TY - JOUR
T1 - Screening computer-assisted dosage programs for anticoagulation with warfarin and other vitamin K antagonists: minimum safety requirements for individual programs
AU - Poller, L
AU - Roberts, C
AU - Ibrahim, S
AU - Keown, M
AU - Ageno, W
AU - Van Den Besselaar, A M H P
AU - Fitzmaurice, D
AU - Harenberg, J
AU - Kitchen, S
AU - Lowe, G
AU - Moia, M
AU - Palareti, G
AU - Tripodi, A
AU - Turpie, A G G
AU - Jespersen, J
AU - Subcommittee on, Control of Anticoagulation of the SSC of the ISTH
N1 - The full text of this report, along with tables and references, is published on the ISTH website at: http://www.isth.org/Publications/OfficialCommunications/Anticoagulation/ScreeningvitaminKantagonists/tabid/293/Default.aspx under “Official Communications”.
PY - 2009/10/1
Y1 - 2009/10/1
N2 - 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.
AB - 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.
U2 - 10.1111/j.1538-7836.2009.03558.x
DO - 10.1111/j.1538-7836.2009.03558.x
M3 - Journal article
C2 - 19624455
SN - 1538-7933
VL - 7
SP - 1736
JO - Journal of Thrombosis and Haemostasis
JF - Journal of Thrombosis and Haemostasis
IS - 10
ER -