Background Screening and diagnostic tests are used to classify people with and without a disease. Diagnostic accuracy measures are used to evaluate the correctness of a classification in clinical research and practice. Although the correctness of a classification based on a measurand depends on the uncertainty of measurement, there has been limited research on their relation. The objective for this work is to develop an exploratory tool for the relation between diagnostic accuracy measures and measurement uncertainty, as diagnostic accuracy is fundamental to clinical decision making, while measurement uncertainty is critical to quality and risk management in laboratory medicine. Results For this reason, a freely available interactive program has been developed, written in Wolfram Language. The program provides four modules for calculating, optimizing, plotting and comparing various diagnostic accuracy measures and the corresponding risk of diagnostic or screening tests measuring a normally distributed measurand, applied at a single point in time in non-diseased and diseased populations. This is done for differing prevalence of the disease, mean and standard deviation of the measurand, diagnostic threshold, standard measurement uncertainty of the tests and expected loss. The application of the program is illustrated with a case study of glucose measurements in diabetic and non-diabetic populations, that demonstrates the relation between diagnostic accuracy measures and measurement uncertainty. Conclusion The presented interactive program is user-friendly and can be used as a flexible educational and research tool in medical decision making, to explore the relation between diagnostic accuracy measures and measurement uncertainty.
Background: Screening and diagnostic tests are used to classify people with and without a disease. Although diagnostic accuracy measures are used to evaluate the correctness of a classification in clinical research and practice, there has been limited research on their uncertainty. The objective for this work is to develop a tool for calculating the uncertainty of diagnostic accuracy measures, as diagnostic accuracy is fundamental to clinical decision-making.Results: For this reason, a freely available interactive program has been developed in Wolfram Language. The program provides six modules with nine submodules, for calculating and plotting the standard and expanded uncertainty and the resultant confidence intervals of various diagnostic accuracy measures of screening or diagnostic tests, which measure a normally distributed measurand, applied at a single point in time in non-diseased and diseased populations. This is done for differing population sample sizes, mean and standard deviation of the measurand, diagnostic threshold and standard measurement uncertainty of the test.The application of the program is illustrated with a case study of glucose measurements in diabetic and non-diabetic populations, that demonstrates the calculation of the uncertainty of diagnostic accuracy measures.Conclusion: The presented interactive program is user-friendly and can be used as a flexible educational and research tool in medical decision making, to calculate and explore the uncertainty of diagnostic accuracy measures.
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