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一项针对患者和全科医生干预措施的群组随机对照试验,旨在改善中风后多种风险因素的管理:停止中风。

Cluster randomized controlled trial of a patient and general practitioner intervention to improve the management of multiple risk factors after stroke: stop stroke.

机构信息

Division of Health and Social Care Research, King's College London, London, UK.

出版信息

Stroke. 2010 Nov;41(11):2470-6. doi: 10.1161/STROKEAHA.110.588046. Epub 2010 Sep 23.

DOI:10.1161/STROKEAHA.110.588046
PMID:20864664
Abstract

BACKGROUND AND PURPOSE

Stroke is a major public health concern worldwide and survivors remain at high risk of recurrence. Secondary prevention requires management of multiple risk factors but current management is suboptimal. Evidence of the effectiveness of interventions to improve poststroke risk factor management from well-designed trials is limited. We assessed the effectiveness of a patient and general practitioner systematic follow-up intervention to improve risk factor management after stroke.

METHODS

We undertook a pragmatic cluster trial involving 523 consecutive incident stroke survivors identified using the population South London Stroke Register and registered with general practices in inner-city London. Practices were randomized to receive the intervention or usual care. The intervention entailed systematically identifying stroke survivors' risk factors for recurrence and providing tailored evidence-based management advice to general practitioners, patients, and caregivers at 10 weeks, 5 months, and 8 months poststroke. The primary outcome was management of key modifiable risk factors for stroke at 1 year with 3 end points: treatment with antihypertensive therapy, treatment with antiplatelet therapy, and smoking cessation. Hierarchical testing was used to adjust for multiple endpoints. Analysis was by intention to treat. This study is registered as number ISRCTN10730637.

RESULTS

The absolute risk reduction (and 95% CI) for each outcome was -3.7% (-13.0% to 5.6%) for treatment with antihypertensives; -2.3% (-12.0% to 7.6%) for treatment with antiplatelets; and -0.6% (-14.5% to 13.5%) for smoking cessation. Treatment effects were confirmed in the generalized linear model adjusting for clustering and predefined confounders.

CONCLUSIONS

No improvement in risk factor management was demonstrated as a result of this patient, caregiver, and healthcare professional systematic follow-up system. Further evidence of how to effectively alter behavior of patients/caregivers and professionals is required if tailored information on risk and its treatment is to be of any clinical benefit.

摘要

背景与目的

卒中是全球范围内的一个重大公共卫生问题,幸存者仍面临高复发风险。二级预防需要管理多种危险因素,但目前的管理效果并不理想。从精心设计的试验中获得的干预措施改善卒中后危险因素管理效果的证据有限。我们评估了患者和全科医生系统随访干预措施在改善卒中后危险因素管理方面的有效性。

方法

我们进行了一项实用的群组试验,纳入了 523 例连续的卒中幸存者,这些患者通过人群南伦敦卒中登记处确定,并在伦敦市中心的全科医生处登记。将诊所随机分配接受干预或常规护理。干预措施包括系统地识别卒中幸存者复发的危险因素,并在卒中后 10 周、5 个月和 8 个月向全科医生、患者和护理人员提供基于证据的个性化管理建议。主要结局是在 1 年内对卒中的主要可改变危险因素的管理,有 3 个终点:抗高血压治疗、抗血小板治疗和戒烟。采用分层检验来调整多重结局。分析采用意向治疗。本研究注册编号为 ISRCTN84715730。

结果

每个结局的绝对风险降低(95%CI)分别为:抗高血压治疗的 3.7%(-13.0%5.6%);抗血小板治疗的 2.3%(-12.0%7.6%);以及戒烟的 0.6%(-14.5%~13.5%)。在调整聚类和预设混杂因素的广义线性模型中,治疗效果得到了证实。

结论

这种患者、护理人员和医疗保健专业人员的系统随访系统并未显示出危险因素管理的改善。如果要使风险及其治疗的个性化信息具有任何临床意义,还需要进一步证明如何有效地改变患者/护理人员和专业人员的行为。

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