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). |
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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. |
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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. |
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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 |