Unidad Docente de Medicina Familiar y Comunitaria de Córdoba, Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC)/Hospital Universitario Reina Sofía/Universidad de Córdoba, Avda, Menéndez Pidal, s/n, Córdoba, 14004, Spain.
BMC Fam Pract. 2012 Oct 30;13:106. doi: 10.1186/1471-2296-13-106.
Clinical Practice Guidelines recommend using peripheral blood pulse measuring as a screening test for Atrial Fibrillation. However, there is no adequate evidence supporting the efficacy of such procedure in primary care clinical practice. This paper describes a study protocol designed to verify whether early opportunistic screening for Atrial Fibrillation by measuring blood pulse is more effective than regular practice in subjects aged 65 years attending primary care centers.
METHODS/DESIGN: An cluster-randomized controlled trial conducted in Primary Care Centers of the Spanish National Health Service. A total of 269 physicians and nurses will be allocated to one of the two arms of the trial by stratified randomization with a 3:2 ratio (three practitioners will be assigned to the Control Group for every two practitioners assigned to the Experimental Group). As many as 12 870 patients aged 65 years or older and meeting eligibility criteria will be recruited (8 580 will be allocated to the Experimental Group and 4 290 to the Control Group). Randomization and allocation to trial groups will be carried out by a central computer system. The Experimental Group practitioners will conduct an opportunistic case finding for patients with Atrial Fibrillation, while the Control Group practitioners will follow the regular guidelines. The first step will be finding new Atrial Fibrillation cases. A descriptive inferential analysis will be performed (bivariate and multivariate by multilevel logistic regression analysis).
If our hypothesis is confirmed, we expect Primary Care professionals to take a more proactive approach and adopt a new protocol when a patient meeting the established screening criteria is identified. Finally, we expect this measure to be incorporated into Clinical Practice Guidelines.
The study is registered as NCT01291953 (ClinicalTrials.gob).
临床实践指南建议使用外周脉搏测量作为心房颤动的筛查试验。然而，在初级保健临床实践中，没有足够的证据支持这种方法的疗效。本文描述了一项研究方案，旨在验证在接受初级保健中心治疗的 65 岁患者中，通过测量脉搏进行早期机会性心房颤动筛查是否比常规实践更有效。
方法/设计：这是一项在西班牙国家卫生服务的初级保健中心进行的群组随机对照试验。总共 269 名医生和护士将通过分层随机化按 3:2 的比例（每两名被分配到实验组的医生中，将有三名被分配到对照组）分配到试验的两个组之一。共有 12870 名年龄在 65 岁及以上且符合入选标准的患者将被招募（8580 名将被分配到实验组，4290 名将被分配到对照组）。随机化和分配到试验组将由中央计算机系统进行。实验组的医生将对符合心房颤动筛查标准的患者进行机会性病例发现，而对照组的医生将遵循常规指南。第一步是发现新的心房颤动病例。将进行描述性推断分析（双变量和多变量通过多层次逻辑回归分析）。
如果我们的假设得到证实，我们预计初级保健专业人员在识别出符合既定筛查标准的患者时，将采取更积极的方法并采用新的方案。最后，我们希望这一措施被纳入临床实践指南。
该研究在 ClinicalTrials.gov 注册为 NCT01291953。
