Rasmussen 2012.
Study characteristics | ||
Methods | Single‐centre, parallel‐group, randomised controlled study. | |
Participants | Participants were individuals requiring oral anticoagulation therapy (n = 54). | |
Interventions |
Self‐monitoring vs usual care Participants were randomised to self‐testing with computer aided decision making, two different algorithms (computer algorithm group A n = 19, computer algorithm group B n = 18), or to usual care (monitoring and treatment by physicians) (n = 17). |
|
Outcomes | Time to therapeutic range, time in therapeutic range, INR. | |
Trial identification | ||
Study duration | Mean 28 week follow‐up | |
Oral anticoagulant used | Warfarin | |
Notes | Authors reported that there were insufficient data to provide valid measurements of thromboembolic events and severe bleeding. in this study it is difficult to estimate the individual effects of self‐testing and of computer dosage calculation. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation was performed by computer. |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment was not reported. |
Intention to treat analysis | Unclear risk | ITT not reported. |
Reporting of losses of follow‐up | Unclear risk | Losses to follow‐up were not reported. |
Blinding | Low risk | Study investigators were blinded to computer algorithm group A vs group B allocation; statisticians were blinded to allocation. |