Uittenbogaart Steven B, Verbiest-van Gurp Nicole, Erkens Petra M G, Lucassen Wim A M, Knottnerus J André, Winkens Bjorn, van Weert Henk C P M, Stoffers Henri E J H
Department of General Practice, Amsterdam Medical Center, J2-118, PO Box 22660, 1100 DD, Amsterdam, The Netherlands.
Department of Family Medicine, School for Public Health and Primary Care (CAPHRI), Maastricht University, PO Box 616, 6200 MD, Maastricht, The Netherlands.
Trials. 2015 Oct 23;16:478. doi: 10.1186/s13063-015-1006-5.
Atrial fibrillation is a common cause of stroke and other morbidity. Adequate treatment with anticoagulants reduces the risk of stroke by 60 %. Early detection and treatment of atrial fibrillation could prevent strokes. Atrial fibrillation is often asymptomatic and/or paroxysmal. Case-finding with pulse palpation is an effective screening method, but new methods for detecting atrial fibrillation have been developed. To detect paroxysmal atrial fibrillation ambulatory rhythm recording is needed. This study aims to determine the yield of case-finding for atrial fibrillation in primary care patients. In addition, it will determine the diagnostic accuracy of three different case-finding methods.
METHODS/DESIGN: In a multicenter cluster randomised controlled trial, we compare an enhanced protocol for case-finding of atrial fibrillation with usual care. We recruit 96 practices. We include primary care patients aged 65 years or older not diagnosed with atrial fibrillation. Within each practice, a cluster of 200 patients is randomly selected and marked. Practices are evenly randomised to intervention or control group. The allocation is not blinded. When a marked patient visits an intervention practice, the case-finding protocol starts, consisting of: pulse palpation, sphygmomanometer with automated atrial fibrillation detection and handheld single-lead electrocardiogram (ECG). All patients with at least 1 positive test and a random sample of patients with negative tests receive a 12-lead ECG. Patients without atrial fibrillation on the 12-lead ECG, undergo additional continuous Holter and use the handheld single-lead ECG at home for 2 weeks. Control practices provide care as usual. The study runs for 1 year in each cluster. The primary outcomes are the difference in detection rate of new AF between intervention and control practices and the accuracy of three index tests to diagnose AF. We are currently recruiting practices. The 'Detecting and Diagnosing Atrial Fibrillation' (D2AF) study will determine the yield of an intensive case-finding strategy and the diagnostic accuracy of three index tests to diagnose atrial fibrillation in a primary care setting.
Netherlands Trial Register: NTR4914 , registered on the 25 of November 2014.
心房颤动是中风和其他发病的常见原因。使用抗凝剂进行充分治疗可将中风风险降低60%。早期发现和治疗心房颤动可预防中风。心房颤动通常无症状和/或呈阵发性。通过脉搏触诊进行病例筛查是一种有效的筛查方法，但已开发出检测心房颤动的新方法。要检测阵发性心房颤动，需要进行动态心律记录。本研究旨在确定基层医疗患者中心房颤动病例筛查的检出率。此外，它将确定三种不同病例筛查方法的诊断准确性。
方法/设计：在一项多中心整群随机对照试验中，我们将心房颤动病例筛查的强化方案与常规护理进行比较。我们招募96家医疗机构。我们纳入65岁及以上未被诊断为心房颤动的基层医疗患者。在每家医疗机构内，随机选择一组200名患者并进行标记。医疗机构被均匀随机分配到干预组或对照组。分配不设盲。当一名被标记的患者就诊于干预组医疗机构时，病例筛查方案开始，包括：脉搏触诊、带有自动心房颤动检测功能 的血压计和手持式单导联心电图（ECG）。所有至少一项检测呈阳性的患者以及检测呈阴性患者的随机样本均接受12导联心电图检查。12导联心电图显示无心房颤动的患者，需额外进行连续动态心电图监测，并在家中使用手持式单导联心电图仪两周。对照组医疗机构提供常规护理。每个整群的研究为期1年。主要结局是干预组和对照组医疗机构中新发房颤检出率的差异以及三种指标检测诊断房颤的准确性。我们目前正在招募医疗机构。“检测和诊断心房颤动”（D2AF）研究将确定强化病例筛查策略的检出率以及三种指标检测在基层医疗环境中诊断心房颤动的诊断准确性。
荷兰试验注册库：NTR4914，于2014年11月25日注册。
