Skip to main content
. 2016 Jul 5;2016(7):CD003839. doi: 10.1002/14651858.CD003839.pub3

Gardiner 2005.

Study characteristics
Methods Single centre, randomised controlled trial.
Participants Participants (n = 84) were adults aged > 18 (mean 58) years who had received anticoagulation therapy for > 8 months and had a record of good compliance.
The study was based in an anticoagulation clinic in University Hospital (London, UK).
Interventions Self‐monitoring vs usual care
Participants were randomised to:
a) self‐testing (n = 44) using the Coagucheck® monitoring device once per week
b) control (n = 40), receiving usual care by visiting the hospital anticoagulation clinic for testing every 4 weeks.
Outcomes Primary and secondary outcomes were not specified. Data were reported for:
Major and minor bleeding, thromboembolism and mortality, percentage of time within target range, and acceptability.
Trial identification  
Study duration 6 months
Oral anticoagulant used Not reported
Notes The intervention group attended two training sessions.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Randomisation sequence generation was not reported
Allocation concealment (selection bias) Unclear risk Concealment of allocation was not reported
Intention to treat analysis High risk ITT analysis was not performed
Reporting of losses of follow‐up Low risk 15/84 (17.9%) of participants were lost to follow‐up; reasons were reported
Blinding High risk Participants and study staff were not blinded to the intervention