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1.
J Intern Med ; 290(3): 646-654, 2021 09.
Article in English | MEDLINE | ID: mdl-33999451

ABSTRACT

BACKGROUND AND OBJECTIVE: We aimed to evaluate the safety and outcomes of thrombectomy in anterior circulation acute ischaemic stroke recorded in the SITS-International Stroke Thrombectomy Register (SITS-ISTR) and compare them with pooled randomized controlled trials (RCTs) and two national registry studies. METHODS: We identified centres recording ≥10 consecutive patients in the SITS-ISTR with at least 70% of available modified Rankin Scale (mRS) at 3 months during 2014-2019. We defined large artery occlusion as intracranial internal carotid artery, first and second segment of middle cerebral artery and first segment of anterior cerebral artery. Outcome measures were functional independence (mRS score 0-2) and death at 3 months and symptomatic intracranial haemorrhage (SICH) per modified SITS-MOST. RESULTS: Results are presented in the following order: SITS-ISTR, RCTs, MR CLEAN Registry and German Stroke Registry (GSR). Median age was 73, 68, 71 and 75 years; baseline NIHSS score was 16, 17, 16 and 15; prior intravenous thrombolysis was 62%, 83%, 78% and 56%; onset to reperfusion time was 289, 285, 267 and 249 min; successful recanalization (mTICI score 2b or 3) was 86%, 71%, 59% and 83%; functional independence at 3 months was 45.5% (95% CI: 44-47), 46.0% (42-50), 38% (35-41) and 37% (35-41), respectively; death was 19.2% (19-21), 15.3% (12.7-18.4), 29.2% (27-32) and 28.6% (27-31); and SICH was 3.6% (3-4), 4.4% (3.0-6.4), 5.8% (4.7-7.1) and not available. CONCLUSION: Thrombectomy in routine clinical use registered in the SITS-ISTR showed safety and outcomes comparable to RCTs, and better functional outcomes and lower mortality than previous national registry studies.


Subject(s)
Brain Ischemia , Stroke , Thrombectomy , Arteries , Brain Ischemia/surgery , Endovascular Procedures , Humans , Intracranial Hemorrhages , Randomized Controlled Trials as Topic , Retrospective Studies , Treatment Outcome
2.
Acta Neurol Scand ; 136(1): 72-77, 2017 Jul.
Article in English | MEDLINE | ID: mdl-28233290

ABSTRACT

INTRODUCTION: Cerebral small vessel disease (SVD) contributes to dementia and disability in the elderly, and may negatively affect stroke outcomes. We aimed to evaluate to what extent single features and global burden of SVD detected with magnetic resonance (MR) are associated with worse outcomes in patients with ischaemic stroke treated with intravenous thrombolysis. METHODS: We accessed anonymized data and MR images from the Stroke Imaging Repository (STIR) and the Virtual International Stroke Trials Archive (VISTA) Imaging. We described SVD features using validated scales and quantified the global burden of SVD with a combined score. Our mainoutcome was the modified Rankin Scale (mRS) at 90 days after stroke. We used logistic regression and ordinal regression models (adjusted for age, sex, stroke severity, onset to treatment time) to examine the associations between each SVD feature, SVD global burden and clinical outcomes. RESULTS: A total of 259 patients had MR scans available at baseline (mean age±SD=68.7±15.5 years; 131 [49%] males). After adjustment for confounders, severe white matter changes were associated with disability (OR=5.14; 95%CI=2.30-11.48), functional dependency (OR=4.38; 95%CI=2.10-9.13) and worse outcomes in ordinal analysis (OR=2.71; 95%CI=1.25-5.85). SVD score was associated with disability (OR=1.66; 95%CI=1.03-2.66) and functional dependency (OR=1.47; 95%CI=1.00-2.45). Lacunes, enlarged perivascular spaces and brain atrophy showed no association with clinical outcomes. CONCLUSION: Our results suggest that SVD negatively affects stroke outcomes after intravenous thrombolysis. Although white matter changes seem to be the major driver in relation to worse outcomes, global estimation of SVD is feasible and may provide helpful information.


Subject(s)
Cerebral Small Vessel Diseases/epidemiology , Stroke/complications , Aged , Aged, 80 and over , Cerebral Small Vessel Diseases/diagnostic imaging , Female , Humans , Magnetic Resonance Imaging , Male , Middle Aged , Stroke/drug therapy , Stroke/pathology , Tissue Plasminogen Activator/therapeutic use
3.
Eur J Neurol ; 24(2): 276-282, 2017 02.
Article in English | MEDLINE | ID: mdl-27862654

ABSTRACT

BACKGROUND AND PURPOSE: Small vessel disease (SVD) and Alzheimer's disease (AD) are two common causes of cognitive impairment and dementia, traditionally considered as distinct processes. The relationship between radiological features suggestive of AD and SVD was explored, and the association of each of these features with cognitive status at 1 year was investigated in patients with stroke or transient ischaemic attack. METHODS: Anonymized data were accessed from the Virtual International Stroke Trials Archive (VISTA). Medial temporal lobe atrophy (MTA; a marker of AD) and markers of SVD were rated using validated ordinal visual scales. Cognitive status was evaluated with the Mini Mental State Examination (MMSE) 1 year after the index stroke. Logistic regression models were used to investigate independent associations between (i) baseline SVD features and MTA and (ii) all baseline neuroimaging features and cognitive status 1 year post-stroke. RESULTS: In all, 234 patients were included, mean (±SD) age 65.7 ± 13.1 years, 145 (62%) male. Moderate to severe MTA was present in 104 (44%) patients. SVD features were independently associated with MTA (P < 0.001). After adjusting for age, sex, disability after stroke, hypertension and diabetes mellitus, MTA was the only radiological feature independently associated with cognitive impairment, defined using thresholds of MMSE ≤ 26 (odds ratio 1.94; 95% confidence interval 1.28-2.94) and MMSE ≤ 23 (odds ratio 2.31; 95% confidence interval 1.48-3.62). CONCLUSION: In patients with ischaemic cerebrovascular disease, SVD features are associated with MTA, which is a common finding in stroke survivors. SVD and AD type neurodegeneration coexist, but the AD marker MTA, rather than SVD markers, is associated with post-stroke cognitive impairment.


Subject(s)
Atrophy/pathology , Cerebral Small Vessel Diseases/pathology , Cognitive Dysfunction/diagnosis , Ischemic Attack, Transient/pathology , Stroke/pathology , Temporal Lobe/pathology , Aged , Atrophy/complications , Atrophy/diagnostic imaging , Atrophy/psychology , Cerebral Small Vessel Diseases/complications , Cerebral Small Vessel Diseases/diagnostic imaging , Cerebral Small Vessel Diseases/psychology , Cognition/physiology , Cognitive Dysfunction/complications , Cognitive Dysfunction/pathology , Cognitive Dysfunction/psychology , Female , Humans , Ischemic Attack, Transient/complications , Ischemic Attack, Transient/diagnostic imaging , Ischemic Attack, Transient/psychology , Magnetic Resonance Imaging , Male , Middle Aged , Neuropsychological Tests , Stroke/complications , Stroke/diagnostic imaging , Stroke/psychology , Temporal Lobe/diagnostic imaging
4.
Acta Neurol Scand ; 135(6): 603-607, 2017 Jun.
Article in English | MEDLINE | ID: mdl-27412470

ABSTRACT

BACKGROUND: Post-stroke cognitive impairment (PSCI) occurs commonly and is linked with development of dementia. We investigated the relationship between demographic, clinical and stroke symptoms at stroke onset and the presence of PSCI at 1 and 3 years after stroke. METHODS: We accessed anonymized data from the Virtual International Stroke Trial Archive (VISTA), including demographic and clinical variables. Post-stroke cognitive impairment was defined as a Mini-Mental State Examination (MMSE) score of ≤26. We assessed univariate relationships between baseline stroke symptoms and PSCI at 1 and 3 years following stroke, retaining the significant and relevant clinical factors as covariates in a final adjusted logistic regression model. RESULTS: We analysed data on 5435 patients with recent (median 33 days) stroke or transient ischaemic attack (TIA). Mean (±SD) age was 62.6 (±12.6) years; 3476 (65%) patients were male. Follow-up data were available for 2270 and 1294 patients at 1 and 3 years, respectively. At 1 year, 781 (34%) patients had MMSE≤26; at 3 years, 391 (30%) had MMSE≤26. After adjusting for age, stroke severity, hypertension, diabetes and type of qualifying event, initial stroke impairment (leg paralysis) was associated with increased rate of PSCI at 1 year (OR=1.62; 95% CI=1.20-2.20) and at 3 years (OR=1.95; 95% CI=1.23-3.09). Associations were consistent on subgroup analysis restricted to ischaemic stroke and transient ischaemic attack (N=4992). CONCLUSIONS: Besides well-known determinants of PSCI such as age, stroke severity and the presence of vascular risk factors, also leg paralysis is associated with subsequent of PSCI up to 3 years after stroke.


Subject(s)
Cognition Disorders/etiology , Stroke/complications , Aged , Cognition Disorders/diagnosis , Cognition Disorders/epidemiology , Female , Humans , Male , Middle Aged , Stroke/diagnosis , Stroke/epidemiology
5.
J R Coll Physicians Edinb ; 46(2): 87-92, 2016 Jun.
Article in English | MEDLINE | ID: mdl-27929570

ABSTRACT

A recording of = 30 seconds is required to diagnose paroxysmal atrial fibrillation when using ambulatory ECG monitoring. It is unclear if shorter runs are relevant with regards to stroke risk. Methods An online survey of cardiologists and stroke physicians was carried out to assess current management of patients with short runs of atrial arrhythmia within Europe. Results Respondents included 311 clinicians from 32 countries. To diagnose atrial fibrillation, 80% accepted a single 12-lead ECG and 36% accepted a single run of > 30 seconds on ambulatory monitoring. Stroke physicians were twice as likely to accept < 30 seconds of arrhythmia as being diagnostic of atrial fibrillation (OR 2.43, 95% CI 1.19-4.98). They were also more likely to advocate anticoagulation for hypothetical patients with lower risk; OR 1.9 (95% CI 1.0-3.5) for a patient with CHA2DS2-VASc = 2. Conclusion Short runs of atrial fibrillation create a dilemma for physicians across Europe. Stroke physicians and cardiologists differ in their diagnosis and management of these patients.


Subject(s)
Atrial Fibrillation/diagnosis , Attitude of Health Personnel , Brugada Syndrome , Electrocardiography/methods , Physicians , Practice Patterns, Physicians' , Stroke , Anticoagulants/therapeutic use , Atrial Fibrillation/complications , Cardiac Conduction System Disease , Cardiologists , Europe , Heart/physiopathology , Humans , Monitoring, Ambulatory/methods , Risk Factors , Stroke/etiology , Stroke/prevention & control , Surveys and Questionnaires
6.
Eur J Neurol ; 23(12): 1750-1756, 2016 12.
Article in English | MEDLINE | ID: mdl-27516056

ABSTRACT

BACKGROUND AND PURPOSE: Elevated heart rate (HR) is associated with worse outcomes in patients with cardiovascular disease. Its predictive value in acute stroke patients is less well established. We investigated the effects of HR on admission in acute ischaemic stroke patients. METHODS: Using the Virtual International Stroke Trials Archive (VISTA) database, the association between HR in acute stroke patients without atrial fibrillation and the pre-defined composite end-point of (recurrent) ischaemic stroke, transient ischaemic attack (TIA), myocardial infarction (MI) and vascular death within 90 days was analysed. Pre-defined secondary outcomes were the composite end-point components and any death, decompensated heart failure and degree of functional dependence according to the modified Rankin Scale after 90 days. HR was analysed as a categorical variable (quartiles). RESULTS: In all, 5606 patients were available for analysis (mean National Institutes of Health Stroke Scale 13; mean age 67 years; mean HR 77 bpm; 44% female) amongst whom the composite end-point occurred in 620 patients (11.1%). Higher HR was not associated with the composite end-point. The frequencies of secondary outcomes were 3.2% recurrent stroke (n = 179), 0.6% TIA (n = 35), 1.8% MI (n = 100), 6.8% vascular death (n = 384), 15.0% any death (n = 841) and 2.2% decompensated heart failure (n = 124). Patients in the highest quartile (HR> 86 bpm) were at increased risk for any death [adjusted hazard ratio (95% confidence interval) 1.40 (1.11-1.75)], decompensated heart failure [adjusted hazard ratio 2.20 (1.11-4.37)] and worse modified Rankin Scale [adjusted odds ratio 1.29 (1.14-1.52)]. CONCLUSIONS: In acute stroke patients, higher HR (>86 bpm) is linked to mortality, heart failure and higher degree of dependence after 90 days but not to recurrent stroke, TIA or MI.


Subject(s)
Atrial Fibrillation/mortality , Brain Ischemia/mortality , Heart Rate/physiology , Stroke/mortality , Aged , Aged, 80 and over , Atrial Fibrillation/complications , Atrial Fibrillation/physiopathology , Brain Ischemia/complications , Brain Ischemia/physiopathology , Female , Humans , Male , Middle Aged , Patient Admission , Stroke/complications , Stroke/physiopathology
7.
Eur J Neurol ; 22(7): 1048-55, 2015 Jul.
Article in English | MEDLINE | ID: mdl-25319957

ABSTRACT

BACKGROUND AND PURPOSE: Ischaemic stroke patients with atrial fibrillation (AF) are at risk of early recurrent stroke (RS). However, antithrombotics commenced at the acute stage may exacerbate haemorrhagic transformation, provoking symptomatic intracerebral haemorrhage (SICH). The relevance of antithrombotics on the patterns and outcome of the cohort was investigated. METHODS: A non-randomized cohort analysis was conducted using data obtained from VISTA (Virtual International Stroke Trials Archive). The associations of antithrombotics with the modified Rankin Scale (mRS) outcome and the occurrence of RS and SICH (each as a combined end-point of fatal and non-fatal events) at 90 days for post-stroke patients with AF were described. Dichotomized outcomes were also considered as a secondary end-point (i.e. mortality and good outcome measure at 90 days). RESULTS: In all, 1644 patients were identified; 1462 (89%) received antithrombotics, 157 (10%) had RS and 50 (3%) sustained SICH by day 90. Combined antithrombotic therapy (i.e. anticoagulants and antiplatelets), 782 (48%), was associated with favourable outcome on ordinal mRS and a significantly lower risk of RS, SICH and mortality by day 90, compared with the no antithrombotics group. The relative risk of RS and SICH appeared highest in the first 2 days post-stroke before attenuating to become constant over time. CONCLUSIONS: The risks and benefits of antithrombotics in recent stroke patients with AF appear to track together. Early introduction of anticoagulants (2-3 days post-stroke), and to a lesser extent antiplatelet agents, was associated with substantially fewer RS events over the following weeks but with no excess risk of SICH. More evidence is required to guide clinicians on this issue.


Subject(s)
Anticoagulants/pharmacology , Atrial Fibrillation , Brain Ischemia/drug therapy , Fibrinolytic Agents/pharmacology , Outcome Assessment, Health Care , Platelet Aggregation Inhibitors/pharmacology , Stroke/drug therapy , Aged , Aged, 80 and over , Anticoagulants/administration & dosage , Anticoagulants/adverse effects , Atrial Fibrillation/epidemiology , Brain Ischemia/epidemiology , Cerebral Hemorrhage/chemically induced , Clinical Trials as Topic , Comorbidity , Female , Fibrinolytic Agents/administration & dosage , Fibrinolytic Agents/adverse effects , Follow-Up Studies , Humans , Male , Middle Aged , Platelet Aggregation Inhibitors/administration & dosage , Platelet Aggregation Inhibitors/adverse effects , Recurrence , Stroke/epidemiology
8.
Eur J Neurol ; 22(1): 163-9, 2015 Jan.
Article in English | MEDLINE | ID: mdl-25370204

ABSTRACT

BACKGROUND AND PURPOSE: There are concerns that systemic thrombolysis might not achieve clinically important outcome amongst chronic heart failure (CHF) patients with acute ischaemic stroke. Our aim was to investigate the relevance of CHF on the outcome of acute stroke patients who received thrombolysis. METHODS: A non-randomized cohort analysis was conducted using data obtained from the Virtual International Stroke Trials Archive. The association of outcome amongst CHF patients with thrombolysis treatment was described using the modified Rankin scale (mRS) distribution at day 90, stratified by the presence of atrial fibrillation. Dichotomized outcomes were considered as a secondary end-point. RESULTS: 5677 patients were identified, of whom 2366 (41.7%) received thombolysis. Five hundred and three (8.9%) patients had CHF, of whom 209 (41.6%) received thrombolysis. The presence of CHF was associated with a negative impact on overall stroke outcome [odds ratio (OR) 0.73 (95% confidence interval (CI) 0.62-0.87), P < 0.001]. However, thrombolysis treatment was associated with favourable functional outcome using ordinal mRS, irrespective of CHF status, after adjustment for age and baseline National Institutes of Health Stroke Scale [OR 1.44 (95% CI 1.04-2.01, P = 0.029) for CHF patients versus OR 1.50 (95% CI 1.36-1.66, P < 0.001) for non-CHF patients]. CHF patients had higher mortality at day 90 than non-CHF patients. There was no significant difference for recurrent stroke or symptomatic intracerebral haemorrhage within 7 days of the initial stroke between CHF and thrombolysis groups. CONCLUSIONS: Chronic heart failure was associated with a worse outcome with or without thrombolysis. However, acute stroke patients who received thrombolysis had more favourable outcome regardless of CHF status, compared with their untreated peers. Our findings should reassure clinicians considering systemic thrombolysis treatment in hyperacute ischaemic stroke patients with CHF.


Subject(s)
Brain Ischemia/drug therapy , Comorbidity , Heart Failure , Outcome Assessment, Health Care , Stroke/drug therapy , Thrombolytic Therapy/methods , Aged , Aged, 80 and over , Atrial Fibrillation/epidemiology , Brain Ischemia/epidemiology , Chronic Disease/epidemiology , Cohort Studies , Female , Heart Failure/epidemiology , Humans , Male , Middle Aged , Stroke/epidemiology , United States
9.
QJM ; 107(11): 895-902, 2014 Nov.
Article in English | MEDLINE | ID: mdl-25174048

ABSTRACT

BACKGROUND: A recording of ≥30 s is required for diagnosis of paroxysmal atrial fibrillation (AF) when using ambulatory electrocardiography (ECG) monitoring. It is unclear if shorter runs of atrial arrhythmia are relevant with regard to stroke risk. AIM: To assess current management of patients with atrial arrhythmia of <30 s duration detected on ambulatory ECG. DESIGN: Online survey. METHODS: An online survey was sent to cardiologists and stroke physicians in the UK, via their national societies. RESULTS: A total of 205 clinicians responded to the survey (130 stroke physicians, 64 cardiologists, 11 other). Regarding diagnosis of AF, 87% of responders would accept a single 12-lead ECG. In contrast, only 45% would accept a single episode lasting <30 s detected on ambulatory monitoring. There was more agreement with regard to the decision to anticoagulate. When asked whether they would anticoagulate eight hypothetical patients with non-diagnostic paroxysms of AF, there was a mean agreement of responses of 78.6%, with up to 94.1% agreement for high-risk patients. There was a trend suggesting that stroke physicians were more likely to accept an atrial arrhythmia of <30 s as 'AF' than cardiology specialists [OR 1.63 (95% CI 0.88-3.01), P = 0.12]. CONCLUSIONS: There is a lack of consensus on the diagnosis and management of patients with brief runs of atrial arrhythmia detected on ambulatory ECG. Further research is needed to clarify the risk of stroke in this unique population of patients.


Subject(s)
Atrial Fibrillation/complications , Cardiology , Neurology , Practice Patterns, Physicians' , Stroke/etiology , Anticoagulants/therapeutic use , Atrial Fibrillation/diagnosis , Electrocardiography , Female , Humans , Male , Risk Factors , Stroke/prevention & control , Surveys and Questionnaires , United Kingdom
10.
Heart ; 100(14): 1085-92, 2014 Jul.
Article in English | MEDLINE | ID: mdl-24790069

ABSTRACT

OBJECTIVE: Central blood pressure (CBP) and carotid intima-media thickness (CIMT) are surrogate measures of cardiovascular risk. Allopurinol reduces serum uric acid and oxidative stress and improves endothelial function and may therefore reduce CBP and CIMT progression. This study sought to ascertain whether allopurinol reduces CBP, arterial stiffness and CIMT progression in patients with ischaemic stroke or transient ischaemic attack (TIA). METHODS: We performed a randomised, double-blind, placebo-controlled study, examining the effect of 1-year treatment with allopurinol (300 mg daily), on change in CBP, arterial stiffness and CIMT progression at 1 year and change in endothelial function and circulating inflammatory markers at 6 months. Patients aged over 18 years with recent ischaemic stroke or TIA were eligible. RESULTS: Eighty participants were recruited, mean age 67.8 years (SD 9.4). Systolic CBP [-6.6 mm Hg (95% CI -13.0 to -0.3), p=0.042] and augmentation index [-4.4% (95% CI -7.9 to -1.0), p=0.013] were each lower following allopurinol treatment compared with placebo at 12 months. Progression in mean common CIMT at 1 year was less in allopurinol-treated patients compared with placebo [between-group difference [-0.097 mm (95% CI -0.175 to -0.019), p=0.015]. No difference was observed for measures of endothelial function. CONCLUSIONS: Allopurinol lowered CBP and reduced CIMT progression at 1 year compared with placebo in patients with recent ischaemic stroke and TIA. This extends the evidence of sustained beneficial effects of allopurinol to these prognostically significant outcomes and to the stroke population, highlighting the potential for reduction in cardiovascular events with this treatment strategy. TRIAL REGISTRATION NUMBER: ISRCTN11970568.


Subject(s)
Allopurinol/therapeutic use , Antihypertensive Agents/therapeutic use , Blood Pressure/drug effects , Brachial Artery/physiopathology , Carotid Intima-Media Thickness , Ischemic Attack, Transient/drug therapy , Stroke/drug therapy , Aged , Body Mass Index , Brain Ischemia/complications , Disease Progression , Double-Blind Method , Female , Follow-Up Studies , Humans , Male , Middle Aged , Risk Factors , Smoking/adverse effects , Stroke/etiology , Treatment Outcome
11.
Int J Stroke ; 9(3): 328-32, 2014 Apr.
Article in English | MEDLINE | ID: mdl-24206445

ABSTRACT

BACKGROUND AND PURPOSE: Clinical deficits from stroke are diverse, prompting measurement in trials by a range of outcome scales. Statistical and clinical advantage can be gained by combining scales into a global outcome provided combinations are chosen with limited correlations. We aimed to clarify the interdependence of outcome scales by systematic review of published data and by novel analysis of data from completed acute trials. SUMMARY OF REVIEW: We systematically searched ScienceDirect and PubMed to summarize published data on correlations between stroke outcome scales. We generated new data on correlations among salient scales at 90 days poststroke in patients from the Virtual International Stroke Trials Archive (VISTA). We calculated Pearson and Spearman-Rank correlation coefficients for continuous and ordinal measures, respectively. We also assessed partial correlations, adjusted for baseline National Institute of Health Stroke Scale (NIHSS), and age. Published estimates of interdependence were limited to small single-trial cohorts and gave divergent results. From the more extensive VISTA dataset, we found that the modified Rankin Scale at 90 days poststroke explained 80.8% of the National Institute of Health Stroke Scale at 90 days poststroke and 86.5% of the European Stroke Scale. National Institute of Health Stroke Scale explained 75.9% of the Barthel Index and 81.2% of the Scandinavian Stroke Scale. After adjustment, modified Rankin Scale explained 56.6% of National Institute of Health Stroke Scale, 75.2% of Barthel Index. National Institute of Health Stroke Scale explained 60.2% of Barthel Index. CONCLUSION: Correlations and partial correlations among stroke outcome scales in trial datasets are higher than previously reported. The new estimates are more reliable for trial planning due to the sample size and diversity.


Subject(s)
Archives , Outcome Assessment, Health Care , Stroke/diagnosis , Treatment Outcome , User-Computer Interface , Humans , Stroke/therapy
12.
Scott Med J ; 58(1): 30-3, 2013 Feb.
Article in English | MEDLINE | ID: mdl-23596026

ABSTRACT

BACKGROUND: Scotland's 'A' Research Ethics Committee (SAREC, previously MREC A) has exclusive authority to consider research involving Adults with Incapacity in Scotland. No appeal facility exists although resubmissions are accepted. Legislation covering research in England and Wales has created anomalies. RECs 'recognised' by the UK Ethics Committee (3 in Scotland, several in England) can approve drug studies involving Adults with Incapacity in Scotland. Several English RECs can approve studies led from outside Scotland. METHODS: We conducted an anonymous online survey of researchers experienced in studies involving Adults with Incapacity to establish their opinions on the role of SAREC. The survey had 5 multiple-choice questions. Two questions invited a free-text comment. RESULTS: Seventy-seven researchers (45% response) completed the survey. The majority (61/76, 80%) received a favourable opinion from SAREC immediately/after minor revision. The consensus was a single, experienced committee is advantageous to researchers (69/77 (90%)) and research participants (65/75 (87%)). There was no association between application outcome and opinion on whether a single committee is advantageous for researchers (p = 0.39 (Fisher's exact test)) or research participants (p = 0.49). Most (42/76, 55%) favoured the current system for reviewing decisions. CONCLUSIONS: The research establishment favours retaining expertise in one committee. Most are content not having an external appeal facility.


Subject(s)
Ethics Committees, Research , Ethics, Research , Mental Competency , Research Personnel , Adult , Data Collection , Humans , Role , Scotland
13.
Br J Anaesth ; 111(3): 417-23, 2013 Sep.
Article in English | MEDLINE | ID: mdl-23592695

ABSTRACT

BACKGROUND: The EuroSCORE associates coronary artery bypass graft (CABG) surgery with higher perioperative risk in the first 3 months after a myocardial infarction (MI). The optimal scheduling of CABG surgery after unstable angina (UA) is unknown. We investigated the preoperative predictors of adverse outcomes in patients undergoing CABG with prior MI or UA and investigated the importance of time interval between the cardiac event and CABG. METHODS: The Hospital Episode Statistics database (April 2006-March 2010) was analysed for elective admissions for CABG. Independent preoperative patient factors influencing length of stay, readmission rates, and mortality, were identified by logistic regression and presented as adjusted odds ratios (ORs). RESULTS: A total of 10 418 patients with prior MI (mortality 1.8%) and 5241 patients with prior UA (mortality 2.2%) were included in the respective cohorts. Multiple risk factors were identified in each population including liver disease and renal failure. The time interval from cardiac event (MI or UA) to elective CABG surgery did not influence perioperative outcomes when analysed as a continuous measure or using the arbitrary 3-month threshold [MI, OR 1.1 (0.78-1.57) and UA, OR 0.65 (0.39-1.09)]. CONCLUSIONS: Our hypothesis generating data suggest that the increased risk currently allocated in the EuroSCORE for an interval of 3 months between MI and CABG should be critically re-evaluated. Furthermore, prior MI should not be discounted as a risk factor if it is more than 3 months old.


Subject(s)
Angina, Unstable/epidemiology , Coronary Artery Bypass/methods , Elective Surgical Procedures/methods , Myocardial Infarction/epidemiology , Preoperative Care/methods , Aged , England/epidemiology , Female , Humans , Male , Risk Factors
14.
Acta Neurol Scand ; 128(3): 172-7, 2013 Sep.
Article in English | MEDLINE | ID: mdl-23410198

ABSTRACT

OBJECTIVES: Paracetamol is frequently prescribed for pain and fever control in acute stroke patients, but its effect on stroke outcome is unclear. The aim was to investigate the safety and benefit of paracetamol administration in the acute phase of ischaemic stroke. METHODS: We analysed the impact of paracetamol exposure on functional outcome at 90 days among ischaemic stroke patients registered in a clinical trials archive. We used an adjusted Cochran-Mantel-Haenszel test to test for significance (P) followed by proportional odds logistic regression analysis to estimate the odds ratios (OR) for more favourable modified Rankin Scale score. RESULTS: Data were available for 6015 patients, of whom 2435 had received paracetamol. No association of paracetamol-use with overall stroke outcome could be detected among those patients who experienced pain and/or fever (OR 1.03, 95% CI 0.86-1.20, P = 0.931). In patients without recorded pain and/or fever events and a baseline temperature below 37°C, in whom paracetamol was started within 3 days of stroke, paracetamol was associated with worse outcome (OR 0.58, 95% CI 0.47-0.72, P = <0.001). CONCLUSION: This retrospective analysis is discouraging for prophylactic use of paracetamol in acute stroke patients, but underlines the need for a sufficiently powered randomized controlled trial.


Subject(s)
Acetaminophen/therapeutic use , Analgesics, Non-Narcotic/therapeutic use , Aged , Aged, 80 and over , Brain Ischemia/complications , Female , Fever/drug therapy , Fever/etiology , Humans , Logistic Models , Male , Middle Aged , Pain/drug therapy , Pain/etiology , Retrospective Studies , Stroke/etiology , Treatment Outcome
15.
Int J Stroke ; 8(8): 652-6, 2013 Dec.
Article in English | MEDLINE | ID: mdl-22813096

ABSTRACT

BACKGROUND: Although the established measure of disability post stroke, the modified Rankin Scale emphasizes motor function and may underestimate the importance of cognitive impairment in more disabled patients. A subset of four items from the National Institutes of Health Stroke Scale has been proposed to assess cognitive function after stroke (Cog-4), and to correlate with modified Rankin Scale. Items correspond to orientation, executive function, language, and inattention. We investigated responsiveness of Cog-4 to treatment with thrombolysis and whether it offers information that supplements modified Rankin Scale. METHODS: We included 6268 patients from the Virtual International Stroke Trials Archive: 2734 received intravenous thrombolysis and 3534 were treated conservatively. We compared day 90 outcomes between treated and untreated groups, by modified Rankin Scale (illustrative) and by Cog-4 (primary measure) adjusting for age, baseline National Institutes of Health stroke scale, hemispheric lateralisation as well as baseline Cog-4 and baseline National Institutes of Health Stroke Scale excluding baseline Cog-4 separately. Analysis of Cog-4 was repeated within strata of 90 day modified Rankin Scale. Statistical analyses included proportional odds logistic regression and Cochran-Mantel-Haenszel test. RESULTS: Modified Rankin Scale showed a difference between treatment groups of expected magnitude (odds ratio 1·56; 95% confidence interval 1·43-1·72; P < 0·001). After adjustment for imbalance in baseline prognostic factors, the distribution of Cog-4 scores at 90 days was better in thrombolysed patients compared with nonthrombolysed patients (odds ratio 1·31; 95% confidence interval 1·18-1·47; P = 0·006). However, Cog-4 analysis stratified by 90-day modified Rankin Scale was neutral between treatment groups (OR 1·01; 95% CI 0·90-1·14), and Cog-4 was not responsive to treatment group even within modified Rankin Scale categories 4 and 5 despite substantial cognitive deficits in these patients. CONCLUSION: Although Cog-4 may be responsive to treatment effects, it does not provide additional information beyond modified Rankin Scale assessment.


Subject(s)
Cognition Disorders/diagnosis , Cognition Disorders/etiology , Stroke/complications , Stroke/psychology , Aged , Female , Humans , Male , Neuropsychological Tests , Stroke/drug therapy , Thrombolytic Therapy
16.
Scott Med J ; 57(4): 204-8, 2012 Nov.
Article in English | MEDLINE | ID: mdl-23028176

ABSTRACT

The aim of this study was to determine the current clinical practice of UK stroke physicians with regard to the early management of blood pressure (BP) and arrhythmia detection following acute stroke. Postal service evaluation questionnaires were sent to the lead physicians for stroke in UK hospitals. Hospitals were identified by their inclusion in the 2008 Scottish Stroke Care Audit and the 2006 Royal College of Physicians Sentinel Stroke Audit. A total of 259 questionnaires were sent with a 33% response rate. Current practice regarding acute post-stroke BP management varied considerably. Approximately one-third of respondents lowered systolic BP within the first 72 hours of stroke, but the majority (65%) delayed intervening for at least seven days. Most would not intervene until systolic BP exceeded 180 mmHg. Of those who intervene, the most commonly quoted target systolic BP was 160 ± 5 mmHg. Post-stroke arrhythmia investigation was similarly varied; 12-lead electrocardiogram recording was frequent, with further investigation being more individualized. Of all respondents, 87% expressed interest in participating in future trials of complex interventions for stroke. Current practice of UK stroke physicians regarding acute BP intervention is diverse, reflecting conflicting evidence. There is interest in the stroke community for further research aiming to answer these important clinical questions.


Subject(s)
Atrial Fibrillation/diagnosis , Blood Pressure , Hypertension/drug therapy , Practice Patterns, Physicians' , Stroke/therapy , Atrial Fibrillation/complications , Electrocardiography/methods , Fibrinolytic Agents/therapeutic use , Humans , Hypertension/complications , Practice Guidelines as Topic , Randomized Controlled Trials as Topic , Stroke/complications , Surveys and Questionnaires , Time Factors , United Kingdom
17.
Neurology ; 77(21): 1866-72, 2011 Nov 22.
Article in English | MEDLINE | ID: mdl-22094479

ABSTRACT

BACKGROUND: Patients with concomitant diabetes mellitus (DM) and prior stroke (PS) were excluded from European approval of alteplase in stroke. We examined the influence of DM and PS on the outcomes of patients who received thrombolytic therapy (T; data from Safe Implementation of Thrombolysis in Stroke-International Stroke Thrombolysis Register) compared to nonthrombolyzed controls (C; data from Virtual International Stroke Trials Archive). METHODS: We selected ischemic stroke patients on whom we held data on age, baseline NIH Stroke Scale score (NIHSS), and 90-day modified Rankin Scale score (mRS). We compared the distribution of mRS between T and C by Cochran-Mantel-Haenszel (CMH) test and proportional odds logistic regression, after adjustment for age and baseline NIHSS, in patients with and without DM, PS, or the combination. We report odds ratios (OR) for improved distribution of mRS with 95% confidence interval (CI) and CMH p value. RESULTS: Data were available for 29,500 patients: 5,411 (18.5%) had DM, 5,019 had PS (17.1%), and 1,141 (5.5%) had both. Adjusted mRS outcomes were better for T vs C among patients with DM (OR 1.45 [1.30-1.62], n = 5,354), PS (OR 1.55 [1.40-1.72], n = 4,986), or concomitant DM and PS (OR 1.23 [0.996-1.52], p = 0.05, n = 1,136), all CMH p < 0.0001. These are comparable to outcomes between T and C among patients with neither DM nor PS: OR = 1.53 (1.42-1.63), p < 0.0001, n = 19,339. There was no interaction on outcome between DM and PS with alteplase treatment (tissue plasminogen activator × DM × PS, p = 0.5). Age ≤80 years or >80 years did not influence our findings. CONCLUSIONS: Outcomes from thrombolysis are better than the controls among patients with DM, PS, or both. We find no statistical justification for the exclusion of these patients from receiving thrombolytic therapy.


Subject(s)
Brain Ischemia/complications , Diabetes Complications/physiopathology , Stroke , Thrombolytic Therapy/methods , Tissue Plasminogen Activator/therapeutic use , Female , Follow-Up Studies , Humans , Logistic Models , Male , Retrospective Studies , Stroke/complications , Stroke/drug therapy , Stroke/etiology , Treatment Outcome
19.
QJM ; 103(9): 679-85, 2010 Sep.
Article in English | MEDLINE | ID: mdl-20601651

ABSTRACT

BACKGROUND: The ABCD and ABCD2 scores have been validated for use as predictors of stroke in community populations up to 90 days after a transient ischemic attack (TIA). TIA outpatient clinics may see a selective group of patients who have not had an early stroke but may be at raised risk in the medium to long term and therefore benefit from preventive treatment. AIM: To describe the prognostic values of the ABCD and ABCD2 scores on long-term stroke risk. DESIGN: Retrospective cohort study of TIA clinic outpatients followed for up to 14 years. METHODS: Absolute and relative stroke risks, Kaplan-Meier survival curves and cumulative stroke incidence were calculated. Receiver Operating Characteristic curves (ROCs) and areas under the curve were calculated for both scores. RESULTS: Seven hundred and ninety-five patients were included and 138 (17.3%) experienced a stroke within 13.8 years follow-up after first TIA clinic visit, a crude risk of 26.3 per 1000 person-years. Compared with baseline scores of 0-2, risk ratios for ABCD of 3-4 were 2.95 (95% CI 1.52-6.40), and for 5-6 were 3.42 (95% CI 1.72-7.54); for the ABCD2, risk ratios for 3-4 were 2.68 (95% CI 1.37-5.84), and for 5-7 were 3.55 (95% CI 1.80-7.79). Scores of > or = 3 for either ABCD or ABCD2 predicted raised stroke risks at 90 days, 1, 5 and 10 years. Areas under the curve were 0.619 (95% CI 0.571-0.668) and 0.630 (95% CI 0.582-0.677) for the ABCD and ABCD2 scores, respectively. CONCLUSION: ABCD and ABCD2 scores of > or = 3 may be clinically useful in identifying TIA outpatients at raised risk of stroke in the medium to long term.


Subject(s)
Ischemic Attack, Transient/complications , Stroke/etiology , Aged , Ambulatory Care Facilities , Cohort Studies , Female , Humans , Male , Predictive Value of Tests , Retrospective Studies , Risk Factors , Severity of Illness Index , Stroke/prevention & control , Time Factors
20.
Int J Stroke ; 5(2): 103-9, 2010 Apr.
Article in English | MEDLINE | ID: mdl-20446944

ABSTRACT

BACKGROUND: The Virtual International Stroke Trials Archive was established to improve stroke care and trial design through the collation, categorization and potential access to data sets from clinical trials for the treatment of stroke. METHODS: Virtual International Stroke Trials Archive currently provides access to a combined data set of 29 anonymised acute stroke trials and one acute stroke registry with data on >27,500 patients aged between 18 and 103 (mean 71) years. RESULTS: Virtual International Stroke Trials Archive has facilitated research across a broad canvas. The prognosis was poor in patients with very high blood pressure at the time of admission or with a wide variability of systolic blood pressure during the acute phase. The late occurrence of hyperthermia following an ischaemic stroke worsens the prognosis. Stroke lateralisation is not an important predictor of cardiac adverse events or 90-day mortality. Haemorrhagic transformation is seen frequently in patients with cardio-embolic strokes and is associated with a poor prognosis when occurring after the acute phase. Virtual International Stroke Trials Archive has allowed various prognostic models for patients with ischaemic or haemorrhagic stroke to be established and validated. More direct outcomes such as lesion volume can be useful in phase II clinical trials for determining whether a phase III trial should be undertaken. New outcome measures such as 'home time' may also strengthen future trials. On a worldwide level, the prognosis of stroke patients differs considerably between various countries. CONCLUSION: Virtual International Stroke Trials Archive provides an excellent opportunity for analysis of natural history data and prognosis. It has the potential to influence clinical trial design and implementation through exploratory data analyses.


Subject(s)
Stroke/drug therapy , Anticoagulants/therapeutic use , Archives , Clinical Trials as Topic , Fibrinolytic Agents/therapeutic use , Forecasting , Humans , Hyperthermia, Induced , Neuroprotective Agents/therapeutic use , Patient Selection , Prognosis , Randomized Controlled Trials as Topic , Stroke/mortality , Stroke/physiopathology , Stroke/prevention & control , User-Computer Interface
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