Element card for assessment element F0017 in HTA Core Model Application for Medical and Surgical Interventions (2.0) application

F. Ethical analysis

Ethical consequences of the HTA

What are the ethical consequences of the choice of end-points, cut-off values and comparators/controls in the assessment?

Core

Is there a risk that the chosen end points, cut-off values or comparators/controls may give a biased description of the results of the technology?

Clinical effectiveness should ideally be directly related to the disease under treatment. This is not always fully possible so other endpoints may have to be used (e.g. surrogate markers for preventing a life-threatening disease). In addition, the technology may have several aims (e.g. those related to treating the disease and preventing secondary morbidity).

The choice of cut-off values for sensitivity and specificity  should be done considering the moral value of different results – for example, high specificity is required if false positives have serious consequences.

Other domains:, safety, effectiveness. Expert opinion, Stakeholder hearing

Critical
Partial

See methodological description in EFF and SAF

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