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巴西一项多方面干预措施对急性冠状动脉综合征患者采用循证治疗的效果:BRIDGE-ACS 随机试验

Effect of a multifaceted intervention on use of evidence-based therapies in patients with acute coronary syndromes in Brazil: the BRIDGE-ACS randomized trial.

机构信息

Research Institute HCor--Hospital do Coração, São Paulo, Brazil.

出版信息

JAMA. 2012 May 16;307(19):2041-9. doi: 10.1001/jama.2012.413.

DOI:10.1001/jama.2012.413
PMID:22665103
Abstract

CONTEXT

Studies have found that patients with acute coronary syndromes (ACS) often do not receive evidence-based therapies in community practice. This is particularly true in low- and middle-income countries.

OBJECTIVE

To evaluate whether a multifaceted quality improvement (QI) intervention can improve the use of evidence-based therapies and reduce the incidence of major cardiovascular events among patients with ACS in a middle-income country.

DESIGN, SETTING, AND PARTICIPANTS: The BRIDGE-ACS (Brazilian Intervention to Increase Evidence Usage in Acute Coronary Syndromes) trial, a cluster-randomized (concealed allocation) trial conducted among 34 clusters (public hospitals) in Brazil and enrolling a total of 1150 patients with ACS from March 15, 2011, through November 2, 2011, with follow-up through January 27, 2012.

INTERVENTION

Multifaceted QI intervention including educational materials for clinicians, reminders, algorithms, and case manager training, vs routine practice (control).

MAIN OUTCOME MEASURES

Primary end point was the percentage of eligible patients who received all evidence-based therapies (aspirin, clopidogrel, anticoagulants, and statins) during the first 24 hours in patients without contraindications.

RESULTS

Mean age of the patients enrolled was 62 (SD, 13) years; 68.6% were men, and 40% presented with ST-segment elevation myocardial infarction, 35.6% with non-ST-segment elevation myocardial infarction, and 23.6% with unstable angina. The randomized clusters included 79.5% teaching hospitals, all from major urban areas and 41.2% with 24-hour percutaneous coronary intervention capabilities. Among eligible patients (923/1150 [80.3%]), 67.9% in the intervention vs 49.5% in the control group received all eligible acute therapies (population average odds ratio [OR(PA)], 2.64 [95% CI, 1.28-5.45]). Similarly, among eligible patients (801/1150 [69.7%]), those in the intervention group were more likely to receive all eligible acute and discharge medications (50.9% vs 31.9%; OR(PA),, 2.49 [95% CI, 1.08-5.74]). Overall composite adherence scores were higher in the intervention clusters (89% vs 81.4%; mean difference, 8.6% [95% CI, 2.2%-15.0%]). In-hospital cardiovascular event rates were 5.5% in the intervention group vs 7.0% in the control group (OR(PA), 0.72 [95% CI, 0.36-1.43]); 30-day all-cause mortality was 7.0% vs 8.4% (ORPA, 0.79 [95% CI, 0.46-1.34]).

CONCLUSION

Among patients with ACS treated in Brazil, a multifaceted educational intervention resulted in significant improvement in the use of evidence-based therapies.

TRIAL REGISTRATION

clinicaltrials.gov Identifier: NCT00958958.

摘要

背景

研究发现,急性冠状动脉综合征(ACS)患者在社区实践中经常未接受基于证据的治疗。在中低收入国家尤其如此。

目的

评估一种多方面的质量改进(QI)干预措施是否可以改善证据为基础的治疗方法的使用,并降低中低收入国家 ACS 患者主要心血管事件的发生率。

设计、地点和参与者:BRIDGE-ACS(巴西干预措施以增加急性冠状动脉综合征中的证据使用)试验是一项在巴西的 34 个(公立医院)集群中进行的集群随机(隐蔽分配)试验,共纳入了 1150 名 ACS 患者,研究时间为 2011 年 3 月 15 日至 2011 年 11 月 2 日,随访至 2012 年 1 月 27 日。

干预措施

多方面的 QI 干预措施包括临床医生的教育材料、提醒、算法和病例管理培训,与常规治疗(对照组)相比。

主要结局测量

主要终点是无禁忌症的患者在最初 24 小时内接受所有基于证据的治疗(阿司匹林、氯吡格雷、抗凝剂和他汀类药物)的合格患者的百分比。

结果

纳入患者的平均年龄为 62(标准差,13)岁;68.6%为男性,40%表现为 ST 段抬高型心肌梗死,35.6%为非 ST 段抬高型心肌梗死,23.6%为不稳定型心绞痛。随机分组的集群包括 79.5%的教学医院,均来自主要城区,其中 41.2%具备 24 小时经皮冠状动脉介入治疗能力。在合格患者(923/1150[80.3%])中,干预组有 67.9%接受了所有合格的急性治疗,而对照组有 49.5%(人群平均优势比[OR(PA)],2.64[95%CI,1.28-5.45])。同样,在合格患者(801/1150[69.7%])中,干预组更有可能接受所有合格的急性和出院药物治疗(50.9%比 31.9%;OR(PA),2.49[95%CI,1.08-5.74])。干预组的总体综合依从性评分较高(89%比 81.4%;平均差异,8.6%[95%CI,2.2%-15.0%])。干预组的院内心血管事件发生率为 5.5%,对照组为 7.0%(OR(PA),0.72[95%CI,0.36-1.43]);30 天全因死亡率为 7.0%比 8.4%(ORPA,0.79[95%CI,0.46-1.34])。

结论

在巴西接受治疗的 ACS 患者中,多方面的教育干预措施显著提高了基于证据的治疗方法的应用。

试验注册

clinicaltrials.gov 标识符:NCT00958958。

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