Key result
Point of Care INR testing was highly correlated with laboratory testing (r=0.953, p<0.0001) with a mean bias of +0.2 units (95% CI 0.145-0.246) in cardiovascular inpatients receiving warfarin.
Why the study?
Does Point of Care INR testing agree with laboratory INR testing in cardiovascular inpatients receiving warfarin?
Observational (n=50)
Blinded
No
Does Point of Care INR testing agree with laboratory INR testing in cardiovascular inpatients receiving warfarin?
Mean Difference: 0.2 (95% CI 0.145–0.246)
p-value: p=<0.0001
Point of Care INR testing demonstrates close agreement with laboratory testing and is suitable for clinical decision-making in cardiovascular inpatients receiving warfarin.
May support POC INR for warfarin monitoring in CV inpatients; leaves open prospective validation before practice change.
AIMS AND OBJECTIVE: To compare agreement between International Normalised Ratio results from Point of Care testing with laboratory testing for cardiac inpatients receiving warfarin sodium. BACKGROUND: Availability of point of care technology for International Normalised Ratio testing offers considerable benefits to patients and health care staff across a range of context. DESIGN: Prospective comparison study. METHOD: Setting--Four cardiac wards in a regional referral hospital in New South Wales, Australia. Participants--50 cardiovascular inpatients receiving warfarin therapy, including those patients being converted from intravenous heparin sodium. Intervention-Point of Care International Normalised Ratio testing via finger prick using the CoaguChek®XS attended within one hour of laboratory International Normalised Ratio testing. Paired International Normalised Ratio results were compared using spearman rank and Mann-Whitney rank sum. Bland-Altman plots were used to demonstrate agreement. RESULTS: One hundred and seventeen blinded paired tests were carried out, 44 on patients receiving intravenous heparin. Laboratory and Point of Care International Normalised Ratio testing were highly significantly correlated (r = 0.953, p < 0.0001, n = 117). There was close agreement between Point of Care International Normalised Ratio and laboratory International Normalised Ratio results for patients receiving warfarin regardless of whether they were receiving heparin sodium. There was a mean bias of +0.2 units (95% CI 0.145-0.246). The presence of diabetes significantly reduced the difference between paired tests. Bias significantly increased above an International Normalised Ratio of 4.5 units. Ninety-seven per cent of all values fell between 20% limits of agreement after accounting for the mean bias of +0.2 units. CONCLUSION: Results indicated Point of Care International Normalised Ratio testing can be used for clinical decision making for cardiovascular inpatients receiving warfarin. Clinical guidelines need to be developed and tested in appropriate population groups and across different contexts, because of the potential for significant patient benefit. RELEVANCE TO CLINICAL PRACTICE: Point of Care International Normalised Ratio results in time and procedural efficiency, care responsiveness, cost saving, increased patient comfort and reduced handling errors (Pharmacotherapy 22; 2002: 677), as well as the potential for continuity of care.
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Giles et al. (2010) conducted an observational in Cardiovascular inpatients receiving warfarin therapy (n=50). Point of Care International Normalised Ratio testing via CoaguChek XS vs. Laboratory International Normalised Ratio testing was evaluated on Agreement between International Normalised Ratio results from Point of Care testing and laboratory testing (MD 0.2, 95% CI 0.145-0.246, p=<0.0001). Point of Care INR testing was highly correlated with laboratory testing (r=0.953, p<0.0001) with a mean bias of +0.2 units (95% CI 0.145-0.246) in cardiovascular inpatients receiving warfarin.
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