Anticoagulation therapy and primary care internal medicine: a nurse practitioner model for combined clinical science.

The anticoagulation clinics at the University of Virginia Health Sciences Center and the University of California at Davis Medical Center are nurse-practitioner-operated, are affiliated with the general medicine clinic, and rely on portable prothrombin time (PT) monitors that use whole blood and provide timely as well as accurate results reported in PT seconds or as the international normalized ratio (INR). On-site PT/INR testing at these clinics simplifies anticoagulation, mandates direct patient contact, and facilitates primary as well as comprehensive care for patients requiring multispecialty services in large tertiary care centers. Encounters are relatively brief, averaging 19 minutes; 72% of the encounter time involves anticoagulation care and 28% involves primary care. Anticoagulation results using portable PT/INR monitors are safe and accurate based on comparisons with results from clinics relying on standard instruments.

Standardizing the prothrombin time. Calibrating coagulation instruments as well as thromboplastin.

Recently, indications for anticoagulation with warfarin have increased, prothrombin time (PT) monitoring at offices and homes has become available, and the international sensitivity index (ISI) has been recognized as a means of adjusting for differences in thromboplastins to standardize warfarin sodium dosing. However, different coagulation instruments may yield differences in PTs even after correcting for the ISI by means of the international normalized ratio (INR) (INR = [PT measured ISI/PT normal]). Because the PTs and INRs from our Anticoagulation Clinic (portable PT monitor, ISI = 2.04, normal PT = 12.0 seconds) differed from the hospital reference laboratory (ISI = 2.01, normal PT = 12.0 seconds) despite nearly identical ISIs and equivalent control or normal PTs, we systematically compared the two systems. During a 3-month period, we studied two groups of 50 consecutive patients who had been receiving a stable dose of warfarin. After a single venipuncture, PTs and INRs were measured independently, and regression lines were calculated. Within each group, the results from the different instruments were not identical, but they were highly correlated. In comparing INRs, the regression lines for the separate and combined groups were as follows: group 1 monitor INR = 0.49 reference INR + 0.81, r = .94; group 2 monitor INR = 0.57 reference INR + 0.86, r = .88; and combined monitor INR = 0.49 reference INR + 0.95, r = .89. Only 82% of the differences for all samples were within 1.0 INR units. We concluded that the instrumentation effect may be clinically meaningful, and coagulation instruments as well as thromboplastins should be calibrated to standardize warfarin therapy.