Assessing bias, precision, and agreement in method comparison studies.

Recently, a new estimation procedure has been developed to assess bias and precision of a new measurement method, relative to a reference standard. However, the author did not develop confidence bands around the bias and standard deviation curves. Therefore, the goal in this paper is to extend this methodology in several important directions. First, by developing simultaneous confidence bands for the various parameters estimated to allow formal comparisons between different measurement methods. Second, by proposing a new index of agreement. Third, by providing a series of new graphs to help the investigator to assess bias, precision, and agreement between the two measurement methods. The methodology requires repeated measurements on each individual for at least one of the two measurement methods. It works very well to estimate the differential and proportional biases, even with as few as two to three measurements by one of the two methods and only one by the other. The repeated measurements need not come from the reference standard but from either measurement methods. This is a great advantage as it may sometimes be more feasible to gather repeated measurements with the new measurement method.