Cromheecke 2000.

Study characteristics
Methods	Single centre, randomised, controlled cross‐over trial.
Participants	Participants were 50 consecutive outpatients who were receiving long‐term anticoagulation (mean age 42 years). The study was based in the departments of cardiology and internal medicine of the Academic Medical Centre (Amsterdam, The Netherlands).
Interventions	Self‐management vs usual care The intervention group used home self‐testing using Coaguchek® to self‐monitor prothrombin time and self‐dosing testing performed once a week. The conventional management was done by the anticoagulation clinic. INR testing was also performed in all participants at 1‐2 week intervals by the central laboratory; these results were not made available to participants or managing physicians. After three months patients crossed over the alternative management strategy.
Outcomes	Primary outcome: no. of INR measurements within 0.5 of therapeutic target INR. Secondary outcomes: Percentage time within target INR range; no. participants within target range for 0%‐100% of the time; no. participants who achieved better control of anticoagulation.
Trial identification
Study duration	3 months (followed by cross‐over to alternative intervention group, for a further 3 months. The outcomes used here are those at the end of the first 3 months)
Oral anticoagulant used	Phenprocoumon (35% of participants) or acenocoumarol (65% of participants)
Notes	All patients were educated and trained to self‐manage anticoagulation during a structured educational program of two 2 hours sessions.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Generation of the randomisation sequence was not reported
Allocation concealment (selection bias)	Low risk	Sealed envelopes concealed the allocation.
Intention to treat analysis	High risk	ITT analysis was not performed
Reporting of losses of follow‐up	Low risk	0% lost to follow‐up
Blinding	Low risk	Blinded outcome assessors