Sawicki 1999.
Study characteristics | ||
Methods | Multicentre, partially blinded, randomised study. | |
Participants | Participants (n = 179) were individuals (mean age 55 years), receiving long term oral anticoagulation. The study was based in 5 referral centres (Germany). | |
Interventions |
Self‐management vs usual care Participants were randomised to a) self‐management (n = 90): home self‐testing and self‐dosing using a Coagucheck® monitor, measuring INR 1‐2 times per week and adjusting their anticoagulant according to their INR values. Participants recorded INR values routinely, recorded the results and anticoagulation dosages in their logbook. b) usual care (n = 89): conventional management via twice monthly clinic visits for INR testing with dosage adjustment advised by the general practitioner. |
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Outcomes | Primary and secondary outcomes were not specified. Data were reported for: squared INR deviation from the mean of the individual INR target range; percentage participants with INR within target range at 3 months and at 6 months; major bleeding; minor bleeding; thromboembolic events; treatment satisfaction. | |
Trial identification | ||
Study duration | 6 months | |
Oral anticoagulant used | Phenprocoumon | |
Notes | Participants randomised to the self‐management group received a structured educational program comprising three consecutive weekly teaching sessions of 60‐90 minutes. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer program. |
Allocation concealment (selection bias) | Unclear risk | Possibly adequate or not used. |
Intention to treat analysis | Low risk | ITT analysis was used |
Reporting of losses of follow‐up | Low risk | 14/179 (7.8%) of participants were lost to follow‐up; reasons not reported |
Blinding | Low risk | Participants were not blinded to the intervention; data collectors were blinded. |