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What are the clinical benefits and harms associated with the use of individual specialized anticoagulation services, compared with usual care for adult patients receiving long-term warfarin therapy? What are the clinical benefits and harms associated with the use of one type of specialized anticoagulation service compared with another type, for adult patients receiving long-term warfarin therapy?


Atrial fibrillation (AF) is the most common cardiac arrhythmia. Patients with AF have an elevated risk of stroke, which is a leading cause of death and disability among patients with the condition.,


The literature search was performed by an information specialist using a peer-reviewed search strategy.


Specialized anticoagulation services improve TTR compared with UC. Improvement of TTR within the included studies did not necessarily translate into a reduction in hemorrhage, thromboembolism, or need for additional medical care. The evidence available that compares different specialized models of care or service components is limited in both quantity and quality. The effect of PST or PSM on TTR was mixed, with studies showing either improved TTR with PST/PSM (patient self-testing alone or in combination with patient self-management) or no difference between models of care. Effects on clinical outcomes were also mixed, but PST/PSM generally resulted in lower mortality rates and reduced incidence of thromboembolism. PST/PSM did not affect the rate of bleeding events. PST/PSM may improve quality of life and patient satisfaction.


Based on a review of existing systematic reviews and additional primary studies, specialized anticoagulation services improve TTR compared with UC. However, depending on the study design, this improvement in TTR may not translate into a reduction in hemorrhage, thromboembolism, or in need for additional medical care.


CERC consists of eight Core Members appointed to serve for all topics under consideration during their term of office, and three or more Specialist Experts appointed to provide their expertise in recommending optimal use for one or more specific topics. For this project, five Specialist Experts were appointed; their expertise included cardiology, hematology, and thrombosis. Two of the Core Members are Public Members, who bring a lay perspective to the committee. The remaining six Core Members hold qualifications as physicians, pharmacists, or health economists, or have other relevant qualifications, with expertise in one or more areas such as, but not limited to, family practice, internal medicine, institutional or community clinical pharmacy, pharmacoeconomics, clinical epidemiology, drug utilization, methodology, affecting behaviour change (through health professional and/or patient and/or policy interventions), and critical appraisal. The Core Members, including Public Members, are appointed by the CADTH Board of Directors.


Results from systematic reviews indicate that specialized anticoagulation clinics result in higher TTR compared with UC, but do not tend to result in significant differences in bleeding events, thromboembolism, or mortality. Two included reviews reported results from RCTs separately from non-randomized studies., One of these found a reduction in thromboembolic events and major bleeds with specialized clinic care in non-RCTs, but no difference among randomized controlled trials. This dichotomy may reflect a difference in care in RCT conditions compared with non-randomized trials, which may better reflect actual practice. The two systematic reviews, reporting clinical outcomes were based on a comprehensive literature search and were generally well conducted, although neither provided a list of included and excluded studies, and one did not attempt to assess the risk of publication bias. Results from the systematic reviews are supported by findings from five additional studies.– Four of these– found improvements in TTR with specialized anticoagulation care compared with UC (one found no difference and one did not report this outcome). Four non-randomized studies, – found an increase in ER visits or need for additional medical attention with UC, while one RCT reported no significant difference in adverse event rates between nurse-led POC testing and dose management and traditional hospital clinic care. Of the five primary studies reporting clinical outcomes, – (including ER or hospital visits), only one took into account loss of patients to follow-up and provided a power calculation. None of these three studies were blinded and one randomized patients to their treatment groups, but did not report the method of randomization. While the additional primary studies are insufficient to identify a trend, their findings reflect the difference between RCTs and non-randomized studies described in the systematic reviews. Clinical practice guidelines produced by the ACCP in 2008 recommend a systematic and coordinated approach to anticoagulation therapy, using specialized anticoagulation management services as an example. This recommendation was based on a comprehensive literature review that showed a similar discrepancy between RCT and observational studies.


The electronic literature search and updates yielded 643 citations. After titles and abstracts were screened, 578 citations were excluded and 65 potentially relevant articles were retrieved for full-text review. An additional 10 potentially relevant reports were identified through grey literature and handsearching. Of the 75 potentially relevant reports, 48 did not meet the inclusion criteria. Twenty-seven publications were included in this review. The study selection process is presented in a PRISMA flowchart (Appendix 2).

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