Intermediate outcomes: diagnostic and therapeutic impact.

The conceptual basis for intermediate outcomes has been established, and scientifically sound methods are available for assessment of these short-term outcomes. While modest intermediate outcomes research experience assessing imaging technology has accumulated in the literature, much more remains to be done, for the benefit of both patients and physicians. I would recommend that intermediate outcomes research become more focused on assessment earlier in the diffusion phase of imaging technology development. These studies should be based on traditional diagnostic accuracy studies, but these should be extended to include well-designed, high scientific quality treatment impact studies. Furthermore, such studies need to be multidisciplinary and multiinstitutional/multisite and include patient utility assessment components.