A Special Inference Problem in Repeated Measures Design-Test of Statistical Hypothesis on Accuracy Root Mean Square-Application to Pulse Oximetry Studies

作者：Ndikintum Nfii K^*; Rao Marepalli^*

来源：Statistics in Biopharmaceutical Research, 2016, 8(1): 60-76.

DOI：10.1080/19466315.2015.1101012

• Simulation.
• Mixed effects models
• Measurement error
• Devices
• Hypothesis testing

The objective of pulse oximetry studies is to demonstrate that paired repeated measurements from a pulse oximeter (SpO(2)) and a co-oximeter (SaO(2)) agree sufficiently with respect to a prespecified agreement score (A(RMS)). The current methods for analyzing pulse oximetry method comparison studies are mostly descriptive. Sample size calculations in the context of a specific test of statistical hypothesis applied to the A(RMS) have been reported. The purpose of this article is to further study the distributional properties of the A(RMS) and recommend a test appropriate to this agreement score. Five tests are considered: Z-Wald test, Z-score test, chi-squared (score) test, chi-squared (Wald) test, and "Exact" test. We propose and evaluate via simulation studies a robust method for testing the hypothesis of the accuracy on a pulse oximeter. Overall, the Z-score test is superior to the other four tests, resulting in estimated alpha-levels that are closest to the nominal alpha-level. The chi-squared (Wald) test is liberal and the "Exact" test is conservative. The chi-squared (Wald) test provides better power compared to the score and Exact tests. The Z-score test is a viable method for assessing the accuracy of pulse oximeters.

• 出版日期2016-1-2