Erik Lundström

Prevalence of disabling spasticity 1 year after first‐ever stroke

Objective:  To estimate the prevalence of disabling spasticity (DS) 1 year after first‐ever stroke.

Four-Fold Increase in Direct Costs of Stroke Survivors With Spasticity Compared With Stroke Survivors Without Spasticity The First Year After the Event

Background and Purpose— The prevalence of spasticity after first-ever stroke is approximately 20%, but there are no health economic studies on costs associated with spasticity after stroke. The objective of our study was to estimate direct costs of stroke with spasticity for patients surviving up to 1 year after the stroke event in comparison to costs of stroke without spasticity. Methods— A representative sample of patients with first-ever stroke hospitalized at Uppsala University Hospital was eligible for our cross-sectional survey. All direct costs during 1 year were identified for each patient, including costs for hospitalization (acute and rehabilitation), primary health care, medication, and costs for municipality services. Swedish currency was converted to Purchasing Power Parities US dollar (PPP

TIME-COURSE AND DETERMINANTS OF SPASTICITY DURING THE FIRST SIX MONTHS FOLLOWING FIRST-EVER STROKE

). Results— Median age (interquartile range) was 73 years (18), and the proportion of women was 48%. The majority of the direct costs (78%) was associated with hospitalization, whereas 20% was associated with municipality services during 1 year after a first-ever stroke. Only 1% of all direct costs were related to primary health care and 1% to medication. The level of costs for patients with stroke was correlated with the presence of spasticity as measured with the modified Ashworth scale (rs=0.524) and with the degree of disability as measured with modified Rankin Scale (rs=0.624). The mean (median, interquartile range) direct cost for stroke patients with spasticity was PPP

Risk factors for stroke-related pain 1 year after first-ever stroke.

84 195 (72 116, 53 707) compared with PPP

Update on the third international stroke trial (IST-3) of thrombolysis for acute ischaemic stroke and baseline features of the 3035 patients recruited

21 842 (12 385, 17 484) for patients with stroke without spasticity (P<0.001). Conclusions— Direct costs for 12-month stroke survivors are 4 times higher than direct costs for patients with stroke without spasticity during the first year after the event.

The FOCUS, AFFINITY and EFFECTS trials studying the effect(s) of fluoxetine in patients with a recent stroke: a study protocol for three multicentre randomised controlled trials

OBJECTIVE To explore the occurrence of, and risk factors for, spasticity until 6 months after first-ever stroke. METHODS Forty-nine patients were examined at day 2-10, at 1 month, and at 6 months. The modified Ashworth Scale was used to assess resistance to passive movements. A comprehensive clinical examination was performed to identify other positive signs of upper motor neurone syndrome, in accordance with a broader definition of spasticity, and to evaluate whether spasticity was disabling. Neurological impairments were determined by use of the National Institutes of Health Stroke Scale and global disability by use of the modified Rankin Scale. RESULTS Spasticity was present in 2 patients (4%) at day 2-10, in 13 patients (27%) at 1 month, and in 11 patients (23%) at 6 months. Severe paresis of the arm at day 2-10 was associated with a higher risk for spasticity at 1 month (odds ratio = 10, 95% confidence interval 2.1-48.4). Disabling spasticity was present in one patient at 1 month and in 6 patients (13%) at 6 months. CONCLUSION Spasticity according to the modified Ashworth Scale usually occurs within 1 month and disabling spasticity later in a subgroup. Severe paresis of the arm is a risk factor for spasticity.

Outcome After Spontaneous Subarachnoid Hemorrhage Measured With the EQ-5D

Objective:  To estimate the prevalence of stroke‐related pain and to explore its relation to spasticity.

Attention Deficits After Aneurysmal Subarachnoid Hemorrhage Measured Using the Test of Variables of Attention

BackgroundIntravenous recombinant tissue plasminogen activator (rtPA) is approved in Europe for use in patients with acute ischaemic stroke who meet strictly defined criteria. IST-3 sought to improve the external validity and precision of the estimates of the overall treatment effects (efficacy and safety) of rtPA in acute ischaemic stroke, and to determine whether a wider range of patients might benefit.DesignInternational, multi-centre, prospective, randomized, open, blinded endpoint (PROBE) trial of intravenous rtPA in acute ischaemic stroke. Suitable patients had to be assessed and able to start treatment within 6 hours of developing symptoms, and brain imaging must have excluded intracranial haemorrhage and stroke mimics.ResultsThe initial pilot phase was double blind and then, on 01/08/2003, changed to an open design. Recruitment began on 05/05/2000 and closed on 31/07/2011, by which time 3035 patients had been included, only 61 (2%) of whom met the criteria for the 2003 European approval for thrombolysis. 1617 patients were aged over 80 years at trial entry. The analysis plan will be finalised, without reference to the unblinded data, and published before the trial data are unblinded in early 2012. The main trial results will be presented at the European Stroke Conference in Lisbon in May 2012 with the aim to publish simultaneously in a peer-reviewed journal. The trial result will be presented in the context of an updated Cochrane systematic review. We also intend to include the trial data in an individual patient data meta-analysis of all the relevant randomised trials.ConclusionThe data from the trial will: improve the external validity and precision of the estimates of the overall treatment effects (efficacy and safety) of iv rtPA in acute ischaemic stroke; provide: new evidence on the balance of risk and benefit of intravenous rtPA among types of patients who do not clearly meet the terms of the current EU approval; and, provide the first large-scale randomised evidence on effects in patients over 80, an age group which had largely been excluded from previous acute stroke trials.Trial registrationISRCTN25765518

Objective assessment of cervical dystonia: a pilot study

BackgroundSeveral 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.Methods/DesignThe 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.DiscussionIf 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.Trial registrationFOCUS: ISRCTN83290762 (23/05/2012), AFFINITY: ACTRN12611000774921 (22/07/2011). EFFECTS: ISRCTN13020412 (19/12/2014).

Letter by Mead et al Regarding Article, "Selective Serotonin Reuptake Inhibitors for Stroke: More Trials are Needed"

Background and Purpose— The EQ-5D measures quality of life based on self-reported health status in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. In this study, the EQ-5D was evaluated as an outcome measure for patients with subarachnoid hemorrhage. Methods— The EQ-5D was completed in 710 patients 9 months after subarachnoid hemorrhage. Relevant demographic and clinical factors were evaluated as predictors of the 5 outcome dimensions in a series of linear regression models. Results— Worse health status in mobility, self-care, and usual activities was predicted by increasing age and by a more severe disease as indicated by the presence of an aneurysm, worse clinical condition at admission, or more blood on the CT scan. Younger age and female gender predicted worse health status regarding anxiety/depression. Conclusions— The evaluation of the EQ-5D reveals age-related differences in the nature of the challenges faced by these patients.