Department of Cardiology, and Department of Medical and Health Sciences, Linköping University, Linköping, Sweden.
Primary Health Care Center in Vikbolandet, and Department of Medical and Health Sciences, Linköping University, Vikbolandet, Sweden.
PLoS Med. 2018 Mar 13;15(3):e1002528. doi: 10.1371/journal.pmed.1002528. eCollection 2018 Mar.
Atrial fibrillation (AF) is associated with substantial morbidity, in particular stroke. Despite good evidence for the reduction of stroke risk with anticoagulant therapy, there remains significant undertreatment. The main aim of the current study was to investigate whether a clinical decision support tool (CDS) for stroke prevention integrated in the electronic health record could improve adherence to guidelines for stroke prevention in patients with AF.
We conducted a cluster-randomized trial where all 43 primary care clinics in the county of Östergötland, Sweden (population 444,347), were randomized to be part of the CDS intervention or to serve as controls. The CDS produced an alert for physicians responsible for patients with AF and at increased risk for thromboembolism (according to the CHA2DS2-VASc algorithm) without anticoagulant therapy. The primary endpoint was adherence to guidelines after 1 year. After randomization, there were 22 and 21 primary care clinics in the CDS and control groups, respectively. There were no significant differences in baseline adherence to guidelines regarding anticoagulant therapy between the 2 groups (CDS group 70.3% [5,186/7,370; 95% CI 62.9%-77.7%], control group 70.0% [4,187/6,009; 95% CI 60.4%-79.6%], p = 0.83). After 12 months, analysis with linear regression with adjustment for primary care clinic size and adherence to guidelines at baseline revealed a significant increase in guideline adherence in the CDS (73.0%, 95% CI 64.6%-81.4%) versus the control group (71.2%, 95% CI 60.8%-81.6%, p = 0.013, with a treatment effect estimate of 0.016 [95% CI 0.003-0.028]; number of patients with AF included in the final analysis 8,292 and 6,508 in the CDS and control group, respectively). Over the study period, there was no difference in the incidence of stroke, transient ischemic attack, or systemic thromboembolism in the CDS group versus the control group (49 [95% CI 43-55] per 1,000 patients with AF in the CDS group compared to 47 [95% CI 39-55] per 1,000 patients with AF in the control group, p = 0.64). Regarding safety, the CDS group had a lower incidence of significant bleeding, with events in 12 (95% CI 9-15) per 1,000 patients with AF compared to 16 (95% CI 12-20) per 1,000 patients with AF in the control group (p = 0.04). Limitations of the study design include that the analysis was carried out in a catchment area with a high baseline adherence rate, and issues regarding reproducibility to other regions.
The present study demonstrates that a CDS can increase guideline adherence for anticoagulant therapy in patients with AF. Even though the observed difference was small, this is the first randomized study to our knowledge indicating beneficial effects with a CDS in patients with AF.
ClinicalTrials.gov NCT02635685.
心房颤动（AF）与大量发病率相关，尤其是中风。尽管有很好的证据表明抗凝治疗可以降低中风风险，但仍存在大量治疗不足的情况。本研究的主要目的是研究在电子病历中集成的中风预防临床决策支持工具（CDS）是否可以提高 AF 患者中风预防指南的依从性。
我们进行了一项聚类随机试验，将瑞典Östergötland 县的所有 43 个初级保健诊所（人口 444,347）随机分为 CDS 干预组或对照组。CDS 为负责 AF 且血栓栓塞风险增加（根据 CHA2DS2-VASc 算法）但未接受抗凝治疗的医生生成警报。主要终点是在 1 年后对指南的依从性。随机分组后，CDS 和对照组分别有 22 个和 21 个初级保健诊所。两组之间在抗凝治疗方面对指南的依从性没有显著差异（CDS 组 70.3%[5,186/7,370;95%CI 62.9%-77.7%]，对照组 70.0%[4,187/6,009;95%CI 60.4%-79.6%]，p=0.83）。经过 12 个月的线性回归分析，调整了初级保健诊所的大小和基线时对指南的依从性，发现 CDS 组的指南依从性显著增加（73.0%，95%CI 64.6%-81.4%）与对照组（71.2%，95%CI 60.8%-81.6%，p=0.013，治疗效果估计为 0.016[95%CI 0.003-0.028]；最终分析中包括的 AF 患者人数分别为 CDS 组 8,292 例和对照组 6,508 例）。在研究期间，CDS 组与对照组的中风、短暂性脑缺血发作或全身性血栓栓塞的发生率没有差异（CDS 组每 1,000 例 AF 患者中发生 49[95%CI 43-55]例，对照组每 1,000 例 AF 患者中发生 47[95%CI 39-55]例，p=0.64）。关于安全性，CDS 组的严重出血发生率较低，每 1,000 例 AF 患者中发生 12 例（95%CI 9-15），而对照组为每 1,000 例 AF 患者中发生 16 例（95%CI 12-20）（p=0.04）。研究设计的局限性包括分析是在基线依从率较高的流域地区进行的，以及在其他地区的可重复性问题。
本研究表明，CDS 可以提高 AF 患者抗凝治疗的指南依从性。尽管观察到的差异很小，但这是我们所知的第一项表明 CDS 对 AF 患者有益的随机研究。
ClinicalTrials.gov NCT02635685。
