Fitzmaurice 2005.
Study characteristics | ||
Methods | Multicentre, randomised controlled trial. | |
Participants | Participants (n = 617) were adults aged > 18 years receiving long‐term anticoagulation therapy at primary care centres within the Midlands Research Consortium (UK). | |
Interventions |
Self‐management vs usual care Participants were randomised to: a) self‐management (n = 337) comprising home self‐testing using Coaguchek® managed anticoagulation for 12 months, testing INR very two weeks (one week after a dose change) and self‐adjusting dosage according to a dosing schedule. b) usual care, comprising anticoagulation management in hospital or practice based anticoagulant clinics (n = 280). |
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Outcomes | Primary outcome: % time within therapeutic INR range. Secondary outcomes: adverse events, serious bleeding rates, serious thrombosis rates. |
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Trial identification | ISRCTN 19313375 | |
Study duration | 12 months | |
Oral anticoagulant used | Warfarin | |
Notes | Intervention participants attended two training sessions. Trained anticoagulation nurses gave participants training at the practice. After the training, participants considered capable of doing self‐management were given home testing equipment Coaguchek® managed anticoagulation for 12 months, testing INR very two weeks (one week after a dose change). Adjusted dosage by using a laminated dosing schedule. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Variable block random allocation |
Allocation concealment (selection bias) | Low risk | Central telephone randomisation |
Intention to treat analysis | Low risk | ITT analysis was performed |
Reporting of losses of follow‐up | Unclear risk | Inadequate report or > 20% losses (41.5% losses to follow‐up) |
Blinding | Low risk | Blinded outcome assessors |