[Show abstract][Hide abstract] ABSTRACT: Several small trials have suggested that fluoxetine improves neurological recovery from stroke. FOCUS, AFFINITY and EFFECTS are a family of investigator-led, multicentre, parallel group, randomised, placebo-controlled trials that aim to determine whether routine administration of fluoxetine (20 mg daily) for 6 months after acute stroke improves patients' functional outcome.
The three trial investigator teams have collaboratively developed a core protocol. Minor variations have been tailored to the national setting in the UK (FOCUS), Australia and New Zealand (AFFINITY) and Sweden (EFFECTS). Each trial is run and funded independently and will report its own results. A prospectively planned individual patient data meta-analysis of all three trials will subsequently provide the most precise estimate of the overall effect of fluoxetine after stroke and establish whether any effects differ between trials and subgroups of patients. The trials include patients ≥18 years old with a clinical diagnosis of stroke, persisting focal neurological deficits at randomisation between 2 and 15 days after stroke onset. Patients are randomised centrally via web-based randomisation systems using a common minimisation algorithm. Patients are allocated fluoxetine 20 mg once daily or matching placebo capsules for 6 months. Our primary outcome measure is the modified Rankin scale (mRS) at 6 months. Secondary outcomes include the Stroke Impact Scale, EuroQol (EQ5D-5 L), the vitality subscale of the Short-Form 36, diagnosis of depression, adherence to medication, adverse events and resource use. Outcomes are collected at 6 and 12 months. The methods of collecting these data are tailored to the national setting. If FOCUS, AFFINITY and EFFECTS combined enrol 6000 participants as planned, they would have 90 % power (alpha 5 %) to detect a common odds ratio of 1.16, equivalent to a 3.7 % absolute difference in percentage with mRS 0-2 (44.0 % to 47.7 %). This is based on an ordinal analysis of mRS adjusted for baseline variables included in the minimisation algorithm.
If fluoxetine is safe and effective in promoting functional recovery, it could be rapidly, widely and affordably implemented in routine clinical practice and reduce the burden of disability due to stroke.
ISRCTN83290762 (23/05/2012), AFFINITY: ACTRN12611000774921 (22/07/2011).
[Show abstract][Hide abstract] ABSTRACT: Background and purpose:
We sought to establish whether the presence (versus absence) of a lesion on magnetic resonance imaging (MRI) with diffusion weighting (DWI-MRI) at presentation with acute stroke is associated with worse clinical outcomes at 1 year.
We recruited consecutive patients with a nondisabling ischemic stroke and performed DWI-MRI. Patients were followed up at 1 year to establish stroke recurrence (clinical or on MRI), cognitive impairment (Addenbrooke Cognitive Assessment Revised,<88) and modified Rankin Scale.
A median of 4 days post stroke, one third (76/264; 29%) of patients did not have a DWI lesion (95% confidence interval, 23%-35%). There was no statistically significant difference between those with and without a DWI lesion with respect to age or vascular risk factors. Patients without a lesion were more likely to be women or have previous stroke. At 1 year, 11 of 76 (14%) patients with a DWI-negative index stroke had a clinical diagnosis of recurrent stroke or transient ischemic attack, 33% had cognitive impairment (Addenbrooke Cognitive Assessment Revised <88), and 40% still had modified Rankin Scale >1, no different from DWI-positive patients; DWI-positive patients were more likely to have a new lesion on MRI (14%), symptomatic or asymptomatic, than DWI-negative patients (2%; P=0.02). Our data were consistent with 6 other studies (total n=976), pooled proportion of DWI-negative patients was 21% (95% confidence interval, 12%-32%).
Nearly one third of patients with nondisabling stroke do not have a relevant lesion on acute DWI-MRI. Patients with negative DWI-MRI had no better prognosis than patients with a lesion. DWI-negative stroke patients should receive secondary prevention.
[Show abstract][Hide abstract] ABSTRACT: Thrombolysis is associated with reduced disability for selected patients who have suffered ischemic stroke. However only a fraction of all patients who have suffered this type of stroke receive thrombolysis. The short time window of 4.5 hours in which treatment is licensed means that rapid care and well-organised pathways are essential. We studied measures to increase the uptake of thrombolysis through a better understanding of the hospital delays which lead to a lack of timely brain scanning and diagnosis. We examine the factors influencing the number of thrombolysed patients, the time between arrival at hospital and the administration of thrombolysis (door to needle time). Our analysis is based on the Scottish Stroke Care Audit (SSCA) data covering all stroke patients admitted to hospitals in Scotland in 2010, as well as on interviews with stroke care staff in Scotland. The data show significant variation in the speed of scanning, thrombolysis treatment and numbers of patients receiving treatment among hospitals. In the best performing hospital, 68% of patients arriving within 4 hours of stroke onset are scanned in time for thrombolysis compared with 40% on average
and 5% in the worst performing hospital. We model the system as a discrete-event simulation following the patient journey, starting when patients have a stroke and ending at thrombolysis for those who qualify. The simulation results show that just improving the performance of all hospitals to the level of the best performing hospital would (even without improvements in onset to arrival times) increase the thrombolysis rate from 6% (in
2010) to 11% of all admitted stroke patients in Scotland. By 2013 9% of patients were receiving thrombolysis, suggesting there is still room for improvement.
Operations Research for Health Care 09/2015; 6. DOI:10.1016/j.orhc.2015.09.003
[Show abstract][Hide abstract] ABSTRACT: Venous thromboembolism (VTE) is a common cause of death and morbidity in stroke patients. There are few data concerning the effectiveness of intermittent pneumatic compression (IPC) in treating patients with stroke.
To establish whether or not the application of IPC to the legs of immobile stroke patients reduced their risk of deep vein thrombosis (DVT).
Clots in Legs Or sTockings after Stroke (CLOTS) 3 was a multicentre, parallel-group, randomised controlled trial which allocated patients via a central randomisation system to IPC or no IPC. A technician blinded to treatment allocation performed compression duplex ultrasound (CDU) of both legs at 7–10 days and 25–30 days after enrolment. We followed up patients for 6 months to determine survival and later symptomatic VTE. Patients were analysed according to their treatment allocation.
We enrolled 2876 patients in 94 UK hospitals between 8 December 2008 and 6 September 2012.
Inclusion criteria: patients admitted to hospital within 3 days of acute stroke and who were immobile on the day of admission (day 0) to day 3. Exclusion criteria: age
[Show abstract][Hide abstract] ABSTRACT: Background The presence of a ‘weekend’ effect has been shown across a range of medical conditions, but has not been consistently observed for patients with stroke.
Aims We investigated the impact of admission time on a range of process and outcome measures after stroke.
Methods Using routine data from National Scottish data sets (2005–2013), time of admission was categorised into weekday, weeknight and weekend/public holidays. The main process measures were swallow screen on day of admission (day 0), brain scan (day 0 or 1), aspirin (day 0 or 1), admission to stroke unit (day 0 or 1), and thrombolysis administration. After case-mix adjustment, multivariable logistic regression was used to estimate the OR for mortality and discharge to home/usual place of residence.
Results There were 52 276 index stroke events. Compared to weekday, the adjusted OR (95%CI) for early stroke unit admission was 0.81 (0.77 to 0.85) for weeknight admissions and 0.64 (0.61 to 0.67) for weekend/holiday admissions; early brain scan 1.30 (0.87 to 1.94) and 1.43 (0.95 to 2.18); same day swallow screen 0.86 (0.81 to 0.91) and 0.85 (0.81 to 0.90); thrombolysis 0.85 (0.75 to 0.97) and 0.85 (0.75 to 0.97), respectively. Seven-day mortality, 30-day mortality and 30-day discharge for weekend admission compared to weekday was 1.17 (1.05 to 1.30); 1.08 (1.00 to 1.17); and 0.90 (0.85 to 0.95), respectively.
Conclusions Patients with stroke admitted out of hours and at weekends or public holidays are less likely to be managed according to current guidelines. They experience poorer short-term outcomes than those admitted during normal working hours, after correcting for known independent predictors of outcome and early mortality.
[Show abstract][Hide abstract] ABSTRACT: Background
Acute lacunar ischaemic stroke, white matter hyperintensities, and lacunes are all features of cerebral small vessel disease. It is unclear why some small vessel disease lesions present with acute stroke symptoms, whereas others typically do not.AimTo test if lesion location could be one reason why some small vessel disease lesions present with acute stroke, whereas others accumulate covertly.Methods
We identified prospectively patients who presented with acute lacunar stroke symptoms with a recent small subcortical infarct confirmed on magnetic resonance diffusion imaging. We compared the distribution of the acute infarcts with that of white matter hyperintensity and lacunes using computational image mapping methods.ResultsIn 188 patients, mean age 67 ± standard deviation 12 years, the lesions that presented with acute lacunar ischaemic stroke were located in or near the main motor and sensory tracts in (descending order): posterior limb of the internal capsule (probability density 0·2/mm3), centrum semiovale (probability density = 0·15/mm3), medial lentiform nucleus/lateral thalamus (probability density = 0·09/mm3), and pons (probability density = 0·02/mm3). Most lacunes were in the lentiform nucleus (probability density = 0·01–0·04/mm3) or external capsule (probability density = 0·05/mm3). Most white matter hyperintensities were in centrum semiovale (except for the area affected by the acute symptomatic infarcts), external capsules, basal ganglia, and brainstem, with little overlap with the acute symptomatic infarcts (analysis of variance, P < 0·01).Conclusions
Lesions that present with acute lacunar ischaemic stroke symptoms may be more likely noticed by the patient through affecting the main motor and sensory tracts, whereas white matter hyperintensity and asymptomatic lacunes mainly affect other areas. Brain location could at least partly explain the symptomatic vs. covert development of small vessel disease.
International Journal of Stroke 06/2015; 10(7). DOI:10.1111/ijs.12558 · 3.83 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Objective The aim of this study was to examine the practicality and accuracy of using an electronic monitoring device as a means of measuring medication adherence in elderly stroke survivors, with emphasis on patients’ experiences. Methods The Medication Event Monitoring System (MEMS), which records date and time of pill-bottle openings, was used to measure adherence to antihypertensive medication in a randomized controlled trial (RCT) of a brief psychological intervention with 58 stroke survivors. Patients were asked to describe and rate their experiences of using the MEMS pill bottle. Results MEMS adherence was related to both pill count and self-reported adherence (Medication Adherence Report Scale). Most patients found the MEMS acceptable and easy to use, although some found it cumbersome and/or experienced difficulties with the cap. Nearly half (48 %) reported at least one instance where MEMS data did not reflect their pill-taking behavior (e.g. taking a tablet out the day before to take on a flight); 55 % of patients indicated that the MEMS helped them remember their medication, suggesting a mere measurement effect. Conclusion Electronic pill monitoring has many flaws, including practical difficulties and data inaccuracies. There was evidence of a measurement effect, indicating that MEMS should be used in both intervention and control arms when used to measure adherence within RCTs. We also observed that the MEMS pill bottle is not suitable for measuring adherence in patients who use their own ‘days of the week’ box for sorting medication, as we found poorer adherence at follow-up in this group. Despite these limitations, we conclude that electronic monitoring presents the best method currently available for objective measurement of adherence, especially where detailed timing information is required. Accuracy may be improved by the concurrent use of other measures (e.g. pill count, self-report).
[Show abstract][Hide abstract] ABSTRACT: Dietary salt intake and hypertension are associated with increased risk of cardiovascular disease including stroke. We aimed to explore the influence of these factors, together with plasma sodium concentration, in cerebral small vessel disease (SVD). In all, 264 patients with nondisabling cortical or lacunar stroke were recruited. Patients were questioned about their salt intake and plasma sodium concentration was measured; brain tissue volume and white-matter hyperintensity (WMH) load were measured using structural magnetic resonance imaging (MRI) while diffusion tensor MRI and dynamic contrast-enhanced MRI were acquired to assess underlying tissue integrity. An index of added salt intake (P=0.021), pulse pressure (P=0.036), and diagnosis of hypertension (P=0.0093) were positively associated with increased WMH, while plasma sodium concentration was associated with brain volume (P=0.019) but not with WMH volume. These results are consistent with previous findings that raised blood pressure is associated with WMH burden and raise the possibility of an independent role for dietary salt in the development of cerebral SVD.Journal of Cerebral Blood Flow & Metabolism advance online publication, 22 April 2015; doi:10.1038/jcbfm.2015.64.
Journal of cerebral blood flow and metabolism: official journal of the International Society of Cerebral Blood Flow and Metabolism 04/2015; DOI:10.1038/jcbfm.2015.64 · 5.41 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Dysphagia is common after stroke, so feeding through a nasogastric (NG) tube may be necessary. These tubes are frequently dislodged, causing interruption to feeding and hydration, and potential aspiration of feed or fluids into the lungs. Interventions to prevent this may include taping tubes to the face; the application of hand mittens or bandaging patients' hands; inserting the NG tube into the nostril on the stroke-affected side; and nasal bridles. The aims of this survey were to investigate the management of NG feeding for stroke patients, including current tube confirmation and securing techniques, and associated nurse education. This was part of a three-phased sequential mixed-methods study. This paper reports on the second quantitative phase.
A quantitative postal survey, based on initial qualitative findings, was sent to registered nurses (n=528) from the National Stroke Nurses Forum and Scottish Stroke Nurses Forum, in addition to registered nurses working on stroke units within the local health board.
The overall response rate was 59% (n=314/528). Tape was the most commonly used method for securing tube position, followed by inserting the tube on the stroke-affected side. Hand mittens were used more frequently than the nasal bridle; bandaging hands was reported once. Taping was considered to be more acceptable and safer than hand mittens or the nasal bridle, but less effective. Training in inserting NG feeding tubes was received by 56% (n=176/314). Methods used for confirming tube position included aspiration and X-ray. Provision of training in confirmation techniques varied.
This study shows that the management of NG feeding for dysphagic stroke patients requires standardisation, as does the education for nurses to ensure that this intervention is carried out safely, effectively and acceptably.
British journal of nursing (Mark Allen Publishing) 03/2015; 24(6):319-25. DOI:10.12968/bjon.2015.24.6.319