A systematic review of patient‐reported outcomes associated with the use of direct‐acting oral anticoagulants

Abstract

Patient-reported outcomes (PROs) are a distinctive method of evaluating patient response to health care or treatment. This systematic review aimed to analyse the impact of PROs in patients on direct oral anticoagulant (DOAC) treatment, prescribed for any indication (e.g. venous thromboembolism treatment or atrial fibrillation) using controlled trials (CT) and real-world observational studies (OS).Methods: A systematic search of articles was conducted according to PRISMA guidelines using databases, with the last update in November 2018. The Cochrane Collaboration tool for assessing bias in randomized CTs and the Newcastle-Ottawa Scale adapted for cross-sectional studies were used. Outcomes evaluated were related to health-related quality of life (HRQoL), satisfaction, adherence and compliance.Results: Twenty-one original studies (6 CT, 15 OS) were included. HRQoL was assessed by 6 (1 CT, 5 OS) studies and reported that HRQoL scores were similar in patients on DOACs and warfarin. Patients prescribed DOACs presented higher HRQoL scores which were attributed to lack of intense monitoring required compared with warfarin but this was not statistically significant. The majority of studies (5 CT, 9 OS) investigated patient-reported satisfaction, indicating greater satisfaction with DOACs with significantly lower burden and increased benefit scores for patients on DOACs. Patient-reported expectations, compliance and adherence were similar for patients on DOACs and warfarin. Conclusion:Patients appear to prefer treatment with DOACs vs warfarin. This is shown by the higher quality of life, satisfaction and adherence described in the studies. However, heterogeneity in the analysed studies does not allow firm conclusions.

World Café approach: exploring the future vision of oral anticoagulants for patients with atrial fibrillation (AF) in Ireland

“…This study explores some key challenges facing patients with AF and the healthcare professionals prescribing and managing their treatment, which were largely consistent with those identified previously. 6 25 36 However, multistakeholder focus groups offer depth by providing multiple individual perspectives by giving them a voice. While anticoagulation therapy for patients with AF using NOACs is widely adopted and is diffusing into routine practice significant operationalisation issues and barriers to effective treatment/management persist.…”

“…In the case of Ireland, a survey of general practitioners (GP) identified lack of integration between primary and secondary care and knowledge gaps among prescribers with regard to prescribing decision-making and managing patients with AF prescribed NOACs (in the absence of INR monitoring requirements). [20][21][22] While there is an abundance of evidence from systematic trials and meta-analysis on the efficacy and effectiveness of safety of oral anticoagulation therapy in the management of AF, there is limited qualitative evidence capturing both the clinicians 25 and patients' views 6 simultaneously. Generating qualitative evidence provides the opportunity to add depth and ensuring focus on patient-level care.…”

“…However, with the emergence of the new oral anticoagulants (NOACs) (also referred to as direct oral anticoagulants) additional choices are now available. These NOACs have revolutionised the treatment of AF [3][4][5][6] and are expected to reduce underprescribing and high discontinuation rates traditionally associated with oral anticoagulation therapy. 7 8 While NOACs have been on the market for some years, their adoption has been slower in some jurisdictions like Ireland; where warfarin was until recently the 'preferred drug' recommended by the national Medicines Management Programme.…”

“…While there is an abundance of evidence from systematic trials and meta-analysis on the efficacy and effectiveness of safety of oral anticoagulation therapy in the management of AF, there is limited qualitative evidence capturing both the clinicians 25 and patients’ views 6 simultaneously. Generating qualitative evidence provides the opportunity to add depth and ensuring focus on patient-level care.…”

Anticoagulation Therapy for Non-valvular Atrial Fibrillation: A Mini-Review

“…There is substantial clinical experience with use of DOACs, and patient-reported outcomes have been summarized in a systematic review ( 28 ). In addition, clinical trials have found that the newer oral anticoagulants can reduce the stroke rate by 19% compared with warfarin ( 11 , 29 ).…”