Background: The management of oral anticoagulation is fraught with dif
ficulties. This study assessed a new model of anticoagulation manageme
nt regarding the ability, safety, and efficacy of patients to self-mon
itor and self-adjust the dose of their oral anticoagulants guided by a
capillary whole-blood prothrombin time (PT) monitor. Methods: This in
vestigation is a retrospective cohort study of 20 patients compared wi
th 20 matched control patients receiving oral anticoagulation at a ter
tiary medical institution. Results: Study patients monitored their PTs
2153 times during a mean interval of 44.7 months compared with 1608 P
Ts in matched control patients during a mean interval of 42.5 months.
Study patients made an average of 11.5 dosage changes per patient, con
trasted with 22.7 changes per control patient (P<.001). The PTs in stu
dy patients were within the recommended therapeutic range in 88.6% (95
% confidence interval, 87.2 to 89.9) of the determinations compared wi
th 68.0% (95% confidence interval, 65.7 to 70.3, P<.001) of the determ
inations made by the matched control patients. In response to the 2153
PTs, study patients made 67 (3.1%) dosage decisions that were conside
red incorrect based on physician guidelines. None of these changes led
to adverse outcomes. There was no significant difference in complicat
ion rates between the two groups. Conclusions: Results from what is th
e first long-term study of patient self-monitoring of PTs and self-adj
ustment of the warfarin sodium dosage for oral anticoagulation suggest
that patients can successfully measure their own PTs, adjust their ow
n warfarin dosage, and achieve a degree of therapeutic effectiveness a
t least as good, if not better than patients managed in an anti- coagu
lation clinic. Larger, prospective, randomized trials are needed to co
nfirm the efficacy and safety of this new approach to therapy and to a
ssess its cost-effectiveness.