Medicine Related Problems in Adult Patients with AF on DOACs
Research type
Research Study
Full title
Medicine Related Problems in Adult Patients with Atrial Fibrillation on Direct Oral Anticoagulants (DOACs).
IRAS ID
190774
Contact name
Huda Alewairdhi
Contact email
Sponsor organisation
University of Hertfordshire
Duration of Study in the UK
1 years, 10 months, 1 days
Research summary
Atrial fibrillation (AF) is the most common type of cardiac arrhythmia, affecting approximately 1.5–2% of the population worldwide (Camm et al. 2012). The presence of AF is associated with a five times higher risk of stroke, three times higher risk of heart failure and increased mortality (Camm et al. 2012). Anticoagulation therapy in patients with AF is recommended to prevent stroke and systemic embolism. Warfarin has been the only oral anticoagulant available for the past few decades; however, warfarin has a narrow therapeutic index that warrants constant monitoring, and it also has a number of notable drug-drug and drug-food interactions. Recently, direct oral anticoagulants (DOACs) have offered an additional option with some practical advantages such as no need for regular blood monitoring and with fewer interactions in contrast to warfarin. However, DOACs lacks a clinically approved agent to reverse bleeding (antidote).
A similar efficacy and safety profile of DOACs has been reported in clinical trials compared to warfarin (Sardar et al. 2015). However, the comparative effectiveness and safety of DOACs relative to warfarin remains elusive, particularly in real-world clinical practice. Furthermore, the incidence of adverse events reported to the Food Drug Administration (FDA) have also been higher for dabigatran compared with warfarin. In addition, the Medicines and Healthcare products Regulatory Agency (MHRA) report that the prescriber should be aware of DOACs risk of bleeding.
Therefore, this study will determine the prevalence of medication related problems (MRPs) as well as barriers and/or facilitators in using DOACs among adult patients with AF, using DOACs in clinical practice setting. A mixed method approach will be used, involving a retrospective review of patients’ medical records and a semi-structured interview with healthcare professionals and patients to explore their perception of safety associated with the use of DOACs. Quantitative data extracted from the medical records review will be analysed using a statistical package for the social sciences (SPSS version 22) with appropriate statistical analysis. NVivo software will be used to analyse the qualitative data to identify specific themes. The findings/results from this research will determine the prevalence of MRPs associated with DOACs therapy along with the identification of barriers and facilitators of their use in adult patients with AF.
REC name
London - Central Research Ethics Committee
REC reference
16/LO/1178
Date of REC Opinion
1 Aug 2016
REC opinion
Favourable Opinion