Annemarei Ranta

Cluster randomized controlled trial of TIA electronic decision support in primary care

Objective: To test if TIA/stroke electronic decision support in primary care improves management. Methods: Multicenter, single-blind, parallel-group, cluster randomized, controlled trial comparing TIA/stroke electronic decision support guided management with usual care. Main outcomes were guideline adherence and 90-day stroke risk. Secondary outcomes were cerebrovascular/vascular/death/adverse events, cost, and user feedback. Main analysis was logistic regression with a normal random effect for clusters using a generalized linear mixed model. Results: Twenty-nine clinics were randomized to intervention, 27 to control, recruiting 172 and 119 eligible patients. More intervention patients received guideline-adherent care (131/172; 76.2%) than control patients (49/119; 41.2%) (adjusted odds ratio [OR] 4.57; 95% confidence interval [CI] 2.39–8.71; p < 0.001). Ninety-day stroke occurred in 2/172 (1.2%) intervention and 5/119 (4.2%) control patients (OR 0.27; 95% CI 0.05–1.41; p = 0.098). Ninety-day TIA or stroke occurrence was lower in the intervention group, 4/172 (2.3%) compared to 10/119 (8.5%) control (adjusted OR 0.26; 95% CI 0.70–0.97; p = 0.045). Fewer vascular events/deaths occurred in intervention, 6/172 (3.5%), than in control patients, 14/119 (11.9%) (adjusted OR 0.27; 95% CI 0.09–0.78; p = 0.016). Treatment cost ratio of 0.65 (95% CI 0.47–0.91; p = 0.013) favored the intervention without increased adverse events. Clinician feedback was positive. Conclusion: Primary care use of the TIA/stroke electronic decision support tool improves guideline adherence, safely reduces treatment cost, achieves positive user feedback, and may reduce cerebrovascular and vascular event risk following TIA/stroke. Classification of evidence: This study provides Class II evidence that a primary care electronic decision support tool improves guideline adherence and might reduce 90-day stroke risk.

Safety and efficacy of intensive vs. guideline antiplatelet therapy in high-risk patients with recent ischemic stroke or transient ischemic attack: rationale and design of the Triple Antiplatelets for Reducing Dependency after Ischaemic Stroke (TARDIS) trial (ISRCTN47823388)

Rationale The risk of recurrence following a stroke or transient ischemic attack is high, especially immediately after the event. Hypothesis Because two antiplatelet agents are superior to one in patients with non-cardioembolic events, more intensive treatment might be even more effective. Sample size estimates The sample size of 4100 patients will allow a shift to less recurrence, and less severe recurrence, to be detected (odds ratio 0·68) with 90% power at 5% significance. Methods and design Triple Antiplatelets for Reducing Dependency after Ischaemic Stroke (ISRCTN47823388) is comparing the safety and efficacy of intensive (combined aspirin, clopidogrel, and dipyridamole) vs. guideline antiplatelet therapy, both given for one-month. This international collaborative parallel-group prospective randomized open-label blinded-end-point phase III trial plans to recruit 4100 patients with acute ischemic stroke or transient ischemic attack. Randomization and data collection are performed over a secure Internet site with real-time data validation and concealment of allocation. Outcomes, serious adverse events, and neuroimaging are adjudicated centrally with blinding to treatment allocation. Study outcome The primary outcome is stroke recurrence and its severity (‘ordinal recurrence’ based on modified Rankin Scale) at 90 days, with masked assessment centrally by telephone. Secondary outcomes include vascular events, functional measures (disability, mood, cognition, quality of life), and safety (bleeding, death, serious adverse events). Discussion The trial has recruited more than 50% of its target sample size (latest number: 2399) and is running in 104 sites in 4 countries. One-third of patients presented with a transient ischemic attack.

Transient ischemic attack service provision: A review of available service models.

TIAs are predictors of high risk of subsequent stroke and require urgent intervention to maximize secondary prevention and minimize adverse health outcomes. TIA patients are often admitted to the hospital to facilitate rapid investigation and comprehensive management. However, over the last 2 decades, alternative service models have emerged in an effort to optimize health resource utilization without compromising patient outcomes. This article reviews recommended interventions and then discusses the inpatient and 6 alternative TIA service models to help modern stroke services determine the model best suited to their local health service environment.

Efficacy and safety of a TIA/stroke electronic support tool (FASTEST) trial: Study protocol

BackgroundStrokes are a common cause of adult disability and mortality worldwide. Transient ischaemic attacks (TIA) are associated with a high risk of subsequent stroke, and rapid intervention has the potential to reduce stroke burden. This study will assess a novel electronic decision support (EDS) tool to allow general practitioners (GPs) to implement evidence-based care rapidly without full reliance on specialists.Methods/designThis is a cluster randomized controlled trial comparing TIA/stroke management of GPs with access to the EDS tool versus usual care. The intervention period is 12 months with a 3-month follow-up period for individual patients. Primary outcomes consist of stroke within 90 days of presenting event and adherence to the New Zealand national TIA guideline.DiscussionA positive study will provide strong evidence for widespread implementation of this tool in practice and has the potential to improve key outcomes for patients and reduce the burden of stroke.Trial registrationAustralia New Zealand Clinical Trials Registry ACTRN12611000792921

Using the Internet to recruit patients for epilepsy trials: Results of a New Zealand pilot study

Purpose:  We created a database that could be accessed via the Internet by any neurologist or pediatric neurologist in New Zealand. The database was designed to facilitate recruitment of patients for investigator‐driven drug trials.

Incidence of Transient Ischemic Attack in Auckland, New Zealand, in 2011 to 2012

Background and Purpose— There have been few recent population-based studies reporting the incidence (first ever) and attack rates (incident and recurrent) of transient ischemic attack (TIA). Methods— The fourth Auckland Regional Community Stroke study (ARCOS IV) used multiple overlapping case ascertainment methods to identify all hospitalized and nonhospitalized cases of TIA that occurred in people ≥16 years of age usually resident in Auckland (population ≥16 years of age is 1.12 million), during the 12 months from March 1, 2011. All first-ever and recurrent new TIAs (any new TIA 28 days after the index event) during the study period were recorded. Results— There were 785 people with TIA (402 [51.2%] women, mean [SD] age 71.5 [13.8] years); 614 (78%) of European origin, 84 (11%) Māori/Pacific, and 75 (10%) Asian/Other. The annual incidence of TIA was 40 (95% confidence interval, 36–43), and attack rate was 63 (95% confidence interval, 59–68), per 100 000 people, age standardized to the World Health Organization world population. Approximately two thirds of people were known to be hypertensive or were being treated with blood pressure–lowering agents, half were taking antiplatelet agents and just under half were taking lipid-lowering therapy before the index TIA. Two hundred ten (27%) people were known to have atrial fibrillation at the time of the TIA, of whom only 61 (29%) were taking anticoagulant therapy, suggesting a failure to identify or treat atrial fibrillation. Conclusions— This study describes the burden of TIA in an era of aggressive primary and secondary vascular risk factor management. Education programs for medical practitioners and patients around the identification and management of atrial fibrillation are required.

Health economics of cerebrovascular disease: Can we do better?

In the face of an aging population, the already substantial burden of stroke will likely increase. Efforts to optimize service implementation and organization, as well as monitor health care costs, must complement the quest for better therapies to prevent and treat stroke.

Transient ischameic attack/stroke electronic decision support: a 14-month safety audit.

BACKGROUND To assess the safety of a Transient Ischameic Attack (TIA)/Stroke Electronic Decision Support (EDS) tool in the primary care setting intended to aid general practitioners in the timely management of transient ischemic attacks (TIAs). METHODS A 14-month safety audit reviewing all patients managed with the help of the TIA/Stroke EDS tool. Major morbidity and mortality were assessed by screening patients for subsequent hospital admissions and investigating potential links to EDS use. RESULTS Seventy-nine patients were managed with the aid of the TIA/Stroke EDS. EDS use resulted in 8 appropriate immediate hospital admissions because of patients being at high risk of stroke. Three patients had delayed admission, but care was fully guideline based and patients had no adverse outcome. Eleven admissions were unrelated to EDS use. Two deaths occurred; these did not result from inappropriate EDS advice. CONCLUSIONS Results suggest that TIA/Stroke EDS use is not associated with major morbidity or mortality. Larger studies are needed to draw more definite conclusions regarding the utility of this TIA/Stroke EDS in preventing strokes.

Appropriateness of general practitioner imaging requests for transient ischaemic attack patients: secondary analysis of a cluster randomised controlled trial

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.

Baseline characteristics of the 3096 patients recruited into the ‘Triple Antiplatelets for Reducing Dependency after Ischemic Stroke’ trial

Background The risk of recurrence following ischemic stroke or transient ischemic attack is highest immediately after the event. Antiplatelet agents are effective in reducing the risk of recurrence and two agents are superior to one in the early phase after ictus. Design The triple antiplatelets for reducing dependency after ischemic stroke trial was an international multicenter prospective randomized open-label blinded-endpoint trial that assessed the safety and efficacy of short-term intensive antiplatelet therapy with three agents (combined aspirin, clopidogrel and dipyridamole) as compared with guideline treatment in acute ischemic stroke or transient ischemic attack. The primary outcome was stroke recurrence and its severity, measured using the modified Rankin Scale at 90 days. Secondary outcomes included recurrent vascular events, functional measures (cognition, disability, mood, quality of life), and safety (bleeding, death, serious adverse events). Data are number (%) or mean (standard deviation, SD). Results Recruitment ran from April 2009 to March 2016; 3096 patients were recruited from 106 sites in four countries (Denmark 1.6%, Georgia 2.7%, New Zealand 0.2%, UK 95.4%). Randomization characteristics included: age 69.0 (10.1) years; male 1945 (62.8%); time onset to randomization 29.4 (11.9) h; stroke severity (National Institutes for Health Stroke Scale) 2.8 (3.6); blood pressure 143.5 (18.2)/79.5 (11.4) mmHg; IS 2143 (69.2%), transient ischemic attack 953 (30.8%). Conclusion Triple antiplatelets for reducing dependency after ischemic stroke was a large trial of intensive/triple antiplatelet therapy in acute ischemic stroke and transient ischemic attack, and included participants from four predominantly Caucasian countries who were representative of patients in many western stroke services.