Self-management Of Oral Anticoagulant Therapy Research Articles

Characteristics of software used in self-management of vitamin K antagonist therapy: A systematic review.

Currently, 1-2% of the population in developed countries are under treatment with oral anticoagulants. An appropriate strategy to deal with this increase in demand of treatment with oral anticoagulants and to manage the costs is the transfer of part or all of the responsibility for managing treatment to the patients. The use of information technology, particularly electronic health software, can be an appropriate method to improve the quality of self-management of treatment with these drugs. Therefore, this systematic review investigated studies that discuss the characteristics of electronic health software in self-management of oral anticoagulation therapy. A systematic review based on PRISMA protocol was conducted. In this study, articles were investigated that were in English. Articles existing in Cochrane, EMBASE and PubMed databases were searched up to 14 May 2017. Then, articles searched through Google Scholar were added to this study. The common characteristics used in most software included 'encryption in exchanging information', having an 'instruction module' and 'being Android-based'. In terms of functionality, 'communication between the patient and healthcare team' existed in most of the software. The results of the study showed that the accuracy of administration of the dose of the drug using computer to reach a target international normalized ratio level was not less than those administered with experienced medical staff. In addition, the results indicated that important characteristics of the software include encryption in exchanging information, instruction module and Android-based instruction module. The most important characteristic was the interaction between the patient and the healthcare team.

Self-monitoring and self-management of oral anticoagulation.

The introduction of point-of-care devices for the management of patients on oral anticoagulation allows self-testing by the patient at home. Patients who self-test can eitheradjust their medication according to a pre-determined dose-INR (international normalized ratio) schedule (self-management), or they can call a clinic to be told the appropriate dose adjustment (self-monitoring). Increasing evidence suggests self-testing of oral anticoagulant therapy is equal to or better than standard monitoring. This is an updated version of the original review published in 2010. To evaluate the effects on thrombotic events, major haemorrhages, and all-cause mortality of self-monitoring or self-management of oral anticoagulant therapy compared to standard monitoring. For this review update, we re-ran the searches of the Cochrane Central Register of Controlled Trials (CENTRAL), 2015, Issue 6, the Cochrane Library, MEDLINE (Ovid, 1946 to June week 4 2015), Embase (Ovid, 1980 to 2015 week 27) on 1 July 2015. We checked bibliographies and contacted manufacturers and authors of relevant studies. We did not apply any language restrictions . Outcomes analysed were thromboembolic events, mortality, major haemorrhage, minor haemorrhage, tests in therapeutic range, frequency of testing, and feasibility of self-monitoring and self-management. Review authors independently extracted data and we used a fixed-effect model with the Mantzel-Haenzel method to calculate the pooled risk ratio (RR) and Peto's method to verify the results for uncommon outcomes.We examined heterogeneity amongst studies with the Chi(2) and I(2) statistics and used GRADE methodology to assess the quality of evidence. We identified 28 randomised trials including 8950 participants (newly incorporated in this update: 10 trials including 4227 participants). The overall quality of the evidence was generally low to moderate. Pooled estimates showed a reduction in thromboembolic events (RR 0.58, 95% CI 0.45 to 0.75; participants = 7594; studies = 18; moderate quality of evidence). Both, trials of self-management or self-monitoring showed reductions in thromboembolic events (RR 0.47, 95% CI 0.31 to 0.70; participants = 3497; studies = 11) and (RR 0.69, 95% CI 0.49 to 0.97; participants = 4097; studies = 7), respectively; the quality of evidence for both interventions was moderate. No reduction in all-cause mortality was found (RR 0.85, 95% CI 0.71 to 1.01; participants = 6358; studies = 11; moderate quality of evidence). While self-management caused a reduction in all-cause mortality (RR 0.55, 95% CI 0.36 to 0.84; participants = 3058; studies = 8); self-monitoring did not (RR 0.94, 95% CI 0.78 to 1.15; participants = 3300; studies = 3); the quality of evidence for both interventions was moderate. In 20 trials (8018 participants) self-monitoring or self-management did not reduce major haemorrhage (RR 0.95, 95% CI, 0.80 to 1.12; moderate quality of evidence). There was no significant difference found for minor haemorrhage (RR 0.97, 95% CI 0.67 to 1.41; participants = 5365; studies = 13). The quality of evidence was graded as low because of serious risk of bias and substantial heterogeneity (I(2) = 82%). Participants who self-monitor or self-manage can improve the quality of their oral anticoagulation therapy. Thromboembolic events were reduced, for both those self-monitoring or self-managing oral anticoagulation therapy. A reduction in all-cause mortality was observed in trials of self-management but not in self-monitoring, with no effects on major haemorrhage.

The Future Landscape of Anticoagulation Management

Back then we had warfarin and unfractionated heparin, and we thought that we knew all we needed to know in order to manage those anticoagulants optimally. We were wrong then, and we are probably more subtly wrong now. But I have been asked to comment on what I anticipate the future holds for anticoagulation management and the role of pharmacy in it. Because of the nature of progress, I realize that the more detailed my vision of the future, the greater is the certainty that that vision will be wrong. First, I will focus on what I believe is needed in the near term and then address how I imagine patient selfmonitoring, novel oral anticoagulants, and pharmacogenomics—three topics discussed in this special issue of Pharmacotherapy that reflect areas of change—will affect the future of anticoagulation management.

Self-testing and self-management of oral anticoagulation therapy in children

Children and adolescents on oral anticoagulation therapy (OAT) present special challenges in terms of rapid fluctuations in International Normalised Ratio (INR) values, interruption in daily life due to frequent hospital/doctor visits, and difficulties and pain in the performance of venepuncture. Optimised management of OAT improves the quality of treatment, potentially accomplished by new methods such as patient self-testing (PST) and patient self-management (PSM). A review was performed, identifying 11 trials with children and adolescents. All studies had different methodological problems, predominantly by being non-randomised trials. A total of 284 patients were included with a mean follow-up of 22 months, finding a time within therapeutic INR target range between 63% and 84%. The coagulometers used for estimating the INR values were found to have sufficient precision and accuracy for clinical use, but external quality control is probably advisable. It can be concluded that PST and PSM are at least as good treatment options as conventional management in highly selected children. Larger studies, preferably randomised, controlled trials using clinical endpoints, are obviously needed in order to elucidate whether these new regimens of treatment are superior to conventional management of oral anticoagulation therapy.

Does self-management of oral anticoagulation therapy improve quality of life and anxiety?

Research related to service requirements for anticoagulation management has focussed on clinical and health economic outcomes and paid little attention to the impact of treatment and service delivery on patients' quality of life. This was the first large UK study to evaluate the effect of patient self-management (PSM) of oral anticoagulation on treatment-related quality of life (TRQoL) and anxiety in comparison with routine care (RC) and to explore the effect of level of therapeutic control on TRQoL and anxiety across and within each model of care. A quantitative survey, set in primary care in the West Midlands. The subjects were 517 randomized controlled trial participants, 242 receiving PSM and 275 RC. Postal questionnaires at baseline and 12 months comprised the State Trait Anxiety Inventory and a treatment-specific measure of positive (satisfaction and self-efficacy) and negative aspects (daily hassles, strained social network and psychological distress) of TRQoL. Change in anxiety and TRQoL scores were compared between PSM and RC. Subgroup analysis was based upon level of therapeutic control (high, medium and low). Overall, 83% (n = 202) PSM and 55% (n = 161) RC patients contributed data. Anxiety scores were similar in both groups. PSM demonstrated greater improvement in self-efficacy than RC across the study period. A statistically significant between-group difference (PSM versus RC) in the self-efficacy also existed in subgroups with medium and high levels of therapeutic control. PSM is not associated with increased anxiety and has a positive effect upon some aspects of TRQoL compared to RC.

Patient self-management of oral anticoagulant therapy results in smaller variance in INR values, a higher median INR and a higher dose of warfarin,

Patient self-management of oral anticoagulant therapy results in smaller variance in INR values, a higher median INR and a higher dose of warfarin,

Direct-to-patient expert system and home INR monitoring improves control of oral anticoagulation

Internet-based disease management programs have the potential to improve patient care. The objective of this study was to determine whether an interactive, internet-based system enabling supervised, patient self-management of oral anticoagulant therapy provided management comparable to an established anticoagulation clinic. Sixty patients receiving chronic oral anticoagulant therapy who had access to the internet and a printer, were enrolled into this prospective, single-group, before-after study from a single clinic and managed between March 2002 and January 2003. Patients learned how to use a home prothrombin time monitor and how to access the system through the internet. Patients used the system for six months, with daily review by the supervising physician. The primary outcome variable was the difference in time in therapeutic range prior to and following introduction of internet-supervised patient self-management. The mean time in therapeutic range increased from 63% in the anticoagulation clinic (control period) to 74.4% during internet-supervised patient self-management (study period). The mean difference score between control and study periods was 11.4% (P = 0.004, 95% confidence interval 5.5-17.3%). There were no hemorrhagic or thromboembolic complications. This novel approach of internet-supervised patient self-management improved time in therapeutic range compared to an anticoagulation clinic. This is the first demonstration of an internet-based expert system enabling remote and effective management of patients on oral anticoagulants. Expert systems may be applicable for management of other chronic diseases.

Self- versus Conventional Management of Oral Anticoagulant Therapy

Comparison of self-management of oral anticoagulant therapy versus conventional management has been hindered by use of different methods. We tested the hypothesis that there is no difference in the International Normalized Ratio (INR) variability, INR level, and coumarin dose among patients randomized to conventional management versus self-management. The study design included uniform analysis of blinded control blood samples in both treatment arms. Ninety-two patients were randomly assigned to either self-management of oral anticoagulant therapy (including a teaching program for self-management followed by 6 months of independent self-management) or 6 months of conventional management. The endpoints were the variance (median square of the standard deviation) of the INR value, the median INR-value (using a blinded control sample analyzed monthly by a reference laboratory), and the coumarin dose. Self-management was associated with a statistically significant smaller variance in INR values, a higher median INR value, and a higher dose of warfarin compared with conventional management. No difference was found in the group of patients using phenprocoumon. Training and implementation of patient self-management leads to a smaller variance in INR values, a higher median INR value and a higher dose of coumarin compared with results obtained for conventionally managed patients.

Self-management of oral anticoagulation therapy improves long-term survival in patients with mechanical heart valve replacement

Self-management of oral anticoagulation therapy improves long-term survival in patients with mechanical heart valve replacement

Self-Management of Oral Anticoagulation Therapy Improves Long-Term Survival in Patients With Mechanical Heart Valve Replacement

The Early Self-Controlled Anticoagulation Trial has demonstrated that in patients with mechanical heart valve replacement self-management of oral anticoagulation results in less major thromboembolic events than conventional measurement by the general practitioner. However, the effects of self-management on long-term survival are currently not known. Nine hundred thirty patients participated in a follow-up study of the aforementioned trial (488 from the self-management group and 442 from the conventional group). Long-term survival was assessed 12 years after the study began using the intent-to treat analysis as well as the per protocol analysis. Univariate and multivariate analyses were performed in order to assess independent predictors of survival. In total, the 930 patients accrued 8,315 patient-years of observation. During follow-up, 236 patients died. According to the intent-to treat analysis, 10-year survival was 76.1% in the conventional group and 84.5% in the self-management group. The corresponding values for the per protocol analysis were 67.7% and 80.6%, respectively. Age, kind of valve surgery, and study group were independent predictors of survival. Self-management of oral anticoagulation increased long-term survival by 23% (intent-to-treat analysis) and 33% (per protocol analysis), respectively, compared with conventional measurement by the general practitioner. Possible reasons for these advantageous results in the self-management group are fewer thromboembolic events due to a higher percentage of international normalized ratio values lying in the target range compared with the conventional group. Data indicate that self-management of oral anticoagulation is a promising strategy in order to increase long-term survival in patients with mechanical prosthetic valves.

Self-management of oral anticoagulant therapy: A systematic review and meta-analysis

Background A number of randomized controlled trials have compared self-management of oral anticoagulant therapy with conventional management. However, the results have not appeared consistent and a systematic review and meta-analysis are therefore needed in order to evaluate self-management of oral anticoagulant therapy. The aim of this study was to evaluate the efficacy and safety of self-management of oral anticoagulant therapy for patients on long-term oral anticoagulant therapy. Methods A systematic review and meta-analysis including randomized controlled trials with highly selected patients comparing self-management of oral anticoagulant therapy with conventional treatment. Data were extracted in terms of study characteristics, quality of trials and outcome (death, minor and major complications (thromboembolic and bleeding events), and time within therapeutic INR target range). Results Ten trials with a total of 2724 patients were included. Two of the trials could be classified as high quality trials. Considering all trials, self-management was associated with a reduced risk of death (relative risk (RR) = 0.48, 95% confidence interval (CI) 0.29–0.79, p = 0.004), major complications (RR = 0.58, 95% CI 0.42–0.81, p = 0.001) and with increasing time within therapeutic INR target range (weighted mean difference = 6.53, 95% CI 2.24–10.82, p = 0.003). No clear effect was found regarding minor complications (RR = 0.98, 95% CI 0.49–1.99, p = 0.96). Conclusions A majority of the existing trials have various methodological problems. However, self-management of oral anticoagulant therapy appeared at least as good and possible better than conventional management in highly selected patients.

Self-management versus conventional management of oral anticoagulant therapy: A randomized, controlled trial

Background The efficacy of self-managed oral anticoagulant therapy has been addressed in few randomized, controlled trials, which have provided inconsistent results. The aim of this study was to compare the quality of self-managed oral anticoagulant therapy with conventional management. Methods This was a pragmatic, open-label, randomized, controlled trial where 100 patients receiving long-term oral anticoagulant therapy referred to a Danish clinic for self-management was randomized to either self-management of oral anticoagulant therapy (including a teaching program of self-management followed by 6 months of self-management) or 6 months of conventional management. The primary endpoint was an intention-to-treat analysis of a composite score combining the variance (median square of the standard deviation) of the International Normalized Ratio (INR) value (using a blinded control sample analyzed monthly by a reference laboratory), death, major complications, or discontinuation from the study. Secondary endpoints – assessed in per-protocol analyses – were the variance of the INR value (using the blinded control sample) and time within therapeutic INR target range using the standard INR values from the coagulometer and laboratory measurement. Results There was no significant difference in the primary endpoint between the self-management and conventional management groups (composite score 0.16 vs. 0.24, respectively, p = 0.09). Self-management was significantly better (0.16 vs. 0.24, p = 0.003) with regard to the variance in a per-protocol analysis. The difference in time within therapeutic INR target range was not significantly better (78.7% vs. 68.9%, p = 0.14) using self-management. Conclusion The quality of self-management of oral anticoagulant therapy is at least as good as that provided by conventional management.

Patient self-management of anticoagulants reduced arterial thromboembolism and adverse effects

Source Citation Menendez-Jandula B, Souto JC, Oliver A, et al. Comparing self-management of oral anticoagulant therapy with clinic management: a randomized trial. Ann Intern Med. 2005;142:1-10. 156...

Patient Self-Management of Oral Anticoagulation

Letters21 June 2005Patient Self-Management of Oral AnticoagulationBenton M. Wheeler III, MDBenton M. Wheeler III, MDFrom The West Clinic, Memphis, TN 38120.Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-142-12_Part_1-200506210-00015 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail TO THE EDITOR:The design of the study by Menéndez-Jándula and colleagues on patient self-management of oral anticoagulant therapy (1) has some important limitations. The authors compared monthly conventional management of anticoagulant therapy with weekly self-management and reported no significant difference in unadjusted percentages of end-range international normalized ratios (INRs). However, this is an unfair comparison.In my office, prothrombin times are checked every 2 weeks and then weekly if the dose has to be adjusted. Patients who do not require frequent dose adjustments can have this interval increased to 3 or 4 weeks. It would seem more reasonable for ...Reference1. Menendez-Jandula B, Souto JC, Oliver A, Montserrat I, Quintana M, Gich I, et al. Comparing self-management of oral anticoagulant therapy with clinic management: a randomized trial. Ann Intern Med. 2005;142:1-10. [PMID: 15630104] LinkGoogle Scholar Author, Article, and Disclosure InformationAffiliations: From The West Clinic, Memphis, TN 38120.Disclosures: None disclosed. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoComparing Self-Management of Oral Anticoagulant Therapy with Clinic Management Bárbara Menéndez-Jándula , Juan Carlos Souto , Arturo Oliver , Isabel Montserrat , Mireia Quintana , Ignasi Gich , Xavier Bonfill , and Jordi Fontcuberta Patient Self-Management of Oral Anticoagulation Juan Carlos Souto , Bárbara Menéndez-Jándula , and Jordi Fontcuberta Patient Self-Management of Oral Anticoagulation Juan Carlos Souto , Bárbara Menéndez-Jándula , and Jordi Fontcuberta Metrics 21 June 2005Volume 142, Issue 12_Part_1Page: 1023KeywordsAnticoagulant therapyAnticoagulantsConflicts of interestResearch laboratoriesThrombin ePublished: 21 June 2005 Issue Published: 21 June 2005 CopyrightCopyright © 2005 by American College of Physicians. All Rights Reserved.PDF DownloadLoading ...

Comparing Self-Management of Oral Anticoagulant Therapy with Clinic Management

Control of oral anticoagulant treatment has been reported to be suboptimal, but previous studies suggest that patient self-management improves control. To compare the quality of control and the clinical outcomes of oral anticoagulant treatment in self-managed patients versus patients following conventional management. Randomized, controlled trial. University-affiliated hospital in Spain. 737 patients with indications for anticoagulant treatment. The self-management group (n = 368) received simple instructions for using a portable coagulometer weekly and self-adjusting treatment dose. The conventional management group (n = 369) received usual care in an anticoagulation clinic (monthly measurement and control of international normalized ratio [INR], managed by hematologists). Percentage of INR values within the target range and major related complications. The median follow-up period was 11.8 months (range, 0.3 to 16.9 months). The unadjusted percentages of in-range INRs were 58.6% in the self-management group and 55.6% in the conventional management group (difference, 3.0 percentage points [95% CI, 0.4 to 5.4 percentage points]). Twenty-seven patients (7.3%) in the conventional management group and 8 (2.2%) in the self-management group had major complications related to anticoagulant treatment. The unadjusted risk difference for major complications between groups was 5.1 percentage points (exact 95% CI, 1.7 to 8.5 percentage points). Fewer patients had minor hemorrhages in the self-management group (14.9%) than in the conventional management group (36.4%). Fifteen patients (4.1%) in the conventional management group and 6 (1.6%) in the self-management group died (unadjusted risk difference, 2.5 percentage points [exact 95% CI, 0.0 to 5.1 percentage points]). The trial was performed at only 1 center and was not blinded. The dropout rate in the intervention group was 21%. Compared with conventional management by an anticoagulation clinic, self-management of oral anticoagulant treatment achieved a similar level of control. Of note, major complications and minor hemorrhages were less common in the self-management group.

Self-Management of Oral Anticoagulant Therapy: A Review

Patient self-management of oral anticoagulant therapy has over the last years gained increasing attention and widespread use. The method implies self-testing using a coagulometer (point-of-care device) and self-dosaging of coumarin. The method entails advantages for selected patients, who do not need to go to the hospital or family doctor for blood specimen and drug dosage adjustment. In contrast to patients on conventional management, patients performing self-managing have a reduced binding to the health care system, and it allows these patients unhindered to travel and manage their job or school. Therefore, the patients have a high degree of compliance because they are highly motivated. This has been the main justification for patient self-management. Furthermore, the conducted trials have also indicated a better quality of treatment compared to conventional management. In this paper the different aspects of this new treatment modality are critically reviewed, with special focus on the published clinical studies and the evaluation of the used coagulometers.

Clinical trial to evaluate the safety and efficacy of an Internet-based system for supervised self-management of oral anti-coagulant therapy

Clinical trial to evaluate the safety and efficacy of an Internet-based system for supervised self-management of oral anti-coagulant therapy

Mechanical heart valve patients can manage oral anticoagulant therapy themselves.

Thromboembolism and anticoagulant related bleeding are still the most common complications in mechanical heart valve patients. Management of the oral anticoagulant therapy is therefore a key determinant for these clinical complications. We hypothesize that patients selected to self-managed oral anticoagulant therapy have a better treatment quality than patients in conventional oral anticoagulant therapy. The aim of this study was to assess the time within the therapeutic International Normalized Ratio (INR) target range and the incidence of clinical complications in our group of patients, and compare these data with published data on conventional management. Mechanical heart valve patients (N=94) with a mean age of 47.6 years (range 4.2-76.6 years) were trained in home blood analysis of INR using a CoaguChek home coagulometer and coumarin dosage adjustment. After training, the patients were followed by weekly INR measurements. The therapeutic range was a target INR +/-0.5. The indications for initiating oral anticoagulant therapy were: aortic valve (N=62), mitral valve (N=29), tricuspid valve (N=1) and multiple valves (N=2). The mean observation time was 2.1 years (range 0.04-6.2 years), and the total number of patient-years was 197. The patients were within the therapeutic INR target range for a median of 76.0% (range 32.1-100.0%) of the time. There were two major thromboembolic events and five major bleedings events, comprised of two deep vein thromboses (both in the same patient), four episodes of epistaxis and one case of gastrointestinal bleeding. All the events required short hospitalization, and after treatment all the patients were discharged from the hospital without any sequelae or other complications. Using published work as references the expected number of major thromboembolic and bleeding complications in conventional management was four and 12, respectively. Self-management of oral anticoagulant therapy provides a good treatment quality for mechanical heart valve patients. We therefore consider self-management of oral anticoagulant therapy as an equally as good or potentially better treatment option for selected patients compared to conventional management.

Self-management of Oral Anticoagulant Therapy for Mechanical Heart Valve Patients

Objective - Self-management of oral anticoagulant therapy (OAT) has shown good results on a short-term basis. We hypothesize that self-management of OAT provides a better quality of treatment than conventional management also on a long-term basis. The aim of this study was to assess the quality of self-management of OAT in patients with mechanical heart valve prostheses on a 4-year perspective in a prospective, non-randomized study. Design - Twenty-four patients with mechanical heart valves and on self-managed OAT were followed for up to 4 years. A matched, retrospectively selected group of conventionally managed heart valve patients (control group) was used as reference. Results -The median observation time was 1175 days (range: 174-1428 days). The self-managed patients were within therapeutic INR target range for a mean of 78.0% (range: 36.1%-93.9%) of the time compared with 61.0% (range 37.4%-2.9%) for the control group. Conclusion - Self-management of OAT is a feasible and safe concept for selected patients with mechanical heart valve prostheses also on a long-term basis. It provides at least as good and most likely better quality of anticoagulant therapy than conventional management assessed by time within the therapeutic International Normalized Ratio (INR) target range.

Oral anticoagulation self-management and management by a specialist anticoagulation clinic: a randomised cross-over comparison

Vitamin K antagonist treatment is effective for prevention and treatment of thromboembolic events but frequent laboratory control and dose-adjustment are essential. Small portable devices have enabled patient self-monitoring of anticoagulation and self-adjustment of the dose. We compared this self-management of oral anticoagulant therapy with conventional management by a specialist anticoagulation clinic in a randomised cross-over study. 50 patients on long-term oral anticoagulant treatment were included in a randomised controlled crossover study. Patients were self-managed or were managed by the anticoagulation clinic for a period of 3 months. After this period the alternative strategy was followed for each patient. Prothrombin time (expressed as international normalised ratio [INR]) were measured at intervals of 1-2 weeks in both periods without knowledge of type of management. The primary endpoint was the number of measurements within the therapeutic range (therapeutic target value +/-50.5 INR units). There was no significant difference in the overall quality of control of anticoagulation between the two study periods. Patients were for 55% and for 49% of the treatment period within a range of +/-0.5 from the therapeutic target INR during self-management and anticoagulation clinic management, respectively (p=0.06). The proportion of patients who spent most time in the therapeutic target range was larger during self-management than during anticoagulation clinic-guided management. The odds ratio for a better control of anticoagulation (defined as the period of time in the therapeutic target range) during self-management compared with anticoagulation clinic-guided management was 4.6 (95% CI 2.1-10.2). A patient-satisfaction assessment showed superiority of self-management over conventional care. Self-management of INR in the population in this study is feasible and appears to result in control of anticoagulation that is at least equivalent to management by a specialist anticoagulation clinic. It is also better appreciated by patients. Larger studies are required to assess the effect of this novel management strategy on the incidence of thromboembolic or bleeding complications.