title: A multicentre randomised clinical endpoint study of PARMA 5 computer-assisted oral anticoagulant dosage.
abstract: To meet growing demand for oral anticoagulation worldwide there has been increased dependence on computer-assistance in dosage although the safety and effectiveness of any of the individual computer-assisted dosage programs has not previously been established. This randomised multicentre clinical end-point study assessed a new version of the PARMA 5 program. It compared PARMA 5 safety and effectiveness with manual dosage by experienced medical staff at 19 centres with a known interest in oral anticoagulation. Target recruitment was 8000 patient-years, randomised to medical staff or PARMA-5 assisted dosage. Safety and effectiveness of the PARMA 5 program was compared with manual dosage. A total of 10,421 patients were recruited (15,369 patient-years) in the 5-year study. International normalised ratio (INR) tests numbered 167,791 with manual and 160,078 with PARMA 5 dosage. With parma 5 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 compared with the dosage by experienced medical staff. This study demonstrated the safety and effectiveness of PARMA 5-assisted dosage.
authors.affiliation: EAA Central Facility, Faculty of Life Sciences, University of Manchester, Oxford Road, Manchester, UK. leon.poller@manchester.ac.uk
authors.forename: Leon
authors.initials: L
authors.lastname: Poller
authors.forename: Michelle
authors.initials: M
authors.lastname: Keown
authors.forename: Saied
authors.initials: S
authors.lastname: Ibrahim
authors.forename: Gordon
authors.initials: G
authors.lastname: Lowe
authors.forename: Marco
authors.initials: M
authors.lastname: Moia
authors.forename: Alexander G
authors.initials: AG
authors.lastname: Turpie
authors.forename: Christopher
authors.initials: C
authors.lastname: Roberts
authors.forename: Aton M H P
authors.initials: AM
authors.lastname: van den Besselaar
authors.forename: Felix J M
authors.initials: FJ
authors.lastname: van der Meer
authors.forename: Armando
authors.initials: A
authors.lastname: Tripodi
authors.forename: Gualtiero
authors.initials: G
authors.lastname: Palareti
authors.forename: Jørgen
authors.initials: J
authors.lastname: Jespersen