Wednesday, April 16, 2014

The Go-To Article on Everything that's been Written on Clinical Utility

In the past decade, much has been written about how to define, assess, or benchmark the clinical utility of clinical laboratory tests, like genetic tests.   Clinical utility, as a term, is most familiar in the triad of terms, "analytical validity, clinical validity, clinical utility" which describes three aspects of the information that pertains to diagnostic tests.   Analytical validity means what goes on inside the test tube - we can measure "X" within 2%; and test to test, the precision is plus-minus 1%.  Clinical validity means that "X" correlates with something clinical; for example, high glucose correlates with having diabetes, and in cancer, elevated expression of certain genes correlates with more aggressive tumors.   Clinical utility means that there is clinical value in using the test; something about the test helps us in a credible way with diagnosis or patient management.

Parkinson et al. knock the ball out of the park

A recent issue of the journal Clinical Cancer Research provides a detailed 18 page review of the literature on clinical utility of diagnostic lab tests, written by David Parkinson and 13 coauthors who are a who's who of top names in the laboratory and evidence based medicine fields.   The article is a keynote within a special issue of Clinical Cancer Research devoted to the rapidly growing role of diagnostic tests in the management of cancer.

Here is the opening section of the article:

The March 15, 2014 table of contents for the journal is here  and the pubmed page for Parkinson's article is here.

Update (8/21/2014): For my own article - Frueh & Quinn, 2014 - published in July, 2014 - see here.