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SPHERE随机对照试验的六年随访:全科医疗中心脏病的二级预防

Six-year follow-up of the SPHERE RCT: secondary prevention of heart disease in general practice.

作者信息

Murphy A W, Cupples M E, Murphy E, Newell J, Scarrott C J, Vellinga A, Gillespie P, Byrne M, Kearney C, Smith S M

机构信息

Discipline of General Practice, National University of Ireland, Galway, Ireland.

UKCRC Centre of Excellence for Public Health (Northern Ireland), Queen's University Belfast, Belfast, Northern Ireland.

出版信息

BMJ Open. 2015 Nov 3;5(11):e007807. doi: 10.1136/bmjopen-2015-007807.

DOI:10.1136/bmjopen-2015-007807
PMID:26534729
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4636612/
Abstract

OBJECTIVE

To determine the long-term effectiveness of a complex intervention in primary care aimed at improving outcomes for patients with coronary heart disease.

DESIGN

A 6-year follow-up of a cluster randomised controlled trial, which found after 18 months that both total and cardiovascular hospital admissions were significantly reduced in intervention practices (8% absolute reduction).

SETTING

48 general practices in the Republic of Ireland and Northern Ireland.

PARTICIPANTS

903 patients with established coronary heart disease at baseline in the original trial.

INTERVENTION

The original intervention consisted of tailored practice and patient plans; training sessions for practitioners in medication prescribing and behavioural change; and regular patient recall system. Control practices provided usual care. Following the intervention period, all supports from the research team to intervention practices ceased.

PRIMARY OUTCOME

hospital admissions, all cause and cardiovascular; secondary outcomes: mortality; blood pressure and cholesterol control.

RESULTS

At 6-year follow-up, data were collected from practice records of 696 patients (77%). For those who had died, we censored their data at the point of death and cause of death was established. There were no significant differences between the intervention and control practices in either total (OR 0.83 (95% CI 0.54 to 1.28)) or cardiovascular hospital admissions (OR 0.91 (95% CI 0.49 to 1.65)). We confirmed mortality status of 886 of the original 903 patients (98%). There were no significant differences in mortality (15% in intervention and 16% in control) or in the proportions of patients above target control for systolic blood pressure or total cholesterol.

CONCLUSIONS

Initial significant differences in the numbers of total and cardiovascular hospital admissions were not maintained at 6 years and no differences were found in mortality or blood pressure and cholesterol control. Policymakers need to continue to assess the effectiveness of previously efficacious programmes.

TRIAL REGISTRATION NUMBER

Current Controlled Trials ISRCTN24081411.

摘要

目的

确定一项旨在改善冠心病患者治疗效果的基层医疗综合干预措施的长期有效性。

设计

对一项整群随机对照试验进行6年随访,该试验在18个月后发现,干预组的总住院次数和心血管疾病住院次数均显著减少(绝对降幅8%)。

地点

爱尔兰共和国和北爱尔兰的48家全科诊所。

参与者

原试验中基线时确诊为冠心病的903例患者。

干预措施

原干预措施包括定制诊所和患者计划;为从业者提供药物处方和行为改变方面的培训课程;以及定期患者召回系统。对照诊所提供常规护理。干预期结束后,研究团队停止了对干预诊所的所有支持。

主要结局

全因及心血管疾病住院次数;次要结局:死亡率;血压和胆固醇控制情况。

结果

在6年随访时,从696例患者(77%)的诊所记录中收集了数据。对于已死亡的患者,我们在死亡时对其数据进行截尾,并确定了死亡原因。干预组和对照组在总住院次数(比值比0.83(95%置信区间0.54至1.28))或心血管疾病住院次数(比值比0.91(95%置信区间0.49至1.65))方面均无显著差异。我们确认了原903例患者中886例(98%)的死亡状态。在死亡率(干预组为15%,对照组为16%)或收缩压或总胆固醇未达目标控制水平的患者比例方面,两组无显著差异。

结论

总住院次数和心血管疾病住院次数最初的显著差异在6年时未持续存在,在死亡率、血压和胆固醇控制方面也未发现差异。政策制定者需要继续评估既往有效方案的有效性。

试验注册号

Current Controlled Trials ISRCTN24081411

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4d10/4636612/d7ffbdc78df7/bmjopen2015007807f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4d10/4636612/d7ffbdc78df7/bmjopen2015007807f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4d10/4636612/d7ffbdc78df7/bmjopen2015007807f01.jpg

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Effect of tailored practice and patient care plans on secondary prevention of heart disease in general practice: cluster randomised controlled trial.
定制化实践与患者护理计划对全科医疗中冠心病二级预防的影响:整群随机对照试验
BMJ. 2009 Oct 29;339:b4220. doi: 10.1136/bmj.b4220.
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