Qualitative assessment of innovations in healthcare provision

Table 2 Description of the steps in diagnostic innovations with examples.

Step	Diagnostic innovation	Example
I	Preliminary data confirm an improvement in the feasibility or the results of diagnostic procedures (likelihood radio) in clinical studies.	Improved tolerance, easier application, or improved result of a diagnostic pro-cedure^a.
II	Diagnostic benefit can be expected under everyday conditions due to the influence of the test result on the strategy of healthcare provision^b.	It will be sufficient if the new diagnostic procedure enables a new therapeutic approach (independent of the success of this therapy).
III	Diagnostic benefit is confirmed under everyday conditions if a patient group can be identified that profits more than other groups from an available therapy.	The diagnostic innovation will be valuable if it enables a new therapy and this new therapy will be effective e.g. it improves QoL.

^aUncontested improvement in diagnosis does not guarantee improvement in treatment results. The quality of healthcare provision can be lowered by a growing gap between diagnostic and therapeutic possibilities. For this reason, isolated diagnostic successes are evaluated with caution. ^bInfluence on the strategy of healthcare provision means that the test result either influences the further diagnostic strategy or crosses the threshold from diagnosis to therapy. Influence on diagnostic strategy is confirmed if a positive test result leads to different diagnostic procedures than a negative test result.

ISSN: 1472-6963