International Journal of Cardiology 99 (2005) 37 – 45 www.elsevier.com/locate/ijcard

Guidelines for implementation of patient self-testing and patient self-management of oral anticoagulation. International consensus guidelines prepared by International Self-Monitoring Association for Oral Anticoagulation Jack Ansell a, Alan Jacobson b, Jonathan Levy c, Heinz Vo¨ller d, J. Michael Hasenkam e,* b

a Department of Medicine, Boston University School of Medicine, 88 East Newton Street, Boston, MA 02118, USA Loma Linda University and Associate Chief of Staff for Research, Loma Linda VA, VAMC (111C), 11201 Benton Street, Loma Linda, CA 92357, USA c General Practitioner Specialist in Patient Self-Monitoring, London, UK d Klinik am See, Rehabilitation Centre for Cardiovascular Diseases, Seebad 84, 15562 Ruedersdorf, Germany e Department of CardioThoracic and Vascular Surgery, Aarhus University Hospital, Skejby Sygehus, 8200 Aarhus N, Denmark

Received 4 July 2003; accepted 10 November 2003 Available online 14 July 2004

Abstract Aims: This document provides health care professionals involved in initiating and monitoring oral anticoagulation therapy with guidelines for the provision of safe and effective patient self-testing/patient self-management of oral anticoagulation. Methods and results: The consensus group has critically reviewed the literature and compared the results of usual care (UC) vs. anticoagulation clinic and patient self-management/patient self-testing (PSM/PST). The education and training of patients for self-monitoring are described, together with the suitability of patients, the effect on quality of life and cost-effectiveness. The consensus agrees that patient self-testing and patient self-management are effective methods of monitoring oral anticoagulation therapy, providing outcomes at least as good as, and possibly better than, those achieved with an anticoagulation clinic. All patients must be appropriately selected and trained. Currently available self-testing/self-management devices give INR results which are comparable with those obtained in laboratory testing. The most frequent testing frequency is weekly but lower frequency of testing can be justified based on institutional or patient conditions. Conclusions: The consensus agrees that there are several points in favour of PST/PSM, for example, a higher degree of medical safety, increased patient education, improved response to changes in lifestyle, increased independence for the patient and improved quality of life. D 2004 Elsevier Ireland Ltd. All rights reserved. Keywords: Patient self-management; Oral anticoagulant therapy; International Normalised Ratio; Coagulometer; International consensus guidelines

1. Introduction Oral anticoagulation with coumarin derivatives is prescribed to a steadily increasing number of patients as lifelong therapy for indications such as mechanical heart valves, atrial fibrillation or inherited/acquired thrombophilic disorders. In addition, oral anticoagulation therapy has been shown to effectively prevent arterial embolism in a wide variety of clinical conditions [1– 3].

* Corresponding author. Tel.: +45-8949-5480; fax: +45-8949-6016. E-mail address: [email protected] (J.M. Hasenkam). 0167-5273/$ - see front matter D 2004 Elsevier Ireland Ltd. All rights reserved. doi:10.1016/j.ijcard.2003.11.008

The ability to maintain patients within a desired therapeutic range required for oral anticoagulation therapy is a challenge due to two main factors. These are the narrow pharmacologic therapeutic range of the coumarin derivatives, and the variability of their biological effect [4]. This variable dose response results in difficulties in initial dose selection and stabilisation, as well as long-term difficulties in maintaining stability. It has been shown that improved anticoagulant control results in improved outcomes, with a decrease in the incidence of bleeding complications and thromboembolic events [5]. It is, therefore, essential to maintain close control of the intensity of anticoagulation in order to minimise the

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J. Ansell et al. / International Journal of Cardiology 99 (2005) 37–45

Table 1 Frequency of major haemorrhage/thromboembolism in patients managed under a usual care model of management Study

Number of patients

Number of patient years

Years of data collection

New or established patients

Indications

Landefeld [8] Gitter [9] Beyth [10] Steffensen [11] Total

565 261 264 682 1772

876 221 440 756 2293

1977 – 1983 1987 – 1989 1986 – 1993 1992 – 1994

New Estab New New

Ven Ven Ven Ven

& & & &

artb art art art

Major haema

Fatal haema

Rec TEa

7.4 8.1 5.0 6.0 6.6

1.1 0.45 0.68 0.9 0.9

NA 8.1 NA NA 8.1

NA = not available; Rec TE = recent thromboembolism; haem = haemorrhage. a Major and fatal haemorrhage and thromboembolism rates expressed as percent per patient year of therapy; fatal haemorrhagic events also included with major haemorrhage. b Ven and art = mixed indications in the venous and arterial system.

adverse thrombotic and haemorrhagic events which occur with under- and over-anticoagulation [6]. Patient self-testing (PST) and patient self-management (PSM) of oral anticoagulation potentially offer further advantages over other approaches. PST is when a patient determines his/her own INR, with dose regulation by the physician; PSM is when the patient is responsible for INR determination and for dose adjustment within given limits, as demonstrated by Cosmi et al. [7]. PST and PSM are not new modalities in chronically ill patients. Regular metabolic monitoring and adjustment of the insulin dose and diabetic diet are accepted worldwide in well-trained diabetic patients and are indispensable parts of diabetic therapy. Patients on long-term oral anticoagulant therapy now also have the option of PST/PSM. There are currently over 100,000 patients performing PST/PSM of oral anticoagulation in Germany alone and a significant amount of information has been collected from these patients over the last few years. This document has been prepared in order to provide health care professionals involved in initiating and monitoring oral anticoagulation therapy with guidelines for the provision of safe and effective Patient self-testing/self-management of oral anticoagulation. This consensus has been

derived from the results of published clinical studies in selected groups of patients, together with extensive experience in clinical practice. It has been developed and agreed upon by specialists with considerable experience in this field as being the best current practice in terms of PST and PSM.

2. Usual care vs. anticoagulation clinic care vs. patient self-testing/self-management Most patients receiving chronic oral anticoagulation today are managed by their own physician, along with all other patients in their physician’s practice. There is no organised programme of management, education or follow-up. Only a few studies have specifically assessed clinical outcomes in this ‘usual care (UC)’ model of management (Table 1) [8– 11]. These studies indicate a rate of major haemorrhage of at least 7 –8% per patient year of therapy. There is a similar rate of recurrent or de novo thromboembolism with an overall serious adverse event rate of at least 15% per patient year of therapy. These adverse events are generally a consequence of poor therapeutic control, with haemorrhage or thrombosis

Table 2 Frequency of major haemorrhage/thromboembolism in patients managed under an anticoagulation management service Study

Number of patients

Number of patient years

Years of data collection

New or established patients

Indications

Target PTR/INR

Maj haema

Fatal haema

Rec TEa

Forfar [12] Errichetti [13] Conte [14] Petty [15] Charney [16] Bussey [17] Seabrook [18] Fihn [19] Van der Meer [20] Cannegieter [21] Palareti [22,23] Total

541 141 140 310 73 82 93 928 6814 1609 2745 13,475

1362 105 153 385 77 199 158 1950 6085 6475 2011 18,960

1970 – 1978 1978 – 1983 1975 – 1984 1977 – 1980 1981 – 1984 1977 – 1986 1981 – 1988 NA 1988 1985 – 1993 1993 – 1995

N&E N&E N&E N&E N&E N N N N&E N&E N

Ven & artb Ven & art Ven & art Ven & art Ven & art Ven & art Ven & art Ven & art Ven & art Mech valves Ven & art

1.8 – 2.6PTR 1.3 – 2.0PTR 1.7 – 2.5PTR NA 1.5 – 2.5PTR NA 1.5 – 2.0PTR 1.3 – 1.5PTR, 1.5 – 1.8PTR 2.4 – 5.3INR 3.6 – 4.8INR 2.0 – 3.0INR, 2.5 – 4.5INR

4.2 6.6 2.6 7.3 0 2.0 3.8 1.7 3.3 2.5 1.4 2.8

0.14 NA NA 0.77 0 NA 0 0.2 0.64 0.33 0.24 0.39

NA NA 8.4 NA 5.0 3.5 2.5 7.5 NA 0.7 3.5 2.6

NA = not available; Rec TE = recent thromboembolism; PTR = prothrombin time ratio; INR = International Normalised Ratio; haem = haemorrhage. a Major and fatal haemorrhage and thromboembolism rates expressed as percent per patient year of therapy; fatal hemorrhagic events also included with major haemorrhage. b Ven and art = mixed indications in the venous and arterial systems.

J. Ansell et al. / International Journal of Cardiology 99 (2005) 37–45

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Table 3 Frequency of major haemorrhage/thromboembolism in patients managed under usual medical care vs. anticoagulation management service Study

Model of care

Number of patients

Number of patient years

Years of data collection

Indications

Target PTR/INR

Maj haema

Fatal haema

Rec TE

Garabedian-Ruffalo [24]

UC AMS UC AMS UC AMS AMS UC AMS

26 26 271 271 44 68 82 142 176

64.3 41.9 677 669 28 60 199 102 123

177 – 1980 1980 – 1983 1982 – 1987 – 1990 1988 – 1993 1988 – 1993 1977 – 1986 1991 – 1992 1992 – 1994

Ven & artb Ven & art Mech valves Mech valves Ven & art Ven & art Ven & art Ven & art Ven & art

1.5 – 2.5PTR 1.5 – 2.5PTR 25 – 35%c 3.0 – 4.5INR NA NA NA NA NA

12.4 2.4 4.7 1.0 17.8 0 2.0 3.9 1.6

0 0 0 0 0 0 NA 0.9 0

6.2 0 6.6 0.6 42.8 0 3.5 11.8d 3.3

Cortelazzo [25] Wilt [26] Chiquette [27]

UC = usual care; AMS = anticoagulation management service; TE = thromboembolism; PTR = prothrombin time ratio; INR = International Normalised Ratio. a Major and fatal haemorrhage, thromboembolism, and cost savings rates expressed as percent per patient year of therapy; fatal haemorrhagic events included with major haemorrhage. b Ven and art = mixed indications in the venous and arterial systems. c Prothrombin activity. d Two TE events fatal.

occurring as a consequence of excessive or subtherapeutic anticoagulation. A co-ordinated and focused approach to the management of therapy by specialised programmes (anticoagulation

clinic care, ACC) significantly improves clinical outcomes by improving therapeutic control and time-in-therapeutic range (TTR), lessening the frequency of haemorrhage or thrombosis and decreasing the use of medical resources,

Table 4 Capillary whole blood (point-of-care) PT instruments Instrument

Clot detection methodology

Type of sample

Home use approval

Protime Monitor 1000 Coumatraka

Clot initiation: Thromboplastin Clot detection: Cessation of blood flow through capillary channel

Capillary WB Venous WB

No

Clot initiation: Thromboplastin

Capillary WB

Yesb (not yet submitted for approval in the USA)

Clot detection: Cessation of movement of iron particles

Venous WB

Ciba Corning 512 Coagulation Monitora CoaguChek Plusa CoaguChek Proa CoaguChek Pro/DMa CoaguChek CoaguChek S Thrombolytic Assessment System Rapidpoint Coag ProTIME Monitor Hemochron Jrc GEM PCLc Avosure Pro + d Avosure Prod Avosure PTd Harmony

INRatioe

Plasma Clot initiation: Thromboplastin Clot detection: Cessation of blood flow through capillary channel

Capillary WB Venous WB

Yes

Clot initiation: Thromboplastin Clot detection: Thrombin generations detected by fluorescent thrombin probe

Capillary WB Venous WB

Yes

Clot initiation: Thromboplastin Clot detection: Cessation of blood flow through capillary channel Clot initiation: Thromboplastin Clot detection: Change in impedance in sample

Plasma Capillary WB Venous WB

Yes

Capillary WB

Approved

WB = whole blood. a All instruments in this category are based on the original Biotrack model (Protime Monitor 1000) and licensed under different names. The latest version available is the CoaguChek Pro and Pro/DM (as models evolved they acquired added capabilities); earlier models no longer available. b CoaguChek not actively marketed for home use at the time of this writing. Thrombolytic Assessment System not available for home use. c Hemochron Jr and GEM PCL are simplified version of the ProTIME Monitor. d Avosure instruments removed from market when manufacturer (Avocet) ceased operations (2001). Technology has since been purchased by BeckmanCoulter. e INRatio, manufactured by Hemosense, gained Self Test FDA approval in the US in November 2002 and has since received the Self-Test CE mark.

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leading to more cost-effective therapy. These positive outcomes from ACC have been demonstrated in a large number of retrospective, and some prospective, studies of care delivered by an anticoagulation clinic (Table 2) [12 – 23]. These mostly observational studies indicate a greater than 50% reduction in both major haemorrhage and thrombosis compared to UC. Lastly, Table 3 summarises studies examining both models of management where co-ordinated care is measured against a control group of UC [24 –27]. These mostly nonrandomised, retrospective analyses provide further evidence for the benefit of co-ordinated care.

3. Patient self-testing and patient self-management There is potential for further simplifying and improving anticoagulation management by point-of-care (POC) testing.

Since the late 1980s, several devices have been introduced or are in development (Table 4) [28]. These instruments are based on clot detection methodology using thromboplastin to initiate clot formation, while the end-point of clot detection varies from instrument to instrument. Although limitations of these instruments have been described, POC instruments have been tested in a number of different clinical settings and their accuracy and precision are considered to be more than adequate for the monitoring of oral anticoagulant therapy [29] in both adults and children [30 –35]. Studies comparing clinical outcomes (either TTR or adverse events) have shown a marked difference between PSM and UC. Other similar comparisons have shown outcomes at least as good as, and possibly better than, those achieved with ACC. Table 5 summarises those studies where clinical outcomes, either TTR or adverse events, have been reported [36 –49].

Table 5 Summary of studies assessing time in therapeutic range or adverse events using patient self-testing or patient self-management-stratified according to whether comparator group was usual care (UC) or anticoagulation clinic (ACC) Study

Study design

Study groups

Number of patients

Time in range (%/pt-yr)

Maj haem (% or days)

TE (%/pt-yr)

Indications (%/pt-yr)

Beyth [36]

RCT

Horstkotte [37]

RCT

Sawicki[38]

RCT

Hasenkam [39] Ko¨rtke [40]

Obs Matched cont RCT

White [41]

RCT

Kaatz [42]

RCT

Ansell [43]

Obs Matched cont Prospective Controlled Randomised Controlled Cross-over RCT

PST UC PSM UC PSM UC PSM UC PSM UC PST ACC PST ACC PSM ACC PSM ACC PSM ACC PST PSM ACC PSM Mixed PSM UC PSM UC

162 163 75 75 90 89 20 20 305 295 23 23 NA NA 20 20 49 53 50 50 28 23 26 1375 355

56 33 92 59 57/53b 34/43b 77 53 78 61 93 75 63 65 89 68 86 80 55 49 70 71 68 69 73.5 62.5 83.1

5.7 12 4.5a 10.9a 2.2 2.2 NA NA 1.7 2.6 0 0 NA NA 0 0 4c 0 0 0 NA NA NA 1.61 3.28 4.67 3.38 6.31

9 13 0.9 3.6 2.2 4.5 NA NA 1.2 2.1 0 0 NA NA 0 0 0 0 0 16 NA NA NA 1.12

Mixed Mixed Heart valves Heart valves Mixed Mixed Heart valves Heart valves Heart valves Heart valves Mixed Mixed NA NA Mixed Mixed Mixed Mixed Mixed Mixed Mixed Mixed Mixed Mixed Heart valves Heart valves Heart valves Heart valves

Watzke [44] Cromheecke [45] Gadisseur [46]

Heidinger [47] Preiss [48]

Obs Prospective

Bernardo [49]

Prospective

92 317

RCT = randomised controlled trial; Obs = observational; PST = patient self-testing; PSM = patient self-management; ACC = anticoagulation clinic; UC = usual care; Mixed = mixed indications. TE = thromboembolic, haem = haemorrhage, maj = major, pt = patient; yr = year. Note: Both PST and PSM studies are included. The studies are grouped according to whether the comparator arm was a UC model of therapy or an anticoagulation management service. It should be noted that the difference between groups for TTR was considerably less marked when compared to an anticoagulation management service vs. UC. a Major and minor bleeding. b Time in range at 3 and 6 months. c % of episodes in 49 pts.

J. Ansell et al. / International Journal of Cardiology 99 (2005) 37–45

None of these PST/PSM studies were adequately designed to clearly answer the important question of what might account for better therapeutic control. The major variables not adequately controlled included the level of patient education, the subtle impact on compliance, the frequency of monitoring and the consistency of reagent and instrumentation. Further studies are needed to define the importance of these parameters. A strong relationship between TTR and bleeding rates has been observed across a large number of studies with different patient populations, different target ranges, different scales for measuring intensity of anticoagulation (i.e. PT, PT ratio and INR) and different models of dosage management [5,17,21,25,26] A similar relationship holds for TTR and rates of thromboembolism. Many studies indicate that an increased frequency of testing leads to more results within the therapeutic range [31,50]. The frequency of testing is dependant on many factors including patient stability, compliance, fluctuations in co-morbid conditions, the addition or discontinuation of other medications, changes in diet, the quality of dose-adjustment decisions and the stage of treatment [6]. The increased frequency of monitoring of the INR may be a factor for improved outcomes with PST/PSM. Recently, a German study [48,51] with over 2800 patients followed for a total of 8061 follow-up years after mechanical heart valve replacement suggested that significant fluctuations in consecutive INR measurements were the strongest predictors for both thromboembolic and bleeding events rather than over or under anticoagulation. Other factors may, however, also be important in this regard. For example, patient education regarding anticoagulation therapy and patient empowerment are important elements in improving quality of treatment and patient awareness and could also be a major factor for improving patient compliance. Based on the above factors, POC PT monitors offer the potential to lower the risk/benefit profile of anticoagulant therapy, improve patient satisfaction and possibly improve patient compliance. By reducing the labour intensity of physician management, PST/PSM can also encourage more widespread use of oral anticoagulants.

4. Quality of life As well as improving TTR and reducing the number of potential complications associated with oral anticoagulant therapy, improvement in quality of life is an important benefit which has been observed with PSM [38,45,52].

5. Cost-effectiveness It has been shown that PSM can be cost-effective in the longer-term. While the initial costs of PSM are higher than

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those for laboratory monitoring of INR due to the cost of training and providing the coagulation monitor and test strips, several studies [53 – 55] suggest that PSM is the most costeffective method of monitoring patients on oral anticoagulation therapy. In a GELIA sub-study [56], the reduction in costs associated with the 30% reduction in severe complications and the 20% reduction in lethal strokes due to bleeding observed with PSM was 52,000 Euro per life year gained. However, it must be noted that cost savings may differ between various countries and different institutions, depending on the costs of the actual system of anticoagulant control.

6. Suitable patients Patient self-testing/self-management should be considered in patients who are on long-term oral anticoagulation with artificial heart valve prosthesis, chronic atrial fibrillation, thrombophilia (e.g. after recurrent deep vein thrombosis in the leg and pulmonary embolism) and post-myocardial infarction with impaired left ventricular pump function, including advanced congestive cardiomyopathy. Various studies have found that, as with self-testing and self-management of insulin-dependant diabetes, most patients who are able to lead an independent and Selfsupporting life are, in principle, capable of self-testing/selfmanagement of oral anticoagulation, irrespective of education and social status [45,57] The only requirement in terms of intellectual ability is that the patient (or care giver) is able to understand the concept of oral anticoagulant therapy and its potential risks. Otherwise, the only necessity is willingness to actively participate in treatment, sufficient manual dexterity and acuity of vision. No previous experience in PST/PSM is necessary. All patients wanting to perform PST/PSM must successfully complete a structured training course and must be willing to accept the responsibility for self-management. The ability to learn how to perform self-management is not associated with a defined age group. However, both age and co-morbidity also play an important role in this decision [58]. If patients are not in a position to perform PSM themselves, care givers, parents [35,59] or other relatives can undertake it on their behalf. Medical supervision of the patient must be continued by regular consultation with the training centre or physician, even when treatment is free from complications.

7. Suitable coagulometers The coagulometers currently available differ in their physical methods of measurement and in their degree of automation (Table 4). Easy, portable, fully automated coagulation monitors have now become available which allow the reliable determination of the PT, expressed as INR, from one drop of capillary whole blood from a fingerstick [28].

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Specific devices shall not be reviewed in these guidelines due to the variations in devices available in different countries. It is sufficient to say that all of the devices that are authorised in each market will have had their accuracy and reliability demonstrated. There are quality assurance programmes available that indicate whether measured INR values are within the recommended consensus values, with numerous coagulometers having been included in these quality assessment programmes (e.g. UK NEQAS). Issues of reimbursement for devices and test strips must be addressed independently in each country and cannot be addressed within the scope of this document.

8. Education and training Education on the theoretical and pharmaceutical aspects of anticoagulation is a fundamental requirement for all patients on anticoagulant therapy; training on point-of-care INR testing is essential for those patients in PST/PSM. Education and training infrastructures will develop differently in each country, depending on local circumstances. However, it will require the development of resources to train the trainers, as well as the patients.

but teach health care professionals directly have also proven successful.

10. Training the patients Providing an appropriate education programme is an important part of PST/PSM. For self-testing, the main goal of training is to teach patients practical skills which enable them to achieve accurate INR results. This must include operation of the monitoring device and finger-pricking technique. For self-management, the main goal is for patients to be able to report INR data, as well as clinical observations regarding their oral anticoagulant therapy, to their health care provider. Furthermore, patients should be able to respond appropriately to required dosage changes. Therefore, PSM requires a more sophisticated patient training programme. The contents of the ASA/SPOG training course include:    

9. Training the trainers 

In order that patient training can be successfully achieved, health care professionals who train patients must themselves be trained in the management of anticoagulant therapy and have practical knowledge of PST/PSM devices. There is a considerable amount of comprehensive material already available for trainers. This material should be used as a model wherever possible since relevant standards have already been set and training courses evaluated in clinical practice (e.g. ASA booklet). Training can be performed successfully by a ‘train-thetrainer’ approach by suitably qualified staff under the supervision of a physician. The training programme for trainers set out by the Anticoagulation Self-management Association (ASA) consists of a 1-day seminar. This covers the theoretical and pharmaceutical aspects of anticoagulation, use of equipment and a practical session. Trainers are then qualified to lead patients through the structured teaching and self-management programme (SPOG) which comprises three lessons of 90– 120 min each [32]. Training centres should be open for queries at prespecified times and it is ideal if 24-h contact details are given to patients in case of emergency. One to threemonthly records of INR values should be monitored by the training centre or the treating physician. In addition to the ‘train-the-trainer’ approach, trials in the US have demonstrated that carefully structured training programmes that do not follow a ‘train-the-trainer’ approach

  

basic information on blood coagulation; theoretical principles of individual anticoagulation/drug interactions with oral anticoagulants; practical information on coagulation monitoring with coagulometers; evaluation of measurements and, if necessary, dose adjustment; signs of bleeding events (overdose) and thromboembolic events (underdose); information on the frequency of INR determination; keeping a patient diary/quality control record keeping; travel, nutrition, endocarditis prophylaxis, intramuscular injections, etc.

All training sessions should be concluded with a formalised test which serves to document each patient’s understanding of oral anticoagulant therapy and PST/PSM. Having passed the test, patient should receive a certificate and their performance should be monitored by regular update sessions. German experience demonstrates efficient, cost-effective training with a patient group size of 3 – 5 [60] with additional interaction and reinforcement between patients. However, group sizes must be determined by national/local, social and medical traditions.

11. Monitoring of PST/PSM Despite the ability of patients to self-test/self-manage, adequate clinical support remains essential. On-going education, advice in cases of sustained lack of anticoagulation control and advice on interruption of therapy in cases of bleeding or the need to undergo an invasive procedure are, amongst others, all issues which must be considered. The

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anticoagulation clinic can play an important role in overseeing such organisation. To provide a methodical guarantee of the reliability of PST/PSM, coagulometers should be assessed by training centres at least once a year. Alternatively, patient devices can be double-checked with a POC device in the physician’s office, clinic or laboratory. This offers the added benefit of monitoring patient handling and ensuring that patient data is stored in the meter instantly.

[2]

[3]

[4]

[5]

12. Summary of consensus A significant number of patients undergoing lifelong oral anticoagulation therapy are eligible for PST/PSM. After structured training by trained health care professionals, suitable patients are in a position to determine their anticoagulation intensity accurately and reliably and selected patients are also able to adjust their dosages accordingly. Recent technical developments have produced high-precision, user-friendly coagulometers. Patients are able to achieve a stable anticoagulant level with weekly testing, or more frequently if required, thereby significantly reducing the number of complications. PSM may be more cost-effective than usual care or anticoagulant clinic care and, above all, considerably improves quality of life by giving the patient more independence. Summary of ISMAA recommendations:

[6]

[7]

[8]

[9]

[10]

[11] 





 

Patient self-testing/self-management is an effective method of monitoring oral anticoagulation therapy, providing outcomes at least as good as, and possibly better than, those achieved with an anticoagulation clinic. Available self-testing/self-management devices give INR results which are comparable with those obtained in laboratory testing. The most frequent testing frequency is weekly but lower frequency of testing can be justified based on institutional or patient conditions. Patients must be appropriately selected and trained. Patient self-testing/self-management is the most patient friendly method for long-term, high frequency monitoring of oral anticoagulation.

[12]

[13]

[14]

[15] [16]

[17]

Acknowledgements The following companies have supported ISMAA by unrestricted educational grants: Avocet, Hemosense, LifeScan, Medtronic, Roche Diagnostics, St. Jude Medical.

[18]

[19]

[20]

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