Sunderji 2004.
Study characteristics | ||
Methods | Single centre, randomised controlled trial. | |
Participants | Participants (n = 139) were adults aged > 18 (mean 60) years, receiving warfarin for at least one month before randomisation and requiring anticoagulation for at least the subsequent year, and competent to manage their own anticoagulation therapy. Exclusion criteria included: known hypercoagulable disorder, mental incompetence, a language barrier or an inability to attend training sessions. Based in a tertiary care setting or by referral as an outpatient at the University of British Colombia (Canada). |
|
Interventions |
Self‐management vs usual care Participants were randomised to: a) self‐management (n = 69): home self‐testing using Protime micro coagulation system and self‐dosing determining the appropriate dose of oral anticoagulant and the time of the next INR test using a nomogram, recording INR results and warfarin doses in a pocket calendar. b) usual care (n = 70): conventional care by primary care physician. |
|
Outcomes | Primary outcomes: proportion of INRs within target range; error rate in warfarin dosage adjustments. Secondary outcomes: concordance between self‐monitored values and laboratory INR measures; patient satisfaction; major thromboembolic events; major bleeding events. |
|
Trial identification | ||
Study duration | Up to 8 months | |
Oral anticoagulant used | Warfarin | |
Notes | Participants in the self‐management group were trained by a pharmacist in a 2‐3 session, then required at a second pharmacist appointment to demonstrate competency in self‐testing and self‐dosing. In a first 2‐yo 3‐hour visit participants received education from a pharmacist. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated randomisation code. |
Allocation concealment (selection bias) | Low risk | Randomisation code concealed. |
Intention to treat analysis | Low risk | ITT analysis was used. |
Reporting of losses of follow‐up | Low risk | 10% of participants were lost to follow‐up; reasons reported |
Blinding | Unclear risk | Participants were not blinded to intervention; it was not reported if study or medical staff were blinded to the intervention |