Ciccone Alfonso, Celani Maria Grazia, Chiaramonte Raimondo, Rossi Cristiana, Righetti Enrico
Department ofNeurology and Stroke Unit, “Carlo Poma”Hospital,Mantua, Italy.
Cochrane Database Syst Rev. 2013 May 31;2013(5):CD008444. doi: 10.1002/14651858.CD008444.pub2.
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.
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.
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 In an effort to identify further published, unpublished and ongoing trials we searched trials registers (November 2012) and reference lists, handsearched conference proceedings and contacted trial authors.
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).
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.
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.
与普通病房相比,卒中单元在降低卒中患者死亡率、机构化程度和依赖性方面有效的原因仍未明确,关于最有效的卒中单元模式的讨论仍在进行中。在许多西方国家,无创机械监测的强度是不同模式的主要问题之一。这是因为它在人员数量、专业技能、基础设施和成本方面对卒中单元的组织有很大影响。
评估与间歇性监测相比,对急性卒中患者进行生理变量的持续强化监测是否能在死亡率或残疾方面改变其预后。
我们检索了Cochrane卒中小组试验注册库(2012年11月)、Cochrane对照试验中央注册库(CENTRAL)(《Cochrane图书馆》2011年第8期)、MEDLINE(1966年至2012年11月)、EMBASE(1980年至2012年11月)、CINAHL(1982年至2012年11月)和英国护理索引(1985年至2012年11月)。为了识别更多已发表、未发表和正在进行的试验,我们检索了试验注册库(2012年11月)和参考文献列表,手工检索了会议论文集并联系了试验作者。
我们纳入了所有在卒中发作三天内比较持续监测与间歇性监测的随机、整群随机和半随机对照试验。我们排除了因在不同环境中提供护理而混淆(即干预地点在试验的两组中不在同一病房的研究)。
三位综述作者独立选择纳入研究,评估方法学质量并提取数据。我们从两项试验的试验者处获取原始数据,并在另外四项试验(三项在会议上发表,一项来自中国临床试验注册库)中核实纳入标准。在可能的情况下,我们提取了触发对给定生理变量进行干预的异常阈值水平、为纠正异常而给予的具体干预措施以及对分配治疗的依从性数据。
三项研究,共涉及354名参与者,符合我们主要结局的纳入标准。与间歇性监测相比,持续监测在三个月或出院时显著降低了死亡和残疾(比值比(OR)0.27,95%置信区间(CI)0.13至0.56),且与出院时任何原因导致的死亡非显著降低相关(OR 0.72,95% CI 0.28至1.85)。这些显著结果取决于一项存在高偏倚风险的研究。持续监测与依赖性非显著降低相关(OR 0.79,95% CI 0.30至2.06)、血管性原因导致的死亡(OR 0.48,95% CI 0.10至2.