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Open Access Study protocol

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]

Dawn Swancutt1, Richard Hobbs1, David Fitzmaurice1*, Jonathan Mant1, Ellen Murray1, Sue Jowett1, James Raftery2, Stirling Bryan2, Michael Davies3 and Gregory Lip4

Author Affiliations

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

2 Health Economics Facility, The University of Birmingham, Birmingham, UK

3 Department of Cardiology, Selly Oak Hospital, Birmingham, UK

4 University Department of Medicine, City Hospital, Birmingham, UK

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BMC Cardiovascular Disorders 2004, 4:12  doi:10.1186/1471-2261-4-12

Published: 29 July 2004

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.