Continuous versus intermittent physiological monitoring for acute stroke.

BACKGROUND: Explanations for the effectiveness of stroke units compared with general wards in reducing mortality, institutionalisation and dependence of people with stroke remain undetermined, and the discussion on the most effective stroke unit model is still up for debate. The intensity of non-invasive mechanical monitoring in many western countries is one of the main issues regarding the different models. This is because of its strong impact on the organisation of the stroke unit in terms of the number of personnel, their expertise, the infrastructure and costs. OBJECTIVES: To assess whether continuous intensive monitoring compared with intermittent monitoring of physiological variables in people with acute stroke can change their prognosis in terms of mortality or disability. SEARCH METHODS: We searched the Cochrane Stroke Group Trials Register (November 2012), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011, Issue 8), MEDLINE (1966 to November 2012), EMBASE (1980 to November 2012), CINAHL (1982 to November 2012) and the British Nursing Index (1985 to November 2012). In an effort to identify further published, unpublished and ongoing trials we searched trials registers (November 2012) and reference lists, handsearched conference proceedings and contacted trial authors. SELECTION CRITERIA: We included all randomised, cluster randomised and quasi-randomised controlled trials comparing continuous monitoring with intermittent monitoring in people within three days of stroke onset. We excluded studies confounded by the delivery of care in different settings (that is studies in which the location of the intervention was not in the same ward in the two arms of the trial). DATA COLLECTION AND ANALYSIS: Three review authors independently selected studies for inclusion, assessed methodological quality and extracted data. We sought original data from trialists in two trials and verified the inclusion criteria in another four trials (three presented at conferences and one was from the Chinese Clinical Trial Registry). Where possible, we extracted data on the threshold level of abnormality that triggered intervention for a given physiological variable, the specific intervention given to correct the abnormality and compliance with the allocated therapy. MAIN RESULTS: Three studies, involving a total of 354 participants, met our inclusion criteria for the primary outcome. Compared with intermittent monitoring, continuous monitoring significantly reduced death and disability at three months or discharge (odds ratio (OR) 0.27, 95% confidence interval (CI) 0.13 to 0.56) and was associated with a non-significant reduction in deaths from any cause at discharge (OR 0.72, 95% CI 0.28 to 1.85). These significant results depend on one study that has a high risk of bias.Continuous monitoring was associated with a non-significant reduction of dependency (OR 0.79, 95% CI 0.30 to 2.06), death from vascular causes (OR 0.48, 95% CI 0.10 to 2.39), neurological complications (OR 0.81, 95% CI 0.46 to 1.43), length of stay (mean difference (MD) -5.24, 95% CI -10.51 to 0.03) and institutionalisation (OR 0.83, 95% CI 0.04 to 15.72) (secondary outcomes). For the last two outcomes we detected consistent heterogeneity across trials.Cardiac complications (OR 8.65, 95% CI 2.52 to 29.66), fever (OR 2.17, 95% CI 1.22 to 3.84) and hypotension (OR 4.32, 95% CI 1.68 to 14.38) were detected significantly more often in participants who received continuous monitoring (surrogate outcomes).We detected no significant increase in adverse events due to immobility (pneumonia, other infections or deep vein thrombosis) in participants who were continuously monitored compared with those allocated to intermittent monitoring. AUTHORS' CONCLUSIONS: Continuous monitoring of physiological variables for the first two to three days may improve outcomes and prevent complications. Attention to the changes in physiological variables is a key feature of a stroke unit, and can most likely be aided by continuous monitoring without complications related to immobility or to treatments triggered by the relief of abnormal physiological variables. Well-designed, high-quality studies are needed because many questions remain open and deserve further research. These include when to start continuous monitoring, when to interrupt it, which people should be given priority, and which treatments are most appropriate after the identification of abnormalities in physiological variables.

Piracetam for acute ischaemic stroke.

BACKGROUND: Piracetam has neuroprotective and antithrombotic effects that may help to reduce death and disability in people with acute stroke. This is an update of a Cochrane Review first published in 1999, and previously updated in 2006 and 2009. OBJECTIVES: To assess the effects of piracetam in acute, presumed ischaemic stroke. SEARCH METHODS: We searched the Cochrane Stroke Group Trials Register (last searched 15 May 2011), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011, Issue 2), MEDLINE (1966 to May 2011), EMBASE (1980 to May 2011), and ISI Science Citation Index (1981 to May 2011). We also contacted the manufacturer of piracetam to identify further published and unpublished studies. SELECTION CRITERIA: Randomised trials comparing piracetam with control, with at least mortality reported and entry to the trial within three days of stroke onset. DATA COLLECTION AND ANALYSIS: Two review authors extracted data and assessed trial quality and this was checked by the other two review authors. We contacted study authors for missing information. MAIN RESULTS: We included three trials involving 1002 patients, with one trial contributing 93% of the data. Participants' ages ranged from 40 to 85 years, and both sexes were equally represented. Piracetam was associated with a statistically non-significant increase in death at one month (approximately 31% increase, 95% confidence interval 81% increase to 5% reduction). This trend was no longer apparent in the large trial after correction for imbalance in stroke severity. Limited data showed no difference between the treatment and control groups for functional outcome, dependence or proportion of patients dead or dependent. Adverse effects were not reported. AUTHORS' CONCLUSIONS: There is some suggestion (but no statistically significant result) of an unfavourable effect of piracetam on early death, but this may have been caused by baseline differences in stroke severity in the trials. There is not enough evidence to assess the effect of piracetam on dependence.

Magnetic resonance imaging versus computed tomography for detection of acute vascular lesions in patients presenting with stroke symptoms.

BACKGROUND: Magnetic resonance imaging (MRI) is increasingly used for the diagnosis of acute ischaemic stroke but its sensitivity for the early detection of intracerebral haemorrhage has been debated. Computed tomography (CT) is extensively used in the clinical management of acute stroke, especially for the rapid exclusion of intracerebral haemorrhage. OBJECTIVES: To compare the diagnostic accuracy of diffusion-weighted MRI (DWI) and CT for acute ischaemic stroke, and to estimate the diagnostic accuracy of MRI for acute haemorrhagic stroke. SEARCH STRATEGY: We searched MEDLINE and EMBASE (January 1995 to March 2009) and perused bibliographies of relevant studies for additional references. SELECTION CRITERIA: We selected studies that either compared DWI and CT in the same patients for detection of ischaemic stroke or examined the utility of MRI for detection of haemorrhagic stroke, had imaging performed within 12 hours of stroke onset, and presented sufficient data to allow construction of contingency tables. DATA COLLECTION AND ANALYSIS: Three authors independently extracted data on study characteristics and measures of accuracy. We assessed data on ischaemic stroke using random-effects and fixed-effect meta-analyses. MAIN RESULTS: Eight studies with a total of 308 participants met our inclusion criteria. Seven studies contributed to the assessment of ischaemic stroke and two studies to the assessment of haemorrhagic stroke. The spectrum of patients was relatively narrow in all studies, sample sizes were small, there was substantial incorporation bias, and blinding procedures were often incomplete. Amongst the patients subsequently confirmed to have acute ischaemic stroke (161/226), the summary estimates for DWI were: sensitivity 0.99 (95% CI 0.23 to 1.00), specificity 0.92 (95% CI 0.83 to 0.97). The summary estimates for CT were: sensitivity 0.39 (95% CI 0.16 to 0.69), specificity 1.00 (95% CI 0.94 to 1.00). The two studies on haemorrhagic stroke reported high estimates for diffusion-weighted and gradient-echo sequences but had inconsistent reference standards. We did not calculate overall estimates for these two studies. We were not able to assess practicality or cost-effectiveness issues. AUTHORS' CONCLUSIONS: DWI appears to be more sensitive than CT for the early detection of ischaemic stroke in highly selected patients. However, the variability in the quality of included studies and the presence of spectrum and incorporation biases render the reliability and generalisability of observed results questionable. Further well-designed studies without methodological biases, in more representative patient samples, with practicality and cost estimates are now needed to determine which patients should undergo MRI and which CT in suspected acute stroke.

Third international stroke trial (IST-3) of thrombolysis for acute ischaemic stroke.

BACKGROUND: Intravenous recombinant tissue plasminogen activator (rt-PA) is approved for use in selected patients with ischaemic stroke within 3 hours of symptom onset. IST-3 seeks to determine whether a wider range of patients may benefit. DESIGN: International, multi-centre, prospective, randomized, open, blinded endpoint (PROBE) trial of intravenous rt-PA in acute ischaemic stroke. Suitable patients must be assessed and able to start treatment within 6 hours of developing symptoms, and brain imaging must have excluded intracerebral haemorrhage. With 1000 patients, the trial can detect a 7% absolute difference in the primary outcome. With 3500 patients, it can detect a 4.0% absolute benefit & with 6000, (mostly treated between 3 & 6 hours), it can detect a 3% benefit. TRIAL PROCEDURES: Patients are entered into the trial by telephoning a fast, secure computerised central randomisation system or via a secure web interface. Repeat brain imaging must be performed at 24-48 hours. The scans are reviewed 'blind' by expert readers. The primary measure of outcome is the proportion of patients alive and independent (Modified Rankin 0-2) at six months (assessed via a postal questionnaire mailed directly to the patient). Secondary outcomes include: events within 7 days (death, recurrent stroke, symptomatic intracranial haemorrhage), outcome at six months (death, functional status, EuroQol). TRIAL REGISTRATION: ISRCTN25765518.

Prognostic factors of activity limitation and discharge destination after stroke rehabilitation.

OBJECTIVE: The aim of this study was to identify predictive variables related to activity limitation and home destination of a large sample of first-time stroke patients at discharge from a rehabilitation hospital. DESIGN: A multicenter observational study was conducted among 1023 first-time stroke patients who were admitted to 18 different Italian inpatient rehabilitation centers between February 1999 and November 2000. Only 997 patients were considered eligible. At admission, sociodemographic and clinical data were considered as independent variables. The outcome measures evaluated the ability to become functionally independent (independence gain [Barthel Index score > or =18]) at discharge and home return. RESULTS: The study data suggest that independence gain is associated with an earlier rehabilitation intervention, being male, and low or absent cognitive deficit. Home return is associated with no indwelling bladder catheterization, no dysphagia, and living with a companion (roommate or family member) before the stroke. CONCLUSIONS: In postacute stroke rehabilitation, level of cognitive impairment, bladder dysfunction and dysphagia, early diagnosis and treatment, early rehabilitation intervention, and living status (whether the person was residing with a companion before the stroke) are important criteria for outcome measurement at the time of admission. These previous characteristics will most certainly provide clinicians with useful information during the acute phase.

Glycerol for acute stroke: a Cochrane systematic review.

Brain oedema is a major cause of early death after stroke. Glycerol is a hyperosmolar agent that is claimed to reduce brain oedema. We sought to determine whether I. V. glycerol treatment in acute stroke, either ischaemic or haemorrhagic, influences death rates and functional outcome in the short or long term and whether the treatment is safe. The Cochrane Stroke Group Trials Register was searched, conference proceedings were screened and some trialists were personally contacted. We considered all completed, controlled, published and unpublished comparisons, evaluating clinical outcome, in which intravenous glycerol treatment was initiated within the first days after stroke onset. Death from all causes, functional outcome and adverse effects were analysed. Analysis of short term death for acute ischaemic and/or haemorrhagic stroke was possible in ten trials where 482 glycerol treated patients were compared with 463 control patients. Glycerol was associated with a non-significant reduction in the odds of death within the scheduled treatment period (OR 0.78, 95 % Confidence Intervals 0.58-1.06). Among patients with definite or probable ischaemic stroke, glycerol was associated with a significant reduction in the odds of death during the scheduled treatment period (odds ratio 0.65, 95 % CI 0.44-0.97). However, at the end of the scheduled follow up period there was no significant difference in the odds of death (odds ratio 0.98, 95 % CI 0.73-1.31). Functional outcome was reported in only two studies and there was a non-significant positive effect on outcome at the end of scheduled follow up (odds ratio 0.73, 95 % CI 0.37-1.42). Haemolysis seems to be the only relevant adverse effect of glycerol treatment. This systematic review suggests a favourable effect of glycerol treatment on short term survival in probable or definite ischaemic stroke, but the magnitude of the treatment effect may be minimal (as low as a 3 % reduction in odds). Because of the relatively small number of patients and because the trials have been performed in the pre-CT era, the results must be interpreted cautiously. The lack of evidence of benefit in long term survival does not support the routine or selective use of glycerol treatment in patients with acute stroke.

Different measures for assessing stroke outcome: an analysis from the International Stroke Trial in Italy.

BACKGROUND AND PURPOSE: We sought to assess the relationship between 2 simple questions on recovery (question 1: do you feel that you have made a complete recovery from your stroke?) and dependency (question 2: do you require help from another person for everyday activities?) and the Barthel Index (BI) and Oxford Handicap Scale (OHS), as well as the relationship between BI and OHS, in a large number of Italian stroke survivors who participated in the International Stroke Trial (IST). METHODS: We used data from 2423 patients interviewed by telephone at 6 months after the event. The kappa statistic, sensitivity, and specificity were calculated for several comparisons. Internal consistency for BI was calculated. RESULTS: The reliability of the dependency question compared with BI=20 (kappa=0.93) and the reliability of the recovery question compared with OHS=0 (kappa=0.89) were good. Sensitivity of the dependency question in predicting whether patients scored BI >18 was 0.98; sensitivity of the recovery question in predicting whether patients scored OHS=0 was 0.99. The reliability of BI=20 compared with OHS <3 was good (kappa=0.87). Internal consistency of BI was very high (Cronbach's alpha=0.96). CONCLUSIONS: The 2 simple questions are a good means of evaluating outcome from a patient's view and of dichotomizing the stroke survivor in a time-effective and reliable way.