Oral anticoagulation self-management and management by a specialist anticoagulation clinic: a randomised cross-over comparison. Self-management of oral anticoagulation in the elderly: rationale, design, baselines and oral anticoagulation control after one year of follow-up. A randomized controlled trial. A randomised controlled trial of patient self management of oral anticoagulation treatment compared with primary care management. Self-management of oral anticoagulation in nonvalvular atrial fibrillation (SMAAF study). [Background and evaluation plan of a study on self-management of anticoagulation in patients with non-valvular atrial fibrillation (SMAAF Study)]. Comparing self-management of oral anticoagulant therapy with clinic management: a randomized trial. A structured teaching and self-management program for patients receiving oral anticoagulation: a randomized controlled trial. Working Group for the Study of Patient Self-Management of Oral Anticoagulation. Optimal Frequency of Patient Monitoring and Intensity of Oral Anticoagulation Therapy in Valvular Heart Disease. Self management of oral anticoagulation: randomised trial.
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. Self-management is safe and reliable in patients with long-term oral anticoagulation (OAC). However, no study has yet assessed the safety and efficacy of OAC self-management in elderly patients with major thromboembolic and haemorrhagic complications as primary outcomes. In this multi-centre, open, randomised controlled trial, patients aged 60 years or more were randomised into the self-management group (SMG) (N = 99) or routine care group (RCG) (N = 96). We describe the rationale, design, baseline characteristics and interim analyses of oral anticoagulation control quality within the first year of follow-up. The medians of the squared international normalised ratio (INR) value deviations after six and 12 months were significantly lower in the SMG with medians of 0.16 and 0.16 compared to the RCG with medians of 0.25 and 0.25. The percentage of time within target range and the percentage of INR measurements within target range were significantly higher in the SMG versus the RCG within the first six months (medians 71% vs. 58% and 69% vs. 57%), and during the second six months of the study (75% vs. 67% and 72% vs. 57%). The numbers of all thromboembolic events requiring hospitalisation, major bleeding events, and deaths were similar in both groups. These preliminary results suggest that self-management of oral anticoagulation is safe and feasible for elderly patients willing to participate in a structured training programme. The increase in numbers of patients receiving warfarin treatment has led to the development of alternative models of service delivery for oral anticoagulant monitoring. Patient self management for oral anticoagulation is a model new to the UK. This randomised trial was the first to compare routine primary care management of oral anticoagulation with patient self management.
                To test whether patient self management is as safe, in terms of clinical effectiveness, as primary care management within the UK, as assessed by therapeutic international normalised ratio (INR) control.
                Patients receiving warfarin from six general practices who satisfied study entry criteria were eligible to enter the study. Eligible patients were randomised to either intervention (patient self management) or control (routine primary care management) for six months. The intervention comprised two training sessions of one to two hours duration. Patients were allowed to undertake patient self management on successful completion of training. INR testing was undertaken using a Coaguchek device and regular internal/external quality control tests were performed. Patients were advised to perform INR tests every two weeks, or weekly if a dose adjustment was made. Dosage adjustment was undertaken using a simple dosing algorithm.
                Seventy eight of 206 (38%) patients were eligible for inclusion and, of these, 35 (45%) declined involvement or withdrew from the study. Altogether, 23 intervention and 26 control patients entered the study. There were no significant differences in INR control (per cent time in range: intervention, 74%; control, 77%). There were no serious adverse events in the intervention group, with one fatal retroperitoneal haemorrhage in the control group. Costs of patient self management were significantly greater than for routine care (pound 90 v pound 425/patient/year).
                These are the first UK data to demonstrate that patient self management is as safe as primary care management for a selected population. Further studies are needed to elucidate whether this model of care is suitable for a larger population. Most patients with atrial fibrillation are at risk of suffering thromboembolic events. This risk can be reduced by twothirds by efficient anticoagulation. This prospective multi-center trial investigated whether the quality of treatment can be improved by self-management in patients with atrial fibrillations (SMAAF Study) compared to conventional patient management by the family doctor.
                Two thousand patients suitable for self-management were to be randomized into the two arms of the study. In the period of investigation from December 1999 to July 2001, only 202 patients (64.3+/-9.2 years, 69.3% men) consented to participate. The study was discontinued prematurely since the number of patients was too low. As a consequence, the group comparison is confined to the evaluation of the INR values measured using the two-tailed t test.
                Of the 202 patients included, 101 were assigned to the self-management group (64.6+/-9.6 years, 71.4% men) and 101 (64.1+/-8.9 years, 61.4% men, n.s.) were assigned to the group managed by the family doctor. The total number of INR measurements was 2 865. This comprised 2 072 measurements in patients under self-management and 793 in the family doctor group. The values were within the target range significantly more frequently (p=0.0061) in patients under self-management (67.8%) as compared to the family doctor group (58.5%). There was a trend with regard to the time within target range, but the difference was not significant (178.8+/-126 days as compared to 155.9+/-118.4 days). In the self-management group, there were two severe hemorrhages, and there was one thromboembolic event in the family doctor group.
                Management of oral anticoagulation by INR self-management in patients with atrial fibrillation is not inferior to conventional care. The objective of this open, randomized, multicenter study is to investigate the benefits and economic efficiency of self-management of oral anticoagulation in patients with atrial fibrillation (SMAAF study) in comparison with a group of patients given conventional care by a general practitioner or specialist. Two thousand patients suitable for self-management will be assigned at random to either the self-management group or the control group. The numbers of thromboembolic and hemorrhagic complications requiring treatment during the 2-year follow-up period will be recorded as the primary end point. The secondary endpoint variables will be maintenance of the INR value in the individual target range, INR variance, the course of complications over time, and the cost efficiency of self-management compared with the routine procedures. The last of these parameters will include the diagnostic and/or therapeutic measures carried out, the duration of inpatient hospital treatment, and the social consequences (subsequent rehabilitation treatment, inability to work, forced retirement). The estimate of the required number of patients was based on the assumption that during long-term anticoagulant therapy within the framework of primary and secondary prevention 4% of patients with chronic non-valvular atrial fibrillation would have severe thromboembolic of hemorrhagic complications each year. Since this rate can be halved by self-management, a one-tailed chi 2-test of 80% power and a 5% significance threshold would require n = 997 patients per group. The results of the SMAAF study will establish the socioeconomic benefits of self-management in patients with non-valvular atrial fibrillation. 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. Control of oral anticoagulation therapy has been reported to often be inadequate. Previous retrospective investigations suggest that patients' self-adjustment of oral anticoagulants may lead to improved control.
                To investigate the effects of patients' self-management of oral anticoagulation therapy on accuracy of control and measures of treatment-related quality of life.
                Randomized, single-blind, multicenter trial.
                A total of 179 patients receiving long-term oral anticoagulation treatment were enrolled at 5 referral centers in Germany.
                Patients were randomized to an oral anticoagulation self-management group based on a structured treatment and teaching program and international normalized ratio (INR) self-monitoring. The control group received conventional care as provided by family physicians, including referral to specialists if necessary.
                Deviation of INR values from the individual INR target range (squared) and the 5 categories of treatment-related quality of life.
                Deviation of INR value from the mean of the INR target range was significantly lower in the intervention group at 3-month (squared INR deviation, 0.59 vs 0.95; P<.001) and 6-month follow-up (0.65 vs 0.83; P=.03) compared with the control group. Also, the intervention group had INR values within the target range more often (repeated measurement analysis for categorical data, P=.006). The results were mainly due to less frequent suboptimal INR values in the intervention group (32.8% vs 50.0% [P=.03] at 3-month, and 33.7% vs 48.2% [P=.08] at 6-month follow-up). Treatment-related quality-of-life measures, especially treatment satisfaction scores, were significantly higher in the intervention group compared with controls.
                An anticoagulation education program that includes self-management of anticoagulation therapy results in improved accuracy of anticoagulation control and in treatment-related quality-of-life measures. Further studies are needed to describe whether the program will reduce risk of bleeding or thromboembolism. The antithrombotic effect of oral anticoagulation therapy and the incidence of anticoagulant-related bleeding complications are both closely correlated with the intensity of treatment. The optimal intensity of oral anticoagulation for an individual patient is the target INR that results in the lowest incidence of thromboembolic plus bleeding complications. For patients with native valve lesions, one must consider the cardiac morphology and pathophysiology, for example, the etiology of the disease, left atrial diameters, loss of active atrial contraction (atrial fibrillation), left ventricular pump function, and left ventricular diameters, to determine an optimal INR target. In patients with prosthetic devices, the "thrombogenicity" of the heart valve prosthesis is an additional risk factor for intracardiac thrombus formation and thromboembolic episodes. This "thrombogenicity" may vary significantly from device to device. INR self-testing improves the overall prognosis of patients on lifelong oral anticoagulation therapy because patients remain more precisely within that target therapeutic INR range. For most patients under phenprocoumon, one to two INR measurements per week are a sufficient frequency to provide a stable intensity of anticoagulation. To determine the clinical effectiveness of self management compared with routine care in patients on long term oral anticoagulants.
                Multicentre open randomised controlled trial.
                Midlands region of the UK.
                617 patients aged over 18 and receiving warfarin randomised to intervention (n = 337) and routine care (n = from 2470 invited; 193/337 (57%) completed the 12 month intervention.
                Intervention patients used a point of care device to measure international normalised ratio twice a week and a simple dosing chart to interpret their dose of warfarin.
                Percentage of time spent within the therapeutic range of international normalised ratio.
                No significant differences were found in percentage of time in the therapeutic range between self management and routine care (70% v 68%). Self managed patients with poor control before the study showed an improvement in control that was not seen in the routine care group. Nine patients (2.8/100 patient years) had serious adverse events in the self managed group, compared with seven (2.7/100 patient years) in the routine care arm (chi2(df = 1) = 0.02, P = 0.89).
                With appropriate training, self management is safe and reliable for a sizeable proportion of patients receiving oral anticoagulation treatment. It may improve the time spent the therapeutic range for patients with initially poor control. Trial registration ISRCTN 19313375.
Compared to standard monitoring, patients who self-monitor or self-manage can improve the quality of their oral anticoagulation therapy. The number of thromboembolic events and mortality were decreased without increases in harms. However, self-monitoring or self-management were not feasible for up to half of the patients requiring anticoagulant therapy. Reasons included patient refusal, exclusion by their general practitioner, and inability to complete training.