Cautionary tales in the clinical interpretation of studies of diagnostic tests

Intern Med J. 2008 Feb;38(2):120-9. doi: 10.1111/j.1445-5994.2007.01436.x. Epub 2007 Jul 23.


The use of investigational tests in making a diagnosis is a core activity of physicians and one that requires an understanding of the accuracy and usefulness of specific tests in discriminating between several diagnostic possibilities. Studies of diagnostic tests are frequently methodologically flawed and their results are often not well understood or applied in clinical practice. This article defines the performance characteristics of diagnostic tests, describes several commonly encountered deficiencies in study design which may invalidate reports of new diagnostic tests, and explains a Bayesian approach to interpreting test results in terms of disease probability.

Publication types

  • Review

MeSH terms

  • Bayes Theorem*
  • Clinical Trials as Topic
  • Data Interpretation, Statistical
  • Diagnostic Tests, Routine / standards*
  • Disease
  • Humans
  • Predictive Value of Tests
  • Research Design*
  • Sensitivity and Specificity