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. 2016 Jul 5;2016(7):CD003839. doi: 10.1002/14651858.CD003839.pub3

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.
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.