Feasibility Study Protocol: Investigating The Impact of Bleed Events On Anticoagulated Patients Diagnosed With Atrial Fibrillation Using Patient Reported Outcome Measures

Abstract BackgroundAtrial fibrillation (AF) is the most common cardiac arrhythmia. Oral anticoagulation therapies (OATs) are often prescribed in conjunction with medications to restore normal heart rate rhythm which can limit the risk of an AF-related stroke and systemic thromboembolism. However, they are associated with the serious side effect of bleeding. Both clinically relevant non-major bleeding (CRNMB) and major bleeding while anticoagulated are believed to have a significant impact on patient quality of life (QoL). There is currently limited research into the effect bleeding has on QoL. The aim of this study is to evaluate the feasibility of identifying and recruiting patients diagnosed with AF, who are taking OATs and have recently experienced a bleed and collecting information on their QoL.MethodsWe will recruit a minimum of 50 patients to this cross sectional, observational study. We will recruit from general practices, secondary care and through an online AF forum. We will ask participants to complete three validated patient-reported outcome measures (PROMs: EQ5D, AFEQT and PACT-Q), approximately four weeks following a bleed and again 3 months later. We will randomly select a subset of 10 participants (of those who agree to be interviewed) to undergo a structured interview with a member of the research team to explore the impact of bleeding on their QoL and to gain feedback on the three PROMs used. We will undertake a descriptive analysis of the PROMs and demographic data. We will analyse the qualitative interviews thematically to identify key themes. DiscussionWe aim to establish if it is possible to recruit patients and use PROMs to collect information regarding how patient QoL is affected when they experience either a CRNMB or major bleed, while taking OATs for the management of AF. We will also explore the appropriateness or otherwise of the three identified PROMs for assessing quality of life following a bleed. Trial registrationThe trial has been adopted onto the NIHR Portfolio (I.D. #47771) and registered with www.ClinicalTrials.gov (#NCT04921176) retrospectively registered in June 2021.