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1.  The association between chronic care management and the quality of thrombosis care 
Introduction
The oral anticoagulant therapy (OAT), used to prevent thrombosis, is associated with substantial avoidable hospitalization.
Aim
Identify the associations between chronic care management and the quality of OAT as suggested by the chronic care model (CCM) of Wagner.
Methods
Regression analysis with data of 61 thrombosis clinics and inductive analysis with 63 interviews with health care professionals of 23 thrombosis clinics.
Results
Results show substantial differences between regions in the quality of thrombosis care and the CCM activities. However, the variation in quality of care was not associated with the differences in CCM activities. The inductive analysis indicates that there are problems in the cooperation between caregivers. Several preferred CCM activities (e.g., multidisciplinary protocol) as well as the barriers to implement these activities (e.g., conflicting interests) were put forward by the health care professionals.
Conclusion
It can be concluded that there is variation in quality of thrombosis care between regions. This variation could not be explained by the observed differences in CCM activities. However, fragmentation is a major source of inefficiency according to health care professionals. The paper concludes with suggestions to improve chronic care management for thrombosis.
PMCID: PMC3031809
quality of care; thrombosis; chronic care management; disease management; effectiveness
2.  Needs and barriers to improve the collaboration in oral anticoagulant therapy: a qualitative study 
Background
Oral anticoagulant therapy (OAT) involves many health care disciplines. Even though collaboration between care professionals is assumed to improve the quality of OAT, very little research has been done into the practice of OAT management to arrange and manage the collaboration. This study aims to identify the problems in collaboration experienced by the care professionals involved, the solutions they proposed to improve collaboration, and the barriers they encountered to the implementation of these solutions.
Methods
In the Netherlands, intensive follow-up of OAT is provided by specialized anticoagulant clinics (ACs). Sixty-eight semi-structured face-to-face interviews were conducted with 103 professionals working at an AC. These semi-structured interviews were transcribed verbatim and analysed inductively. Wagner's chronic care model (CCM) and Cabana's framework for improvement were used to categorize the results.
Results
AC professionals experienced three main bottlenecks in collaboration: lack of knowledge (mostly of other professionals), lack of consensus on OAT, and limited information exchange between professionals. They mentioned several solutions to improve collaboration, especially solutions of CCM's decision support component (i.e. education, regular meetings, and agreements and protocols). Education is considered a prerequisite for the successful implementation of other proposed solutions such as developing a multidisciplinary protocol and changing the allocation of tasks. The potential of the health care organization to improve collaboration seemed to be underestimated by professionals. They experienced several barriers to the successful implementation of the proposed solutions. Most important barriers were the lack motivation of non-AC professionals and lack of time to establish collaboration.
Conclusions
This study revealed that the collaboration in OAT is limited by a lack of knowledge, a lack of consensus, and a limited information exchange. Education was identified as the best way to improve collaboration and considered a prerequisite for a successful implementation of other proposed solutions. Hence, the implementation sequence is of importance in order to improve the collaboration successfully. First step is to establish alignment regarding collaboration with all involved professionals to encounter the lack of motivation of non-AC professionals and lack of time.
doi:10.1186/1471-2261-11-76
PMCID: PMC3268100  PMID: 22192088
3.  Care Transitions in Anticoagulation Management for Patients With Atrial Fibrillation: An Emphasis on Safety 
The Ochsner Journal  2013;13(3):419-427.
Background
Thromboprophylaxis with oral anticoagulants is an important but underused element of atrial fibrillation (AF) treatment. Reduction of stroke risk by anticoagulants comes at the price of bleeding risk. Patients with AF receiving anticoagulants require heightened attention with transition from one care setting to another.
Methods
This review of the literature focuses on issues specific to the anticoagulation treatment of patients with AF.
Results
Patients presenting for emergency care of anticoagulant-related bleeding should be triaged for the severity and source of the bleeding using appropriate measures, such as discontinuing the oral anticoagulant, administering vitamin K when appropriate to reverse warfarin-induced bleeding, or administering clotting factors for emergent bleeding. Reversal of oral anticoagulants in patients admitted to the hospital for surgery can be managed similarly to patients with bleeding, depending on the urgency of the surgical procedure. Patients with AF who are admitted for conditions unrelated to AF should be assessed for adequacy of stroke risk prophylaxis and bleeding risk. Newly diagnosed AF should be treated in nearly all patients with either warfarin or a newer anticoagulant.
Conclusions
Patient education is critically important with all anticoagulants. Close adherence to the prescribed regimen, regular international normalized ratio testing for warfarin, and understanding the stroke risk conferred by AF and aging are goals for all patients receiving oral anticoagulants. Detailed handoff from the hospitalist to the patient's primary care physician is required for good continuity of care. Monitoring by an anticoagulation clinic is the best arrangement for most patients. The elderly, particularly frail or debilitated patients who are transferring to long-term care, need a detailed transfer of information between settings, education for the patient and family, and medication reconciliation. Communication and coordination of care among outpatient, emergency, inpatient, subacute, and long-term care settings are vital in patients with AF who are receiving anticoagulants to balance stroke prevention and bleeding risk.
PMCID: PMC3776521  PMID: 24052775
Anticoagulant drugs; atrial fibrillation; hemorrhage; stroke
4.  Comparing the quality of oral anticoagulant management by anticoagulation clinics and by family physicians: a randomized controlled trial 
Background
There is growing evidence that better outcomes are achieved when anticoagulation is managed by anticoagulation clinics rather than by family physicians. We carried out a randomized controlled trial to evaluate these 2 models of anticoagulant care.
Methods
We randomly allocated patients who were expected to require warfarin sodium for 3 months either to anticoagulation clinics located in 3 Canadian tertiary hospitals or to their family physician practices. We evaluated the quality of oral anticoagulant management by comparing the proportion of time that the international normalized ratio (INR) of patients receiving warfarin sodium was within the target therapeutic range ± 0.2 INR units (expanded therapeutic range) while they were managed in anticoagulation clinics as opposed to family physicians' care over 3 months. We measured the rates of thromboembolic and major hemorrhagic events and patient satisfaction in the 2 groups.
Results
Of the 221 patients enrolled, 112 were randomly assigned to anticoagulation clinics and 109 to family physicians. The INR values of patients who were managed by anticoagulation clinics were within the expanded therapeutic range 82% of the time versus 76% of the time for those managed by family physicians (p = 0.034). High-risk INR values (defined as being < 1.5 or > 5.0) were more commonly observed in patients managed by family physicians (40%) than in patients managed by anticoagulation clinics (30%, p = 0.005). More INR measurements were performed by family physicians than by anticoagulation clinics (13 v. 11, p = 0.001). Major bleeding events (2 [2%] v. 1 [1%]), thromboembolic events (1 [1%] v. 2 [2%]) and deaths (5 [4%] v. 6 [6%]) occurred at a similar frequency in the anticoagulation clinic and family physician groups respectively. Of the 170 (77%) patients who completed the patient satisfaction questionnaire, more were satisfied when their anticoagulant management was managed through anticoagulation clinics than by their family physicians (p = 0.001).
Interpretation
Anticoagulation clinics provided better oral anticoagulant management than family physicians, but the differences were relatively modest.
PMCID: PMC180652  PMID: 12925422
5.  Self-monitoring of oral anticoagulation: does it work outside trial conditions? 
Journal of Clinical Pathology  2009;62(2):168-171.
Background:
Patient self-monitoring (PSM) of oral anticoagulation therapy (OAT) can improve anticoagulant control, but poor uptake and high dropout rates have prompted suggestions that PSM is suitable for only a minority of patients in the UK.
Aims:
To determine whether PSM could be a viable alternative to regular hospital anticoagulant clinic attendance, if offered from the start of treatment.
Methods:
318 consecutive patients referred, for the first time, to an anticoagulation clinic were assessed for eligibility using established criteria. Patients electing for PSM attended training and, following successful assessment, performed a capillary blood INR every two weeks or more frequently if directed to do so by the anticoagulation clinic. Primary outcome measures were uptake of PSM and the percentage time in target therapeutic INR range (TIR) compared to patients electing for routine clinic care.
Results:
Of 318 patients referred for OAT, 188 were eligible for PSM. 84 (26%) elected to self-monitor, of whom 72 (23%) remained self-monitoring or had completed their course of treatment at the end of the audit. Self-monitoring patients had significantly better anticoagulant control than those receiving routine hospital anticoagulation clinic care (TIR 71% vs 60%, p = 0.003) and significantly less time outside critical limits, ie, INR <1.5 or >5.0 (0.45% vs 2.04%, p = 0.008).
Conclusions:
Patients offered PSM from the start of treatment show increased uptake compared to previous UK studies and a level of oral anticoagulation control comparable to that reported in previous clinical trials.
doi:10.1136/jcp.2008.059634
PMCID: PMC2629005  PMID: 19181634
6.  Implementation of Pharmacist-Managed Anticoagulation Clinic in a Saudi Arabian Health Center 
Hospital Pharmacy  2014;49(3):260-268.
Abstract
Background:
During the past 2 decades, a paradigm shift in the management of oral anticoagulation therapy has occurred. A multidisciplinary approach has been used and has proved beneficial from both a cost and quality perspective. However, this approach to anticoagulation therapy is not well established in Saudi Arabia and the Middle East, and the traditional way of managing anticoagulation patients is still the mainstay of care. The Pharmacy Services Division (PSD) in collaboration with physician, nursing, and medical support enterprises at the Dhahran Health Center established the pharmacy-managed anticoagulation clinic (ACC).
Objective:
To describe the implementation process of the first pharmacist-managed anticoagulation clinic in the eastern province of Saudi Arabia and its impact on patient care.
Methods:
The PSD in collaboration with medical staff successfully created a care delivery model utilizing clinical pharmacists’ expertise to provide comprehensive anticoagulation management services at Saudi Aramco Medical Services Organization (SAMSO). Planning included analyzing existing practices, reviewing the relevant literature, obtaining physician input, formulating a business proposal, and developing clinical protocols and guidelines. Collaborative relationships were established with the center laboratory, scheduling services, and nursing and medical departments. Clinic services include patient assessment, anticoagulation monitoring, warfarin dosage adjustment, medication dispensing at the clinic, patient education, and feedback to referring physicians. Data (2 years before and after clinic inception) for all patients enrolled at the anticoagulation clinic were reviewed to evaluate the impact of the clinic on anticoagulation management, adverse events, and patient satisfaction.
Results:
A total of 578 patients were enrolled in the ACC. The total percentage of international normalized ratio (INR) within the target range was 59% versus 48% when compared to the previous traditional practice. The number of INR tests per patient dropped by 19%. Minor and major adverse events occurred in 10% and 1.5% of patients, respectively. Overall, the patients were very satisfied with the new clinic compared to the previous practice.
Conclusion:
Implementation of the pharmacist-managed ACC in the eastern province of Saudi Arabia had a positive impact on patient care based on the improvements in the number of patients whose INR was within therapeutic range and patient satisfaction scores.
doi:10.1310/hpj4903-260
PMCID: PMC3971112  PMID: 24715746
ambulatory care; anticoagulation; INR; pharmacist-managed clinic; warfarin
7.  Introduction of computer assisted control of oral anticoagulation in general practice. 
Journal of Clinical Pathology  1995;48(12):1144-1146.
The number of patients referred to hospital clinics for monitoring of oral anticoagulation continues to rise rapidly. Introduction of computer programs for the control of oral anticoagulation improves the quality of anticoagulant control in hospital clinics. This approach has now been extended to include patients managed in general practice. Results confirm that the quality of anticoagulation can also be improved in these patients. A standard approach to anticoagulation for hospital and community based patients has also facilitated the transfer of patients on warfarin from the hospital anticoagulant clinics to the community with no deterioration in the quality of anticoagulant control. As a result, the workload in the hospital anticoagulant clinic has fallen for the first time.
PMCID: PMC503046  PMID: 8568006
8.  Point-of-Care International Normalized Ratio (INR) Monitoring Devices for Patients on Long-term Oral Anticoagulation Therapy 
Executive Summary
Subject of the Evidence-Based Analysis
The purpose of this evidence based analysis report is to examine the safety and effectiveness of point-of-care (POC) international normalized ratio (INR) monitoring devices for patients on long-term oral anticoagulation therapy (OAT).
Clinical Need: Target Population and Condition
Long-term OAT is typically required by patients with mechanical heart valves, chronic atrial fibrillation, venous thromboembolism, myocardial infarction, stroke, and/or peripheral arterial occlusion. It is estimated that approximately 1% of the population receives anticoagulation treatment and, by applying this value to Ontario, there are an estimated 132,000 patients on OAT in the province, a figure that is expected to increase with the aging population.
Patients on OAT are regularly monitored and their medications adjusted to ensure that their INR scores remain in the therapeutic range. This can be challenging due to the narrow therapeutic window of warfarin and variation in individual responses. Optimal INR scores depend on the underlying indication for treatment and patient level characteristics, but for most patients the therapeutic range is an INR score of between 2.0 and 3.0.
The current standard of care in Ontario for patients on long-term OAT is laboratory-based INR determination with management carried out by primary care physicians or anticoagulation clinics (ACCs). Patients also regularly visit a hospital or community-based facility to provide a venous blood samples (venipuncture) that are then sent to a laboratory for INR analysis.
Experts, however, have commented that there may be under-utilization of OAT due to patient factors, physician factors, or regional practice variations and that sub-optimal patient management may also occur. There is currently no population-based Ontario data to permit the assessment of patient care, but recent systematic reviews have estimated that less that 50% of patients receive OAT on a routine basis and that patients are in the therapeutic range only 64% of the time.
Overview of POC INR Devices
POC INR devices offer an alternative to laboratory-based testing and venipuncture, enabling INR determination from a fingerstick sample of whole blood. Independent evaluations have shown POC devices to have an acceptable level of precision. They permit INR results to be determined immediately, allowing for more rapid medication adjustments.
POC devices can be used in a variety of settings including physician offices, ACCs, long-term care facilities, pharmacies, or by the patients themselves through self-testing (PST) or self-management (PSM) techniques. With PST, patients measure their INR values and then contact their physician for instructions on dose adjustment, whereas with PSM, patients adjust the medication themselves based on pre-set algorithms. These models are not suitable for all patients and require the identification and education of suitable candidates.
Potential advantages of POC devices include improved convenience to patients, better treatment compliance and satisfaction, more frequent monitoring and fewer thromboembolic and hemorrhagic complications. Potential disadvantages of the device include the tendency to underestimate high INR values and overestimate low INR values, low thromboplastin sensitivity, inability to calculate a mean normal PT, and errors in INR determination in patients with antiphospholipid antibodies with certain instruments. Although treatment satisfaction and quality of life (QoL) may improve with POC INR monitoring, some patients may experience increased anxiety or preoccupation with their disease with these strategies.
Evidence-Based Analysis Methods
Research Questions
1. Effectiveness
Does POC INR monitoring improve clinical outcomes in various settings compared to standard laboratory-based testing?
Does POC INR monitoring impact patient satisfaction, QoL, compliance, acceptability, convenience compared to standard laboratory-based INR determination?
Settings include primary care settings with use of POC INR devices by general practitioners or nurses, ACCs, pharmacies, long-term care homes, and use by the patient either for PST or PSM.
2. Cost-effectiveness
What is the cost-effectiveness of POC INR monitoring devices in various settings compared to standard laboratory-based INR determination?
Inclusion Criteria
English-language RCTs, systematic reviews, and meta-analyses
Publication dates: 1996 to November 25, 2008
Population: patients on OAT
Intervention: anticoagulation monitoring by POC INR device in any setting including anticoagulation clinic, primary care (general practitioner or nurse), pharmacy, long-term care facility, PST, PSM or any other POC INR strategy
Minimum sample size: 50 patients Minimum follow-up period: 3 months
Comparator: usual care defined as venipuncture blood draw for an INR laboratory test and management provided by an ACC or individual practitioner
Outcomes: Hemorrhagic events, thromboembolic events, all-cause mortality, anticoagulation control as assessed by proportion of time or values in the therapeutic range, patient reported outcomes including satisfaction, QoL, compliance, acceptability, convenience
Exclusion criteria
Non-RCTs, before-after studies, quasi-experimental studies, observational studies, case reports, case series, editorials, letters, non-systematic reviews, conference proceedings, abstracts, non-English articles, duplicate publications
Studies where POC INR devices were compared to laboratory testing to assess test accuracy
Studies where the POC INR results were not used to guide patient management
Method of Review
A search of electronic databases (OVID MEDLINE, MEDLINE In-Process & Other Non-Indexed Citations, EMBASE, The Cochrane Library, and the International Agency for Health Technology Assessment [INAHTA] database) was undertaken to identify evidence published from January 1, 1998 to November 25, 2008. Studies meeting the inclusion criteria were selected from the search results. Reference lists of selected articles were also checked for relevant studies.
Summary of Findings
Five existing reviews and 22 articles describing 17 unique RCTs met the inclusion criteria. Three RCTs examined POC INR monitoring devices with PST strategies, 11 RCTs examined PSM strategies, one RCT included both PST and PSM strategies and two RCTs examined the use of POC INR monitoring devices by health care professionals.
Anticoagulation Control
Anticoagulation control is measured by the percentage of time INR is within the therapeutic range or by the percentage of INR values in the therapeutic range. Due to the differing methodologies and reporting structures used, it was deemed inappropriate to combine the data and estimate whether the difference between groups would be significant. Instead, the results of individual studies were weighted by the number of person-years of observation and then pooled to calculate a summary measure.
Across most studies, patients in the intervention groups tended to have a higher percentage of time and values in the therapeutic target range in comparison to control patients. When the percentage of time in the therapeutic range was pooled across studies and weighted by the number of person-years of observation, the difference between the intervention and control groups was 4.2% for PSM, 7.2% for PST and 6.1% for POC use by health care practitioners. Overall, intervention patients were in the target range 69% of the time and control patients were in the therapeutic target range 64% of the time leading to an overall difference between groups of roughly 5%.
Major Complications and Deaths
There was no statistically significant difference in the number of major hemorrhagic events between patients managed with POC INR monitoring devices and patients managed with standard laboratory testing (OR =0.74; 95% CI: 0.52- 1.04). This difference was non-significant for all POC strategies (PSM, PST, health care practitioner).
Patients managed with POC INR monitoring devices had significantly fewer thromboembolic events than usual care patients (OR =0.52; 95% CI: 0.37 - 0.74). When divided by POC strategy, PSM resulted in significantly fewer thromboembolic events than usual care (OR =0.46.; 95% CI: 0.29 - 0.72). The observed difference in thromboembolic events for PSM remained significant when the analysis was limited to major thromboembolic events (OR =0.40; 95% CI: 0.17 - 0.93), but was non-significant when the analysis was limited to minor thromboembolic events (OR =0.73; 95% CI: 0.08 - 7.01). PST and GP/Nurse strategies did not result in significant differences in thromboembolic events, however there were only a limited number of studies examining these interventions.
No statistically significant difference was observed in the number of deaths between POC intervention and usual care control groups (OR =0.67; 95% CI: 0.41 - 1.10). This difference was non-significant for all POC strategies. Only one study reported on survival with 10-year survival rate of 76.1% in the usual care control group compared to 84.5% in the PSM group (P=0.05).
Summary Results of Meta-Analyses of Major Complications and Deaths in POC INR Monitoring Studies
Patient Satisfaction and Quality of Life
Quality of life measures were reported in eight studies comparing POC INR monitoring to standard laboratory testing using a variety of measurement tools. It was thus not possible to calculate a quantitative summary measure. The majority of studies reported favourable impacts of POC INR monitoring on QoL and found better treatment satisfaction with POC monitoring. Results from a pre-analysis patient and caregiver focus group conducted in Ontario also indicated improved patient QoL with POC monitoring.
Quality of the Evidence
Studies varied with regard to patient eligibility, baseline patient characteristics, follow-up duration, and withdrawal rates. Differential drop-out rates were observed such that the POC intervention groups tended to have a larger number of patients who withdrew. There was a lack of consistency in the definitions and reporting for OAT control and definitions of adverse events. In most studies, the intervention group received more education on the use of warfarin and performed more frequent INR testing, which may have overestimated the effect of the POC intervention. Patient selection and eligibility criteria were not always fully described and it is likely that the majority of the PST/PSM trials included a highly motivated patient population. Lastly, a large number of trials were also sponsored by industry.
Despite the observed heterogeneity among studies, there was a general consensus in findings that POC INR monitoring devices have beneficial impacts on the risk of thromboembolic events, anticoagulation control and patient satisfaction and QoL (ES Table 2).
GRADE Quality of the Evidence on POC INR Monitoring Studies
CI refers to confidence interval; Interv, intervention; OR, odds ratio; RCT, randomized controlled trial.
Economic Analysis
Using a 5-year Markov model, the health and economic outcomes associated with four different anticoagulation management approaches were evaluated:
Standard care: consisting of a laboratory test with a venipuncture blood draw for an INR;
Healthcare staff testing: consisting of a test with a POC INR device in a medical clinic comprised of healthcare staff such as pharmacists, nurses, and physicians following protocol to manage OAT;
PST: patient self-testing using a POC INR device and phoning in results to an ACC or family physician; and
PSM: patient self-managing using a POC INR device and self-adjustment of OAT according to a standardized protocol. Patients may also phone in to a medical office for guidance.
The primary analytic perspective was that of the MOHLTC. Only direct medical costs were considered and the time horizon of the model was five years - the serviceable life of a POC device.
From the results of the economic analysis, it was found that POC strategies are cost-effective compared to traditional INR laboratory testing. In particular, the healthcare staff testing strategy can derive potential cost savings from the use of one device for multiple patients. The PSM strategy, however, seems to be the most cost-effective method i.e. patients are more inclined to adjust their INRs more readily (as opposed to allowing INRs to fall out of range).
Considerations for Ontario Health System
Although the use of POC devices continues to diffuse throughout Ontario, not all OAT patients are suitable or have the ability to practice PST/PSM. The use of POC is currently concentrated at the institutional setting, including hospitals, ACCs, long-term care facilities, physician offices and pharmacies, and is much less commonly used at the patient level. It is, however, estimated that 24% of OAT patients (representing approximately 32,000 patients in Ontario), would be suitable candidates for PST/PSM strategies and willing to use a POC device.
There are several barriers to the use and implementation of POC INR monitoring devices, including factors such as lack of physician familiarity with the devices, resistance to changing established laboratory-based methods, lack of an approach for identifying suitable patients and inadequate resources for effective patient education and training. Issues of cost and insufficient reimbursement strategies may also hinder implementation and effective quality assurance programs would need to be developed to ensure that INR measurements are accurate and precise.
Conclusions
For a select group of patients who are highly motivated and trained, PSM resulted in significantly fewer thromboembolic events compared to conventional laboratory-based INR testing. No significant differences were observed for major hemorrhages or all-cause mortality. PST and GP/Nurse use of POC strategies are just as effective as conventional laboratory-based INR testing for thromboembolic events, major hemorrhages, and all-cause mortality. POC strategies may also result in better OAT control as measured by the proportion of time INR is in the therapeutic range and there appears to be beneficial impacts on patient satisfaction and QoL. The use of POC devices should factor in patient suitability, patient education and training, health system constraints, and affordability.
Keywords
anticoagulants, International Normalized Ratio, point-of-care, self-monitoring, warfarin.
PMCID: PMC3377545  PMID: 23074516
9.  Safety and effectiveness of point-of-care monitoring devices in patients on oral anticoagulant therapy: a meta-analysis 
Open Medicine  2007;1(3):e131-e146.
Background
Point-of-care devices (POCDs) for monitoring long-term oral anticoagulation therapy (OAT) may be a useful alternative to laboratory-based international normalized ratio [INR] testing and clinical management.
Purpose
To determine clinical outcomes of the use of POCDs for OAT management by performing a meta-analysis. Previous meta-analyses on POCDs have serious limitations.
Data sources
PubMed, the Cochrane Library, DIALOG, MEDLINE, EMBASE, BIOSIS Previews and PASCAL databases.
Study selection
Randomized controlled trials of patients on long-term OAT, comparing anticoagulation monitoring by POCD with laboratory INR testing and clinical management.
Data extraction
1) rates of major hemorrhage; 2) rates of major thromboembolic events; 3) percentage of time that the patient is maintained within the therapeutic range; 4) deaths. Outcomes were compared using a random-effects model. Summary measures of rates were determined. The quality of studies was assessed using the Jadad scale.
Data synthesis
Seventeen articles (16 studies) were included. Data analysis showed that POCD INR testing reduced the risk of major thromboembolic events (odds ratio [OR] = 0.51; 95% confidence interval [CI] 0.35–0.74), was associated with fewer deaths (OR = 0.58; 95% CI = 0.38–0.89), and resulted in better INR control compared with laboratory INR testing. No significant difference between the two management modalities with respect to odds ratios for major hemorrhage was found.
Limitations
Quality scores varied from 1 to 3 (out of a maximum of 5). Only 3 studies defined how thromboembolic events would be diagnosed, casting doubt on the accuracy of the reporting of thromboembolic events. The studies suggest that only 24% of patients are good candidates for self-testing and self-management. Compared with patients managed with laboratory-based monitoring, POCD patients underwent INR testing at a much higher frequency and received much more intensive education on OAT management.
Conclusions
The use of POCDs is safe and may be more effective than laboratory-based monitoring. However, most patients are not good candidates for self-testing and self-management. Patient education and frequency of testing may be the most important factors in successful PODC management. Definitive conclusions about the clinical benefits provided by self-testing and self-management require more rigorously designed trials.
PMCID: PMC3113217  PMID: 21673942
10.  Comparison of pharmacist managed anticoagulation with usual medical care in a family medicine clinic 
BMC Family Practice  2011;12:88.
Background
The beneficial outcomes of oral anticoagulation therapy are dependent upon achieving and maintaining an optimal INR therapeutic range. There is growing evidence that better outcomes are achieved when anticoagulation is managed by a pharmacist with expertise in anticoagulation management rather than usual care by family physicians. This study compared a pharmacist managed anticoagulation program (PC) to usual physician care (UC) in a family medicine clinic.
Methods
A retrospective cohort study was carried out in a family medicine clinic which included a clinical pharmacist. In 2006, the pharmacist assumed anticoagulation management. For a 17-month period, the PC group (n = 112) of patients on warfarin were compared to the UC patients (n = 81) for a similar period prior to 2006. The primary outcome was the percentage of time patients' INR was in the therapeutic range (TTR). Secondary outcomes were the percentage of time in therapeutic range within ± 0.3 units of the recommended range (expanded TTR) and percentage of time the INR was >5.0 or <1.5.
Results
The baseline characteristics were similar between the groups. Fifty-five percent of the PC group was male with a mean age of 67 years; 51% of the UC group was male with a mean age of 71 years. The most common indications for warfarin in both groups were atrial fibrillation, mechanical heart valves and deep vein thrombosis. The TTR was 73% for PC and 65% for UC (p < 0.0001). The expanded TTR for PC was 91% and 85% for UC (p < 0.0001). The percentage of time INR values were <1.5 was 0.7% for PC patients and 1.9% for UC patients (p < 0.0001), and >5 were 0.3% for PC patients and 0.1% for UC (p < 0.0001).
Conclusion
The pharmacist-managed anticoagulation program within a family practice clinic compared to usual care by the physicians achieved significantly better INR control as measured by the percentage of time patients' INR values were kept in both the therapeutic and expanded range. Based on the results of this study, a collaborative family practice clinic using pharmacists and physicians may be an effective model for anticoagulation management with these results verified in future prospective randomized studies.
doi:10.1186/1471-2296-12-88
PMCID: PMC3176160  PMID: 21849052
11.  Evaluation of computerized decision support for oral anticoagulation management based in primary care. 
BACKGROUND: Increasing indications for oral anticoagulation has led to pressure on general practices to undertake therapeutic monitoring. Computerized decision support (DSS) has been shown to be effective in hospitals for improving clinical management. Its usefulness in primary care has previously not been investigated. AIM: To test the effectiveness of using DSS for oral anticoagulation monitoring in primary care by measuring the proportions of patients adequately controlled, defined as within the appropriate therapeutic range of International Normalised Ratio (INR). METHOD: All patients receiving warfarin from two Birmingham inner city general practices were invited to attend a practice-based anticoagulation clinic. In practice A all patients were managed using DSS. In practice B patients were randomized to receive dosing advice either through DSS or through the local hospital laboratory. Clinical outcomes, adverse events and patient acceptability were recorded. RESULTS: Forty-nine patients were seen in total. There were significant improvements in INR control from 23% to 86% (P > 0.001) in the practice where all patients received dosing through DSS. In the practice where patients were randomized to either DSS or hospital dosing, logistic regression showed a significant trend for improvement in intervention patients which was not apparent in the hospital-dosed patients (P < 0.001). Mean recall times were significantly extended in patients who were dosed by the practice DSS through the full 12 months (24 days to 36 days) (P = 0.033). Adverse events were comparable between hospital and practice-dosed patients, although a number of esoteric events occurred. Patient satisfaction with the practice clinics was high. CONCLUSION: Computerized DSS enables the safe and effective transfer of anticoagulation management from hospital to primary care and may result in improved patient outcome in terms of the level of control, frequency of review and general acceptability.
PMCID: PMC1239749  PMID: 8917873
12.  The Development of Evidence-Based Care Recommendations to Improve the Safe Use of Anticoagulants in Children 
Evidence-based care recommendations and standardized protocols improve outcomes. In addition, anticoagulant management has been recognized by The Joint Commission (TJC) as an opportunity for improving patient safety. A National Patient Safety Goal requiring a standardized process for patients receiving anticoagulants was established by TJC. This requirement provided an opportunity to apply evidence-based care recommendations to the issue of safe anticoagulant use. To meet TJC requirement, the following searchable clinical question was drafted: “In children receiving anticoagulation therapy, what are the appropriate dosing, laboratory monitoring, timing, and dosing adjustments for warfarin, unfractionated heparin, and low-molecular-weight heparin to prevent coagulation-related complications?” The team used the Appraisal of Guidelines Research and Evaluation Collaboration (AGREE) instrument to evaluate the quality and relevance of identified guidelines in answering the clinical question. Best Evidence Statements (BESts) were developed for each of the medications (warfarin, low-molecular-weight heparin, and unfractionated heparin). BESts provide the format for the presentation of recommendations, discussion, and methods for point-of-care providers seeking synthesized evidence to guide care decisions. The primary goal of developing and implementing these statements was to standardize the use of anticoagulants and to prevent unsafe practices. A secondary goal was to ensure accessibility of the BESts throughout our organization, including the electronic medical record, various internal division home pages, and our organization's external website. The anticoagulant BESts developed at our organization show how an interprofessional approach to patient care results in the development of evidence-based care recommendations. The BESts were developed to standardize care associated with the use of anticoagulants and to provide dosing and monitoring parameters to ensure safe care to all patients receiving these medications. The development of evidence-based care recommendations can be accomplished with a focused interprofessional team dedicated to providing the safest possible care to patients.
doi:10.5863/1551-6776-17.2.155
PMCID: PMC3470435  PMID: 23118667
anticoagulants; children; evidence-based
13.  Superficial Siderosis and Anticoagulation Therapy: Different Presentations, Different Outcomes 
Superficial siderosis is a potentially manageable neurodegenerative disorder, caused by chronic subarachnoid haemorrhage and iron deposition along the central nervous system surfaces. Association with oral anticoagulant therapy is well known, but its definite role as a causative agent is yet to be clarified. Two Caucasian women, both under long-term oral anticoagulation: a 74 year old woman with slowly progressive hearing loss and mild cerebellar ataxia; a 72 year old woman suffering from behavioural changes, rapidly progressive cognitive decline and latter developing paraparesis. Magnetic resonance imaging showed striking hypointensities along the surfaces of cerebellum, brainstem, frontotemporal cortices, spinal cord, and lumbar arachnoid therefore suggesting superficial siderosis. No specific bleeding source was found in any of the patients. Anticoagulation could not be stopped in the first patient due to a mechanic valve and slowly progressive worsening occurred. In contrast, for the second patient anticoagulation withdrawal was feasible and marked motor and cognitive improvement ensued. Superficial siderosis is associated with unvarying progression, mostly when no direct source of bleeding is identified. Nonetheless, we verified striking motor and cognitive improvement after anticoagulants withdrawal in one of the patients. This may reinforce the need to consider such modifiable factor in future patient management.
doi:10.1155/2012/745430
PMCID: PMC3474227  PMID: 23091751
14.  Current and future management of pediatric venous thromboembolism 
American journal of hematology  2012;87(0 1):S68-S74.
Venous thromboembolism (VTE) is an increasingly common complication encountered in tertiary care pediatric settings. The purpose of this review is to summarize the epidemiology, current and emerging pharmacotherapeutic options, and management of this disease. Over 70% of VTE occur in children with chronic diseases. Although they are seen in children of all ages, adolescents are at greatest risk. Pediatric VTE is associated with an increased risk of in-hospital mortality; recurrent VTE and post-thrombotic syndrome are commonly seen in survivors. In recent years, anticoagulation with low molecular weight heparin has emerged as the mainstay of therapy, but compliance is limited by its onerous subcutaneous administration route. New anticoagulants either already approved for use in adults or in the pipeline offer the possibility of improved dose stability and oral routes of administration. Current recommended anticoagulation course durations are derived from very limited case series and cohort data, or extrapolations from adult literature. However, the pathophysiologic underpinnings of pediatric VTE are dissimilar from those seen in adults and are often variable within groups of pediatric patients. Clinical studies and trials in pediatric VTE are underway which will hopefully improve the quality of evidence from which therapeutic guidelines are derived.
doi:10.1002/ajh.23131
PMCID: PMC3790464  PMID: 22367975
15.  The Chronic Care Model as vehicle for the development of disease management in Europe 
The Chronic Care Model (Wagner, WHO) aims to improve the functioning and clinical situation of chronic patients by focussing on the patient, the practice team and the conditions that determine the functioning of the team.
The patient is the most important actor who must be stimulated proactively by a competent, integrated practice team. Six interdependent conditional components are essential: health care organisation, delivery system design, community resources and policies, self-management support systems, decision support and clinical information systems.
While the Chronic Care Model focuses on quality and effectiveness of care, disease management programmes underline more the efficiency of care. These programmes apply industrial management principles in health care. Information about process, structure and outcome is gathered and used systematically and human and material sources are used efficiently.
There is evidence that the approaches of the Chronic Care Model and disease management can be integrated. Both approaches underline the need of information and focus on the patient as the main actor to improve and that a balance can be found between effectiveness and efficiency. Ideas will be given how the Chronic Care Model can be used as a framework for the development of a European way of disease management for people with a chronic condition.
PMCID: PMC2430288
chronic care model; disease management programme
16.  A new instrument for measuring anticoagulation-related quality of life: development and preliminary validation 
Background
Anticoagulation can reduce quality of life, and different models of anticoagulation management might have different impacts on satisfaction with this component of medical care. Yet, to our knowledge, there are no scales measuring quality of life and satisfaction with anticoagulation that can be generalized across different models of anticoagulation management. We describe the development and preliminary validation of such an instrument – the Duke Anticoagulation Satisfaction Scale (DASS).
Methods
The DASS is a 25-item scale addressing the (a) negative impacts of anticoagulation (limitations, hassles and burdens); and (b) positive impacts of anticoagulation (confidence, reassurance, satisfaction). Each item has 7 possible responses. The DASS was administered to 262 patients currently receiving oral anticoagulation. Scales measuring generic quality of life, satisfaction with medical care, and tendency to provide socially desirable responses were also administered. Statistical analysis included assessment of item variability, internal consistency (Cronbach's alpha), scale structure (factor analysis), and correlations between the DASS and demographic variables, clinical characteristics, and scores on the above scales. A follow-up study of 105 additional patients assessed test-retest reliability.
Results
220 subjects answered all items. Ceiling and floor effects were modest, and 25 of the 27 proposed items grouped into 2 factors (positive impacts, negative impacts, this latter factor being potentially subdivided into limitations versus hassles and burdens). Each factor had a high degree of internal consistency (Cronbach's alpha 0.78–0.91). The limitations and hassles factors consistently correlated with the SF-36 scales measuring generic quality of life, while the positive psychological impact scale correlated with age and time on anticoagulation. The intra-class correlation coefficient for test-retest reliability was 0.80.
Conclusions
The DASS has demonstrated reasonable psychometric properties to date. Further validation is ongoing. To the degree that dissatisfaction with anticoagulation leads to decreased adherence, poorer INR control, and poor clinical outcomes, the DASS has the potential to help identify reasons for dissatisfaction (and positive satisfaction), and thus help to develop interventions to break this cycle. As an instrument designed to be applicable across multiple models of anticoagulation management, the DASS could be crucial in the scientific comparison between those models of care.
doi:10.1186/1477-7525-2-22
PMCID: PMC420491  PMID: 15132746
17.  Occurrence and quality of anticoagulant treatment of chronic atrial fibrillation in primary health care in Sweden: a retrospective study on electronic patient records 
Background
Chronic atrial fibrillation is a prevalent cardiac disorder. The literature indicates varying proportions of those treated with anticoagulants, and varying intensity of anticoagulation. Electronic patient records are providing us with clinical data concerning management of anticoagulant treatment in real-life practice that is useful for audits. We aimed to assess warfarin treatment for chronic atrial fibrillation in primary health care with regard to prevalence, incidence, the proportion treated and the quality of anticoagulation control.
Methods
Five primary health care centres in Stockholm with a registered population of 75146 participated in a one-year retrospective study of electronic patient records up until May 2000. All patients over 18 years of age with an encounter labelled 'Atrial fibrillation' were identified, and all records of patients on warfarin treatment were manually reviewed. Main outcome measures were number of patients with chronic atrial fibrillation, number of patients on wafarin treatment, and time within the therapeutic prothrombin range.
Results
In total, 419 patients had chronic atrial fibrillation, giving a prevalence of 0.60% (age-adjusted 0.62%), the age group 65 years or older accounted for 91.6%, and 50.1% were women. Out of these, 50.4% (211 patients) were established on warfarin treatment for chronic atrial fibrillation (0.28% of the population), and there was a predominance of men (p = 0.02). Fifty-four patients started treatment with warfarin for chronic atrial fibrillation (0.07% of the population). Among 25 randomly selected patients on established treatment, the proportion of time within the therapeutic range was 70.2%. Among 24 randomly selected patients starting treatment, the proportion of time with therapeutic values was 54.2% and 66.9% the first and second months of treatment, respectively.
Conclusions
Chronic atrial fibrillation is common among the elderly in primary health care, and about half of these patients are treated with warfarin. It appears to be under-diagnosed, and may also be under-treated. About two thirds of treatment time is spent within the therapeutic range, and further improvement of the quality of anticoagulation control with warfarin may therefore be hard to achieve.
doi:10.1186/1472-6904-4-1
PMCID: PMC368440  PMID: 15028124
anticoagulant treatment; atrial fibrillation; primary health care; prevalence; quality assurance
18.  Evaluation of a pharmacist-managed anticoagulation clinic: Improving patient care 
Open Medicine  2009;3(1):e16-e21.
Background
Anticoagulation management services (AMSs) are widely used for anticoagulation management in many countries. Our AMS is a pharmacist-run ambulatory clinic with a physician advisory committee that manages patients referred with complicated anticoagulation histories. This paper assesses the adequacy of anticoagulation, rates of anticoagulant-related events and associated health care resource utilization for patients before and after referral to our AMS.
Methods
Consecutive patients referred to the AMS with 4 months of prior anticoagulation management who also had anticoagulation management for 4 months within the AMS were included in the evaluation. The primary endpoint was adequacy of anticoagulation (target international normalized ratio [INR] ± 0.5). Secondary outcomes included adverse events requiring an emergency department (ED) visit or hospital stay. These were classified by International Classification of Diseases (ICD) codes as thromboembolic, hemorrhagic, or non-anticoagulant related. Health care system resource consumption data were collected as number of hours spent in an ED and hospitalization costs.
Results
A total of 125 patients were included: 57.6% were male, with a mean age of 62.9 (standard deviation [SD]) ± 15.0 years. Indications for warfarin therapy were atrial fibrillation (40.0%), mechanical valve replacement (24.0%) and venous thromboembolism (19.2%). The adequacy of anticoagulant control was significantly greater during AMS care compared with the period before referral; patients were in the target INR range 66.5% versus 48.8% of the time, respectively (95% confidence interval [CI] 13.4%–22.0%; p < 0.0001). The relative risk of a thromboembolic event before referral to AMS care was 17.6 (95% CI 6.0–51.9; p < 0.0001), while the relative risk of a hemorrhagic event before AMS care was 1.6 (95% CI 0.7–3.7; p = 0.25). During AMS care, savings included 572 hours in the ED and Cdn$122,145.40 in hospitalization costs.
Conclusions
A pharmacist-directed, physician-supported AMS program achieved significantly better INR control and reduced rates of thromboembolic complications compared with standard care. Resource utilization was substantially reduced during AMS care.
PMCID: PMC2765765  PMID: 19946388
19.  Quality of Life analysis of patients in chronic use of oral anticoagulant: an observational study 
Background
Treatment with oral anticoagulant may influence the quality of life perception as it promotes changes in the patient's life, not offering an evident symptomatic relief and presenting well defined risks, such as bleeding. In this trial, the influence of chronic use of anticoagulants on the quality of life perception has been analyzed in patients assisted at the anticoagulation outpatient unit.
Methods
The health related quality of life was evaluated through a cross-section study with a sample composed of 72 patients seen from July 23, 2009 to September 2, 2010 at the Anticoagulation Outpatient Unit of the Federal University of Bahia's University Hospital. The study's population was composed by patients with atrial fibrillation and mechanical heart valve. The patients were submitted to two quality of life evaluation questionnaires: a generic questionnaire - the Medical Outcomes Study SF-36 Health Survey (SF36) - and a specific questionnaire - the Duke Anticoagulation Satisfaction Scale (DASS).
Results
The quality of life perception of the patients studied, based on both the DASS and the SF36, was positive regarding the treatment with oral anticoagulant. The SF36 presented an average score of 62.2 (± 20.0). Among the SF36 evaluated domains, the physical-emotional aspect was the most compromised one regarding life quality perception. The DASS presented an average score of 67.1 (± 18.2) and the domain presenting a greater compromise was the one related to the treatment inconveniences (annoyances, burdens and obligations). Previous hemorrhagic event, comorbidities, drug interactions with medicines that increase the anticoagulant effect, lower education level in the SF36 and younger age group influence a more negative perception of the quality of life, whereas lower education level in the DASS and the duration of treatment for more than 1 year offer a more positive perception.
Conclusion
Patients seen at the anticoagulation outpatient unit of the University Hospital of Federal University of Bahia/Brazil had a positive perception of the treatment. Factors such as hemorrhagic event, comorbidities, drug interactions, education level, age group and duration of treatment have an influence on the quality of life perception.
doi:10.1186/1477-7525-9-91
PMCID: PMC3221633  PMID: 22027368
20.  Limited English Proficient Patients and Time Spent in Therapeutic Range in a Warfarin Anticoagulation Clinic 
Background
While anticoagulation clinics have been shown to deliver tailored, high‐quality care to patients receiving warfarin therapy, communication barriers with limited English proficient (LEP) patients may lead to disparities in anticoagulation outcomes.
Methods and Results
We analyzed data on 3770 patients receiving care from the Massachusetts General Hospital Anticoagulation Management Service (AMS) from 2009 to 2010. This included data on international normalized ratio (INR) tests and patient characteristics, including language and whether AMS used a surrogate for primary communication. We calculated percent time in therapeutic range (TTR for INR between 2.0 and 3.0) and time in danger range (TDR for INR <1.8 or >3.5) using the standard Rosendaal interpolation method. There were 241 LEP patients; LEP patients, compared with non‐LEP patients, had a higher number of comorbidities (3.2 versus 2.9 comorbidities, P=0.004), were more frequently uninsured (17.0% versus 4.3%, P<0.001), and less educated (47.7% versus 6.0% ≤high school education, P<0.001). LEP patients compared with non‐LEP patients spent less TTR (71.6% versus 74.0%, P=0.007) and more TDR (12.9% versus 11.3%, P=0.018). In adjusted analyses, LEP patients had lower TTR as compared with non‐LEP patients (OR 1.5, 95% CI [1.1, 2.2]). LEP patients who used a communication surrogate spent less TTR and more TDR.
Conclusion
Even within a large anticoagulation clinic with a high average TTR, a small but significant decrease in TTR was observed for LEP patients compared with English speakers. Future studies are warranted to explore how the use of professional interpreters impact TTR for LEP patients.
doi:10.1161/JAHA.113.000170
PMCID: PMC3828815  PMID: 23832325
adverse drug events; limited English proficiency; outcomes research; quality of care; warfarin
21.  Home prophylactic warfarin anticoagulation program after hip and knee arthroplasty  
Canadian Journal of Surgery  1999;42(5):360-362.
Objective
To determine the efficiency of a program designed to maintain prophylactic oral anticoagulation within a target range for 6 weeks after hip and knee arthroplasty.
Design
A prospective continuous quality improvement indicator.
Setting
A tertiary care university hospital.
Patients
Patients who underwent hip and knee arthroplasty and had no indications for routine anticoagulation other than postoperative thromboembolism prophylaxis.
Intervention
An outpatient warfarin prophylaxis program, which included an information letter given to the patient, Home Care coordinated community laboratory services, communication with and anticoagulant dosage adjustment by the patient’s personal family physician.
Outcome measures
The proportion of international normalized ratio (INR) values within, below and above the target range of 2.0 to 3.0.
Results
Sixty-two patients were enrolled over a 3-month period. On the day of hospital discharge, 64% of patients had INR values that were within the target range, 31% were below and 5% were above. After hospital discharge, 42% of the INR values were within the target range, 48% were below and 10% were above.
Conclusion
Despite a program designed to address patient information, physician communication and laboratory testing, tight control of home INR values could not be achieved with the existing resources of Home Care and family physicians.
PMCID: PMC3788901  PMID: 10526520
22.  Oral anticoagulation and self-management: analysis of the factors that determine the feasibility of using self-testing and self-management in primary care 
Background
The skills of patients on oral anticoagulants are critical for achieving good outcomes with this treatment. Self-management, or the capacity of patients to control their INR level and adjust their treatment, is an effective strategy of treatment. Capacity of patients to self manage is determined by a range of factors. The identification of these factors would improve the design of self management programmes and in turn increase the number of patients able to self-manage. The objective of our study is to identify those factors that determine the ability of patients on oral anticoagulant therapy to achieve self-management of their treatment.
Design
This will be a three year quasi- experimental prospective study with a control group. 333 patients on anticoagulant therapy from five health centres of the Basque Health Service are to be followed up for a period of six months each after the intervention, to assess their ability to self-test and self-manage. The intervention will consist of a patient training programme involving the provision of information and practical training concerning their condition and its treatment, as well as how to use a portable blood coagulation monitoring device and adjust their anticoagulant dose.
Discussion
The ease-of-use of this technique lead us to believe that self-management is feasible and will represent an innovative advance that should have a substantial impact on the quality of life of this patients and their families as well as on the health care provision systems.
Trial registration
Osakidetza Protocol Record ISCIII-11/02285, Oral anticoagulation and self-management, ClinicalTrials.gov Identifier: NCT01878539
doi:10.1186/1471-2261-13-59
PMCID: PMC3765739  PMID: 23968316
Oral anticoagulants; Self-management; Determinants
23.  An Audit of Management of Patients on Oral Anticoagulant Therapy With International Normalized Ratio (INR) Five or Above 
Maintaining the international normalized ratio (INR) within the therapeutic range in patients on oral anticoagulant treatment is a challenge for the physician. Excessive anticoagulation poses the risk of bleeding in patients. Management strategies vary among clinicians although standard guidelines exist for the same. We conducted an audit in patients on oral anticoagulant therapy in our hospital with excessive anticoagulation. This retrospective study was carried out among patients on oral anticoagulant therapy for various thrombotic conditions with at least a single INR recording of 5 or more. Other than demographic details, the type of oral anticoagulant used, indication, duration of treatment, dosage and concomitant use of interacting drugs or alcohol were also recorded. Detail of the nature and site of bleed and management for the same was also noted. Data were analyzed using descriptive statistics. Fifty episodes with INR ≥ 5 (5.0–10.75) were noted in 44 patients (M:F = 1:1). Their age ranged from 20 to 88 years (mean 50.3 ± 16.4 years). The duration of anticoagulant therapy varied from 3 days to 180 months. Of the 43 episodes in patients who had no bleeding, the anticoagulant was stopped on 32 occasions for variable periods with dose reduction in the rest of the patients. Spontaneous bleeding was seen in seven patients (6 major and 1 minor). Among the seven patients with bleeding, other than stopping he oral anticoagulant drug, other measures taken were vitamin K therapy, fresh frozen plasma or packed red cell transfusion. Overall management strategy of patients with high INR was in compliance with standard recommendations.
doi:10.1007/s12288-011-0137-4
PMCID: PMC3572249  PMID: 24426326
Bleeding; International normalized ratio (INR); Management; Oral anticoagulant
24.  The Cost-Effectiveness of Different Management Strategies for Patients on Chronic Warfarin Therapy 
OBJECTIVE
To examine the cost-effectiveness of moving from usual care to more organized management strategies for patients on chronic warfarin therapy.
DESIGN
Using information available in the scientific literature, supplemented with data from a large health system and, when necessary, expert opinion, we constructed a 5-year Markov model to evaluate the health and economic outcomes associated with each of three different anticoagulation management approaches: usual care, anticoagulation clinic testing with a capillary monitor, and patient self-testing with a capillary monitor.
PATIENTS
Three hypothetical cohorts of patients beginning long-term warfarin therapy were used to generate model results.
MAIN RESULTS
Model results indicated that moving from usual care to anticoagulation clinic testing would result in a total of 1.7 thromboembolic events and 2.0 hemorrhagic events avoided per 100 patients over 5 years. Another 4.0 thromboembolic events and 0.8 hemorrhagic events would be avoided by moving to patient self-testing. When direct medical care costs and those incurred by patients and their caregivers in receiving care were considered, patient self-testing was the most cost-effective alternative, resulting in an overall cost saving.
CONCLUSIONS
Results illustrate the potential health and economic benefits of organized care management approaches and capillary monitors in the management of patients receiving warfarin therapy.
doi:10.1046/j.1525-1497.2000.01239.x
PMCID: PMC1495325  PMID: 10632831
anticoagulation management; cost-effectiveness analysis; decision analytic model; warfarin
25.  Warfarin and atrial fibrillation: from ideal to real the warfarin affaire 
Thrombosis Journal  2014;12:5.
Vitamin K Antagonists (VKAs) are widely used in clinical practice and nearly 1% of the entire population receives oral anticoagulation at least once in life. However, the rate of prescription of anticoagulation is low, compared to what it should be. No more than 50-60% of patients affected by atrial fibrillation (AF) receive anticoagulation. In the setting of AF, VKAs are safe and effective when properly managed, reducing stroke and systemic embolism by more than 60%. VKAs safety and effectiveness are closely related to the quality of anticoagulation (e.g. time in therapeutic range), and anticoagulation clinics offer the best management of anticoagulant therapy. However, a sizeable proportion of patients are managed elsewhere. In clinical practice, in the setting of AF, a low prescription rate of VKAs is frequently observed and this is due also to difficulties in managing laboratory monitoring and drug dose adjustment. The suboptimal management of therapy with VKAs leads to a lesser efficacy than that reported in clinical trials, and to an increase in adverse reactions. VKAs still remain the first and only available therapy for a number of diseases (e.g. valvular atrial fibrillation and mechanical prosthetic heart valves). Now, since approval of the new oral anticoagulants (NOAs), the choice of anticoagulant therapy in definite settings, such as stroke prevention in non-valvular atrial fibrillation (SPAF) or treatment of venous thromboembolism, has surely become more intriguing but also more problematic. In light of these new therapeutic options, we reviewed VKAs therapy, in the setting of atrial fibrillation, focusing on VKAs impact in real life. We analyzed the data about efficacy and safety of warfarin at three levels: clinical trial and real life, outside and inside anticoagulation clinics.
doi:10.1186/1477-9560-12-5
PMCID: PMC3937065  PMID: 24548437
Atrial fibrillation; Warfarin; Real life; Anticoagulation therapy

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