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一项关于65岁以上人群心房颤动检测的系统筛查(针对性筛查和全人群筛查)与常规做法的随机对照试验及成本效益研究:(SAFE)[国际标准随机对照试验编号19633732]

A randomised controlled trial and cost effectiveness study of systematic screening (targeted and total population screening) versus routine practice for the detection of atrial fibrillation in the over 65s: (SAFE) [ISRCTN19633732].

作者信息

Swancutt Dawn, Hobbs Richard, Fitzmaurice David, Mant Jonathan, Murray Ellen, Jowett Sue, Raftery James, Bryan Stirling, Davies Michael, Lip Gregory

机构信息

Department of Primary Care and General Practice, The University of Birmingham, UK.

出版信息

BMC Cardiovasc Disord. 2004 Jul 29;4:12. doi: 10.1186/1471-2261-4-12.

Abstract

BACKGROUND

Atrial fibrillation (AF) has been recognised as an important independent risk factor for thromboembolic disease, particularly stroke for which it provides a five-fold increase in risk. This study aimed to determine the baseline prevalence and the incidence of AF based on a variety of screening strategies and in doing so to evaluate the incremental cost-effectiveness of different screening strategies, including targeted or whole population screening, compared with routine clinical practice, for detection of AF in people aged 65 and over. The value of clinical assessment and echocardiography as additional methods of risk stratification for thromboembolic disease in patients with AF were also evaluated.

METHODS

The study design was a multi-centre randomised controlled trial with a study population of patients aged 65 and over from 50 General Practices in the West Midlands. These purposefully selected general practices were randomly allocated to 25 intervention practices and 25 control practices. GPs and practice nurses within the intervention practices received education on the importance of AF detection and ECG interpretation. Patients in the intervention practices were randomly allocated to systematic (n = 5000) or opportunistic screening (n = 5000). Prospective identification of pre-existing risk factors for AF within the screened population enabled comparison between high risk targeted screening and total population screening. AF detection rates in systematically screened and opportunistically screened populations in the intervention practices were compared to AF detection rate in 5,000 patients in the control practices.

摘要

背景

心房颤动(AF)已被公认为血栓栓塞性疾病的重要独立危险因素,尤其是中风,其发病风险会增加五倍。本研究旨在根据多种筛查策略确定AF的基线患病率和发病率,并在此过程中评估不同筛查策略(包括针对性筛查或全人群筛查)与常规临床实践相比,在65岁及以上人群中检测AF的增量成本效益。还评估了临床评估和超声心动图作为AF患者血栓栓塞性疾病额外风险分层方法的价值。

方法

该研究设计为一项多中心随机对照试验,研究人群为西米德兰兹郡50家全科诊所中65岁及以上的患者。这些经过特意挑选的全科诊所被随机分为25个干预诊所和25个对照诊所。干预诊所的全科医生和执业护士接受了关于AF检测和心电图解读重要性的培训。干预诊所的患者被随机分配到系统筛查组(n = 5000)或机会性筛查组(n = 5000)。通过前瞻性识别筛查人群中预先存在的AF危险因素,能够比较高风险针对性筛查和全人群筛查。将干预诊所中系统筛查和机会性筛查人群的AF检测率与对照诊所中5000名患者的AF检测率进行比较。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9f84/509245/61a7301ecbd5/1471-2261-4-12-1.jpg

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