A randomized trial comparing INR monitoring devices in patients with anticoagulation self-management: evaluation of a novel error-grid approach
| Autor: | U. Didjurgeit, Roland Hansen, Thomas Kaiser, Lars G. Hemkens, Peter T. Sawicki, Stephan Hartschen, Kristian M. Hilden, Ralf Bender |
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| Rok vydání: | 2007 |
| Předmět: |
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medicine.medical_specialty MEDLINE Administration Oral law.invention Randomized controlled trial Predictive Value of Tests law INR self-monitoring Statistical significance medicine Humans Clinical significance International Normalized Ratio Intensive care medicine Blood Coagulation Aged Point of care Cross-Over Studies business.industry Anticoagulants Reproducibility of Results Equipment Design Hematology Middle Aged Crossover study Self Care Predictive value of tests Female Drug Monitoring Cardiology and Cardiovascular Medicine business |
| Zdroj: | Journal of Thrombosis and Thrombolysis. 26:22-30 |
| ISSN: | 1573-742X 0929-5305 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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