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

BMC Family Practice

Study Protocol

Remedios Martín-Alvarez¹  Antonio Valero-Martín²  MiguelÁ Martínez-Adell³  Emili Burdoy-Joaquín⁴  Enrique Martín-Rioboó⁵  José M Baena-Díez⁶  Montserrat Coma-Solé⁷  Juan M Parras-Rejano⁸  Lluís Cuixart-Costa⁹  Mercè Cervera-León⁹  JoséÁ Fernández-García^1,10  Carlos Pérula-de-Torres^1,11  Ana Roldán-Villalobos^1,12  Jesús González-Lama^1,13  Modesto Pérez-Díaz^1,14  Joaquin Ruiz-de-Castroviejo^1,15  Margarita Criado-Larumbe^1,16  LuisÁ Pérula-de-Torres^1,17  Roger Ruiz-Moral^1,18  Virginia González-Blanco^1,19 

[1] CAP Vallcarca, CatSalut, Av. Hospital Militar, 169-205, 08023, Barcelona, Spain;Centro Salud Villafranca (Córdoba), Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC)/Hospital Universitario Reina Sofía/Universidad de Córdoba, Avda. Menéndez Pidal, s/n, 14004, Córdoba, Spain;Centro de Salud Argentona, Consorci Sanitari del Maresme, C/Joan Fuster I Ortells, 1, 08310, Argentona, Barcelona, Spain;Centro de Salud Collblanch, Consorci Sanitari Intergral, C/Creu Roja, 18, L′Hospitalet de Llobregat, 08904, Barcelona, Spain;Centro de Salud Fuensanta, Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC)/Hospital Universitario Reina Sofía/Universidad de Córdoba, Avda. Menéndez Pidal, s/n., 14004, Córdoba, Spain;Centro de Salud La Marina. SAP Esquerra de Barcelona, Institut Català de la Salut, C/ Amnistia Internacional, 9, 08038, Barcelona, Spain;Centro de Salud Les Planes, Institut Català de la Salut, Av. Barcelona, 62, Sant Joan Despí, 08970, Barcelona, Spain;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., 14004, Córdoba, Spain;Centro de Salud Roger de Flor, Equipo de Atención Primaria Dreta de l′Eixample, C/Roger de Flor, 194, 08013, Barcelona, Spain;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., 14004, Córdoba, Spain;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, 14004, Córdoba, Spain;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, 14004, Córdoba, Spain;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., 14900, Lucena, Córdoba, Spain;Distrito Sanitario Córdoba-centro, Servicio Andaluz de Salud, Calle Dr. Blanco Soler, 4, 14004, Córdoba, Spain;Hospital Regional Universitario Reina Sofía, Servicio Andaluz de Salud, Avda. Menéndez Pidal s/n, 14004, Córdoba, Spain;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, 14004, Córdoba, Spain;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, 14004, Córdoba, Spain;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., 14004, Córdoba, Spain;Unidad Docente de Medicina Familiar y Comunitaria de Córdoba, Servicio Andaluz de Salud, C/Dr. Blanco Soler, s/n, 14004, Córdoba, Spain;

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

DOI  :  10.1186/1471-2296-13-106

 received in 2012-08-21, accepted in 2012-10-16,  发布年份 2012

来源: Springer

【 摘 要 】

BackgroundClinical 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/designAn 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).DiscussionIf 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 registrationThe study is registered as NCT01291953 (ClinicalTrials.gob)

【 授权许可】

CC BY   
© Pérula-de-Torres et al.; licensee BioMed Central Ltd. 2012