human
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: 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 ) 
    Output:
    
agent
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 .
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: 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 ) 
    Output:
    