[Benefit assessment of diagnostics - Dealing with incomplete evidence]

Incomplete evidence in diagnostic studies results from missing or too few randomised test-treatment studies or from studies of too low quality. In order to be able to carry out a benefit assessment, it is helpful in the first step to design a hypothetical randomised test-treatment study. In the second step, the linked evidence approach can be used to link the evidence of the individual components of the test-treatment pathway and to assess the potential benefits and risks. In the third step, based on the linked evidence approach, decision analytic models can be used to quantify the benefit-risk ratio. In the case of incomplete evidence, the assessment can thus be made by linking the individual components of the test-treatment pathway, provided that their evidence is sufficient.