Point-of-Care International Normalized Ratio (INR) Monitoring Devices for Patients on Long-term Oral Anticoagulation Therapy: An Evidence-Based Analysis. Clinical impact of point-of-care vs laboratory measurement of anticoagulation. 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‐testing is a reliable and acceptable alternative to laboratory INR monitoring Patient self-management of warfarin therapy: pragmatic feasibility study in Canadian primary care. Is home warfarin self-management effective? Results of the randomised Self-Management of Anticoagulation Research Trial. Oral anticoagulation self-management and management by a specialist anticoagulation clinic: a randomised cross-over comparison 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 lowers the risk of thromboembolic events after prosthetic heart valve replacement. Oral anticoagulant therapy in Italian patients 80 yr of age or older with atrial fibrillation: a pilot study of low vs. standard PT/INR targets. Effects of computer-assisted oral anticoagulant therapy Comparison of two different models of anticoagulation management services with usual medical care. Quality of life (QoL) and International Normalized Ratio (INR) control of patients attending anticoagulation clinics. Pharmacology and management of the vitamin K antagonists: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Randomized controlled trial of supervised patient self-testing of warfarin therapy using an internet-based expert system. Poor anticoagulation quality in the first 3 months after unprovoked venous thromboembolism is a risk factor for long-term recurrence. Comparing Self-Management of Oral Anticoagulant Therapy with Clinic Management Improving anticoagulation control in hospitalized elderly patients on warfarin. INR Self-Management Permits Lower Anticoagulation Levels After Mechanical Heart Valve Replacement Self-management of oral anticoagulant therapy for mechanical heart valve patients. [INR self-management after mechanical heart valve replacement: ESCAT (Early Self-Controlled Anticoagulation Trial)]. International normalized ratio self-management after mechanical heart valve replacement: is an early start advantageous? 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.
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 . The current st and ard of care in Ontario for patients on long-term OAT is laboratory-based INR determination with management carried out by primary care physicians or anticoagulation clinics ( ACCs ) . Patients also regularly visit a hospital or community-based facility to provide a venous blood sample s ( venipuncture ) that are then sent to a laboratory for INR analysis . Experts , however , have commented that there may be under-utilization of OAT due to patient factors , physician factors , or regional practice variations and that sub-optimal patient management may also occur . There is currently no population -based Ontario data to permit the assessment of patient care , but recent systematic 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 . 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 . EVIDENCE -BASED ANALYSIS METHODS RESEARCH QUESTIONS 1 . 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 ? Setting s include primary care setting s with use of POC INR devices by general practitioners or nurses , ACCs , pharmacies , long-term care homes , and use by the patient either for PST or PSM . 2 . Cost-effectivenessWhat is the cost-effectiveness of POC INR monitoring devices in various setting s compared to st and ard laboratory-based INR determination ? INCLUSION CRITERIA English- language RCTs , systematic review s , and meta-analysesPUBLICATION DATE S : 1996 to November 25 , 2008 POPULATION : patients on OATINTERVENTION : anticoagulation monitoring by POC INR device in any setting including anticoagulation clinic , primary care ( general practitioner or nurse ) , pharmacy , long-term care facility , PST , PSM or any other POC INR strategy MINIMUM SAMPLE SIZE : 50 patients Minimum follow-up period : 3 monthsCOMPARATOR : usual care defined as venipuncture blood draw for an INR laboratory test and management provided by an ACC or individual practitioner OUTCOMES Hemorrhagic events , thromboembolic events , all-cause mortality , anticoagulation control as assessed by proportion of time or values in the therapeutic range , patient reported outcomes including satisfaction , QoL , compliance , acceptability , convenience EXCLUSION CRITERIA Non- RCTs , before-after studies , quasi-experimental studies , observational studies , case reports , case series , editorials , letters , non- systematic review s , conference proceedings , abstract s , non-English articles , duplicate publications Studies where POC INR devices were compared to laboratory testing to assess test accuracy Studies where the POC INR results were not used to guide patient management METHOD OF REVIEW A search of electronic data bases ( OVID MEDLINE , MEDLINE In-Process & Other Non-Indexed Citations , EMBASE , The Cochrane Library , and the International Agency for Health Technology Assessment [ INAHTA ] data base ) was undertaken to identify evidence published from January 1 , 1998 to November 25 , 2008 . Studies meeting the inclusion criteria were selected from the search results . Reference lists of selected articles were also checked for relevant studies . SUMMARY OF FINDINGS Five existing review s and 22 articles describing 17 unique RCTs met the inclusion criteria . Three RCTs examined POC INR monitoring devices with PST strategies , 11 RCTs examined PSM strategies , one RCT included both PST and PSM strategies and two RCTs examined the use of POC INR monitoring devices by health care professionals .  ANTICOAGULATION CONTROL Anticoagulation control is measured by the percentage of time INR is within the therapeutic range or by the percentage of INR values in the therapeutic range . Due to the differing method ologies and reporting structures used , it was deemed inappropriate to combine the data and estimate whether the difference between groups would be significant . Instead , the results of individual studies were weighted by the number of person-years of observation and then pooled to calculate a summary measure . Across most studies , patients in the intervention groups tended to have a higher percentage of time and values in the therapeutic target range in comparison to control patients . When the percentage of time in the therapeutic range was pooled across studies and weighted by the number of person-years of observation , the difference between the intervention and control groups was 4.2 % for PSM , 7.2 % for PST and 6.1 % for POC use by health care practitioners . Overall , intervention patients were in the target range 69 % of the time and control patients were in the therapeutic target range 64 % of the time leading to an overall difference between groups of roughly 5 % . MAJOR COMPLICATIONS AND DEATHS There was no statistically significant difference in the number of major hemorrhagic events between patients managed with POC INR monitoring devices and patients managed with st and ard laboratory testing ( OR = 0.74 ; 95 % CI : 0.52- 1.04 ) . This difference was non-significant for all POC strategies ( PSM , PST , health care practitioner ) . Patients managed with POC INR monitoring devices had significantly fewer thromboembolic events than usual care patients ( OR = 0.52 ; 95 % CI : 0.37 - 0.74 ) . When divided by POC strategy , PSM result ed in significantly fewer thromboembolic events than usual care ( OR = 0.46 . ; 95 % CI : 0.29 - 0.72 ) . The observed difference in thromboembolic events for PSM remained significant when the analysis was limited to major thromboembolic events ( OR = 0.40 ; 95 % CI : 0.17 - 0.93 ) , but was non-significant when the analysis was limited to minor thromboembolic events ( OR = 0.73 ; 95 % CI : 0.08 - 7.01 ) . PST and GP/Nurse strategies did not result in significant differences in thromboembolic events , however there were only a limited number of studies examining these interventions . No statistically significant difference was observed in the number of deaths between POC intervention and usual care control groups ( OR = 0.67 ; 95 % CI : 0.41 - 1.10 ) . This difference was non-significant for all POC strategies . Only one study reported on survival with 10-year survival rate of 76.1 % in the usual care control group compared to 84.5 % in the PSM group ( P=0.05 ) . ES Table 1 : Summary Results of Meta-Analyses of Major Complications and Deaths in POC INR Monitoring Studies EventNo . of trials ( patients ) OR(M-H , R and om Effects)95 % CIMajor Haemorrhages16 (5057)0.740.52 to 1.04Thromboembolic events16 (5057)0.520.37 to 0.74Deaths11 (2906)0.670.41 to 1.10 PATIENT SATISFACTION AND QUALITY OF LIFE : Quality of life measures were reported in eight studies comparing POC INR monitoring to st and ard laboratory testing using a variety of measurement tools . It was thus not possible to calculate a quantitative summary measure . The majority of studies reported favourable impacts of POC INR monitoring on QoL and found better treatment satisfaction with POC monitoring . Results from a pre- analysis patient and caregiver focus group conducted in Ontario also indicated improved patient QoL with POC monitoring . ( Patients using anticoagulation point-of-care ( POC ) monitors are advised to periodically test these systems against laboratory methods to monitor performance . The international normalized ratio ( INR ) , however , can vary between test systems owing to different instrument-reagent combinations . In a r and omized study evaluating warfarin self-management , we compared INR measured by patients on a POC monitor (  ProTime , International Technidyne Corporation , Edison , NJ ) with those obtained at a hospital laboratory  within 1 hour Ninety-one paired INR determinations from 55 patients met inclusion criteria .  Clinical agreement in which POC and laboratory INR were within or outside the target INR range occurred in 56 ( 62 % ) of 91 cases ( kappa = 0.35 ) . The mean ( SD ) difference between POC and laboratory INR was 0.44 ( 0.61 ) . Six pairs differed by 1 or more INR units , 3 at study initiation result ing in POC monitor replacement . The accuracy of INR self-testing with ProTime was acceptable . The small failure rate of INR agreement might be clinical ly important , suggesting the need for external quality control systems 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 ) 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 OBJECTIVE To investigate the effectiveness of patient self-management ( PSM ) of anticoagulation using warfarin in a typical primary care site in Canada and to determine the feasibility of conducting a future large-scale trial in this setting . DESIGN An 8-month pragmatic open-label r and omized crossover trial . SETTING A typical Canadian primary care practice in British Columbia . INTERVENTION Patients were r and omized to PSM or physician management for 4 months , after which allocation was reversed . The PSM group members were instructed to monitor their serum international normalized ratio ( INR ) at community laboratories and to adjust their warfarin doses independently using provided nomograms . Education on warfarin dose adjustment was limited to a single 15-minute office visit . MAIN OUTCOME MEASURES The primary outcome was the proportion of INR values in the therapeutic range among participants . Feasibility outcomes included proportion of eligible patients consenting , patients ' preference of management strategy , patients ' satisfaction , and visits or phone communication with physicians regarding dose adjustment . Safety outcomes included bleeding or thromboembolic events . RESULTS Eleven patients completed the trial , contributing 99 patient-months of monitoring and providing 122 INR measures . The mean proportion of INR values in therapeutic range among subjects in the PSM and physician-management groups was 82 % and 80 % , respectively ( P = .82 ) . The improvement in patient satisfaction with PSM was not significant . Ten of the 11 patients preferred PSM to physician management and elected to continue with this strategy after study completion ( P = .001 ) . No calls or visits were made to the physician regarding dose adjustment during the PSM period . There were no episodes of major bleeding or thromboembolic events . CONCLUSION Patient self-management was not demonstrated to be superior to st and ard care , but was easily implemented and was the method preferred by patients . Our feasibility outcomes justify a larger trial and suggest that subject recruitment and protocol adherence would not pose barriers for such a study . Trial registration number NCT00925028 ( Clinical Trials.gov ) AIMS The Warfarin Self-Management Anticoagulation Research Trial ( Warfarin SMART ) was design ed to determine whether  patients self-managing warfarin ( PSM )  using the CoaguChek device and a dosing algorithm developed for the trial could keep the INR ( International Normalised Ratio ) test in target range at least as often as patients managed by usual care by the family doctor or hospital clinic . METHODS AND RESULTS 310 patients were r and omly assigned to PSM or usual care . The PSM group was trained to perform home INR testing and warfarin dosing using a vali date d ColourChart algorithm . The primary endpoint was the proportion of times over 12 months that a monthly , blinded " outcome INR test " , measured in a central laboratory , was outside the patient 's target therapeutic range . The rate of out-of-range outcome INRs was lower in PSM , and non-inferior to the usual care group ( PSM : 36 % vs. usual care : 41 % , P<0.001 for non-inferiority ; P=0.08 for superiority in closed-loop testing ) . The deviations from the patient 's midpoint of target INR range ( P=0.02 ) and number of extreme INRs ( P=0.03 ) were significantly less in the PSM group than the usual-care group . There was no significant difference between groups in rates of bleeding or thrombotic adverse events . CONCLUSION Patient self-management performed at least as well as usual care in maintaining the INR within the target range , without any safety concerns . This treatment modality for the long-term use of warfarin has the potential to change current local and international practice 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 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 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 BACKGROUND Oral anticoagulation therapy ( OAT ) , which aims to prevent thromboembolism in patients with atrial fibrillation ( AF ) , is underused in subjects who are over the age of 80 yr because of the associated bleeding risk . The aim of this study was to evaluate the efficacy and safety of OAT with low ( 2.0 ) vs. st and ard ( 2.5 ) PT/international normalised ratio ( INR ) targets in patients over the age of 80 . MATERIAL S AND METHODS Of 233 patients aged 80 yr or older with AF on OAT , 58 had unstable PT/INR values and achieved reduced targets . These patients were enrolled as a group ( A ) in a case-control study and were treated with a low ( 2.0 ) PT/INR target . They were compared with a second group ( B ) of 58 additional patients who were matched for age and CHADS scores and treated with a st and ard ( 2.5 ) PT/INR target . Group A OAT parameters were also compared before and after the PT/INR reduction . The time in the therapeutic range ( TTR% ) , PT/INR values > 5 , haemorrhages and strokes were prospect ively evaluated in the two groups after 2 yr of follow-up . RESULTS Of the 116 enrolled patients , 55 group A and 57 group B patients were evaluated . The TTR was 72.59 % in group A and 64.43 % in group B ( P < 0.01 ) . The percent of PT/INR values > 5 was 0.68 % for group A and 1.42 % for group B ( P < 0.05 ) . Haemorrhages and thromboses occurred only in group B patients . The before and after analysis in group A showed that a low INR target produced an increase in the TTR ( 53.05 % vs. 72.59 % ; P < 0.0001 ) and a reduction in the PT/INR values > 5 ( 1.72 % vs. 0.68 % ; P < 0.001 ) . CONCLUSIONS A low PT/INR target seems effective and safe in Italian patients with AF over the age of 80 . Further trials are needed to confirm the hypothesis generated by this study Background Computer-assistance and self-monitoring lower the cost and may improve the quality of anticoagulation therapy . The main purpose of this clinical investigation was to use computer-assisted oral anticoagulant therapy to improve the time to reach and the time spent within the therapeutic target range compared to traditional oral anticoagulant therapy by physicians . Methods 54 patients were r and omized equally into 3 groups . Patients in two groups used CoaguChek ® systems to measure international normalized ratio ( INR ) values  and had dosages of anticoagulation treatment calculated in a computer system by an algorithm specific to each group . The third group received traditional anticoagulation treatment by physicians . The obtained INR values were compared regarding the time to reach , and the time spent within , the therapeutic target range , corresponding to INR values from 2 to 3 . Results Patients r and omized to computer-assisted anticoagulation and the CoaguChek ® system reached the therapeutic target range after 8 days compared to 14 days by prescriptions from physicians ( p = 0.04 ) . Time spent in the therapeutic target range did not differ between groups . The median INR value measured throughout the study from all patients by CoaguChek ® at 2.5 ( 2.42–2.62 ) was lower than measured by a hospital-based Clinical and Biochemical Laboratory at 2.6 ( 2.45–2.76 ) , ( p = 0.02 ) . Conclusions The therapeutic target range was reached faster by the use of computer-assisted anticoagulation treatment than prescribed by physicians , and the total time spent within the therapeutic target range was similar . Thus computer-assisted oral anticoagulant therapy may reduce the cost of anticoagulation therapy without lowering the quality . INR values measured by CoaguChek ® were reliable compared to measurements by a clinical and biochemical laboratory STUDY OBJECTIVE To evaluate the safety and economic impact of three models of anticoagulation management services : usual medical care , a nurse-managed service , and a pharmacist-managed service . DESIGN Retrospective medical record review . SETTING An eight-county health care system in central New York State . PATIENTS Nine hundred ninety-six patients ( age range 19 - 99 yrs ) who were receiving warfarin therapy for at least 6 months and who had three or more international normalized ratio ( INR ) values reported during the 1-year study period ; 489 patients ( 6243 INR values ) were in the pharmacist-managed group , 307 patients ( 3618 INR values ) were in the nurse-managed group , and 200 patients ( 3142 INR values ) were in the usual care group . MEASUREMENTS AND MAIN RESULTS All INR measurements were performed by the central laboratory or by on-site point-of-care testing . Data were queried from calendar year 2003 for the usual care and nurse-managed services and calendar year 2006 for the pharmacist-managed service .  Anticoagulation indication , INR goal , baseline characteristics , and rates and costs of hospitalization and emergency department visits directly related to anticoagulation therapy were extracted from the medical record . If the INR goal was not documented , a range was assigned as appropriate from the American College of Chest Physicians anticoagulation guidelines . Markers of anticoagulation control -- time in range ( percentage of time a patient is maintained within their therapeutic range ) and percentage of INR values in range -- were calculated for each study group . Baseline characteristics were similar among all study groups . The pharmacist-managed service yielded the lowest rates of hospitalization and emergency department visits , with hospitalizations reduced by 56 % versus nurse-managed service and 61 % versus usual care ( p<0.01 ) . Emergency department visits were reduced by 78 % in both the nurse-managed and usual care models ( p<0.002 ) . Based on visit rates , the pharmacist-managed service averted $ 141,277.34 in hospitalization costs and $ 10,183.76 in emergency department visit costs versus the nurse-managed service and $ 95,579.08 in hospitalization costs and $ 5511.21 in emergency department costs compared with the usual care model . CONCLUSION Pharmacist-managed anticoagulation management services reduced the rates of anticoagulation-related emergency department visits and hospitalizations , with significant financial impact . Based on results of this study , a collaborative clinic using pharmacists , nurses , and physicians may be the optimal structure for an anticoagulation management service , with these results verified in future prospect i ve r and omized studies OBJECTIVES To investigate association between quality of life ( QoL ) and International Normalized Ratio ( INR ) control , with the secondary aim of assessing QoL using generic and anticoagulation-specific , the Short Form Health Survey ( SF-12 ) and the Duke Anticoagulation Satisfaction Scale ( DASS ) . STUDY DESIGN This study assessed anticoagulation related QoL at three time intervals in two groups of patients on long-term warfarin therapy .  METHODS Data of 326 r and omly sample d patients ( 163 patients each in DASS and SF-12 groups ) who had been on warfarin therapy for at least one year at anticoagulation clinics were analysed . QoL was assessed at three time intervals : at the start , six months and one year of warfarin therapy . Indications and target INR ranges and subjects INR values were recorded . Time in Therapeutic Range ( TTR ) was estimated for four subject subgroups , based on target ranges of INR for clustered indications . RESULTS Of the total , 43 % of the subjects were aged between 50 and 64 years , and 51 % were female . DASS assessed subjects older than 35 years perceived significant decrease in overall mean scores of anticoagulation related QoL , whilst all SF-12 assessed subjects perceived an increase in QoL. The mean percentage days in range for all INR target range subgroups did not exceed more than 60 % but there was only a weak correlation ( Rs = 0.104 , P > 0.05 ) between INR control and overall QoL. CONCLUSION Malaysian urban out patients on warfarin treatment longer than one year report a significant overall decrease in QoL , as measured using a vali date d condition-specific instrument . These patients appeared to adapt well to lifestyle limitations imposed by long-term anticoagulation 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 ) BACKGROUND Increased frequency of prothrombin time testing , facilitated by patient self-testing ( PST ) of the International Normalized Ratio ( INR ) can improve the clinical outcomes of oral anticoagulation therapy ( OAT ) . However , oversight of this type of management is often difficult and time-consuming for healthcare professionals . This study reports the first r and omized controlled trial of an automated direct-to-patient expert system , enabling remote and effective management of patients on OAT . METHODS A prospect i ve , r and omized controlled cross-over study was performed to test the hypothesis that supervised PST using an internet-based , direct-to-patient expert system could provide improved anticoagulation control as compared with that provided by an anticoagulation management service ( AMS ) . During the 6 months of supervised PST , patients measured their INR at home using a portable meter and entered this result , along with other information , onto the internet web page . Patients received instant feedback from the system as to what dose to take and when the next test was due . During the routine care arm , patients attended the AMS at least every 4 - 6 weeks and were dosed by the anticoagulation pharmacist or physician . The primary outcome variable was the difference in the time in therapeutic range ( TTR ) between both arms . RESULTS One hundred and sixty-two patients were enrolled ( male 61.6 % , mean age 58.7 years ) , and 132 patients ( 81.5 % ) completed both arms .  TTR was significantly higher during PST management than during AMS management ( median TTR 74 % vs 58.6 % ; z=5.67 , P < 0.001 ) . CONCLUSIONS The use of an internet-based , direct-to-patient expert system for the management of PST improves the control of OAT as compared with AMS management BACKGROUND AND AIM Several factors are associated with an increased risk of recurrent venous thromboembolism ( VTE ) .  The aim of the study was to investigate whether the quality of oral anticoagulation therapy ( OAT ) is a long-term risk factor for recurrence of VTE after OAT interruption . METHODS AND RESULTS A total of 297 patients ( 170 males ) with a recent acute unprovoked VTE episode were prospect ively monitored during  OAT  in our anticoagulation clinic  and followed up for 21 months after OAT interruption . Recurrent events were recorded in 42 subjects for 493 years of follow-up [ 14.1 % of patients ; 8.5 % patient-years ( pt-y ) ] after OAT withdrawal . The rate of recurrence was not correlated to OAT duration . Subjects experiencing recurrence after OAT interruption had spent significantly more time at markedly subtherapeutic international normalized ratio ( INR ) levels ( < 1.5 ) and less time within the therapeutic range ( 2.0 - 3.0 INR ) during OAT . Relative risk ( RR ) of recurrence was significantly higher [ 2.77 ( 95 % confidence interval ( CI ) 1.49 - 5.18 ; P = 0.001 ) and 2.70 ( 95 % CI 1.39 - 5.25 ; P = 0.003 ) at univariate and multivariate analysis , respectively ] in those who spent more time ( upper quintile ) at INR values < 1.5 , being especially evident in the first 90 days of OAT . RR was significantly higher at univariate [ 2.05 ( 95 % CI 1.07 - 3.96 ; P = 0.031 ) ] but not at multivariate [ 1.98 ( 95 % CI 0.98 - 4.0 ; P = 0.056 ) ] analysis when the entire OAT period was considered . Subjects in the upper quintile of time spent at INR values < 1.5 had significantly higher D-dimer values when OAT was stopped and after 3 months . CONCLUSIONS The amount of time that subjects with an acute unprovoked VTE event spend at near-normal INR values ( < 1.5 ) during the first 3 months of treatment is associated with higher D-dimer values measured during OAT and after its interruption and is a significant risk factor for late VTE recurrence 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 . OBJECTIVES To determine the effect of patient characteristics and of specific guidelines that were developed for managing warfarin therapy in older adults and included in an in-house computer program on anticoagulation quality . DESIGN Thirteen-month observational study . SETTING Acute care , extended care , and rehabilitation geriatric wards of a teaching hospital in Paris , France . PARTICIPANTS Hospitalized patients ( N=307 , mean age 86.1 + /- 6.1 ) treated with warfarin with a therapeutic international normalized ratio range of 2.0 to 3.0 . INTERVENTION Patients were assigned according to care unit to the computer-generated dosing group ( CGD ) or the st and ard management group ( SM ; usual physician-based care ) . MEASUREMENTS Relationships between anticoagulation quality criteria and covariates ( age , sex , warfarin indication , treatment phase , follow-up duration , model of care ) . RESULTS According to multivariate analysis , only model of care and follow-up duration independently influenced anticoagulation control ; the proportion of time within therapeutic INR range 2.0 to 3.0 was significantly greater in the CGD group than in the SM group ( 59 % vs 48 % , P=.004 ) . When a wider INR range was analyzed ( 1.8 - 3.2 ) , the proportion of time within range was 73 % versus 64 % ( P=.006 ) . Use of the computer was associated with fewer days with INRs greater than 3 , a smaller percentage of INRs of 4 or greater , a longer time to the first INR of 4.0 or greater , and a smaller mean number of INRs per month than SM ( all P<.01 ) . CONCLUSION Initiation regimen and long-term rules that have specifically been developed and included in a computerized dosage program improve quality of anticoagulation in elderly in patients , allowing them to benefit from a quality of care as high as that of younger ambulatory patients Background —The Early Self Controlled Anticoagulation Trial ( ESCAT I ) showed that anticoagulation self-management after mechanical heart valve replacement decreased complication rates by maintaining INR levels closer to the target range than International Normalized Ratio ( INR ) home doctor management . The therapeutic range for the INR in that study was between 2.5 and 4.5 for all positions of prosthetic valves . ESCAT II should find out whether lowering the target range for INR self-management would further reduce complication rates . Methods —ESCAT II is a prospect i ve controlled r and omized ( valves : St. Jude Medical St and ard or Medtronic Hall , treatment : conventional/low-dose ) multicenter study with 3 300 patients . We present interim results of 1 818 patients . 908 were categorized as having a low-dose target range , which was INR 1.8 to 2.8 for prostheses in aortic position and 2.5 to 3.5 for prostheses in mitral position or in combined valve replacement . The control group ( conventional group ) with 910 patients aim ed at an INR of 2.5 to 4.5 for all valve positions . Results —In the conventional group , 74 % of INR values measured were within the therapeutic range . In the low-dose group , 72 % of the values were within that range . The linearized thromboembolism rate ( % per patient year ) was 0.21 % for both groups . The bleeding complication rate was 0.56 % in the low-dose regimen group versus 0.91 % in the conventional group . Conclusions —Early onset INR self-management under oral anticoagulation after mechanical heart valve replacement enables patients to keep within a lower and smaller INR target range . The reduced anticoagulation level result ed in fewer grade III bleeding complications without increasing thromboembolic event rates OBJECTIVE Self-management of oral anticoagulant therapy ( OAT ) has shown good results on a short-term basis . We hypothesize that self-management of OAT provides a better quality of treatment than conventional management also on a long-term basis . The aim of this study was to assess the quality of self-management of OAT  in patients with mechanical heart valve prostheses on a 4-year perspective in a prospect i ve , non-r and omized study . DESIGN Twenty-four patients with mechanical heart valves and on self-managed OAT  were followed for up to 4 years . A matched , retrospectively selected group of  conventionally managed heart valve patients ( control group )  was used as reference . RESULTS The median observation time was 1175 days ( range : 174 - 1428 days ) . The self-managed patients were within therapeutic INR target range for a mean of 78.0 % ( range : 36.1%-93.9 % ) of the time compared with 61.0 % ( range 37.4%-2.9 % ) for the control group . CONCLUSION Self-management of OAT is a feasible and safe concept for selected patients with mechanical heart valve prostheses also on a long-term basis . It provides at least as good and most likely better quality of anticoagulant therapy than conventional management assessed by time within the therapeutic International Normalized Ratio ( INR ) target range Severe thromboembolic and hemorrhagic complications following mechanical heart valve replacement essentially occur due to intense oral anticoagulation and fluctuating individual INR values around the target range . INR self-management can help to minimize these fluctuations . Beginning this therapeutic control immediately after mechanical heart valve replacement further reduces anticoagulant-induced complications . Included in the study were 1200 patients . The quality of oral anticoagulation  also improved through INR self-management . Over an observation period of two years , nearly 80 % of INR values recorded by the patients themselves were within the target therapeutic range of 2.5 - 4.5 . This corresponds to a high significance of p < = 0.001 in favor of  INR self-management . Only 64.9 % of INR values monitored by family practitioners were within the desired range . The results differed slightly in quality between patient groups with different levels of training ( comprehensive , secondary modern , grammar with or without university ) . Of patients trained in  INR self-management  following mechanical heart valve replacement  , 91.7 % maintained their competence in this technique throughout the entire follow-up period . Only 8.3 % of those trained immediately after surgery were unable to continue with INR self-management 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 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
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 .
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 .