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. 2016 Jul 5;2016(7):CD003839. doi: 10.1002/14651858.CD003839.pub3

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).
Outcomes Primary outcome: % time within therapeutic INR range.
Secondary outcomes: adverse events, serious bleeding rates, serious thrombosis rates.
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