Körtke 2001.

Study characteristics
Methods	Single centre, randomised controlled trial.
Participants	Participant (n = 600) were adults (mean age 63 years) receiving life long‐term oral anticoagulation after mechanical heart valve replacement. The study was based in Ruhr University (Germany).
Interventions	Self‐management vs usual care Participants were randomised to: a) self‐management (n = 305): self‐testing using Coagucheck® system, and self‐adjustment of dosage. In addition, monthly INR measurements were reviewed by the anticoagulation clinic. b) control (n = 295): outpatient cardiologic check up and coagulation controls every 6 months. It is unclear if these participants adjusted their anticoagulation dosage themselves.
Outcomes	Primary and secondary outcomes were not specified. Data were reported for: Percentage of INR within therapeutic range; haemorrhagic events; thromboembolic events.
Trial identification	ESCAT
Study duration	≤ 51 months.
Oral anticoagulant used	Phenprocoumon
Notes	No details about training. It is unclear if participants in the control group adjusted their own anticoagulation dosages or whether this was done by clinic or study staff.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomisation sequence was generated using a standard randomisation list
Allocation concealment (selection bias)	Low risk	Opaque randomisation envelopes were used
Intention to treat analysis	High risk	ITT analysis was not performed.
Reporting of losses of follow‐up	Unclear risk	90/600 (15%) of participants were lost to follow‐up; reasons were not reported
Blinding	Unclear risk	Blinding of participants, study staff or medical staff was not reported.