost of care and themes around access barriers. The study is underway, with national and institutional ethics approvals in place. A total of 2379 patients have been recruited for Part 1, Study A 6837 patients have been recruited for Part 1, Study B 10 focus groups have been conducted and 70 surveys have been completed in Part 2. Data collection has essentially been completed, including follow-up assessment however, primary and secondary analyses, data linkage, data validation, and health economics analysis are still underway. The methods of this study may provide the basis for future epidemiological studies that will guide care improvements in other countries and populations. DERR1-10.2196/25374
Comparison of idraparinux with vitamin K antagonists for prevention of thromboembolism in patients with atrial fibrillation: a randomised, open-label, non-inferiority trial
Publisher: Elsevier BV
Date: 2008
Central adjudication of serious adverse events did not affect trial’s safety results: Data from the Efficacy of Nitric Oxide in Stroke (ENOS) trial
Publisher: Public Library of Science (PLoS)
Date: 26-11-2018
Effect of B Vitamins and Lowering Homocysteine on Cognitive Impairment in Patients With Previous Stroke or Transient Ischemic Attack
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 08-2013
DOI: 10.1161/STROKEAHA.113.001886
Abstract: High plasma total homocysteine (tHcy) has been associated with cognitive impairment but lowering tHcy with B-vitamins has produced equivocal results. We aimed to determine whether B-vitamin supplementation would reduce tHcy and the incidence of new cognitive impairment among in iduals with stroke or transient ischemic attack ≥6 months previously. A total of 8164 patients with stroke or transient ischemic attack were randomly allocated to double-blind treatment with one tablet daily of B-vitamins (folic acid, 2 mg vitamin B6, 25 mg vitamin B12, 500 μg) or placebo and followed up for 3.4 years (median) in the VITAmins TO Prevent Stroke (VITATOPS) trial. For this prespecified secondary analysis of VITATOPS, the primary outcome was a new diagnosis of cognitive impairment, defined as a Mini-Mental State Examination (MMSE) score on ≥2 follow-up visits. Secondary outcomes were cognitive decline, and the mean tHcy and MMSE at final follow-up. A total of 3089 participants (38%) voluntarily undertook the MMSE months after the qualifying stroke 2608 participants were cognitively unimpaired (MMSE ≥24), of whom 2214 participants (1110 B-vitamins versus 1104 placebo) had follow-up MMSEs during 2.8 years (median). At final follow-up, allocation to B-vitamins, compared with placebo, was associated with a reduction in mean tHcy (10.2 μmol/L versus 14.2 μmol/L P .001) but no change from baseline in the mean MMSE score (−0.22 points versus −0.25 points difference, 0.03 95% confidence interval, −0.13 to 0.19 P =0.726) and no difference in the incidence of cognitive impairment (5.51% versus 5.47% risk ratio, 1.01 95% confidence interval, 0.69–1.48 P =0.976), cognitive decline (9.1% versus 10.3% risk ratio, 0.89 0.67–1.18 P =0.414), or cognitive impairment or decline (11.0% versus 11.3% risk ratio, 0.98 0.75–1.27 P =0.855). Daily supplementation with folic acid, vitamin B6, and vitamin B12 to a self-selected clinical trial cohort of cognitively unimpaired patients with previous stroke or transient ischemic attack lowered mean tHcy but had no effect on the incidence of cognitive impairment or cognitive decline, as measured by the MMSE, during a median of 2.8 years. URL: www.controlled-trials.com . Unique identifier: ISRCTN74743444 URL: www.clinicaltrials.gov . Unique identifier: NCT00097669.
Relationship between nitrate headache and outcome in patients with acute stroke: results from the efficacy of nitric oxide in stroke (ENOS) trial
Publisher: BMJ
Date: 05-11-2020
Abstract: Nitrate-induced headache is common and may signify responsive cerebral vasculature. We assessed the relationship between nitrate headache and outcome in patients with acute stroke. Patients were those randomised to glyceryl trinitrate (GTN) versus no GTN in the efficacy of nitric oxide in stroke trial. Development of headache by end of treatment (day 7), and functional outcome (modified Rankin Scale, primary outcome) at day 90, were assessed. Analyses are adjusted for baseline prognostic factors and give OR and mean difference (MD) with 95% CI. In 4011 patients, headache was more common in GTN than control (360, 18.0% vs 170, 8.5% p .001). Nitrate-related headache was associated with: younger age, female sex, higher diastolic blood pressure, non-total anterior circulation syndrome, milder stroke and absence of dysphasia (p .05). Nitrate headache was not associated with improved functional outcome (OR 0.90, 95% CI 0.73 to 1.10, p=0.30) or death (day 90) (HR 0.64, 95% CI 0.40 to 1.02, p=0.062), but reduced death or deterioration (day 7) (OR 0.45, 95% CI 0.25 to 0.82), death in hospital (OR 0.44, 95% CI 0.22 to 0.88) and improved activities of daily living (Barthel index, MD 3.7, 95% CI 0.3 to 7.1) and cognition (telephone interview cognitive screen, MD 2.0, 95% CI 0.7 to 3.3) (day 90). Non-nitrate headache was not associated with death, disability or cognition. Development of a nitrate headache by day 7 after stroke may be associated with improved activities of daily living and cognitive impairment at day 90, which was not seen with non-nitrate headache.
Improving the quality of written prescriptions in a general hospital: the influence of 10 years of serial audits and targeted interventions.
Publisher: Wiley
Date: 20-02-2008
DOI: 10.1111/J.1445-5994.2007.01518.X
Abstract: Poor quality prescribing has been identified as one of the leading causes of medication error and adverse drug events. The aim of this study was to improve the quality of written prescriptions in a general hospital by a combination of serial audits and interventions designed to address identified deficiencies. Inpatient medication charts were audited annually from 1998 to 2007. Charts were assessed against predetermined standards for good-quality prescribing. Initially an unacceptable proportion of medication charts failed to document adequately one or more of the following: prescriber identification (58%), legible prescriptions (14%), route of administration (14%), a dose (11%), date (11%) or adequate patient identification (8%). Only 53% of charts had any information about medication alerts and 15% contained at least one verbal order. Interventions designed to address these deficiencies included educational strategies (e.g. feedback of audit results, education sessions for doctors and nurses on prescribing and medication errors) and changes to systems (e.g. modifications to medication charts, development of hospital wide prescribing standards and an alert notification system). Serial audits showed progressive improvements in all items by 2007 including legibility (97%), patient identification (100%), documentation of date (98%), drug dose (99%) and route (97%), use of medication alerts (98%) and the prevalence of verbal orders (<1%). Identification of prescribers remained suboptimal (81% in 2006, 53% in 2007). Serial audits of the quality of prescribing on hospital medication charts can rapidly identify the extent of deficiencies in prescribing practice, facilitate interventions specifically designed to address these and monitor their influence.
Central masked adjudication of stroke diagnosis at trial entry offered no advantage over diagnosis by local clinicians: Secondary analysis and simulation
Publisher: Elsevier BV
Date: 12-2018
A cohesive, person-centric evidence-based model for successful rehabilitation after stroke and other disabling conditions
Publisher: SAGE Publications
Date: 20-12-2022
Management problems of spontaneous ICH
Publisher: Mark Allen Group
Date: 04-2005
DOI: 10.12968/HMED.2005.66.4.18447
Abstract: The management of spontaneous intracerebral haemorrhage (ICH) can be challenging for hospital doctors. Although the management of ICH is covered in stroke guidelines, many difficult clinical questions remain. In this article the authors suggest approaches to ten common and difficult questions.
Appropriateness of general practitioner imaging requests for transient ischaemic attack patients: secondary analysis of a cluster randomised controlled trial
Publisher: CSIRO Publishing
Date: 2017
DOI: 10.1071/HC17005
Abstract: Abstract AIMS Many transient ischaemic attack (TIA) patients receive initial assessments by general practitioners (GPs). In a randomised controlled trial (RCT) we showed that BPAC Inc. TIA/stroke electronic decision support (EDS) for GPs improves patient outcomes and guideline adherence. This secondary analysis assesses the impact of trial associated enhanced GP access to radiological investigation. METHODS Post-hoc analysis of a multi-centre, single blind, parallel group, cluster RCT comparing TIA/stroke EDS guided GP management with usual care to assess whether imaging requests and their appropriateness differed between study groups. RESULTS GPs requested 15/291 (5.2%) carotid ultrasounds and 19/291 (6.5%) computed tomography (CT) head scans. Scans were obtained more frequently in the intervention group (ultrasound cluster adjusted OR (95% CI) 1.41 (0.44 to 4.49), P = 0.56 and CT 13.8 (1.7 to 110.7), P 0.001). All CTs were clinically appropriate. More ultrasounds were appropriate in the EDS group (cluster adjusted OR (95% CI) of 8.4 (0.39 to 92.3), P = 0.18). Overall investigation costs did not differ between groups (P = 0.83). Some apparent avoidable imaging duplication occurred where patients were subsequently assessed by secondary services. CONCLUSION In the setting of a RCT assessing GP electronic decision support, frequency of GP initiated imaging requests was low and largely appropriate especially in the setting of EDS use. Thus enhanced GP imaging access as part of the EDS tool did not result in inappropriate or excessive GP imaging requests. However, some duplication occurred and practitioners need to ensure that test referrals and results are adequately communicated between sectors.
Patient, carer and health worker perspectives of stroke care in New Zealand: a mixed methods survey.
Publisher: Informa UK Limited
Date: 05-09-2022
DOI: 10.1080/09638288.2022.2117862
Abstract: It is important to understand how consumers (person with stroke/family member/carer) and health workers perceive stroke care services. Consumers and health workers from across New Zealand were surveyed on perceptions of stroke care, access barriers, and views on service centralisation. Quantitative data were summarised using descriptive statistics whilst thematic analysis was used for free-text answers. Of 149 consumers and 79 health workers invited to complete a survey, 53 consumers (36.5%) and 41 health workers (51.8%) responded. Overall, 40/46 (87%) consumers rated stroke care as 'good/excellent' compared to 24/41 (58.6%) health workers. Approximately 72% of consumers preferred to transfer to a specialised hospital. We identified three major themes related to perceptions of stroke care: 1) 'variability in care by stage of treatment' 2) 'impact of communication by health workers on care experience' and 3) 'inadequate post-acute services for younger patients'. Four access barrier themes were identified: 1) 'geographic inequities' 2) 'knowing what is available' 3) 'knowledge about stroke and available services' and 4) 'healthcare system factors'. Perceptions of stroke care differed between consumers and health workers, highlighting the importance of involving both in service co-design. Improving communication, post-hospital follow-up, and geographic equity are key areas for improvement.Implications for rehabilitationProvision of detailed information on stroke recovery and available services in the community is recommended.Improvements in the delivery of post-hospital stroke care are required to optimise stroke care, with options including routine phone follow up appointments and wider development of early supported discharge services.Stroke rehabilitation services should continue to be delivered 'close to home' to allow community integration.Telehealth is a likely enabler to allow specialist urban clinicians to support non-urban clinicians, as well as increasing the availability and access of community rehabilitation.
Economic analysis of the ‘Take Charge’ intervention for people following stroke: Results from a randomised trial
Publisher: SAGE Publications
Date: 20-08-2021
DOI: 10.1177/02692155211040727
Abstract: To undertake an economic analysis of the Take Charge intervention as part of the Taking Charge after Stroke (TaCAS) study. An open, parallel-group, randomised trial comparing active and control interventions with blinded outcome assessment Community. Adults ( n = 400) discharged to community, non-institutional living following acute stroke. The Take Charge intervention, a strengths based, self-directed rehabilitation intervention, in two doses (one or two sessions), and a control intervention (no Take Charge sessions). The cost per quality-adjusted life year (QALY) saved for the period between randomisation (always post hospital discharge) and 12 months following acute stroke. QALYs were calculated from the EuroQol-5D-5L. Costs of stroke-related and non-health care were obtained by questionnaire, hospital records and the New Zealand Ministry of Health. One-year post hospital discharge cost of care was mean (95% CI) $US4706 (3758–6014) for the Take Charge intervention group and $6118 (4350–8005) for control, mean (95% CI) difference $ −1412 (−3553 to +729). Health utility scores were mean (95% CI) 0.75 (0.73–0.77) for Take Charge and 0.71 (0.67–0.75) for control, mean (95% CI) difference 0.04 (0.0–0.08). Cost per QALY gained for the Take Charge intervention was $US −35,296 (=£ −25,524, € −30,019). Sensitivity analyses confirm Take Charge is cost-effective, even at a very low willingness-to-pay threshold. With a threshold of $US5000 per QALY, the probability that Take Charge is cost-effective is 99%. Take Charge is cost-effective and probably cost saving.
The effect of the Take Charge intervention on mood, motivation, activation and risk factor management: Analysis of secondary data from the Taking Charge after Stroke (TaCAS) trial
Publisher: SAGE Publications
Date: 15-02-2021
Abstract: To use secondary data from the Taking Charge after Stroke study to explore mechanisms for the positive effect of the Take Charge intervention on physical health, advanced activities of daily living and independence for people after acute stroke. An open, parallel-group, randomised trial with two active and one control intervention and blinded outcome assessment. Community. Adults ( n = 400) discharged to community, non-institutional living following acute stroke. One, two, or zero sessions of the Take Charge intervention, a self-directed rehabilitation intervention which helps a person with stroke take charge of their own recovery. Twelve months after stroke: Mood (Patient Health Questionnaire-2, Mental Component Summary of the Short Form 36) ‘ability to Take Charge’ using a novel measure, the Autonomy-Mastery-Purpose-Connectedness (AMP-C) score activation (Patient Activation Measure) body mass index (BMI), blood pressure (BP) and medication adherence (Medication Adherence Questionnaire). Follow-up was near-complete (388/390 (99.5%)) of survivors at 12 months. Mean age (SD) was 72.0 (12.5) years. There were no significant differences in mood, activation, ‘ability to Take Charge’, medication adherence, BMI or BP by randomised group at 12 months. There was a significant positive association between baseline AMP-C scores and 12-month outcome for control participants (1.73 (95%CI 0.90 to 2.56)) but not for the Take Charge groups combined (0.34 (95%CI −0.17 to 0.85)). The mechanism by which Take Charge is effective remains uncertain. However, our findings support a hypothesis that baseline variability in motivation, mastery and connectedness may be modified by the Take Charge intervention.
Glyceryl Trinitrate for Acute Intracerebral Hemorrhage
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 2016
DOI: 10.1161/STROKEAHA.115.010368
Abstract: The Efficacy of Nitric Oxide in Stroke (ENOS) trial found that transdermal glyceryl trinitrate (GTN, a nitric oxide donor) lowered blood pressure but did not improve functional outcome in patients with acute stroke. However, GTN was associated with improved outcome if patients were randomized within 6 hours of stroke onset. In this prespecified subgroup analysis, the effect of GTN (5 mg/d for 7 days) versus no GTN was studied in 629 patients with intracerebral hemorrhage presenting within 48 hours and with systolic blood pressure ≥140 mm Hg. The primary outcome was the modified Rankin Scale at 90 days. Mean blood pressure at baseline was 172/93 mm Hg and significantly lower (difference −7.5/−4.2 mm Hg both P ≤0.05) on day 1 in 310 patients allocated to GTN when compared with 319 randomized to no GTN. No difference in the modified Rankin Scale was observed between those receiving GTN versus no GTN (adjusted odds ratio for worse outcome with GTN, 1.04 95% confidence interval, 0.78–1.37 P =0.84). In the subgroup of 61 patients randomized within 6 hours, GTN improved functional outcome with a shift in the modified Rankin Scale (odds ratio, 0.22 95% confidence interval, 0.07–0.69 P =0.001). There was no significant difference in the rates of serious adverse events between GTN and no GTN. In patients with intracerebral hemorrhage within 48 hours of onset, GTN lowered blood pressure was safe but did not improve functional outcome. Very early treatment might be beneficial but needs assessment in further studies. URL: www.isrctn.com/ISRCTN99414122 . Unique identifier: 99414122.
Reducing Ethnic and Geographic Inequities to Optimise New Zealand Stroke Care (REGIONS Care): Protocol for a Nationwide Observational Study (Preprint)
Publisher: JMIR Publications Inc.
Date: 16-11-2020
Abstract: troke systems of care differ between larger urban and smaller rural settings and it is unclear to what extent this may impact on patient outcomes. Ethnicity influences stroke risk factors and care delivery as well as patient outcomes in nonstroke settings. Little is known about the impact of ethnicity on poststroke care, especially in Māori and Pacific populations. ur goal is to describe the protocol for the Reducing Ethnic and Geographic Inequities to Optimise New Zealand Stroke Care (REGIONS Care) study. his large, nationwide observational study assesses the impact of rurality and ethnicity on best practice stroke care access and outcomes involving all 28 New Zealand hospitals caring for stroke patients, by capturing every stroke patient admitted to hospital during the 2017-2018 study period. In addition, it explores current access barriers through consumer focus groups and consumer, carer, clinician, manager, and policy-maker surveys. It also assesses the economic impact of care provided at different types of hospitals and to patients of different ethnicities and explores the cost-efficacy of in idual interventions and care bundles. Finally, it compares manual data collection to routine health administrative data and explores the feasibility of developing outcome models using only administrative data and the cost-efficacy of using additional manually collected registry data. Regarding s le size estimates, in Part 1, Study A, 2400 participants are needed to identify a 10% difference between up to four geographic subgroups at 90% power with an α value of .05 and 10% to 20% loss to follow-up. In Part 1, Study B, a s le of 7645 participants was expected to include an estimated 850 Māori and 419 Pacific patients and to provide over 90% and over 80% power, respectively. Regarding Part 2, 50% of the patient or carer surveys, 40 provider surveys, and 10 focus groups were needed to achieve saturation of themes. The main outcome is the modified Rankin Scale (mRS) score at 3 months. Secondary outcomes include mRS scores EQ-5D-3L (5-dimension, 3-level EuroQol questionnaire) scores stroke recurrence vascular events death readmission at 3, 6, and 12 months cost of care and themes around access barriers. he study is underway, with national and institutional ethics approvals in place. A total of 2379 patients have been recruited for Part 1, Study A 6837 patients have been recruited for Part 1, Study B 10 focus groups have been conducted and 70 surveys have been completed in Part 2. Data collection has essentially been completed, including follow-up assessment however, primary and secondary analyses, data linkage, data validation, and health economics analysis are still underway. he methods of this study may provide the basis for future epidemiological studies that will guide care improvements in other countries and populations. ERR1-10.2196/25374
Effect of Glyceryl Trinitrate on Hemodynamics in Acute Stroke
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 02-2019
DOI: 10.1161/STROKEAHA.118.023190
Abstract: Increased blood pressure (BP), heart rate, and their derivatives (variability, pulse pressure, rate-pressure product) are associated with poor clinical outcome in acute stroke. We assessed the effects of glyceryl trinitrate (GTN) on hemodynamic parameters and these on outcome in participants in the ENOS trial (Efficacy of Nitric Oxide in Stroke). Four thousand and eleven patients with acute stroke and raised BP were randomized within 48 hours of onset to transdermal GTN or no GTN for 7 days. Peripheral hemodynamics were measured at baseline (3 measures) and daily (2 measures) during treatment. Between-visit BP variability over days 1 to 7 (as SD) was assessed in quintiles. Functional outcome was assessed as modified Rankin Scale and cognition as telephone mini-mental state examination at day 90. Analyses were adjusted for baseline prognostic variables. Data are mean difference or odds ratios with 95% CI. Increased baseline BP (diastolic, variability), heart rate, and rate-pressure product were each associated with unfavorable functional outcome at day 90. Increased between-visit systolic BP variability was associated with an unfavourable shift in modified Rankin Scale (highest quintile adjusted odds ratio, 1.65 95% CI, 1.37–1.99), worse cognitive scores (telephone mini-mental state examination: highest quintile adjusted mean difference, −2.03 95% CI, −2.84 to −1.22), and increased odds of death at day 90 (highest quintile adjusted odds ratio, 1.57 95% CI, 1.12–2.19). GTN lowered BP and rate-pressure product and increased heart rate at day 1 and reduced between-visit systolic BP variability. Increased between-visit BP variability was associated with poor functional and cognitive outcomes and increased death 90 days after acute stroke. In addition to lowering BP and rate-pressure product, GTN reduced between-visit systolic BP variability. Agents that lower BP variability in acute stroke require further study.
The effect of homocysteine-lowering with B-vitamins on osteoporotic fractures in patients with cerebrovascular disease: substudy of VITATOPS, a randomised placebo-controlled trial
Publisher: Springer Science and Business Media LLC
Date: 03-09-2013
Abstract 137: Efficacy and Safety of a TIA Electronic Support Tool (FASTEST): A Cluster Randomized Controlled Trial
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 02-2014
DOI: 10.1161/STR.45.SUPPL_1.137
Abstract: Introduction: The risk of stroke after a transient ischaemic attack (TIA) is greatest within the first few days of the TIA and then tapers over time. It is known that early initiation of best medical therapy significantly reduces this risk. Hypothesis: To test whether a TIA/Stroke Electronic Decision Support (EDS) tool in primary care promotes faster access to optimal TIA management and reduces the risk of recurrent stroke and vascular events. Methods: A cluster randomized controlled trial (FASTEST Trial ACTRN12611000792921) with general practitioner (GP) practices randomized to use an EDS tool versus usual care. Results: The study period was 28 February 2012 to 15 May 2013 and 46 GP practices (145 GPs) registered 373 patients. Eligibility criteria were met by 291/373 (78%) patients of whom 178 received GP care using the EDS and 113 usual care. Ninety day follow up was completed on 13 August 2013. Stroke occurred in 2/178 (1.1%) of the intervention group and 5/113 (4.4%) in the usual care group odds ratio (95% CI), unadjusted for cluster randomization, 0.25 (0.05 to 1.29), p=0.073. Any vascular event or death occurred in 7/178 (3.9%) of the EDS group and 14/113 (12.4%) of the control group, unadjusted OR (95% CI) 0.29 (0.11 to 0.74), p=0.007. The time to starting anti-platelet medication, in those not previously using these, was similar in the two groups, median (inter-quartile range) of 0 days (0 to 0) and 0 days (0 to 1) in the EDS and usual care groups. Statin and anti-hypertensive prescription, in those not previously using these, occurred more quickly in the EDS group compared to usual care median (inter-quartile range) 2 days (0 to 7) versus 3 days (0 to7) for statin and 3 days (0 to 7) versus 5 days (1.5 to 37) for anti-hypertensive prescription. Conclusion: The preliminary analysis of this trial supports improved outcomes and process of care with EDS versus usual care for TIA management in primary care. The full analysis, adjusted for the cluster randomization, will be presented at the meeting.
Cluster randomized controlled trial of TIA electronic decision support in primary care
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 20-03-2015
Impact and implementation of a sustainable regional telestroke network
Publisher: Wiley
Date: 11-2017
DOI: 10.1111/IMJ.13557
Abstract: Telestroke uses videoconferencing technology to allow off-site experts to provide stroke thrombolysis decision support to less experienced front line clinicians. To assess the impact of a new telestroke service on thrombolysis rates and door-to-needle times in participating provincial hospitals and service resources to aid transition to a sustainable telestroke service. This is a sequential comparison of 'pre' (December 2015 to May 2016) and 'post' (June 2016 to December 2016) implementation outcomes. The main outcomes were thrombolysis rate and door-to-needle time. All patient data were captured prospectively in a central database. Data captured and analysed also included technical problems, consumer and clinician feedback, and additional service resources required. Over the study period, 164 telestroke assessments were completed, including the 'hub' hospital. Among the participating provincial hospitals, 21 of 343 patients (6.1%) were thrombolysed in the 6-months prior to June 2016 and 50 of 318 patients (15.7%) during the 6-month following implementation of telestroke odds ratio 2.86 (95% confidence interval 1.68-4.89) P = 0.0001. Overall, mean (standard deviation) regional hospital door-to-needle time reduced from 79.6 (31.4) to 62.7 (23.3) min (P = 0.015). Videoconferencing failure occurred in 4.8% of cases. Consumer and clinician feedback was positive. The main resource challenge was doubling of out-of-hours neurologist workload. Telestroke was associated with a significant increase in thrombolysis rate and reduction in door-to-needle time in provincial hospitals indicating improved patient care. Quantification of the extra neurologist workload allowed for a seamless transition to 'business as usual' using a novel annual subscription funding and service model.
Infections Up to 76 Days After Stroke Increase Disability and Death
Publisher: Springer Science and Business Media LLC
Date: 27-07-2017
43. Substantial Under-Provision of TIA Services in New Zealand
Publisher: Elsevier BV
Date: 11-2009
Imaging markers of small vessel disease and brain frailty, and outcomes in acute stroke
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 27-12-2019
DOI: 10.1212/WNL.0000000000008881
Abstract: To assess the association of baseline imaging markers of cerebral small vessel disease (SVD) and brain frailty with clinical outcome after acute stroke in the Efficacy of Nitric Oxide in Stroke (ENOS) trial. ENOS randomized 4,011 patients with acute stroke ( hours of onset) to transdermal glyceryl trinitrate (GTN) or no GTN for 7 days. The primary outcome was functional outcome (modified Rankin Scale [mRS] score) at day 90. Cognition was assessed via telephone at day 90. Stroke syndrome was classified with the Oxfordshire Community Stroke Project classification. Brain imaging was adjudicated masked to clinical information and treatment and assessed SVD (leukoaraiosis, old lacunar infarcts/lacunes, atrophy) and brain frailty (leukoaraiosis, atrophy, old vascular lesions/infarcts). Analyses used ordinal logistic regression adjusted for prognostic variables. In all participants and those with lacunar syndrome (LACS 1,397, 34.8%), baseline CT imaging features of SVD and brain frailty were common and independently associated with unfavorable shifts in mRS score at day 90 (all participants: SVD score odds ratio [OR] 1.15, 95% confidence interval [CI] 1.07–1.24 brain frailty score OR 1.25, 95% CI 1.17–1.34 those with LACS: SVD score OR 1.30, 95% CI 1.15–1.47, brain frailty score OR 1.28, 95% CI 1.14–1.44). Brain frailty was associated with worse cognitive scores at 90 days in all participants and in those with LACS. Baseline imaging features of SVD and brain frailty were common in lacunar stroke and all stroke, predicted worse prognosis after all acute stroke with a stronger effect in lacunar stroke, and may aid future clinical decision-making. ISRCTN99414122.
VITATOPS, the VITAmins TO Prevent Stroke Trial: Rationale and Design of a Randomised Trial of B-Vitamin Therapy in Patients with Recent Transient Ischaemic Attack or Stroke (NCT00097669) (ISRCTN747434
Publisher: SAGE Publications
Date: 05-2007
DOI: 10.1111/J.1747-4949.2007.00111.X
Abstract: Epidemiological studies suggest that raised plasma concentrations of total homocysteine (tHcy) may be a common, causal and treatable risk factor for atherothromboembolic ischaemic stroke, dementia and depression. Although tHcy can be lowered effectively with small doses of folic acid, vitamin B 12 and vitamin B 6 , it is not known whether lowering tHcy, by means of B vitamin therapy, can prevent stroke and other major atherothromboembolic vascular events. To determine whether the addition of B-vitamin supplements (folic acid 2 mg, B 6 25 mg, B 12 500 μg) to best medical and surgical management will reduce the combined incidence of stroke, myocardial infarction (MI) and vascular death in patients with recent stroke or transient ischaemic attack (TIA) of the brain or eye. A prospective, international, multicentre, randomised, double blind, placebo-controlled clinical trial. One hundred and four medical centres in 20 countries on five continents. Eight thousand (6600 recruited as of 5 January, 2006) patients with recent (7 months) stroke (ischaemic or haemorrhagic) or TIA (brain or eye). Randomisation and data collection are performed by means of a central telephone service or secure internet site. One tablet daily of either placebo or B vitamins (folic acid 2mg, B 6 25 mg, B 12 500 μg). The composite of stroke, MI or death from any vascular cause, whichever occurs first. Outcome and serious adverse events are adjudicated blinded to treatment allocation. TIA, unstable angina, revascularisation procedures, dementia, depression. With 8000 patients followed up for a median of 2 years and an annual incidence of the primary outcome of 8% among patients assigned placebo, the study will have at least 80% power to detect a relative reduction of 15% in the incidence of the primary outcome among patients assigned B vitamins (to 6·8%/year), applying a two-tailed level of significance of 5%. VITATOPS aims to recruit and follow-up 8000 patients between 1998 and 2008, and provide a reliable estimate of the safety and effectiveness of folic acid, vitamin B 12 , and vitamin B 6 supplementation in reducing recurrent serious vascular events among a wide range of patients with TIA and stroke throughout the world.
Stroke thrombolysis in patients taking dabigatran
Publisher: Wiley
Date: 07-2013
DOI: 10.1111/IMJ.12182
Abstract: Stroke thrombolysis is becoming a common practice in Australian and New Zealand hospitals. There are no established guidelines for thrombolysis of patients who are taking dabigatran, and accurate medication reconciliation may not be possible. Patients with normal activated partial thromboplastin time are unlikely to have clinically significant dabigatran concentration in the blood. For safest outcomes, we suggest incorporating thrombin time assay for acute stroke patients suspected to be taking dabigatran.
Effect of Hyperacute Administration (Within 6 Hours) of Transdermal Glyceryl Trinitrate, a Nitric Oxide Donor, on Outcome After Stroke
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 11-2015
DOI: 10.1161/STROKEAHA.115.009647
Abstract: Nitric oxide donors are candidate treatments for acute stroke, potentially through hemodynamic, reperfusion, and neuroprotectant effects, especially if given early. Although the large Efficacy of Nitric Oxide in Stroke (ENOS) trial of transdermal glyceryl trinitrate (GTN) was neutral, a prespecified subgroup suggested that GTN improved functional outcome if administered early after stroke onset. Prospective analysis of subgroup of patients randomized into the ENOS trial within 6 hours of stroke onset. Safety and efficacy of GTN versus no GTN were assessed using data on early and late outcomes. Two hundred seventy-three patients were randomized within 6 hours of ictus: mean (SD) age, 69.9 (12.7) years men, 154 (56.4%) ischemic stroke, 208 (76.2%) Scandinavian Stroke Scale, 32.1 (11.9) and total anterior circulation syndrome, 86 (31.5%). When compared with no GTN, the first dose of GTN lowered blood pressure by 9.4/3.3 mm Hg ( P .01, P =0.064) and shifted the modified Rankin Scale to a better outcome by day 90, adjusted common odds ratio, 0.51 (95% confidence interval, 0.32–0.80). Significant beneficial effects were also seen with GTN for disability (Barthel Index), quality of life (EuroQol-Visual Analogue Scale), cognition (telephone Mini-Mental State Examination), and mood (Zung Depression Scale). GTN was safe to administer with less serious adverse events by day 90 (GTN 18.8% versus no GTN 34.1%) and death (hazard ratio, 0.44 95% confidence interval, 0.20–0.99 P =0.047). In a subgroup analysis of the large ENOS trial, transdermal GTN was safe to administer and associated with improved functional outcome and fewer deaths when administered within 6 hours of stroke onset. URL: www.clinicaltrials.gov . Unique identifier: NCT00989716.
Comparison of Stroke Care Costs in Urban and Nonurban Hospitals and Its Association With Outcomes in New Zealand: A Nationwide Economic Evaluation
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 03-2023
DOI: 10.1161/STROKEAHA.122.040869
Abstract: Although geographical differences in treatment and outcomes after stroke have been described, we lack evidence on differences in the costs of treatment between urban and nonurban regions. Additionally, it is unclear whether greater costs in one setting are justified given the outcomes achieved. We aimed to compare costs and quality-adjusted life years in people with stroke admitted to urban and nonurban hospitals in New Zealand. Observational study of patients with stroke admitted to the 28 New Zealand acute stroke hospitals (10 in urban areas) recruited between May and October 2018. Data were collected up to 12 months poststroke including treatments in hospital, inpatient rehabilitation, other health service utilization, aged residential care, productivity, and health-related quality of life. Costs in New Zealand dollars were estimated from a societal perspective and assigned to the initial hospital that patients presented to. Unit prices for 2018 were obtained from government and hospital sources. Multivariable regression analyses were conducted when assessing differences between groups. Of 1510 patients (median age 78 years, 48% female), 607 presented to nonurban and 903 to urban hospitals. Mean hospital costs were greater in urban than nonurban hospitals ($13 191 versus $11 635, P =0.002), as were total costs to 12 months ($22 381 versus $17 217, P .001) and quality-adjusted life years to 12 months (0.54 versus 0.46, P .001). Differences in costs and quality-adjusted life years remained between groups after adjustment. Depending on the covariates included, costs per additional quality-adjusted life year in the urban hospitals compared to the nonurban hospitals ranged from $65 038 (unadjusted) to $136 125 (covariates: age, sex, prestroke disability, stroke type, severity, and ethnicity). Better outcomes following initial presentation to urban hospitals were associated with greater costs compared to nonurban hospitals. These findings may inform greater targeted expenditure in some nonurban hospitals to improve access to treatment and optimize outcomes.
It is safe to use transdermal glyceryl trinitrate to lower blood pressure in patients with acute ischaemic stroke with carotid stenosis
Publisher: BMJ
Date: 03-2019
Abstract: There is concern that blood pressure (BP) lowering in acute stroke may compromise cerebral perfusion and worsen outcome in the presence of carotid stenosis. We assessed the effect of glyceryl trinitrate (GTN) in patients with carotid stenosis using data from the Efficacy of Nitric Oxide in Stroke (ENOS) Trial. ENOS randomised 4011 patients with acute stroke and raised systolic BP (140–220 mm Hg) to transdermal GTN or no GTN within 48 hours of onset. Those on prestroke antihypertensives were also randomised to stop or continue their medication for 7 days. The primary outcome was the modified Rankin Scale (mRS) at day 90. Ipsilateral carotid stenosis was split: % 30– % 50– % ≥70%. Data are ORs with 95% CIs adjusted for baseline prognostic factors. 2023 (60.5%) ischaemic stroke participants had carotid imaging. As compared with %, ≥70% ipsilateral stenosis was associated with an unfavourable shift in mRS (worse outcome) at 90 days (OR 1.88, 95% CI 1.44 to 2.44, p .001). Those with ≥70% stenosis who received GTN versus no GTN had a favourable shift in mRS (OR 0.56, 95% CI 0.34 to 0.93, p=0.024). In those with 50– % stenosis, continuing versus stopping prestroke antihypertensives was associated with worse disability, mood, quality of life and cognition at 90 days. Clinical outcomes did not differ across bilateral stenosis groups. Following ischaemic stroke, severe ipsilateral carotid stenosis is associated with worse functional outcome at 90 days. GTN appears safe in ipsilateral or bilateral carotid stenosis, and might improve outcome in severe ipsilateral carotid stenosis.
Twelve-Month Outcomes of the AFFINITY Trial of Fluoxetine for Functional Recovery After Acute Stroke
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 08-2021
DOI: 10.1161/STROKEAHA.120.033070
Abstract: The AFFINITY trial (Assessment of Fluoxetine in Stroke Recovery) reported that oral fluoxetine 20 mg daily for 6 months after acute stroke did not improve functional outcome and increased the risk of falls, bone fractures, and seizures. After trial medication was ceased at 6 months, survivors were followed to 12 months post-randomization. This preplanned secondary analysis aimed to determine any sustained or delayed effects of fluoxetine at 12 months post-randomization. AFFINITY was a randomized, parallel-group, double-blind, placebo-controlled trial in adults (n=1280) with a clinical diagnosis of stroke in the previous 2 to 15 days and persisting neurological deficit who were recruited at 43 hospital stroke units in Australia (n=29), New Zealand (4), and Vietnam (10) between 2013 and 2019. Participants were randomized to oral fluoxetine 20 mg once daily (n=642) or matching placebo (n=638) for 6 months and followed until 12 months after randomization. The primary outcome was function, measured by the modified Rankin Scale, at 6 months. Secondary outcomes for these analyses included measures of the modified Rankin Scale, mood, cognition, overall health status, fatigue, health-related quality of life, and safety at 12 months. Adherence to trial medication was for a mean 167 (SD 48) days and similar between randomized groups. At 12 months, the distribution of modified Rankin Scale categories was similar in the fluoxetine and placebo groups (adjusted common odds ratio, 0.93 [95% CI, 0.76–1.14] P =0.46). Compared with placebo, patients allocated fluoxetine had fewer recurrent ischemic strokes (14 [2.18%] versus 29 [4.55%] P =0.02), and no longer had significantly more falls (27 [4.21%] versus 15 [2.35%] P =0.08), bone fractures (23 [3.58%] versus 11 [1.72%] P =0.05), or seizures (11 [1.71%] versus 8 [1.25%] P =0.64) at 12 months. Fluoxetine 20 mg daily for 6 months after acute stroke had no delayed or sustained effect on functional outcome, falls, bone fractures, or seizures at 12 months poststroke. The lower rate of recurrent ischemic stroke in the fluoxetine group is most likely a chance finding. URL: www.anzctr.org.au/ Unique identifier: ACTRN12611000774921.
Taking Charge after Stroke: A randomized controlled trial of a person-centered, self-directed rehabilitation intervention
Publisher: SAGE Publications
Date: 15-04-2020
Abstract: “Take Charge” is a novel, community-based self-directed rehabilitation intervention which helps a person with stroke take charge of their own recovery. In a previous randomized controlled trial, a single Take Charge session improved independence and health-related quality of life 12 months following stroke in Māori and Pacific New Zealanders. We tested the same intervention in three doses (zero, one, or two sessions) in a larger study and in a broader non-Māori and non-Pacific population with stroke. We aimed to confirm whether the Take Charge intervention improved quality of life at 12 months after stroke in a different population and whether two sessions were more effective than one. We randomized 400 people within 16 weeks of acute stroke who had been discharged to institution-free community living at seven centers in New Zealand to a single Take Charge session (TC1, n = 132), two Take Charge sessions six weeks apart (TC2, n = 138), or a control intervention (n = 130). Take Charge is a “talking therapy” that encourages a sense of purpose, autonomy, mastery, and connectedness with others. The primary outcome was the Physical Component Summary score of the Short Form 36 at 12 months following stroke comparing any Take Charge intervention to control. Of the 400 people randomized (mean age 72.2 years, 58.5% male), 10 died and two withdrew from the study. The remaining 388 (97%) people were followed up at 12 months after stroke. Twelve months following stroke, participants in either of the TC groups (i.e. TC1 + TC2) scored 2.9 (95% confidence intervals (CI) 0.95 to 4.9, p = 0.004) points higher (better) than control on the Short Form 36 Physical Component Summary. This difference remained significant when adjusted for pre-specified baseline variables. There was a dose effect with Short Form 36 Physical Component Summary scores increasing by 1.9 points (95% CI 0.8 to 3.1, p 0.001) for each extra Take Charge session received. Exposure to the Take Charge intervention was associated with reduced odds of being dependent (modified Rankin Scale 3 to 5) at 12 months (TC1 + TC2 12% versus control 19.5%, odds ratio 0.55, 95% CI 0.31 to 0.99, p = 0.045). Confirming the previous randomized controlled trial outcome, Take Charge—a low-cost, person-centered, self-directed rehabilitation intervention after stroke—improved health-related quality of life and independence. www.anzctr.org.au . Unique identifier: ACTRN12615001163594
Impact of General Practitioner Transient Ischemic Attack Training on 90-Day Stroke Outcomes: Secondary Analysis of a Cluster Randomized Controlled Trial
Publisher: Elsevier BV
Date: 07-2018
DOI: 10.1016/J.JSTROKECEREBROVASDIS.2018.02.064
Abstract: Many patients with transient ischemic attack (TIA) receive initial assessments by general practitioners (GPs) who may lack TIA management experience. In a randomized controlled trial (RCT), we showed that electronic decision support for GPs improves patient outcomes and guideline adherence. Some stroke services prefer to improve referrer expertise through TIA/stroke education sessions instead of promoting TIA decision aids or triaging tools. This is a secondary analysis of whether a GP education session influenced TIA management and outcomes. Post hoc analysis of a multicenter, single blind, parallel group, cluster RCT comparing TIA/stroke electronic decision support guided GP management with usual care to assess whether a pretrial TIA/stroke education session also affected RCT outcomes. Of 181 participating GPs, 79 (43.7%) attended an education session and 140 of 291 (48.1%) trial patients were managed by these GPs. There were fewer 90-day stroke events and 90-day vascular events or deaths in patients treated by GPs who attended education 2 of 140 (1.4%) and 10 of 140 (7.1%) respectively, compared with those who did not 5 of 151 (3.3%), and 14 of 151 (9.3%), respectively. Logistic regression for association between 90-day stroke and 90-day vascular events or death and education, however, was nonsignificant (odds ratio [OR] .42 (.08 to 2.22), P = .29 and .59 (95% confidence interval [CI] .27 to 1.29), P = .18 respectively. Guideline adherence was not improved by the education session: OR .84 (95% CI .49 to 1.45), P = .54. In the described setting, a GP TIA/stroke education session did not significantly enhance guideline adherence or reduce 90-day stroke or vascular events following TIA.
Ethnic differences in stroke outcomes in Aotearoa New Zealand: A national linkage study
Publisher: SAGE Publications
Date: 24-03-2023
DOI: 10.1177/17474930231164024
Abstract: Ethnic differences in post-stroke outcomes have been largely attributed to biological and socioeconomic characteristics resulting in differential risk factor profiles and stroke subtypes, but evidence is mixed. This study assessed ethnic differences in stroke outcome and service access in New Zealand (NZ) and explored underlying causes in addition to traditional risk factors. This national cohort study used routinely collected health and social data to compare post-stroke outcomes between NZ Europeans, Māori, Pacific Peoples, and Asians, adjusting for differences in baseline characteristics, socioeconomic deprivation, and stroke characteristics. First and principal stroke public hospital admissions during November 2017 to October 2018 were included (N = 6879). Post-stroke unfavorable outcome was defined as being dead, changing residence, or becoming unemployed. In total, 5394 NZ Europeans, 762 Māori, 369 Pacific Peoples, and 354 Asians experienced a stroke during the study period. Median age was 65 years for Māori and Pacific Peoples, and 71 and 79 years for Asians and NZ Europeans, respectively. Compared with NZ Europeans, Māori were more likely to have an unfavorable outcome at all three time-points (odds ratio (OR) = 1.6 (95% confidence interval (CI) = 1.3–1.9) 1.4 (1.2–1.7) 1.4 (1.2–1.7), respectively). Māori had increased odds of death at all time-points (1.7 (1.3–2.1) 1.5 (1.2–1.9) 1.7 (1.3–2.1)), change in residence at 3 and 6 months (1.6 (1.3–2.1) 1.3 (1.1–1.7)), and unemployment at 6 and 12 months (1.5 (1.1–2.1) 1.5 (1.1–2.1)). There was evidence of differences in post-stroke secondary prevention medication by ethnicity. We found ethnic disparities in care and outcomes following stroke which were independent of traditional risk factors, suggesting they may be attributable to stroke service delivery rather than patient factors.
Antiplatelet therapy and the effects of B vitamins in patients with previous stroke or transient ischaemic attack: a post-hoc subanalysis of VITATOPS, a randomised, placebo-controlled trial
Publisher: Elsevier BV
Date: 06-2012
Depression Outcomes Among Patients Treated With Fluoxetine for Stroke Recovery
Publisher: American Medical Association (AMA)
Date: 09-2021
Effect of the neutral CLOTS 1 trial on the use of graduated compression stockings in the Efficacy of Nitric Oxide Stroke (ENOS) trial
Publisher: BMJ
Date: 31-10-2012
Abstract: Current evidence suggests that the time lag from the publication of randomised clinical trial results to changes in prescribing behaviour for drugs is gradually reducing. However, the effect of results of clinical trials of devices and non-pharmacological interventions on clinical practice is less clear. Prospective data from the ongoing international 'Efficacy of Nitric Oxide Stroke' (ENOS) trial were analysed to assess the use of graduated compression stockings (GCS) for deep vein thrombus (DVT) prophylaxis in acute stroke patients before and after publication of the large 'Clots in Legs Or sTockings after Stroke' (CLOTS-1) trial. Data on GCS use were available for 1971 patients with acute stroke enrolled into ENOS from February 2003 to April 2011 of these, 498 (25.3%) wore GCS. Prior to publication of CLOTS-1, GCS use was common (>50%) in the UK, Australasia and Canada but infrequent in Asia and the rest of Europe. After publication of CLOTS-1, use of GCS in the UK declined from 398/656 (61%) to 20/567 (4%) (p<0.001) but not elsewhere (eg, in Australasia (57% before publication vs 70% after publication, p=0.24, but based on small numbers). Practice change was apparent within 3 months of the study publication and was sustained thereafter. There was no change in DVT rates before and after CLOTS-1 (0.8% vs 1.0%). GCS use declined dramatically following the reporting of the CLOTS-1 trial. The results support the notion that a neutral trial of a device can influence clinical practice rapidly, which is important with a widely used and moderately expensive (time and finance) intervention.
Glyceryl Trinitrate vs. Control, and Continuing vs. Stopping Temporarily Prior Antihypertensive Therapy, in Acute Stroke: Rationale and Design of the Efficacy of Nitric Oxide in Stroke (ENOS) Trial (I
Publisher: SAGE Publications
Date: 11-2006
DOI: 10.1111/J.1747-4949.2006.00059.X
Abstract: High blood pressure (BP) is common in acute stroke and is independently associated with a poor outcome. Many patients with acute stroke are taking antihypertensive medications. To test the safety and efficacy of 7 days of transdermal glyceryl trinitrate (GTN, 5 mg/day) vs. no GTN in patients with acute stroke patients taking antihypertensive therapy immediately before their stroke are also randomised to continue vs. stop this temporarily. ENOS is a prospective international multicentre single-blind randomised-controlled trial in 5000 patients with acute ( 48 h of onset) ischaemic or haemorrhagic stroke. The primary outcome is combined death and dependency (modified Rankin scale 2) at 90 days measured by blinded central telephone follow-up. Secondary outcomes include: BP over the 7 days of treatment death, impairment (Scandinavian stroke scale), recurrence, and neuroimaging at 7 days discharge disposition, disability (Barthel index), cognition (mini-mental status examination) and quality of life (EuroQoL). The s le size will allow an absolute difference in death/dependency of 5% to be detected with 90% power at 5% significance for GTN versus no GTN. Randomisation and data collection are performed over a secure Internet site with real-time data validation. Neuroimaging and serious adverse events are adjudicated blinded to treatment.
B vitamins in patients with recent transient ischaemic attack or stroke in the VITAmins TO Prevent Stroke (VITATOPS) trial: a randomised, double-blind, parallel, placebo-controlled trial
Publisher: Elsevier BV
Date: 09-2010
Associations between change in blood pressure and functional outcome, early events and death
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 10-2019
The FOCUS, AFFINITY and EFFECTS trials studying the effect(s) of fluoxetine in patients with a recent stroke: statistical and health economic analysis plan for the trials and for the individual patien
Publisher: Springer Science and Business Media LLC
Date: 12-2017
DOI: 10.1186/S13063-017-2385-6
Abstract: Small trials have suggested that fluoxetine may improve neurological recovery from stroke. FOCUS, AFFINITY and EFFECTS are a family of investigator-led, multicentre, parallel group, randomised, placebo-controlled trials which aim to determine whether the routine administration of fluoxetine (20 mg daily) for six months after an acute stroke improves patients’ functional outcome. The core protocol for the three trials has been published (Mead et al., Trials 20:369, 2015). The trials include patients aged 18 years and older with a clinical diagnosis of stroke and persisting focal neurological deficits at randomisation 2–15 days after stroke onset. Patients are randomised centrally via each trials’ web-based randomisation system using a common minimisation algorithm. Patients are allocated fluoxetine 20 mg once daily or matching placebo capsules for six months. The primary outcome measure is the modified Rankin scale (mRS) at six months. Secondary outcomes include: living circumstances the Stroke Impact Scale EuroQol (EQ5D-5 L) the vitality subscale of the 36-Item Short Form Health Survey (SF36) diagnosis of depression adherence to medication serious adverse events including death and recurrent stroke and resource use at six and 12 months and the mRS at 12 months. Minor variations have been tailored to the national setting in the UK (FOCUS), Australia, New Zealand and Vietnam (AFFINITY) and Sweden (EFFECTS). Each trial is run and funded independently and will report its own results. A prospectively planned in idual patient data meta-analysis of all three trials will provide the most precise estimate of the overall effect and establish whether any effects differ between trials or subgroups. This statistical analysis plan describes the core analyses for all three trials and that for the in idual patient data meta-analysis. Recruitment and follow-up in the FOCUS trial is expected to be completed by the end of 2018. AFFINITY and EFFECTS are likely to complete follow-up in 2020. FOCUS: ISRCTN , ISRCTN83290762 . Registered on 23 May 2012. EudraCT, 2011-005616-29. Registered on 3 February 2012. AFFINITY: Australian New Zealand Clinical Trials Registry, ACTRN12611000774921 . Registered on 22 July 2011. EFFECTS: ISRCTN , ISRCTN13020412 . Registered on 19 December 2014. Clinicaltrials.gov, NCT02683213 . Registered on 2 February 2016. EudraCT, 2011-006130-16 . Registered on 8 August 2014.
Treatment With B Vitamins and Incidence of Cancer in Patients With Previous Stroke or Transient Ischemic Attack
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 06-2012
DOI: 10.1161/STROKEAHA.111.641613
Abstract: To determine the effect of B vitamin treatment on the incidence of cancer among patients with stroke or transient ischemic attack. A total of 8164 patients with recent stroke or transient ischemic attack were randomly allocated to double-blind treatment with 1 tablet daily of placebo or B vitamins (2 mg folic acid, 25 mg vitamin B 6 , 500 μg vitamin B 12 ) and followed for a median of 3.4 years for any cancer as an adverse event. There was no significant difference in the incidence of any cancer among participants assigned B vitamins compared with placebo (4.04% versus 4.59% risk ratio, 0.86 95% CI, 0.70–1.07) and no difference in cancer mortality (2.35% versus 2.09% risk ratio, 1.09 0.81–1.46). Among 1899 patients with diabetes, the incidence of cancer was higher among participants assigned B vitamins compared with placebo (5.35% versus 3.28% adjusted risk ratio, 2.21 1.31–3.73), whereas among 6168 patients without diabetes, the incidence of cancer was lower among participants assigned B vitamins compared with placebo (3.66% versus 5.03% adjusted risk ratio, 0.67 0.51–0.87 P for interaction=0.0001). Daily administration of folic acid, vitamin B 6 , and vitamin B 12 to 8164 patients with recent stroke or transient ischemic attack for a median of 3.4 years had no significant effect, compared with placebo, on cancer incidence or mortality. However, a post hoc subgroup analysis raises the hypothesis that folic acid treatment may increase the incidence of cancer among diabetics and reduce the incidence of cancer among nondiabetics with a history of stroke or transient ischemic attack. URL: www.clinicaltrials.gov . Unique identifier: NCT00097669. URL: www.controlled-trials.com . Unique identifier: ISRCTN74743444.
Switching to Tenecteplase for Stroke Thrombolysis
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 10-2021
DOI: 10.1161/STROKEAHA.121.035931
Abstract: Due to practical advantages, increasing trial safety data, recent Australian Guideline endorsement and local population needs we switched to tenecteplase for stroke thrombolysis from alteplase. We describe our change process and real-world outcome data. Mixed-methods including stakeholder engagement, preimplementation and postimplementation surveys, and assessment of patient treatment rates, metrics, and clinical outcomes preimplementation and postimplementation adjusting regression analyses for age, sex, National Institutes of Health Stroke Scale, premorbid modified Rankin Scale score, and thrombectomy using New Zealand National Stroke Registry data. Preswitch consultation involved stroke and emergency clinicians, pharmacists, national regulatory bodies, and hospital legal teams. All survey responders (90% response rate) supported the proposed change and remained satisfied 12 months postimplementation. Between January 2018 and February 2021, we treated 555 patients with alteplase and 283 with tenecteplase. Patients treated with tenecteplase had greater odds of a favorable modified Rankin Scale using both shift (adjusted odds ratio, 1.60 [95% CI, 1.15–2.22]) and dichotomous analyses (modified Rankin Scale score, 0–2 adjusted odds ratio, 2.17 [95% CI, 1.31–3.59]) and shorter median (interquartile range) door-to-needle time (median, 53 [38–73.5] versus 61 minutes [45–85], P =0.0002). Symptomatic intracranial hemorrhage rates (tenecteplase 1.8% versus 3.4% adjusted odds ratio, 0.46 [95% CI, 0.13–1.64]), death by day 7 (tenecteplase 7.5% versus 11.8% adjusted odds ratio, 0.46 [95% CI, 0.21–0.99]), and median (interquartile range) needle to groin time for the 42 transferred regional patients (tenecteplase 155 [113–248] versus 200 [158–266] P =0.27) did not significantly differ. Following stakeholder endorsement, a region-wide switch from alteplase to tenecteplase was successfully implemented. We found evidence of benefit and no evidence of harm.
Managing acute medical admissions: a survey of acute medical services and medical assessment and planning units in New Zealand.
Publisher: Wiley
Date: 2010
DOI: 10.1111/J.1445-5994.2010.02331.X
Abstract: To determine the current provision of acute medical services, including the development of medical assessment and planning units (MAPUs), by district health boards (DHBs) throughout New Zealand (NZ). A questionnaire-based survey about organisation of acute medical services and establishment of MAPUs was sent to all 21 DHBs in NZ. All 21 DHBs responded. Seven DHBs serving 42% of the population have established MAPUs since 2003 and a further six have plans to do so over the next 3 years, potentially expanding service to 73% of the NZ population. All seven current MAPUs are in close proximity to and accept patients directly from emergency departments. Each MAPU has a documented target length of stay, four units have referral protocols, five provide guidelines for management of common medical emergencies and five routinely audit unit performance. Five MAPUs have cardiac monitored beds and isolation rooms. Rapid access is available to computed tomography scanning (six units), ultrasound (five) and echocardiography (four). Two units have no nominated physician leadership and two lack dedicated therapy resources. General physicians are involved in provision of acute medical services in 20 of 21 DHBs. Medical assessment and planning units have become an important component of acute medical service provision in NZ. The established units largely comply with Australasian recommendations, although important deficiencies exist. Training of physicians must combine the needs of acute medical patients and clinical roles of physicians within MAPUs with local DHB requirements for services to be most effective.
Continuing versus Stopping Prestroke Antihypertensive Therapy in Acute Intracerebral Hemorrhage: A Subgroup Analysis of the Efficacy of Nitric Oxide in Stroke Trial
Publisher: Elsevier BV
Date: 05-2016
Repeated Measures of Modified Rankin Scale Scores to Assess Functional Recovery From Stroke: AFFINITY Study Findings
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 16-08-2022
Abstract: Function after acute stroke using the modified Rankin Scale (mRS) is usually assessed at a point in time. The analytical implications of serial mRS measurements to evaluate functional recovery over time is not completely understood. We compare repeated‐measures and single‐measure analyses of the mRS from a randomized clinical trial. Serial mRS data from AFFINITY (Assessment of Fluoxetine in Stroke Recovery), a double‐blind placebo randomized clinical trial of fluoxetine following stroke (n=1280) were analyzed to identify demographic and clinical associations with functional recovery (reduction in mRS) over 12 months. Associations were identified using single‐measure (day 365) and repeated‐measures (days 28, 90, 180, and 365) partial proportional odds logistic regression. Ninety‐five percent of participants experienced a reduction in mRS after 12 months. Functional recovery was associated with age at stroke years no prestroke history of diabetes, coronary heart disease, or ischemic stroke prestroke history of depression, a relationship partner, living with others, independence, or paid employment no fluoxetine intervention ischemic stroke (compared with hemorrhagic) stroke treatment in Vietnam (compared with Australia or New Zealand) longer time since current stroke and lower baseline National Institutes of Health Stroke Scale & Patient Health Questionnaire‐9 scores. Direction of associations was largely concordant between single‐measure and repeated‐measures models. Association strength and variance was generally smaller in the repeated‐measures model compared with the single‐measure model. Repeated‐measures may improve trial precision in identifying trial associations and effects. Further repeated‐measures stroke analyses are required to prove methodological value. URL: www.anzctr.org.au Unique identifier: ACTRN12611000774921.
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