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

Luis Á Pérula-de-Torres, Miguel Á Martínez-Adell, Virginia González-Blanco, José M Baena-Díez, Enrique Martín-Rioboó, Juan M Parras-Rejano, Jesús González-Lama, Remedios Martín-Alvarez, Roger Ruiz-Moral, José Á Fernández-García, Modesto Pérez-Díaz, Joaquin Ruiz-de-Castroviejo, Carlos Pérula-de-Torres, Antonio Valero-Martín, Ana Roldán-Villalobos, Margarita Criado-Larumbe, Emili Burdoy-Joaquín, Montserrat Coma-Solé, Mercè Cervera-León, Lluís Cuixart-Costa, Collaborative Group DOFA-AP, Luis Á Pérula-de-Torres, Miguel Á Martínez-Adell, Virginia González-Blanco, José M Baena-Díez, Enrique Martín-Rioboó, Juan M Parras-Rejano, Jesús González-Lama, Remedios Martín-Alvarez, Roger Ruiz-Moral, José Á Fernández-García, Modesto Pérez-Díaz, Joaquin Ruiz-de-Castroviejo, Carlos Pérula-de-Torres, Antonio Valero-Martín, Ana Roldán-Villalobos, Margarita Criado-Larumbe, Emili Burdoy-Joaquín, Montserrat Coma-Solé, Mercè Cervera-León, Lluís Cuixart-Costa, Collaborative Group DOFA-AP

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).

Figures

Figure 1
Figure 1
Design of DOFA-AP study.

References

    1. Fibrilación auricular. 20/10/2009-Guías Clínicas. 2009. .
    1. Go AS, Hylek EM, Phillips KA, Chang Y, Henault LE, Selby JV, Singer DE. Prevalence of diagnosed atrial fibrillation in adults: national implications for rhythm management and stroke prevention: the AnTicoagulation and Risk Factors in Atrial Fibrillation (ATRIA) Study. JAMA. 2001;285:2370–2375. doi: 10.1001/jama.285.18.2370.
    1. Furberg CD, Psaty BM, Manolio TA, Gardin JM, Smith VE, Rautaharju PM. Prevalence of atrial fibrillation in elderly subjects (the Cardiovascular Health Study) Am J Cardiol. 1994;236:41.
    1. Psaty BM, Manolio TA, Kuller LH, Kronmal RA, Cushman M, Fried LP. et al.Incidence of and risk factors for atrial fibrillation in older adults. Circulation». Circulation. 1997;96:61. doi: 10.1161/01.CIR.96.1.61.
    1. Cea-Calvo L, Redón J, Lozano JV, Fernández-Pérez C, Martí-canales JC, Llisterri JL, González Esteban J, Aznar J. Prevalencia de fibrilación auricular en la población española de 60 o más años de edad. Estudio PREV-ICTUS. Rev Esp Cardiol. 2007;60:616–624. doi: 10.1157/13107118.
    1. Miyasaka Y, Barnes ME, Bailey KR, Cha SS, Gersh BJ, Seward JB, Tsang TS. Mortality trends in patients diagnosed with first atrial fibrillation: a 21-year community-based study. J Am Coll Cardiol. 2007;49:986–992. doi: 10.1016/j.jacc.2006.10.062.
    1. Murphy NF, Simpson CR, Jhund PS, Stewart S, Kirkpatrick M, Chalmers J, MacIntyre K, McMurray JJV. A national survey of the prevalence, incidence, primary care burden and treatment of atrial fibrillation in Scotland. Heart. 2007;93:606–612. doi: 10.1136/hrt.2006.107573.
    1. Heeringa J, Van der Kuip DAM, Hofman A, Kors JA, Van Herpen G, Stricker BHC. et al.Prevalence, incidence and lifetime risk of atrial fibrillation: the Rotterdam study. Eur Heart J. 2006;27:949–953.
    1. Lloyd-Jones DM, Wang TJ, Leip EP, Larson MG, Levy D, Vasan RS. et al.Lifetime Risk for Development of Atrial Fibrillation: the Framingham heart study. Circulation. 2004;110:1042–1046. doi: 10.1161/01.CIR.0000140263.20897.42.
    1. Wolf PA, Dawber TR, Thomas HE Jr, Kannel WB. Epidemiologic assessment of chronic atrial fibrillation and risk of stroke: the Framingham study. Neurology. 1978;28:973–977. doi: 10.1212/WNL.28.10.973.
    1. Stewart S, Hart CL, Hole DJ, McMurray JJ. A population-based study of the long-term risks associated with atrial fibrillation: 20-year follow-up of the Renfrew/Paisley study. Am J Med. 2002;113:359–364. doi: 10.1016/S0002-9343(02)01236-6.
    1. Benjamin EJ, Wolf PA, D'Agostino RB, Silbershatz H, Kannel WB, Levy D. Impact of atrial fibrillation on the risk of death: the Framingham Heart Study. Circulation. 1998;98:946–952. doi: 10.1161/01.CIR.98.10.946.
    1. Wang TJ, Larson MG, Levy D, Vasan RS, Leip EP, Wolf PA. et al.Temporal relations of atrial fibrillation and congestive heart failure and their joint influence on mortality: the Framingham Heart Study. Circulation. 2003;107:2920–2925. doi: 10.1161/01.CIR.0000072767.89944.6E.
    1. Hart RG, Halperin JL. Atrial fibrillation and thromboembolism: a decade of progress in stroke prevention. Ann Intern Med. 1999;131:688–695.
    1. Hamer ME, Blumenthal JA, McCarthy EA, Phillips BG, Pritchett EL. Quality-of-life assessment in patients with paroxysmal atrial fibrillation or paroxysmal supraventricular tachycardia. Am J Cardiol. 1994;74:826–829. doi: 10.1016/0002-9149(94)90448-0.
    1. Friberg J, Buch P, Scharling H, Gadsbphioll N, Jensen GB. Rising rates of hospital admissions for atrial fibrillation. Epidemiology. 2003;14:666–672. doi: 10.1097/01.ede.0000091649.26364.c0.
    1. Samuel Wann L, Curtis AB, Craig T, Ellenbogen KA, Lowe JE, Mark NA. ACCF/AHA/HRS Focused Update on the Management of Patients With Atrial Fibrillation (Updating the 2006 Guideline) A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2011;123:104–123.
    1. Los cardiólogos hacen un llamamiento para fomentar la concienciación y la educación sobre la fibrilación auricular. Sociedad Española de Cardiología. .
    1. Mant J, Fitzmaurice DA, Hobbs FDR, Jowett S, Murray ET, Holder R. et al.Accuracy of diagnosing atrial fibrillation on electrocardiogram by primary care practitioners and interpretative diagnostic software: analysis of data from screening for atrial fibrillation in the elderly (SAFE) trial. BMJ. 2007;335:380. doi: 10.1136/.
    1. Sudlow M, Rodgers H, Kenny RA, Thomson R. Identification of patients with atrial fibrillation in general practice. BMJ. 1999;318:264.
    1. Benjamin EJ, Chen PS, Bild DE, Mascette AM, Albert CM, Alonso A. et al.Prevention of Atrial Fibrillation: Report From a National Heart, Lung, and Blood Institute Workshop. Circulation. 2009;119:606–618. doi: 10.1161/CIRCULATIONAHA.108.825380.
    1. Koenig KL. Screening for AF in Elders: Keep Your Finger on the Pulse. J Watch Emergency Med. 2007. August 30:3-3 [ ]
    1. Van Weert HCPM. Diagnosing atrial fibrillation in general practice. BMJ. 2007;335:355–356. doi: 10.1136/.
    1. Robledo E, González P, Burgos A, García R, Barasoain P, Lorenzo A. Estudio de prevalencia de la fibrilación auricular en la población de 65 años o más. Validez de la toma de pulso radial como cribado de fibrilación auricular. SEMERGEN. 2005;31:303–306.
    1. Fitzmaurice DA, Hobbs FD, Jowett S, Mant J, Murray ET, Holder R. et al.Screening versus routine practice in detection of atrial fibrillation in patients aged 65 or over: cluster randomised controlled trial. BMJ. 2007;335:383. doi: 10.1136/bmj.39280.660567.55.
    1. Wilson JMC, Jungner G. The principles and practices of screening for diseases. Public Health papers34. Geneva, Switzerland: WHO; 1968.
    1. Hobbs FDR, Fitzmaurice DA, Mant J, Murray E, Jowett S, Bryan S. et al.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 people aged 65 and over: the SAFE study. Health Technol Assess. 2005;9:40.
    1. Guías de práctica clínica para el manejo de la fibrilación auricular. Rev Esp Cardiol. 2010;63(1483):e1–e83. .
    1. Programa EPIDAT. Dirección Xeral de Innovación e Xestión da Saúde Pública (Edificio administrativo San Lázaro, s/n. 15703, Santiago de Compostela, Spain) and PAHO-WHO (525 Twenty-third St, NW, Washington, DC 20037)
    1. Viana C. Fibrilación auricular (fecha de la última revisión: 08/03/2012) 2012. .
    1. Second International Clasiffication of Primary Care (ICPC-2-E) .
    1. The Anatomical Therapeutic Classification (AT). European Pharmaceutical Market Research Association (EPhMRA) .
    1. Programa estadístico SPSS Inc. 11th Fl, Chicago, IL 60606L: 233 S Wacker Dr;
    1. Programa estadístico MLwiN. Centre for Multilevel Modelling. Senate House, Tyndall Ave, Bristol BS8 1TH, UK: University of Bristol;

Source: PubMed

Szponzorok és közreműködők

Egészségi állapot

Kábítószer-beavatkozások

3
Iratkozz fel