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Open Access Study protocol

Opportunistic detection of atrial fibrillation in subjects aged 65 years or older in primare care: a randomised clinical trial of efficacy. DOFA-AP study protocol

LuisÁ Pérula-de-Torres1*, MiguelÁ Martínez-Adell2, Virginia González-Blanco3, José M Baena-Díez4, Enrique Martín-Rioboó5, Juan M Parras-Rejano6, Jesús González-Lama7, Remedios Martín-Alvarez8, Roger Ruiz-Moral9, JoséÁ Fernández-García10, Modesto Pérez-Díaz11, Joaquin Ruiz-de-Castroviejo12, Carlos Pérula-de-Torres13, Antonio Valero-Martín14, Ana Roldán-Villalobos15, Margarita Criado-Larumbe16, Emili Burdoy-Joaquín17, Montserrat Coma-Solé18, Mercè Cervera-León19, Lluís Cuixart-Costa19 and Collaborative Group DOFA-AP19

Author Affiliations

1 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

2 Centro de Salud Argentona, Consorci Sanitari del Maresme, C/Joan Fuster I Ortells, 1, Argentona, Barcelona, 08310, Spain

3 Unidad Docente de Medicina Familiar y Comunitaria de Córdoba, Servicio Andaluz de Salud, C/Dr. Blanco Soler, s/n, Córdoba, 14004, Spain

4 Centro de Salud La Marina. SAP Esquerra de Barcelona, Institut Català de la Salut, C/ Amnistia Internacional, 9, Barcelona, 08038, Spain

5 Centro de Salud Fuensanta, Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC)/Hospital Universitario Reina Sofía/Universidad de Córdoba, Avda. Menéndez Pidal, s/n., Córdoba, 14004, Spain

6 Centro de Salud Peñarroya-Pueblonuevo, Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC)/Hospital Universitario Reina Sofía/Universidad de Córdoba, Avda. Menéndez Pidal, s/n., Córdoba, 14004, Spain

7 Distrito Sanitario Córdoba Sur, Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC)/Hospital Universitario Reina Sofía/Universidad de Córdoba, Complejo Municipal Los Santos. Carretera Córdoba-Málaga s/n., Lucena, Córdoba, 14900, Spain

8 CAP Vallcarca, CatSalut, Av. Hospital Militar, 169-205, Barcelona, 08023, Spain

9 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

10 Centro de Salud Villarrubia-Azahara, Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC)/Hospital Universitario Reina Sofía/Universidad de Córdoba, Avda. Menéndez Pidal, s/n., Córdoba, 14004, Spain

11 Distrito Sanitario Córdoba-centro, Servicio Andaluz de Salud, Calle Dr. Blanco Soler, 4, Córdoba, 14004, Spain

12 Hospital Regional Universitario Reina Sofía, Servicio Andaluz de Salud, Avda. Menéndez Pidal s/n, Córdoba, 14004, Spain

13 Centro de Salud Villavisiosa de Córdoba (Córdoba), Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC)/Hospital Universitario Reina Sofía/Universidad de Córdoba, Avda. Menéndez Pidal, s/n, Córdoba, 14004, Spain

14 Centro Salud Villafranca (Córdoba), Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC)/Hospital Universitario Reina Sofía/Universidad de Córdoba, Avda. Menéndez Pidal, s/n, Córdoba, 14004, Spain

15 Centro de Salud de Huerta de la Reina (Córdoba), Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC)/Hospital Universitario Reina Sofía/Universidad de Córdoba, Avda. Menéndez Pidal, s/n, Córdoba, 14004, Spain

16 Unidad Docente de Medicina Familiar y Comunitaria de Córdoba, Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC)/Hospital Universitario Reina Sofía/Universidad de Córdoba, Av. Menéndez Pidal, s/n, Córdoba, 14004, Spain

17 Centro de Salud Collblanch, Consorci Sanitari Intergral, C/Creu Roja, 18, L′Hospitalet de Llobregat, Barcelona, 08904, Spain

18 Centro de Salud Les Planes, Institut Català de la Salut, Av. Barcelona, 62, Sant Joan Despí, Barcelona, 08970, Spain

19 Centro de Salud Roger de Flor, Equipo de Atención Primaria Dreta de l′Eixample, C/Roger de Flor, 194, Barcelona, 08013, Spain

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BMC Family Practice 2012, 13:106  doi:10.1186/1471-2296-13-106

Published: 30 October 2012

Abstract

Background

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).

Discussion

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.

Trial registration

The study is registered as NCT01291953 (ClinicalTrials.gob)

Keywords:
Atrial fibrillation; Screening; Opportunistic case finding; Secondary prevention; Primary care