The weighted generalized estimating equations approach for the evaluation of medical diagnostic test at subunit level

Sensitivity and specificity are common measures used to evaluate the performance of a diagnostic test. A diagnostic test is often administrated at a subunit level, e.g. at the level of vessel, ear or eye of a patient so that the treatment can be targeted at the specific subunit. Therefore, it is essential to evaluate the diagnostic test at the subunit level. Often patients with more negative subunit test results are less likely to receive the gold standard tests than patients with more positive subunit test results. To account for this type of missing data and correlation between subunit test results, we proposed a weighted generalized estimating equations (WGEE) approach to evaluate subunit sensitivities and specificities. A simulation study was conducted to evaluate the performance of the WGEE estimators and the weighted least squares (WLS) estimators (Barnhart and Kosinski, 2003) under a missing at random assumption. The results suggested that WGEE estimator is consistent under various scenarios of percentage of missing data and sample size, while the WLS approach could yield biased estimators due to a misspecified missing data mechanism. We illustrate the methodology with a cardiology example.