Innovation in European healthcare – what can Sweden learn? - LIF

Implementation and use of innovations
in the outpatient sector (SHI)
• Evaluation of diagnostic testing methods
– A special point here is ->
• to list the consequences for the patients of the use of the test in comparison, or in
addition to, the established standard
– Matters relevant to the patient include, for example, demonstrable
therapeutic or prognostically relevant changes in disease stages as a
consequence of the new diagnostic testing method, which can lead to a
change in the therapeutic procedure and thus to a change in the morbidity
or mortality
– This normally requires studies extending beyond diagnostic accuracy
(sensitivity and specificity)
– Patient-relevant outcomes accepted by the Code of the Procedure
(Verfahrensordnung – VerfO) of the G-BA include mortality, morbidity,
quality of life, as well as physical and psychological function. Surrogate
(intermediate) outcomes should be causally related to patient-relevant
outcomes.
63