Evidence based diagnostics

Abstract
No international consensus exists on the methods for assessing diagnostic tests. Previous recommendations stress that studies of diagnostic tests should match the type of diagnostic question.1 2 Once the specificity and sensitivity of a test have been established, the final question is whether tested patients fare better than similar untested patients. This usually requires a randomised trial. Few tests are currently evaluated in this way. In this paper, we propose an architecture for research into diagnostic tests that parallels the established phases in drug research.