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

Abstract

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)

Screening strategies for atrial fibrillation: a systematic review and cost-effectiveness analysis

“…Two RCTs involved only individuals without a previous diagnosis of AF. 81,83 Three RCTs each evaluated systematic population screening 19,40,82 and systematic opportunistic screening, 19,79,82 one RCT evaluated systematic targeted screening directly, 83 and one RCT evaluated systematic targeted screening indirectly by using results from those individuals identified at 'high risk' among those randomised to systematic population screening. 19 Screening tests employed across the RCTs were mainly pulse palpation and ECG with AF diagnosis predominantly by ECG.…”

“…40 Four studies 19,26,81,82 were multicentre RCTs and one was a single-centre RCT. 83 Four RCTs involved individuals aged ≥ 65 years 19,[81][82][83] and one RCT involved individuals aged 75 and 76 years. 40 All five RCTs involved both sexes.…”

“…All of the RCTs were conducted in Europe, with two each conducted in the UK 19,82 and Spain 81,83 and one conducted in Sweden. 40 Four studies 19,26,81,82 were multicentre RCTs and one was a single-centre RCT.…”

“…All of the RCTs were conducted in Europe, with two each conducted in the UK 19,82 and Spain 81,83 and one conducted in Sweden. 40 Four studies 19,26,81,82 were multicentre RCTs and one was a single-centre RCT. 83 Four RCTs involved individuals aged ≥ 65 years 19,[81][82][83] and one RCT involved individuals aged 75 and 76 years.…”

“…After removing duplicates, 2204 records remained. Sifting of these records revealed six eligible articles 26,40,[81][82][83] representing four RCTs, all involving two study arms. These four RCTs, together with the previously identified RCT from the original Cochrane review involving three study arms (with two reference articles), 19,84 were included in this review.…”