Abstract

People at risk for blood clots are often treated with anticoagulants, warfarin is such an anticoagulant. The dose's effect is measured by comparing the time for blood to clot to a control time called an INR value. Previous anticoagulant studies have addressed agreement between fingerstick (POC) devices and the standard laboratory, however these studies rely on mathematical formulas as criteria for clinical evaluations, i.e. clinical evaluation vs. precision and bias. Fourteen such criteria were found in the literature. There exists little consistency among these criteria for assessing clinical agreement, furthermore whether these methods of assessing agreement are reasonable estimates of clinical decision-making is unknown and has yet to be validated. One previous study compared actual clinical agreement by having two physicians indicate a dosing decision based on patient history and INR values. This analysis attempts to justify previously used mathematical criteria for clinical agreement. Generalized additive models with smoothing spline estimates were calculated for each of the 14 criteria and compared to the smoothing spline estimate for the method using actual physician decisions (considered the "gold standard"). The area between the criteria method spline and the gold standard method spline served as the comparison, using bootstrapping for statistical inference. Although some of the criteria methods performed better than others, none of them matched the gold standard. This stresses the need for clinical assessment of devices.

Degree

College and Department

Physical and Mathematical Sciences; Statistics

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