Element card for assessment element D0029 in HTA Core Model Application for Screening Technologies 1.0 application

D. Clinical Effectiveness

Benefit-harm balance

What are the overall benefits and harms of the technology in health outcomes?


This question integrates all benefits and harms concerning mortality, morbidity, QoL and further patient relevant outcomes, also considering the amount of false positive and false negative test results. It is the central question about clinical effectiveness. There is no common quantitative summary measure, and even qualitatively a balanced and meaningful presentation is difficult to reach. In diagnostic technologies one should consider also the benefits and harms of subsequent diagnostic testing and treatments in patients with true positive test result in a prior diagnostic or screening test. For true positive cases there is a benefit-harm balance, because diagnostics and treatment can harm. Consequences for true negative cases are identical with the possible harms of the screening test (see D0004, D0008).The integration of some assessment elements of other domains into the benefit-harm-balance is essential and differs between the core model applications. For screening the frequency of disease and coverage of screening are essential AES

RCT, CT, observational studies, modelling studies


A0007, A0011, C0001, C0003, C0004, C0005, C0006, C0007, C0061, Ethical Domain