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Screening computer‐assisted dosage programs for anticoagulation with warfarin and other vitamin K antagonists: minimum safety requirements for individual programs
Author(s) -
POLLER L.,
ROBERTS C.,
IBRAHIM S.,
KEOWN M.,
AGENO W.,
VAN DEN BESSELAAR A. M. H. P.,
FITZMAURICE D.,
HARENBERG J.,
KITCHEN S.,
LOWE G.,
MOIA M.,
PALARETI G.,
TRIPODI A.,
TURPIE A. G. G.,
JESPERSEN J.
Publication year - 2009
Publication title -
journal of thrombosis and haemostasis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.947
H-Index - 178
eISSN - 1538-7836
pISSN - 1538-7933
DOI - 10.1111/j.1538-7836.2009.03558.x
Subject(s) - warfarin , medicine , vitamin k antagonist , confidence interval , oral anticoagulant , vitamin k , atrial fibrillation
Summary. Based on the results of the previous European Action on Anticoagulation (EAA) multicenter study, a simplified minimum procedure is described for screening the safety and effectiveness of marketed programs for dosage of oral anticoagulant drugs (vitamin K antagonists). The aim was to demonstrate non‐inferiority to the manual dosage at the experienced centers in the EAA study. With the use of a cluster sampling procedure, a minimum number of centers and a minimum total of patients required to establish non‐inferiority were determined. At least four centers, each recruiting 50 patients over a period of 6 months, were shown to be required (excluding the results from the first 3 weeks of treatment). To achieve non‐inferiority, the lower 95% confidence interval of the ‘time in target International Normalized Ratio range’ (TIR) of a marketed program must be above the TIR limit set by the manual dosage group in the EAA study, that is, 57.5%. The simplified procedure proposed, although not an absolute guide to safety, is designed to screen against gross unreliability of a test program, without the need to repeat a massive clinical endpoint study for each and every program.