title: Self- versus Conventional Management of Oral Anticoagulant Therapy Oral anticoagulation management in primary care with the use of computerized decision support and near-patient testing: a randomized, controlled trial. 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 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. The Belgian Improvement Study on Oral Anticoagulation Therapy: a randomized clinical trial. A pragmatic cluster randomised controlled trial to evaluate the safety, clinical effectiveness, cost effectiveness and satisfaction with point of care testing in a general practice setting – rationale, design and baseline characteristics Patient self management of oral anticoagulation in routine care in the UK A randomised controlled trial of patient self management of oral anticoagulation treatment compared with primary care management Potentially Preventable Strokes in High-Risk Patients With Atrial Fibrillation Who Are Not Adequately Anticoagulated Patient self-management of oral anticoagulant care vs. management by specialized anticoagulation clinics: positive effects on quality of life. Oral anticoagulation self-management and management by a specialist anticoagulation clinic: a randomised cross-over comparison A randomized trial of patient self-managed versus physician-managed oral anticoagulation. Pharmacology and management of the vitamin K antagonists: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). INR Self-Management Following Mechanical Heart Valve Replacement Comparing the quality of oral anticoagulant management by anticoagulation clinics and by family physicians: a randomized controlled trial. The Impact of Patient Self-Testing of Prothrombin Time for Managing Anticoagulation: Rationale and Design of VA Cooperative Study #481—The Home INR Study (THINRS) Patient self‐management of anticoagulation therapy: a trial‐based cost‐effectiveness analysis A prospective controlled trial comparing weekly self-testing and self-dosing with the standard management of patients on stable oral anticoagulation. International normalized ratio self-management after mechanical heart valve replacement: is an early start advantageous? Comparison of the quality of oral anticoagulant therapy through patient self-management and management by specialized anticoagulation clinics in the Netherlands: a randomized clinical trial. A randomised control trial of patient self‐management of oral anticoagulation compared with patient self‐testing Patient preferences for capillary vs. venous INR determination in an anticoagulation clinic: a randomized controlled trial. Improving the quality of anticoagulation of patients with atrial fibrillation in managed care organizations: results of the managing anticoagulation services trial. Self-Management of oral Anticoagulation in nonvalvular Atrial Fibrillation (SMAAF study) An analysis of the lowest effective intensity of prophylactic anticoagulation for patients with nonrheumatic atrial fibrillation. Direct-to-patient expert system and home INR monitoring improves control of oral anticoagulation Home prothrombin time monitoring after the initiation of warfarin therapy. A randomized, prospective study. Comparing Self-Management of Oral Anticoagulant Therapy with Clinic Management Reliability of point‐of‐care prothrombin time testing in a community clinic: a randomized crossover comparison with hospital laboratory testing Self-management versus conventional management of oral anticoagulant therapy: A randomized, controlled trial. The value of education and self‐monitoring in the management of warfarin therapy in older patients with unstable control of anticoagulation Self-managed anticoagulation: results from a two-year prospective randomized trial with heart valve patients. A Multicomponent Intervention To Prevent Major Bleeding Complications in Older Patients Receiving Warfarin Patient self‐testing is a reliable and acceptable alternative to laboratory INR monitoring Self-management of oral anticoagulation reduces major outcomes in the elderly. A randomized controlled trial. International normalized ratio self-management lowers the risk of thromboembolic events after prosthetic heart valve replacement.
abstract: Background 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 r and omized to conventional management versus self-management .  Methods The study design included uniform analysis of blinded control blood sample s in both treatment arms . Ninety-two patients were r and omly 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 st and ard deviation ) of the INR value , the median INR-value ( using a blinded control sample analyzed monthly by a reference laboratory ) , and the coumarin dose . Results 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 . Conclusion 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 BACKGROUND There is increased pressure on primary care physicians to monitor oral anticoagulation . OBJECTIVE To test the null hypothesis that oral anticoagulation care can be provided at least as well in primary care through a nurse-led clinic , involving near-patient testing and computerized decision support software , compared with routine hospital management based on a variety of clinical outcome measures . METHODS A r and omized , controlled trial in 12 primary care practice s in Birmingham , Engl and ( 9 intervention and 3 control ) . Two control population s were used :  patients individually r and omly allocated as controls in the intervention practice s ( intra practice controls ) and all patients in control practice s ( inter practice controls ) . Intervention practice s ' patients were r and omized to the intervention ( practice -based anticoagulation clinic ) or control ( hospital clinic ) group . The main outcome measure was therapeutic control of the international normalized ratio . RESULTS Three hundred sixty-seven patients were recruited ( 122 intervention patients , 102 intra practice control patients , and 143 inter practice control patients ) . St and ard measures of control of the international normalized ratio ( point prevalence ) showed no significant difference between the intervention and control groups . Data on proportion of time spent in the international normalized ratio range showed significant improvement for patients in the intervention group ( paired t test , P = .008 ) . CONCLUSIONS Nurse-led anticoagulation clinics can be implemented in novice primary care setting s by means of computerized decision support software and near-patient testing . Care given by this model is at least as good as routine hospital follow-up . The model is generalizable to primary health care centers operating in developed health care systems 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 , r and omised controlled trial , patients aged 60 years or more were r and omised 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 CONTEXT 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 . OBJECTIVE To investigate the effects of patients ' self-management of oral anticoagulation therapy on accuracy of control and measures of treatment-related quality of life . DESIGN R and omized , single-blind , multicenter trial . SETTING AND PARTICIPANTS A total of 179 patients receiving long-term oral anticoagulation treatment were enrolled at 5 referral centers in Germany . INTERVENTION Patients were r and omized 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 . MAIN OUTCOME MEASURES Deviation of INR values from the individual INR target range ( squared ) and the 5 categories of treatment-related quality of life . RESULTS 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 . CONCLUSIONS 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 AIMS In Belgium , general practitioners ( GPs ) mainly manage oral anticoagulation therapy . To improve the quality of oral anticoagulation management by GPs and to compare different models and interventions , a r and omized clinical trial was performed . METHODS AND RESULTS Stratified r and omization divided 66 GP- practice s into four groups . A 6-month retrospective analysis assessed the baseline quality . In the prospect i ve study , each group received education on oral anticoagulation , anticoagulation files , and patient information booklets ( groups A , B , C , and D ) . Group B additionally received feedback every 2 months on their anticoagulation performance ; group C determined the international normalized ratio ( INR ) with a CoaguChek device in the doctor 's office or at the patient 's home ; and group D received Dawn AC computer assisted advice for adapting oral anticoagulation . For the different groups , the time spent in target INR range ( Rosendaal 's method ) and adverse events related to anticoagulation were determined and compared with the same quality indicators at baseline . There was a significant increase in per cent of time within 0.5 INR from target , from 49.5 % at baseline to 60 % after implementing the different interventions . However , neither the per cent in target range nor the event rates differed among the four groups . CONCLUSION The interventions significantly improved the quality of management of oral anticoagulation by Belgian GPs , mainly as a result of an education and support programme Background Point of care testing ( PoCT ) may be a useful adjunct in the management of chronic conditions in general practice ( GP ) . The provision of pathology test results at the time of the consultation could lead to enhanced clinical management , better health outcomes , greater convenience and satisfaction for patients and general practitioners ( GPs ) , and savings in costs and time . It could also result in inappropriate testing , increased consultations and poor health outcomes result ing from inaccurate results . Currently there are very few r and omised controlled trials ( RCTs ) in GP that have investigated these aspects of PoCT . Design / Methods The Point of Care Testing in General Practice Trial ( PoCT Trial ) was an Australian Government funded multi-centre , cluster r and omised controlled trial to determine the safety , clinical effectiveness , cost effectiveness and satisfaction of PoCT in a GP setting .The PoCT Trial covered an 18 month period with the intervention consisting of the use of PoCT for seven tests used in the management of patients with diabetes , hyperlipidaemia and patients on anticoagulant therapy .  The primary outcome measure was the proportion of patients within target range , a measure of therapeutic control . In addition , the PoCT Trial investigated the safety of PoCT , impact of PoCT on patient compliance to medication , stakeholder satisfaction , cost effectiveness of PoCT versus laboratory testing , and influence of geographic location . Discussion The paper provides an overview of the Trial Design , the rationale for the research methodology chosen and how the Trial was implemented in a GP environment . The evaluation protocol and data collection processes took into account the large number of patients , the broad range of practice types distributed over a large geographic area , and the inclusion of pathology test results from multiple pathology laboratories . The evaluation protocol developed reflects the complexity of the Trial setting , the Trial Design and the approach taken within the funding provided . The PoCT Trial is regarded as a pragmatic RCT , evaluating the effectiveness of implementing PoCT in GP and every effort was made to ensure that , in these circumstances , internal and external validity was maintained . Trial Registration Background : Self management of anticoagulation : a r and omised trial ( SMART ) was the first large scale UK trial to assess clinical and cost effectiveness of patient self management ( PSM ) of oral anticoagulation therapy compared to routine care . SMART showed that while PSM was as clinical ly effective as routine care , it was not as cost effective . SMART adds to the growing body of trial data to support PSM ; however there are no data on clinical effectiveness and cost of PSM in routine care . Aim : To evaluate clinical effectiveness of PSM compared to routine care outside trial conditions . Methods : A retrospective multicentre matched control study . 63 PSM patients from primary care in the West Midl and s were matched by age and international normalised ratio ( INR ) target with controls .  INR results were collected for the period 1 July 2003–30 June 2004 . The primary outcome measure was INR control . Results : 38 PSM and 40 control patients were recruited .  INR percentage time in range was 70 % PSM vs 64 % controls . 60 % PSM were having a regular clinical review , 45 % were performing an internal quality control ( IQC ) test and 82 % were performing external quality assurance ( EQA ) on a regular basis . Conclusion : PSM outside trial conditions is as clinical ly effective as routine UK care Background : 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 r and omised trial was the first to compare routine primary care management of oral anticoagulation with patient self management . Aim : 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 . Method : Patients receiving warfarin from six general practice s who satisfied study entry criteria were eligible to enter the study . Eligible patients were r and omised 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 . Results : 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 ( £ 90 v £ 425/patient/year ) . Conclusion : 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 eluci date whether this model of care is suitable for a larger population Background and Purpose — Warfarin is the most effective stroke prevention medication for high-risk individuals with atrial fibrillation , yet it is often underused . This study examined the magnitude of this problem in a large contemporary , prospect i ve stroke registry . Methods — We analyzed data from the Registry of the Canadian Stroke Network , a prospect i ve data base of consecutive patients with stroke admitted to 12 design ated stroke centers in Ontario ( 2003 to 2007 ) . We included patients admitted with an acute ischemic stroke who ( 1 ) had a known history of atrial fibrillation ; ( 2 ) were classified as high risk for systemic emboli according to published guidelines ; and ( 3 ) had no known contraindications to anticoagulation . Primary end points were the use of prestroke antithrombotic medications and admission international normalized ratio . Results — Among patients admitted with a first ischemic stroke who had known atrial fibrillation ( n=597 )  , strokes were disabling in 60 % and fatal in 20 % . Preadmission medications were warfarin ( 40 % ) , antiplatelet therapy ( 30 % ) , and no antithrombotics ( 29 % ) . Of those taking warfarin , three fourths had a subtherapeutic international normalized ratio ( < 2.0 ) at the time of stroke admission . Overall , only 10 % of patients with acute stroke with known atrial fibrillation were therapeutically anticoagulated ( international normalized ratio ≥2.0 ) at admission . In stroke patients with a history of atrial fibrillation and a previous transient ischemic attack or ischemic stroke ( n=323 ) , only 18 % were taking warfarin with therapeutic international normalized ratio at the time of admission for stroke , 39 % were taking warfarin with subtherapeutic international normalized ratio , and 15 % were on no antithrombotic therapy . Conclusions — In high-risk patients with atrial fibrillation admitted with a stroke , and who were c and i date s for anticoagulation , most were either not taking warfarin or were subtherapeutic at the time of ischemic stroke . Many were on no antithrombotic therapy . These findings should encourage greater efforts to prescribe and monitor appropriate antithrombotic therapy to prevent stroke in individuals with atrial fibrillation BACKGROUND Oral anticoagulant therapy ( OAT ) implies frequent blood checks and dose changes to prevent thromboembolic or hemorrhagic complications . This may interfere with patients ' social and working circumstances in addition to the possible stress caused by the condition necessitating this treatment . We studied whether patient self-management could be a way to improve quality of life in these patients . METHODS Within a multicenter r and omized study performed by two Dutch anticoagulation clinics , design ed to study the effect on treatment quality ( time within target range ) of different modalities of patient self-management , we looked at the effect of increased patient education ( n = 28 ) , self-monitoring of the International Normalized Ratio ( INR ) ( n = 47 ) and full patient self-management ( INR monitoring and dosing of the OAT ) ( n = 41 ) on the quality of life of the patients . This was done with the aid of a written question naire ( 32 questions , minimum score = 1 , maximum score = 6 ) at baseline ( n = 163 ) , and after 26 weeks ( n = 118 ) . We compared the results after 26 weeks with those at baseline , as well as between groups . RESULTS General treatment satisfaction was already high under routine care ( 5.11 on a scale of 1 - 6 ) and increased further through self-monitoring of the INR ( + 0.19 ) and full self-management ( + 0.32 ) . Distress ( -0.44 ) , perceived daily hassles ( -0.31 ) and strain on the social network ( -0.21 ) were reduced through full self-management . Improved patient education was associated with increased distress ( + 0.33 ) and perceived daily hassles ( + 0.23 ) . Comparison at 26 weeks between groups showed similar improvements on these outcomes for self-monitoring and self-management vs. routine care after education BACKGROUND 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 r and omised cross-over study . METHODS 50 patients on long-term oral anticoagulant treatment were included in a r and omised 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 ) . FINDINGS 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 . INTERPRETATION 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 BACKGROUND Self-management ( SM ) of warfarin by patients is an attractive strategy , particularly if it improves anticoagulation control and can be done safely under minimal physician supervision . OBJECTIVE To compare the effect of SM with physician-management ( PM ) on the maintenance of therapeutic anticoagulation . METHODS A r and omized , open-label eight-month trial was performed . Patients 18 years of age and older were eligible if they were receiving warfarin for at least one month before enrolment and required anticoagulation for at least one year to a target international normalized ratio ( INR ) of 2.0 to 3.0 or 2.5 to 3.5 . Exclusion criteria were a known hypercoaguable disorder , mental incompetence , a language barrier or an inability to attend training sessions . Patients r and omly assigned to SM tested their INR using a point-of-care device ( Pro Time Microcogulation System , International Technidyne Corporation , USA ) and adjusted their warfarin doses using a nomogram . Patients r and omly assigned to PM received usual care from their general practitioner . The primary outcome was to demonstrate 20 % improvement in anticoagulation control by SM . RESULTS One hundred forty patients were r and omly assigned ( 70 per group ) . Thirteen patients dropped out of SM early due to an inability to self-manage . Based on intention-to-treat analysis , there was no difference in the proportion of INR in range ( SM 64.8 % versus PM 58.7 % , P=0.23 ) or time in target range ( SM 71.8 % versus PM 63.2 % , P=0.14 ) . Patients managing their own therapy spent less time below the therapeutic range ( 15.0 % versus 27.3 % , P=0.04 ) . There were three major complications of thrombosis or bleeding , all occurring in the PM arm . All patients who completed SM preferred to continue with that strategy . CONCLUSIONS SM was not significantly better than PM in maintaining therapeutic anticoagulation . SM was feasible and appeared safe in the present study population This article concerning the pharmacokinetics and pharmacodynamics of vitamin K antagonists ( VKAs ) is part of the American College of Chest Physicians Evidence -Based Clinical Practice Guidelines ( 8th Edition ) . It describes the antithrombotic effect of the VKAs , the monitoring of anticoagulation intensity , and the clinical applications of VKA therapy and provides specific management recommendations . Grade 1 recommendations are strong and indicate that the benefits do or do not outweigh the risks , burdens , and costs . Grade 2 recommendations suggest that the individual patient 's values may lead to different choices . ( For a full underst and ing of the grading , see the " Grade s of Recommendation " chapter by Guyatt et al , CHEST 2008 ; 133:123S-131S . ) Among the key recommendations in this article are the following : for dosing of VKAs , we recommend the initiation of oral anticoagulation therapy , with doses between 5 mg and 10 mg for the first 1 or 2 days for most individuals , with subsequent dosing based on the international normalized ratio ( INR ) response ( Grade 1B ) ; we suggest against pharmacogenetic-based dosing until r and omized data indicate that it is beneficial ( Grade 2C ) ; and in elderly and other patient subgroups who are debilitated or malnourished , we recommend a starting dose of < or = 5 mg ( Grade 1C ) . The article also includes several specific recommendations for the management of patients with nontherapeutic INRs , with INRs above the therapeutic range , and with bleeding whether the INR is therapeutic or elevated . For the use of vitamin K to reverse a mildly elevated INR , we recommend oral rather than subcutaneous administration ( Grade 1A ) . For patients with life-threatening bleeding or intracranial hemorrhage , we recommend the use of prothrombin complex concentrates or recombinant factor VIIa to immediately reverse the INR ( Grade 1C ) . For most patients who have a lupus inhibitor , we recommend a therapeutic target INR of 2.5 ( range , 2.0 to 3.0 ) [ Grade 1A ] . We recommend that physicians who manage oral anticoagulation therapy do so in a systematic and coordinated fashion , incorporating patient education , systematic INR testing , tracking , follow-up , and good patient communication of results and dose adjustments [ Grade 1B ] . In patients who are suitably selected and trained , patient self-testing or patient self-management of dosing are effective alternative treatment models that result in improved quality of anticoagulation management , with greater time in the therapeutic range and fewer adverse events . Patient self-monitoring or self-management , however , is a choice made by patients and physicians that depends on many factors . We suggest that such therapeutic management be implemented where suitable ( Grade 2B ) INR self-management can reduce severe thromboembolic and hemorrhagic  complications following mechanical heart valve replacement . Beginning anticoagulation therapy immediately in the postoperative period further reduces anticoagulant-induced complications . Data were collected from the first 600 surviving patients ( from a total study sample of 1200 patients ) who completed follow-up of at least 2 years . Patients were r and omly divided into a self-management group and a control group . INR  self-management reduced severe hemorrhagic and thromboembolic complications ( P=0.018 ) . Nearly 80 % of INR values recorded by patients themselves , regardless of educational level , were within the target therapeutic range of INR 2.5–4.5 , compared with 62 % of INR values monitored by family practitioners . Only 8.3 % of patients trained in self-management immediately after surgery were unable to continue with INR self-management . The results differed slightly between patient groups with different levels of education . We conclude that all patients for whom anticoagulation is indicated are c and i date s for INR self-management regardless of education level 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 r and omized controlled trial to evaluate these 2 models of anticoagulant care . METHODS We r and omly 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 practice s. 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 ( exp and ed 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 r and omly assigned to anticoagulation clinics and 109 to family physicians . The INR values of patients who were managed by anticoagulation clinics were within the exp and ed 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 question naire , 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 Background : Anticoagulation ( AC ) with warfarin reduces the risk of thromboembolism ( TE ) in a variety of applications , yet despite compelling evidence of the value and importance of high quality AC , warfarin remains underused , and dosing is often suboptimal . Approaches to improve AC quality include ( 1 ) an AC service ( ACS ) , which allows the physician to delegate day-to-day details of AC management to another provider dedicated to AC care , and ( 2 ) incorporating into the treatment plan patient self-testing ( PST ) under which , after completing a training program , patients perform their own blood testing ( typically , using a finger-stick blood analyzer ) , have dosage adjustments guided by a st and ard protocol , and forward test results , dosing and other information to the provider . Studies have suggested that PST can improve the quality of AC and perhaps lower TE and bleed rates . The purpose of Department of Veterans Affairs ( VA ) Cooperative Studies Program ( CSP ) # 481 , “ The Home INR Study ” ( THINRS ) is to compare AC management with frequent PST using a home monitoring device to high quality AC management ( HQACM ) implemented by an ACS with conventional monitoring of prothrombin time by international normalized ratio ( INR ) on major health outcomes . PST in THINRS involves use of an INR monitoring device that is FDA approved for home use . Study design : Sites are VA Medical Centers where the ACS has an active roster of more than 400 patients . THINRS includes patients with atrial fibrillation ( AF ) and /or mechanical heart valve ( MHV ) expected to be anticoagulated indefinitely . THINRS has two parts . In Part 1 , c and i date s for PST are evaluated for 2 to 4 weeks for their ability to use home monitoring devices . In Part 2 , individuals capable of performing PST are r and omized to ( 1 ) HQACM with testing every 4 weeks and as indicated for out of range values , medication/ clinical changes , or ( 2 ) PST with testing every week and as indicated for out of range values , medication/ clinical changes . The primary outcome measure is event rates , defined as the percent of patients who have a stroke , major bleed , or die . Secondary outcomes include total time in range ( TTR ) , other events ( myocardial infa rct ion ( MI ) , non-stroke TE , minor bleeds ) , competence and compliance with PST , satisfaction with AC , AC associated quality of life ( QOL ) , and cost-effectiveness . To assess the effect of PST frequency on TTR and other outcomes , at selected sites patients r and omized to perform PST are assigned one of three test frequencies ( weekly , twice weekly , or once every four weeks ) Dem and for anticoagulation management is increasing due to an expansion of clinical indications for therapy . One possible model of care to meet dem and is patient self‐management ( PSM ) , beneficial to patients who need control over their condition . This study aim ed to determine the cost and cost‐effectiveness of PSM of anticoagulation compared with routine clinic‐based care for patients receiving long‐term anticoagulation .  A cost – utility analysis was conducted alongside a r and omised controlled trial ; 617 patients were recruited and followed up for 12 months . There was no significant difference in mean quality ‐adjusted life years ( QALYs ) between groups – after adjusting for baseline , the mean difference in QALYs was 0·009 ( 95 % CI , −0·012 to 0·030 ) . Overall mean healthcare costs in the PSM arm were significantly higher at £ 417 ( CI £ 394–£442 ) compared with £ 122 ( CI £ 103–£144 ) in the control arm . Therefore , using a formal cost‐effectiveness analysis  , PSM of anticoagulation does not appear to be cost‐effective . However , PSM may have other benefits in relieving pressure on traditional clinic‐based care , and the cost‐effectiveness of this model of care for some subgroups of anticoagulation patients needs to be explored further Oral anticoagulant therapy requires frequent laboratory controls of its intensity to assure therapeutic efficacy and to prevent potentially life threatening adverse events . It is generally assumed , that increasing the frequency of testing would lead to a better control of anticoagulation . We tested this hypothesis in a prospect i ve controlled trial comparing weekly self-testing and self-dosing ( self management ) with the st and ard-management of these patients in an anticoagulation clinic . Only patients with stable anticoagulation were included into the study . We recorded 2733 weekly determinations of the intensity of anticoagulation ( INR ) in 49 patients on self-testing and self-dosing and 539 determinations of the INR in 53 patients on st and ard-management .  Two intensities of anticoagulation were used in each group : a target INR of 3.5 for patients with artificial heart valves ( target range : 2.5 - 4.5 ) and a target INR 2.5 ( target range : 2.0 - 3.0 ) for patients with atrial fibrillation or venous thromboembolism . The deviation from the target INR , the fraction of INR determinations within the preset therapeutic range and the difference between the target INR and the actually achieved mean INR were the three major endpoints of the study . The mean deviation from the target INR was smaller in the groups of patients on self-management compared to the patients on st and ard-management . Individual deviations were significantly ( p < 0.0001 ) dependent on the type of management in interaction with the treatment intensity in a general linear model . Patients on weekly self-testing and self-dosing  had more INR values within the therapeutic range than patients on st and ard-management ( 86.2 % vs. 80.1 % at INR range 2.5 - 4.5 ; 82.2 vs. 68.9 at INR range 2.0 - 3.0 ) . The achieved mean INR was almost identical with the target INR in the patients on self-management but was significantly ( p < 0.005 ) below the target INR in the high intensity anticoagulation group on st and ard-management ( target INR:3.5 ; achieved mean INR : 3.19 ; CI 0.95 : 3.05 - 3.34 ) . Our data show , that weekly self-testing and self-dosing leads to a better control of anticoagulation than st and ard treatment in an anticoagulation clinic BACKGROUND Severe thromboembolic and hemorrhagic complications after mechanical heart valve replacement essentially depend on the intensity of oral anticoagulation and the fluctuation of individual international normalized ratio ( INR ) values . METHODS After heart valve replacement with Medtronic Hall , St. Jude Medical , and CarboMedics implants , patients were r and omly divided into two groups , one controlling INR values at home , the other being monitored by family practitioners . RESULTS Almost 80 % of the INR values recorded by patients at home were within the stipulated therapeutic range , INR 2.5 to 4.5 , compared with just 62 % of INR values recorded by family practitioners . The overall complication rate ( hemorrhages and thromboembolic events ) of the self-management group was significantly ( p < 0.05 ) decreased compared with the conventional group . CONCLUSIONS Through INR self-management , an improvement in the quality of ongoing oral anticoagulation could be shown . Starting this form of therapeutic control early after mechanical heart valve replacement appears to effect a further reduction in anticoagulant-induced complications BACKGROUND Several studies have demonstrated that patient self-management of oral anticoagulant therapy ( OAT )  can improve treatment quality . However , most of these studies were not conducted within a specialized anticoagulation care system . The objective of the present study was to determine whether patient self-management of OAT improves the quality of care delivered by anticoagulation clinics . METHODS In this r and omized study by 2 Dutch anticoagulation clinics 341 patients aged between 18 and 75 years and receiving long-term OAT were divided into 4 groups : an existing routine care group of patients untrained in self-management ; a routine care group of trained patients ; a group managed weekly at an anticoagulation clinic where international normalized ratios were measured by trained patients ; and weekly patient self-management . A 2-step r and omization procedure was followed : first , a Zelen- design r and omization was performed to distribute patients ( without informing them ) to the existing care group or to receive training in self-management ; second , trained patients were r and omized to the 3 other study groups . RESULTS Only 25.6 % of invited patients agreed to participate in the training program . Patients who remained in the existing care group were within the international normalized ratio target range 63.5 % of the time . The type of coumarin taken was a major predicting factor of OAT quality . In all study groups phenprocoumon outperformed acenocoumarol by 11.6 % ( 95 % confidence interval [ CI ] , 6.6%-16.5 % ) . Weekly management with phenprocoumon led to a 6.5 % improvement ( 95 % CI , 0.0%-13.1 % ) in time in the international normalized ratio target range when patients were managed at an anticoagulation clinic and to an 8.7 % improvement ( 95 % CI , 1.6%-15.9 % ) when patients were self-managed . Weekly management with acenocoumarol did not improve the quality of OAT . CONCLUSION With selected patients , the quality of OAT obtained through patient self-management is at least as high as that delivered by specialized physicians at anticoagulation clinics . Weekly management of OAT with long-acting phenprocoumon has to be preferred at anticoagulation clinics or , where possible , through patient self-management Several studies suggest that patient self‐management ( PSM ) may improve the quality of oral anticoagulation therapy as measured by time spent within the international normalised ratio ( INR ) target range . We performed a prospect i ve r and omised control trial to determine whether the improvement in quality of treatment afforded by PSM is greater than that achieved by patient self‐testing ( PST ) alone . A total of 104 of 800 eligible patients aged 22–88 years ( median = 59·8 ) , attending our hospital anticoagulant clinic and receiving long‐term warfarin for > 8 months agreed to participate . Patients were r and omised to PSM ( n = 55 ) or PST ( n = 49 ) . Both groups measured their INR using the CoaguChek S every 2 weeks or more frequently if required , for a period of 6 months . Seventy‐seven of 104 ( 74 % ) patients completed the study ( PSM = 41 and PST = 36 ) . The ‘ drop out ’ rates for both groups were similar . There was no significant difference between the percentage time in target therapeutic range  for PSM ( 69·9 % ) and PST ( 71·8 % ) . Both groups combined showed a significant improvement over the previous 6 months ( 71·0 % vs. 62·5 % ; P = 0·04 ) . Changes in time within the therapeutic range in individual patients ( + 5·86 ) also showed a significant difference . The quality of warfarin control  in both PST and PSM may be superior to that achieved by conventional management in a specialised hospital anticoagulation clinic BACKGROUND Patients who are receiving warfarin therapy require frequent blood testing to monitor the intensity of anticoagulation . Although previous studies suggest that capillary blood monitoring of the international normalize ratio ( INR ) is rapid and reliable , patient preferences for the method of blood drawing have not been investigated . METHODS We performed a r and omized controlled trial of patients attending an anticoagulation clinic in which patients were r and omly allocated to undergo capillary or venous INR monitoring .  Patient satisfaction with the outpatient visit , pain associated with blood drawing , and time spent in the clinic were assessed for each patient . RESULTS Sixty patients were studied . Using a 10-point visual analogue scale to quantify patient satisfaction ( 0-very satisfied ; 10-very dissatisfied ) , patients expressed a strong preference for capillary INR monitoring over venous INR monitoring ( 1.64 vs. 4.45 ; P < 0.001 ) . Using a 10-point visual analogue scale to quantify pain with blood sampling ( 0-no pain ; 10-very painful ) , patients who underwent capillary INR testing had less pain than venous INR testing ( 0.83 vs. 2.23 ; P < or = 0.004 ) . Patients spent , on average , 33 fewer minutes in the clinic with capillary INR testing than venous INR testing ( P < 0.001 ) . DISCUSSION Our findings support the routine use of capillary blood testing , using a portable monitor , for the management of patients in outpatient anticoagulation clinics R and omized trials have indicated that well-managed anticoagulation with warfarin could prevent more than half of the strokes related to atrial fibrillation . However , many patients with atrial fibrillation who are eligible for this therapy either do not receive it or are not maintained within an optimal prothrombin time-international normalized ratio ( INR ) range . We sought to determine whether an anticoagulation service within a managed care organization would be a feasible alternative for providing anticoagulation care . We performed a multi-site r and omized trial in six large managed care organizations in the United States . Subjects were aged 65 years or older and had nonvalvular atrial fibrillation . At each site , physician practice s were divided into two geographically defined practice clusters ; each site was r and omly assigned to have one intervention and one control cluster . The intervention cluster received an anticoagulation service that satisfied specifications for high- quality anticoagulation care and was coordinated through the managed care organization . Control clusters continued with their usual provider-based care . We measured the proportion of time that warfarin-treated patients in each of the clusters ( intervention and control ) were in the target range for the INR at baseline , and again during a follow-up period . Five of the six selected sites succeeded at developing an anticoagulation service . Patients in the intervention and control clusters had similar demographic characteristics , contraindications to warfarin , and risk factors for stroke . Among patients ( n = 144 in the intervention clusters ; n = 118 in the control clusters ) for whom data were available during the baseline and follow-up periods , the changes in percentages of time in the target range were similar for those in the intervention clusters ( baseline : 47.7 % ; follow-up : 55.6 % ) and in the control clusters ( baseline : 49.1 % ; follow-up : 52.3 % ; intervention effect : 5 % ; 95 % confidence interval : -5 % to 14 % ; P = 0.32 ) . Although it was feasible in a managed care organization to implement anticoagulation services that were tailored to local circumstances , provision of this service did not improve anticoagulation care compared with usual care . The effect of the anticoagulation service was limited by the utilization of the service , the degree to which the referring physician supports strict adherence to recommended target ranges for the INR , and the ability of the anticoagulation service to identify and to respond to out-of-range values promptly Der Großteil der Patienten mit Vorhofflimmern ist durch ein thromboembolisches Ereignis gefährdet . Die Komplikationsrate kann durch eine effiziente Antikoagulation um zwei Drittel reduziert werden . Ob die Qualität der Therapieüberwachung durch das Selbstmanagement bei Patienten mit Vorhofflimmern  ( SMAAF-Studie ) i m Vergleich zur herkömmlichen bei Hausarzt betreuten Patienten verbessert werden kann , war Gegenst and dieser prospektiven Multicenter- Studie . Bei Eignung zum Selbstmanagement sollten 2 000 Patienten in die beiden Studienarme r and omisiert werden . I m Untersuchungszeitraum von 12/99 bis 07/01 gaben lediglich 202 Patienten ( 64,3±9,2 Jahre , 69,3 % Männer ) ihr Einverständnis . Bei vorzeitigem Studienabbruch aufgrund zu niedriger Patientenzahl beschränkt sich der Gruppenvergleich auf die Auswertung gemessener INR-Werte mittels zweiseitigem t-Test . Von den 202 eingeschlossenen Patienten wurden 101 der Selbstmanagement-Gruppe ( 64,6±9,6 Jahre , 71,4 % Männer ) und 101 ( 64,1±8,9 Jahre , 61,4 % Männer , n.s . ) der Hausarztgruppe zugeordnet . Die Gesamtzahl der INR-Messungen betrug 2 865 , wobei 2 072 auf Patienten i m Selbstmanagement und 793 auf die Hausarztgruppe entfielen . Die Werte lagen bei Patienten i m Selbstmanagement mit 67,8 % i m Vergleich zur Hausarztgruppe mit 58,5 % signifikant häufiger ( p=0,0061 ) i m Zielbereich . Bezüglich der Verweildauer i m therapeutischen Bereich best and zwar ein Trend zugunsten der Selbstmanagement-Gruppe , jedoch kein signifikanter Unterschied ( 178,8±126 Tage vs. 155,9±118,4 Tage ) . In der Selbstmanagement- Gruppe traten zwei schwere Blutungen , in der Hausarztgruppe ein thromboembolisches Ereignis auf . Die Therapieüberwachung der oralen Antikoagulation durch das INR-Selbstmanagement  ist bei Patienten mit Vorhofflimmern der Betreuung durch den Hausarzt nicht unterlegen . Most patients with atrial fibrillation are at risk of suffering thromboembolic events . This risk can be reduced by twothirds by efficient anticoagulation . This prospect i ve 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 thous and patients suitable for self-manage- ment were to be r and omized 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 BACKGROUND To avert major hemorrhage , physicians need to know the lowest intensity of anticoagulation that is effective in preventing stroke in patients with atrial fibrillation . Since the low rate of stroke has made it difficult to perform prospect i ve studies to resolve this issue , we conducted a case-control study . METHODS We studied 74 consecutive patients with atrial fibrillation who were admitted to our hospital from 1989 through 1994 after having an ischemic stroke while taking warfarin .  For each patient with stroke , three controls with nonrheumatic atrial fibrillation who were treated as out patients were r and omly selected from the 1994 registry of the anticoagulant-therapy unit ( 222 controls ) . We used the  international normalized ratio ( INR )  to measure the intensity of anticoagulation .  For the patients with stroke , we used INR at admission ; for the controls , we selected the INR that was measured closest to the month and day of the matched case patient 's hospital admission . RESULTS The risk of stroke rose steeply at INRs below 2.0 . At an INR of 1.7 , the adjusted odds ratio for stroke , as compared with the risk at an INR of 2.0 , was 2.0 ( 95 percent confidence interval , 1.6 to 2.4 ) ; at an INR of 1.5 , it was 3.3 ( 95 percent confidence interval , 2.4 to 4.6 ) ; and at an INR of 1.3 , it was 6.0 ( 95 percent confidence interval , 3.6 to 9.8 ) . Other independent risk factors were previous stroke ( odds ratio , 10.4 ; 95 percent confidence interval , 4.4 to 24.5 ) , diabetes mellitus ( odds ratio , 2.95 ; 95 percent confidence interval , 1.3 to 6.5 ) , hypertension ( odds ratio , 2.5 ; 95 percent confidence interval , 1.1 to 5.7 ) , and current smoking ( odds ratio , 5.7 ; 95 percent confidence interval , 1.4 to 24.0 ) . CONCLUSIONS Among patients with atrial fibrillation , anticoagulant prophylaxis is effective at INRs of 2.0 or greater . Since previous studies have indicated that the risk of hemorrhage rises rapidly at INRs greater than 4.0 to 5.0 , tight control of anticoagulant therapy to maintain the INR between 2.0 and 3.0 is a better strategy than targeting lower , less effective levels of anticoagulation Background and objective 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 . Patients / methods Sixty patients receiving chronic oral anticoagulant therapy who had access to the internet and a printer , were enrolled into this prospect i ve , 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 . Results 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 . Conclusions 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 STUDY OBJECTIVE To evaluate the efficacy and accuracy of monitoring prothrombin times at home . DESIGN R and omized , prospect i ve cohort study . SETTING Out patients discharged from a university hospital or a community hospital . PATIENTS Fifty patients started on warfarin for the first time who demonstrated an ability to use the monitor and who had not achieved a stable response to warfarin in the hospital . INTERVENTION Oral anticoagulation therapy managed using a portable prothrombin time monitor compared with specialized anticoagulation clinic care . MEASUREMENTS AND MAIN RESULTS In the 46 patients who completed the 8-week study , the median percentage of time that patients in the home-monitor group ( n = 23 ) were within a range equal to the target prothrombin ratio + /- 0.3 , but always above 1.25 , was 93 % , compared with 75 % for patients in the clinic group ( n = 23 ) ( P = 0.003 ) . There was no significant difference between groups in the percentage of time above the therapeutic range ; however , the percentage of time that patients were subtherapeutic was significantly greater in the clinic group ( P less than 0.001 ) . There were no major thromboembolic or hemorrhagic complications in either group . Differences between home monitor measurements and corresponding clinical laboratory measurements using blood sample s drawn within 4 hours of the home test were comparable to differences observed between measurements using two different clinical laboratory instruments . CONCLUSIONS Use of a portable prothrombin time monitor by patients at home is feasible and provides accurate measurements . Patients doing home monitoring achieve superior anticoagulation control compared with those receiving st and ard anticoagulation clinic care Context Although many out patients require oral anticoagulation , the optimal management of outpatient anticoagulation remains uncertain . Studies have demonstrated the feasibility of patient self-management using portable coagulometers , but the studies that compared patient outcomes with self-management and those with conventional management in an anticoagulation clinic did not find a better outcome with self-management . Contribution In this r and omized , controlled trial of 737 patients , patients assigned to self-management of anticoagulation achieved a similar level of control and had fewer adverse events than patients assigned to conventional management . Implication s Health care providers should begin to implement patient self-management of oral anticoagulation with portable coagulometers in mainstream practice . The Editors Indications for oral anticoagulant treatment to prevent thromboembolic disease have increased in recent years ( 1 ) . Prothrombin times must be monitored frequently in patients taking oral anticoagulants to determine the safest dose and to minimize the risk for complications . The clinical management of oral anticoagulant treatment improved greatly after the international normalized ratio ( INR ) was introduced as a measurement of anticoagulation intensity ( 1 ) . The establishment of accurate therapeutic INR ranges was also beneficial . Target ranges include the safest INR values that carry the lowest risk for hemorrhagic or thromboembolic complications ( 2 ) . Despite these improvements , however , serious complications are still associated with oral anticoagulant treatment ( 3 , 4 ) , and management by specialized staff at anticoagulation clinics seems to be safer than other clinical strategies in terms of numbers of complications ( 5 - 7 ) . Currently , portable coagulometers are available for determining INR easily and reliably ( 8) . This technology provides interesting clinical models for the control of oral anticoagulant treatment , the most promising of which are patient self-testing and patient self-management . For patient self-testing , patients measure INRs themselves and ask their referring physicians for the proper anticoagulant dose . Patient self-management assumes that patients will adjust their own doses and is the most autonomous strategy . Several published studies have compared these strategies with usual care ( that is , monitoring of oral anticoagulant treatment by practitioners ) ( 9 - 13 ) or with specialized anticoagulation clinics ( 14 - 18 ) . Although these studies showed that both patient self-testing and patient self-management are feasible , their sample s were relatively small ( 9 , 11 , 13 , 14 - 18 ) or included selected patients with mechanical valve prostheses ( 10 ) or patients older than 65 years of age ( 12 ) . In general , previous studies indicate that patient self-management may be superior to management by general practitioners or anticoagulation clinics in quality of INR control ( 10 - 18 ) . In addition , Krtke and Krfer ( 10 ) , Beyth and associates ( 12 ) , and Sawicki ( 13 ) reported a decrease in major complications among self-managed patients compared with patients managed by general practitioners . To date , no published data have suggested a better clinical outcome ( decrease in associated complications ) with patient self-management than with specialized management at an anticoagulation clinic ( 5 , 19 ) . We performed a r and omized , controlled trial to directly compare self-management of oral anticoagulant treatment , as evaluated in terms of efficacy and safety in unselected patients , with management in an anticoagulation clinic . Methods Study Design The Alternative Control of Oral Anticoagulant Treatment ( ACOA ) trial is a single-center , central ly r and omized , controlled study that was performed at Hospital de la Santa Creu i Sant Pau , Barcelona , Spain , from January 2001 to July 2002 . The hematologists who manage our anticoagulation clinic use a homogeneous dosing protocol and st and ard protocol s to manage situations that increase clinical risk . The clinical staff includes trained nurses . Computers control the clinical data and INR records , ensuring excellent follow-up . Patients and their relatives receive basic education at the beginning of oral anticoagulant treatment , including information on the main characteristics of oral anticoagulants , potential risks , rationale for periodic monitoring , and drug interactions . Samsa and Matchar ( 20 ) recommended that these characteristics be used to provide an appropriate control group in a trial on patient self-management . The institutional review board of our hospital approved the study . Recruitment Phase The recruitment phase began with computerized r and om selection of 1500 patients from the more than 5000 who were receiving oral anticoagulant treatment controlled in our hospital . We included any ambulatory patient 18 years of age or older who had been receiving long-term anticoagulant therapy for at least 3 months before entering the study . We excluded patients who were younger than 18 years of age , who had a severe physical or mental illness without a responsible caregiver , or who were of foreign origin and were unable to underst and Spanish . Once the patient ( or his or her caregiver ) agreed to participate , written informed consent was obtained . Next , central ized telephone r and omization assigned the patient to the experimental group ( patient self-management ) or to the control group ( conventional management ) . The allocation sequence was generated at the hospital 's epidemiology department , and the sequence of r and omization was concealed until the patient was assigned to a group . To facilitate comparability between study groups , this r and omization was stratified according to sex , age ( 70 years of age or < 70 years of age ) , and indication for oral anticoagulant treatment ( 4 groups ) . Members of our anticoagulation clinic enrolled participants and assigned them to groups . Baseline data included demographic details , clinical information on associated risk factors , other medications , previous length of anticoagulant therapy , bleeding or thromboembolic complications during oral anticoagulant treatment , and target INR range . Follow-up for patients assigned to the conventional management group was done immediately . Patients in the self-management group received a training course first , and follow-up was not performed until the nurse teaching the course judged that the patients had acquired a minimum of expertise in self-management . Training Course An educational program was design ed to optimize the number of patients able to underst and and safely perform  self-management  ( Appendix ) . It was similar to the German program developed by Sawicki ( 13 ) but was demographically adapted to the characteristics of the Spanish population , considering differences in daily schedules , diet , educational level , and other idiosyncratic factors . The program consisted of 2 sessions of 2 hours each on consecutive days . A specially trained nurse was responsible for teaching the patients in small , organized groups . The lessons included basic theoretical and practical concepts involving the use of a coagulometer , interpretation of INR , and adjustment of dose . The concepts of target range and dose modification were emphasized when necessary . A simple card system was design ed to help the patient select the correct dose . For each target range , a specific card was provided . Patients were taught to use the portable coagulometer CoaguChek S ( Roche Diagnostics , Mannheim , Germany ) with the appropriate reagent strips . Follow-up Phase Normally , the patients in the conventional management group visited our hospital every 4 weeks to check their INRs . When the INR result was out of target range , our dosing protocol indicated that we should advance the next appointment for INR testing to 1 or 2 weeks . International normalized ratio was determined by means of a st and ard KC 10 coagulometer ( Amelung , Lemgo , Germany ) . As a thromboplastin , we used Thromborel S ( Behring , Marburg , Germany ) . A hematologist experienced in oral anticoagulation management adjusted the dose and made the appointment for the next INR test . Patients in the self-management group performed the INR tests at home once per week using the CoaguChek S kit . They determined the appropriate dose of oral anticoagulant and the time of the next INR test . All of the INR results in both groups were entered into a computer ( in the central system of our anticoagulation clinic or in the portable coagulometers ) to facilitate data management . Patients in both groups were interviewed monthly by telephone to record any complications or changes in their health status . For the conventional management group , these interviews were done approximately midway between hospital visits . The questions addressed minor or major bleeding , thromboembolic events , episodic diseases , changes in long-term medications , and hospital stays . Associated complications were diagnosed and evaluated by a third physician who was not involved in the trial and was unaware of patients ' study group . St and ard criteria were used to diagnose any thromboembolic complications . Transient ischemic attack was diagnosed clinical ly by a neurologist , and superficial thrombophlebitis was diagnosed clinical ly by an angiologist . To diagnose stroke , arterial embolism , venous thromboembolism , pulmonary embolism , or valve thrombosis , we used widely accepted methods ( computed tomography or magnetic nuclear resonance imaging , angiography , surgical diagnosis , Doppler ultrasonography , phlebography , lung angiography or ventilation-perfusion lung scanning , cardiac ultrasonography , or fluoroscopy ) . All thromboembolic complications were considered major events . Life-threatening bleeding or bleeding requiring transfusion or hospital admission was considered a major event . Any other bleeding was considered a minor event . Statistical Analysis Study outcomes were evaluated on an intention-to-treat basis and also on an on-treatment basis . Summary . The success in achieving therapeutic international normalized ratio ( INR ) targets in the control of warfarin using a whole‐blood point‐of‐care testing ( POCT ) monitor ( CoaguChek ) in a community clinic was compared with hospital laboratory coagulometer prothrombin time ( PT ) testing in a r and omized crossover study . Forty‐six patients were r and omized into two groups . At each visit , capillary blood was taken for the POCT monitor and venous blood for the laboratory coagulometer . In Group 1 , for 6 months , dosage was based on the CoaguChek and for the second 6 months on the coagulometer . In the second group , the order was reversed . Dosages were determined using the dawn ac computer programme . Success was assessed by the percentage of time patients were maintained within the INR targets . Agreement between laboratory and monitor INR , and patient satisfaction were also assessed . Results with the POCT monitor compared well with the hospital coagulometer . Time in INR target range between the groups was similar , with 60·9 % on the POCT monitor and 59·3 % with the laboratory coagulometer in Group 1 and in Group 2 , respectively , 64·3 % and 63·4 % with no significant difference in mean INR . An INR above 4·0 gave some discrepant results . International Sensitivity Index calibrations of the two test systems indicated that the INRs were dependable . Patient question naires showed greater satisfaction with community POCT monitoring BACKGROUND The efficacy of self-managed oral anticoagulant therapy has been addressed in few r and omized , 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 , r and omized , controlled trial where 100 patients receiving long-term oral anticoagulant therapy referred to a Danish clinic for self-management was r and omized 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 st and ard 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 st and ard 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 Of 125 patients aged 65 years or over , with atrial fibrillation taking warfarin for at least 12 months , with a st and ard deviation ( SD ) of prothrombin time , expressed as the International Normalized Ratio ( INR ) > 0·5 over the previous 6 months , 40 were r and omized to continue with usual clinic care and 85 to receive education about warfarin .  Of these , 44 were r and omized to self‐monitor their INR and 41 returned to clinic . Compared with the previous 6 months there was a significant increase in percentage time within the therapeutic range for the 6 months following education [ 61·1 vs. 70·4 ; mean difference 8·8 ; 95 % confidence interval ( CI ) : −0·2–17·8 ; P = 0·054 ] and following education and self‐monitoring ( 57 vs. 71·1 ; mean difference 14·1 ; 95 % CI : 6·7–21·5 ; P < 0·001 ) , compared with those patients following usual clinic care ( 60·0 vs. 63·2 ; mean difference 3·2 ; 95 % CI : −7·3–13·7 ) . Using the same comparative periods , the INR SD fell by 0·24 ( P < 0·0001 ) in the group allocated to education and self‐monitoring , 0·26 ( P < 0·0001 ) in the group receiving education alone and 0·16 ( P = 0·003 ) in the control group . Inter‐group differences were not statistically significant ( intervention groups 0·26 ± 0·30 vs. control 0·16 ± 0·3 , P = 0·10 ) . Quality ‐of‐life measurements and health beliefs about warfarin were unchanged ( apart from emotional role limitation ) with education or education and self‐monitoring .  Patient  education regarding anticoagulation therapy could be a cost‐effective initiative and is worthy of further study BACKGROUND This study was conducted to assess the ability of patients receiving heart valve replacements to practice self-managed anticoagulation using a portable coagulometer . METHODS We carried out a prospect i ve , r and omized trial , comparing self-managed anticoagulation with conventional management .  Patients practicing self-managed anticoagulation ( 51 patients ) did so at home , measuring their international normalized ratio and then deciding on their dosage of warfarin , while  conventionally controlled patients ( n = 49 ) attended hospital clinics or were managed by their family physicians . RESULTS We successfully trained 41 of 44 patients who agreed to self-manage their anticoagulant therapy ; 34 of the 41 managed their own anticoagulation at home for 2 years . Their control , assessed by a number of tests in range ( 67.6 % versus 58.0 % ) and time in therapeutic range ( 76.5 % versus 63.8 % ) , was significantly better than that for the group managed conventionally ( p < 0.0001 ) . There was no significant difference in mortality or morbidity between the two groups . CONCLUSIONS Self-managed anticoagulation is a reliable , easily learned method of controlling anticoagulation , and it is suitable for approximately two thirds of patients , with excellent results Bleeding is the major side effect of warfarin and is a major deterrent to its use , especially in older patients . Older people are widely thought to be at increased risk for warfarin-related bleeding ( 1 - 8 ) , and they are less likely to be treated with warfarin , even when it has been proven efficacious , in part because of concern about risk for bleeding ( 9 - 13 ) . Efforts that reduce the frequency of major warfarin-related bleeding not only will increase the net benefit of therapy but also will facilitate more appropriate and widespread use of warfarin therapy in older patients . Methods for identifying patients at highest risk for bleeding have recently advanced ( 5 - 7 , 14 - 21 ) , and experience with specialized programs that coordinate the management of anticoagulant therapy suggests that clinical outcomes may be improved ( 6 , 14 , 18 , 22 - 27 ) . However , there is little controlled or experimental evidence on how to optimize management of anticoagulant therapy in older patients and prevent bleeding . We developed a multicomponent comprehensive program for management of warfarin therapy aim ed at improving control of the anticoagulant effect and reducing events ( such as use of an interacting medicine ) that might precipitate bleeding . We hypothesized that this intervention would be acceptable to most elderly persons starting warfarin therapy and would reduce the frequency of warfarin-related major bleeding . Methods Patients Patients hospitalized at University Hospitals of Clevel and , a 900-bed teaching hospital , between September 1992 and October 1995 who were 65 years of age or older and were receiving 10 000 units or more of intravenous unfractionated heparin every 24 hours were screened daily . Of these patients , we identified 426 persons who were 65 years of age or older , who resided in Cuyahoga County , Ohio , and for whom treatment with warfarin was planned for 10 or more days ( Figure 1 ) . Patients were excluded if they had been treated with warfarin at any time during the previous 6 months , were admitted from a nursing home , were enrolled in another clinical trial , were too ill to give consent and had no available surrogate , were discharged prematurely , or did not speak English ; if their private physician refused to participate ; or if no r and om allocation was taking place ( for example , during vacations or holidays ) . Eligible patients who were enrolled did not differ significantly from those who were not enrolled with regard to age , ethnicity , sex , or indication for therapy . Figure 1 . Eligibility and r and om assignment of patients . Patients were stratified according to their baseline risk for major bleeding by using the Outpatient Bleeding Risk Index ( 20 ) . This index includes four independent risk factors for  major bleeding :  age 65 years or older , history of gastrointestinal bleeding , history of stroke , and one or more of four specific comorbid conditions ( recent myocardial infa rct ion , hematocrit<30 % , creatinine concentration>133 mol/L [ 1.5 mg/dL ] , or diabetes mellitus ) . Patients with one or two risk factors were classified as intermediate risk , and those with three or more risk factors were classified as high risk ; estimated frequencies of major bleeding in 6 months were 6 % and 35 % , respectively . After stratification , patients were r and omly assigned to receive usual care or intervention . Informed consent for observation and data collection was then sought from both groups , and informed consent to participate in the intervention was sought from the intervention group . This method , initially proposed by Zelen ( 28 ) , allows the study to test the effectiveness of offering the intervention rather than simply the efficacy of the intervention in patients who consent to participation before r and om assignment . The sample size was calculated to provide 80 % power and an level of 0.05 . The study protocol and informed consent procedures were approved by the hospital 's institutional review board . Intervention The intervention had two main components . The first component consisted of a guideline -based consultation that assessed the patient 's indications for therapy and potential risk factors for warfarin-related bleeding .  We used this method previously to reduce the frequency of anticoagulant-related bleeding  during hospitalization ( 27 ) . Specific recommendations about modifiable risk factors , such as use of nonsteroidal anti-inflammatory drugs , were made and implemented . The study investigators directed warfarin dosing and international normalized ratio ( INR ) testing after hospital discharge . The second component included patient education , coaching , and self-monitoring of prothrombin time ;  this component was grounded in social learning theory ( 29 - 31 ) and experimental evidence ( 32 , 33 ) showing that increasing participation of patients in their care can improve clinical outcomes but that increasing patient knowledge alone is insufficient ( 34 , 35 ) . Patient education consisted of one-on-one teaching by a lay educator using a specifically formatted workbook for older adults to teach them about warfarin , indications for its use , drug and food interactions , and the signs and symptoms of bleeding . The lay educator review ed the workbook and was taught how to use the prothrombin time monitor by one of the authors but had no formal medical training . Coaching was aim ed to increase patients ' participation in their care and to improve information-seeking skills . Patients were trained and encouraged to communicate more effectively with physicians and other health personnel about a range of issues , such as health concerns , drug interactions , or changes in lifestyle or diet . Finally , patients were taught to self-monitor the  prothrombin time by using a home portable monitor ( Coumatrak Protime Test System , Biotrack , Inc. , Mountain View , California ) . The monitor uses a fingerstick to obtain a blood sample and has well-established accuracy ( 36 - 38 ) . Patients were initially assessed , educated , and taught to use the portable monitor while hospitalized ; training lasted 30 minutes to 1 hour . They were seen daily while hospitalized , warfarin therapy was adjusted as needed , and any concerns or questions about anticoagulant therapy were addressed . Within 3 days of discharge from the hospital , the lay educator or study investigator made a home visit to assess patients ' use of the portable monitor and to check the  prothrombin time .  In general , patients were instructed to check their prothrombin time three times during the first week after hospital discharge , weekly for the remainder of the first month , and monthly thereafter depending on their results . Patients phoned in their results to the coach , who review ed the results with one of the investigators and provided same-day follow-up , including recommendations for dose and subsequent INR testing . Patients were instructed to call whenever they had questions or concerns about their  warfarin management or possible side effects , if they were hospitalized for any reason , or if they began receiving new medications . After the 6-month intervention period , management and dosing of warfarin therapy reverted back to patients ' personal physicians . Patients assigned to usual care received medical care , including management , dosing , and medical information , according to the discretion and practice s of their personal physician . Data Collection Trained abstract ors who were not involved with the intervention component of the study collected data from the medical chart at the start of anticoagulant therapy ; at each subsequent hospitalization ; and by blinded interview at enrollment and 1 , 3 , and 6 months after enrollment and every 6 months thereafter . Data elements included demographic characteristics , clinical history including comorbid diagnoses , indications for therapy , potential risk factors for bleeding , functional status , and new illnesses or comorbid conditions that developed after enrollment . Surveillance for bleeding and thromboembolism was conducted identically in the intervention and control groups and consisted of 12 items inquiring about bleeding and thromboembolism at each follow-up interview . Whenever an event was reported , the clinical characteristics of the bleeding or thromboembolic episode were determined by review of the relevant medical record and abstract ed without identifying patient information onto a st and ard form . All date s of death were confirmed by death certificates , and all causes of death were confirmed by review of death certificates and medical records . Follow-up was complete for all patients . End Points The primary end point was the first major bleeding event during the 6-month intervention period . Using explicit criteria in the Bleeding Severity Index ( 39 ) for the amount , rate , and consequences of bleeding , we defined major bleeding as overt bleeding that led to the loss of at least 2.0 units of blood in 7 days or less or was otherwise life-threatening ( for example , intracranial bleeding ) . Bleeding was classified without information about possible risk factors or r and omization status . Two author- review ers who were blinded to group assignment adjudicated bleeding events ; their agreement was high ( statistic , 0.97 ) . Secondary outcomes were death and recurrent venous thromboembolism at 6 months ; major bleeding after 6 months ; and control of anticoagulant therapy during the first 6 months of therapy , as measured by the INR . The therapeutic range of the INR was defined as 2.5 to 3.5 for persons with mechanical heart valves and 2.0 to 3.0 for persons with all other indications ( 40 ) . Therapeutic quality control was assessed by using the patient-time approach , described by Rosendaal and colleagues ( 41 ) , for three time periods after discharge from the hospital : 0 to 1 month , 1 to 3 months , and 3 to 6 months of therapy . This approach estimates the amount of time a patient is in the therapeutic range based on the actual INRs measured , assuming a linear relationship between consecutive INRs . Patients with only one An ageing population and the continuing expansion of clinical indications for coumadin therapy have increased pressure on hospital anticoagulant clinics . One solution is patient self‐testing ( PST ) of the international normalized ratio ( INR ) using capillary blood sample s on point‐of‐care coagulation monitors at home . We conducted a prospect i ve study to determine whether patients can achieve accurate INR values through PST , using the CoaguChek S ( Roche Diagnostics , Lewes , UK ) . The main outcome measurements were : comparability of INR values obtained by PST and the hospital laboratory , patient acceptability as assessed by a question naire and anticoagulant control . Eighty‐four patients [ 53 men , 31 women ; median age 59 years ( range 26–83 ) ] , receiving long‐term oral anticoagulation ( warfarin ) , were recruited from our Anticoagulation Clinic . Patients were r and omized to weekly self‐testing or continuing 4‐weekly hospital laboratory monitoring of INR . Comparison of INRs ( n = 234 ) showed no significant differences between the CoaguChek ( median INR 3·02 ) and laboratory testing ( median INR 3·07 ) . There was excellent correlation between the two methods ( r = 0·95 ) , with 85 % of CoaguChek results within 0·5 INR units of the laboratory method . On four occasions , differences of > 1 unit INR were obtained , but in each case the patient 's anticoagulation was unstable ( INR > 4·5 by both methods ) and the differences in INR would not have altered patient management . 87 % of patients found self‐testing straightforward , 87 % were confident in the result they obtained and 77 % preferred self‐testing . We conclude that PST is a reliable alternative to hospital clinic attendance and is acceptable to the majority of suitably trained patients Although many patients with long-term oral anticoagulation ( OAC )  can manage their medication safely and reliably themselves , no study on elderly patients has as yet assessed the safety and efficacy of OAC self-management  with major thromboembolic and haemorrhagic complications as primary outcomes . In this multi-centre trial , patients aged 60 years or more were r and omised into a  self-management ( SMG ) ( N = 99 ) or routine care group  ( RCG ) ( N = 96 ) . The primary outcome was the combined endpoint of all thromboembolic events requiring hospitalisation and all major bleeding complications . Mean follow-up was 2.9 + /- 1.2 and 3.0 + /- 1.1 years in the SMG and RCG , respectively . In intention-to-treat analysis , 12 patients in the SMG versus 22 patients in the RCG reached a primary endpoint ( hazard ratio [ HR ] : 0.50 ; 95 % confidence interval [ CI ] : 0.25 to 1.00 ; p = 0.049 ) . The post-hoc analysis on OAC treatment sensitivity supported the benefit of self-management ( HR 0.27 ; 95 % CI : 0.13 to 0.71 ; p = 0.006 ) . Fifteen patients in the SMG died during the study , but none of the deaths was directly associated with anticoagulation therapy . In the RCG , 11 patients died ; of those , three deaths were directly associated with anticoagulation therapy and there was one death of unknown cause . During follow-up , the quality of OAC control was significantly better in the SMG than in the RCG . In elderly patients , long-term self-management of oral anticoagulation is superior for the prevention of major thromboembolic and bleeding complications and for the quality of oral anticoagulation control compared to routine care for a mean follow-up period of three years BACKGROUND Although prosthetic valves are durable and easy to implant , the need for lifetime warfarin-based anticoagulation restricts their exclusive usage . We investigated if anticoagulation self-management improves outcome in a single-center series . METHODS Between 1994 and 1998 , 765 patients with prosthetic valve replacements were prospect ively enrolled and r and omized to receive conventional anticoagulation management by their primary physician ( group 1 , n = 295 ) or to pursue anticoagulation self-management ( group 2 , n = 470 ) . A study head office was implemented to coordinate and monitor  anticoagulation protocol s ,  international normalized ratios ( INR ) , and  adverse events . Patients were instructed on how to obtain and test their own blood sample s and to adjust warfarin dosages according to the measured INR ( target range , 2.5 to 4 ) . RESULTS Mean INR values were slightly yet significantly smaller in group 1 than in group 2 ( 2.8 + /- 0.7 vs 3.0 + /- .6 , p < 0.001 ) . Moreover , INR values of patients with conventional INR management were frequently measured outside the INR target range , whereas those with anticoagulation self-management mostly remained within the range ( 35 % vs 21 % , p < 0.001 ) . In addition , the scatter of INR values was smaller if self-managed . Freedom from thromboembolism at 3 , 12 , and 24 months , respectively , was 99 % , 95 % , and 91 % in group 1 compared with 99 % , 98 % , and 96 % in group 2 ( p = 0.008 ) . Bleeding events were similar in both groups . Time-related multivariate analysis identified INR self-management and higher INR as independent predictors for better outcome . CONCLUSIONS Anticoagulation self-management can improve INR profiles up to 2 years after prosthetic valve replacement and reduce adverse events . Current indications of prosthetic rather than biologic valve implantations may be extended if the benefit of INR self-management is shown by future studies with longer follow-up
target: 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 .
  These models are not suitable for all patients and require the identification and education of suitable c and i date s. 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 .
  The majority of studies reported favourable impacts of POC INR monitoring on QoL and found better treatment satisfaction with POC monitoring .
background: UNLABELLED 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 infa rct ion , 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 .
  There is currently no population -based Ontario data to permit the assessment of patient care , but recent systematic review s 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 setting s 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 .
  EffectivenessDoes POC INR monitoring improve clinical outcomes in various setting s compared to st and ard laboratory-based testing?Does POC INR monitoring impact patient satisfaction , QoL , compliance , acceptability , convenience compared to st and ard laboratory-based INR determination ?
  Cost-effectivenessWhat is the cost-effectiveness of POC INR monitoring devices in various setting s compared to st and ard laboratory-based INR determination ?
  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 .