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促进抗凝治疗并降低中风风险的自动化软件系统:整群随机对照试验

Automated Software System to Promote Anticoagulation and Reduce Stroke Risk: Cluster-Randomized Controlled Trial.

作者信息

Holt Tim A, Dalton Andrew, Marshall Tom, Fay Matthew, Qureshi Nadeem, Kirkpatrick Susan, Hislop Jenny, Lasserson Daniel, Kearley Karen, Mollison Jill, Yu Ly-Mee, Hobbs F D Richard, Fitzmaurice David

机构信息

From the Nuffield Department of Primary Care Health Sciences, Oxford University, United Kingdom (T.A.H., S.K., J.H., D.L., K.K., J.M., L.-M.Y., F.D.R.H.); Postgraduate School of Public Health, Health Education West Midlands, Birmingham, United Kingdom (A.D.); Primary Care Clinical Sciences, Birmingham University, United Kingdom (T.M., D.F.); Westcliffe Medical Centre, Shipley, United Kingdom (M.F.); and School of Medicine, University of Nottingham, United Kingdom (N.Q.).

出版信息

Stroke. 2017 Mar;48(3):787-790. doi: 10.1161/STROKEAHA.116.015468. Epub 2017 Jan 24.

DOI:10.1161/STROKEAHA.116.015468
PMID:28119433
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5351848/
Abstract

BACKGROUND AND PURPOSE

Oral anticoagulants (OAC) substantially reduce risk of stroke in atrial fibrillation, but uptake is suboptimal. Electronic health records enable automated identification of people at risk but not receiving treatment. We investigated the effectiveness of a software tool (AURAS-AF [Automated Risk Assessment for Stroke in Atrial Fibrillation]) designed to identify such individuals during routine care through a cluster-randomized trial.

METHODS

Screen reminders appeared each time the electronic health records of an eligible patient was accessed until a decision had been taken over OAC treatment. Where OAC was not started, clinicians were prompted to indicate a reason. Control practices continued usual care. The primary outcome was the proportion of eligible individuals receiving OAC at 6 months. Secondary outcomes included rates of cardiovascular events and reports of adverse effects of the software on clinical decision-making.

RESULTS

Forty-seven practices were randomized. The mean proportion-prescribed OAC at 6 months was 66.3% (SD=9.3) in the intervention arm and 63.9% (9.5) in the control arm (adjusted difference 1.21% [95% confidence interval -0.72 to 3.13]). Incidence of recorded transient ischemic attack was higher in the intervention practices (median 10.0 versus 2.3 per 1000 patients with atrial fibrillation; =0.027), but at 12 months, we found a lower incidence of both all cause stroke (=0.06) and hemorrhage (=0.054). No adverse effects of the software were reported.

CONCLUSIONS

No significant change in OAC prescribing occurred. A greater rate of diagnosis of transient ischemic attack (possibly because of improved detection or overdiagnosis) was associated with a reduction (of borderline significance) in stroke and hemorrhage over 12 months.

CLINICAL TRIAL REGISTRATION

URL: http://www.isrctn.com. Unique Identifier: ISRCTN55722437.

摘要

背景与目的

口服抗凝剂(OAC)可显著降低心房颤动患者的中风风险,但使用率并不理想。电子健康记录能够自动识别有风险但未接受治疗的人群。我们通过一项整群随机试验,研究了一种软件工具(AURAS-AF [心房颤动中风自动风险评估])在常规护理期间识别此类个体的有效性。

方法

每次访问符合条件患者的电子健康记录时都会出现筛查提醒,直至就OAC治疗做出决定。如果未开始使用OAC,会提示临床医生说明原因。对照实践继续常规护理。主要结局是6个月时接受OAC治疗的符合条件个体的比例。次要结局包括心血管事件发生率以及软件对临床决策影响的不良反应报告。

结果

47个实践被随机分组。干预组6个月时OAC的平均处方比例为66.3%(标准差=9.3),对照组为63.9%(9.5)(调整差异1.21% [95%置信区间 -0.72至3.13])。干预实践中记录的短暂性脑缺血发作发生率较高(每1000例心房颤动患者中位数为10.0对2.3;P=0.027),但在12个月时,我们发现全因中风(P=0.06)和出血(P=0.054)的发生率均较低。未报告软件的不良反应。

结论

OAC处方无显著变化。短暂性脑缺血发作的诊断率较高(可能是由于检测改善或过度诊断)与12个月内中风和出血的减少(具有临界显著性)相关。

临床试验注册

网址:http://www.isrctn.com。唯一标识符:ISRCTN55722437。

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