Off-label direct oral anticoagulants dosing in atrial fibrillation and venous thromboembolism is associated with higher mortality

Anticoagulation therapy is standard for conditions like atrial fibrillation, venous thromboembolism, and valvular heart disease, yet it is unclear if there are ethnoracial disparities in its quality and delivery in the United States. For this scoping review, electronic databases were searched for publications between January 1, 2011 – March 30, 2022. Eligible studies included all study designs, any setting within the United States, patients prescribed anticoagulation for any indication, outcomes reported for ≥ 2 distinct ethnoracial groups. The following four research questions were explored: Do ethnoracial differences exist in 1) access to guideline-based anticoagulation therapy, 2) quality of anticoagulation therapy management, 3) clinical outcomes related to anticoagulation care, 4) humanistic/educational outcomes related to anticoagulation therapy. A total of 5374 studies were screened, 570 studies received full-text review, and 96 studies were analyzed. The largest mapped focus was patients’ access to guideline-based anticoagulation therapy (88/96 articles, 91.7%). Seventy-eight articles made statistical outcomes comparisons among ethnoracial groups. Across all four research questions, 79 articles demonstrated favorable outcomes for White patients compared to non-White patients, 38 articles showed no difference between White and non-White groups, and 8 favored non-White groups (the total exceeds the 78 articles with statistical outcomes as many articles reported multiple outcomes). Disparities disadvantaging non-White patients were most pronounced in access to guideline-based anticoagulation therapy (43/66 articles analyzed) and quality of anticoagulation management (19/21 articles analyzed). Although treatment guidelines do not differentiate anticoagulant therapy by ethnoracial group, this scoping review found consistently favorable outcomes for White patients over non-White patients in the domains of access to anticoagulation therapy for guideline-based indications and quality of anticoagulation therapy management. No differences among groups were noted in clinical outcomes, and very few studies assessed humanistic or educational outcomes. Graphical Abstract Scoping Review: Differences in quality of United States anticoagulation care delivery by ethnoracial group. AF = atrial fibrillation; AMS = anticoagulation management service; DOACs = direct oral anticoagulants; INR = international normalized ratio; PSM = patient self-management; PST = patient self-testing

Section: Research Question 2: Do Ethnoracial Differences Exist In The...mentioning

confidence: 99%

Section: Research Question 3: Do Ethnoracial Differences Exist In The...mentioning

confidence: 99%

Differences in quality of anticoagulation care delivery according to ethnoracial group in the United States: A scoping review

Vazquez,

Yates,

Beavers

et al. 2024

“…This risk can be magnified in situations of inappropriate prescribing, drug-drug interactions, misuse by patients, and poorly managed care transitions [ 7 ]. Likewise, under-prescribing, prescribing inconsistent with FDA-approved labeling, and suboptimal patient adherence may contribute to avoidable thrombotic events, such as stroke [ 8 , 9 ]. In fact, anticoagulants are the leading cause of adverse drug events in the emergency room [ 10 ].…”

Section: Background and Significancementioning

confidence: 99%

Digital dashboards for oral anticoagulation management: a literature scoping review

Wilson,

Triller,

Allen

et al. 2023

This scoping review summarizes the extent and characteristics of the published literature describing digital population management dashboards implemented to improve the quality of anticoagulant management. A standardized search protocol was executed to identify relevant manuscripts published between January 1, 2015 and May 31, 2022. The resulting records were systematically evaluated by multiple blinded reviewers and the findings from selected papers were evaluated and summarized. Twelve manuscripts were identified, originating from 5 organizations within the US and 2 from other countries. The majority (75%) described implementation in the outpatient setting. The identified papers described a variety of positive results of dashboard use, including a 24.5% reduction of questionable direct oral anticoagulant dosing in one organization, a 33.3% relative improvement in no-show appointments in an ambulatory care clinic, and a 75% improvement in intervention efficiency. One medical center achieved a 98.4% risk-appropriate venous thromboembolism risk prophylaxis prescribing rate and 40.6% reduction in anticoagulation-related adverse event rates. The manuscripts primarily described retrospective findings from single-center dashboard implementation experiences. Digital dashboards have been successfully implemented to support the anticoagulation of acute and ambulatory patients and available manuscripts suggest a positive impact on care-related processes and relevant patient outcomes. Prospective studies are needed to better characterize the implementation and impact of dashboards for anticoagulation management. Published reports suggest that digital dashboards may improve the quality, safety, and efficiency of anticoagulation management. Additional research is needed to validate these findings and to understand how best to implement these tools.

“…Modifiable factors such as inappropriate prescribing, drug-drug interactions, misuse by patients, and poorly managed care transitions can contribute to serious and life-threatening bleeding events that may be preventable through improved management processes [ 3 ]. Likewise, under-prescribing, “off-label” dosing, and suboptimal patient adherence may contribute to avoidable thrombotic events, such as stroke [ 4 , 5 ].…”

Section: Introductionmentioning

confidence: 99%

Digital dashboards for direct oral anticoagulant surveillance, intervention and operational efficiency: uptake, obstacles, and opportunities

Triller,

Wilson,

Allen

et al. 2023

Direct oral anticoagulants (DOAC) are the most widely prescribed oral anticoagulants in the United States. Despite advantages over warfarin, system-level improvements are needed to optimize outcomes. While Veterans Health Administration and others have described successful DOAC management dashboard implementation, the extent of use nationally is unknown. A survey of Anticoagulation Forum’s members was conducted to assess access to digital tools available within a dashboard and to describe implementation models. An Expert Forum was subsequently convened to identify barriers to dashboard development and adoption. Responses were received from 340 targeted recipients (8.5% of invitees). Only a minority of inpatient (25/52, 48.1%) and outpatient (47/133, 35.3%) respondents outside of Veterans Health Administration were able to generate rosters of DOAC users on-demand, and fewer had the ability to digitally display key clinical data elements, identify drug-related problems, document interventions, or generate reports. The lack of regulatory requirements regarding Anticoagulation Stewardship was identified by the Expert Forum as the major barrier to widespread development of digital tools for improved anticoagulation management. While some health systems have demonstrated the feasibility of DOAC dashboards and described their impact on quality and efficiency, these tools do not appear to be widely available in the United States apart from Veterans Health Administration. The lack of regulatory requirements for Anticoagulation Stewardship may be the primary barrier to the development of digital resources to better manage anticoagulants. Efforts to secure regulatory requirements for Anticoagulation Stewardship are needed, and evidence of improvements in clinical and financial outcomes through DOAC dashboard use will likely bolster such efforts.