The Clinical Relevance of Methods for Handling Inconclusive Medical Test Results: Quantification of Uncertainty in Medical Decision-Making and Screening.

Background: although the existence of inconclusive medical test results or bio-markers is widely recognized, there are indications that this inherent diagnostic uncertainty is sometimes ignored. This paper discusses three methods for defining and determining inconclusive medical test results, which use different definitions and differ in clinical relevance.

Methods: the TG-ROC (two graphs receiver operating characteristics) method is the easiest to use, while the grey zone method and the uncertain interval method require more extensive calculations.

Results: this paper discusses the technical details of the methods, as well as advantages and disadvantages for their clinical use. TG-ROC and the grey zone method can help in the acquisition of high rates of diagnostic certainty, but can exclude large groups. The uncertain interval method can prevent decisions that are the most uncertain, invalid and unreliable, while excluding smaller groups.

Conclusions: the identification of uncertain test scores is relevant, because these scores indicate the need to obtain better information or to await further developments. The methods presented help to determine inconclusive test scores and can help to reduce erroneous decisions. However, further research and development is desirable.