Clinicians often need to know if a new method of measurement is equivalent to an established one already in clinical use. This paper reviews the methodology of a method-comparison study to assist the clinician with the conduct and evaluation of such studies. Temperature data from one subject are used to illustrate the procedures. Although one would not make decisions based on the findings from one subject, the large number of paired measurements in the data set permits its use for illustrative purposes. Currently available software eliminates the need for tedious statistical computation, but does not reduce the burden of understanding the concepts underlying a method-comparison study and accurate interpretation of the findings.
KeywordsBias; Clinical Measurement; Method-comparison; Precision; Temperature With the rapid development and adoption of critical care technology, clinicians increasingly need to know if the newest technique is equivalent to that in current use. Such a question can be answered with a method-comparison study. For example, when noninvasive infrared thermometers were introduced, a plethora of studies was published reporting comparisons of body temperature values when measured simultaneously with the infrared thermometer and such established thermal sensors as the pulmonary artery catheter. [1][2][3][4][5] Other examples of method-comparisons include arterial pulse contour versus pulmonary artery thermodilution cardiac output and point-of-care versus laboratory testing of blood glucose levels. [6][7][8] The basic indication for a method-comparison study is the need to determine if two methods for measuring the same thing (e.g., body temperature, cardiac output) do so in an equivalent manner. The clinical question is one of substitution: Can one measure X with either Method A or Method B and get the same results?In this paper the author discusses, and illustrates with two examples, the design, analysis and interpretation of a method-comparison study. The examples use partial data from a published report of in vitro and in vivo testing of multiple methods of measuring core body temperature in a pre-clinical critical care laboratory setting. 9 Clinicians may wish to conduct a method-comparison study before adopting new technology in practice. This paper provides information on how to do so. At the very least, the information should help clinicians interpret the findings of method-comparison studies encountered in the literature.
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Method-Comparison MethodologyA review of terminology precedes discussion of methodology as statistical reporting terms are used inconsistently in the literature. 10 "Accuracy" and "precision" are used often when "bias" and "repeatability" are the properties being assessed. Accuracy is the degree to which an instrument measures the real value of a variable and is assessed by comparing the measurement method with a gold standard that has been calibrated to be highly accurate. In a methodcomparison study, however, the investigator is comparing a l...