Element card for assessment element D0020 in HTA Core Model Application for Screening Technologies 1.0 application

D. Clinical Effectiveness

Change-in management

Does use of the test lead to improved detection of the condition?


Although the test is reliable, the information it provides does not necessarily affect clinical decision making. If it does not change sufficiently the pre-test probability the added value of the information may be low. E.g there may be routine preoperative lab tests that nobody uses in decision making. Moreover, users´ ability to make a correct diagnosis may depend on their knowledge and ability to interpret the results.

RCT, CT, accuracy studies, before-after studies, interrupted time series, change-in management studies


Organisational domain