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 .
A prospective controlled trial comparing weekly self-testing and self-dosing with the standard management of patients on stable oral anticoagulation.
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
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 .