The decision to implement a new medical technology requires that it no
t only increases survival or quality of life, but that it is also econ
omically sound. The unique feature in the assessment of diagnostic tes
ts is that the results of such tests are intermediate outcomes. Both r
andomized controlled clinical trials and decision analysis have an imp
ortant role to play in the assessment of diagnostic tests. Important p
oints to consider when performing a cost-effectiveness study are what
perspective to take; comparing the technology with the next best strat
egy; including both effectiveness and costs; the distinction between d
escribing and valuing the quality of life; intangibles such as the val
ue of information; and the incremental cost-effectiveness ratio.