• diagnostic research

In his contribution “Misguided efforts and future challenges for research on diagnostic tests”¹ Dr Feinstein has identified major gaps and shortcomings in previous and current diagnostic research. While we fully agree with most of his criticisms, we would like to take issue with him over the role of statistics and mathematical formalisation in diagnostic research. In particular, we would like to emphasise the need and potential of expanding and re-focusing rather than abandoning statistical approaches in diagnostic research.

The traditional concepts of sensitivity and specificity as well as of the “posterior probabilities” have certainly been useful as a methodological framework for structuring efforts to quantify accuracy of diagnostic markers in well defined, very special settings in the past, and they may continue to be useful as such in the future. The major limitation of these concepts does not so much lie in their intrinsic properties, but in the uncritical adoption of these concepts to a wide range of different, usually more complex settings. This misapplication along with some misconceptions outlined below have often been severely misguiding indeed.