Risultati finali
This has been the largest controlled clinical study of oral anticoagulation ever performed and by far the largest randomised.
(1) The two programs (DAWN and PARMA 5) INR tests numbered 193,890 with manual and 193,424 with computer dosage.
(2) Clinical events with computer-dosage were lower overall.
(3) In the 3209 patients with deep vein thrombosis/pulmonary embolism, they were significantly reduced (p=0.001).
(4) Time in target international normalised ratio (INR) range was also significantly improved by computer assistance compared with medical staff dosage at the majority of centres (p<0"01).
(5) Cost-Effectiveness Analysis. The mean dosing time for computer dosing was 94 seconds compared with 149 seconds for manual dosing. Including the cost of the software in the computer dosing arm, the mean dosing costs per patient visit was £2.35 (¬3.3) for computer dosing compared with £3.12 (¬4.3) for manual dosing.
(6) New PARMA 5 computer-assisted anticoagulant dosage randomised trial. 10,421 patients were recruited (15,369 patient-years). There was overall a non-significant reduction in clinical events but in the 2542 patients with deep vein thrombosis/pulmonary embolism, clinical events were significantly reduced (p=0.005). Success in achieving "time in target INR range" was also significantly greater with PARMA 5.
(7) ISI Calibrations of Local Test Systems. Calibration results produced high ISI values with rabbit reagents. No INR correction was necessary with Human Reagents and Bovine Combined.
(8) External Quality Control of Local Prothrombin Time Test Systems. The value of QC exercises has been shown by the improvement in observed INR compared to reference values over the series.
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