Element card for assessment element F0017 in HTA Core Model Application for Screening Technologies 1.0 application

F. Ethical analysis

Questions about effectiveness and accuracy

What are the proper end-points for assessment and how should they be investigated?


The acceptable and feasible endpoints must be carefully considered early in the analysis. The context must be especially considered; some technologies require extensive interpretative skills, and sometimes the consequences will depend on the target population. This is especially true in disorders related to life style. The importance of context relates to what kinds of studies are deemed acceptable. For diagnostic technologies and screening programmes, clinical effectiveness – improved health outcome -should ideally be directly investigated. This is not always possible so other endpoints may have to be used. In addition, screening programmes may have several aims (e.g. screening for hearing disorder in newborn - early institution of therapy and possibility for cochelar implant).

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