A randomised control trial of patient self-management of oral anticoagulation compared with patient self-testing


Chris Gardiner, Chief Biomedical Scientist, Department of Haematology, University College London Hospitals, 4th Floor, 60 Whitfield Street, London W1T 4EU, UK.
E-mail: chris.gardiner@uchevaluation.co.uk


Several studies suggest that patient self-management (PSM) may improve the quality of oral anticoagulation therapy as measured by time spent within the international normalised ratio (INR) target range. We performed a prospective randomised control trial to determine whether the improvement in quality of treatment afforded by PSM is greater than that achieved by patient self-testing (PST) alone. A total of 104 of 800 eligible patients aged 22–88 years (median = 59·8), attending our hospital anticoagulant clinic and receiving long-term warfarin for >8 months agreed to participate. Patients were randomised to PSM (n = 55) or PST (n = 49). Both groups measured their INR using the CoaguChek S every 2 weeks or more frequently if required, for a period of 6 months. Seventy-seven of 104 (74%) patients completed the study (PSM = 41 and PST = 36). The ‘drop out’ rates for both groups were similar. There was no significant difference between the percentage time in target therapeutic range for PSM (69·9%) and PST (71·8%). Both groups combined showed a significant improvement over the previous 6 months (71·0% vs. 62·5%; P = 0·04). Changes in time within the therapeutic range in individual patients (+5·86) also showed a significant difference. The quality of warfarin control in both PST and PSM may be superior to that achieved by conventional management in a specialised hospital anticoagulation clinic.