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实施基于证据的治疗方案以管理急性脑卒中患者的发热、高血糖和吞咽功能障碍(QASC):一项整群随机对照试验。

Implementation of evidence-based treatment protocols to manage fever, hyperglycaemia, and swallowing dysfunction in acute stroke (QASC): a cluster randomised controlled trial.

机构信息

Nursing Research Institute, St Vincent's & Mater Health Sydney and School of Nursing, Australian Catholic University, NSW, Australia.

出版信息

Lancet. 2011 Nov 12;378(9804):1699-706. doi: 10.1016/S0140-6736(11)61485-2. Epub 2011 Oct 11.

DOI:10.1016/S0140-6736(11)61485-2
PMID:21996470
Abstract

BACKGROUND

We assessed patient outcomes 90 days after hospital admission for stroke following a multidisciplinary intervention targeting evidence-based management of fever, hyperglycaemia, and swallowing dysfunction in acute stroke units (ASUs).

METHODS

In the Quality in Acute Stroke Care (QASC) study, a single-blind cluster randomised controlled trial, we randomised ASUs (clusters) in New South Wales, Australia, with immediate access to CT and on-site high dependency units, to intervention or control group. Patients were eligible if they spoke English, were aged 18 years or older, had had an ischaemic stroke or intracerebral haemorrhage, and presented within 48 h of onset of symptoms. Intervention ASUs received treatment protocols to manage fever, hyperglycaemia, and swallowing dysfunction with multidisciplinary team building workshops to address implementation barriers. Control ASUs received only an abridged version of existing guidelines. We recruited pre-intervention and post-intervention patient cohorts to compare 90-day death or dependency (modified Rankin scale [mRS] ≥2), functional dependency (Barthel index), and SF-36 physical and mental component summary scores. Research assistants, the statistician, and patients were masked to trial groups. All analyses were done by intention to treat. This trial is registered at the Australia New Zealand Clinical Trial Registry (ANZCTR), number ACTRN12608000563369.

FINDINGS

19 ASUs were randomly assigned to intervention (n=10) or control (n=9). Of 6564 assessed for eligibility, 1696 patients' data were obtained (687 pre-intervention; 1009 post-intervention). Results showed that, irrespective of stroke severity, intervention ASU patients were significantly less likely to be dead or dependent (mRS ≥2) at 90 days than control ASU patients (236 [42%] of 558 patients in the intervention group vs 259 [58%] of 449 in the control group, p=0·002; number needed to treat 6·4; adjusted absolute difference 15·7% [95% CI 5·8-25·4]). They also had a better SF-36 mean physical component summary score (45·6 [SD 10·2] in the intervention group vs 42·5 [10·5] in the control group, p=0·002; adjusted absolute difference 3·4 [95% CI 1·2-5·5]) but no improvement was recorded in mortality (21 [4%] of 558 in intervention group and 24 [5%] of 451 in the control group, p=0·36), SF-36 mean mental component summary score (49·5 [10·9] in the intervention group vs 49·4 [10·6] in the control group, p=0·69) or functional dependency (Barthel Index ≥60: 487 [92%] of 532 patients vs 380 [90%] of 423 patients; p=0·44).

INTERPRETATION

Implementation of multidisciplinary supported evidence-based protocols initiated by nurses for the management of fever, hyperglycaemia, and swallowing dysfunction delivers better patient outcomes after discharge from stroke units. Our findings show the possibility to augment stroke unit care.

FUNDING

National Health & Medical Research Council ID 353803, St Vincent's Clinic Foundation, the Curran Foundation, Australian Diabetes Society-Servier, the College of Nursing, and Australian Catholic University.

摘要

背景

我们评估了在急性卒中单元(ASU)中针对发热、高血糖和吞咽功能障碍进行多学科干预后,患者在卒中后 90 天的结局。

方法

在质量急性卒中护理(QASC)研究中,我们对澳大利亚新南威尔士州的 ASU 进行了单盲、聚类随机对照试验,将 ASU(集群)随机分为干预组或对照组。如果患者符合以下条件,则有资格入组:讲英语、年龄在 18 岁或以上、患有缺血性卒中和/或颅内出血、并在症状发作后 48 小时内就诊。干预组 ASU 接受治疗方案以管理发热、高血糖和吞咽功能障碍,并进行多学科团队建设研讨会以解决实施障碍。对照组 ASU 仅接受现有指南的简化版本。我们招募了干预前和干预后的患者队列,以比较 90 天的死亡或依赖(改良 Rankin 量表[ mRS ]≥2)、功能依赖(巴氏指数)和 SF-36 身体和精神成分综合评分。研究助理、统计学家和患者对试验组均设盲。所有分析均按意向治疗进行。本试验在澳大利亚新西兰临床试验注册中心(ANZCTR)注册,编号为 ACTRN12608000563369。

结果

19 个 ASU 被随机分配到干预组(n=10)或对照组(n=9)。在评估的 6564 名患者中,有 1696 名患者的数据被纳入研究(687 名干预前患者;1009 名干预后患者)。结果表明,无论卒中严重程度如何,与对照组相比,干预组患者在 90 天时的死亡或依赖(mRS≥2)发生率显著降低(干预组 558 例患者中 236 例[42%],对照组 449 例患者中 259 例[58%],p=0·002;需要治疗的人数 6·4;调整后的绝对差异 15·7%[95%CI 5·8-25·4])。他们还具有更好的 SF-36 平均身体成分综合评分(干预组 45·6[10·2],对照组 42·5[10·5],p=0·002;调整后的绝对差异 3·4[95%CI 1·2-5·5]),但死亡率没有改善(干预组 558 例患者中有 21 例[4%],对照组 451 例患者中有 24 例[5%],p=0·36),SF-36 平均心理成分综合评分(干预组 49·5[10·9],对照组 49·4[10·6],p=0·69)或功能依赖(巴氏指数≥60:干预组 532 例患者中有 487 例[92%],对照组 423 例患者中有 380 例[90%];p=0·44)。

解释

由护士启动的多学科支持的基于证据的方案的实施,可改善卒中单元出院后患者的结局。我们的研究结果表明,有可能增加卒中单元的护理。

资金

澳大利亚健康与医学研究委员会 ID 353803,圣文森特诊所基金会,柯兰基金会,澳大利亚糖尿病协会-施维雅,护理学院和澳大利亚天主教大学。

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