A meta-analysis and metaregression analysis of recent data on oral anticoagulation (INR) management using portable prothrombin systems Monica Cepoiu-Martin, Sarah Rose , Diane Lorenzetti, Ken Fyie,
Download ReportTranscript A meta-analysis and metaregression analysis of recent data on oral anticoagulation (INR) management using portable prothrombin systems Monica Cepoiu-Martin, Sarah Rose , Diane Lorenzetti, Ken Fyie,
Slide 1
A meta-analysis and metaregression analysis of recent
data on oral anticoagulation
(INR) management using
portable prothrombin
systems
Monica Cepoiu-Martin, Sarah Rose , Diane Lorenzetti,
Ken Fyie, Tom Noseworthy, Lloyd Sutherland
University of Calgary
Centre for Health and Policy Studies (CHAPS)
Slide 2
Supported by a financial contribution from
Albert Health Services through Alberta
Health Technologies Decision Process: the
Alberta model for technology assessment
and policy analysis.
ACKNOWLEDGMENTS
Slide 3
The views expressed herein do not
necessarily represent the official policy of
Alberta Health Services.
DISCLAMER
Slide 4
PPTS PORTABLE PROTHROMBIN SYSTEMS
INR
INTERNATIONAL NORMALIZED RATIO
OAT ORAL ANTICOAGULATION THERAPY
RCTs RANDOMIZED CONTROLLED TRIALS
OR
ODDS RATIO
SMD STANDARDIZED MEAN DIFFERENCE
ABBREVIATIONS
Slide 5
Long-term OAT is indicated in patients
suffering from clotting disorders.
The most widely used agents for OAT are
vitamin K antagonists.
Clotting or hemorrhages are life
threatening complications of inadequate
OAT.
ORAL ANTICOAGULATION
Slide 6
The prothrombin time, expresses as INR,
is the best indicator of the intensity of
anticoagulation.
Generally, the INR reflecting optimal
anticoagulation is between 2 and 3.
INR monitoring and OAT doseadjustments have to be performed
regularly.
INR MONITORING
Slide 7
The current gold-standard method for
monitoring the INR is laboratory testing
of blood obtained by venipuncture.
Disadvantages:
Results are not available on the spot
Patients have to travel regularly
Costly
USUAL CARE
Slide 8
PPTS measure INR outside the laboratory
setting.
Advantages:
Results are available in 3 minutes
Venipuncture is not necessary
Self-testing and self-management are
possible
NEW TECHNOLOGY
Slide 9
What is the effectiveness and safety of
PPTS compared to usual care?
What are the factors that may increase or
decrease the effectiveness of PPTS in
monitoring oral anticoagulation?
RESEARCH QUESTIONS
Slide 10
Studies included: 22 RCTs (24 papers)
Publication date: 1989-2009
Sources:
Electronic databases: MEDLINE, Cochrane
Library, EMBASE, HTA Database –
University of York, DARE.
Gray literature
Reference lists
LITERATURE SEARCH
Slide 11
Selection criteria:
Patients on OAT for at least 3 months
PPTS testing vs usual care
Outcomes reported:
% time in INR range
% INR measurements in range
Rates of major or minor hemorrhage
Rates of major and minor thromboembolic
events
SELECTION OF THE LITERATURE
Slide 12
Qualitative analysis
CONSORT statement checklist
Quantitative analysis
Pooled standardized mean differences
Summary OR
Chi-square heterogeneity test
Meta-regression analysis
Statistical program: STATA version 9.0
DATA ANALYSIS
Slide 13
Type of intervention: PPTS patient selftesting, PPTS patient self-management
and POC testing
OAT drug
Patient education
Indications for OAT
Age of the sample
Gender of the sample
HETEROGENEITY VARIABLES
Slide 14
High variability in patient selection
criteria, follow-up duration, amount of
education for control patients
Variability in the quality of reporting
Lack of consistency in defining and
reporting of clinical outcomes and adverse
events
QUALITATIVE ANALYSIS
Slide 15
Intervention (PPTS testing) versus Control (usual care)
Outcomes
Pooled
SMD
95% CI
Mean % time in INR range
0.156*
0.032 – 0.280
Mean % INR measurements in range
0.317*
0.190 – 0.444
Pooled OR
95% CI
Major hemorrhagic events
0.677*
0.460 – 0.995
Major thromboembolic events
0.526*
0.377 – 0.733
Adverse events
*Statistically significant (p<0.05)
META-ANALYSIS
Slide 16
Age of the sample: studies that included
only elderly patients reported better
clinical outcomes.
Oral anticoagulation management:
studies that used self-testing or selfmanagement in the intervention group
reported better clinical outcomes.
META-REGRESSION ANALYSIS
Slide 17
Great variability in methods between RCTs
Relatively low quality of RCTs
Patients included in the studies reviewed
were highly selected
Difficult to define meaningful clinical
outcomes
LIMITATIONS
Slide 18
PPTS testing of INR is at least as effective
as the usual care of patients on OAT.
The incidence of adverse events seems to
be lower in PPTS testing patients.
More research is necessary to determine
the characteristics of the patients that
would benefit the most from PPTS testing.
CONCLUSIONS
Slide 19
THANK YOU!
A meta-analysis and metaregression analysis of recent
data on oral anticoagulation
(INR) management using
portable prothrombin
systems
Monica Cepoiu-Martin, Sarah Rose , Diane Lorenzetti,
Ken Fyie, Tom Noseworthy, Lloyd Sutherland
University of Calgary
Centre for Health and Policy Studies (CHAPS)
Slide 2
Supported by a financial contribution from
Albert Health Services through Alberta
Health Technologies Decision Process: the
Alberta model for technology assessment
and policy analysis.
ACKNOWLEDGMENTS
Slide 3
The views expressed herein do not
necessarily represent the official policy of
Alberta Health Services.
DISCLAMER
Slide 4
PPTS PORTABLE PROTHROMBIN SYSTEMS
INR
INTERNATIONAL NORMALIZED RATIO
OAT ORAL ANTICOAGULATION THERAPY
RCTs RANDOMIZED CONTROLLED TRIALS
OR
ODDS RATIO
SMD STANDARDIZED MEAN DIFFERENCE
ABBREVIATIONS
Slide 5
Long-term OAT is indicated in patients
suffering from clotting disorders.
The most widely used agents for OAT are
vitamin K antagonists.
Clotting or hemorrhages are life
threatening complications of inadequate
OAT.
ORAL ANTICOAGULATION
Slide 6
The prothrombin time, expresses as INR,
is the best indicator of the intensity of
anticoagulation.
Generally, the INR reflecting optimal
anticoagulation is between 2 and 3.
INR monitoring and OAT doseadjustments have to be performed
regularly.
INR MONITORING
Slide 7
The current gold-standard method for
monitoring the INR is laboratory testing
of blood obtained by venipuncture.
Disadvantages:
Results are not available on the spot
Patients have to travel regularly
Costly
USUAL CARE
Slide 8
PPTS measure INR outside the laboratory
setting.
Advantages:
Results are available in 3 minutes
Venipuncture is not necessary
Self-testing and self-management are
possible
NEW TECHNOLOGY
Slide 9
What is the effectiveness and safety of
PPTS compared to usual care?
What are the factors that may increase or
decrease the effectiveness of PPTS in
monitoring oral anticoagulation?
RESEARCH QUESTIONS
Slide 10
Studies included: 22 RCTs (24 papers)
Publication date: 1989-2009
Sources:
Electronic databases: MEDLINE, Cochrane
Library, EMBASE, HTA Database –
University of York, DARE.
Gray literature
Reference lists
LITERATURE SEARCH
Slide 11
Selection criteria:
Patients on OAT for at least 3 months
PPTS testing vs usual care
Outcomes reported:
% time in INR range
% INR measurements in range
Rates of major or minor hemorrhage
Rates of major and minor thromboembolic
events
SELECTION OF THE LITERATURE
Slide 12
Qualitative analysis
CONSORT statement checklist
Quantitative analysis
Pooled standardized mean differences
Summary OR
Chi-square heterogeneity test
Meta-regression analysis
Statistical program: STATA version 9.0
DATA ANALYSIS
Slide 13
Type of intervention: PPTS patient selftesting, PPTS patient self-management
and POC testing
OAT drug
Patient education
Indications for OAT
Age of the sample
Gender of the sample
HETEROGENEITY VARIABLES
Slide 14
High variability in patient selection
criteria, follow-up duration, amount of
education for control patients
Variability in the quality of reporting
Lack of consistency in defining and
reporting of clinical outcomes and adverse
events
QUALITATIVE ANALYSIS
Slide 15
Intervention (PPTS testing) versus Control (usual care)
Outcomes
Pooled
SMD
95% CI
Mean % time in INR range
0.156*
0.032 – 0.280
Mean % INR measurements in range
0.317*
0.190 – 0.444
Pooled OR
95% CI
Major hemorrhagic events
0.677*
0.460 – 0.995
Major thromboembolic events
0.526*
0.377 – 0.733
Adverse events
*Statistically significant (p<0.05)
META-ANALYSIS
Slide 16
Age of the sample: studies that included
only elderly patients reported better
clinical outcomes.
Oral anticoagulation management:
studies that used self-testing or selfmanagement in the intervention group
reported better clinical outcomes.
META-REGRESSION ANALYSIS
Slide 17
Great variability in methods between RCTs
Relatively low quality of RCTs
Patients included in the studies reviewed
were highly selected
Difficult to define meaningful clinical
outcomes
LIMITATIONS
Slide 18
PPTS testing of INR is at least as effective
as the usual care of patients on OAT.
The incidence of adverse events seems to
be lower in PPTS testing patients.
More research is necessary to determine
the characteristics of the patients that
would benefit the most from PPTS testing.
CONCLUSIONS
Slide 19
THANK YOU!