SummaryTo 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 = 0AE005). 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.
Background: There are comparatively few international studies investigating suicide in military veterans and no recent UK studies. We aimed to investigate the rate, timing, and risk factors for suicide in personnel who left the UK Armed Forces (UKAF) over a 22-year period. Methods and findings: We conducted a retrospective cohort study of suicide in personnel who left the regular UKAF between 1996 and 2018 by linking national databases of discharged personnel and suicide deaths. Of the 458,058 individuals who left the UKAF, 1,086 (0.2%) died by suicide. The overall rate of suicide in veterans was not greater than the general population (SMR [95% CI] 94 [88-99]). However, suicide risk was two to four times higher in male and female veterans aged under 25 years than in the same age groups in the general population (age-specific mortality ratios ranging from 160 to 409). Male veterans aged 35 years and older were at reduced risk of suicide (age-specific mortality ratios 47 to 80). Male sex, Army service, discharge between the ages of 16 and 34 years, being untrained on discharge, and length of service under 10 years were associated with increased suicide risk. Factors associated with reduced risk included being married, a higher rank and deployment on combat operations. The rate of contact with specialist NHS mental health services (273/1,086, 25%) was lowest in the youngest age groups (10% for 16-19-year-olds; 23% for 20-24-year-olds). Conclusions: Suicide risk in veterans is not high but there are important differences according to age, with higher risk in young men and women. We found a number of factors which increased the risk of suicide but deployment was associated with reduced risk. Our focus should be on improving and maintaining access to mental health care and social supports for young service leavers, as well as implementing general suicide prevention measures for all veterans.
A system for quality assessment (QA) of the CoaguChek (Roche Diagnostics, Mannheim, Germany) point-of-care testing prothrombin time monitor has been developed by the European Concerted Action on Anticoagulation. Hitherto there has not been an adequate rapid method for CoaguChek QA. Sets of 5 certified international normalized ratio (INR) plasma samples were tested on 539 CoaguChek monitors by experienced staff at 9 Netherlands Thrombosis Centers and results compared with certified INR. A 15% or more deviation has been classified as significant deviation. Overall mean and certified INR values were similar, but 20.3% of participants showed a 15% or more deviation from the certified INR on at least 1 of the 5 QA plasma samples. Statistically significant differences in results with different lots of CoaguChek test strips were found. There is need for large scale QA of CoaguChek monitors. The importance of the 5 CoaguChek certified INR QA plasma samples being tested on a single occasion is demonstrated.
Summary. Background: New antithrombotic drugs for prevention and treatment of thromboembolic disorders in AF that are less demanding on local staff and facilities than warfarin should be welcomed if proved successful. Objectives: The comparative value and possible dangers of substituting the new drug dabigatran as a replacement remain to be established. Its safety and effectiveness must be reviewed and assessed by further study. Methods: Clinical results of the European Action on Anticoagulation (EAA) computer-assisted dosage study and the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) trial have been compared. Results: Clinical events were lower in patients on warfarin in the EAA study compared to patients on both warfarin and dabigatran in the RE-LY study. Conclusion: Evaluations should recognize optimum requirements for safe and effective administration of both types of drug. In the warfarin arm improvements in effectiveness and safety recently introduced (i.e. the PT/INR line and variance growth analysis) should be included as they have been shown to be successful in improved prediction of bleeding and further thromboembolism. The incidence of bleeding with dabigatran, for which there is no antidote, will require evaluation.
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