Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz
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Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz · Mar 2015
[Health-related quality of life: a pivotal endpoint in benefit assessment of medical procedures].
According to German law, health-related quality of life is a relevant criterion in the early assessment of the benefits of drug treatment. In spite of its regulatory importance, the role of quality of life assessment in quantifying the additional benefits of novel vs standard treatments is not yet clear. ⋯ In spite of the acceptance of quality of life measures and their inclusion in the dossiers, they have rarely been the basis for the declaration of additional benefits. This reluctance does not stem from the availability of instruments, but results from problems in their selection, the design and conduct of the study, data interpretation, together with shortcomings regarding the statistical and clinical significance of quality of life data.