Proposing the stroke levity scale: a valid, reliable, simple, and time-saving measure of stroke severity

Background and purpose:  National Institutes of Health Stroke Scale (NIHSS) is long and complex. Our objective was to design a valid, reliable, simple, and time-saving stroke severity scale.
Methods:  About 103 and 100 consecutive stroke patients in Berlin (Germany) and Ibadan (Nigeria), respectively were evaluated using the measures listed below. The Stroke Levity Scale (SLS) was calculated as maximum power (0–5) in the dexterous hand + maximum power in the weaker lower limb + mobility score−1(if aphasia present).
Results:  It took less than 2 min to administer the SLS in contrast to 8 min for the NIHSS. The SLS showed significant correlation to the NIHSS ( ρ  = −0.79, P  < 0.0001), the modified Rankin Scale ( ρ  = −0.79, P  < 0.0001), and the health-related quality of life (QOL) in stroke patient's questionnaire ( ρ  = 0.78, P  < 0.0001). It had Cronbach's α of 0.75 (Ibadan) and 0.71 (Berlin). The κ -value for test-retest reliability was 0.77 with P  < 0.0001.
Conclusions:  The SLS is a concise, valid, and reliable stroke impairment scale that can be used routinely to monitor outcome in stroke patients. Because it is brief and simple to apply, non-neurologists can be taught to administer it in addition to QOL and disability scales for stroke survivors without significantly increasing the respondent burden.     

Development of a stroke-specific quality of life scale.

BACKGROUND AND PURPOSE: Clinical stroke trials are increasingly measuring patient-centered outcomes such as functional status and health-related quality of life (HRQOL). No stroke-specific HRQOL measure is currently available. This study presents the initial development of a valid, reliable, and responsive stroke-specific quality of life (SS-QOL) measure, for use in stroke trials. METHODS: Domains and items for the SS-QOL were developed from patient interviews. The SS-QOL, Short Form 36, Beck Depression Inventory, National Institutes of Health Stroke Scale, and Barthel Index were administered to patients 1 and 3 months after ischemic stroke. Items were eliminated with the use of standard psychometric criteria. Construct validity was assessed by comparing domain scores with similar domains of established measures. Domain responsiveness was assessed with standardized effect sizes. RESULTS: All 12 domains of the SS-QOL were unidimensional. In the final 49-item scale, all domains demonstrated excellent internal reliability (Cronbach's alpha values for each domain >/=0.73). Most domains were moderately correlated with similar domains of established outcome measures (r2 range, 0.3 to 0.5). Most domains were responsive to change (standardized effect sizes >0.4). One- and 3-month SS-QOL scores were associated with patients' self-report of HRQOL compared with before their stroke (P<0.001). CONCLUSIONS: The SS-QOL measures HRQOL, its primary underlying construct, in stroke patients. Preliminary results regarding the reliability, validity, and responsiveness of the SS-QOL are encouraging. Further studies in diverse stroke populations are needed.     

Measuring quality of life in a way that is meaningful to stroke patients

OBJECTIVE: To identify predictors of poststroke quality of life. BACKGROUND: Health-related quality of life (HRQOL) measures assess the impact of disease on the physical, emotional, and social aspects of patients' lives. Although HRQOL measures are used increasingly, factors associated with HRQOL poststroke and the ability of stroke-specific versus generic HRQOL measures to predict patient-reported HRQOL are not well known. METHODS: A total of 71 patients were evaluated 1 month postischemic stroke with a new stroke-specific HRQOL measure-the SS-QOL-and the SF-36, a generic HRQOL measure. Stroke severity, impairments, and functional limitations were also measured. Demographic variables and outcome measure scores were compared between patients rating their overall HRQOL the same as pre-stroke versus those with overall HRQOL worse than prestroke. Independent predictors of overall HRQOL were identified using multivariable modeling. RESULTS: Variables associated with better overall HRQOL were higher (better) SS-QOL and Barthel Index scores, and lower (better) NIH Stroke Scale and Beck Depression Inventory scores. Independent predictors of good overall HRQOL were the SS-QOL score (odds ratio [OR], 2.97; 95% CI, 1.3, 7.1; p = 0.01) and NIH Stroke Scale score (OR, 0.69; 95% CI, 0.47, 0.99; p = 0.05). Demographic factors and SF-36 scores were not associated with overall HRQOL ratings. CONCLUSIONS: Stroke-specific quality of life score and patient impairments predict patient-reported overall health-related quality of life (HRQOL) poststroke. SF-36 scores were not associated with overall HRQOL ratings. Disease-specific HRQOL measures are more sensitive to meaningful changes in poststroke HRQOL and may thus aid in identifying specific aspects of poststroke function that clinicians and "trialists" can target to improve patients' HRQOL after stroke.     

Interleukin-6 and soluble intercellular adhesion molecule-1 in acute brain ischaemia

Inflammation plays a critical role in the pathogenesis of atherothrombosis. Our aim was to examine the association between plasma concentrations of inflammatory biomarkers and severity and outcome of acute brain ischaemia. Plasma samples were collected within 36 h of symptom onset in patients with acute brain ischaemia, and assessed by conventional ELISA kits for concentration of interleukin-6 (IL-6) and soluble intercellular adhesion molecule-1 (sICAM-1). Patients were assessed serially for stroke severity (National Institute of Health stroke scale) and outcome during follow-up (modified Rankin Scale, mRS; and Stroke Impact Scale-16, SIS). Patients ( n  = 113, 65% men, mean age 64 ± 12 years) had a mean IL-6 concentrations of 5.1 ± 5.0 pg/ml and sICAM-1 of 377 ± 145 ng/ml. IL-6, but not sICAM-1, concentrations were strongly associated with stroke severity ( P  < 0.01 at all serial assessments). Ln-transformed IL-6 levels (per 1 SD) were associated with disability (mRS ≥2, OR = 1.7; 95% CI 1.1–3.0) and poor physical function (SIS ≤85, OR = 1.7; 95% CI 1.0–2.8). Further adjustment for baseline stroke severity, however, eliminated these associations. Our results suggest that high plasma concentrations of the inflammatory biomarker IL-6 but not sICAM-1 are associated with stroke severity and poorer functional outcome. IL-6 does not add, however, additional prognostic information for stroke outcome beyond that conveyed by the stroke severity.     

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.
Design:  Cross-sectional survey 1 year after first-ever stroke.
Methods:  Patients above 18 years from one county with first-ever stroke were identified by use of the national stroke registry. A representative sample of 163 patients was created and 140 of these were followed up. Assessments of motor function and ability with the modified Ashworth Scale, the modified Rankin Scale (mRS), the Barthel Index (BI) and clinical evaluation were performed in order to identify patients with spasticity-related disability.
Results:  The observed prevalence of any spasticity was 17% and of DS 4%. Patients with DS scored significantly worse than those with no DS on the mRS ( P  = 0.009) and the BI ( P  = 0.005). DS was more frequent in the upper extremity, correlated positively with other indices of motor impairment and inversely with age. There was an independent effect of severe upper extremity paresis (OR 22, CI 3.9–125) and age below 65 years (OR 9.5, CI 1.5–60).
Conclusions:  The prevalence of DS after first-ever stroke is low but corresponds to a large number of patients and deserves further attention with regards to prevention and treatment .     

Even a single seizure negatively impacts pediatric health-related quality of life

Purpose:  Both a single seizure and chronic recurrent seizures (epilepsy) occur commonly in childhood. Although several studies have documented the impact of pediatric epilepsy on psychosocial functioning, such as health-related quality of life (HRQOL), no studies have examined the impact of a single seizure on HRQOL. The primary objectives of this study were: (1) to compare parent–proxy HRQOL in children with a single seizure and newly diagnosed untreated epilepsy to normative data and (2) to examine differences in parent–proxy HRQOL between children with single seizure and newly diagnosed untreated epilepsy.
Methods:  A retrospective medical chart review was conducted on a consecutive cohort of children being evaluated for seizures at a New-Onset Seizure Disorder Clinic. Information from the medical chart review included demographic data, seizure information, and the parent–proxy Pediatric Quality of Life Inventory (PedsQL), a well-validated measure of HRQOL in pediatric chronic illnesses.
Results:  Participants included 109 children (n = 53 single seizure; n = 56 newly diagnosed untreated epilepsy). Results indicated that both children with a single seizure and children with newly diagnosed untreated epilepsy had significant impairments in HRQOL compared to normative data. However, no significant HRQOL differences were found between the single seizure and the untreated epilepsy groups.
Discussion:  Children diagnosed with a single seizure or epilepsy have similar clinically significant impairments in HRQOL. Evaluation of HRQOL, even after a first seizure, is important and will identify children at risk at the earliest opportunity, allowing for timely psychosocial intervention.     

Impact of seizures on morbidity and mortality after stroke: a Canadian multi-centre cohort study

Introduction:  Limited information is available about the impact of seizures on stroke outcome, health care delivery and resource utilization.
Objective:  To determine whether the presence of seizures after stroke increases disability, mortality and health care utilization (length of hospital stay, ICU admission, consults, discharge to a long-term care facility).
Methods:  This cohort study included consecutive patients with acute stroke between July 2003 and June 2005 from the Registry of the Canadian Stroke Network (RCSN), the largest clinical database of patients in Canada with acute stroke seen at selected acute care hospitals. We compared clinical characteristics and outcomes amongst patients experiencing stroke without and with seizures occurring during inpatient stay. Main outcome measures included: case-fatality, disability at discharge, length-of-stay, and discharge disposition. A logistic regression analysis was used to determine whether the presence of seizures was associated with poor stroke outcomes.
Results:  Amongst 5027 patients included in the study; seizures occurred in 138 (2.7%) patients with stroke. Patients with seizures had a higher mortality at 30-day (36.2% vs. 16.8%, P  < 0.0001) and at 1-year post-stroke (48.6% vs. 27.7%, P  < 0.001), longer hospitalization, and greater disability at discharge ( P  < 0.001). Multivariate analysis revealed that stroke severity, hemorrhagic stroke, and presence of neglect were associated to occurrence of seizures after stroke.
Conclusions:  The presence of seizures after stroke was associated with increased resources utilization, length of hospital stay, whilst decreasing both 30-day and 1-year survival. Quality improvement strategies targeting patients with seizures may help optimize the management of this subgroup of more disabled patients.     

Natural history of complications after intracerebral haemorrhage

Background and purpose:  Numerous trials of haemostatic and neuroprotective agents for intracerebral haemorrhage (ICH) have failed. We characterized the risk of complications after ICH in a trial-eligible patient population, to inform safety in future trials.
Methods:  We used the Virtual International Stroke Trials Archive database to identify placebo-treated patients with spontaneous ICH, who were not comatose at admission, where randomization took place within 4 h of symptom onset, and where serious complication and outcome data were available. We described the complications encountered and assessed whether the absence of common complications influenced attainment of good functional outcome (mRS ≤4) at 90 days using logistic regression.
Results:  Of 201 patients examined, 70.2% experienced at least one serious complication. Neurological complications occurred in 21%, infections amongst 11%, and thromboembolic complications in 2%. Extension of the haemorrhage occurred most frequently: its absence was a significant predictor of good functional outcome ( P  < 0.0001, adjusted OR for good functional outcome = 21.9, 95% CI: [5.5, 88.3]). Neither infection, nor cardiac, nor thromboembolic complications influenced functional outcome at 90 days.
Conclusions:  Three month outcome in ICH patients depends on initial stroke severity and on enlargement of the haemorrhage. Our results should inform safety in future clinical trials of putative ICH therapies.     

Development and validation of NEWSQOL, the Newcastle Stroke-Specific Quality of Life Measure

BACKGROUND: A review of stroke-specific quality of life (QOL) measures indicated little evidence of their validity/reliability. PURPOSE: To describe the development/validation of a new measure - the Newcastle Stroke-Specific Quality of Life Measure (NEWSQOL). METHODS: Phase I: qualitative interviews (28 stroke patients) determined QOL issues for inclusion in the measure. Initial items/response categories were pre-tested (30 patients). Administration of the NEWSQOL in the item reduction stage (100 patients) identified poorly performing items and factor analysis showed likely domains. Internal consistency was examined. Phase II: NEWSQOL and comparator measures were administered (106 patients) to examine validity/test-retest reliability. RESULTS: Phase I: 140 items were identified for initial inclusion. Qualitative pre-testing led to an extensive revision. Item reduction resulted in a final measure of 56 items in 11 domains (feelings, activities of daily living/self-care, cognition, mobility, emotion, sleep, interpersonal relationships, communication, pain/sensation, vision, fatigue; Cronbach's alpha = 0.71-0.90). Phase II: NEWSQOL domain scores, except cognition, were moderately/highly correlated (0.45-0.76) with relevant comparator measures. NEWSQOL domains feelings, communication and cognition low/moderately correlated with Barthel Index scores (-0.49 to -0.28), as predicted. Test-retest reliability was high (intraclass correlation coefficient range 0.78-0.92). CONCLUSIONS: NEWSQOL is an acceptable, patient-derived, interviewer-administered, stroke-specific QOL measure with evidence of reliability and validity, making it a promising instrument for assessing QOL after stroke. Involvement of relevant patients in determining the content and format considerably enhances confidence in its validity.     

Cerebral autoregulation in patients with obstructive sleep apnea syndrome during wakefulness

Background and purpose:  Obstructive sleep apnea syndrome (OSAS) is an independent risk factor for stroke. Impairment of cerebral autoregulation may play a potential role in the pre-disposition to stroke of OSAS patients. In this study, we aimed to assess dynamic cerebral autoregulation (DCA) during wakefulness in OSAS patients and a group of matched controls.
Methods:  Patients and controls were examined in the morning after an overnight complete polysomnography. Mean cerebral blood flow velocity (CBFV) in the middle cerebral artery and mean arterial blood pressure (ABP) were continuously recorded using transcranial Doppler and Finapres. DCA was assessed using the Mx autoregulatory index. Mx is a moving correlation coefficient between mean CBFV and mean ABP. More positive value of Mx indicates worse autoregulation.
Results:  Eleven OSAS patients (mean age ± SD; 52.6 ± 7.9) and 9 controls (mean age ± SD; 49.1 ± 5.3) were enrolled. The mean apnea–hypopnea index (AHI) in the OSAS group was of 22.7 ± 11.6. No significant difference was found between the two groups as for age, body mass index, mean ABP and endtidal CO₂ pressure. Cerebral autoregulation was impaired in OSAS patients compared with controls (Mx index: 0.414 ± 0.138 vs. 0.233 ± 0.100; P  = 0.009). The severity of autoregulation impairment correlated to the severity of the sleep respiratory disturbance measured by the AHI ( P  = 0.003).
Conclusion:  Cerebral autoregulation is impaired in patients with OSAS during wakefulness. Impairment of cerebral autoregulation is correlated with the severity of OSAS.     

The beneficial effect of statins treatment by stroke subtype

Background and purpose:  Statins have shown some protective effect after ischaemic stroke in observational studies. However, this effect has never been assessed by etiological subtypes.
Methods:  Observational study using data from the Stroke Unit Data Bank from consecutive patients with cerebral infarction. Variables analyzed: demographic data, cardiovascular risk factors, treatment with statins at stroke onset, stroke severity, stroke subtype, in-hospital complications, length of stay, and functional status at discharge (modified Rankin Scale).
Results:  A total of 2742 patients were included, 1539 were men. Mean age was 69.17 years (SD 12.19). Of these, 281 patients (10.2%) were receiving statins when admitted. The logistic regression analyses showed that previous treatment with statins was an independent predictor for better outcome at discharge among all strokes (OR, 2.08; 95% CI, 1.39 to 3.1) as well as for the atherothrombotic (OR, 2.79; 95% CI, 1.33 to 5.84) and lacunar strokes (OR, 2.28; 95% CI, 1.15 to 4.52) after adjustment for demographic data, risk factors, previous treatments, stroke subtypes, stroke severity, in-hospital complications and length of stay. This benefit was not observed either in cardioembolic or in other etiology strokes.
Conclusions:  Previous treatment with statins is an independent factor associated with good outcomes in patients with ischaemic stroke. Atherothrombotic and small vessel strokes show the greatest benefit.     

Serum VEGF levels in acute ischaemic strokes are correlated with long-term prognosis

Background and purpose:  We investigated whether serum vascular endothelial growth factor (VEGF) levels in acute-stage ischaemic stroke patients with small vessel disease (SVD) or large vessel disease (LVD) are correlated with long-term prognoses, based on the difference in NIH Stroke Scale (NIHSS) scores between acute and chronic stages.
Methods:  From March 2007 to May 2008, we evaluated patients who experienced an ischaemic stroke for the first time, defined as SVD ( n  = 89) or LVD ( n  = 91) using the TOAST classification. Serum samples were taken immediately after admission (within 24 h of stroke onset) to evaluate VEGF levels. After 3 months, follow-up NIHSS scores were collected for all patients.
Results:  Serum VEGF levels in the acute stage (within 24 h of stroke onset) were higher in the LVD group than in the SVD group and were correlated with infarction volume. The increase in serum VEGF levels in the acute stage was proportional to an improved NIHSS score after 3 months. After adjustment for covariates, serum VEGF levels in the acute stage were still significantly correlated with the long-term prognosis of ischaemic stroke.
Conclusion:  Serum VEGF levels are correlated with long-term prognoses in acute ischaemic stroke patients.     

Knowledge and perception of stroke amongst hospital workers in an African community

Background and purpose:  Stroke is a growing public health problem worldwide. Hospital workers are sources of knowledge on health issues including stroke. The present study aimed at assessing the knowledge and perception of a sample of Nigerian hospital workers about stroke.
Methods:  Hospital-based, cross-sectional survey. Respondents selected by systematic random sampling were interviewed using a 29-item pre-tested, structured, semi-closed questionnaire.
Results:  There were 370 respondents (63% female, mean age: 34.4 ± 7.5 years; 61% non-clinical workers). Twenty-nine per cent of respondents did not recognize the brain as the organ affected. Hypertension (88.6%) was the commonest risk factor identified; 13.8% identified evil spirit/witchcraft as a cause of stroke, whilst one-sided body weakness (61.9%) was most commonly identified as warning symptom. Hospital treatment was most preferred by 61.1% of respondents whilst spiritual healing was most preferred by 13.0%. In the bivariate analysis, higher level of education and being a clinical worker correlated with better stroke knowledge ( P  < 0.001).
Conclusion:  This study demonstrates gaps in the knowledge of these hospital workers about stroke, and treatment choice influenced by cultural and religious beliefs. Health education is still important, even, amongst health workers and stroke awareness campaigns may need to involve faith-based organizations.     

Organized multi-disciplinary stroke team care improves acute stroke outcomes in resource limited settings; Results of a retrospective study from a Nigerian tertiary hospital

BackgroundEvidence for the impact of organized stroke multidisciplinary teams (MDTs) on outcomes in Africa is sparse.AimTo compare stroke outcomes, before and after the establishment (September 16, 2016) of a pioneer MDT at a tertiary hospital in southern Nigeria.MethodsUsing a retrospective, observational study design, the in-patient record of all stroke patients admitted between September 2014 to September 2018 was retrieved and rigorously reviewed. 155 patients seen 2 years before the MDT were compared with 169 stroke patients seen 2 years after the MDT. Stroke severity at admission and functioning at discharge were assessed using the Stroke Levity Scale (SLS) and the modified Rankin scale (mRS).ResultsMean ages (in years) were 60 pre-MDT vs 59.57 post MDT (p = 0.754). There were more males, 51% pre-MDT vs 54.2% post MDT (p = 0.565). SLS and mRS were not significantly different; severe SLS and mRS pre-MDT, 52.9% vs post-MDT, 49.4% (p = 0.727) and pre-MDT 19.4% vs post-MDT 19.5% (p = 0.685) respectively. More post-MDT patients were discharged alive, pre-MDT,56.8% vs 79.2% post MDT (p < 0.001); had swallow tests, pre-MDT 9.23% vs post-MDT 33.5% (p < 0.001); on secondary prevention, pre-MDT 67.7% vs post-MDT 78.9% (p = 0.023); had more clinic visits, pre-MDT,0.7% vs post-MDT 38.3% (p < 0.001). MDT was independently associated with lower in-hospital mortality on multivariable regression, adjusted odds ratio (OR) (95% Confidence interval CI) 0.17 (0.09–0.32).ConclusionOur results suggest that an organized MDT may improve acute outcomes and reduce mortality in resource constrained settings where there may be no stroke units. These findings need further prospective validation.     

Distribution of etiologies in patients above and below age 45 with first-ever ischemic stroke

Background –  There is limited information about distribution of etiologies of ischemic stroke in different age groups.
Materials and methods –  In this study, we applied the Trial of ORG 10172 in Acute Stroke Treatment (TOAST) classification in 87 patients aged ≤45, and in 347 patients aged 46–60 years with first-ever ischemic stroke in order to follow the distribution of stroke etiologies in different age groups.
Results –  Traditional risk factors, except smoking and atrial fibrillation, were more frequent in older patients. The most frequent etiologies in the younger stroke patients (aged ≤45) were 'other' than routine causes (26.4%), cardioembolism (22.4%) and 'idiopathic' strokes (20.7%), when no cause was found. In older patients (aged 46–60), small vessel disease (25.1%) and cardioembolism (22.2%) were the most frequent etiologies of stroke.
Conclusions –  In stroke patients below the age of 45, the TOAST classification should be expanded to better classify the wide diversity of stroke etiologies. The relatively low frequency of routine stroke etiologies in patients aged ≤45 can be explained by the significantly lower prevalence of traditional risk factors in these patients. In patients 46–60 years old, the TOAST classification is adequate in the characterization of ischemic stroke etiologies.     

Intravenous thrombolysis in stroke patients with hyperdense middle cerebral artery sign

Background and purpose:  We assessed the safety and efficacy of intravenous thrombolysis (IVT) in acute stroke patients with hyperdense middle cerebral artery sign (HMCAS).
Patients and methods:  Data from consecutive patients with acute (within 6 h of symptom onset) ischaemic stroke admitted between January 1999 and November 2007, in whom HMCAS was diagnosed on admission CT scan was retrospectively analysed. Seventy-one patients, admitted within the 3-h window, were treated with IVT, whilst further 42, admitted 3–6 h after symptom onset, were not. At 3-month clinical follow-up, outcome, mortality at 3 months and incidence of symptomatic intracranial haemorrhage were evaluated.
Results:  The two groups were comparable concerning age, stroke risk factors, prior antithrombotic treatment and NIHSS scores on admission. Good outcome (mRS score ≤ 1) was observed in 12/71 (17%) patients who were treated with IVT and in 1/42 (2%) patients who were not ( P  = 0.02). IVT treatment was identified as independent predictor of good outcome ( P  = 0.05). Mortality was 20% in patients treated with IVT and 12% in remaining patients ( P  = 0.3). Symptomatic intracranial haemorrhage occurred in 1 patient of each group (2%).
Conclusions:  These findings suggest that IVT in patients with HMCAS results in significantly better outcome, without significantly influencing mortality.     

Pre‐stroke use of beta‐blockers does not affect ischaemic stroke severity and outcome

Background and purpose: It is unclear whether pre‐stroke beta‐blockers use may influence stroke outcome. This study evaluates the independent effect of pre‐stroke use of beta‐blockers on ischaemic stroke severity and 3 months functional outcome. Methods: Pre‐stroke use of beta‐blockers was investigated in 1375 ischaemic stroke patients who had been included in two placebo‐controlled trials with lubeluzole. Stroke severity was assessed by either the National Institute of Health Stroke Scale (NIHSS) or the European Stroke Scale (ESS). A modified Rankin scale (mRS) score of >3 at 3 months was used as measure for the poor functional outcome. Results: Two hundred and sixty four patients were on beta‐blockers prior to stroke onset, and 105 patients continued treatment after their stroke. Pretreatment with beta‐blockers did not influence baseline stroke severity. There was no difference in stroke severity between nonusers and those on either a selective beta₁‐blocker or a non‐selective beta‐blocker. The likelihood of a poor outcome at 3 months was not influenced by pre‐stroke beta‐blocker use or beta‐blocker use before and continued after stroke onset. Conclusions: Pre‐stroke use of beta‐blockers does not appear to influence stroke severity and functional outcome at 3 months.     

Prior use of statins and outcome in patients with intracerebral haemorrhage

Background:  Pre-treatment with cholesterol lowering drugs of the statin family may exert protective effects in patients with ischaemic stroke and subarachnoid haemorrhage but their effects are not clear in patients with intracerebral haemorrhage (ICH).
Methods:  We recruited patients admitted to our University Hospital with an acute ICH and analysed pre-admission demographic variables, pre-morbid therapy, clinical and radiological prognostic markers and outcome variables including 90-day modified Rankin score and NIH stroke scale score (NIHSS).
Results:  We recruited 399 patients with ICH of which 101 (25%) were using statins. Statin users more often had vascular risk factors, had significantly lower haematoma volumes ( P  = 0.04) and had lower mortality rates compared with non-users (45.6% vs. 56.1%; P  = 0.11). However, statin treatment did not have a statistically significant impact on mortality or functional outcome on multiple logistic regression analysis.
Conclusions:  Treatment with statins prior to ICH failed to show a significant impact on outcome in this analysis despite lower haematoma volumes.     

A 3-week, randomized, placebo-controlled trial of asenapine in the treatment of acute mania in bipolar mania and mixed states

Objective:  Asenapine is approved for bipolar disorder and schizophrenia. This was a 3-week, randomized, double-blind, placebo-controlled trial of asenapine for treating acute bipolar mania.
Methods:  After a single-blind placebo run-in period, adults (n = 488) experiencing manic or mixed episodes were randomized to flexible-dose sublingual asenapine (10 mg BID on day 1; 5 or 10 mg BID thereafter; n = 194), placebo (n = 104), or oral olanzapine (15 mg BID on day 1; 5–20 mg QD thereafter; n = 191). Primary efficacy, change in Young Mania Rating Scale (YMRS) total score from baseline to day 21, was assessed using analysis of covariance with last observation carried forward [(LOCF); primary analysis]. A mixed model for repeated measures [(MMRM); prespecified secondary analysis] was also used to assess efficacy. Tolerability and safety assessments included adverse events, physical examinations, extrapyramidal symptom ratings, and laboratory values.
Results:  Mean daily dosages were asenapine 18.2 mg and olanzapine 15.8 mg. Significantly greater least squares (LS) mean ± SE changes in YMRS scores were observed on day 2 with asenapine (−3.0 ± 0.4) and olanzapine (−3.4 ± 0.4) versus placebo (−1.5 ± 0.5, both p < 0.01) and were maintained until day 21 (−10.8 ± 0.8 with asenapine, −12.6 ± 0.8 with olanzapine; both p ≤ 0.0001 versus placebo, −5.5 ± 1.1) with LOCF. The results of MMRM analyses were consistent with those of LOCF. Asenapine had a modest impact on weight and metabolic measures.
Conclusions:  These results indicate that asenapine is rapidly acting, efficacious, and well tolerated for patients with bipolar I disorder experiencing an acute manic episode.     

A new scale for assessing patients with vertebrobasilar stroke-the Israeli Vertebrobasilar Stroke Scale (IVBSS): inter-rater reliability and concurrent validity

OBJECTIVES: Most of existing stroke scoring systems have limited ability to evaluate patients with cerebrovascular events in the vertebrobasilar territory. We devised a new scale, the Israeli Vertebrobasilar Stroke Scale (IVBSS) in order to directly and more accurately assess clinical deficits of patients with vertebrobasilar stroke. The present study measured the reliability and validity of the IVBSS. PATIENTS AND METHODS: Forty-three patients (mean age+/-S.D., 70.9+/-8.8 years, 27 males) with vertebrobasilar stroke were evaluated with the IVBSS (11 items), the NIH Stroke Scale (NIHSS) and the disability modified Rankin Scale (mRS) by independent examiners. Interobserver agreement was rated by weighted kappa statistics for each item and the total IVBSS score. Validity was examined with Spearman rank coefficients to compare the IVBSS with NIHSS and mRS. RESULTS: Excellent reliability was demonstrated between the examiners for almost each item and the total score of the IVBSS (kappa>0.75). The total IVBSS score was strongly associated with NIHSS and mRS results (r=0.80 and 0.76, respectively; P<0.0002). CONCLUSIONS: The IVBSS is a valid instrument that allows the assessment of patients with vertebrobasilar stroke with high reliability. Further observations are warranted to determine the predictive value of the IVBSS for stroke outcome.