Azarnoush 2009.

Study characteristics
Methods	Single‐centre, randomised, parallel‐group controlled trial.
Participants	206 adult patients who had undergone valve replacement with a mechanical prosthesis, with or without myocardial revascularisation.
Interventions	Self‐monitoring vs standard monitoring Randomised to standard monitoring of INR at a laboratory including at least one monthly assay at a medical analysis laboratory (n = 103), or self‐testing using either the CoaguChek® system (n = 55) or the INRatio® system (n = 48). Self‐testing was performed weekly, and in addition once monthly INR measurements were carried out at the laboratory on the same day as the self‐measurement. Only the results of the monthly tests for each group were compared. Education relating to VKA therapy was provided, the same to all participants in all allocation groups. The target INR and target range were determined for each participant on the basis of the type of surgery, and according to their risk factors for thromboembolic disease (target ranges were between 2 and 3.5 INR). Aspirin was prescribed to some participants according to risk factors.
Outcomes	Mean time within target range. Clinical adverse events, and serious bleeding.
Trial identification	Clinicaltrials.gov NCT00925197
Study duration	49.0 ± 10.3 weeks
Oral anticoagulant used	Not reported
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Randomisation stated to have been done but no methods reported.
Allocation concealment (selection bias)	Unclear risk	Possibly adequate or not used.
Intention to treat analysis	High risk	ITT not performed.
Reporting of losses of follow‐up	Low risk	7% of participants were lost to follow‐up.
Blinding	Unclear risk	Blinding not reported.