Element card for assessment element F0018 in HTA Core Model Application for Screening Technologies 1.0 application

F. Ethical analysis

Questions about effectiveness and accuracy

Are the accuracy measures decided and balanced on a transparent and acceptable way?


Are the accuracy measures (sensitivity and specificity) chosen so that they accord with the purpose of the HTA? How and by whom are cut-off values decided? How and by whom has balancing sensitivity and specificity been done? This should be done considering the moral value of different results – for example, high specificity is required if false positives have serious consequences.

Other domains of analysis: accuracy, safety, effectiveness. Expert opinion