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Table 4 Stakeholder experiences review characteristics and themes

From: Oral anticoagulants: a systematic overview of reviews on efficacy and safety, genotyping, self-monitoring, and stakeholder experiences

Review authors (year), and topic focus

Methods and study details

Themes

Afzal et al. (2019); [50] patient-reported outcomes of DOAC vs warfarin

Search: November 2018

Included: 21 studies, AF and VTE, participants NR

Published: 2013 to 2018

Quality tool: Cochrane and NOS

Patients: Equivalent health-related quality of life. Greater satisfaction with DOACs. Expectations, compliance and adherence were equivalent between DOACs and warfarin

Alamneh et al. (2016); [68] practices of anticoagulation in AF, uptake, impact, and persisting challenges

Search: NR

Included: 140 observational studies, reviews, RCTs, experimental studies and guidelines; participants NR

Published: 1991 to 2015

Quality tool: NR

Patients: 

The lack of a specific reversal agent was a major concern (also for practitioners). Other major concerns were medication adherence and continuation of medication use, higher costs, and the lack of data for some groups of patients. A lesser concern was difficulty in remembering to take direct OACs without the requirement for regular monitoring

Practitioners: 

The uptake of direct OACs has been variable, with slow integration into clinical practice in most countries and limited impact on prescribing

Buck et al. (2021); [51] reasons for discontinuing DOAC or warfarin

Search: 2019

Included: 12 studies, AF, participants NR

Published: 2014 to 2019

Quality tool: Gough’s weight of evidence

Medical records: Reasons for discontinuation – bleeding, gastrointestinal events, frailty and risk of fall

Clarkesmith et al. (2017); [44] educational and behavioural interventions

Search: update of 2013 review; February 2016

Included: 11 RCTs on AF; 2246 participants

Published: 1999 to 2014

Quality tool: Cochrane and GRADE

Patients: 

Small positive effects of education on anxiety (MD − 0.62, 95% CI − 1.21 to − 0.04; HADS score) and depression (MD − 0.74, 95% CI − 1.34 to − 0.14), compared with usual care, over 12 months. Decision aids had no significant impact on AF patients’ anxiety levels or satisfaction. One study found a decline in both anxiety and depression at 6-month follow-up. Patients may feel more anxious and depressed in the first few months after diagnosis

Entezari-Maleki et al. (2016); [45] pharmacist-managed warfarin therapy

Search: January 2014

Included: 24a RCTs and non-RCTs on AF and VTE; 11,607 participants

Published: 1995 to 2013

Quality tool: Downs and Black, and Jadad

Patients: 

All patients in the pharmacist management group and 55% of the usual care group preferred pharmacist management. Patients believed that pharmacists were more expert in OAC control than their physicians. One study reported that health-related quality of life was similar between pharmacist and usual care

Generalova et al. (2018); [76] views and experiences of DOAC vs warfarin

Search: July 2017

Included: 10 studies, 1246 participants, NVAF

Published: 2013 to 2016

Quality tool: STROBE and COREQ

Clinicians: DOAC perceived to be equally, or more, effective and safer than warfarin, particularly better for those who might miss appointments, but concerns about reversal and bleeding

Jang (2021) [55]; education on warfarin

Search: May 2020

Included: 12 studies, participants NR, AF or other condition

Published: 2014 to 2020

Quality tool: Downs and Black

Patients: Education improves knowledge, adherence, satisfaction and clinical outcomes and a positive effect on continuing health care

Katerenchuk et al.b(2021) [74]; satisfaction with DOAC vs VKAs

Search: September 2019

Included: 20 studies, 18,684 participants, AF or VTE

Published: 2013 to 2019

Quality tool: Cochrane, NOS and GRADE

Patients: Improvements in satisfaction score on switching to DOACs. Higher satisfaction on DOACs vs VKA. Mainly due to lower treatment burden with DOACs

Loewen et al. (2017); [69] values and preferences for treatment, and patient-specific factors that affect them

Search: September 2016

Included: 25 discrete-choice experiments; 641 participants

Published: 1996 to 2016

Quality tool: CONSORT, STROBE, COREQ, ISPOR

Patients: 

Stroke prevention was highly valued. After efficacy and safety, one versus two daily doses, antidote availability, absence of dietary restrictions and drug-drug interactions were moderately important, but this varied by study. Treatment choices were unpredictable. Cultural or family attitudes, beliefs, and personal experiences could affect OAC choice. As preferences varied, values and preferences should be discussed with patients

Mas Dalmau et al. (2017); [70] perceptions and attitudes to vitamin K antagonists, and factors related to underuse

Search: May 2013

Included: nine qualitative or mixed-methods studies; 250 patients and 91 physicians

Published: 1999 to 2012

Quality tool: CASP

Patients: 

Lack of information and understanding of OACs was patients’ main concern. The choice of OAC was determined by the individual’s experiences and values, as well as the downsides of treatment. The impact of treatment on daily life was important to patients

Practitioner: 

Physicians regarded the lack of a specific recommended OAC for each type of patient, the need for individual decision-making, and the delegated responsibility in decision-making as the main difficulties in using OACs. Some of the guidelines were ambiguous, and the included populations did not usually represent most patients (i.e., the very elderly). It was considered crucial to improve the quality of the information provided to patients because this was the main dissatisfaction with therapy

Pandya et al. (2017); [71] factors underpinning non-adherence

Search: NR

Included: 47 surveys, interviews, or discrete-choice experiments on AF; 4151 participants

Published: 1991 to 2014

Quality tool: NR

Patients: 

The main reason for non-adherence was a lack of understanding about AF and stroke, and the importance of taking OACs. Reluctance to take warfarin was due to factors negatively affecting daily life (such as regular monitoring, dose adjustments, and diet). Some patients found it harder to accept, manage and adhere to direct OACs due to the absence of regular monitoring, limited access to antidotes, high costs of the medications, twice-daily dosing (dabigatran and apixaban) and timing of doses with respect to meals (dabigatran and rivaroxaban). Forgetfulness, attitudes toward stroke and bleeding risk, condition-related factors, social and economic factors, and healthcare system-related factors could affect adherence to direct OACs in a similar way to warfarin

Salmasi et al. (2019); [75] knowledge gaps on condition and treatment

Search: May 2018

Included: 21 studies, participants NR, AF

Published: 2002 to 2018

Quality tool: STROBE and COREQ

Patients: Knowledge gaps on AF, stroke, medications, medical terms, and actions on missing a dose

Wilke et al. (2017); [72] preferences for OAC treatment

Search: 1980 to 2015

Included: 27 quantitative preference studies on AF; 7295 patients and 266 physicians

Published: 1996 to 2016

Quality tool: unnamed

Patients: 

AF patient preferences for OACs were inconsistent, except that some patients who did not mind a risk of bleeding chose the same OAC, while those who were more averse to bleeding preferred other OACs. Patients valued clinical attributes, such as bleeding risk, over convenience. Where OACs were similar in efficacy and safety, convenience, such as mode of application and availability of an antidote, affected choice

Willett and Morrill (2017) [73]; dosing for direct OACs, use in renal-impaired patients, and adherence, satisfaction and cost

Search: week 1, 2016 (MEDLINE) and week 2, 2017 (Embase)

Included: 10 systematic reviews, trials or surveys on AF or VTE (nine cited); participants NR

Published: 2001 to 2016

Quality tool: NR

Patients: 

Most studies focussed on patients’ willingness to switch from warfarin to dabigatran or their satisfaction with dabigatran. Frequency of blood tests, along with dosing frequency and drug–food interactions, was less important than efficacy and safety. Cost was important; direct OACs became more attractive as their cost decreased. Adherence studies suggested that direct OACs that were taken daily were preferred over those taken twice daily

Zhou et al. (2016); [49] Pharmacist-managed anticoagulation control of warfarin

Search: July 2015

Included: eight RCTs; 1493 participants

Published: 2003 to 2013

Quality tool: Cochrane and GRADE

Patients: 

High satisfaction (MD 0.41, 95% CI 0.01 to 0.81) with pharmacist management was attributed to improved patient quality of life (e.g., self-efficacy, daily hassles, and distress), pharmacist service, interpersonal manner, communication, time spent, and accessibility. Pharmacists focussed on clinical counselling, patient education, home-visit monitoring, anticoagulation clinics, standardised follow-up, and comprehensive pharmaceutical care

  1. RCT randomised controlled trial, AF atrial fibrillation, OAC oral anticoagulant, NR not reported, NVAF non-valvular atrial fibrillation, GRADE Grading of Recommendations Assessment, Development and Evaluation, MD mean difference, CI confidence interval, CONSORT Consolidated Standards of Reporting Trials, STROBE STrengthening the Reporting of OBservational studies in Epidemiology, COREQ consolidated criteria for reporting qualitative research, ISPOR International Society for Pharmacoeconomics and Outcomes Research, CASP Critical Appraisal Skills Programme, VTE venous thromboembolism, OR odds ratio, DOAC direct oral anticoagulant, VKA vitamin K antagonist
  2. aOnly six of these 24 studies (11,607 participants) were relevant to this part of the review
  3. bNo access to full text, but sufficient information in the abstract to include