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A randomized trial comparing INR monitoring devices in patients with anticoagulation self-management: evaluation of a novel error-grid approach

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Abstract

Background In addition to the metrological quality of international normalized ratio (INR) monitoring devices used in patients’ self-management of long-term anticoagulation, the effectiveness of self-monitoring with such devices has to be evaluated under real-life conditions with a focus on clinical implications. An approach to evaluate the clinical significance of inaccuracies is the error-grid analysis as already established in self-monitoring of blood glucose. Two anticoagulation monitors were compared in a real-life setting and a novel error-grid instrument for oral anticoagulation has been evaluated. Methods In a randomized crossover study 16 patients performed self-management of anticoagulation using the INRatio® and the CoaguChek S® system. Main outcome measures were clinically relevant INR differences according to established criteria and to the error-grid approach. Results A lower rate of clinically relevant disagreements according to Anderson’s criteria was found with CoaguChek S® than with INRatio® without statistical significance (10.77% vs. 12.90%; P = 0.787). Using the error-grid we found principally consistent results: More measurement pairs with discrepancies of no or low clinical relevance were found with CoaguChek S®, whereas with INRatio® we found more differences with a moderate clinical relevance. A high rate of patients’ satisfaction with both of the point of care devices was found with only marginal differences. Conclusions A principal appropriateness of the investigated point-of-care devices to adequately monitor the INR is shown. The error-grid is useful for comparing monitoring methods with a focus on clinical relevance under real-life conditions beyond assessing the pure metrological quality, but we emphasize that additional trials using this instrument with larger patient populations are needed to detect differences in clinically relevant disagreements.

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Abbreviations

INR:

International normalized ratio

ISI:

International sensitivity index

MAD:

Mean absolute deviation

MRD:

Mean relative deviation

SD:

Standard deviation

SPOG:

Structured teaching and self-management program for patients receiving oral anticoagulation

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Acknowledgements

We would like to thank Ute Sternenberg and Margit Seimel, who together with the principal investigators were responsible for the training and practical and administrative follow-up of the patients. DIeM – Institute for Evidence Based Medicine, Cologne, Germany has received scientific grants from Roche Diagnostics, Mannheim, Germany for development and evaluation of structured programs for self-management of oral anticoagulation. Conflict of Interest Statement: L.G.H., K.M.H., S.H., T.K., U.D., R.H., R.B., and P.T.S. have no conflict of interest.

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Authors and Affiliations

  1. DIeM – Institute for Evidence Based Medicine, Venloer Str. 301–303, 50823, Cologne, Germany

    Lars G. Hemkens, Kristian M. Hilden, Stephan Hartschen & Ulrike Didjurgeit

  2. Institute for Quality and Efficiency in Health Care, Cologne, Germany

    Thomas Kaiser, Ralf Bender & Peter T. Sawicki

  3. Medical Laboratory, Dr. Stein & Partner, St. Vinzenz-Hospital Cologne, Cologne, Germany

    Roland Hansen

Authors
  1. Lars G. Hemkens
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  2. Kristian M. Hilden
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  3. Stephan Hartschen
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  4. Thomas Kaiser
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  5. Ulrike Didjurgeit
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  6. Roland Hansen
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  7. Ralf Bender
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  8. Peter T. Sawicki
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Correspondence to Lars G. Hemkens.

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Hemkens, L.G., Hilden, K.M., Hartschen, S. et al. A randomized trial comparing INR monitoring devices in patients with anticoagulation self-management: evaluation of a novel error-grid approach. J Thromb Thrombolysis 26, 22–30 (2008). https://doi.org/10.1007/s11239-007-0070-4

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  • DOI: https://doi.org/10.1007/s11239-007-0070-4

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