Fitzmaurice 2002.
Study characteristics | ||
Methods | Multicentre, randomised controlled trial. | |
Participants | Participants were ambulatory adults aged > 18 years attending an anticoagulation clinic, receiving anticoagulation therapy for > 6 months, judged as capable of self‐management, and with satisfactory INR control (n = 56). The study was based in six general practices that used the Birmingham model of anticoagulation management (West Midlands, UK). |
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Interventions |
Self‐management vs usual care Participants were randomised to: a) self‐management (n = 30): self‐testing using Coaguchek® device and self‐adjustment of dosing. Testing was performed every 2 weeks or after 1 week following dosage adjustment. b) conventional management (n = 26) in practice clinics. |
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Outcomes | Primary and secondary outcomes were not specified. Data were reported for: percentage time in INR range; adverse events; frequency of testing; costs; quality of life. |
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Trial identification | ||
Study duration | 6 months | |
Oral anticoagulant used | Warfarin | |
Notes | Participants in the intervention group attended two 1‐2 hour duration educational workshops on anticoagulation self‐management. Workshops were based within individual practices, were organised by research staff and attended by practice staff. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated coding |
Allocation concealment (selection bias) | Low risk | Concealment of allocation was not reported, contact with author led to information on appropriate method of concealment |
Intention to treat analysis | High risk | ITT analysis was not performed |
Reporting of losses of follow‐up | Low risk | 7/56 (12.5%) of participants were lost to follow‐up; reasons reported |
Blinding | High risk | Participants and study staff were not blinded to the intervention |